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EU: REACH WTO draft restriction on Formaldehyde

MAY 2022 - ELECTRICAL AND ELECTRONICS, HARDLINES, SOFTLINES, TOYS AND CHILDREN'S PRODUCTS

On 2 May 2022, the European Commission (EC) submitted a draft amendment to the World Trade Organization (WTO)1 to amend the REACH Annex XVII by adding the new restriction on formaldehyde released from articles.

The basis of the proposed restriction concerns consumer exposure to formaldehyde in indoor environments. Formaldehyde is mainly used as a chemical intermediate in the production of formaldehyde-based resins and other chemicals. Such formaldehyde-based resins are the biggest group of formaldehyde releasers which can release formaldehyde under foreseeable conditions of use. Formaldehyde-based resins are widely used as adhesives and binders in the woodworking, pulp and paper, and the synthetic vitreous fibre industries, in the production of plastics and coatings, and textile finishing. Consumers can be exposed to formaldehyde by breathing air containing off-gassed formaldehyde.

In 2019, the European Chemicals Agency (ECHA) prepared a restriction report to propose a restriction on formaldehyde released from articles. After 1st and 2nd public consultations, the ECHA’s Committee for Risk Assessment (RAC) and Committee for Socio-Economic Analysis (SEAC) modified the restriction proposal, and the ECHA submitted the opinions to the EC. Based on the submitted opinions, the EC concluded that the REACH Annex XVII should be amended by adding the new restriction on formaldehyde released from articles. Compared with the opinions submitted by the ECHA, the WTO draft amended the limit of formaldehyde release and some exemptions.

The new restriction is expected to be published in the last quarter of 2022. It will set a 36-month transition period, and the road vehicles will have a longer transition period, i.e. 48 months.

Proposed restriction on formaldehyde released from articles (contents in blue are modified in the WTO draft)

Target substance  Formaldehyde and formaldehyde releasing substances
Proposed scope of restriction
Articles
Proposed limit

a) 0.062 mg/m3 for wood-based articles and furniture, the interior of the road vehicles;
b) 0.08 mg/m3 for articles other than wood-based articles and furniture.

Note: the test method is specified in Appendix.

Proposed exemption
  • Articles within the scope of entry 72, i.e. clothing, textile accessories and footwear;
  • The use of formaldehyde and formaldehyde releasers as biocide subject to Regulation (EU) 528/2012;
  • Medical devices subject to Regulation (EU) 2017/745;
  • Personal protective equipment (PPE) subject to Regulation (EU) 2016/425;
  • Articles intended to come into contact directly or indirectly with food within the scope of Regulation (EC) No 1935/2004;
  • Second-hand articles;
  • Articles only for outdoor use under reasonably foreseeable conditions;
  • Articles exclusively for industrial and professional use if formaldehyde from them does not generate exposure to consumers under foreseeable conditions of use.
Proposed date of application 36 months from the date of entry into force (for the road vehicles, the application date is 48 months from the date of entry into force)

 

 

[1]  EC Notification sent to WTO

[2]  Draft text sent to WTO (Part 1)

[3]  Draft text sent to WTO (Part 2)

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