EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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 Chemic als 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/EC1, 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 rep roductive toxicant (CMR), categories 1A 
or 1B , and listed in Appendices 1 to 6 to that Annex  and of mixtures containing such 
substances above  specified concentration s. 
(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 Council2. 
(3) Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006, as last amended 
by Commission Regulation (EU) 2020/20963, do not yet reflect the new classifications 
of substances as CMR under Regul ation (EC) No 1272/2008 , as amend ed by 
Commission Delegated Regulation s (EU) 2020/ 11824 and (EU) 2021 /…5. It is 
                                                 
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 packa ging of substances and mixtures , amending and repealing Directives 
67/548/EEC and 1999/4 5/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 Regist ration, 
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 orga nic 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 EN 2  EN therefore appropriate to add the newly classified CMR substances of categories 1A or 
1B listed in Delegated Regu lation s (EU) 2020/1182  and (EU) 2021 /… to Appendices 
2, 4 and  6 to Annex XVII to Regulation (EC) No 1907/2006 . 
(4) The classif ication 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 Regulation  (EU) 2020/1182  
should therefore apply from 1 March  2022 . The date of application does not prevent 
operators from applying the restrictio ns related to the CMR substances category 1A or 
1B classified under  Regulation (EU) 2020/1182 earlier.  
(5) The classifica tion of substances listed in  Delegated Regulation (EU) 2021 /… will 
apply from …. The  restriction introduced by this Regulation as regards substances 
classified as CMR category 1A or 1B by Regulation  (EU) 2021 /… should therefore 
apply from  …. The date of application does not prevent operators from applying the 
restrictions related to the C MR substances category 1A or 1B classified under  
Regulation (EU) 2021 /… 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 establis hed 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 Regulatio n shall enter into force on the twe ntieth  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 methy l 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 …. 
                                                                                                                                                         
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 /… 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 classificati on, labelling and packaging of substances and 
mixtures (OJ …) . [This is the act adopted  under number C(2021)1533 final . It appears in the Register 
of delegated and implementing acts under  https://webgate.ec.europa.eu/regdel/#/delegatedActs/1452 .] EN 3  EN 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)vin ylsilan e; 6 -(2-methoxyethoxy )-6-
vinyl -2,5,7,10 -tetraoxa -6-silaundecane, d ichlorodioctylstannane, dioctyltin 
dilaurate; [1] stannane, dioctyl -, bis(coco acyloxy) derivs. [2],  ipconazole  
(ISO); (1 RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl) -5-isopropyl -1-(1H-
1,2,4 -triazol -1-ylmethyl)cycl opentanol, 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  .… 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen