AUTOMATICALLY TRANSLATED FROM FRENCH
In order to better protect consumers from the risks of skin allergies, ANSES and the Swedish Chemicals Agency (KEMI) jointly submitted a proposal for the restriction of sensitizing substances under the European REACH chemicals regulation. This proposal aims to prohibit or limit more than 1,000 skin allergenic substances in textiles, leather, furs and skins.
Faced with cases of skin allergies linked to clothing textiles, in June 2018 ANSES carried out an expertise to identify the chemical substances present in certain articles that could be the cause of these cases. For its part, KEMI has carried out an analysis of risk management options (RMAAs) under the REACH Regulation on skin sensitizers in textiles. As a continuation of this work, ANSES and KEMI have jointly developed a proposal for the restriction of sensitizing substances to ECHA (European Chemicals Agency) in order to better protect consumers from the risks of cutaneous allergies.
Restrict more than 1000 skin sensitizers
The purpose of the restriction proposal is to limit the presence of skin sensitizers in textiles, leather, furs and skins sold to the general public. It covers more than 1000 chemical substances and more precisely all substances classified as skin sensitizers under the CLP (Classification, Labeling and Packaging) Regulation and 25 substances of the family of disperse dyes with sensitizing properties.
In the context of this restriction dossier, a risk assessment was carried out to determine the maximum concentrations that should not be exceeded for these substances in order to protect consumers. This work led to the following proposals:
(1) Prohibit the presence of disperse dyes with sensitizing properties in finished articles made of textile, leather, furs and skins
(2) 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 (textile) and 110 mg / kg (leather, furs and skins) for nickel and its compounds
(*) 70 mg / kg (textile) 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 (textile) and 210 mg / kg (leather, furs and skins) for1,4 phenylene diamine
(*) 130 mg / kg (textile) and 110 mg / kg (leather, furs and skins) for other substances classified as skin sensitizers.
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 already underway in Europe. For other families of substances such asdiisocyanates, the implementation of best production practices should reduce or eliminate the presence of these substances in finished articles.
The restriction proposal also includes a detailed assessment of the economic impacts (substitution, control and implementation costs) 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 the ECHA 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 sent 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, hides, furs and skins placed on the market in Europe.
SOURCE www.anses.fr (Automatically translated from French)