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Formaldehyde REACH Annex XVII

The European Commission has issued Bulletin L 180, adding formaldehyde to the Annex XVII restricted substance list of the REACH regulation. Formaldehyde, commonly known as formalin, is widely used in industries such as chemical, textile, pharmaceutical, and wood processing. It can be used as a disinfectant and preservative, as well as in the preparation of various products such as phenolic resin, urea formaldehyde resin, melamine resin, urotropine, and pentaerythritol.

On October 27, 2017, the International Agency for Research on Cancer of the World Health Organization released a list of carcinogens, which listed formaldehyde as a Class 1 carcinogen.

Formaldehyde and formaldehyde releasing substances:

CAS number: 50-00-0

EC number: 200-001-8

After August 6, 2026, if tested according to the testing conditions specified in Appendix 14, the formaldehyde concentration released from the item exceeds the following concentrations and will not be put on the market: 0.062 mg/m3 for furniture and wooden products; Products other than furniture and wooden products are 0.080 mg/m3.

Article 1 does not apply to: formaldehyde or formaldehyde releasing substances that only naturally exist in the materials used to produce the item; Items specifically designed for outdoor use under foreseeable conditions; Specially used for building items outside of the building shell and moisture-proof layer, without releasing formaldehyde into indoor air; Articles exclusively intended for industrial or professional use, unless their released formaldehyde causes public exposure under foreseeable conditions of use; Items subject to the restrictions specified in Article 72; Articles that fall within the scope of Regulation (EU) No 528/2012 of the European Parliament and Council for sterilization products; Equipment regulated by Regulation (EU) 2017/745; Personal protective equipment within the scope of Regulation (EU) 2016/425; Items that come into direct or indirect contact with food within the scope of (EC) No 1935/2004; Second hand items.

If the indoor formaldehyde concentration of road vehicles exceeds 0.062 mg/m3 under the testing conditions specified in Appendix 14, they shall not be put into the road vehicle market after August 6, 2027.

The first paragraph does not apply to road vehicles specifically designed for industrial or professional use, unless the formaldehyde concentration inside these vehicles causes the public to come into contact with formaldehyde under foreseeable conditions of use; Used car.

The European Commission issued Directive (EU) 2019/1929 on November 20, 2019, amending Annex II of Toy Safety Directive 2009/48/EC to add formaldehyde limits for toys or other toys intended for use by children under 36 months of age. Each member state shall implement this regulation from May 21, 2021.

According to this directive, the limit for formaldehyde (CAS No. 50-00-0) has been added to Appendix C of Annex II of the Toy Safety Directive, which specifies the requirements for harmful chemicals in toys or other toys intended for children under 36 months of age. The formaldehyde limits are as follows:

Polymer materials in toys: 1.5 mg/L (formaldehyde migration)

Resin bonded wood material in toys: 0.1 mL/m3 (formaldehyde release)

Textile materials in toys: 30 mg/kg (formaldehyde content)

Leather material in toys: 30 mg/kg (formaldehyde content)

Paper materials in toys: 30 mg/kg (formaldehyde content)

Water based materials in toys: 10 mg/kg (formaldehyde content)

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