Faced with cases of skin allergies linked in particular to clothing textiles, ANSES carried out an expert appraisal in June 2018 to identify the chemical substances present in certain articles that might be the cause of these cases. For its part, KemI carried out a risk management options analysis (RMOA) under the REACH regulation concerning skin sensitizing substances in textiles. As a continuation of this work, ANSES and KemI have jointly drawn up a proposal to restrict sensitizing substances to ECHA (European Chemicals Agency) in order to better protect consumers from the risks of skin allergies.
Restrict over 1000 skin sensitizing substances
The restriction proposal aims to limit the presence of skin sensitizing substances in textile, leather, fur and skin articles sold to the general public. It covers more than 1,000 chemical substances and more specifically all substances classified as skin sensitizers under the CLP Regulation (classification, labeling and packaging) as well as 25 substances from the family of disperse dyes with sensitizing properties.
As part of this restriction dossier, a risk assessment was carried out to determine the maximum concentrations not to be exceeded for these substances in order to protect consumers. This work led to the following proposals:
- prohibit the presence of disperse dyes with sensitizing properties in finished textile, leather, fur and skin articles;
- limit the concentration of sensitizing substances to the following thresholds:
- 1 mg/kg for chromium VI compounds (textiles, leather, furs and skins);
- 130 mg/kg (textiles) and 110 mg/kg (leather, furs and skins) for nickel and its compounds;
- 70 mg/kg (textiles) and 60 mg/kg (leather, furs and skins) for cobalt and its compounds;
- 75 mg/kg for formaldehyde (textiles, leather, furs and skins);
- 250 mg/kg (textiles) and 210 mg/kg (leather, furs and skins) for 1,4 paraphenylenediamine;
- 130 mg/kg (textiles) and 110 mg/kg (leather, furs and skins) for other substances classified as skin sensitisers.
In addition, an analysis of possible alternatives to these substances was carried out. Chemical alternatives exist in particular for disperse dyes for which substitution is feasible and has already begun in Europe. For other families of substances such as diisocyanates, the implementation of best production practices should make it possible to reduce or eliminate the presence of these substances in finished articles.
The restriction proposal also includes a detailed assessment of the economic impacts (costs of substitution, control and implementation) with regard to the expected health benefits (avoided skin allergies), which are also quantified in terms of avoided costs.
This restriction proposal has been published on ECHA’s website since 24 April 2019. It will soon be the subject of a public consultation for a period of six months. Following this consultation stage, the ECHA committees will formulate, on the basis of all the data, an opinion which will be transmitted to the European Commission to decide on the adoption of this restriction. If this proposal is adopted, it will be included in Annex XVII of REACH Regulation No. 1907/2006 and will therefore be mandatory for textiles, leathers, furs and skins marketed in Europe.
