Update of the RAC Work Plan

58th meeting ofthe Committee for Risk Assessment

7-10 Septemberand13-16 September 2021

RAC work programme: Q3-4/2021

24/09/2021 2

Restrictions:

• 2 opinions on the current restriction proposals to be adopted in 2021

• 2 new restriction proposals to arrive in 2021 (and at least 5 expected in 2022)

Article 77(3)c

• 1 ongoing CLH requests (COM): lead env. properties

Applications for Authorisation:

• 6 applications (6 uses) received during the May 2021 submission window

• 5 applications (6 uses) received during the August 2021 submission window

• 22(!) applications expected in November 2021 submission window

Harmonised classification and labelling: minimum of 55-60 for adoption in 2021

• 5 dossiers currently in consultation

Occupational Exposure Limits:

• 4 further dossiers requested in January 2021, 5th (cobalt and inorganic cobalt coumpounds) was received recently, two are scoping reports before an OEL is derived, e.g. welding fume

*Synchronised with the LADs in June/July

Restrictions

Indicative timelines and dossiers preliminary planning for

RAC 58-61

24/09/2021 4

Submission substanceDL adoption

in RACComment

1 October 2021 PAHs in clay targets (ECHA) September 2022

2 October 2021 Per- and polyfluoroalkyl substances (PFAS) (ECHA) September 2022

Submission of new restriction proposals 2021

Upcoming restriction’s

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Substances Sep-21 Dec-21 Mar-22 Jun-22

RAC 58 RAC 59 RAC 60 RAC 61

Disposable

diapers

Lead in

ammunition &

fishing tackle

Dechlorane Plus

2,4-

dinitrotoluene

PAHs in clay

targets

PFAS in FFF

DMAC, BPA (tbc)

Number per

meeting 4 5 5 4

Meetings of the RAC REST WG in 2021-2022

• 3rd Meeting of the RAC REST WG 3-4 November 2021

• 4th Meeting of the RAC REST WG 9-10 February 2022

• 5th Meeting of the RAC REST WG 4-5 May 2022

• 6th Meeting of the RAC REST WG 18-19 August 2022

• 7th Meeting of the RAC REST WG 3-4 November 2022

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Applications for Authorisation

Preliminaryplanning for RAC

88

Authorisation applications

24/09/2021

AfAs Uses

November 20204

received4

received

February 20215

received6

received

May 20216

received6

received

August 20215

received6

received

November 202122

expected22-30expected

99

Applications for Authorisation 2021/2022

Opinion development process in a nutshell:Submission of AfA in the window + 2 to 2.5 months for checks, broad information on uses and payment = start of public consultation (PC) Start of PC = start of Working procedure, first RAC meeting 16(-17) weeks (4 months), second RAC meeting 29(-30) weeks (7 months)

24/09/2021

RAC-58(Sep 21)

• No opinions to finalise• 3 draft opinions to agree (CrO3, TCE) 9• Key issues in 6 AfAs

RAC-59(Dec 21)

• 2 opinions to finalise (CrO3, Na2Cr2O7)• 7 draft opinions to agree (Cr(VI), NPnEO) 14• Key issues in 5 AfAs

RAC-60(Mar 22)

• Up to 4 opinions to finalise (CrO3, TCE, EDC)• 6 draft opinions to agree (Cr(VI), O-/NPnEO) ≤ 32• Key issues in up to 22 AfAs

RAC-61(Jun 22)

• Up to 7 opinions to finalise (Cr(VI), NPnEO)• 6 draft opinions to agree (CrO3, TCE, MOCA) ≤ 21• Key issues in up to 8 AfAs

Meetings of the RAC AFA WG in 2021/2022

• 9th Meeting 5-9 July 2021 - CANCELLED

• 10th Meeting 12-13 October 2021

• 11th Meeting 31 January-4 February 2022

• …

24/09/2021 10

Harmonised classification and labelling

Dossiers planned for RAC 59-60

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▪ This is an indicative planning for RAC 59–60 which is regularly updated / revised based on the exact submission dates for CLH intentions

▪ RAC CLH Working Group has been introduced since April 2021 to discuss dossiers prior to plenaries (dossiers marked in green in the

planning table will be discussed in the July WG, starting from October, all dossiers will be discussed in the WG)

▪ Additional deadlines for different steps (including the steps after the adoption of an opinion) are introduced in order to allow for better planning of the process

▪ In some cases (for complex and/or complicated (groups of) dossiers) two or more plenary meetings may be needed

▪ Dossiers / hazard classes which would be proposed for A-listing will be identified at later stage - based on the outcome of the PC and the RAC consultation

Classification & Labelling

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PC DL substance Legal DL comment

1 12/03/21methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate; bifenox (EC 255-894-7; CAS 42576-02-3)

26/05/22

2 12/03/21

Reaction mass of N,N'-ethane-1,2-diylbis(decanamide) and 12-

hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]octadecanamide and N,N'-

ethane-1,2-diylbis(12-hydroxyoctadecanamide) (EC 430-050-2; CAS -)02/06/22

3 05/02/21

benalaxyl (ISO); methyl N-(2,6-dimethylphenyl)-N-(phenylacetyl)-DL-

alaninate (EC 275-728-7; CAS 71626-11-4) 05/05/22

4 22/01/21 tetramethylene dimethacrylate (EC 218-218-1; CAS 2082-81-7) 12/01/22

5 22/01/217,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate (EC 276-957-5; CAS 72869-86-4

10/04/22

6 05/02/21 2,2'-ethylenedioxydiethyl dimethacrylate (EC 203-652-6; CAS 109-16-0) 13/05/22

