149
Practical Guide on Fast-Tracking the Supply of Disinfectants during the COVID-19 Pandemic under the EU Biocides Rules Appendix 1 Overview of national measures to make disinfectants available on the EU market Index Austria......................................................................................................................................................................................................................... 2 Belgium ....................................................................................................................................................................................................................... 2 Bulgaria..................................................................................................................................................................................................................... 23 Croatia ...................................................................................................................................................................................................................... 24 Cyprus ....................................................................................................................................................................................................................... 25 Czech Republic ......................................................................................................................................................................................................... 26 Denmark ................................................................................................................................................................................................................... 27 Estonia....................................................................................................................................................................................................................... 31 Finland ...................................................................................................................................................................................................................... 32 France........................................................................................................................................................................................................................ 32 Germany ................................................................................................................................................................................................................... 33 Greece........................................................................................................................................................................................................................ 35 Hungary .................................................................................................................................................................................................................... 36 Ireland ....................................................................................................................................................................................................................... 36 Italy............................................................................................................................................................................................................................ 37 Latvia ...................................................................................................................................................................................................................... 106 Lithuania................................................................................................................................................................................................................. 106 Luxembourg ........................................................................................................................................................................................................... 107 Malta ....................................................................................................................................................................................................................... 110 Netherlands ............................................................................................................................................................................................................. 113 Poland...................................................................................................................................................................................................................... 116 Portugal ................................................................................................................................................................................................................... 117 Romania .................................................................................................................................................................................................................. 118 Slovak Republic...................................................................................................................................................................................................... 119 Slovenia ................................................................................................................................................................................................................... 132 Spain ........................................................................................................................................................................................................................ 134 Sweden .................................................................................................................................................................................................................... 139 United Kingdom ..................................................................................................................................................................................................... 141 Iceland (EEA) ......................................................................................................................................................................................................... 146 Liechtenstein (EEA) ............................................................................................................................................................................................... 146 Norway (EEA) ........................................................................................................................................................................................................ 146 Switzerland(EFTA) ................................................................................................................................................................................................ 147 Montenegro (Candidate) ....................................................................................................................................................................................... 148 Turkey (Candidate) ............................................................................................................................................................................................... 148 LEGAL NOTICE: This practical guide is made available by the Cross-Industry Alliance on COVID-19, EGAL NOTICE: This practical guide is made available by the Cross- Industry Alliance on COVID-19, an initiative of A.I.S.E., Biocides for Europe Biocides for Europe (formerly known as EBPF), a Sector Group of Cefic and FECC with voluntary contributions from Fieldfisher, Steptoe & Johnson, and CEHTRA. It takes the Practical Guides developed by the European Chemicals Agency (“ECHA”) on various issues as its inspiration. The Cross-Industry Alliance on COVID-19 aims to assist users in complying with their obligations under the Biocidal Products Regulation (BPR) and equivalent national laws on biocides, to facilitate the availability of disinfectants and help combat the COVID-19 pandemic. This is designed to be a living-documents and will be updated from time to time. The contributions from law firms Steptoe & Johnson LLP and Fieldfisher (Belgium) LLP do not create an attorney-client relationship with any user of this document. Usage of the information remains under the sole responsibility of the user. No liability is accepted with regard to the use that may be made of the information contained in this document. In particular, this Appendix 1 is not exhaustive, and countries might have taken additional decisions which are not reflected in this table or its updates. The authors or the organisations involved in the drafting of this guide are not responsible nor liable for any reproduction of the guide or the Appendices other parties might make. © A.I.S.E., Biocides for Europe and FECC 2020. Version 1.22 25 January 2021 Updates compared to the previous version (and related countries) have been highlighted in yellow throughout the document. In case of further questions related to measures in a specific country, companies are invited to contact directly the relevant national federation(s): - A.I.S.E. national associations members - Cefic national federations members - FECC national associations members

Appendix 1 Overview of national measures to make

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Page 1: Appendix 1 Overview of national measures to make

Practical Guide on Fast-Tracking the Supply of Disinfectants

during the COVID-19 Pandemic under the EU Biocides Rules

Appendix 1

Overview of national measures to make disinfectants available on the EU

market

Index Austria ......................................................................................................................................................................................................................... 2

Belgium ....................................................................................................................................................................................................................... 2

Bulgaria ..................................................................................................................................................................................................................... 23

Croatia ...................................................................................................................................................................................................................... 24

Cyprus ....................................................................................................................................................................................................................... 25

Czech Republic ......................................................................................................................................................................................................... 26

Denmark ................................................................................................................................................................................................................... 27

Estonia ....................................................................................................................................................................................................................... 31

Finland ...................................................................................................................................................................................................................... 32

France........................................................................................................................................................................................................................ 32

Germany ................................................................................................................................................................................................................... 33

Greece........................................................................................................................................................................................................................ 35

Hungary .................................................................................................................................................................................................................... 36

Ireland ....................................................................................................................................................................................................................... 36

Italy............................................................................................................................................................................................................................ 37

Latvia ...................................................................................................................................................................................................................... 106

Lithuania ................................................................................................................................................................................................................. 106

Luxembourg ........................................................................................................................................................................................................... 107

Malta ....................................................................................................................................................................................................................... 110

Netherlands ............................................................................................................................................................................................................. 113

Poland...................................................................................................................................................................................................................... 116

Portugal ................................................................................................................................................................................................................... 117

Romania .................................................................................................................................................................................................................. 118

Slovak Republic ...................................................................................................................................................................................................... 119

Slovenia ................................................................................................................................................................................................................... 132

Spain ........................................................................................................................................................................................................................ 134

Sweden .................................................................................................................................................................................................................... 139

United Kingdom ..................................................................................................................................................................................................... 141

Iceland (EEA) ......................................................................................................................................................................................................... 146

Liechtenstein (EEA) ............................................................................................................................................................................................... 146

Norway (EEA) ........................................................................................................................................................................................................ 146

Switzerland(EFTA) ................................................................................................................................................................................................ 147

Montenegro (Candidate) ....................................................................................................................................................................................... 148

Turkey (Candidate) ............................................................................................................................................................................................... 148

LEGAL NOTICE: This practical guide is made available by the Cross-Industry Alliance on COVID-19, EGAL NOTICE: This practical guide is made available by the Cross-

Industry Alliance on COVID-19, an initiative of A.I.S.E., Biocides for Europe Biocides for Europe (formerly known as EBPF), a Sector Group of Cefic and FECC with

voluntary contributions from Fieldfisher, Steptoe & Johnson, and CEHTRA. It takes the Practical Guides developed by the European Chemicals Agency (“ECHA”) on various

issues as its inspiration. The Cross-Industry Alliance on COVID-19 aims to assist users in complying with their obligations under the Biocidal Products Regulation (BPR) and

equivalent national laws on biocides, to facilitate the availability of disinfectants and help combat the COVID-19 pandemic. This is designed to be a living-documents and will

be updated from time to time. The contributions from law firms Steptoe & Johnson LLP and Fieldfisher (Belgium) LLP do not create an attorney-client relationship with any

user of this document. Usage of the information remains under the sole responsibility of the user. No liability is accepted with regard to the use that may be made of the

information contained in this document. In particular, this Appendix 1 is not exhaustive, and countries might have taken additional decisions which are not reflected in this

table or its updates. The authors or the organisations involved in the drafting of this guide are not responsible nor liable for any reproduction of the guide or the Appendices

other parties might make. © A.I.S.E., Biocides for Europe and FECC 2020.

Version 1.22 – 25 January 2021 Updates compared to the previous version (and related countries) have been highlighted in yellow

throughout the document.

In case of further questions related to measures in a specific country, companies are invited to contact directly the relevant national

federation(s):

- A.I.S.E. national associations members

- Cefic national federations members

- FECC national associations members

Page 2: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Austria Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_AT (Industry)_ethanol, propan-1-ol, propan-2-ol.pdf 2. National

law(s):

Requires

application.

Example of

application (in

German)

granted to

Federal

Economic

Chamber

(WKO) and its

Members

No ☐

Ethanol,

Propan-1-ol,

Propan-2-ol

Products

containing

ethanol, Propan-

1-ol and Propan-

2-ol

PT 1

PT 2

PT 4

Licensed producers

of disinfectants and

producers of ethanol.

In the example

application

companies need to

be established in

Austria

19/03/2020 31/08/2020 12.000 €. Substance may

be purchased

from entities not

listed on Article

95 List, provided

they comply

with the quality

criteria set out in

the exemption.

Federal Ministry for Climate

Action, Environment, Energy,

Mobility, Innovation and

Technology

[email protected]

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_AT (Pharmacies).pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol WHO II

Formulation

PT 1

PT 2

For pharmacies only 12/03/2020 31/08/2020

Article 55(1)?

Yes ☒

1. Notification:

Art55(1)_Coronaviru

s emergency derogation_AT (Military pharmacies).pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol WHO II

Formulation

PT 1

PT 2

For military

pharmacies only

23/03/2020 31/08/2020

Belgium Article 55(1)?

Yes ☒

1. Notification:

70% alcohol Following

WHO

formulations

PT 1

No new

applications

Pharmacists and

pharmacists in

hospitals

20/03/2020 Free Federal Public Service Health,

Food Chain Safety and

Page 3: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Notification

2020/140/B to

Commission

dated 19 March

2020

2. National

law(s):

Arrêté royal 18

March 2020 (in

French and

Dutch)

No ☐

for PT1

possible*

Environment - Directorate-

General 5: Environment

[email protected]

Head of unit of the biocide unit of

the Federal Public Service

Environment:

[email protected]

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_ACIDOFOAM CF & Sopuroxid 3.2.pdf 2. National

law(s):

Art. 21 of Arrêté

royal 4 April

2019 (in French

and Dutch)

No ☐

Peracetic acid (CAS-

nr. 79-21-0)

ACIDOFOAM

CF

Sopuroxid 3.2

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 2

Derogations granted

to applicants

Full list of

authorisation holders

for PT 2

See here for details

on obtaining

derogations

22/03/2020 18/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Aero-Sense Alcohol Hand Gel 70%.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

Aero-Sense

Alcohol Hand

Gel 70%

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1

Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

25/03/2020 21/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Propan-2-ol (CAS-nr

67-63-0)

ALCANAF

Full list of

temporary

authorisations

PT 1

Derogations granted

to applicants. No

new applications for

PT1 possible*

26/03/2020 22/09/2020 Free

* See announcement here: “As the production of disinfectants used for human hygiene purposes (product type 1) is currently sufficient, temporary authorisations for this type of products will no longer be delivered as of next week. We still accept applications for this kind of

disinfectants until Sunday 12 April. We will process them and deliver a temporary authorisation provided that they are complete and in good order. Only products used for the disinfection of surfaces (product type 2) will still be eligible for a temporary authorisation.”

Page 4: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Art

55(1)_Coronavirus emergency derogation_BE_ALCANAF.pdf 2. National

law(s):

See above.

No ☐

delivered in the

context of the

fight against

Covid-19

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_ALCOGEL.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

ALCOGEL

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1

Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

01/04/2020 28/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_ALCO-JETH 75 Gel.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

ALCO-JETH 75

Gel

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1

Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

01/04/2020 28/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_ALCO-JETH 75 Liquid.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

ALCO-JETH 75

Liquid

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1

Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

01/04/2020 28/09/2020 Free

* See announcement here: “As the production of disinfectants used for human hygiene purposes (product type 1) is currently sufficient, temporary authorisations for this type of products will no longer be delivered as of next week. We still accept applications for this kind of

disinfectants until Sunday 12 April. We will process them and deliver a temporary authorisation provided that they are complete and in good order. Only products used for the disinfection of surfaces (product type 2) will still be eligible for a temporary authorisation.”

Page 5: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Alphades.pdf 2. National

law(s):

See above.

No ☐

Hydrogen peroxide

(CAS-nr. 7722-84-1)

Lactic acid (CAS-

nr.79-33-4)

Alphades

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 2 Derogations granted

to applicants

Full list of

authorisation holders

for PT 2

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

23/03/2020 19/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Autoactin.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

Autoactin

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1

Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

22/03/2020 18/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Gel hydroalcoolique mains 75%.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

Gel

hydroalcoolique

mains 75%

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1

Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No

new applications for

PT1 possible*

30/03/2020 26/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_HOLIS - spray hydro-alcoolique .pdf 2. National

law(s):

See above.

Propan-2-ol (CAS-nr

67-63-0)

HOLIS - spray

hydro-

alcoolique

Full list of

temporary

authorisations

delivered in the

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

16/03/2020 12/09/2020 Free

* See announcement here: “As the production of disinfectants used for human hygiene purposes (product type 1) is currently sufficient, temporary authorisations for this type of products will no longer be delivered as of next week. We still accept applications for this kind of

disinfectants until Sunday 12 April. We will process them and deliver a temporary authorisation provided that they are complete and in good order. Only products used for the disinfection of surfaces (product type 2) will still be eligible for a temporary authorisation.”

Page 6: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

context of the

fight against

Covid-19

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Laquick Pro & Desinfectz Pro.pdf 2. National

law(s):

See above.

No ☐

Hydrogen peroxide

(CAS-nr. 7722-84-1)

Lactic acid (CAS-

nr.79-33-4)

Laquick Pro

Desinfectz Pro

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 2 Derogations granted

to applicants

Full list of

authorisation holders

for PT 2

See here for details

on obtaining

derogations

23/03/2020 19/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Nerta Manobac 100.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

Nerta Manobac

100

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

27/03/2020 23/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Ontsmettingsmiddel oppervlakken-Vloeistof.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

Ontsmettingsmi

ddel

oppervlakken –

Vloeistof

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 2 Derogations granted

to applicants

Full list of

authorisation holders

for PT 2

See here for details

on obtaining

derogations

26/03/2020 22/09/2020 Free

* See announcement here: “As the production of disinfectants used for human hygiene purposes (product type 1) is currently sufficient, temporary authorisations for this type of products will no longer be delivered as of next week. We still accept applications for this kind of

disinfectants until Sunday 12 April. We will process them and deliver a temporary authorisation provided that they are complete and in good order. Only products used for the disinfection of surfaces (product type 2) will still be eligible for a temporary authorisation.”

Page 7: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Phago products.pdf 2. National

law(s):

See above.

No ☐

Peracetic acid (CAS-

nr. 79-21-0)

Phago’Sanit

Phago’Spore

Phago’Wipes

spore

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 2 Derogations granted

to applicants

Full list of

authorisation holders

for PT 2

See here for details

on obtaining

derogations

22/03/2020 18/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Phytogel By HUCKERT'S sanitizer.pdf 2. National

law(s):

See above.

No ☐

Propan-1-ol (CAS-nr

71-23-8)

Phytogel By

HUCKERT'S

sanitizer

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

27/03/2020 23/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Protectol® schützt (I).pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

Protectol®

schützt (I)

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

26/03/2020 22/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_RADIA C 182 .pdf 2. National

law(s):

See above.

Propan-2-ol (CAS-nr.

67-63-0)

RADIA C 182

Full list of

temporary

authorisations

delivered in the

context of the

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

22/03/2020 18/09/2020 Free

* See announcement here: “As the production of disinfectants used for human hygiene purposes (product type 1) is currently sufficient, temporary authorisations for this type of products will no longer be delivered as of next week. We still accept applications for this kind of

disinfectants until Sunday 12 April. We will process them and deliver a temporary authorisation provided that they are complete and in good order. Only products used for the disinfection of surfaces (product type 2) will still be eligible for a temporary authorisation.”

Page 8: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

fight against

Covid-19

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_SOLUTION HYDROALCOOLIQUE.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

SOLUTION

HYDROALCO

OLIQUE

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

01/04/2020 28/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Solution hydroalcoolique désinfectante.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

Solution

hydroalcoolique

désinfectante

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

26/03/2020 22/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Solution hydroalcoolique recommandée par l’OMS.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

Solution

hydroalcoolique

recommandée

par

l’Organisation

mondiale de la

Santé pour

l’antisepsie des

mains

Full list of

temporary

authorisations

delivered in the

context of the

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

29/03/2020 25/09/2020 Free

* See announcement here: “As the production of disinfectants used for human hygiene purposes (product type 1) is currently sufficient, temporary authorisations for this type of products will no longer be delivered as of next week. We still accept applications for this kind of

disinfectants until Sunday 12 April. We will process them and deliver a temporary authorisation provided that they are complete and in good order. Only products used for the disinfection of surfaces (product type 2) will still be eligible for a temporary authorisation.”

Page 9: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

fight against

Covid-19

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_TueTous Alcogel.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr

67-63-0)

TueTous

Alcogel

Full list of

temporary

authorisations

delivered in the

context of the

fight against

Covid-19

PT 1 Derogations granted

to applicants

Full list of

authorisation holders

for PT 1

See here for details

on obtaining

derogations. No new

applications for PT1

possible*

31/03/2020 27/09/2020 Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_EcoClearProx 7.9%_2.pdf 2. National

law(s):

See above.

No ☐

Hydrogen peroxyde

(CAS-nr. 7722-84-1)

EcoClearProx

7.9%

PT 2 General public

Professional user

2/4/2020

Update

01/10/2020

29/9/2020

Update

30/03/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Clean 'n Easy desinfectie spray_2.pdf 2. National

law(s):

See above.

No ☐

Hydrogen peroxide

(CAS-nr. 7722-84-1)

Lactic acid (CAS-

nr.79-33-4)

Clean 'n Easy

desinfectie

spray

PT 2 General public

Professional user

7/4/2020

Update

06/10/2020

4/10/2020

Update

04/04/2021

* See announcement here: “As the production of disinfectants used for human hygiene purposes (product type 1) is currently sufficient, temporary authorisations for this type of products will no longer be delivered as of next week. We still accept applications for this kind of

disinfectants until Sunday 12 April. We will process them and deliver a temporary authorisation provided that they are complete and in good order. Only products used for the disinfection of surfaces (product type 2) will still be eligible for a temporary authorisation.”

