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08 March 2023

REACH Restriction on Formaldehyde Released from Articles

On 13 February, EU Member States approved the text of a REACH Restriction on Formaldehyde released from articles. The text will in the coming weeks be published in the Official Journal of the European Union, after which it will become law. A relatively long transition period is foreseen as it shall apply 48 months after its entry into force for road vehicles, and 36 months after its entry into force for all other articles within its scope.

Formaldehyde is a chemical that is widely used in various industries, including the production of adhesives, resins, and textiles. However, formaldehyde is also a known a) carcinogen, meaning that it has the potential to cause cancer in humans and b) sensitiser, meaning that it can cause allergic reactions in some people. 

Consumers can be exposed to formaldehyde by breathing air containing off-gassed formaldehyde from consumer articles. However there are also naturally occuring sources  of formaldehyde and exposure can also occur by eating apples and walking in a pine forest. The age-old maxim of dose makes the poison applies here. Too much is harmful. 

Due to the potential health risks associated with formaldehyde from consumer articles, the European Union (EU) has implemented a Restriction on the use of formaldehyde under the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation. By restricting the emission of formaldehyde from articles, the EU aims to minimise the exposure of consumers to this hazardous substance. 

What is the REACH regulation?

The REACH regulation is a European Union regulation that came into force on 1st June 2007. The aim of the REACH regulation is to ensure the safe use of chemicals within the EU, whilst promoting the competitiveness of the EU chemicals industry. The REACH regulation places obligations on manufacturers, importers, and downstream users of chemicals, with the aim of improving the safety of chemicals throughout their lifecycle for both humans and the environment.

Is formaldehyde already restricted under the REACH regulation?

At the moment there are already restrictions on formaldehyde in the REACH Regulation. Restriction entry 28 bans the sale of carcinogens as such or in a mixture to the general public and textile articles are subject to a content limit for formaldehyde as included in entry 72.

So what has changed in the new restriction on formaldehyde?

The new restriction imposes limits expressed as an emission limit. There is a general article limit of 0.08 mg/m³ as measured in conditions largely equivalent to EN 717-1.For wood-based articles, and furniture, a limit is set to 0.062 mg/m³.  Some exceptions apply, for example for articles to be used exclusively outdoors. 

A specific emission limit for the indoor air of automotive vehicles was set at 0.062 mg/m³ as tested according to ISO 12219-1

What are the implications of the restriction on formaldehyde for companies?

The restriction on formaldehyde under the REACH regulation has implications for businesses that manufacture or import products that may release formaldehyde. These businesses must ensure that their products comply with the emission limit set out in Annex XVII of the regulation. This may require changes to the manufacturing process or the use of alternative chemicals.

What are the consequences for the flexible PU foam industry?

All flexible polyurethane foam as many organic materials – such as paper – releases formaldehyde. While the analytical basis for the restriction proposal was about wood panels, the text adopted covers all articles that release formaldehyde. As was demonstrated in submissions by EUROPUR containing 100+ measurement results to the public consultation, flexible polyurethane foam should never exceed the emission limits for general articles. As such the general article limit should only result in the occasional customer request to prove compliance for which an emission test may be considered or the results of a CertiPUR test can be used with appropriate correction for test conditions. 

The impact of the new limit on the vehicle interior air is however somewhat more difficult to predict. For years now the automotive industry maintained a global largely voluntary limit of 0.1 mg/m³ and set specifications for suppliers of parts to the automotive industry to comply with this. The lowering of this limit value to 0.062 mg/m³ may result in increased pressure on PU parts suppliers to lower formaldehyde emissions further. This could potentially require changes in formulations and modifications of plant infrastructure. 

Overall, the European flexible PU foam industry has shown that it is capable of adapting to the new requirements and finding alternative solutions that do not compromise the safety or performance of our products.