Reach: amendments to Annex XVII as a result of the publication of Commission regulation (EU) of 13 December 2021, n.2021/2204 on the Official Journal L of 14 December 2021, n.446.

The variations concern some carcinogenic, mutagenic or toxic for reproduction (CMR) substances. 99.5% acrylonitrile

The new regulation is binding in its entirety and directly applicable in all Member States.

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Below is the text of the Commission Regulation (EU) of 13 December 2021, n.2021/2204.

having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No.1907/2006 of the European Parliament and of the Council, of 18 December 2006, concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), which establishes a European Agency for Chemicals, amending Directive 1999/45/EC and repealing Regulation (EEC) no.793/93 of the Council and the regulation (CE) n.1488/94 of the Commission, as well as the directive 76/769/CEE of the Council and the directives of the Commission 91/155/CEE, 93/67/CEE, 93/105/CE and 2000/21/CE[1]OJ L 396 of 30.12.2006, p.1. , in particular Article 68(2),

(1) In Annex XVII of Regulation (EC) No.1907/2006, items 28, 29 and 30 prohibit the placing on the market and the use for sale to the public of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A or 1B, listed in Appendices 1 to 6 of that Annex, and of mixtures in which these substances exceed certain concentrations.

(2) Substances classified as CMRs are listed in Part 3 of Annex VI to Regulation (EC) No 1906/2006.1272/2008 of the European Parliament and of the Council[2]Regulation (EC) n.1272/2008 of the European Parliament and of the Council, of 16 December 2008, relating to the classification, labeling and packaging of substances and mixtures which amends and repeals directives 67/548/EEC and 1999/45/EC and which amending Regulation (EC) No.1907/2006 (OJ L 353, 31.12.2008, p. 1)..

(3) Regulation (EC) No.1907/2006, Annex XVII, Appendices from 1 to 6, in the latest version amended by Commission Regulation (EU) 2020/2096[3]Commission Regulation (EU) 2020/2096 of 15 December 2020, amending the Annex XVII of Regulation (EC) No.1907/2006 of the European Parliament and of the Council concerning the registration, evaluation, authorization and restriction of chemical substances (REACH), as regards carcinogenic, mutagenic or toxic substances for reproduction (CMR), the devices governed by the Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and test methods for azo dyes (OJ L 425, 16.12.2020, p. 3)., does not yet implement the new classifications as CMR of the substances referred to in Regulation (EC) No.1272/2008, amended by Commission delegated regulations (EU) 2020/1182[4]Commission delegated regulation (EU) 2020/1182, of 19 May 2020, amending, for the purpose of adapting to technical and scientific progress, the part 3 of Annex VI to Regulation (EC) No1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures (OJ L 261, 11.8.2020, p. 2).and (EU) 2021/849[5] Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 amending, for the purpose of adapting to technical and scientific progress, Annex VI, part 3, of the regulation (EC) no.1272/2008 of the European Parliament and of the Council on classification, labeling and packaging of substances and mixtures (OJ L 188, 28.5.2021, p. 27)..Therefore, it is appropriate to add the substances recently classified as CMR category 1A or 1B listed in Delegated Regulations (EU) 2020/1182 and (EU) 2021/849 to Regulation (EC) No.1907/2006, annex XVII, appendices 2, 4 and 6.

(4) The classification of substances listed in Delegated Regulation (EU) 2020/1182 applies from 1 March 2022. The restriction introduced by this Regulation with regard to substances classified as CMR category 1A or 1B by Delegated Regulation ( 2020/1182 should therefore apply from 1 March 2022. The date of application does not prevent operators from applying earlier the restrictions relating to category 1A or 1B CMR substances classified under Delegated Regulation (EU) 2020 /1182.

(5) The classification of substances listed in Delegated Regulation (EU) 2021/849 applies from 17 December 2022. The restriction introduced by this Regulation with regard to substances classified as CMR category 1A or 1B in Delegated Regulation ( EU) 2021/849 should therefore apply from 17 December 2022. The date of application does not prevent operators from applying earlier the restrictions relating to category 1A or 1B CMR substances classified according to the delegated regulation (EU) 2021 /849.