Page 10: Appendix 1 Overview of national measures to make

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limited to

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Approach to

exports/

imports

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Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Cillit Bang Pistolet Javel_2.pdf 2. National

law(s):

See above.

No ☐

Active chlorine

released from sodium

hypochlorite (CAS-nr.

7681-52-9)

Cillit Bang

Pistolet Javel

Super

Nettoyante et

Désinfectante

PT 2 General public

Professional user

5/5/2020

Update

03/11/2020

3/11/2020

Update

02/05/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Calgonit Des-H_2.pdf 2. National

law(s):

See above.

No ☐

Propan-1-ol (CAS-nr.

71-23-8) Propan-2-ol

(CAS-nr. 67-63-0)

Calgonit Des-H PT 1 General public

Professional user

Update

09/10/2020

Update

07/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_APESIN spray F_2.pdf 2. National

law(s):

See above.

No ☐

Propan-1-ol (CAS-nr.

71-23-8) Propan-2-ol

(CAS-nr. 67-63-0)

APESIN spray F PT 2 SARS-CoV-2

General public

Professional user

09/04/2020

Update

08/10/2020

6/10/2020

Update

06/04/2021

Page 11: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_ANNO HAND SANITIZER_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

ANNO HAND

SANITIZER

PT 1 General public

Profesional user

02/04/2020

Update

01/10/2020

29/09/2020

Update

30/03/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_TOTAL SOL-HA_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

TOTAL SOL-

HA

PT 1 General public

Professional user

12/4/2020

Update

11/10/2020

11/10/2020

Update

09/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Vloeibaar handdesinfectiemiddel_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63destop-0)

Vloeibaar

handdesinfectie

middel - Liquide

Désinfectant

pour les mains

PT 1 General public

Professional user

16/4/2020

Update

15/10/2020

15/10/2020

Update

13/04/2021

Page 12: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Spray Nettoyant avec javel_2.pdf 2. National

law(s):

See above.

No ☐

Active chlorine

released from sodium

hypochlorite (CAS-nr.

7681-52-9)

Spray Nettoyant

avec javel - 750

ml

PT 2 General public

Professional user

24/4/2020 23/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_SHA-IPA_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

SHA-IPA

Solution hydro-

alcoolique

recommandée

par

l’Organisation

mondiale de la

santé pour

l’antisepsie des

mains

PT 1 General public

Professional user

15/4/2020

Update

14/10/2020

14/10/2020

Update

12/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_EMPC Hand Sanitizer_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

EMPC Hand

Sanitizer

PT1 General public

Professional user

07/04/2020

Update

06/10/2020

04/10/2020

Update

04/04/2021

Page 13: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Hand Sanitizer formula 2_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

Hand Sanitizer

formula 2

PT1 General public

Professional user

04/04/2020

Update

03/10/2020

01/10/2020

Update

01/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Nerta Alkalinet 20_2.pdf 2. National

law(s):

See above.

No ☐

Active chlorine

released from sodium

hypochlorite (CAS-nr.

7681-52-9)

Nerta Alkalinet

20

PT2 General public

Professional user

19/04/2020

Update

16/10/2020

18/10/2020

Update

14/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Nerta Alkalinet 200_2.pdf 2. National

law(s):

See above.

No ☐

Active chlorine

released from sodium

hypochlorite (CAS-nr.

7681-52-9)

Nerta Alkalinet

200

PT2 General public

Professional user

19/04/2020

Update

16/10/2020

18/10/2020

Update

14/04/2021

Page 14: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Nerta Bacchlor_2.pdf 2. National

law(s):

See above.

No ☐

Active chlorine

released from sodium

hypochlorite (CAS-nr.

7681-52-9)

Nerta Bacchlor PT2 General public

Professional user

19/04/2020

Update

16/10/2020

18/10/2020

Update

14/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_O2 Safe 7.4_2.pdf 2. National

law(s):

See above.

No ☐

Hydrogen peroxyde

(CAS-nr. 7722-84-1)

O2 Safe 7.4 PT2 General public

Professional user

02/04/2020

Update

01/10/2020

29/09/2020

Update

30/03/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Phileasafe_2.pdf 2. National

law(s):

See above.

No ☐

Peracetic acid (CAS-

nr. 79-21-0)

Philesafe PT2 General public

Professional user

03/04/2020

Update

02/10/2020

30/09/2020

Update

31/03/2021

Page 15: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_SMI Solution hydro-alcoolique_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

SMI Solution

hydro-

alcoolique

PT1 General public

Professional user

15/04/2020

Update

14/10/2020

14/10/2020

Update

12/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Solution hydro-alcoolique désinfectante_2.pdf 2. National

law(s):

See above.

No ☐

Propan-2-ol (CAS-nr.

67-63-0)

Solution hydro-

alcoolique

désinfectante

PT1 General public

Professional user

12/04/2020

Update

11/10/2020

11/10/2020

Update

09/04/2021

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Hydrogen peroxide Oxivir Excel PT2 General public,

Professionals

Used against:

SARS-CoV-2

23/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificat

Active chlorine

released from sodium

hypochlorite

LODA SUPER

JAVEL 8°

PT2 General public,

Professionals

Update

11/11/2020

Update

10/05/2021

Page 16: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

ion: no pdf

available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx 2. National

law(s):

No ☐

Used against:

SARS-CoV-2

Article 55(1)?

Yes ☒

1.

Notificat

ion: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Hydrogen peroxide

Oxivir Excel

Foam

PT2 General public,

Professionals

Used against:

SARS-CoV-2

23/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

Hydrogen peroxide Oxivir Excel

Wipe

PT2 General public,

Professionals

Used against:

SARS-CoV-2

23/07/2020

– date of

notification

Page 17: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificat

ion:

No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Biphenyl-2-ol Preventol™

CD601

PT2 General public,

Professionals

Used against:

SARS-CoV-2

23/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificat

ion: no pdf

available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Peracetic acid Bacty Spore

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

29/12/2020

Update

27/06/2021

Page 18: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

Cillit Bang Zéro

Moisissure

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

29/12/2020

Update

27/06/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Peracetic acid Bacty Spore

Lingettes

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

29/12/2020

Update

27/06/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Hydrogen peroxide Huwa-San TR-

7.9

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

21/12/2020

Update

19/06/2021

Page 19: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Dec 2020(0).xlsx 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Hydrogen peroxide Huwa-San TR-

12.5

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

21/12/2020

Update

19/06/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx 2. National

law(s):

No ☐

Hydrogen peroxide Huwa-San TR-

25

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

21/12/2020

Update

19/06/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Hydrogen peroxide BioXeco 3S

PT2 General public,

Professionals

Update

21/12/2020

Update

19/06/2021

Page 20: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx 2. National

law(s):

No ☐

Used against:

SARS-CoV-2

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

Harpic Gel Javel

Désinfectant

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

09/12/2020

Update

07/06/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2.National

law(s):

Peracetic acid Tevan

Panox®300

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

29/11/2020

Update

28/05/2021

Page 21: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

Destop

Entretien

Canalisations

Javel

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

29/11/2020

Update

28/05/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

LODA JAVEL

18°

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

11/11/2020

Update

10/05/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Active chlorine

released from sodium

hypochlorite

LODA JAVEL

15°

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

11/11/2020

Update

10/05/2021

Page 22: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

LODA JAVEL

12°

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

11/11/2020

Update

10/05/2021

Article 55(1)?

Yes ☒

1.Notification:

no pdf available

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

LODA JAVEL

10°

PT2 General public,

Professionals

Used against:

SARS-CoV-2

Update

11/11/2020

Update

10/05/2021

Article 55(1)? Alcotens WHO PT1 General Public 02/10/2020 31/03/2021

Page 23: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BE_Alcotens WHO.pdf

2. National

law(s):

No ☐

Propan-2-ol (CAS-nr. 67-63-

0)

Professional user

SARS-CoV-2

Bulgaria Article 55(1)?

Yes ☒

1. Notification:

2.

Art

55(1)_Coronavirus emergency derogation_BG_ANTIBAK.pdf National

law(s):

[Insert]

No ☐

[Insert]

WHO Formulation 1:

Ethanol Glycerol

Hydrogen peroxide

ANTIBAK /

АНТИБАК

PT 1 General public

Professional users

13/04/2020 10/10/2020 1890

BGN

(circa €

1000)

Ministry of Health

State Health Control Directorate

[email protected]

+359 2 9301 214

Article 55(1)?

Yes ☒☐

1. Notification:

Art

55(1)_Coronavirus emergency derogation_BG_Primasept.pdf 2. National

law(s):

[Insert]

No ☐

[Insert]

WHO Formulation 1:

Ethanol Glycerol

Hydrogen peroxide

Primasept /

Примасепт

PT 1 General public

Professional users

06/04/2020 03/10/2020 1890

BGN

(circa €

1000)

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

Update in

overview Article

55(1)

Active chlorine

released from sodium

hypochlorite (Натриев

хипохлорит Активен

хлор)

Ecolab

BACFORCE

EL 900/Еколаб

БАКФОРС EL

900

PT2, PT4 Professional 16/12/2020 14/06/2021

Active chlorine

released from sodium

hypochlorite

Ecolab P3-

Topax

66/Еколаб Р3-

Топакс 66

PT2, PT4 Professional 16/12/2020 14/06/2021

Page 24: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

notifications

January 2021

Overview Art55(1)

notifications_Jan 2021 (1).xlsx

2.National

law(s):

No ☐

Croatia Article 55(1)?

Yes ☒

1. Notification:

Notification

Croatia.docx (in Croatian)

Nothing on

circabc yet.

2. National

law(s):

Registration of

biocidal

products

No ☐

Ethanol 27/03/2020

Publication

date of the

notification

document

01/09/2020 Proof of Article

95 listing not

required and

substance may

be purchased

from entities not

listed on Article

95 List

Ministry of Health

[email protected]

+385 (1) 4607 555

Email address for application:

[email protected].

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview

table

September

2020

2. National

law(s):

[Insert]

Peracetic acid

generated from tetra-

acetylethylenediamine

(TAED) and sodium

percarbonate

Desosan PT2 Professional use

Against Virus

04/09/2020

– date of

notification

Page 25: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

[Insert]

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview

table

September

2020

2. National

law(s):

[Insert]

No ☐

[Insert]

Propan-2-ol Stella

izopropilni

alkohol 70%

PT1, PT2 General public and

professional use

Against SARS-CoV-

2

04/09/2020

– date of

notification

Cyprus Article 55(1)?

Yes ☐

1. Notification:

[Insert]

2. National

law(s):

[Insert]

No ☐

[Insert]

The Min of

Agriculture

claims that due

to Covid-19

pandemic, they

have accelerated

significantly

their NORMAL

authorization

procedure,

making it only

1-2 weeks long!

1,2 and 4 300

Euros

Only Art 95

suppliers

Ministry of Agriculture, Natural

Resources and Environment -

Department of Agriculture

[email protected]

+357 224 08 519

Article 55(1)? Hydrogen peroxide DrySan Oxy PT2, PT4 Professional users 17/07/2020 13/01/2021

Page 26: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Yes ☒☐

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_CY_DrySan Oxy.pdf

2. National

law(s):

[Insert]

No ☐

[Insert]

Article 55(1)?

Yes ☒☐

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_CY_NOCOLYSE.pdf

2. National

law(s):

[Insert]

No ☐

[Insert]

Hydrogen peroxide

(CAS no.: 7722-84-1)

NOCOLYSE PT2 Professional users 03/09/2020 02/03/2021

Article 55(1)?

Yes ☒☐

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_CY_Bioquell HPV-AQ.pdf.pdf 2. National

law(s):

[Insert]

No ☐

[Insert]

Hydrogen peroxide

(CAS no.: 7722-84-1)

Bioquell HPV-

AQ

PT2, PT4 Professional users 19/10/2020 17/04/2021

Czech

Republic

Article 55(1)?

Yes ☐

1. Notification:

Ethanol

Propan-2-ol

WHO

formulations 1

and 2

PT1 Art 55 BPR

exemption about

WHO

From

21.4.2020 the

export of

Ministry of Health of the Czech

Republic

Page 27: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

[Insert]

2. National

law(s):

[Insert]

No ☐

[Insert]

formulation is

about to expire

(30.4.2020). In

meantime more

than 70

producers

registered

production of

this biocide on

"regular basis"

and will cover

the market

according the

usual rules.

disinfectants

is not

restricted

anymore.,

However, it

seems that

imported

product

should be

registered

also by

authorities of

importing

country

Department of Strategy and

Management of Public Health

[email protected]

+4202 6708 2305

Denmark Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DK_TUNAP.pdf 2. National

law(s):

Hand

Disinfectant 17

March 2020

Hand

disinfectant 22

March

2020Hand

sprays 23 March

2020

No ☐

Propan-2-ol TUNAP

Hånddesinfektio

nsmiddel

PT 1 All producers of

hand sanitizer must

still be registered in

the Danish Product

register or the The

Danish

Environmental

Protection Agency.

03/04/2020 30/06/2020

The

Minister

for

Environme

nt decided

to extend

the

deadline,

see column

“Approach

to Article

95”

Derogati

on based

on earlier

assessme

nts DKK

2.500

Derogati

on under

Article

55(1)

DKK

238.000

The Danish

Environmental

Protection

Agency ("EPA")

can derogate

from the demand

that active

substance

suppliers need to

be on the article

95 list.

Substance may

be purchased

from entities not

listed on Article

95 List , but the

Danish EPA

must be

informed at

[email protected]

if the active

substance does

not come from a

supplier on

ECHA's Article

95 list until 30.

June.

The Minister for

the Environment

decided to

extend the

deadline for

Danish Environmental Protection

Agency (Miljøstyrelsen)

Ministry of Environment and

Food of Denmark, the Department

[email protected]

+45 72 54 40 00

+45 22 34 95 89

Page 28: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

disinfectant

produced/sold

from suppliers

not listed on the

Article 95 List.

Manufacture and

import: until 30

June 2020. Sale

to retailers: until

30 July 2020.

Sale by retailers:

until 21

September 2020.

The Danish EPA

has extended the

deadline for sale

of hand

disinfectants to

31 December

2020. This

means that

retailers can sell

products to

consumers until

31. December

2020. The

exemption only

covers products

which have been

produced or

imported by 30

June 2020 and

which have

already received

an exemption

from the article

95- requirement.

Postponing the

exemption is to

prevent effective

hand

disinfectants

from being

destroyed and

thus limiting

Page 29: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

waste of

resources.

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DK_UniBlue UDF2_UDW2.pdf 2. National

law(s):

[Insert]

No ☐

Tartaric acid, Lactic

acid Lavender

oil, Peppermint oil

Uniblue

UDF2/UDW2

PT 2

PT 3

PT 4

03/04/2020 30/09/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DK.pdf 2. National

law(s):

[Insert]

No ☐

Propan-2-ol WHO,

formulation 2

PT 1 23/03/2020 30/06/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DK_BacTerminator.pdf

Overview Art55(1)

notifications_Nov 2020(0).xlsx

2. National

law(s):

[Insert]

No ☐

Active chlorine

released from

hypochlorous acid

BacTerminator PT 1 Professionals and

non-professionals

15/5/2020

Update

12/11/2020

11/11/2020

Update

11/05/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DK_Neuthox.pdf

Active chlorine

released from

hypochlorous acid

Neuthox PT 1 Professionals and

non-professionals

15/5/2020

Update

12/11/2020

11/11/2020

Update

11/05/2021

Page 30: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Nov 2020(0).xlsx

2. National

law(s):

[Insert]

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DK_Bright Water.pdf

2. National

law(s):

[Insert]

No ☐

Active chlorine

released from

hypochlorous acid

Bright Water PT1 Professionals and

non-professionals

09/06/2020 06/12/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DK_Hand disinfectants_ethanol_propan-2-ol.pdf

2. National

law(s):

[Insert]

No ☐

Ethanol and Propan-2-

ol

Handdesinfectio

n

PT1 Professionals

General public

14/08/2020 31/12/2020

Page 31: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

information

based on

overview table

November 2020:

Overview Art55(1)

notifications_Nov 2020(0).xlsx

2.National

law(s):

No ☐

Calcium hydroxide /

Slaked lime

Hydratkalk PT 2, 3 Professional 06/11/2020 05/05/2021

Estonia Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_EE_WHO II formula.pdf 2. National

law(s):

[Insert]

No ☐

Propan-2-ol WHO

Formulation 2

PT 1 27/03/2020 01/05/2020 Health Board

[email protected]

[email protected]

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_EE.pdf 2. National

law(s):

[Insert]

No ☐

Ethanol Biocide

containing

ethanol

PT 1

PT 2

PT 4

19/03/2020 01/05/2020 “In order to

secure the supply

of disinfection

product a

temporary

exemption form

the BPR Article

95 for the

making available

on the market

and use of the

disinfectants

containing

ethanol have

been granted in

Estonia”

Page 32: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Substance may

be purchased

from entities not

listed on Article

95 List

Finland Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_FI_OxyskinPlus.pdf

Art

55(1)_Coronavirus emergency derogation_FI_OxiskinPlus.pdf

2. National

law(s):

[Insert]

No ☒

Hydrogen peroxide 3% OxiskinPlus PT 1

PT 2

General Public,

Professional

Geographical area of

use Finland

Product have to be

registered in the

national chemicals

product register

27/03/2020

Update

24/09/2020

23/09/2020

Update

23/03/2021

During

normal

times, the

basic the

basis fee

is € 3000

(but they

are now

working

on a

hourly

rate)

Only ethanol is

exempted from

the article 95

requirement

from March 31

to July 31, 2020.

