Restriction updating Annex XVII REACH regarding CMRs (2025)

This submission concerns multi-walled carbon nanotubes (MWCNTs) covered by the harmonised CLP entry for multi-walled carbon tubes with a geometric tube diameter 30 nm to 3:1, classified as Carcinogenicity Category 1B (H350i, inhalation) and STOT RE 1 (lung). Our comments address how any future Annex XVII restriction can most effectively and proportionately manage the associated inhalation risk in practice.

FNADE welcomes the European Commissions recent initiatives regarding the reclassification and the ban on nitrous oxide as of 1 February 2027, aimed at addressing the scourge of this substance as a public health, environmental and operational issue, while still allowing its continued use for legitimate purposes.

The opportunity to provide feedback on the proposed amendments to Regulation (EC) No 1907/2006 (REACH) concerning substances classified as carcinogens, germ cell mutagens or reproductive toxicants and subject to restrictions is welcomed. The European Unions objectives of protecting human health and ensuring regulatory alignment with updated harmonised classifications are fully supported.

Founded in 1904, the Fédération Internationale de lAutomobile (FIA) brings together leading national motoring organisations from 146 countries worldwide and is the governing body for world motor sport. The FIA Region I, based in Brussels, is a consumer body comprising 102 Mobility Clubs that represent over 41 million members from across Europe, the Middle East and Africa.

Sirk Norge represents Norway's waste and recycling industry and its stakeholders. Our 200 members, both private and public companies, handle materials across all waste streams. We have more than 30 years of industry-specific expertise in promoting and developing responsible waste management and circular economy policies.

AEB Amsterdam is one of the largest waste-to-energy companies in Europe, operating a large-scale municipal and commercial waste incineration facility that provides essential public services, including safe waste treatment, electricity generation and district heating.

Dow appreciates the opportunity to comment on the proposed new rules extending restrictions for CMR substances under the REACH regulation. Dow is committed, as part of our Safer Materials approach, to ensuring that the materials we bring to marketand the way we manage them along the wayare designed for safety (https://corporate.dow.com/en-us/purpose-in-action/safer-materials.html).

SUEZ welcomes the classification of nitrous oxide as a category 1B reproductive toxicant under the CLP Regulation and supports the subsequent restriction under REACH as proposed by the European Commission. SUEZ fully supports the proposed REACH restrictions, in particular on large NO canisters, which have proven to be a significant hazard in waste management.

Samfunnsbedriftene - the Norwegian Organisation for Public Entities (incl. all public waste companies) - welcomes the Commissions proposal to classify N2O as a reproductive toxicant 1B, and to ban sales of the substance to the general public from 1 February 2027. We also appreciate the recognition in Recitals 6 and 7 of the substances misuse as a drug.

1. Executive Summary The Nanotechnology Business Creation Initiative (NBCI) has submitted comments since August 2021 regarding the harmonised classification and labelling (CLH) discussions related to multi-walled carbon nanotubes (MWCNT) defined under Index No. [phone removed].

MWE welcomes the Commission's proposal to include dinitrogen oxide (also called nitrous oxide or laughing gas) as a reproductive toxicant category 1B, referred to in Recital 5 and amendment 5(h) in the annex of this draft regulation, prohibiting the substance for being put on the market and supplied to the general public as of 1 February 2027.

essenscia, representing producers of industrial and medical gases in Belgium, supports the proposal to introduce a derogation on the consumer sales ban on nitrous oxide (NO) under REACH Annex XVII (point (6) b) of the annex).

The Belgian dairy federation (BCZ) welcomes the European Commissions initiative to grant a targeted derogation from the REACH Annex XVII Appendix 6 requirements for nitrousoxide (NO, E942) as a food additive, following its classification as reprotoxic 1B under the CLP Regulation.

Belgian waste-to-energy (BW2E) represents all Belgian installations that energetically valorise both household and similar residual waste. Each year, the 14 members process 2.75 million tonnes of residual waste and produce more than 1.5 million MWh of partly renewable electricity. In addition, BW2E is increasingly deploying heat and steam for residential and industrial heat networks.

Filed in Dutch · English published by the European Commission

iSi and Kayser, global leaders in the production of N2O chargers for culinary solutions, support the European Commissions proposal for a REACH restriction on nitrous oxide (NO) that includes a targeted derogations for essential culinary applications.

Concerning dinitrogen oxide, (nitrous oxide), the European Cylinder Makers Association, ECMA, along with the Confederation of European Waste to Energy Plants, CEWEP, and the European Waste Management Association, FEAD, have been closely monitoring the evolution of this dossier and recognise the Commissions commitment to risk-proportionate regulatory action.

A2A welcomes the European Commissions proposal to restrict the supply of nitrous oxide (NO) to the general public under Annex XVII of the REACH Regulation and supports its timely adoption without amendments. The proposal addresses a concrete and increasingly severe safety risk affecting waste management systems across Europe, linked to the improper disposal of large pressurised NO canisters.

CEWEP, the Confederation of European Waste-to-Energy Plants, together with the European Cylinder Makers Association (ECMA) and FEAD welcome the European Commissions proposal for a REACH restriction on nitrous oxide (N2O). Our associations have been closely monitoring the evolution of this dossier and recognise the Commissions commitment to risk-proportionate regulatory action.

FEAD, the European Waste Management Association representing the private waste management industry in Europe, as well as the European Cylinder Makers Association (ECMA) and the Confederation of European Waste-to-Energy Plants (CEWEP), welcome the European Commissions proposal for a REACH restriction on nitrous oxide (NO).

FrieslandCampina welcomes the European Commissions proposal for a derogation for the use of nitrous oxide as a food additive. We support the derogation as it specifically addresses the use of nitrous oxide as a propellant in aerosol dispensers for food products, as well as its use in food products prepared with nitrous oxide as a food additive.

The Dutch Dairy Association (NZO) welcomes the initiative from the European Commission to grant a targeted derogation from the requirements of the REACH Annex XVII Appendix 6 to Nitrous oxide (dinitrogen oxide, N2O, E942) placed on the market as a food additive and used as food additive by food business operators following its classification as reprotoxic 1B within the CLP Regulation.

Chemicals: new rules on restricted carcinogenic, mutagenic or reprotoxic substances. Rather than restricting it, its use must be prohibited immediately because the value of human life is greater than any production. Furthermore, given that the subject has long been heard, the abolition of these substances will lead to the emergence of other non-toxic substances, as has been the case with paints.

Filed in Italian · English published by the European Commission

In October 2025, 21 Flemish intermunicipal waste companies conducted a one-month monitoring exercise to count the number of nitrous oxide canisters collected at recycling centres. Wherever possible, these figures were supplemented with data from municipal services and police authorities.

Related to Dinitrogen Oxide: The European Industrial Gases Association (EIGA) has been monitoring the evolution of the dossier on nitrous oxide (N2O) and recognises the European Commissions commitment to regulatory action. We welcome the Commissions proposal for a REACH restriction, including the targeted derogation for culinary applications in small volumes.

It should be noted that the reproductive toxicity of nitrous oxide has been assessed for exceptionally high concentrations (similar to recreational drug use) - 80% in air, on mice, whereas 2% is the usual threshold for such assessments. This makes perfect sense for its toxicity in the context of recreational drug (ab)use, but leads to very undesirable side effects.

The objective pursued by the draft Regulation, aimed at strengthening the protection of human health through the update of restrictions applicable to substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), is fully shared and consistent with the core principles of European policy on chemical safety and consumer protection.