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Toys | Changing Threshold Values for Aniline - CE Marking | Product compliance for the European market
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Toys | Changing Threshold Values for Aniline


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Aniline (CAS number 62-53-3) is classified as a category 2 carcinogen and a category 2 mutagen under Regulation (EC) No 1272/2008. According to Annex II, Part III, point 5(a) of Directive 2009/48/EC, category 2 carcinogens, such as aniline, may be used in toys in individual concentrations equal to or less than the established applicable concentration. in Regulation (EC) No 1272/2008 for the classification of mixtures containing these substances, namely 1 % , which corresponds to 10 000 mg/kg (threshold). The same limit applies to mutagenic substances in category 2.

Given the classification of aniline as a CMR substance, the aniline risk assessment report prepared by the European Union, the opinion of the RAC and CCRSA and the opinions of the expert group on the safety of toys and its subgroup Chemicals, as well as with studies on the presence of aniline in textiles, it is necessary to set a limit of 30 mg/kg for aniline in toy textile material and in toy leather after reducing cleavage and a limit of 10 mg/kg for aniline in paints to paint with your fingers as aniline in free form and 30 mg/kg after reducing cleavage

Member States shall adopt and publish, by 4 December 2022, the laws, regulations and administrative provisions necessary to comply with these requirements (DIRECTIVE (EU) 2021/903) in order to apply these provisions from 5 December 2022Aniline (CAS number 62-53-3) is classified as a category 2 carcinogen and a category 2 mutagen under Regulation (EC) No 1272/2008. According to Annex II, Part III, point 5(a) of Directive 2009/48/EC, category 2 carcinogens, such as aniline, may be used in toys in individual concentrations equal to or less than the established applicable concentration. in Regulation (EC) No 1272/2008 for the classification of mixtures containing these substances, namely 1 % , which corresponds to 10 000 mg/kg (threshold). The same limit applies to mutagenic substances in category 2.

Given the classification of aniline as a CMR substance, the aniline risk assessment report prepared by the European Union, the opinion of the RAC and CCRSA and the opinions of the expert group on the safety of toys and its subgroup Chemicals, as well as with studies on the presence of aniline in textiles, it is necessary to set a limit of 30 mg/kg for aniline in toy textile material and in toy leather after reducing cleavage and a limit of 10 mg/kg for aniline in paints to paint with your fingers as aniline in free form and 30 mg/kg after reducing cleavage

Member States shall adopt and publish, by 4 December 2022, the laws, regulations and administrative provisions necessary to comply with these requirements (DIRECTIVE (EU) 2021/903) in order to apply these provisions from 5 December 2022

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