However,

ethanol for

disinfectants can

only be

purchased from

Finland or other

EU countries.

Finnish Safety and Chemicals

Agency (TUKES)

[email protected]

+358 50 597 6338

France Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_FR_ethanol_propan-2-ol.pdf

Art

55(1)_Coronavirus emergency derogation_FR_ethanol_propan-2-ol_Updated.pdf 2. National

law(s):

https://www.legi

france.gouv.fr/el

i/arrete/2020/4/1

7/TREP2009928

A/jo/texte 17

avril 2020

(modifying

Arrêté du 13

mars 2020)

Arrêté du 20

mars 2020

(modifying

Arrêté du 13

mars

2020),Arrêté du

6 mars 2020;

Ethanol, Propan-2-ol 3 products

containing

ethanol (WHO

formulation as

well as 2

additional

formulations

discussed with

manufacturers)

1 product

containing

isopropanol

(WHO

formulation)

PT 1 Pharmacies: WHO

Formulation I;

Industrial facilities

(cosmetic and

biocidal industries

and installations

classified for

environmental

protection subject to

authorisation or

registration): WHO

Formulations I-II

and or a fourth

(ethanol based)

Update of previously

granted permits to

include alternative

coformulants to

prevent any

shortage.

06/03/2020 31/05/2020

Extension

until 01

September

2020

Further

extension

until 31.

December

2020

Substance may

be purchased

from entities not

listed on Article

95 List, but the

derogations

contain source-

specifications

(see: Arrêté du

20 mars 2020) During the

derogation

period, alcohol

may be purchased

from producers

other than art. 95

of the BPR

considering the

shortage of

ethanol all over

the country.

However, the

derogation

specifies the

sources allowed

in order to

guarantee the

safety and

efficacy of the

Ministère de l'écologie, du

développement durable et de

l'énergie

biocides@developpement-

durable.gouv.fr

+33(0)140 81 87 00

Page 33: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Arrêté du 27

mars 2020

FAQ

joe_20200702_0162_

0020.pdf

(all in French)

No ☐

end product.

These sources can

also be used for

the production of

PT2 and PT4

alcohol-based

products, until

September 1st.

Article 55(1)?

Yes ☒

1. Notif

icatio

n:

Art

55(1)_Coronavirus emergency derogation_FR_ethanol_propan-2-ol_Update July2020.pdf

2. National

law(s):

No ☐

Ethanol

Propan-2-ol

3 products

containing

ethanol (WHO

formulation as

well as 2

additional

formulations

1 product

containing

ispropanol

(WHO formula)

PT1 General public,

Professionals

Used against:

SARS-CoV-2

06/03/2020

(pharmacist

s)

13/03/2020

(industrials

)

31/12/2020

Germany Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DE.pdf 2. National

law(s):

Allgemeinverfü

gung vom 09.

April aktualisiert

Aktenzeichen

5.0- 710

30/01.00003

(Fassung vom

15.April 2020)

Allgemeinverfuegung

-Haendedesinfektion.pdf

(in German)

No ☐

Propan-2-ol, Ethanol,

propan-1-ol

WHO

Formulation 2;

70% (v/v)

Propan-2-ol in

aqueous

solution

PT 1 Only produced by

pharmacies,

pharmaceutical and

chemical industry

and legal entities

under public law

Propan-2-ol and

Ethanol containing

products to be used

by professional and

non-professional

users,

Propan-1-ol

containing products

for professional use

only

Against bactericide,

levurocide and

virucide

04/03/2020 06/10/2020 Substance may

be purchased

from entities not

listed on Article

95 List (see

German FAQs in

German)

Importers

need to be

part of

chemical /

pharmaceutic

al industry

(see German

FAQs in

German)

Bundesanstalt für Arbeitsschutz

und Arbeitsmedizin Bundesstelle

Chemikalien / Zulassung Biozide

(Federal Institute for Occupational

Safety and Health)

[email protected]

+49 231 9071 2443

+49 231 9071 2326

+49 231 9071 2518

Page 34: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_DE_ethanol, 1-, 2-propanol.pdf National law(s):

see above

No ☐

Propan-2-ol; Propan-1-

ol; Ethanol

Products for

hygienic hand

disinfection

PT 1 Pharmacies,

pharmaceutical and

chemical industry

and legal entities

under public law,

only to be

distributed to

professional users

(specific rules and

conditions apply for

ethanol)

13/03/2020 06/10/2020 See above. See above.

Article 55(1)?

Yes ☒

1. Notification

:

Nothing on

circabc yet

2. National

law(s):

Allgemeinverfü

gung vom

02.04.2020 (in

German)

No ☐

Ethanol;

Natriumhypochlorit;

Chloramin-T

Surface

disinfection

PT 2 Use by professional

users

(specific rules and

conditions apply for

ethanol)

02/04/2020 30/09/2020 See above. See above.

Article 55(1)?

Yes ☐

1. Notification:

2. National

law(s):

https://www.bau

a.de/DE/Themen

/Anwendungssic

here-

Chemikalien-

und-

Produkte/Chemi

kalienrecht/Bioz

ide/FAQ/FAQ_n

ode.html

No ☐

Other ethanol based Disinfection Specific rules and

conditions apply for

ethanol, for

conditions see

German FAQs (in

German)

National rules for

transitional period

apply (simple

notification)

[Insert] [Insert]

Article 55(1)?

Yes ☐

Propan-2-ol and

Ethanol

Products for

hygienic hand

PT1 Specific rules and

conditions apply for

07/10/2020 05/04/2021 Substance may

be purchased

Importers

need to be

Page 35: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

3. Notification:

Art

55(1)_Coronavirus emergency derogation_DE_propan-2-ol, ethanol.pdf

4. National

law(s):

Allgemeinverfü

gung vom

16.09.2020 (in

German)

No ☐

NB: the Propan-1-ol

based formulations are

no longer covered.

disinfection,

based on one of

the three

specific

formulations

(Formulations

A-G) for each

active substance

(Propan-2-ol

and Ethanol,)

ethanol, for

conditions see

German FAQs (in

German)

Use by professional

users and by

consumers/general

public.

The preparations in

question are only to

be manufactured and

placed on the market

by pharmacies, the

chemical and

pharmaceutical

industry and

corporate bodies

under public law in

Germany.

New notification

requirements to the

Bundesstelle für

Chemikalien (BfC)

each month (see

here). Amounts

manufactured or

imported have to be

reported on a

monthly basis.

from entities not

listed on Article

95 List (see

German FAQs in

German)

part of

chemical /

pharmaceutic

al industry or

legal persons

under public

law (see

German

FAQs in

German)

Greece Article 55(1)?

Yes ☐

1. Notification:

[Insert]

2. National

law(s):

A plain

Announcement

on the site of the

National

Medicines

Organization,

responsible for

PT1 (among

others)

All foreseen for PT1 a)Locally

produced and

imported from

3rd countries,

both according

to the WHO

recipes ONLY,

b)Imported from

the EU, with

exactly the same

formulation, IF

authorized or

registered there

(according to

local system)

PT 1 PT1 for both

consumer and

professional use.

Since authorized

production sites (for

PT1) were almost

non-existent, the

government granted

the right to

pharmaceutical and

cosmetic industries

to produce the WHO

recipes

24th March Not

specified in

the

announcem

ent;

however,

the fast-

track

product

authorizati

ons

themselves,

will have a

validity of

6 months,

2048

Euros per

authoriza

tion

Derogation

foreseen

Substance may be

purchased from

entities not listed

on Article 95 List

Imports of

alcohols ex

third

countries is

permitted

Only for

ethanol

imports

a)National Medicines

Organization, Dept. of Biocides

[email protected]

+30 213 2040 200 &

+30 213 2040 374

Page 36: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

[Insert]

with the

potential to

be

elongated

if the

pandemic

continues

or revives

Hungary Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_HU.pdf

2. National

law(s):

[Insert]

No ☐

[Insert]

Ethanol, Propan-2-ol,

Sodium hypochlorite,

ADBAC, DDAC,

glutaraldehyde

According to

WHO

specifications

WHO

formulations,

products in line

with ECDC

recommendation

sand production

permits for

previously

authorised

formulations

under the scope

of transitional

measures

PT 1

PT 2

General public,

professional,

industrial

16/03/2020 31/08/2020 National Public Health Center,

Department for Chemical Safety

and Competent Authorities

[email protected]

[email protected]

[email protected]

[email protected]

+36 1 476 1100

Ireland Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IE_propan-1-ol_propan-2-ol.pdf 2. National

law(s):

[Insert]

No ☐

Propan-1-ol, propan-2-

ol

Propan-1-ol and

propan-2-ol

containing

products

PT 1 Individual

application for

derogation necessary

20/03/2020 16/09/2020 €300 Pesticide Registration and Control

Divisions

Department of Agriculture, Food

and the Marine

Biocide-

[email protected]

+353 1 615 7552

Article 55(1)?

Yes ☒

1.

Notificati

on:

2020-09-18 COM

Notification Art 55.1 IRE - Propanol Products.pdf

2. National

law(s):

[Insert]

Propan-1-ol, propan-

2-ol

Propan-1-ol and

propan-2-ol

containing

products

PT1 General public &

professional

(General)

Geographical area of

use Ireland

Applicants have

been informed that

the exemption will

expire on 16th

March 2021 and that

18/09/2020 16/03/2021

Page 37: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

use of the products

after that date will

not be permitted. A

grace period for

sales will be allowed

to facilitate the

phased withdrawal

of these products

from the market. For

Article 95 compliant

sources the last date

for sale to end-users

is prescribed as 31st

January 2021.

Italy Article 55(1)?

Yes ☐

No ☒

National laws:

”Presidi

Medico-

Chirurgici”

(PMC) of 19

March 2020

(also see Section

1.1.

Authorization

procedures for

the Marketing

and Production

of Disinfectant

Products in Italy

by Ministero

della Salute)

Submission to

be made to:

dgfdm@postace

rt.sanita.it or to

the helpdesk at:

[email protected]

, with

indication of the

object: “Covid

Emergency-19 -

Request for

authorization in

derogation

Active substances

currently under

evaluation (not yet

approved)

All products that

claim a

disinfectant,

bactericidal,

virucidal action

or any action

able to fight

microorganisms

PT 1

PT 2

1520,40

euro to

Ministero

della

Salute

and 3000

euro to

Istituto

Superiore

di

Sanità.]

Substance may

not be purchased

from entities not

listed on Article

95 List

Presentation of

declaration of

conformity to

art. 95 of the

BPR.

Istituto Superiore di Sanità

[email protected]

+39 06 4990 3192

According to the Commission

Notification:

Ministero della salute

Direzione generale dei dispositivi

medici e del servizio farmaceutico

[email protected]

[email protected]

Page 38: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

pursuant to art.

55 BPR

Individual

application for

authorisation is

necessary,

submitting

documents

relating to:

chemical

analysis

certificate,

complete

qualitative-

quantitative

composition of

the formulation,

analytical

method (test

method) for

qualitative and

quantitative

control of the

active

substance(s),

stability test,

technical data

sheet,

classification

and labelling in

accordance with

Regulation (EC)

N.1272/2008

(CLP), the

evaluation of

efficiency is

made according

to EN 14885;

specifically with

regard to

viruses, the

evaluation shall

be made

according to EN

14476 for hand

disinfection and

Page 39: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

according to

EN14476 and

EN16777 for

surfaces.”

Article 55(1)?

Yes ☒

1. Notification:

Art 55(1)_Coronavirus

emergency derogation_IT _HOLLUDES PROMANO GEL.pdf see Section

1.2.Authorizatio

n procedures for

the Marketing

and Production

of Disinfectant

Products in Italy

by Ministero

della Salute

2. National

law(s):

see above

No ☐

Individual

application for

derogation

necessary,

submitting

documents

relating to:

active substance

supplier, product

efficacy study

(EN 14476) if

not already

included in

R4BP3.

It has been

clarified that it is

not necessary to

present efficacy

studies in the

following three

cases:

Propan-1-ol;

Propan-2-ol

HOLLUDES

PROMANO

GEL

PT 1

08/04/2020 05/10/2020 Free Not explicitly

indicated in the

derogation

Page 40: Appendix 1 Overview of national measures to make

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

1.Products with

a composition

similar to the

formulations

recommended

by ECDC and/or

WHO;

2.Products

authorised in

other Member

States and for

which virucidal

efficacy has

been assessed

(submit a copy

of the product

authorisation in

a Member State

where virucidal

efficacy has

been assessed);

3.Products

whose efficacy

can be inferred

from their

composition

(submit

justification).

Technical data

sheet, full

composition and

product label

proposal that

will show the

following

indication:

"Exemption

authorization

pursuant to art.

55.1 BPR "

Submission to

be made to:

dgfdm@postace

rt.sanita.it or to

the helpdesk at:

[email protected]

, with

Page 41: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

indication of the

object: “Covid

Emergency-19 -

Request for

authorization in

derogation

pursuant to art.

55 BPR”

Article 55(1)?

Yes ☒

1. Notification:

Art 55(1)_Coronavirus

emergency derogation_IT _HOLLUDES PROMANO MED.pdf 2. National

law(s):

see above

No ☐

Propan-1-ol;

Propan-2-ol

HOLLUDES

PROMANO

MED

PT1 See above 08/04/2020 05/10/2020

Article 55(1)?

Yes ☒☐

1. Notification:

[Insert]

3. National

law(s):

see above

Propan-2-ol Hydrogen

peroxide

Preparato

disinfettante ad

azione

antimicrobica

per frizione

igienica delle

mani (i.e. hands

disinfectant)

PT 1 Professional 15/04/2020 12/10/2020 Free

Article 55(1)?

Yes ☒☐

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SANIK ISOCSAN SOL.pdf

2. National

law(s):

see above

Active chlorine

released from

sodium hypochlorite

SANIK

ISOCSAN SOL

PT 1

PT 2

Professional 22/04/2020 19/10/2020 Free

Article 55(1)?

Yes ☒☐

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_ RIFRAX SAN.pdf

Biphenyl-2-ol RIFRAX SAN PT 2

PT 4

Professional 22/04/2020 19/10/2020 Free

Page 42: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

see above

Article 55(1)?

Yes ☒☐

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT _PERACID FORTE.pdf

2. National

law(s):

see above

Peracetic acid PERACID

FORTE (Trade

names

PERACID

FORTE,

PERACID 150,

OXY Master

150)

PT 2

PT 4

Professional 22/04/2020 19/10/2020 Free

Article 55(1)?

Yes ☒☐

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_PERACID.pdf

2. National

law(s):

see above

Peracetic acid PERACID

(Trade names

PERACID,

PERACID 90,

OXY Master 90,

NEXT PEROX,

L'ENOCLEAN

PERACETIC L)

PT 2

PT 4

Professional 22/04/2020 19/10/2020 Free

Article 55(1)?

Yes ☒☐

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_OXY Master LY 50.pdf

2. National

law(s):

see above

Peracetic acid OXY Master

LY 50

PT 2 Professional 22/04/2020 19/10/2020 Free

Article 55(1)?

Yes ☒☐

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SANIK ISOCSAN SOL SD.pdf

2. National

law(s):

see above

Active chlorine

released from

sodium hypochlorite

SANIK

ISOCSAN SOL

SD

PT 2 Professional 22/04/2020 19/10/2020 Free

Page 43: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_BIOVIRAL – DISINFETTANTE MULTIUSO.pdf 2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

BIOVIRAL –

DISINFETTAN

TE MULTIUSO

PT2 Professional

General public

28/04/2020 26/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_MANO SAN.pdf 2. National

law(s):

No ☐

Propan-2-ol MANO SAN PT1, PT2 Professional 28/04/2020 26/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SIRGERM.pdf 2. National

law(s):

No ☐

Propan-2-ol SIRGERM PT1 Professional 28/04/2020 26/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SOLUZIONE IDROALCOLICA 65% IN GEL n.2.pdf 2. National

law(s):

No ☐

Propan-2-ol SOLUZIONE

IDROALCOLI

CA 65% IN

GEL n.2

PT1 Professional 28/04/2020 26/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Propan-2-ol, Hydrogen

peroxide

SOLUZIONE

IDROALCOLI

CA FORMULA

OMS n.2

PT1 Professional 28/04/2020 26/10/2020

Page 44: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Art

55(1)_Coronavirus emergency derogation_IT_SOLUZIONE IDROALCOLICA FORMULA OMS n.2.pdf 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SOLUZIONE IDROALCOLICA ISOPROPILICO 70%.pdf 2. National

law(s):

No ☐

Propan-2-ol SOLUZIONE

IDROALCOLI

CA

ISOPROPILIC

O 70%

PT2 Professional 28/04/2020 26/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT _CHLOR ACTIVE.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

CHLOR

ACTIVE

PT2 Professional 04/05/2020 02/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_PUBLICARE IGIENIZZANTE MANI.pdf 2. National

law(s):

No ☐

Propan-2-ol

Hydrogen peroxide

PUBLICARE

IGIENIZZANT

E MANI

PT1 Professional 04/05/2020 02/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_DISINFETTANTE PER SUPERFICI.pdf 2. National

law(s):

No ☐

Propan-2-ol

DISINFETTAN

TE PER

SUPERFICI

PT2 Professional 04/05/2020 02/11/2020

Page 45: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_BACTIACT OXY+.pdf 2. National

law(s):

No ☐

Hydrogen peroxide BACTIACT

OXY+

PT2 Professional 04/05/2020 02/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_CHLOR TOP.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

BACTIACT

CHLOR TOP

PT2 Professional 04/05/2020 02/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_BACTIACT CHLOR.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

BACTIACT

CHLOR

PT2 Professional 04/05/2020 02/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SANY-SPECIAL.pdf 2. National

law(s):

No ☐

Propan-2-ol SANY-

SPECIAL

PT 1

PT 2

General Public

Professional

13/5/2020 10/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_IGIENIZZANTE MANI-HAND SANITIZER.pdf

Propan-2-ol IGIENIZZANT

E MANI-

HAND

SANITIZER

PT 1 General Public

Professional

13/5/2020 10/11/2020

Page 46: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SF 300 (5).pdf 2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

SF 300 PT 2

PT 4

Professional 13/5/2020 10/11/2020

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation _IT_CHLOR NEXT SAN PLUS.pdf

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

CHLOR, NEXT

SAN PLUS

PT 2

PT 4

Professional 06/05/2020 03/11/2020

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_FOAM CHLOR, OENOFOAM.pdf

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

FOAM

CHLOR,

OENOFOAM

PT 2, PT 4 Professional 06/05/2020 03/11/2020

Article 55(1)?

