Mark Ward (Dublin Mid West, Sinn Fein)
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900. To ask the Minister for Enterprise, Trade and Employment his views on a new EU Delegated Act (Commission Delegated Regulation (EU) 2025/1222) that classifies nitrous oxide as harmful to reproductive health; if this will trigger a critical clause under the REACH Regulation (Entry 30, Annex XVII), that effectively prohibits the sale of nitrous oxide to the general public; and if he will make a statement on the matter. [41700/25]

Alan Dillon (Mayo, Fine Gael)
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The classification of dinitrogen oxide as a reproductive toxicity category 1B (Repr. 1B) will trigger restriction obligations under Article 67 of the REACH Regulation, when the substance is added to Entry 30 of Annex XVII. Consequently, sale of the substance to the general public will be prohibited unless a specific derogation is provided.

At the December 2024 CARACAL meeting, the European Commission outlined consideration of a targeted derogation to allow for the continued use of dinitrogen oxide in culinary applications. The Commission is still considering the issue and thus no final position or proposal has been presented yet.

The European Union has developed a comprehensive regulatory framework for chemicals to ensure a high level of protection of human health and the environment from their harmful effects. The European Chemicals Agency was established under the REACH Regulation (EC No. 1907/2006) on 1 June 2007.

The European Chemicals Agency's (ECHA) Risk Assessment (Scientific) Committee has tasks under the EU REACH Regulation and the EU Classification, Labelling and Packaging (CLP) Regulation (EC No. 1272/2008).

CLP standardises the way chemicals are classified, labelled, and packaged within the EU.

Within Title VIII of the REACH Regulation entries 28, 29, and 30 of Annex XVII prohibit the placing on the of market and use of chemicals classified as category 1A and 1B carcinogens, mutagens and reproductive toxicants (so called “CMR”) substances or the substances use in mixtures supplied to the general public if they exceed specific or generic concentration limit.

In 2022, ECHA’s Risk Assessment Committee evaluated a dossier prepared by France and prepared a scientific opinion on the substance dinitrogen oxide. The French proposal to classify the substance was subject to an ECHA public consultation in 2022. The scientific opinion was adopted by the EU Commission through the Commission Delegated Regulation (EU 2025/1222) requiring an EU harmonised classification for dinitrogen oxide to apply from 1 February 2027 under the Classification, Labelling and Packaging Regulation.

The European Commission adoption of the Chemicals Agency’s (ECHA) scientific opinion on dinitrogen oxide resulted in its classification as a Reproductive toxicity category 1B (Repr. 1B), Specific target organ toxicant – single exposure category 3 (STOT SE 3), specific target organ toxicant – repeated exposure category 1 (STOT RE 1) for effects on nervous system, and hazardous to the ozone layer (Ozone 1).

To make provision for REACH to apply the European Commission will prepare an amendment to include the substance in the Appendices of REACH Annex XVII. The enforcement of the provisions of Annex XVII can then be activated once this Regulation is adopted. The REACH Regulation amendment is adopted in accordance with the procedures in Article 68(2) of REACH, before the substance is covered by the REACH restriction Entries 28-30.