Eurasia REACH: what’s next after...Page 1 Eurasia REACH: what’s next after inventory process December 11th, 2020 Chemical Watch Expo Virtual Event TR041 (“Eurasia REACH”) and

Eurasia REACH: what’s next after

inventory process

December 11th, 2020

Chemical Watch Expo

Virtual Event

TR041 (“Eurasia REACH”) and GOST-300333 – major hurdles for the industry. How to comply?TR041 (“Eurasia REACH”) and GOST-300333 – major hurdles for the industry. How to comply?TR041 (“Eurasia REACH”) and GOST-300333 – major hurdles for the industry. How to comply?

Workshop Presenter

OLESIA POCHAPSKASenior Manager

[email protected]

REACHLaw Finland

mailto:[email protected]

Agenda

1. REACHLaw in Brief

2. Eurasia REACH (TR041) Recap

3. Chemical inventory in Russia and the EAEU: transitional results and current activities

4. Mandatory Chemical Safety Passports

5. Registration Requirements

6. Main uncertainties and next steps

7. Contact Information

8. Q&A Session

1. REACHLAW IN BRIEF

2. EURASIA REACH RECAP

3. CHEMICAL INVENTORY IN RUSSIA/EAEU

4. MANDATORY CHEMICAL SAFETY PASSPORTS

5. REGISTRATION REQUIREMENTS

6. MAIN UNCERTAINTIES AND NEXT STEPS

7. CONTACT INFORMATION

8. Q&A SESSION

UK REACH / CLP *

EU REACH / CLP

TURKEY KKDIK / SEA / GBF

EURASIA “REACH”

KOREA REACH

CHINA “REACH”/ GHS

* Upon entry into force

We Specialize in Chemical Regulatory

Compliance and

Sustainability

Providing Support for REACH and “REACH-Like” Chemical

Regulations Globally

INDIA “REACH”*

About

• Established in Helsinki, Finland 2006

• Offices in six (6) countries

• Multidisciplinary team - Business, Legal & Technical: Toxicologists,

Eco-toxicologists, Chemists, Socio-econ. analysts and Environmental specialists

• 20+ local partners in Europe, Asia, Latin-America & USA Support in

10+ different languages

• Major industries served: Oil, Chemicals, Specialty Chemicals, Metals, Aerospace

sector, Pulp & Paper and Other downstream users (DU) industries, etc.

• More info at: www.reachlaw.f i

http://www.reachlaw.fi/

REACHLaw ServicesEURASIA “REACH” Services (incl. Russia)

1. Inventory Notification

2. Nominated Representation (through REACHLaw OOO in Moscow, Russia)

3. Chemical Safety Passports

4. Registration of Existing Chemicals

5. New Substance Notification

6. Legal & Technical Services

7. Legislation Monitoring Service

8. Consulting

9. Training …and more

Name:REACHLaw OOO

Address: 3

rdGolutvinski pereulok,

house 11, building 6,Moscow, 119180The Russian Federation

Registration No. / Tax ID: 9706002574

REACHLAW TALKS on YouTubeB

EN

AN

DE

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ON

Follow us on YouTube! REACHLAW TALKS is now live!

https://www.youtube.com/channel/UCrivV4JsJ33EsF8FbJECeug








8. Q&A SESSION

Eurasia REACH Recap

Overview

• Technical Regulation of Eurasian Economic Union (EAEU) on Safety of chemical products (TR041/2017) approved on March 3rd 2017 → Commonly called “Eurasia REACH”

• EAEU-level horizontal regulation covering the following countries: 1. Russia

2. Belarus

3. Kazakhstan

4. Armenia

5. Kyrgyzstan

• Official commencement date - 2nd June 2021

• New draft EEC Decision to postpone the commencement date to 30th November 2022 …

• 2nd tier (implementing regulations) have not been approved …

Note to keep in mind: Technical Regulation on Safety of chemical products approved on October 7th 2016 (Decree No. 1019) →

“Russia REACH” → Russia’s national-level law was supposed to enter into force – 1st July 2021 (end of June 2019 → revoked!)