Yes ☒

1.

Notificati

Active chlorine

generated from sodium

hypochlorite

SANIFOAM PT 2, PT 4 Professional 06/05/2020 03/11/2020

Page 47: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

on:

Art

55(1)_Coronavirus emergency derogation_IT_SANIFOAM EF, SANIFOAM R.pdf

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_IPOSAN.pdf 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

IPOSAN PT2

PT4

Professional 6/5/2020 3/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_VICHLOR.pdf 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

VICHLOR PT 2 Professional 6/5/2020 3/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_TORESAN.pdf 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

TORESAN PT 2

PT 4

Professional 6/5/2020 3/11/2020

Article 55(1)?

Yes ☒

1.

Notificati

Active chlorine

generated from sodium

hypochlorite

SAN

OENOCLONO

R

PT 2

PT 4

Professional 06/5/2020 03/11/2020

Page 48: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

on:

Art

55(1)_Coronavirus emergency derogation_IT_SAN, OENOCLOR.pdf

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_OXY.pdf 2. National

law(s):

No ☐

Hydrogen peroxide OXY PT 2 Professional General

Public

6/5/2020 3/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_SADEPUR.pdf

2. National

law(s):

No ☐

Propan-2-ol Hydrogen

peroxide

SADEPUR PT 1 Professional 6/05/2020 3/11/2020

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_BIOXCARE DISINFETTANTE SPRAY.pdf

2. National

law(s):

No ☐

Hydrogen Peroxide BIOXCARE

DISINFETTAN

TE SPRAY

PT2

PT4

General Public

Professional

28/05/2020 25/11/2020

Article 55(1)?

Yes ☒

Active chlorine

generated from sodium

hypochlorite

BIOXCARE

DISINFETTAN

TE

PT2

PT4

Professional 28/05/2020 25/11/2020

Page 49: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_BIOXCARE DISINFETTANTE.pdf

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

3. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_DISINFETTANTE MANI.pdf

2. National

law(s):

No ☐

Propan-2-ol DISINFETTAN

TE MANI

PT1 General Public

Professional

28/05/2020 25/11/2020

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_RV 35.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

RV 35 PT 2

PT 4

Professional

Geographical area of

use: Italy

12/06/2020 09/12/2020

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_VIRUGERM.pdf 2. National

law(s):

No ☐

Propan-2-ol VIRUGERM PT 1 General Public

Professional

Geographical area of

use: Italy

12/06/2020 09/12/2020

Article 55(1)? Propan-2-ol PURIMANI PT 1 General Public 12/06/2020 09/12/2020

Page 50: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_ PURIMANI.pdf 2. National

law(s):

No ☐

Professional

Geographical area of

use: Italy

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_ BORMACID 01.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

BORMACID 01 PT 1

PT 2

PT 4

General Public

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_ AMOLLO CLORO.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

AMOLLO

CLORO

PT 2 Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_ CLOROSAN F READY(0).pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

CLOROSAN/F

READY

PT 2

PT 4

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Article 55(1)?

Yes ☒

Active chlorine

generated from

CLOROSAN PT 2

PT 4

Professional 10/06/2020 07/12/2020

Page 51: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_ CLOROSAN.pdf 2. National

law(s):

No ☐

sodium hypochlorite Geographical area of

use: Italy

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_BIANCO GEL.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

BIANCO GEL PT 2

PT 4

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_CLOROSAN_F.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

CLOROSAN/F PT 2

PT 4

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Article 55(1)?

Yes ☒

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_SODIO IPOCLORITO 12-13%.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

SODIO

IPOCLORITO

12-13%

PT 2

PT 4

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Article 55(1)?

Yes ☒

Active chlorine

generated from

sodium hypochlorite

ANOSAN

CONCENTRAT

O

PT 2

PT 4

General Public

Professional

10/06/2020 07/12/2020

Page 52: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_IT_ANOSAN CONCENTRATO.pdf 2. National

law(s):

No ☐

Geographical area of

use: Italy

Article 55(1)?

Yes ☒

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_IT_ANOSAN.pdf 2. National

law(s):

No ☐

Active chlorine

generated from

sodium hypochlorite

ANOSAN PT 2

PT 4

General Public

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Yes ☒

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_IT_LCC26.pdf 2. National

law(s):

No ☐

Propan-2-ol

Hydrogen Peroxide

LCC26 PT 1

PT 2

PT 4

General Public

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Yes ☒

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_IT_LCC27.pdf 2. National

law(s):

No ☐

Propan-2-ol

Hydrogen Peroxide

LCC27 PT 1

PT 2

PT 4

General Public

Professional

Geographical area of

use: Italy

10/06/2020 07/12/2020

Yes ☒

1. Notification

:

Propan-2-ol

ULTRA HG

DISINFETTAN

TE

PT 2

PT 4

General Public

Professional

10/06/2020 07/12/2020

Page 53: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Art

55(1)_Coronavirus emergency derogation_IT_ULTRA HG DISINFETTANTE.pdf 2. National

law(s):

No ☐

Geographical area of

use: Italy

Article 55(1)?

Yes ☒

1. Notification

:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Hydrogen peroxide SPEEDY

CARE Salviette

Mani

Disinfettanti

1 07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Hydrogen peroxide SPEEDY CARE

Gel Mani

Disinfettante

1 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

Active chlorine

generated from sodium

hypochlorite

SPEEDY

CLEAN Panni

Superfici

Disinfettanti

2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Page 54: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

DT 076

SUPERCLOR

2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification

:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Hydrogen peroxide OXIGEN 30 2, 4 Viruses, bacteria,

fungi, spores

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

Hydrogen peroxide TOTAL OXY 2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Page 55: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Propan-2-ol SANIK

ISOCSAN

TECSAN

2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Propan-2-ol SANIK

ISOCSAN

MORE B GEL

MANI

1 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

Propan-2-ol SANIK

ISOCSAN GEL

MANI

1 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Page 56: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification

:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Hydrogen peroxide V SAN OXI 2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

1MM PRONTO 2, 4 Bacteria, fungi,

viruses

07.07.2020

– date of

notification

Page 57: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

1MM

CONCENTRAT

O

2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification

:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Hydrogen peroxide ACQUA DI

MADRAS

CONCENTRAT

O

2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

Hydrogen peroxide ACQUA DI

MADRAS

PRONTO

ALL’USO

2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Page 58: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Propan-2-ol

Propan-1-ol

APESIN Spray

F

PT2, PT4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Lactic acid APESIN SAN 2 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx

Propan-2-ol SANIDORGEL 1 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Page 59: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Propan-2-ol BioDefend PRO

Gel Mani

1 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification

:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Propan-2-ol I880 1, 2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Hydrogen peroxide AL SAN 880 2, 4 Bacteria, fungi,

viruses

07.07.2020

– date of

notification

Page 60: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

IGIENCLORO

DIACLOR GEL

2, 4 Viruses, bacteria,

fungi

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

IGIENCLORO

DIACTIVE

HOSPITAL

2, 4 Viruses, bacteria,

fungi, spores

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

Active chlorine

generated from sodium

hypochlorite

IGIENCLORO

DIACTIVE

2, 4 Viruses, bacteria,

fungi, spores

07.07.2020

– date of

notification

Page 61: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notificati

on:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

IGIENCLORO

DIACLOR

2, 4 Viruses, bacteria,

fungi, spores

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

IGIENCLORO

DIACLOR

SPRAY

HOSPITAL

2, 4 Viruses, bacteria,

fungi, spores

07.07.2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

Active chlorine

generated from sodium

hypochlorite

IGIENCLORO

DIACLOR

SPRAY

2, 4 Viruses, bacteria,

fungi, spores

07.07.2020

– date of

notification

Page 62: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

information

based on

overview table

July 2020

Overview Art55(1)

notifications_July 2020(0).xlsx 2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

VIAGERM

DISINFETTAN

TE PRONTO

ALL’USO

PT2, PT4 Viruses, bacteria,

fungi

13/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

Active chlorine

generated from sodium

hypochlorite

VIAGERM

DISINFETTAN

TE

CONCENTRAT

O

PT2, PT4 Viruses, bacteria,

fungi

13/07/2020

– date of

notification

Page 63: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Propan-2-ol SANALC

SPRAY

SUPERFICI

DISINFETTAN

TE

PT2 Viruses, bacteria,

fungi

13/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Propan-2-ol GENEBACT PT1 Viruses, bacteria,

fungi

20/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

Active chlorine

generated from sodium

hypochlorite

THEMA 710

DISINFETTAN

TE

PT2, PT4 Viruses, bacteria,

fungi, yeasts

20/07/2020

– date of

notification

Page 64: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

THEMA 710

DISINFETTAN

TE SPRAY

PT2, PT4 Viruses, bacteria,

fungi, yeasts

20/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

Active chlorine

generated from sodium

hypochlorite

RESET PLUS

DISINFETTAN

TE

PT2, PT4 Viruses, bacteria,

fungi, yeasts

20/07/2020

– date of

notification

Page 65: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Hydrogen peroxide OXY GEL PT2 Bacteria, fungi,

viruses

20/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Propan-2-ol SANGEN

MEDICAL

SPRAY

DISINFETTAN

TE

PT1, PT2,

PT4

Viruses, bacteria,

fungi, yeasts

20/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

Active chlorine

generated from sodium

hypoclorite

FLORIL CLOR PT2, PT4 Viruses, bacteria,

fungi

20/07/2020

– date of

notification

Page 66: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Propan-2-ol DISINTYLME

D SPRAY

DISINFETTAN

TE

PT1, PT2,

PT4

Viruses, bacteria,

fungi, yeasts

20/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

Propan-2-ol ISODET

superfici

PT2, PT4 Viruses, bacteria,

fungi

20/07/2020

– date of

notification

Page 67: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on: No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Propan-2-ol DERMO GEL PT1 Viruses, bacteria,

fungi

20/07/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notificati

on:

No pdf

available,

information

based on

overview table

July 2020:

Overview Art55(1)

notifications_July 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypoclorite

LYSOFORM W

C GEL

CANDEGGINA

ATTIVA

PT2 Viruses, bacteria,

fungi

20/07/2020

– date of

notification

Article 55(1)?

Yes ☒

Hydrogen peroxide SEPTAVIR

AMBIENTE

PT2 Professionals

04/08/2020

– date of

notification

Page 68: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Used against:

Viruses, bacteria,

fungi

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

SEPTAVIR IPO

SUPERFICI

PT2 Professionals

Used against:

Viruses, bacteria,

fungi

04/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

Lactic acid SEPTAVIR

SOAP

PT1 Professionals

Used against:

Viruses, bacteria,

fungi

04/08/2020

– date of

notification

Page 69: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Hydrogen peroxide SEPTAVIR

OXI

SUPERFICI

PT2 Professionals

Used against:

Viruses, bacteria,

fungi

04/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

Propan-2-ol STERIALCOO

L

PT2 General public,

Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Page 70: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Propan-2-ol STERIGEL PT1 General public,

Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Hydrogen peroxide SILVER

CLEAN

PT2, PT4 Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Page 71: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

DS

CLORODET

PT2, PT4 Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

Active chlorine

generated from sodium

hypochlorite

SANIT GEL PT2, PT4 Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Page 72: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

ARNOX ALTA

SCHIUMA

CLOROATTIV

O

PT2, PT4 Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

ARNOX

BASSA

SCHIUMA

CLOROATTIV

O

PT2, PT4 Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Page 73: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

BICLOR PT2 Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020 - Copy.xlsx

2. National

law(s):

No ☐

Propan-2-ol EOLO

PT2 General public

Professionals

Used against:

Viruses, bacteria,

fungi

05/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

Propan-2-ol GEL MANI

DISINFETTAN

TE HYCLEAN

A70

PT 1 General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 74: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Propan-2-ol SOLUZIONE

MANI

HYCLEAN L-

A70

PT1 General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

Propan-2-ol GEL MANI

DISINFETTAN

TE HYCLEAN

A60

PT1 General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 75: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Propan-2-ol MANI

MASTEK

PT1 General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Hydrogen peroxide FOR OXY

READY

PT2 General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 76: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Propan-2-ol SOLUZIONE

IDROALCOLI

CA

PT1 General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

Peracetic acid SANITIZER

DISINFETTAN

TE SPRAY

OXY PLUS

PT2 Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 77: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Hydrogen peroxide SANITIZER

DISINFETTAN

TE SPRAY

OXY CLEAN

PT2 Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

SANITIZER

DISINFETTAN

TE SPRAY

CLORO

ACTIVE

PT2 Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 78: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

SANITIZER

DISINFETTAN

TE GEL

CLORO

ACTIVE

PT2 Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Hydrogen peroxide SANITIZER

DISINFETTAN

TE OXY

CLEAN

PT2 Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

Active chlorine

released from sodium

hypochlorite

SANITIZER

DISINFETTAN

TE

SOLUZIONE

PT2 Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 79: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

CLORO

ACTIVE

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Propan-2-ol Soluzione

idroalcolica

Maison Berger

PT1 General public

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

Propan-2-ol CLEAN &

SPRAY SPACE

PT2 General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 80: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Propan-2-ol DisintylMED

Gel

Disinfettante

PT1 General public

Professional

Used against:

Viruses, bacteria

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Propan-2-ol Sangen Medical

Gel

Disinfettante

PT1 General public

Professional

Used against:

Viruses, bacteria

10/08/2020

– date of

notification

Page 81: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

ACTIVERAIN

CHLORINE

PT2

PT4

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

Active chlorine

generated from sodium

hypochlorite

SANIFOAM PT2

PT4

General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Page 82: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Propan-2-ol Soluzione

idroalcolica

70% alcol

isopropilico

PT2

PT4

General public

Professional

Used against:

Viruses, bacteria,

fungi

10/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2. National

law(s):

No ☐

Propan-2-ol We2Care+

disinfettante

superfici

PT2 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

Propan-2-ol We2Care+Spray

disinfettante

mani

PT1 General Public and

professional use

02/09/2020

– date of

notification

Page 83: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

September 2020:

2. National

law(s):

No ☐

Against virus,

bacteria, fungi

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

IPO-

VIRUKILL-

CLORITO

KILL-

CLORITO

VIRUCIDA

PT2 Professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

Propan-2-ol We2Care+gel

disinfettante

mani

PT1 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Page 84: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Propan-2-ol HOLLU DES

AL

PT2, PT4 Professional use and

trained professional

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Hydrogen peroxide Oxipro-3 PT2 Professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Page 85: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Hydrogen peroxide OX 7.44 PT2 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification

:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Propan-2-ol CLEAN & DRY

GERM

PT1 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

Active chlorine

generated from sodium

hypochlorite

COVIGEN

ACT

PT2 Professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Page 86: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

September 2020:

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Hydrogen peroxide SANITER®

STRONG

PT2 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

Hydrogen peroxide

Peracetic acid

Enviroplus™

1010

MICROBIOCID

E

PT2 Professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Page 87: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Hydrogen peroxide

Peracetic acid

Enviroplus™

1020

MICROBIOCID

E

PT2 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

Biosperse™

3001

MICROBIOCID

E

PT2 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

Active chlorine

generated from sodium

hypochlorite

CIBA ATOM

PUR

PT1, PT2,

PT4

Professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Page 88: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

September 2020:

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Active chlorine

generated from sodium

hypochlorite

DISINFETTAN

TE SUPERFICI

PROFUMATO

PT2 General Public and

professional use

Against virus,

bacteria, fungi

02/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

Propan-2-ol SPORATEX PT2 General Public and

professional use

Against virus,

bacteria, fungi

07/09/2020

– date of

notification

Page 89: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Propan-2-ol CYD GEL PT1 General Public and

professional use

Against virus,

bacteria, fungi

07/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Propan-2-ol AMOLIQUID PT2 General Public and

professional use

Against virus,

bacteria, fungi

07/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

Propan-2-ol AMOGEL PT1 General Public and

professional use

Against virus,

bacteria, fungi

07/09/2020

– date of

notification

Page 90: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

September 2020:

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

2. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Propan-2-ol HELISAN

AMBIENTI PT2, PT4 General Public and

professional use

Against virus,

bacteria, fungi

07/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

Propan-2-ol HELISAN MANI PT1 General Public and

professional use

Against virus,

bacteria, fungi

07/09/2020

– date of

notification

Page 91: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1. Notification

:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

Propan-2-ol AMOCLEAN®

ISO-SPRAY PT2 General Public and

professional use

Against virus,

bacteria, fungi

07/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

No pdf

available,

information

based on

overview table

September 2020:

2.National

law(s):

No ☐

L-(+)-lactic acid BIOCYD SANY PT2, PT4 General Public and

professional use

Against virus,

bacteria

07/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

Propan-2-ol MANORAPID

r.f.u. PT1 General public

Professional

24/09/2020

– date of

notification

Page 92: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Hydrogen peroxide ACTIVE-OXY 3 PT2 General public

Professional

24/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

Active chlorine

released from sodium

hypochlorite

VAREKINA

CANDEGGINA

DISINFETTANT

E AL CLORO

ATTIVO PER

SUPERFICI

SOLUZIONE

CONCENTRAT

A

PT2

PT4

Professional 24/09/2020

– date of

notification

Page 93: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

VAREKINA

CANDEGGINA

DISINFETTANT

E AL CLORO

ATTIVO PER

SUPERFICI

SOLUZIONE

PRONTA

ALL’USO

PT2

PT4

General public 24/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Active chlorine

released from sodium

hypochlorite

AMOCLEAN

SANIFY PT2

PT4

Professional 24/09/2020

– date of

notification

Page 94: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

DISINFETTANT

E CL-E PT2 Professional

Industrial

24/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

Hydrogen peroxide KEOCID OX 10 PT2 Professional

Industrial

24/09/2020

– date of

notification

Page 95: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Hydrogen peroxide KEOCID OX 35 PT2 Professional

Industrial

24/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

KEOCID CL

ACTIVE PT2 Professional

Industrial

24/09/2020

– date of

notification

Page 96: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Propan-2-ol SANIBIOHAND PT1 General public

Professional

24/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Hydrogen peroxide ACTRIL PT2 Professional 24/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

Active chlorine

released from sodium

hypochlorite

DAGOS CLOR

488 P PT2

PT4

General public

Professional

16/09/2020

– date of

notification

Page 97: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Hydrogen peroxide R.285_BID

HYGI-OX PT2 Professional 16/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

Active chlorine

released from sodium

hypochlorite

ARGONIT

CLORATTIVO PT 2 General public

Professional

14/09/2020

– date of

notification

Page 98: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

No pdf

available,

information

based on

overview table

October 2020:

Overview Art55(1)

notifications_Oct 2020.xlsx

2.National

law(s):

No ☐

Propan-2-ol Tewua soluzione

idroalcolica PT2 General public 14/09/2020

– date of

notification

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_WPH202B.pdf.pdf

2.National

law(s):

No ☐

Hydrogen peroxide WPH202B PT2, PT4 Trained professional

against virus,

bacteria, fungi

19/10/2020 19/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Propan-2-ol PULISVELT

DISINFETTANT

E PER

SUPERFICI

PT2 General public and

professionals against

virus, bacteria, fungi

19/10/2020 19/04/2021

Page 99: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Art

55(1)_Coronavirus emergency derogation_IT_PULISVELT DISINFETTANTE PER SUPERFICI.pdf.pdf

2.National

law(s):

No ☐

Article 55(1)?

