Commission Regulation (EU) 2023/1132 of 8 June 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards carcinogenic, mutagenic or reproductive toxicant substances subject to restrictions (Text with EEA relevance)
Date: 2023-06-08
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: carcinogenic substance, chemical product, health risk, market supervision, marketing standard, reproductive health, toxic substance








L_2023149EN.01004901.xml










9.6.2023   


EN


Official Journal of the European Union


L 149/49








            COMMISSION REGULATION (EU) 2023/1132
of 8 June 2023
         
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards carcinogenic, mutagenic or reproductive toxicant substances subject to restrictions
(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 2 and 6 to Annex XVII to Regulation (EC) No 1907/2006 should be amended in order to reflect the new classification of substances as CMR in Regulation (EC) No 1272/2008 as amended by Commission Delegated Regulation (EU) 2022/692 (3). It is therefore appropriate to insert the newly classified CMR substances of categories 1A and 1B in Appendices 2 and 6 to Annex XVII to Regulation (EC) No 1907/2006.












(4)


The new classification of substances in Regulation (EC) No 1272/2008 will apply from 1 December 2023. The restriction introduced by this Regulation as regards the substances classified by Regulation (EU) 2022/692 as CMR category 1A or 1B should therefore apply from the same date. The date of application does not prevent operators from applying the restrictions related to the CMR substances of category 1A or 1B listed in the Annex to Delegated Regulation (EU) 2022/692 earlier.












(5)


A number of group entries are included in Part 3 of Annex VI to Regulation (EC) No 1272/2008. In some cases, there are classification requirements for specific substances that would be covered by the group entry. In such cases a specific entry is included in Part 3 of Annex VI to Regulation (EC) No 1272/2008 for the substance and the group entry in that Regulation is then annotated with the phrase ‘except those specified elsewhere in this Annex’. The incorporation of those substances in Appendices 1 to 6 of Annex XVII to Regulation (EC) No 1907/2006 thus needs to reflect that annotation referring to Annex VI to Regulation (EC) No 1272/2008. However, the text in the entries with index numbers 033-005-00-1, 050-008-00-3, 082-001-00-6, 609-026-00-2 and 650-017-00-8 seems to refer to an Annex to Regulation (EC) No 1907/2006 instead of Annex VI to Regulation (EC) No 1272/2008. Those entries should therefore be adapted accordingly.












(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.
Points (2) and (5) of the Annex shall apply from 1 December 2023.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 June 2023.


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 Delegated Regulation (EU) 2022/692 of 16 February 2022 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 129, 3.5.2022, p. 1).




ANNEX
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:






(1)


in Appendix 1, the entry with index number 033-005-00-1 is replaced by the following:









Substances


Index No


EC No


CAS No


Notes




‘Arsenic acid and its salts, except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008


033-005-00-1


-


-


A’














(2)


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




‘Divanadium pentaoxide; vanadium pentoxide


023-001-00-8


215-239-8


1314-62-1’


 




‘Cumene


601-024-00-X


202-704-5


98-82-8’


 




‘2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol


603-243-00-6


253-057-0


36483-57-5; 1522-92-5’


 




‘Benzophenone


606-153-00-5


204-337-6


119-61-9’


 














(3)


in Appendix 2, the entry with index number 650-017-00-8 is replaced by the following:









Substances


Index No


EC No


CAS No


Notes




‘Refractory Ceramic Fibres, Special Purpose Fibres, except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008; [Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18 % by weight]


650-017-00-8


-


-


A, R’














(4)


in Appendix 5, the entry with index number 082-001-00-6 is replaced by the following:









Substances


Index No


EC No


CAS No


Notes




‘Lead compounds, except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008


082-001-00-6


-


-


A’














(5)


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




‘Ammonium bromide


035-005-00-7


235-183-8


12124-97-9’


 




‘Dibutyltin bis(2-ethylhexanoate)


050-032-00-4


220-481-2


2781-10-4’


 




‘Dibutyltin di(acetate)


050-033-00-X


213-928-8


1067-33-0’


 




‘Tellurium


052-001-00-0


236-813-4


13494-80-9’


 




‘Tellurium dioxide


052-002-00-6


231-193-1


7446-07-3’


 




‘Barium diboron tetraoxide


056-005-00-3


237-222-4


13701-59-2’


 




‘2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether


603-107-00-6


203-906-6


111-77-3’


 




‘2,4,6-tri-tert-butylphenol


604-097-00-6


211-989-5


732-26-3’


 




‘4,4'-sulphonyldiphenol; bisphenol S


604-098-00-1


201-250-5


80-09-1’


 




‘2-ethylhexanoic acid and its salts, with the exception of those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008


607-230-00-6


-


-’


 




‘Pentapotassium 2,2',2",2"’,2""-(ethane-1,2-diylnitrilo)pentaacetate


607-734-00-6


404-290-3


7216-95-7’


 




‘N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid)


607-735-00-1


200-652-8


67-43-6’


 




‘Pentasodium(carboxylatomethyl)iminobis (ethylenenitrilo)tetraacetate


607-736-00-7


205-391-3


140-01-2’


 




‘Perfluoroheptanoic acid; tridecafluoroheptanoic acid


607-761-00-3


206-798-9


375-85-9’


 




‘6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid, sodium and tris(2-hydroxyethyl)ammonium salts


607-763-00-4


-


-’


 




‘6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid


607-764-00-X


-


2156592-54-8’


 




‘6-[C12-18-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid


607-765-00-5


-


-’


 




‘Theophylline; 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione


613-342-00-6


200-385-7


58-55-9’


 




‘N-(2-nitrophenyl)phosphoric triamide


616-238-00-9


477-690-9


874819-71-3’


 




‘Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide [> 78 % syn isomers < 15 % anti isomers relative content]; isopyrazam


616-240-00-X


-


881685-58-1’


 














(6)


in Appendix 6, the entries with index numbers 050-008-00-3 and 609-026-00-2 are replaced by the following:









Substances


Index No


EC No


CAS No


Notes




‘Tributyltin compounds, except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008


050-008-00-3


-


-’


 




‘Salts and esters of dinoseb, except those specified elsewhere in Annex VI to Regulation (EC) No 1272/2008


609-026-00-2


-


-’