• EEC Decision Draft on amendments to the Decision of the Council of the

Eurasian Economic Commission of March 3rd 2017 No.19

• EEC Decision Draft from 29th Sep 2020

• Order of the formation and management of the inventory of chemicals

and mixtures

• Order of the new substance notification

• The Decision of the EEC Board on transitional provisions of the technical

regulation of the Eurasian Economic Union on the safety of chemical

products (TR EAEU 041/2017)

Eurasia REACH Recap

List of 2nd Tier Legislation*

* 2nd Tier Legislation → https://docs.eaeunion.org/ria/ru-ru/0102992/ria_29052018 https://docs.eaeunion.org/ria/ru-ru/0104253/ria_29092020

https://docs.eaeunion.org/ria/ru-ru/0102992/ria_29052018https://docs.eaeunion.org/ria/ru-ru/0104253/ria_29092020

Eurasia REACH Recap

News: delayed entry into force?

• Commission Draft Decision

– Proposal to shift commencement date to 30th

Nov 2022

• Explanatory Note (reasoning)

– More time needed due to 2nd tier delay

• 2nd tier to be finalized during 2020-2021

– Issues due to Covid

– More time needed for resolving CBI disclosure

issues addressed heavily by the industry

• Background information document

• Questionnaire (Public Consultation)

– Closed on 28th Oct 2020

1. Preamble

2. Chapter I: Application area

3. Chapter II: Basic Concepts (Definitions)

4. Chapter III: Requirements for classification of

chemical products

5. Chapter IV: Rules for the identification of

chemical products

6. Chapter V: Classification requirements

7. Chapter VI: General safety requirements

8. Chapter VII: Requirements for labelling of

chemicals

9. Chapter VIII: Requirements for precautionary

labelling

10. Chapter IX: Requirements for SDS

11. Chapter X: Ensuring compliance with the

Regulation

12. Chapter XI: New substance notification

13. Chapter XII: Evaluation of compliance

14. Chapter XIII: Common sign for Labelling products

in the union

15. Chapter XIV: Enforcement

16. Annex 1: Exemptions

17. Annex 2: Allowed concentration limits of

hazardous substances in chemical products

18. Annex 3: CSR structure

19. Annex 4: Concentration limits for restricted

chemicals in chemical products

20. Annex 5: Registration application form (template)

21. Annex 6: Certificate for record-keeping

registration

22. Annex 7: Certificate for permitted registration

Eurasia REACH Recap

Structure of the Legal Text of Eurasia REACH

Eurasia REACH Recap

Scope

All chemical products: substances or mixtures placed on the EAEU market

are in scope of the TR041

Identification rules - so-called “0,1% w/w rule”

“All substances, including potential additives, impurities and etc.

present at a concentration of more than 0.1% (w/w) in chemical products

have to be identified”

Exemption of chemical products placed in the EAEU below 1t/year is

planned to be decided by the 2nd June 2028 …

Eurasia REACH Recap

Exemptions?

TR041 ANNEX 1 EXEMPTIONSScientific and research purpose

Mineral resources unless chemically modified

Pharmaceutical and veterinary products

Cosmetics

Chemical products constituting a source of ionizing

radiation

Food & additives and feed products

Products included in manufactured articles (with certain

conditions, e.g. hazardous substances are not released)

Waste subject to disposal/recycling

Chemical products in-transit

PARTIAL EXEMPTIONSChemical products under other technical

regulations of the EAEU are exempted from

the future registration requirements under

TR041, but have to fulfill C&L and Chemical

Safety Passport requirements under TR041

POTENTIAL EXEMPTIONS ?Biocides …

GOST 30333-20XX EXEMPTIONS ?Additional exemptions to be added to

TR041 in line with the new GOST 30333-

… ?