Yes ☒

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_IT_DISINFECT POWER ALL.pdf.pdf 2.National

law(s):

No ☐

Propan-2-ol DISINFECT

POWER ALL PT1 General public and

professionals against

virus, bacteria, fungi

19/10/2020 19/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_IT_BioBlu disinfettante.pdf.pdf 2.National

law(s):

No ☐

Propan-2-ol BIO-BLU

DISINFETTANT

E

PT2, PT4 General public and

professionals against

virus, bacteria, fungi

19/10/2020 19/04/2021

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

information

based on

overview table

20 October

2020:

Hydrogen peroxide

DISINFETTAN

TE SUPERFICI

AUTO PT2

General public

Professional

12/10/2020 12/04/2021

Hydrogen peroxide KILLVIR PLUS PT2, PT4 Professional 12/10/2020 12/04/2021

Hydrogen peroxide KILLVIR PT2, PT4

General public

Professional

12/10/2020 12/04/2021

Active chlorine

released from sodium

hypochlorite CLOVIR PLUS PT2, PT4 Professional

12/10/2020 12/04/2021

Active chlorine

released from sodium

hypochlorite CLOVIR PT2, PT4

General public

Professional

12/10/2020 12/04/2021

Page 100: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Overview Art55(1)

notifications_Nov 2020.xlsx

2.National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

SMAC GEL con

CANDEGGINA PT2

General public

Professional

05/10/2020 05/04/2021

Hydrogen peroxide OXINET PT2, PT4 Professional

Propan-2-ol

MANI GEL

FAST Virucida PT1 Professional

12/10/2020 12/04/2021

Hydrogen peroxide OXINET RTU PT2, PT4 Professional 12/10/2020 12/04/2021

Hydrogen peroxide OXY 70 PT2, PT4

General public

Professional

12/10/2020 12/04/2021

Active chlorine

released from sodium

hypochlorite

SMAC express

Candeggina +

Sgrassatore PT2

General public

Professional

05/10/2020 05/04/2021

Active chlorine

released from sodium

hypochlorite

WC NET

CANDEGGINA

GEL –

Mountain fresh PT2

General public

Professional

05/10/2020 05/04/2021

Active chlorine

released from sodium

hypochlorite

WC NET

CANDEGGINA

GEL – Ocean

fresh PT2

General public

Professional

05/10/2020 05/04/2021

Active chlorine

released from sodium

hypochlorite

P1 RTU

VIRUCIDA PT2, PT4 Professional

05/10/2020 05/04/2021

Peracetic acid

PHAGO’SPOR

E PT2, PT4 Professional

05/10/2020 05/04/2021

Peracetic acid STEP 44 PT2 Professional 05/10/2020 05/04/2021

Active chlorine

released from sodium

hypochlorite IPO 20 PT2, PT4 Professional

05/10/2020 05/04/2021

Active chlorine

released from sodium

hypochlorite SANI-CLOR PT2

General public

Professional

12/10/2020 12/04/2021

Active chlorine

released from sodium

hypochlorite

BACTOCCID PT2, PT4 General public

Professional

21/10/2020 20/04/2021

Active chlorine

released from sodium

hypochlorite

CLEANFOAM

CHLOR 300

PT2, PT4 Professional 21/10/2020 20/04/2021

Active chlorine

released from sodium

hypochlorite

CHLOROSAN

FORTE

PT2, PT4 Professional 21/10/2020 20/04/2021

Active chlorine

released from sodium

hypochlorite

REV CHLOR

CD

PT2, PT4 Professional 21/10/2020 20/04/2021

Page 101: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Active chlorine

released from sodium

hypochlorite

BIO CHLOR

AL

PT2, PT4 Professional 21/10/2020 20/04/2021

Active chlorine

released from sodium

hypochlorite

DAILY

CHLOR

PT2, PT4 Professional 21/10/2020 20/04/2021

unknown SUPER BIO

600

PT2, PT4 Professional 21/10/2020 20/04/2021

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

Update in

overview Article

55(1)

notifications

December 2020

Overview Art55(1)

notifications_Dec 2020(0).xlsx 2.National

law(s):

No ☐

Propan-2-ol BIOVIRAL

ACTIVE SPRAY PT2 General public 28/10/2020 26/04/2021

Hydrogen Peroxide ICESAN OXI

SOLUTION PT2, PT4

General public

Professional 28/10/2020 26/04/2021

Hydrogen Peroxide OXISKIN PLUS PT1

General public

Professional 28/10/2020 26/04/2021

Hydrogen Peroxide OXY CLEAN PT2, PT4 Professional 28/10/2020 26/04/2021

Active chlorine

released from sodium

hypochlorite SANACLOR PT2, PT4 Professional 28/10/2020 26/04/2021

Active chlorine

released from sodium

hypochlorite FAST CLOREX PT2, PT4 Professional 28/10/2020 26/04/2021

Hydrogen peroxide OXY DEL PT2 Professional 28/10/2020 26/04/2021

Hydrogen peroxide VIRUS STOP

PLUS PT2

General public

Professional 04/11/2020 03/05/2021

Lactic acid TASKI SANI 4 IN

1 PLUS SPRAY PT2

Professional 04/11/2020 03/05/2021

Lactic acid TASKI SANI 4 IN

PLUS PT2

Professional 04/11/2020 03/05/2021

Propan-2-ol ITIALCOHOL 70

D

PT2, PT4 General public

Professional 04/11/2020 03/05/2021

Hydrogen Peroxide BATGRAM

PT2, PT4

Professional

Notificatio

n date

30/11/2020

Active chlorine

released from sodium

hypochlorite ACE WC Gel

Candeggina

PT2

General public

Professional 04/11/2020 03/05/2021

Active chlorine

released from sodium

hypochlorite ACE Spray Mousse

Candeggina

PT2

General public

Professional 04/11/2020 03/05/2021

Active chlorine

released from sodium

hypochlorite ACE Denso Più

PT2

General public

Professional 04/11/2020 03/05/2021

Active chlorine

released from sodium

hypochlorite ACE CLASSICA

PT2

General public

Professional 04/11/2020 03/05/2021

Propan-2-ol SPRAYCID - 19 PT1, PT2 General public 04/11/2020 03/05/2021

Hydrogen Peroxide OP MULTI PIU’ PT2 Professional 04/11/2020 03/05/2021

Page 102: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Active chlorine

released from sodium

hypochlorite CANDEGGINA

CANDEX SAN 2, 4 Professional 11/11/2020 10/05/2021

Active chlorine

released from sodium

hypochlorite

DISINFETTANTE

AL CLORO

ATTIVO SPRAY

PT2, PT4

General public

Professional 11/11/2020 10/05/2021

Active chlorine

released from sodium

hypochlorite CL17 PLUS

PT2, PT4

Professional 11/11/2020 10/05/2021

Propan-2-ol CLEAN & SPRAY

GERM PT1

General public

Professional 11/11/2020 10/05/2021

Hydrogen peroxide INFINITY H2O2 PT2, PT4 Trained professional 11/11/2020 10/05/2021

Hydrogen peroxide IGIENOX

PT2, PT4 General public

Professional 11/11/2020 10/05/2021

Hydrogen peroxide ARGONIT

OXIGEN

PT2 General public

Professional 11/11/2020 10/05/2021

Hydrogen peroxide ARGONIT

OXIGEN 10C

PT2 Industrial

Professional 11/11/2020 10/05/2021

Propan-2-ol SEPTISOL GEL 75

C20 PT1

General public

Professional 11/11/2020 10/05/2021

Propan-2-ol SANYDROPS PT2 Professional 11/11/2020 10/05/2021

Hydrogen peroxide SANYPEROX

PROFESSIONAL PT2

Professional 11/11/2020 10/05/2021

Hydrogen peroxide SANYPEROX PT2 General public 11/11/2020 10/05/2021

Propan-2-ol SIRGEL PT1 General public 11/11/2020 10/05/2021

Propan-2-ol SIRPROTECT PT1, PT2 General public 11/11/2020 10/05/2021

Propan-2-ol IGIEN CUTE

PT1 General public

Professional 27/11/2020 26/05/2021

Propan-2-ol

IGIEN

SURFACE&TEXT

ILE

PT1 General public

Professional 27/11/2020 26/05/2021

Active chlorine

released from sodium

hypochlorite PLURI IGIEN

DISINFETTANTE

PT2

Professional 27/11/2020 26/05/2021

Active chlorine

released from sodium

hypochlorite HYDRUS

PT2

Professional

Notificatio

n date

11/12/2020

Propan-2-ol SANAGIEN CUTE PT1

General public

Professional 27/11/2020 26/05/2021

Hydrogen peroxide

Peracetic acid SANAGIEN

PT2 General public

Professional 27/11/2020 26/05/2021

Hydrogen peroxide OXYVIR Excel PT2 Professional 27/11/2020 26/05/2021

Hydrogen peroxide OXYVIR Excel

Foam PT2

Professional 27/11/2020 26/05/2021

Hydrogen peroxide OXIVIR EXCEL

WIPE PT2

Professional 27/11/2020 26/05/2021

Hydrogen peroxide

Peracetic acid DECCOSAN 5% PT2, PT4 Professional 27/11/2020 26/05/2021

Page 103: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Active chlorine

released from sodium

hypochlorite

LAVAVERDE

DISINFETTANTE

SUPERFICI

PT2

Professional 27/11/2020 26/05/2021

Active chlorine

released from sodium

hypochlorite

LAVAVERDE

DISINFETTANTE

PAVIMENTI

PT2

General public

Professional 27/11/2020 26/05/2021

Lactic acid

EVOGEN

PROFESSIONAL

CONCENTRATO

DISINFETTANTE

MULTIUSO

PT2, PT4

Professional 25/11/2020 24/05/2021

Hydrogen peroxide

SADEPUR

GRANDI

SUPERFICI

PT2, PT4 General public

Professional 25/11/2020 24/05/2021

Propan-2-ol

SADEPUR

SUPERFICI

DELICATE PT2, PT4 Professional 25/11/2020 24/05/2021

Propan-2-ol VIRUCID IPA PT2 Professional 25/11/2020 24/05/2021

Propan-2-ol

ALA SALVIETTE

DISINFETTANTI

MANI E

SUPERFICI PT1, PT2

General public

Professional 18/11/2020 17/05/2021

Hydrogen peroxide SANEOS PT2, PT4 Professional 20/11/2020 19/05/2021

Hydrogen peroxide PULOXI

PT2, PT4 General public

Professional 20/11/2020 19/05/2021

Hydrogen peroxide M 7 OXYGEN

PT2, PT4 General public

Professional 20/11/2020 19/05/2021

Active chlorine

released from sodium

hypochlorite TERACHLOR

ACT

PT2, PT4

Professional 20/11/2020 19/05/2021

Hydrogen peroxide OXIMAX 2.0

PT2, PT4 General public

Professional 20/11/2020 19/05/2021

Active chlorine

released from sodium

hypochlorite EVERCIDE PT2 Professional 20/11/2020 19/05/2021

Propan-2-ol BIOCLEAN PT2, PT4 Professional 20/11/2020 19/05/2021

Hydrogen peroxide ECOCLEARPROX

7.9% PT2, PT4

Professional 20/11/2020 19/05/2021

Hydrogen peroxide PEROXY PT2 General public 18/11/2020 17/05/2021

Hydrogen peroxide

Desir Xsan

DISINFETTANTE

PER SUPERFICI

PT2

General public 18/11/2020 17/05/2021

Hydrogen peroxide

Desir Xsan

DISINFETTANTE

PER PAVIMENTI

e SUPERFICI

PT2

Professional 18/11/2020 17/05/2021

Hydrogen peroxide BIOZONO®

LIGHT C20

PT2 General public

Professional 18/11/2020 17/05/2021

Page 104: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Active chlorine

released from sodium

hypochlorite OSSINA

PT2, PT4

Professional 18/11/2020 17/05/2021

Active chlorine

released from sodium

hypochlorite CANDEGGINA

CANDEX GEL

PT2, PT4

General public 18/11/2020 17/05/2021

Active chlorine

released from sodium

hypochlorite CHLORINE

DISINFECTANT

PT2, PT4

General public 18/11/2020 17/05/2021

Active chlorine

released from sodium

hypochlorite DISINFETTANTE

SUPERFICI IPO

PT2, PT4

Professional 18/11/2020 17/05/2021

Propan-2-ol

GEL

DISINFETTANTE

MANI PT1 General public 18/11/2020 17/05/2021

Active chlorine

released from sodium

hypochlorite ITICHLOR GEL D PT2 Professional 18/11/2020 17/05/2021

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

Update in

overview Article

55(1)

notifications

January 2021

Overview Art55(1)

notifications_Jan 2021 (1).xlsx

2.National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite

SANIKLOR PT2, PT4 Professional 28/12/2020 28/06/2021

Active chlorine

released from sodium

hypochlorite

IGE 04 PT2, PT4 Professional 28/12/2020 28/06/2021

Active chlorine

released from sodium

hypochlorite

GEMCLOR 15 SD PT2, PT4 Professional 28/12/2020 28/06/2021

Propan-2-ol GELVIR PT1 Professional 28/12/2020 28/06/2021

Page 105: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Propan-2-ol SEPTISOL

WHO C 20

PT1 General public 28/12/2020 28/06/2021

Active chlorine

released from sodium

hypochlorite

BIOFORM

PLUS CLORO

ATTIVO

PT2, PT4 General public

Professional

28/12/2020 28/06/2021

Propan-2-ol OZOCIDINA

ISO-GERM

PT1 General public

Professional

28/12/2020 28/06/2021

Active chlorine

released from sodium

hypochlorite

FARM-OXI PT2, PT4 General public 28/12/2020 28/06/2021

Peracetic acid IGIENTEX

OXY PLUS

PT2 Professional 28/12/2020 28/06/2021

Hydrogen peroxide OXYGEL + PT2 General public 16/12/2020 15/06/2021

Hydrogen peroxide CLIMAPUR PT2

General public

Professional 16/12/2020 15/06/2021

Hydrogen peroxide OXY SPRAY PT2, PT4 Professional 16/12/2020 15/06/2021

Active chlorine

released from sodium

hypochlorite

IPO SPRAY PT2, PT4 Professional 16/12/2020 15/06/2021

Hydrogen Peroxide XTRA-OXY PT2 Professional 07/12/2020 07/06/2021

Propan-2-ol ALCOL

SPRAY IPA

DISINFETTAN

TE PER

SUPERFICI

PT2 Professional 16/12/2020 15/06/2021

Hydrogen peroxide MULTI GEN

PRO

PT2, PT4 General public

Professional

07/12/2020 07/06/2021

Active chlorine

released from sodium

hypochlorite

CLORO

SPRAY

DISINFETTAN

TE

PT2, PT4 General public 07/12/2020 07/06/2021

Hydrogen Peroxide OXIDAL

AT/PU

PT2, PT4 Professional 07/12/2020 07/06/2021

Hydrogen Peroxide OXIDAL PU PT2, PT4 General public

Professional

07/12/2020 07/06/2021

Hydrogen Peroxide OXIDAL PT2, PT4 Professional 07/12/2020 07/06/2021

Hydrogen Peroxide AD VANXE

GEL MANI

DISINFETTAN

TE

PT1 General public 07/12/2020 07/06/2021

Hydrogen Peroxide AD VANXE

SPRAY SPORT

PT2 General public 07/12/2020 07/06/2021

Page 106: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

DISINFETTAN

TE

Hydrogen Peroxide SPALDING

SANIBALL

SPRAY SPORT

DISINFETTAN

TE

PT2 General public 07/12/2020 07/06/2021

Hydrogen Peroxide SPALDING

GEL MANI

DISINFETTAN

TE

PT1 General public 07/12/2020 07/06/2021

Latvia Article 55(1)?

