On 14 July 2023, the European Commission adopted measures to restrict the use of formaldehyde in many consumer products. With Commission Regulation (EU) 2023/1464, the European Union established a maximum emission limit to further protect human health.
What is formaldehyde?
Formaldehyde is “a highly reactive gas at ambient temperature and atmospheric pressure conditions” (EUR-Lex 2023). It is a carcinogenic and mutagenic substance. Specifically, it is classified as carcinogen category 1B, mutagen category 2, acute toxicant category 3, skin corrosive category 1B and skin sensitiser category 1. Indeed, formaldehyde is banned in cosmetic products and cosmetic preservatives that release this substance are restricted. Some products that can release formaldehyde are wood-based panels, thermoplastics, furniture and flooring, wallpapers, foams, parts for road vehicles and aircraft, and textile and leather products.
New formaldehyde emission limits to better protect human health
In December 2017, the Commission asked the European Chemicals Agency to evaluate the risks of formaldehyde and formaldehyde-releasing substances in mixtures and articles. The Dossier of the Agency analysed the risks considering different exposures and effects. It concluded that the sensory irritation derived from inhalation is the most sensitive effect in humans. Afterwards, the Agency’s Committee for Risk Assessment (‘RAC’) and the Agency’s Committee for Socio-Economic Analysis (‘SEAC’) issued their opinions on the matter.
Consequently, the Commission introduced new rules establishing an emission limit of 0.062 mg/m3 of formaldehyde into indoor air. This impacts products such as wood-based articles, furniture, and interior parts of road vehicles. The emission limit for other articles is 0.08 mg/m3, affecting, among others, textiles, leather, plastic, construction materials, and electronics.
Compliance process, exemptions, and transition to the new rules
Manufacturers of products, such as resin-bonded wooden toys for children younger than 3 years impacted by the restrictions have 36 months from July 2023 to implement the new rules. As of August 6, 2026, new limits should be respected. For road vehicles, the transition time is 48 months, with a final deadline by August 6, 2027. Notably, some products are not included in the scope of the restrictions. For instance, some exceptions concern the following:
- Articles in which formaldehyde is exclusively emitted due to its natural occurrence
- Articles that are exclusively for outdoor use under foreseeable conditions
- Articles in constructions that are exclusively used outside the building and that do not emit or contribute to the exposure of this substance into indoor air
- Articles that are exclusively for industrial or professional use if the use does not impact the general public’s exposure
- Articles whose formaldehyde emissions decrease over time (e.g., second-hand articles)
- Articles intended to come into contact directly or indirectly with food
- Medical devices, PPE, biocides
- Any other articles whose formaldehyde emissions are already regulated
Time to act and check your technical documentation
If you are a manufacturer of products that might emit formaldehyde, you need to make sure that your products comply with the new rules within 36 or 48 months. This applies to EU and non-EU manufacturers placing their products on the EU and EEA markets. Your regulatory consultant or authorised representative can be your guide and reference point for any regulatory concerns.
PRODlaw Library of Documents collects all relevant documents that help manufacturers navigate the European regulatory landscape.
Eur-Lex (2023) Commission Regulation (EU) 2023/1464 of 14 July 2023 amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards formaldehyde and formaldehyde releases. Retrieved on 24.07.2023.