(6) It is therefore appropriate to amend Regulation (EC) No 1999/2006 accordingly.1907/2006.

(7) The measures provided for in this Regulation are in accordance with the opinion of the committee set up by Article 133(1) of Regulation (EC) No 1924/2006.1907/2006,

Annex XVII of Regulation (EC) No.1907/2006 is amended in accordance with the annex to this regulation.

This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

Point 1 of the Annex applies as follows:

— the rows related to the substances silicon carbide fibers (diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1), dibenzo[def,p]chrysene;dibenzo[a,l]pyrene, m-bis(2,3-epoxypropoxy)benzene;resorcinol diglycidyl ether, 2,2-bis(bromomethyl)propane-1,3-diol, sodium N-(hydroxymethyl)glycinate;[formaldehyde released from sodium N-(hydroxymethyl)glycinate], butanone oxime;ethyl methyl ketoxime;ethyl methylethione oxime and N-(hydroxymethyl) acrylamide;methylolacrylamide;[NMA] apply from 1 March 2022;— the rows relating to the substances tetrafluoroethylene, 1,4-dioxane and 7-oxa-3-oxranylbicyclo[4.1.0]heptane;1,2-epoxy-4-epoxyethylcyclohexane;4-Vinylcyclohexane diepoxide shall apply from 17 December 2022. Point 2 of the Annex shall apply from 1 March 2022. Point 3 of the Annex shall apply as follows:

— the rows relating to the substances tris(2-methoxyethoxy)vinylsilane;6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane, dichlorodioctylstannane, dioctyl dilaurate;[1] stannane, dioctyl-, bis(cocoacyloxy) derivatives [2], ipconazole (ISO);(1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol, bis(2-( 2-methoxyethoxy)ethyl)ether;tetraglyme, 2-(4-tert-butylbenzyl)propionaldehyde, diisooctylphthalate, 2-methoxyethyl acrylate, zinc pyrithione;(T-4)-bis[1-(hydroxy-.kappa.O)pyridin-2(1H)-thionato-.kappa.S]zinc, fluorochloridone (ISO);3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one and bis(α,α-dimethylbenzyl peroxide) apply from 1 March 2022;

— the rows relating to the substances mancozeb (ISO), (polymeric) complex of ethylenebis (dithiocarbamate) of manganese with zinc salt, 7-oxa-3-oxanylbicyclo[4.1.0]heptane;1,2-epoxy-4-epoxyethylcyclohexane;4-vinylcyclohexane diepoxide, 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol;[DBMC], dimethomorph (ISO);(E, Z)-4-(3-(4-chlorophenyl)- 3-(3,4-dimethoxyphenyl)acryloyl)morpholine, 1,2,4-triazole and 3-methylpyrazole apply from 17 December 2022.

This Regulation is binding in its entirety and directly applicable in all Member States.

Annex XVII is amended as follows:

< 3 μm, length > 5 μm and aspect ratio ≥ 3:1)

«dibenzo[def,p]crisene; dibenzo[a,l]pirene

«m-bis(2,3-epoxypropoxy)benzene;diglycidyl ether of resorcinol

«7-oxa-3-oxyranylbicyclo[4.1.0]heptano;1,2-epoxy-4-epoxyethylcycloesano;

«N-(hydroxymethyl)glycinate sodium;[formaldehyde released from N-(hydroxymethyl) glycinate sodium]

«butanonoxime;ethyl methyl ketoxime;ethyl methyl ketone oxime

«N-(hydroxymethyl)acrylamide;methylolacrylamide;[NMA]

«N-(hydroxymethyl)acrylamide;methylolacrylamide;[NMA]

«mancozeb (ISO);complex (polymeric) of manganese ethylenebis(dithiocarbamate) with zinc salt

stannane, dioctyl-, bis(cocoacyloxy) derivatives [2]

2-(4-chlorobenzyl)-5-isopropyl- 1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol

4-(3-(4-clorofenil)-3-(3,4-dimetossifenil) acriloil)morfolina

4-(clorometil)-1-[3-(trifluorometil)fenil] pirrolidin-2-one

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