Yes ☒

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_LV.pdf 2. National

law(s):

Order of

Latvian

Environment

Geology and

Meteorology

Centre

(LEGMC) of 19

March 2020

No ☐

Ethanol WHO I

Formulation

PT 1 Pharmacies only 19/03/2020 14/09/2020 Substance may

not be purchased

from entities not

listed on Article

95 List

Latvian Environment, Geology

and Meteorology Centre

[email protected]

+371 67 032 600

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_LV_DEZIZO75.pdf 2. National

law(s):

No ☐

Propan-2-ol DEZIZO75 PT 1

PT 2

General public

Professional user

8/5/2020 4/11/2020

Lithuania Article 55(1)?

Yes ☐

1. Notification:

Nothing on

circabc yet

[Insert]

Ethanol WHO

Formulation I

PT 1 Professional users;

General public

For all applications:

No permission of

efficacy claims

05/03/2020 180 days Free When placing a

product on the

market email to

[email protected]

containing name

of the person,

Not regulated

by mentioned

Order No

VKE-88

National Public Health Centre

under the Ministry of Health

[email protected]

+370 5 264 9676

Page 107: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

VKE-88

consolidated_LT.pdf Original

Decree, and

Consolidated

version as of 30

April 2020.

No ☐

[Insert]

against SARS-CoV-

2 when no efficacy

test available

placing on the

market and

volume of the

delivered

product

Luxembourg Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_LU_ethanol_propan-2-ol.pdf 2. National

law(s):

[Insert]

No ☐

Ethanol

Propan-2-ol

WHO

Formulation I

and II

PT 1 Distribution of

products only

through pharmacies

26/03/2020 15/09/2020 Administration de

l'environnement Unité substances

chimiques et produits Biocides

[email protected]

+352 40 56 56 300

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_LU_Lerasept WHO.pdf 2. National

law(s):

[Insert]

No ☐

isopropanol Lerasept®

WHO

PT 1 Professional Users 4/05/2020 31/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_LU_Difrulux_Robhydral.pdf

2. National

law(s):

[Insert]

No ☐

Ethanol WHO

Formulation I

Difrulux-

formulation

6075

Difrulux- WHO

Typ I

formulation

PT 1 General public

Professional user

06/04/2020 03/10/2020

Page 108: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

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exports/

imports

Contact Details

Difrulux-

formulation

6098875

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_LU_Difrulux_Robhydral.pdf

2. National

law(s):

[Insert]

No ☐

Ethanol WHO

Formulation I

Robhydral L-

28464

PT 1 General public

Professional user

09/04/2020 06/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_LU_Difrulux_Robhydral.pdf

2. National

law(s):

[Insert]

No ☐

Ethanol

Propan-2-ol

WHO

Formulation II

Robhydral L-

28460

PT 1 General public

Professional user

09/04/2020 06/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation _LU_PS-Stérile Solution hydro-alcoolique.pdf

2. National

law(s):

[Insert]

No ☐

Ethanol PS-Stérile

Solution hydro-

alcoolique

PT 1 General public

Professional user

25/05/2020 21/11/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation _LU_Desinf-K.pdf

Isopropanol Desinfektionsmi

ttel K

PT 1 Professional user 25/05/2020 21/11/2020

Page 109: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

[Insert]

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_LU_Kenolox 10.pdf 2. National

law(s):

[Insert]

No ☐

Lactic acid

Hydrogen peroxide

Kenolox 10 PT 2

PT 4

General public

Professional user

The AH has the

obligation to keep

record quantities

placed on the

market.

The authorisation

can be withdrawn

before the date of

expiry.

Selling-out of

remaining stocks is

not possible after

revocation/expiratio

n.

12/06/2020 09/12/2020

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_LU_Oxivir Excel - FOAM.pdf

2. National

law(s):

[Insert]

No ☐

Hydrogen peroxide Oxivir Excel -

FOAM

PT 2

PT 4

Professional user

Geographical area of

use: Luxembourg

18/6/2020 15/12/2020

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_LU_Oxivir Excel - WIPE.pdf

2. National

law(s):

[Insert]

Hydrogen peroxide Oxivir Excel -

WIPE

PT 2

PT 4

Professional user

Geographical area of

use: Luxembourg

18/6/2020 15/12/2020

Page 110: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_LU_Oxivir Excel.pdf

2. National

law(s):

[Insert]

No ☐

Hydrogen peroxide Oxivir Excel PT 2

PT 4

Professional user

Geographical area of

use: Luxembourg

18/6/2020 15/12/2020

Malta Article 55(1)?

Yes ☒

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_MT.pdf 2. National

law(s):

[Insert]

No ☐

Ethanol, Propan-2-ole Handex Hand

Sanitizer

Refreshing Gel

PT 1 Alcohol based

products which do

not contain

impurities or

components

classified as

carcinogenic

category 1.

15/03/2020 15/06/2020 €100 Substance may

not be purchased

from entities not

listed on Article

95 List

Malta Competition and Consumer

Affairs Authority

[email protected]

+356 2395 2000

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_MT_Alcohol Sanitizer Darren Vassallo MT.pdf 2. National

law(s):

[Insert]

No ☐

Propan-2-ol Alcohol

Sanitizer 2020-

03-28-B01;

Darren Vassallo

MT

PT 1 Professional,

General public

28/03/2020 28/06/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_MT_Morgan's Hand Sanitising Gel - Kemimport.pdf

Propan-2-ol Morgan's Hand

Sanitising Gel

2020-04-17-

B01;

Kemimport Ltd

MT

PT 1 General Public 17/04/2020 17/07/2020

Page 111: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

[Insert]

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_MT_Prime Guard Hand Sanitizer - SKAT.pdf 2. National

law(s):

[Insert]

No ☐

Propan-2-ol Prime Guard

Hand Sanitizer

2020-04-13-

B01; SKAT Ltd

MT

PT 1 Professional,

General public

13/04/2020 13/07/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_MT_WHO recommended handrub formulation_propan-2-ol.pdf 2. National

law(s):

[Insert]

No ☐

Isopropyl alcohol WHO-

recommended

handrub

formulation

2020-03-18-

B01; The Bio

Arte Limited

MT

PT 1 Professional,

General public

26/03/2020 26/06/2020

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_MT_Ultra HG.pdf

2. National

law(s):

[Insert]

No ☐

Propan-2-ol Ultra HG PT2 Professional 24/05/2020 24/08/2020

Article 55(1)?

Yes ☒

Propan-2-ol Sanitaz PT1 General public 18/05/2020 18/08/2020

Page 112: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_MT_Sanitaz.pdf

2. National

law(s):

[Insert]

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_MT_PERACLEAN® 5.pdf

2. National

law(s):

[Insert]

No ☐

Peracetic acid PERACLEAN®

5 2020-05-05-

B01; Evonik

Resource

Efficiency

GmbH

PT2

PT4

Professional 05/05/2020 5/08/2020

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_MT_OX-AIRE CONDUCTOS.pdf

2. National

law(s):

[Insert]

No ☐

Hydrogen Peroxide OX-AIRE

CONDUCTOS

PT2

PT4

Professional 24/05/2020 24/08/2020

Article 55(1)?

Yes ☒

1.

Notificati

on:

Propan-2-ol Isopropyl Wipes

2020-04-30-

B03; Signature

Entertainment

Festivals

Limited MT

PT2 Professional 30/04/2020 30/07/2020

Page 113: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Art

55(1)_Coronavirus emergency derogation_MT_Isopropyl Wipes.pdf

2. National

law(s):

[Insert]

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_MT_Hand sanitizer.pdf

2. National

law(s):

[Insert]

No ☐

Propan-2-ol Hand Sanitizer PT1 Professional 18/05/2020 18/08/2020

Netherlands Article 55(1)?

Yes ☒

1. Notification:

UPDATE 1

Art

55(1)_Coronavirus emergency derogation_NL Second exemption pharmacies.pdf.pdf 2. National

law(s):

No ☐

Ethanol

Glycerol

Propan-2-ol

Products for

hand

disinfection

formulated by

the Laboratory

of Pharmacists

in The

Netherlands

(LNA) and

subject either to

Dutch national

Law or the BPR

PT 1 Professional users in

the healthcare sector

SARS-CoV-2

06/09/2020 04/03/2021

Contact details:

Ministry of Infrastructure and

Water Management (RIVM)

[email protected]

Article 55(1)?

Yes ☒

1. Notification:

UPDATE 1

Art

55(1)_Coronavirus emergency derogation_NL Second exemption Authorised products without virucidal claim.pdf.pdf 2. National

law(s):

[Insert]

Products with at least

one of the

following active

substances:

• Alcohols (minimum

70%);

• Hydrogen peroxide

(minimum 0,5%); and

• Sodium Hypochlorite

(minimum 0,1%).

Products

authorised under

Dutch

National Law or

the BPR, for

hygienic hand

disinfection

(without a

virucidal claim)

PT 1 Professional user

SARS-CoV-2

10/09/2020 04/03/2021

Page 114: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1. Notification

UPDATE 1:

Art

55(1)_Coronavirus emergency derogation_NL Second exemption disinfection surfaces.pdf.pdf 2. National

law(s):

[Insert]

No ☐

Biocides contain at

least one of the

following substances:

• Alcohols (minimum

70%);

• Sodium Hypochlorite

(minimum 0,025%

active Chlorine); and

• Sodium Dichloro

Isocyanurate

(in a user concentration

of minimum 1.000

ppm active Chlorine).

Products

authorised under

Dutch National

Law or the BPR,

without a

virucidal claim,

for disinfection

of surfaces in

healthcare,

cosmetic or

pharmaceutical

industry or for

use in spaces for

human

residence.

PT 2 For professional

healthcare and

pharmaceutical

industry

SARS-CoV-2

21/09/2020 04/03/2021

Article 55(1)?

Yes ☒

1. Notification:

UPDATE 1

Art

55(1)_Coronavirus emergency derogation_NL Second exemption WHO formulations.pdf.pdf 2. National

law(s):

See above

No ☐

Formulation 1:

Ethanol

Glycerol

Hydrogen peroxide

Formulation 2:

Propan-2-ol

Glycerol

Hydrogen peroxide

WHO-

recommended

formulations

for hygienic

hand

disinfection

(formulations

Ethanol and

Propan2-ol)

PT 1 For professional

SARS-CoV-2

11/09/2020 04/03/2021

Article 55(1)?

Yes ☒

1. Notification:

UPDATE 1

Art

55(1)_Coronavirus emergency derogation_NL Second exemption disinfection products easier on the marketx.pdf.pdf 2. National

law(s):

[Insert]

No ☐

The disinfectants

contain at least one of

the following active

substances Ethanol

Propan-1-olPropan-2-

ol Hydroxen peroxide

(only PT1) Sodium

hypochlorite Sodium

dichloro isocyanurate

(only PT2)

Products for

disinfection that

are authorized to

the Dutch

market under

Dutch National

Law, the BPR

(except for

Union

Authorisations)

against viruses

(including

SARS-CoV-2),

for the

disinfection of

hands (PT1) or

surfaces (PT2),

and the products

PT 1

PT 2

Professional user in

healthcare

SARS-CoV-2

30/09/2020 04/03/2021

Page 115: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

that are

temporarily

released for the

disinfection of

hands and

surfaces under

the Temporary

exemptions for

hand

disinfection and

the disinfection

surfaces:

1.in packaging

other than that

specified in the

authorization;

2. produced at

locations other

than specified in

the

authorization ;

3. provided with

a label, other

than in the

Dutch language,

in English;

4.supplied in

ready-to-use

dilutions, other

than the

concentrated

solution such as

is specified in

the

authorization.

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_NL adding user category pharma industry to existing exemption (1).pdf

2. National

law(s):

[Insert]

No ☐

The disinfectants

contain at least one

of the following active

substances

Ethanol

Propan-1-ol,

Propan-2-ol

Hydroxen peroxide

(only PT1)

Products

authorised under

Dutch

National Law or

the BPR, for

hygienic hand

disinfection

(without

a virucidal

claim) and the

products

PT 1

PT 2

Professional users in

the

pharmaceutical

industry

10/04/2020 29/09/2020

Page 116: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

that are

temporarily

released for the

disinfection of

hands and

surfaces in

the health care

sector under

four

temporary

exemptions, for

hand

disinfection and

the disinfection

of

surfaces.

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_NL professional use disinfectants.pdf 2. National

law(s):

[Insert]

No ☐

Ethanol

Propan-1-ol,

Propan-2-ol

Hydroxen peroxide

Sodium hypochlorite

Products

authorised under

Dutch National

Law or the BPR,

for hygienic

hand

disinfection

(with a virucidal

claim) and the

products that are

temporarily

released for

hygienic hand

disinfection in

the health care

sector under

temporary

exemptions.

PT1 Professional users 01/06/2020 29/09/2020

Poland Article 55(1)?

Yes ☒

1. Notification:

Art 55(1)_Emergency

derogation_PL_Propan-2-ol_ethanol products.pdf 2. National

law(s):

Registration

under national

procedure

Ethanol

Propan-2-ol

Combination of active

substances

Biocides with

the active

substances

PT 1

PT 2

PT 4

10/03/2020

Update

10/09/2020

31/10/2020

Update

10/03/2021

Export ban

of sanitizers

from Poland

has been

entirely

repealed.

Article 7.1 of

the above

Polish Act

still refers to

protective

clothing like

coveralls,

Office for Registration of

Medicinal Products, Medical

Devices and Biocidal Products

Biocidal Products Assessment

Unit

[email protected]

[email protected]

+48 22 49 20 900

Page 117: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐ masks,

gloves

(export of

protective

clothing can

be banned)

but excludes

sanitizers

Portugal Article 55(1)?

Yes ☐

1. Notification:

Nothing on

circabc yet

2. National

law(s):

[Insert]

No ☐

[Insert]

Portuguese

Competent

Authorities for

Biocides – DGS

and DGAV:

Exceptional

measures during

the pandemia for

biocide products

PT1, PT2 and

PT4

Doc

IAPMEI-DGS-DGAV - Desinfetantes_Requisitos-e-procedimentos-estabelecidos-pela-Autoridades-Competentes_27.04.2020.pdf

Active substances not

yet approved by BPR

but part of the

evaluation program,

for example ethanol

(CAS64-17-5), CHDG

(CAS18472-51-0).

(including ethanol

from agriculture or

wine/beer – after

distillation – but only

for PT 1 products).

Approved active

substances: for

example, isopropanol

(CAS67-63-0), Propan-

1-ol (CAS71-28-3),

sodium hypochlorite

(CAS7681-52-9),

hydrogen peroxide

(CAS772-84-1)

All products that

claim biocide

action

(disinfectant,

bactericidal,

virucide) or any

action able to

fight

microorganisms

PT 1 PT 2

PT 4

Domestic and

professional uses.

For AS not yet

approved: Existing

notifications/authori

zations for PT1,

PT2, PT4 remain

valid.

New products:

Notification of

PT1,PT2,PT4 to CA,

should include

mainly,

identification of the

biocide product,

SDS of the AS, SDS

of the BP, prove of

notification in NPC,

declaration that the

AS supplier is in the

list of art. 95 of BPR

or if the supplier of

the AS is not listed,

a declaration

identifying the

origin and

manufacturer of the

AS.

For AS approved by

BPR:

Existing

notifications/authori

zations for

PT1,PT2,PT4

remain valid.

New products:

Notification of

The day

after the

notification

is sent to

DGS (by

email).

The day

DGAV

confirms

(by email)

that the

submission

was

received.

(by email)

The

existing BP

notification

s/authorizat

ions remain

valid

during the

pandemic

period,

even if the

AS are

already

approved

by BPR.

For new

BP

notification

s/authorizat

ions:

180 days

after the

day after

the

notification

is sent to

DGS (by

email).

180 days

after the

companies

receives

(by email)

the

confirmatio

n from

DGAV that

the

submission

Free The supplier of

the AS (already

approved or not)

may not be

included in

ECHA`s art. 95

list.

No LoA is

required.

Imported

products

from any

other

country,

including EU

and EEA

should

comply with

the national

(exceptional)

rules.

Export: No

restrictions

Direção-Geral da Saúde (DGS)

[email protected]

+351 218 430 500

https://www.dgs.pt/

Direção-Geral da Alimentação e

Veterinária (DGAV)

[email protected]

+351 213 239 500

www.dgav.pt

Page 118: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

PT1,PT2,PT4to CA,

should include

mainly,

identification of the

biocide product,

SDS of the AS, SDS

of the BP, prove of

notification in NPC,

declaration that the

AS supplier is in the

list of art. 95 of BPR

or if the supplier of

the AS is not listed,

a declaration

identifying the

origin and

manufacturer of the

AS.

was

received.

Due to the

ongoing

pandemic

situation,

the

exceptional

notification

s will

remain

valid until

31 January

2021, in

most

situations

(see the

2nd

document

included in

the

"Procedure

" column).

Romania Article 55(1)?

Yes ☐

1. Notification:

Nothing on

circabc yet

2. National

law(s):

Article 10 of

Military

Ordinance no. 4

No ☐

Only punctually to

biocidal industries

that have a solid

experience

Export

restriction

seems to be

in place "Art.

11. -

(1) Are

excepted

from the

provisions of

art. 1 the

biocidal

products

manufacture

d by the

Romanian

producers, as

well as be

producers of

EU states

with office in

Romania,

including

those

Ministry of Health

National Committee for Biocidal

Products

[email protected]

+40 21 311 86 20

Information from Ministry:

'Article 10 - (1) during the state of

emergency, the Center for Medical-

Military Scientific Research, the Center

for Scientific Research on Defense,

CBRN1 and Ecology, the Research

Agency for Military Technical and

Technology and the national Institute

for Research on Medical-Military

Development "Cantacuzino" shall be

authorized for the

approval/authorization of materials,

components, Medical equipment and

devices necessary for the prevention and

control of spread, as well as for the

Page 119: Appendix 1 Overview of national measures to make

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

manufacture

d under

contract, as

well as

biocidal

products that

transit

Romania's

territory and

are intended

for other

markets

outside the

Romania's

territory."

treatment of SAR-CoV-2 virus infection

and biocids respectively.’

Slovak

Republic

Article 55(1)?

Yes ☒

1. Notification:

See below

2. National

law(s):

No ☐

[Insert]

Ethanol

Isopropanol

Peracetic acid

Hydrogen peroxide, as

specified below.

Klercide 70/30 IPA

Klercide Sporicidal

Low Residue

Peroxide

Klercide Sporicidal

Enhanced Peroxide

INCIDIN

OXYFOAM S

DrySan Oxy

Ozonit Super

Ozonit

PERformance

Hyg-dez surface

Fortea VIRUS

KILLER

Lactosan HPX

2,5%

DusIPA

DusIPA G

DEZIX

Dezinfekčný

prípravok na ruky s

izopropylalkoholo

m

CHLÓRNAN

SODNÝ C19, as

listed below.

PT 1 PT 2

PT 4, as

specified

below.

Obligation to collect

and keep records of

sale volumes,

customer

identifications etc. in

the whole supply

chain, lies with the

decision holder

See below See below Free Article 95

applies

(2) As part of

a declared

emergency

regulatory

measure, the

Government

imposes a

ban on the

export of

certain vital

goods from

the Slovak

Republic to

another

Member

State of the

European

Union or to a

State party to

the

Agreement

on the

European

Economic

Area and to

third

countries no

matter where

they were

manufacture

d. These are:

Ministry of Economy of the

Slovak Republic

Centre for Chemical Substances

and Preparations

Biocides Unit

[email protected]

+4212 4854 4513

+421 907 957 583

Page 120: Appendix 1 Overview of national measures to make

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

a) the

personal

protective

equipment

listed in the

Annex,

b)

antibacterial

soaps, gels

and

disinfectants,

c) artificial

lung

ventilation

devices.

(3) Export of

vital goods

pursuant to

paragraph 2

from the

Slovak

Republic to

another

Member

State of the

European

Union or to

a State party

to the

Agreement

on the

European

Economic

Area or to

third

countries

shall be

authorized

by the

Government

in

exceptional

cases."

Article 55(1)?

Yes ☒

1. Notification:

Hydrogen peroxide;

CAS 7722-84-1

INCIDIN

OXYFOAM S

PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

02/04/2020

Update

30/9/2020

29/09/2020

Update

28/3/2021

Page 121: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Art

55(1)_Coronavirus emergency derogation_SK_INCIDIN OXYFOAM S.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

[Insert]

identifications etc. in

the whole supply

chain, lies with the

decision holder.

professional

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Klercide 70-30 IPA.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

[Insert]

Propan-2-ol; CAS 67-

63-0

Klercide 70/30

IPA

PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

professional

02/04/2020

Update

30/9/2020

29/09/2020

Update

28/3/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Klercide Sporicidal Enhanced Peroxide.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

Hydrogen peroxide;

CAS 7722-84-1

Klercide

Sporicidal

Enhanced

Peroxide

PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

professional

02/04/2020

Update

30/9/2020

29/09/2020

Update

28/3/2021

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Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

[Insert]

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Lacto San HPX 2,5%.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

[Insert]

Hydrogen peroxide;

CAS 7722-84-1

Lactic acid; CAS 79-

33-4

Lacto San HPX

2,5%

PT 1

PT 4

Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

professional

06/04/2020

Update

1/10/2020

03/10/2020

Update

29/03/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Ozonit Super.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

[Insert]

Peracetic acid; CAS

79-21-0

Ozonit Super PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

professional

02/04/2020

Update

30/9/2020

29/09/2020

Update

28/3/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_CHLÓRNAN SODNÝ C19.pdf

2. National

law(s):

[Insert]

Active chlorine

released from sodium

hypochlorite; CAS

7681-52-9

CHLÓRNAN

SODNÝ C19

PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

08/04/2020 05/10/2020

Page 123: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

[Insert]

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Desinto - alkoholová dezinfekcia na ruky.pdf

2. National

law(s):

[Insert]

No ☐

[Insert]

Propan-2-ol; CAS 67-

63-0

Desinto -

alkoholová

dezinfekcia na

ruky

PT 1 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

14/04/2020 11/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Dezinfekčný roztok na povrchy Saneca.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

[Insert]

Propan-2-ol; CAS 67-

63-0

Dezinfekčný

roztok na

povrchy Saneca

PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

Non-professional

professional

15/04/2020

Update

13/10/2020

12/10/2020

Update

10/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Dezinfekčný roztok na ruky Saneca.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

Propan-2-ol; CAS 67-

63-0

Dezinfekčný

roztok na ruky

Saneca

PT 1 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

Non professional

15/04/2020

Update

13/10/2020

12/10/2020

Update

10/04/2021

Page 124: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

[Insert]

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_DEZIX Dezinfekčný prípravok na ruky s izopropylalkoholom.pdf

2. National

law(s):

[Insert]

No ☐

[Insert]

Propan-2-ol; CAS 67-

63-0

DEZIX

Dezinfekčný

prípravok na

ruky s

izopropylalkoho

lom

PT 1 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

08/04/2020 05/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_DrySan Oxy.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

[Insert]

Hydrogen peroxide;

CAS 7722-84-1

DrySan Oxy PT 2, 4 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

professional

02/04/2020

Update

30/9/2020

29/09/2020

Update

28/3/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_DusIPA G.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

Propan-2-ol; CAS 67-

63-0

DusIPA G PT 1 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

Non professional

07/04/2020

Update

5/10/2020

04/10/2020

Update

02/04/2021

Page 125: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

[Insert]

No ☐

[Insert]

Article 55(1)?

Yes ☒

Art

55(1)_Coronavirus emergency derogation_SK_DusIPA.pdf

Update in

overview Article

55(1) notifications

November 2020

1. Notification:

2. National

law(s):

[Insert]

No ☐

[Insert]

Propan-2-ol; CAS 67-

63-0

DusIPA PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

Non professional

07/04/2020

Update

5/10/2020

04/10/2020

Update

02/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Fortea VIRUS KILLER.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

[Insert]

Hydrogen peroxide;

CAS 7722-84-1

Fortea VIRUS

KILLER

PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

Non-professional

03/04/2020

Update

01/10/2020

30/09/2020

Update

29/03/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Hyg-dez surface.pdf

Hydrogen peroxide;

CAS 7722-84-1

Propan-2-ol; CAS 67-

63-0

Hyg-dez surface PT 2 Yes, obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

03/04/2020 30/09/2020

Page 126: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

[Insert]

No ☐

[Insert]

chain, lies with the

decision holder.

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_C19 solution.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

Propan-2-ol; CAS 67-

63-0

C19 solution PT 1

PT 2

Non-professional

user

Professional user

16/04/2020

Update

21/10/2020

13/10/2020

Update

19/04/2021

Free

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Ozonit PERformance.pdf Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

No ☐

Peracetic acid; CAS

79-21-0

Ozonit

PERformance

PT 2 Professional user 02/04/2020

Update

30/9/2020

29/09/2020

Update

28/3/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Derogation_SK_Dezinfekt G - dezinfekčný prostriedok na ruky s hydratačnou zložkou.pdf 2. National

law(s):

Propan-2-ol Dezinfect G PT1 Professional and

non-professional

user

Against bacteria and

virus

Obligations to

collect and keep

records of sale

24/04/2020 20/10/2020

Page 127: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

Article 55(1)?

Yes ☒

1. Notificatio

n:

Art

55(1)_Coronavirus emergency derogation_SK_VIROSTOP.pdf Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

No ☐

Chlorocresol CAS 59-

50-7

Biphenyl-2-ol CAS 90-

43-7

Glutaral CAS 111-30-8

VIROSTOP PT2 Professional and

non-professional

user

Against bacteria,

fungi, virus

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

23/04/2020

Update

21/10/2020

20/10/2020

Update

18/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_RHOBASAN ANTISEPT DES SKIN.pdf 2. National

law(s):

No ☐

Propan-2-ol RHOBASAN

ANTISEPT

DES SKIN

PT1 Professional and

non-professional

user

Against bacteria and

virus (SARS-CoV-2)

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

21/04/2020 18/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Dezintol.pdf 2. National

law(s):

Propan-2-ol Dezintol PT1, PT2 Professional and

non-professional

user

Against bacteria

(and virus?)

Obligations to

collect and keep

records of sale

21/04/2020 18/10/2020

Page 128: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐ volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_DEZINFEKČNÝ SPREJ NA RUKY DULCIA.pdf Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

No ☐

Propan-2-ol DEZINFEKČN

Ý SPREJ NA

RUKY

DULCIA

PT1 Professional and

non-professional

user

Against bacteria and

virus (SARS-CoV-2)

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

21/04/2020

Update

20/10/2020

18/10/2020

Update

17/04/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Clean + H2O2.pdf 2. National

law(s):

No ☐

Hydrogen peroxide;

CAS 7722-84-1

Clean + H2O2 PT2 Professional and

non-professional

user

Against bacteria

(and virus?)

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder.

22/04/2020 19/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_DiskPax preparát chlórový 3 v 1.pdf 2. National

law(s):

No ☐

Active chlorine

released from sodium

hypochlorite; CAS

7681-52-9

DiskPax

preparát

chlórový 3 v 1

PT2 Professional and

non-professional

user

Against bacteria and

fungi

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

29/04/2020 26/10/2020

Page 129: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

chain, lies with the

decision holder

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_RUKKY alkoholová dezinfekcia s esenciálnymi olejmi.pdf Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

No ☐

Propan-2-ol; CAS 67-

63-0

RUKKY

alkoholová

dezinfekcia s

esenciálnymi

olejmi

PT1 Non-professional

user

Against SARS-CoV-

2

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder

29/04/2020

Update

11/11/2020

26/10/2020

Update

08/05/2021

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Wiki Solution GF.pdf 2. National

law(s):

No ☐

Propan-2-ol; CAS 67-

63-0

Wiki Solution

GF

PT1 Professional and

non-professional

user

Against bacteria

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder

28/04/2020 25/10/2020

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Wiki Solution G.pdf Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

No ☐

Propan-2-ol; CAS 67-

63-0

Wiki Solution G PT1 Professional and

non-professional

user

Against SARS-CoV-

2

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder

28/04/2020

Update

26/10/2020

25/10/2020

Update

24/04/2021

Page 130: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Article 55(1)?

Notification: Update in

overview Article

55(1) notifications

November 2020

1.

Art

55(1)_Coronavirus emergency derogation _SK_HBM SkinDesin.pdf

2. National

law(s):

[Insert]

No ☐

Propan-2-ol HBM SkinDesin PT 1 Non-professional

and professional

users

13/05/2020

Update

10/11/2020

09/11/2020

Update

08/05/2021

Article 55(1)?

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_HBM SurfDesin.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

Propan-2-ol HBM SurfDesin PT 2 Non-professional

and professional

users

13/05/2020

Update

10/11/2020

09/11/2020

Update

08/05/2021

Article 55(1)?

1. Notification: Update in

overview Article

55(1) notifications

November 2020

Art

55(1)_Coronavirus emergency derogation_SK_Steriland derma.pdf

2. National

law(s):

[Insert]

No ☐

Active chlorine

released from

hypochlorous acid

Steriland derma PT 1 Non-professional

and professional

users

12/05/2020

Update

09/11/2020

08/11/2020

Update

07/05/2021

Article 55(1)? Active chlorine

released from

hypochlorous acid

EkoPuro plus PT 1 Non-professional

and professional

users

Page 131: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_EkoPuro plus.pdf

2. National

law(s):

[Insert]

No ☐

Article 55(1)?

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SK_Dezanol.pdf

Update in

overview Article

55(1) notifications

November 2020

2. National

law(s):

[Insert]

No ☐

Active chlorine

released from

hypochlorous acid

Dezanol PT 1 Non-professional

and professional

users

11/05/2020

Update

08/11/2020

07/11/2020

Update

06/05/2021

Article 55(1)

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_SK_FORCHEM AIR 250 PLUS.pdf 2. National

law(s):

[Insert]

No ☐

Active chlorine

released from

hypochlorous acid

FORCHEM

AIR 250 PLUS

PT 1 Non-professional

user

Professional user

Obligations to

collect and keep

records of sale

volumes, customer

identifications etc. in

the whole supply

chain, lies with the

decision holder

18/06/2020 14/12/2020

Article 55(1)?

Yes ☒

1.

Notificat

ion:

Art

55(1)_Coronavirus emergency derogation_SK_OXYCHLORINE CARE.pdf

Active chlorine

released from

hypochlorous acid

OXYCHLORIN

E CARE

PT1 Non-professional

and professional

users

Used against

/bacteria, enveloped

viruses

31/07/2020 27/01/2021

Page 132: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

No ☐

Article 55(1)?

Yes ☒

1.

Notificati

on:

Art

55(1)_Coronavirus emergency derogation_SK_DENZIN EcoPURE Hand.pdf 2. National

law(s):

No ☐

Active chlorine

released from

hypochlorous acid

DENZIN

EcoPURE Hand

PT1 Non-professional

user

Professional user

30/07/2020 26/01/2021

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

information

based on

overview table

November 2020:

Overview Art55(1)

notifications_Nov 2020(0).xlsx

2.National

law(s):

No ☐

Hydrogen peroxide Klercide

Sporicidal Low

Residue

Peroxide

PT 2 Professional 30/9/2020 28/3/2021

Active chlorine

released from sodium

hypochlorite

BrillSept PT 2 Non-professional

Professional

1/10/2020 29/03/2021

Propan-2-ol Dezinfekt G -

dezinfekčný

prostriedok na

ruky s

hydratačnou

zložkou

PT 1 Non-professional

Professional

22/10/2020 19/04/2021

Active chlorine

released from

hypochlorous acid

Salvesan PT 1 Non-professional 30/10/2020 24/04/2021

Slovenia Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SI_Hand sanitizer_Stella izopropilni alkohol.pdf 2. National

law(s):

[Insert]

Propan-2-ol,

Hydrogen peroxide

Propan-2-ol

HAND

SANITIZER

STELLA

izopropilni

alkohol 70 %

PT 1

PT 2

PT1 for use in health

and other institutions

by professional users

PT 2 for use by

general public and

professional users

30/03/2020 26/09/2020 Substance may

be purchased

from entities not

listed on Article

95 List

Chemicals Office of the Republic

of Slovenia, Ministry of Health

[email protected]

+386 1 400 6051

Page 133: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SI_propan-2-ol.pdf 2. National

law(s):

[Insert]

No ☐

Propan-2-ol 70%

Izopropanol

PT 2 Derogation granted

to one

pharmaceutical

company to donate

product for use in

health and other

public institutions, in

units of Armed

Forces, Policy and

Administration and

economic operators.

26/03/2020 22/09/2020

Article 55(1)?

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_SI_Virosept h, Virosept p.pdf

2. National

law(s):

[Insert]

No ☐

Propan-2-ol Active

chlorine released from

sodium hypochlorite

Viroseptp

Virosepth

PT 1

PT 2

Professional users

General public and

professional users

17/04/2020 14/10/2020

Article 55(1)?

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SI_SKINTASTIC LEOCID P7.pdf 2. National

law(s):

[Insert]

No ☐

Propan-2-ol SKINTASTIC

LEOCID P7

PT 1 Professional users 11/05/2020 7/11/2020

Article 55(1)?

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SI_SOLTEX I 70, 70B(0).pdf

2. National

law(s):

[Insert]

No ☐

Propan-2-ol SOLTEX I 70

SOLTEX I 70B

PT 1

PT 2

Derogation is

granted to a

company in order to

produce and place

on the Slovenian

market a:

- PT1 biocidal

product for use by

professional users in

health and other

public

institutions,

28/04/2020 25/10/2020

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Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

- PT1 and PT2

biocidal product for

use by professional

users in health and

other

public institutions.

Spain Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_ES_1- and 2-propanol.pdf 2. National

law(s):

Real Decreto

463/2020 and

Notice to

producers of 24

March 2020

(both in

Spanish)

No ☐

- Propan-1-ol

- Propan-2-ol

Biocides

containing the

active

substances.

PT 1

PT 2

PT 4

Non-professional

user (general public)

Professional user

Trained professional

-

24/03/2020 24/09/2020 Derogation from

Article 95 in

place. Substance

may be

purchased from

entities not listed

on Article 95

List, but sources

have to be

notified to the

authorities

Information to

submitted to the

authority: the

commercial

name of the

product,

composition,

information on

safety

requirements,

contact

information of

the firm,

registration

number of the

product in other

member states

where they are

commercialized,

purity of active

substance,

identification of

relevant

impurities and

method of

analysis for a.s.

Ministry of Health

[email protected]

+34 91 5962085

Page 135: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

If a dossier has

been already

submitted for

national

authorization,

the Spanish

authority does

not allow to

switch the claim

to Article 55(1)

BPR.

Authorities claim

the lack of a fast

track procedure

for surface

disinfectants

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_ES_active chlorine released from sodium hypochlorite.pdf 2. National

law(s):

the above Real

Decreto and

Notice to

producers of 31

March 2020

No ☐

Active chlorine

released

from sodium

hypochlorite

(CAS number: 7681-

52-9)

Biocides

containing the

active

substances

PT 2

PT 4

Non-professional

user (general public)

Professional user

Trained professional

31/03/2020 01/10/2020 See above

Article 55(1)?

