Commission Regulation (EU) 2021/2204 of 13 December 2021 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances (Text with EEA relevance)
Date: 2021-12-13
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: chemical product, dangerous substance, health risk, market approval, market supervision, marketing standard, reproductive health








L_2021446EN.01003401.xml










14.12.2021   


EN


Official Journal of the European Union


L 446/34








            COMMISSION REGULATION (EU) 2021/2204
of 13 December 2021
         
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

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, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 68(2) thereof,

Whereas:







(1)


Entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006 prohibit the placing on the market and use, for supply to the general public, of substances that are classified as carcinogenic, mutagenic or reproductive toxicant (CMR), categories 1A or 1B, and listed in Appendices 1 to 6 to that Annex and of mixtures containing such substances above specified concentrations.












(2)


Substances classified as CMR are listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2).












(3)


Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006, as last amended by Commission Regulation (EU) 2020/2096 (3), do not yet reflect the new classifications of substances as CMR under Regulation (EC) No 1272/2008, as amended by Commission Delegated Regulations (EU) 2020/1182 (4) and (EU) 2021/849 (5). It is therefore appropriate to add the newly classified CMR substances of categories 1A or 1B listed in Delegated Regulations (EU) 2020/1182 and (EU) 2021/849 to Appendices 2, 4 and 6 to Annex XVII to Regulation (EC) No 1907/2006.












(4)


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












(5)


The classification of substances listed in Delegated Regulation (EU) 2021/849 will apply from 17 December 2022. The restriction introduced by this Regulation as regards substances classified as CMR category 1A or 1B by Delegated Regulation (EU) 2021/849 should therefore apply from 17 December 2022. The date of application does not prevent operators from applying the restrictions related to the CMR substances category 1A or 1B classified under Delegated Regulation (EU) 2021/849 earlier.












(6)


Regulation (EC) No 1907/2006 should therefore be amended accordingly.












(7)


The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 133(1) of Regulation (EC) No 1907/2006,





HAS ADOPTED THIS REGULATION:



Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.


Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Point (1) of the Annex shall apply as follows:






—


rows concerning silicon carbide fibres (with 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 methyl ketone oxime and N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA] shall apply from 1 March 2022,










—


rows concerning tetrafluoroethylene, 1,4-dioxane and 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene 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:






—


rows concerning tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane, dichlorodioctylstannane, dioctyltin dilaurate; [1] stannane, dioctyl-, bis(coco acyloxy) derivs. [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, diisooctyl phthalate, 2-methoxyethyl acrylate, pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc, flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one and bis(α,α-dimethylbenzyl) peroxide shall apply from 1 March 2022,










—


rows concerning mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt, 7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene 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 shall apply from 17 December 2022.








This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 December 2021.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 396, 30.12.2006, p. 1.

(2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

(3)  Commission Regulation (EU) 2020/2096 of 15 December 2020 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), as regards carcinogenic, mutagenic or reproductive toxicant (CMR) substances, devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council, persistent organic pollutants, certain liquid substances or mixtures, nonylphenol and testing methods for azocolourants (OJ L 425, 16.12.2020, p. 3).

(4)  Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 261, 11.8.2020, p. 2).

(5)  Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 amending, for the purposes of its adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 188, 28.5.2021, p. 27).




ANNEX
Annex XVII is amended as follows:






(1)


in Appendix 2, the following entries are inserted in the table in the order of the index numbers set out therein:









Substances


Index No


EC No


CAS No


Notes




‘silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1)


014-048-00-5


206-991-8


409-21-2
308076-74-6’


 




‘dibenzo[def,p]chrysene; dibenzo[a,l]pyrene


601-092-00-0


205-886-4


191-30-0’


 




‘tetrafluoroethylene


602-110-00-X


204-126-9


116-14-3’


 




‘1,4-dioxane


603-024-00-5


204-661-8


123-91-1’


 




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


603-065-00-9


202-987-5


101-90-6’


 




‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide


603-066-00-4


203-437-7


106-87-6’


 




‘2,2-bis(bromomethyl)propane-1,3-diol


603-240-00-X


221-967-7


3296-90-0’


 




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


607-746-00-1


274-357-8


70161-44-3’


 




‘butanone oxime; ethyl methyl ketoxime; ethyl methyl ketone oxime


616-014-00-0


202-496-6


96-29-7’


 




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


616-230-00-5


213-103-2


924-42-5’;


 














(2)


in Appendix 4, the following entries are inserted in the table in the order of the index numbers set out therein:









Substances


Index No


EC No


CAS No


Notes




‘2,2-bis(bromomethyl)propane-1,3-diol


603-240-00-X


221-967-7


3296-90-0’


 




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


616-230-00-5


213-103-2


924-42-5’;


 














(3)


in Appendix 6, the following entries are inserted in the table in the order of the index numbers set out therein:









Substances


Index No


EC No


CAS No


Notes




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


006-076-00-1


-


8018-01-7’


 




‘tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane


014-050-00-6


213-934-0


1067-53-4’


 




‘dichlorodioctylstannane


050-021-00-4


222-583-2


3542-36-7’


 




‘dioctyltin dilaurate; [1]
stannane, dioctyl-, bis(coco acyloxy) derivs. [2]


050-031-00-9


222-883-3 [1]
293-901-5 [2]


3648-18-8 [1]
91648-39-4 [2]’


 




‘7-oxa-3-oxiranylbicyclo[4.1.0]heptane; 1,2-epoxy-4-epoxyethylcyclohexane; 4-vinylcyclohexene diepoxide


603-066-00-4


203-437-7


106-87-6’


 




‘ipconazole (ISO); (1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol


603-237-00-3


-


125225-28-7
115850-69-6
115937-89-8’


 




‘bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme


603-238-00-9


205-594-7


143-24-8’


 




‘6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC]


604-095-00-5


204-327-1


119-47-1’


 




‘2-(4-tert-butylbenzyl)propionaldehyde


605-041-00-3


201-289-8


80-54-6’


 




‘diisooctyl phthalate


607-740-00-9


248-523-5


27554-26-3’


 




‘2-methoxyethyl acrylate


607-744-00-0


221-499-3


3121-61-7’


 




‘dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine


613-102-00-0


404-200-2


110488-70-5’


 




‘1,2,4-triazole


613-111-00-X


206-022-9


288-88-0’


 




‘pyrithione zinc; (T-4)-bis[1-(hydroxy-.kappa.O)pyridine-2(1H)-thionato-.kappa.S]zinc


613-333-00-7


236-671-3


13463-41-7’


 




‘flurochloridone (ISO); 3-chloro-4-(chloromethyl)-1-[3-(trifluoromethyl)phenyl]pyrrolidin-2-one


613-334-00-2


262-661-3


61213-25-0’


 




‘3-methylpyrazole


613-339-00-X


215-925-7


1453-58-3’


 




‘bis(α,α-dimethylbenzyl) peroxide


617-006-00-X


201-279-3


80-43-3’