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Document Ares(2024)8681048

COMMISSION REGULATION (EU) …/… amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards carcinogens, germ cell mutagens or reproductive toxicants subject to restrictions

Please be aware that this draft act does not constitute the final position of the institution.

COMMISSION REGULATION (EU) …/…

of XXX

amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards carcinogens, germ cell mutagens or reproductive toxicants 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 carcinogen, germ cell mutagen or reproductive toxicant (CMR) categories 1A or 1B in Part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European Parliament and of the Council 2 , and that are listed in Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006, and of mixtures containing such substances above specified concentrations.

(2)Appendices 2, 4 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) 2024/197 3 . It is therefore appropriate to include the newly classified CMR substances of category 1B in Appendices 2, 4 and 6 to Annex XVII to Regulation (EC) No 1907/2006.

(3)The classification of substances in Regulation (EC) No 1272/2008 as amended by Delegated Regulation (EU) 2024/197 will apply from 1 September 2025. The restriction introduced by this Regulation as regards the substances classified by Delegated Regulation (EU) 2024/197 as CMR category 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 1B listed in the Annex to Delegated Regulation (EU) 2024/197 earlier.

(4)Commission Regulation (EU) 2023/1132 4  included cumene in Appendix 2 to Annex XVII to Regulation 1907/2006 as of 1 December 2023. Cumene is present in certain aviation fuels for small airplanes, including those flown by non-professional pilots. Such non-professional pilots are members of the general public as referred to in entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006. Accordingly, cumene is not allowed to be placed on the market or used in aviation fuels for supply to non-professional pilots in a concentration of 0,1 % w/w or more as of 1 December 2023.

(5)Entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006 do not apply to, inter alia, several fuels and oil products, including motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council 5 . Such motor fuels include petrol and diesel fuels for road vehicles equipped with positive ignition and compression-ignition engines. Therefore, the restriction on cumene does not apply to the placing on the market or use of motor fuels for supply to non-professional car drivers.

(6)In view of the similarities between the use of motor fuels by non-professional car drivers and the use of aviation fuels by non-professional small airplane pilots, and the fact that there are far fewer non-professional small airplane pilots using aviation fuels than non-professional car drivers using motor fuels and that  Directive 98/70/EC itself does not restrict cumene in such motor fuels, cumene present in aviation fuel should be exempted from the restriction of entries 28, 29 and 30 of Annex XVII to Regulation (EC) No 1907/2006.

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

(8)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 (1), (2) and (3) of the Annex shall apply from 1 September 2025.

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
   

(1)    OJ L 396, 30.12.2006, p. 1, ELI: http://data.europa.eu/eli/reg/2006/1907/oj.
(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, ELI:  http://data.europa.eu/eli/reg/2008/1272/oj ).
(3)    Commission Delegated Regulation (EU) 2024/197 of 19 October 2023 amending Regulation (EC) No 1272/2008 as regards the harmonised classification and labelling of certain substances (OJ L, 2024/197, 5.1.2024, ELI:  http://data.europa.eu/eli/reg_del/2024/197/oj .
(4)    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 (OJ L 149, 9.6.2023, p. 49, ELI: http://data.europa.eu/eli/reg/2023/1132/oj ).
(5)

   Directive 98/70/EC of the European Parliament and of the Council of 13 October 1998 relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC (OJ L 350, 28.12.1998, p. 58, ELI: http://data.europa.eu/eli/dir/1998/70/oj).

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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

‘diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea

006-015-00-9

206-354-4

330-54-1’

‘2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol; tetrabromobisphenol-A

604-074-00-0

201-236-9

79-94-7’

‘N,N-dimethyl-p-toluidine

612-296-00-4

202-805-4

99-97-8’

‘4-nitrosomorpholine

613-346-00-8

-

59-89-2’

‘4-methylimidazole

613-349-00-4

212-497-3

822-36-6’

(2)in Appendix 4, the following entry is inserted in the table in the order of the index numbers set out therein:

Substances

Index No

EC No

CAS No

Notes

‘dimethyl propylphosphonate

015-208-00-7

242-555-3

18755-43-6’

(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

‘diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide

015-203-00-X

278-355-8

75980-60-8’

‘benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate

015-204-00-5

479-100-5

577705-90-9’

‘benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)

015-205-00-0

278-305-5

75768-65-9’

‘reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate (1:1)

015-206-00-6

-

- ’

‘reaction mass of 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol (1:1)

015-207-00-1

-

- ’

‘dimethyl propylphosphonate

015-208-00-7

242-555-3

18755-43-6’

‘dibutyltin maleate

050-034-00-5

201-077-5

78-04-6’

‘dibutyltin oxide

050-035-00-0

212-449-1

818-08-6’

‘reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3-epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2-hydroxymethyl butane

603-244-00-1

-

- ’

‘4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF

604-099-00-7

216-036-7

1478-61-1’

‘1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.;

612-298-00-5

273-227-8

68953-84-4’

‘4-methylimidazole

613-349-00-4

212-497-3

822-36-6’

(4)in Appendix 11, the following entry is added:

Substances

Derogations

‘2. Cumene

CAS No 98-82-8

EC No 202-704-5

As a substance on its own or as a constituent of other substances in either of the following:

(a)kerosene used as aviation fuel conforming to DEF STAN 91-091, ASTM specification D1655 or equivalent recognised standards and marketed under descriptions such as Jet-A, Jet-A1 or JP-(x);

(b)gasoline used as aviation fuel conforming to DEF STAN 91-090, ASTM D910, ASTM D7547, EN 228 or equivalent recognised standards.’

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