OTHER EXEMPTIONS ?Pesticide formulations …

• On the 23rd of July, upon request of

Minpromtorg Russia, CIS Center organised an

online panel discussion in relation to biocides under TR041

• The participants of discussion: Minpromtorg, Rospotrebnadzor, CIS Center and

industry representatives

• The discussion was held around inclusion of biocidal products in the list of

exemptions under TR041

• The following decision has been reached:

• Rospotrebnadzor will prepare scientific justifications and applicable wording

(definitions) to be used in the potentially upcoming amendments of TR041

• CIS Center wil be taking this information into account (together with the requested

amendments by Kazakhstan) in the review process of TR041

Eurasia REACH Recap

Biocides to be potentially exempted ? …

Eurasia REACH Recap

Banned and Restricted Substances

• Restricted substances are specified in

the Annex 7 to the Draft Order on Inventory

formation

• Permitted registration is applicable

• Banned substances will be published on the website of EEC

• Separate Decision by the EEC (not yet known)

• In the version_1 30 substances in the Annex 7 “Banned Substances”

• Manufacturer • Definition in the Annex 9 of the EAEU Treaty: means a legal entity or a natural person registered as an

individual entrepreneur, including foreign manufacturers, engaged, on their own behalf, in the

manufacture or manufacture and sale of products and responsible for their conformity to technical

regulations of the Union

• Importer• Definition in the TR041: a resident of the member state of the EAEU, who has entered into a foreign trade

agreement with a non-resident member of the EAEU for the importation of chemical products into the

customs territory of the EAEU, places chemical products on the EAEU market and is responsible for product

compliance with the requirements of this technical regulation

• Nominated Representative (“Authorised Representative”)• Definition in the Annex 9 of the EAEU Treaty: means a legal entity or a natural person registered as an

individual entrepreneur, duly incorporated in accordance with the legislation of a Member State on its

territory, acting on behalf of a manufacturer, including foreign manufacturers, under an agreement when

carrying out conformity assessments and releasing products into circulation on the territory of the EAEU

and responsible for non-compliance of such products with the technical regulations of the EAEU

Eurasia REACH Recap

Roles in the regulation

Eurasia REACH Recap

Nominated (Authorised) Representative

An official agreement between NR and the Manufacturer is

mandatory.

The agreement has to contain among other the following clauses:

1. Authorisation to act on behalf of the Manufacturer in relation to

regulatory conformity assessment and placement of chemical

products on the EAEU market …

2. Liability issues to be clearly stated (according to the TR041 NR is

responsible for any non-compliances, incl. Chemical Safety

Passports!) …

• Inventory process – non-mandatory (but recommended…)

• Timeline: by 1st August 2020 in Russia

• Transitional Inventory: https://gisp.gov.ru/cheminv/pub/app/search/

• Chemical Safety Passport (including C&L) - mandatory

• Timeline: required once TR041 enters into force

• New Substance Notification – mandatory for new chemicals

• Timeline: required once TR041 enters into force and before chemical product containing

new substance is placed on the EAEU market

• Registration of chemical products - mandatory

• Timeline: depending on whether your product a substance or a mixture and according to

the applicable tonnage band

Eurasia REACH Recap

Main requirements under TR041

https://gisp.gov.ru/cheminv/pub/app/search/








8. Q&A SESSION

Chemical inventory in Russia & EAEU

Transitional Results and Ongoing

Activities

• Transitional inventory is still work-in-progress

– Inventory will be updated in the end of 2020 … more substances will be added from re-submission results and

those checked/accepted after 15th June 2020

– Combined EAEU Inventory will be published in 2021 …

– Chemical inventory for mixtures will start formation based on the mixture registration after 2027 …

• According to the CIS Center, Minpromtorg has received 500 000 chemical substances out of

which 80 000 were unique chemicals

– Most of the chemicals were submitted after the 1st and 2nd deadline extensions..

– CIS Center has pointed out a number of mistakes in inventory notification files, especially emphasized non

acceptable information submitted only in English language and C&L according to CLP

• Transitional Inventory in Russia


– Re-submissions for additional information closed on 23rd

Oct 2020)


COMMON EAEU CHEMICAL INVENTORY WILL BE

PUBLISHED IN 2021 …ESTIMATED FEBRUARY 2021 ?