7 09/04/21Hexyl salicylate (EC 228-408-6; CAS 6259-76-3)

08/06/22

8 09/04/21

2,2'-[[3-methyl-4-[(4-nitrophenyl)azo]phenyl]imino]bisethanol (EC

221-665-5; CAS 3179-89-3) 09/07/22

9 09/04/214-methylimidazole (EC 212-497-3; CAS 822-36-6)

16/06/22

10 09/04/21

3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol (EC 211-477-1; CAS

647-42-7) 20/07/22

11 14/05/21

1,2-benzisothiazol-3(2H)-one; 1,2-benzisothiazolin-3-one (EC 220-120-9; CAS 2634-33-5)

13/08/22

RAC-59 / December 2021 (1)

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PC DL substance Legal DL comment

12 14/05/21

1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. ; Reaction mass of N-phenyl,N’-o-tolyl-phenylene diamine, N,N’-diphenyl-p-phenylene diamine and N,N’-di-o-tolyl-phenylene diamine (EC 273-227-8; CAS 68953-84-4)

02/09/22

13 18/12/20 silver (EC 231-131-3; CAS 7440-22-4) 16/03/22

RAC-59 / December 2021 (2)

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PC DL substance Legal DL comment

1 18/06/212-[ethyl[3-methyl-4-[(5-nitrothiazol-2-yl)azo]phenyl]amino]ethanol (EC 271-183-4; CAS 68516-81-4)

25/09/22

2 06/08/21 (3E)-dec-3-en-2-one (EC no available; CAS 18402-84-1) 02/11/22

3 06/08/21 2,3-epoxypropyl neodecanoate (EC 247-979-2; CAS 26761-45-5) 04/11/22

4 09/04/21

benthiavalicarb-isopropyl (ISO); isopropyl [(S)-1-{[(R)-1-(6-fluoro-

1,3-benzothiazol-2-yl)ethyl]carbamoyl}-2-methylpropyl]carbamate

(CAS 177406-68-7)

22/07/22

5 03/09/21

S-metolachlor (ISO); 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide; (RaSa)-2-chloro-N-(6-ethyl-o-tolyl)-N-[(1S)-2-methoxy-1-methylethyl]acetamide [contains 80-100 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2S)-1-methoxypropan-2-yl]acetamide and 0-20 % 2-chloro-N-(2-ethyl-6-methylphenyl)-N-[(2R)-1-methoxypropan-2-yl]acetamide] (EC -; CAS 87392-12-9)

24/11/22

6 03/09/21 propyl 3,4,5-trihydroxybenzoate (EC 204-498-2; CAS 121-79-9) 18/11/22

7 03/09/21 Acetone oxime (EC 204-820-1; CAS 127-06-0) 08/10/22

8 03/09/21

Multi-Walled Carbon Tubes (synthetic graphite in tubular shape) with a geometric tube diameter range ≥ 30 nm to < 3 μm and a length ≥ 5 μm and aspect ratio > 3:1, including Multi-Walled Carbon Nanotubes, MWC(N)T (EC -; CAS -)

9 03/09/21 Sulfur (EC 231-722-6; CAS 7704-34-9) 16/12/22

RAC-60 / March 2022

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PC DL substance Legal DL comment

10 18/12/20 silver (EC 231-131-3; CAS 7440-22-4) 16/03/22

11 18/06/21dicamba (ISO); 2,5-dichloro-6- methoxybenzoic acid; 3,6- dichloro-2-methoxybenzoic acid (EC 217-635-6; CAS 1918-00-9)

13/10/22

12 08/10/21

α-methyl-1,3-benzodioxole-5-propionaldehyde (EC 214-881-6; CAS 1205-

17-0) 01/12/22

13 08/10/21peracetic acid …% (EC 201-186-8; CAS 79-21-0)

24/12/22

14 08/10/21formaldehyde …% (EC 200-001-8; CAS 50-00-0)

29/12/22

RAC-60 / March 2022 (2)

Meetings of the RAC CLH WG in 2021-2022

• 3rd Meeting of the RAC CLH WG 25-29 October 2021(combined with the AfA WG)

• 4th Meeting of the RAC CLH WG 24-28 January 2022

• 5th Meeting of the RAC CLH WG 18-22 April 2022

• 6h Meeting of the RAC CLH WG 4-8 July 2022

• 7th Meeting of the RAC CLH WG 24-28 October 2022

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Overview of RAC WGs in 2021 and 2022

24/09/2021 18

Restirictions WG AfA WG CLH WG

2021

3-4 November 12-13 October 25-29 October

2022

9-10 February31 January-4 February

24-28 January

4-5 May 25-29 April 2022 18-22 April

18-19 August 4-8 July 2022 4-8 July

3-4 November 10-14 October 2022 24-28 October

Occupational Exposure Limits

Indicative timelines for opinions (RAC)

New OEL requests: 2021-2022

24/09/2021 20

chemical agents

Substances under CMD:

▪ Welding fumes (scoping study (only));▪ Polycyclic aromatic hydrocarbons (scoping study and OEL

evaluation);▪ Isoprene; ▪ 1,4 –dioxane;▪ Cobalt

The provisional start times for starting the development of a draft opinion are: • 1,4-dioxane: Oct/Nov 2021• Isoprene: Nov/Dec 2021• Polycyclic aromatic hydrocarbons: April/May 2022• Cobalt: April/May 2022

Thank You.

RAC/SEAC Secretariat

Diana Sadam CLP and OELsdiana.sadam@echa.europa.eu

Katja Orispää Restrictionskatja.orispaa@echa.europa.eu

Arnis Ludboržs Authorisationsarnis.ludborzs@echa.europa.eu