The EU has published legislation to regulate aniline in specific toy materials. The restrictions will become effective on December 5, 2022.
Appendix C to Annex II of Directive 2009/48/EC (Toy Safety Directive, TSD, consolidated version dated May 2021) regulates 11 substances in toys for children under 36 months or in other toys intended to be placed in the mouth. These substances are:
- Tris (2-chloroethyl) phosphate (TCEP, CAS 115-96-8)
- Tris (2-chloro-1-methylethyl) phosphate (TCPP, 13674-84-5)
- Tris [2-chloro-1-(chloromethyl)ethyl] phosphate (TDCP, 13674-87-8)
- Bisphenol A (BPA, CAS 80-05-7)
- Formamide (CAS 75-12-7)
- 1,2-Benzisothiazol- 3(2H)-one (BIT, CAS 2634-33-5)
- 5-Chloro-2-methylisothiazolin-3(2H)-one (CMI, CAS 26172-55-4)
- 2-Methylisothiazolin-3(2H)-one (MI, CAS 2682-20-4)
- 3 to 1 mixture of 5-chloro-2-methyl-4-isothiazolin-3-one (CMI) and 2-methyl-2H-isothiazol-3-one (MI) (CMI:MI (3:1), CAS 55965-84-9)
- Phenol (CAS 108-95-2)
- Formaldehyde (CAS 50-00-0)
On June 4, 2021, the European Union (EU) published Directive (EU) 2021/903 to restrict aniline in specific toy materials falling under Appendix C to Annex II of the TSD (Appendix C). The new Directive expands the number of substances in Appendix C to 12.
According to Regulation (EC) 1272/2008 on Classification, Labeling and Packaging of Substances and Mixtures (CLP Regulation, consolidated version dated May 2021), aniline is a carcinogenic category 2 and mutagenic category 2 substance.
This substance was found in textiles after reductive cleavage and a finger paint after reductive cleavage. There are also indications that the substance could be present in leather after reductive cleavage or as free aniline in finger paints.
Member States shall adopt and publish, by December 4, 2022, at the latest, the laws, regulations and administrative provisions necessary to comply with the new Directive and apply them from December 5, 2022.
Highlights of the new law are summarized in Table 1.
DIRECTIVE (EU) 2021/903 OF JUNE 3, 2021, AMENDING APPENDIX C TO ANNEX II OF DIRECTIVE 2009/48 AS REGARDS SPECIFIC LIMIT VALUES FOR ANILINE IN CERTAIN TOYS
≤ 30 mg/kg after reductive cleavage in textile and leather materials
≤ 30 mg/kg after reductive cleavage in finger paints
≤ 10 mg/kg as free aniline in finger paints
December 5, 2022
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