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.

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)

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.