Chemical Inventory in Russia

Late inventory notification for substances missing from the inventory

Late Inventory Notification: Until 2nd June 2023 substances that are not

listed in the inventory, but can be proved to have been placed in the

EAEU before Eurasia REACH entered into force, can be added to the

inventory without going through the NEW SUBSTANCE NOTIFICATION

procedure (similar to Lead Registration in the EU REACH).

SUFFICIENT PROOF AND WHAT WOULD BE THE PROCEDURE TO BE

CONFIRMED IN 2021








8. Q&A SESSION

Chemical Safety Passport

What is GOST 30333?

• Chemical Safety Passport = CSP will be the

most important compliance document under

TR041

• GOST 30333-2007 is a valid standard applied

when developing a chemical safety

passports - “Chemical Safety Passport.

General Requirements.” valid in Russia (and

the EAEU) from 2009

– Chemical Safety Passport = CSP


Mandatory CSP – why and how?

TR041 – Eurasia REACH GOST 30333-2007 Guidance P 50.1.102-2014


GOST 30333-2007 and other related GOSTs are to be updated

• GOST standards under review and to be updated during 2020-2021

– GOST 30333–2007 ”Chemical Safety Passport. General requirements”

– GOST 32419–2013 ”Classification of chemical products. General requirements”

– GOST 31340–2013 ”Precautionary Labelling of chemical products. General requirements”

• GOST 30333-2007 update is supposed to reflect TR041 (Eurasia REACH) requirements

– CSP registration as such will no longer be required at the competent authority, however CSP will be

provided to the registration authority during chemical product registration according to the applicable

registration deadline set by TR041, where CSP will serve as a ”registration dossier”

• Even after update most of the requirements of GOST 30333-2007 will migrate to the

new GOST 30333-20XX → the procedure will not become easier


Scope

Under GOST 30333-2007, CSP is required for chemical

substances, chemical mixtures, materials and industrial waste

Under draft GOST 30333-20XX, CSP is required for commercial

products …


Current and potential exemptions

• Mineral resources (bedding state)

• Finished pharmaceutical products

• Finished cosmetic-perfumery products

• Emitting, nuclear and radioactive substances

• Finished food products

• Products manufactured according to closed

nomenclature

Note: CSP is not required for finished articles →

articles are not considered to be chemical products

• Mineral resources (bedding state)

• Finished pharmaceutical and finished veterinary

medicine products

• Finished cosmetic-perfumery products

• Emitting, nuclear and radioactive substances

• Finished food products, biologically active food

additives, food additives, finished animal feed

• Smokable and smokeless tobacco products

• Liquid for electronic system of adding nicotine

• Medical device

Note: CSP is not required for finished articles → articles

are not considered to be chemical products

Exemptions under GOST 30333-2007 Exemptions under updated GOST 30333-20XX


EU REACH SDS vs. CSP (GOST 30333-2007)EU REACH SDS GOST 30333-2007 Compliant CSP

GHS Format 16 Sections GHS Format 16 SectionsNote: more detailed information, where all mandatory subsections have

to be filled according to the competent information sources (also, see

slide: GOST 30333-2007 compliant CSP Part 2/4 )

Required for hazardous substances and mixtures Required for all chemical products (incl. non-hazardous!),

unles exempted

- Official format for the Title page

- Registration is required (for now)

- Limited Validity (3 or 5 years)

- QR code assigned by the authority after registration

- All sources have to noted in the CSP text with references and

in listed in Section 16

Exposure Scenarios -

EU member-state language is required Russian language (+ if required by specific EAEU member in

the local language)

Classification: GHS Rev.5 Classification: GHS Rev.4

TRANSITIONAL PROVISIONS FOR CSP ARE NOT

CURRENTLY FORESEEN IN THE TR041 AND/OR 2ND

TIER LEGISLATION DRAFTS …

MEANING CHEMICAL SAFETY PASSPORT ACCORDING TO

GOST 30333 IS MANDATORY FROM TR041 DAY ONE








8. Q&A SESSION

Registration Process Overview

Competent authorities appointed in Russia

• Minpromtorg Russia competent auhtority No.1

– Inventory formation and management of substances and

mixtures (national inventory)

