Formaldehyde is a highly reactive gas at ambient temperature and atmospheric pressure. It has been classified as a carcinogen, mutagen, skin sensitizer, skin corrosive, and acutely toxic under the EU CLP Regulation (EC) No 1272/2008. An ECHA assessment report released on March 11, 2019, revealed that formaldehyde released from consumer products in indoor environments has serious negative effects on human health.
Formaldehyde is a highly produced, widely used chemical. According to European Commission statistics, 98% of formaldehyde produced or imported into the EU is used as a reaction intermediate in the production of formaldehyde-based resins, thermoplastics, and other chemicals. These materials, or their extended industrial applications, may release formaldehyde into the environment during use. However, formaldehyde has been classified as carcinogenic, mutagenic, skin sensitizing, skin corrosive, and acutely toxic by the European Parliament and of the Council ((EC) No 1272/2008). Exposure to certain concentrations of formaldehyde can be harmful to the human body.
The WTO Official Journal (G/TBT/N/EU/888) of May 2, 2022, revealed that the European Commission had notified the WTO of a draft amendment to REACH Annex 17. This proposed amendment would limit formaldehyde emissions from finished products placed on the market, prohibiting them from being placed on the market if the concentration exceeded. After nearly a year of deliberation, this draft regulation is set to take effect. The official announcement in the EU Official Journal on July 14, 2023, added formaldehyde to REACH Annex 17 for regulation.
The detailed prohibitions and restrictions on formaldehyde added in REACH Annex 17 are summarized in the following table:
化學物質(群組)或混合物中之化學物質名稱
Designation of the substance, of the groups of substances or of the preparation | 限制條件 (Conditions of Restriction) |
77. Formaldehyde
CAS No 50-00-0
EC No 200-001-8
and release formaldehyde
| After 6 August 2026, these articles shall not be permitted to be used if, under the test conditions specified in Appendix 14, the formaldehyde concentration emitted by them exceeds: Wood products and furniture: 0.062 mg/m3 Finished products other than wood products and furniture: 0.08 mg/m3 Paragraph 1 does not apply to: articles made of materials that naturally contain formaldehyde or formaldehyde-releasing substances; articles intended for outdoor use only under reasonably foreseeable conditions; building envelopes and vapor barriers designed for outdoor use that do not release formaldehyde into indoor air; articles intended for industrial or professional use, unless the formaldehyde emitted by them under foreseeable conditions of use could result in general public exposure; articles falling within the scope of Regulation (EU) 528/2012 of the European Parliament and of the Council on biocidal products; and the Equipment Regulation (EU) 2017/745. Finished articles intended for direct or indirect contact with foodstuffs within the scope of Regulation (EC) 1935/2004 on personal protective equipment within the scope of 2016/425 shall not be placed on the road vehicle market after 6 August 2027 if the formaldehyde concentration in the road vehicle interior exceeds 0.062 mg/m3 under the test conditions specified in Appendix 14. Paragraph 2 does not apply to: road vehicles intended for industrial or professional use unless the formaldehyde concentration in the interior of these vehicles, under foreseeable conditions of use, would lead to general exposure of the public. |
Note: The above Chinese translation is for reference only. In case of any discrepancies, the original text of the regulations shall prevail.
Sources:歐盟 (European Union, EU)