Yes ☐

1. Notification:

Nothing on

circabc yet

2. National

law(s):

the above Real

Decreto and

Notice to

producers of 27

March 2020

(both in

Spanish)

Concerns active

substances undergoing

evaluation:

-Cloruro de C12-16-

alquildimetilbencilamo

nio (ADBAC/BKC

(C12-16))

-Cloruro de C12-18-

alquildimetilbencilamo

nio (ADBAC (C12-

18))

-Cloruro de C12-14-

alquildimetilbencilamo

PT 2, 4

See above

Page 136: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

nio (ADBAC (C12-

14))

-Cloruro de C12-14-

alquiletilbencilamonio

(ADEBAC (C12-14))

-Cloruro de

didecildimetilamonio

(DDAC (C8-10))

-Cloruro de

didecildimetilamonio

(DDAC)

-Cloruro de

dimetiloctadecil[3-

(trimetoxisilil)propil]a

monio

Article 55(1)?

Yes ☐

1. Notification:

Nothing on

circabc yet

No ☒

2. National

law(s):

Procedural

instructions for

TP1 products

containing

ethanol (in

Spanish)

Ethanol PT1 Only applies to

producers that had

been previously

authorized to

commercialize

products containing

ethanol before.

.

Producers

should, after the

payment of a fee,

submit to the

AEMPS at

biocidas-

[email protected]

s, an application

containing the

data listed here.

The

authorizations

are granted for

three months and

producers can

request an

extension within

15 days before

the expiry date.

Article 55(1)?

Yes ☐

1. Notification:

Nothing on

circabc yet

No ☒

2. National

law(s):

Orden

SND/321/2020,

de 3 de abril (in

Spanish)

Use of bioethanol in the

composition of such

products for a period

corresponding to the

implementation period

of Royal Decree

463/2020.

For such uses, the

bioethanol must

comply with the

following conditions:

Hand

disinfectant

PT 1

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

SND/321/2020,

de 3 de abril has

been updated

and special

measures are

established for

the use of

bioethanol in the

manufacture of

hydroalcoholic

solutions and

gels for hand

disinfection on

the occasion of

health crises

caused by

COVID-19

– Metanol < 200 ppm

(V/V).

– Acetaldehído < 10

ppm (V/V).

– Benceno < 2 ppm

(V/V).

– Total, de otras

impurezas < 300 ppm.

The total mix of

carcinogenic

components must be

<0,1%.

Article 55(1)?

Yes ☐

1. Notification:

No ☒

2. National

law(s):

the above Real

Decreto and

https://www.boe.

es/boe/dias/2020

/05/12/pdfs/BOE

-A-2020-

4931.pdf

D-gluconic acid,

compound with N,N''-

bis(4-chlorophenyl)-

3,12-diimino-

2,4,11,13-

tetraazatetradecanedia

midine (2:1) (CHDG)

Chlorhexidine

Digluconate

(CAS 18472-51-0)

PT1 Derogation from

Article 95 (PT1)

in place.

Substance may

be purchased

from entities not

listed on Article

95.

The active

substance should

with the

specifications

established in the

European

Pharmacopoeia

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_ES_Products containing propan-1-ol, propan-2-ol.pdf

2. National

law(s):

No ☐

Propan-1-ol

Propan-2-ol

Propan-1-ol and

propan-2-ol

containing

products (255

products listed

in the attached

notification

form)

PT1

PT2

PT4

General public

Professional

Trained professional

Geographical area of

use Spain

The competent

authority is already

in possession of

information on the

24/09/2020 24/03/2021

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Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

source of the active

substances and

products which

invoke this measure.

In order to ensure

that this exceptional

situation does not

constitute a loop in

the ordinary

procedures, the

Ministry of Health is

gathering

information on the

intentions of the

holders of the

exceptional

authorization to

follow the ordinary

authorization path.

This information

will allow us to plan

any future regulatory

action.

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_ES_Koruma sodyum hypochlorite.pdf

2. National

law(s):

Active chlorine

released from sodium

hypochlorite (CAS

number: 7681-52-9)

KORUMA

SODYUM

HYPOCHLORI

TE

PT 2

PT4

Non-professional

user (general public)

Professional user

Trained professional

Geographical area of

use Spain

The competent

authority is already

in possession of

information on the

source of active

substance that

invokes this

measure. In order to

ensure that this

exceptional situation

does not constitute a

loop in the ordinary

procedures, the

Ministry of Health is

gathering

information on the

intentions of the

01/10/2020 01/04/2021

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

holders of the

exceptional

authorization to

include this supplier

as a supplier listed in

Article 95. This

information will

allow us to plan any

future regulatory

action to include this

supplier as a supplier

listed in Article 95

Sweden Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SE_1-and 2-propanol.pdf 2. National

law(s):

Beslut om

dispens 20

March 2020

(in Swedish)

No ☐

Propan-1-ol Propan-2-ol

Disinfectants

containing 1- or

2-

propanol

PT 1-4 Sale to general

public only though

pharmacies or

grocery stores

20/03/2020 16/09/2020

Extended

to

30/12/2020

Until 30 June,

the Swedish

Chemicals

Agency accepts

manufacturing

and selling of

disinfectants

without the

suppliers being

on the Article 95

List

Until the 30

December, the

Swedish

Chemicals

Agency accepts

labelling also in

English, Danish,

and Norwegian

for professional

disinfectant

products

Swedish Chemicals Agency

[email protected]

+46 8 519 41100

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SE_Active Chlorine.pdf 2. National

law(s):

Beslut om

dispens 20

March 2020

Active chlorine

generated from

sodium chloride by

electrolysis

Active chlorine

released from

hypochlorous acid

Disinfectants

containing

- Active

chlorine

generated

from sodium

chloride by

electrolysis

or

- Active

chlorine

released from

PT 1 Sale to general

public only though

pharmacies or

grocery stores

20/03/2020 30/12/2020 See above

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Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

No ☐

hypochlorous

acid

Article 55(1)?

Yes ☒

1. Notification:

Art

55(1)_Coronavirus emergency derogation_SE_Active Chlorine and Hydrogen Peroxide.pdf 2. National

law(s):

Beslut om

dispens 20

March 2020

No ☐

-Hydrogen Peroxide

-Active chlorine

released

from sodium

hypochlorite

Disinfectants

containing

- Hydrogen

Peroxide

or

- Active

chlorine

released

from sodium

hypochlorite

PT 1-4 Sale to general

public only though

pharmacies or

grocery stores

23/03/2020 30/12/2020 See above

Article 55(1)?

Yes ☐

1. Notification:

2. National

law(s):

No ☒

See KEMI FAQ

Ethanol Until 30 June,

the Swedish

Chemicals

Agency accepts

manufacturing

and selling of

disinfectants

without the

suppliers being

on the Article 95

List

Article 55(1)?

Yes ☐

1.Notification:

Art

55(1)_Coronavirus emergency derogation_SE_Active chlorine,1-2-propanol, hydrogen peroxide.pdf

2. National

law(s):

No ☒

Active chlorine

generated from sodium

chloride by electrolysis

(PT 1)

Active chlorine

released from

hypochlorous acid (PT

1)

Active chlorine

released from sodium

hypochlorite (PT 1-4)

Hydrogen peroxide

(PT 1-4)

1- propanol (PT 1-4)

2-propanol (PT 1-4)

Disinfectants

containing those

active

substances:

Active chlorine

generated from

sodium chloride

by electrolysis

(PT 1)

Active chlorine

released from

hypochlorous

acid (PT 1)

Active chlorine

released from

sodium

hypochlorite

(PT 1-4)

PT1 - 4 General public

Professional use

Geographical area of

use

Sweden

Sales to the general

public may only be

made through

pharmacies or

grocery stores.

17/09/2020 15/03/2021

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Hydrogen

peroxide (PT 1-

4)

1- propanol (PT

1-4)

2-propanol (PT

1-4)

United

Kingdom

Article 55(1)?

Yes ☐

1. Notification:

2. National

law(s):

No ☒

Also see HSE

FAQ

Ethanol: Transitional

rules, no authorization

required (see HSE

FAQ)

HSE will adopt a

pragmatic and

proportionate

approach to

regulatory

requirements that

relate to supply

chain obligations

during this

period. The

focus of any

HSE activity by

inspectors will

be to ensure that

products on the

market are

effective in

combating the

coronavirus and

do not pose an

unacceptable risk

to people or the

environment.

HSE expects

product

manufacturers to

take all

reasonable steps

to source

ingredients in

such a way that

compliest with

Article 95

obligations.

However, HSE

Inspectors will

take a sensible

and

Health and Safety Executive

(HSE)

[email protected]

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Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

proportionate

approach if they

come across

hand sanitisers

that are not

strictly in line

with normal

BPR supply

chain

requirements

under Article 95,

recognising the

urgent wider

need for safe and

effective

products.

In making

commercial

decisions,

manufacturers

need to be

mindful of

maintaining high

levels of safety

and efficacy of

the products they

make available

to the public and

others.

Article 55(1)?

Yes ☒

1. Notification

:

Art

55(1)_Coronavirus emergency derogation_UK_WHO formula 2.pdf 2. National

law(s):

[Insert]

Also see HSE

FAQ

No ☐

Propan-2-ol

WHO-

recommended

handrub

Formulation 2

(Propan-2-ol)

PT 1 Companies must

notify HSE to obtain

derogation

certificate:

biocidesenquiries@h

se.gov.uk using

‘Propan-2-ol Article

55’ as the subject

title

30/03/2020 25/09/2020 See above.

Article 55(1)?

Yes ☐

Propan-2-ol ChemoxyCare

HSG

PT1 Professional 07/05/2020 03/11/2020 See above.

Page 143: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

1.Notification:

Art

55(1)_Coronavirus emergency derogation_UK_Chemoxycare HSG.pdf

2. National

law(s):

No ☒

Also see HSE

FAQ

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_UK_First Thing Sanitiser PSM744.pdf

2. National

law(s):

[Insert]

Also see HSE

FAQ

No ☐

Propan-2-ol First Thing

Sanitiser PSM

744

PT 1 Professional

Geographical area of

use United Kingdom

12/06/2020 10/01/2021 See above.

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_UK_First Thing Sanitiser PSM748.pdf

2. National

law(s):

[Insert]

Also see HSE

FAQ

Propan-2-ol First Thing

Sanitiser

PSM748

PT 1 Professional

Geographical area of

use United Kingdom

12/06/2020 10/01/2021 See above.

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_UK_M-0-8 Hand Sanitiser Gel.pdf

2. National

law(s):

[Insert]

Propan-2-ol M-0-8 Hand

Sanitiser Gel

PT 1 Not defined in the

notification

07/07/2020 03/01/2021

Page 144: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

Also see HSE

FAQ

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2. National

law(s):

No ☐

Propan-2-ol Cosmo Hand

Sanitizer

PT1 General Public 13/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

information

based on

overview table

August 2020:

Overview Art55(1)

notifications_Aug 2020.xlsx

2.National

law(s):

No ☐

Propan-2-ol Isopropanol

Solution

PT1 Professional

Used against:

Bacteria, enveloped

viruses, yeasts

12/08/2020

– date of

notification

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_UK_University of Bristol Isopropanol Gel Hand Sanitizer.pdf

Propan-2-ol University of

Bristol

Isopropanol Gel

Hand Sanitizer

PT 1 General Public

Used against:

Bacteria, enveloped

viruses, yeasts

Geographical area of

use

United Kingdom

13/08/2020 10/01/2021

Page 145: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

[Insert]

Also see HSE

FAQ

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_UK_WHO-recommended handrub Formulation 2 Propan-2-ol_Oct2020.pdf

2. National

law(s):

[Insert]

Also see HSE

FAQ

Propan-2-ol WHO-

recommended

handrub

Formulation 2

(Propan-2-ol)

PT 1 General public,

professional

Geographical area of

use United Kingdom

Companies must

notify HSE and be

granted permission

to make products

available in

accordance with the

permit issued under

the derogation.

26/09/2020 25/03/2021

Article 55(1)?

Yes ☒

1.Notification:

Art

55(1)_Coronavirus emergency derogation_UK_Fusion 70% Alcohol Hand Sanitiser Gel.pdf

2. National

law(s):

[Insert]

Also see HSE

FAQ

Propan-2-ol Fusion 70%

Alcohol Hand

Sanitiser Gel

PT1 General public,

Industrial

Geographical area of

use United Kingdom

02/10/2020 31/03/2021

Article 55(1)?

Yes ☒

1.Notification:

No pdf

available,

information

based on

overview table

November 2020:

Overview Art55(1)

notifications_Nov 2020(0).xlsx

Propan-2-ol Micronclean

Hand Sanitiser

PT 1 Professional 20/11/2020 19/05/2021

Page 146: Appendix 1 Overview of national measures to make

Country Procedure Active Substance Product PTs Use controlled and

limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

2. National

law(s):

Non-EU Member States

Iceland

(EEA)

Article 55(1)?

Yes ☐

1. Notification:

[Insert]

2. National

law(s):

[Insert]

No ☐

[Insert]

EUR 500 Environment and Food Agency of

Iceland

[email protected]

+354 591 2000

Liechtenstein

(EEA) Article 55(1)?

Yes ☐

1. Notification:

[Insert]

2. National

law(s):

[Insert]

No ☐

[Insert]

Norway

(EEA)

Article 55(1)?

Yes ☐

1. Notification:

[Insert]

2. National

law(s):

[Insert]

No ☐

[Insert]

Norway is currently

considering certain

general derogations for

disinfectants in PT 1,2

and 4 containing

ethanol, propan-1-ol og

propan-2-ol. They will

update our webpages

with further

information as soon as

a formal decision is

made.

Norwegian Environment Agency

[email protected]

+47 735 80500

Article 55(1)?

Yes ☐

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_NO_ethanol_1- and 2- propanol based products.pdf 2. National

law(s):

Ethanol, propan-1-ol,

propan-2-ol

Various

disinfectants

containing

ethanol, propan-

1-ol and/or

propan2-ol

PT 1

PT 2

PT 4

Professionals and

non-professionals

Geographical area of

use : Norway

The authorisation (in

the form of a

temporary national

regulation) is limited

to 180

days.

07/04/2020 04/10/2020

Page 147: Appendix 1 Overview of national measures to make

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

[Insert]

No ☐

[Insert]

Article 55(1)?

Yes ☐

1. Notificati

on:

Art

55(1)_Coronavirus emergency derogation_NO_Sterling Håndsprit 70% ww.pdf 2. National

law(s):

[Insert]

No ☐

[Insert]

Propan-2-ol (CAS 67-

63-0)

Sterling

Håndsprit 70 %

w/w

PT 1 Professionals and

non-professionals

Geographical area of

use : Norway

The authorisation is

limited to 180 days.

The product is sold

to private consumers

via the grocery retail

company

NorgesGruppen.

08/04/2020 05/10/2020

Switzerland(

EFTA)

1. National

law(s):

Ordinance 1

August 2005

and Décision 28

February 2020

Kommunikation

Allgemeinverfügung Abverkauf_final_FR.docx

https://www.an

meldestelle.admi

n.ch/chem/de/ho

me/themen/pflic

ht-

hersteller/zulass

ung-

biozidprodukte/a

usnahmezulassu

ng-fuer-

desinfektionsmit

tel/abverkaufsfri

sten-fuer-die-

ausnahmezulass

ungen.html

70 à 80 % d’éthanol

[No CAS 64-17-5], ou

– 60 à 80 % de 1-

propanol [No CAS 71-

23-8], ou

– 60 à 80 % de 2-

propanol [No CAS Nr.

67-63-0], ou

– 60 à 80 % d’un

mélange des alcools

précités, et

– ≤ 0,5 % d’autres

adjuvants tels que

parfum, colorants ou

glycérine, et

– ≤ 2 % de

méthyléthylcétone, ou

– ≤ 5 % de 2-propanol

comme agent

dénaturant, et

– x %3 d’eau.

PT 1, 2, 4 31/08/2020

From

1.9.2020:

no more

disinfectant

s may be

produced

or imported

on the basis

of the

general

decrees of

28.2.2020

and

9.4.2020.

Stocks of

the above

mentioned

disinfectant

s may be

sold within

the whole

supply

chain until

28.2.2021

This also

includes

Derogation from

Article 95

possible.

Substance may

be purchased

from entities not

listed on Article

95 List, but need

to be notified to

authorities

(authorization

certificate will

be issued if

agreed)

Notification Authority for

Chemicals

[email protected]

+41 58 462 73 05

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limited to

Start date Expiry

date

Fees Approach to

Article 95

Approach to

exports/

imports

Contact Details

the sale

(distributio

n) of the

products to

end users.

This means

that trade

within the

supply

chain must

be

organised

accordingly

Montenegro

(Candidate)

1. National

law(s):

[Insert]

Turkey

(Candidate)

1. National

law(s):

Turkish

Ministry of

Health, 23th

March 2020 and

new regulation

or amendment to

dated

31.12.2009/

27449 numbered

official gazette

as well as Art 15

of Turkish

Biocidal

regulation.

Decree (dated

19.3.2020).

Issues a 3-

months-valid

transitional

approval

certificate

(stability and

efficiency tests

must be

submitted within

1 month

otherwise this

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date

Fees Approach to

Article 95

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exports/

imports

Contact Details

approval will be

revoked).

Authorities

implemented an

accelerated

registration

program for

disinfectant,

hygienic and

antibacterial

cleaners.

Formerly,

registration took

min. 6 months

while it is now

provided in 2 to

3 weeks (but the

related

authorizations

are valid for 3

months)

In Turkey there

is not the

opportunity to

use non-

approved

ingredients in

the formulation.