– New substance notification management upon

Rospotrebnadzor expert conclusion

– Organisation and management of record-keeping and

permitted registration with conlusion of the appointed expert

organization (CIS Center?) + expert conclusion of

Rospotrebnadzor if chemcial products contain new

substances

• Rospotrebnadzor competent authority No.2

– Management of new susbtance notification and providing

expert conclusion to Minpromtorg

– Management of Permitted Registration of new susbtances:

expert conclusion preparation

Note: Due to complexity of TR041 other ministries can be

involved in course of work…


Options for non-EAEU manufacturersEA

EU

terr

itory

Non-E

AEU

terr

itory OPTION NO.1

Own subsidiary as

NR (or importer?)

Company A

Company A

Subsidiary

Company A

Importer

OPTION NO.2

Relying on

your importers

OPTION NO.3

Using a Nominated

Representative

Company A

Professional

Consultant as

Nominated

Representative

Pros & Cons+ CBI is safe

- Liabilities

- Up-to-date regulatory advice?

+ no direct liabilities

- CBI to be disclosed

- Dependence ….

+ no direct liabilities

+ CBI in hand of professionals

+ Up-to-date regulatory advice

- Dependence ….


New substance definition

• New Substance = Not Existing Substance

= Not listed in the chemical inventory

when TR041 enters into force

• There is no such concept as ”new

mixture”, therefore new substance

notifcation is relevant for substances

placed on the EAEU market either on

their own or as part of mixture

Mixtures containing New Substances in their composition will not be allowed on the

EAEU market unless New Substance Notification procedure criteria is fulfilled …


New substance Notification

Authority has 60

days to review

the application

If accepted

substance added

to the chemicals

inventory

New Substance

Notification

Submission of advanced

information:

• Chemical safety passport,

administrative info, Chemical

Safety Report, Substance

identification data, physico-

chemical properties, toxicology,

ecotoxicology data, uses etc

Estimated to take 2 years and cost 250 000 €

New

chemical

(Substance not

on the chemicals

inventory)

Existing

chemical

(Substance on the

chemicals

inventory)

Status: Allowed,

Restricted or Banned

Record-

keeping

registration

Permitted

registration

View Page 1/2 …

Substance

as such or

as part of a

mixture

Applicable for New Substances before placed on the EAEU market


Existing substance definition

• Existing Substance = Listed in the

chemical inventory when TR041 enters

into force

• Mixtures will be listed in the chemicals

inventory for mixtures only after 2027

Only existing chemicals and mixtures of existing chemicals can be registered.

New substances placed on their own or in mixtures have to go via New

Substance Notification Procedure before proceeding to Registration.


Registration of existing substances and mixtures

of existing substances

Existing

chemical

(Substance on the

chemicals inventory)

Substances and

mixtures

Record-keeping registration

Submission of basic information:

• Chemical safety passport, administrative

info and some chemical property

information

Registration

certificate provided

within 10 days incl.

registration number –

Validity does not

expire

Submission

deadline

Restricted

substances or

mixtures

containing such

substances (above allowed

concentration limits in

Annex 4 of Eurasia

REACH)

Applicable for Chemical Products placed on the EAEU market

Restricted substances are specified in the Annex 7 to

the “Order on Inventory Formation”

Registration

certificate provided

within 45 days incl.

registration number –

Valid for 5 years

Permitted registration

Submission of basic information:

• Chemical safety passport, administrative

info and some chemical property

information


Registration Submission Deadlines DRAFT …

• The registration deadlines are foreseen in the draft EEC Decision and are not yet confirmed (there are

no deadlines in the text of TR No.41).

– The dates are preliminary and indicate the start of the registration window → transitional period will apply (3

years?)

• Substance registration window: – > 1000 t/a: from the date of TR041 entering into force → deadline to be confirmed

– 100 - 1000 t/a: from 2nd of June 2023 → deadline to be confirmed

– 10 -100 t/a: from 2nd of June 2025 → deadline to be confirmed

– < 10 t/a: from 2nd of June 2027 → deadline to be confirmed

• Mixture registration window:– > 1000 t/a: from 2nd of June 2027 → deadline to be confirmed

– 100-1000 t/a: from 2nd of June 2029 → deadline to be confirmed

– 10-100 t/a: from 2nd of June 2031 → deadline to be confirmed

– < 10 t/a: from 2nd of June 2033 → deadline to be confirmed

• < 1 t/a: Substances and Mixtures may be exempted, but is currently under discussion (the decision on

exemption should be made by 2nd of June 2028)

The registration timeline is not

applicable for new substances (=not

listed in the inventory)! New

substances have to go through NEW

SUBSTANCE NOTIFICATION PROCESS

before being placed on the market!

Mixture AB is placed on the EAEU market in

the tonnage of 10-100 t/y. Components A & B

are not placed on the market on their own,

but as part of Mixture AB only.


Practical example of Mixture AB 10-100t/y

• Regulatory obligations applicable to Mixture AB

1. Inventory status of the components A & B once

TR041 enters into force and before Mixture AB is

placed on the market

• Components A &B are listed in the chemical inventory

• Components A & B are not banned substances in the

EAEU

• Components A & B are not restricted substances (not

in the Annex 7 to the Order of Inventory Formation)

2. Chemical Safety Passport once TR041 enters into

force before Mixture AB is placed on the market and

even before registration in this case!

3. Record-keeping registration of Mixture AB in the

period of 2nd June 2031-2nd June 2034

COMPONENT BBenzenesulfonicacid, 4-dodecyl-CAS No. 121-65-3

50%

COMPONENT A

Isopropyl alcohol CAS No. 67-63-0

50%


Documents/data required explained …

Testing reports(if required!)

Note: reports are not

required for chemicals

listed in the inventory

and/or those chemical

products that can be

classified by calculation

methods

Application CSP

Nominated

Representative

Agreement ?








8. Q&A SESSION

Main uncertainties and next steps

Way Forward ….

Inventory Notification

Note: ended 1st August

2020

2nd tierlegislative

acts approval

TR041 GOST standardsupdateversionsapproval

Russian finalinventorypublished

CommonEAEU

Invneotry is published

Late Inventory notifiation (based on

proof)

TR041 entering into

force

CSP is mandatory

from day one!

Substances registration (deadline

depends on the tonnage

band)

Polymer registration

Mixtureregistrationper tonnage

band

Mixtureinventory

compilationbased on

registration

Nov 2019 - Aug 2020

In Russia

Dec 2020- Spring

2021

In Russia ?

Jan – Feb 2021 ?Later in 2021 ? – 2nd

June 2023 30th Nov 2022?

30th Nov 2022 – 2nd

June 2030

2nd June 2027 – 2nd

June 2036

Conclusions

Step to get ready for TR041 compliance

• Make an extensive list of all chemical products supplied or planned to be

supplied on the EAEU market to verify those in scope of TR041 and CSP

– Substances (0,1% w/w)

– Mixtures (0,1% w/w)

– Application area (uses)

– Tonnage per year

• Check the inventory status of each chemical: if all substances above 0,1% w/w

in your chemical products are listed in the transitional inventory https://gisp.gov.ru/cheminv/pub/app/search/

• Monitor TR041 developments and GOST 30333-20XX official approval

• CSP and New Substance Notification will be the first requirements to comply

under TR041









8. Q&A SESSION

OLESIA POCHAPSKASenior Manager | REACHLaw, Finland

Mobile: + 358 504 534 465

Office: +358 9 412 3055

E-mail: [email protected]

CONTACT US:

mailto:[email protected]








8. Q&A SESSION

Thank you!

Questions & Answers Session

We Specialize in Chemical Regulatory Compliance