1.

Notifying Member: EUROPEAN UNION

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

European Commission

EU-TBT Enquiry Point,

Fax: +(32) 2 299 80 43,

E-mail: grow-eu-tbt@ec.europa.eu

Website: https://technical-barriers-trade.ec.europa.eu/en/home

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Recently classified carcinogens, germ cell mutagens and reproductive toxicants (CMR) of category 1A and 1B as substances on their own, as constituents of other substances or in mixtures that are placed on the market or used for supply to the general public.

5.

Details of notified document(s) (title, number of pages and languages, means of access): Draft Commission Regulation 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; (4 page(s), in English), (6 page(s), in English)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

European Commission

EU-TBT Enquiry Point

Fax: + (32) 2 299 80 43

E-mail: grow-eu-tbt@ec.europa.eu

The text is available on the Website: https://technical-barriers-trade.ec.europa.eu/en/home

6.

Description of content: This draft Commission Regulation aims to include within the scope of entries 28 to 30 of Annex XVII to Regulation (EC) No 1907/2006 ("REACH") several substances, with the effect of restricting their placing on the market or use for supply to the general public as substances on their own, as constituents of other substances or in mixtures and to impose the requirement to mark packaging with the label "restricted to professional users". This is consequent to the recent harmonised classification of these substances as CMR category 1A or 1B under 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, as amended by Commission Delegated Regulations (EU) 2024/2564 (OJ L, 2024/2564, 30.9.2024, ELI: https://eur-lex.europa.eu/eli/reg_del/2024/2564/oj) and (EU) 2025/1222 (OJ L, 2025/1222, 2.4.2025, ELI: http://data.europa.eu/eli/reg_del/2025/1222/oj).

This draft Commission Regulation furthermore aims to introduce additivity rules, to align with the European implementation of GHS (CLP). For those substances for which the CLP specifically foresees that additivity rules apply to determine the classification of a mixture, also in the restriction the sum of the concentrations of these individual classified substances would be used to determine whether the concentration limit applicable in the restriction is reached.

This draft Commission Regulation also aims to introduce a derogation from entry 30 of Annex XVII to REACH for dinitrogen oxide (also known as nitrous oxide) (EC No. 233-032-0; CAS No 10024-97-2) for the placing on the market and use of nitrous oxide as food additive.

This aims to ensure the continued legitimate sale of the substance used as food additive, e.g. as a propellant in spray cans for whipped cream or of small cartridges of nitrous oxide for amateur chefs for preparing espumas, as well as the presence of the food additive in food.

7.

Objective and rationale, including the nature of urgent problems where applicable: The abovementioned substances recently received new harmonised classifications as CMR category 1A or 1B. In accordance with Article 68(2) of Regulation (EC) No 1907/2006 (REACH), the Commission may propose a restriction preventing the use of these substances and mixtures containing them by consumers.; Protection of human health or safety

8.

Relevant documents:

-Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH Regulation): http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1423064258789&uri=CELEX:32006R1907

9.

Proposed date of adoption: First quarter of 2026

Proposed date of entry into force: 20 days from publication in the Official Journal of the EU. For the substances classified by Commission Delegated Regulation (EU) 2025/1222 and the related derogation[s] for nitrous oxide, the date of application will be 1 February 2027. This is to ensure alignment of the date of application of the inclusion of the substances in the scope of the restriction with the date of application of the classification of the substances under Commission Delegated Regulation (EU) 2025/1222. As the entry into force of the present Draft Commission Regulation is anticipated to be later than the date of applicability of the classifications under Commission Delegated Regulation (EU) 2024/2564, no date of application different from the date of entry into force is foreseen for substances classified by Commission Delegated Regulation (EU) 2024/2564.

10.

Provision of comments

Final date for comments: 20 March 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

European Commission,

EU-TBT Enquiry Point,

Fax: + (32) 2 299 80 43,

E-mail: grow-eu-tbt@ec.europa.eu