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EU harmonised classification of nitrous oxide and potential ban of the substance in culinary applications

Question écrite de M. Tomáš ZDECHOVSKÝ - Commission européenne

Question de M. Tomáš ZDECHOVSKÝ,

Diffusée le 1 avril 2024

Subject: EU harmonised classification of nitrous oxide and potential ban of the substance in culinary applications

In response to the alarming rise in abuse of nitrous oxide (N2O), the Commission is considering an EU harmonised classification of the substance as a category 1B reproductive toxicant. This would not have any health benefits and would likely lead to a follow-up ban of the substance in culinary applications, despite its safe use for over 40 years all over the world, including in Parliament’s canteen. N2O chargers are widely employed in the hotel, restaurant and catering sector and are essential for certain innovative culinary techniques. Moreover, other regulatory agencies1 have adopted different conclusions, based on the same science, which do not imply a restriction of the substance.

1. Has the Commission considered alternative regulatory options and conclusions by other regulatory agencies to address the abuse of the substance without restricting its legitimate uses?

2. To what extent is it appropriate to base the classification of a substance on inhalation studies, which are only relevant for anesthetic applications and not its illegal abuse?

3. Will the Commission consider an alternative classification which would not lead to a potential ban on legitimate European companies that have heavily invested in the EU in recent years?

Submitted:2.4.2024

1 UK Health & Safety Executive (HSE) opinion of December 2023 and Dutch Health Council evaluation of May

Réponse - Commission européenne

Diffusée le 18 juin 2024

Answer given by Mr Sinkevičius on behalf of the European Commission (19 June 2024)

1. The Commission wishes to recall the Honourable Member that the classification process under the Classification, Labelling and Packaging (CLP) Regulation (2) aims at classifying chemical substances solely based on their hazard and to properly communicate these hazards to all users to ensure proper risk management. The CLP does not provide for the possibility to ban substances. The process of harmonised classification of dinitrogen oxide (also called nitrous oxide) was initiated by a proposal by France followed by an opinion by the European Chemicals Agency (ECHA)’s Risk Assessment Committee (RAC) (3), which recommended its classification as reproductive toxicant Category cB.

2. The RAC opinion was developed in full compliance with the CLP. A public consultation was held by ECHA, complemented by ad-hoc stakeholder participation in the RAC meeting. RAC performed an in-depth assessment of all available scientific information using the most appropriate weight of evidence determination according to CLP criteria. The opinion considered a comprehensive data set including animal studies and evidence from human exposure and concluded that the substance met the reproductive toxicant Category cB classification criteria.

3. The Commission is currently analysing all the scientific arguments before taking its final decision expected later in 2024. It discussed the classification in meetings with Member States and stakeholders.

1 ∙ ⸱ UK Health & Safety Executive (HSE) opinion of December 2023 and Dutch Health Council evaluation of May 2000.

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- 1355. 3 ∙ ⸱

RAC, March 2023, https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment





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