EUCTL fully supports the aim of reducing the risk of allergic contact dermatitis and skin diseases for consumer, but to achieve a targeted, helpful and reasonable legislation, some fundamental amendments of the current proposal are considered necessary.
1. Limiting the scope of the restriction to a closed list of substances
The scope of the proposed restriction should be limited to substances that can be found in the final article and can actually pose a risk to the consumer. The proposal suggests to restrict the presence of any substance with an harmonized classification as skin sensitizer Category 1/1A/1B, plus a ban on a specific list of disperse dyes with no harmonised classification. As stated by SEAC in its final opinion: “in total, more than a thousand substances fall within the scope of the restriction proposal. However, it is acknowledged that not all chemical substances within the scope will be used in the production of textile and leather articles, and not all will be present in the finished article placed on the market.”
EUCTL confirms this statement by SEAC: many substances classified as skin sensitizers are not used in these value chains; in other cases, skin sensitizing substances are used in the production phase but cannot be found in the final product (due to reaction processes); other substances can be present in the final articles but they cannot be released, as they are strongly bound to the textile or leather matrix . For these reasons, EUCTL advocates for a restriction on a closed list of substances which are relevant for the textile, leather and fur articles because of their application in the production process and the fact that they really pose a risk to consumers. This would contribute to more targeted testing and enforcement activities, thereby providing effective consumer protection. Availability of standard methods to assess the presence of the restricted substances in leather/textile products should also be considered, to give EU Member States authorities the possibility of developing a control system fit for granting an adequate control also for the imported articles; this is felt as a a crucial point to avoid restriction effects only on the European supply chain, which will be strongly affected by the proposed measures.This closed list could be developed on the basis of the so-called “IN-List” proposed by the Dossier Submitter: a list of 94 substances (70 with harmonised classification as skin sensitizers + 24 disperse dyes) that may be present in finished textile and leather articles, with related information as CAS numbers and expected concentration in articles at point of sale.
2. Possibility for derogations
The restriction proposal applies to every substance classified as skin sensitizer Category 1/1A/1B (harmonized classification) and foresees a so-called “dynamic link”: any new substance that will be classified as skin sensitizer under the CLP Regulation in the future will automatically enter the scope of the restriction.
EUCTL questions this proposal, pointing out to various problems allocated with such an approach. To mention only some of those problems: the difficulties related to enforcement, the fact that chemical industry would have to prove the absence of substances on the final article which had never been applied, or the legal uncertainty and ever-changing requirements the chemical companies would have to deal with.
EUCTL understands the underlying motivation to capture all substances in this restriction, including recently classified ones. So if a link to Annex VI of CLP Regulation is made, the approach should be a reasonable one as well. EUCTL supports SEAC’s proposal of a ‘semi-dynamic’ link “to increase predictability for substances classified according to CLP in the future.” In combination with EUCTL’s next point, an appropriate deferral between a new CLP harmonised classification and the substance’s potential restriction or ban in articles, this would enable a derogation mechanism: REACH Registrants and European downstream users in the textile or leather value chain should have the possibility to present data and information on actual risk for consumers, to be evaluated by competent authorities for a possible exclusion from the scope of the restriction.
3. Appropriate transition period for new classified substances
Should there be a (semi-) automatic link to Annex VI CLP, EUCTL suggests for at least 36 months transition time between a new classification of one substance and its inclusion in the restriction.
This corresponds with SEAC’s statement in its final opinion where SEAC calls for a “deferral time of three years” that could be used for a consultation with affected stakeholders “to consider information on alternatives, the feasibility of the generic concentration limits proposed by RAC or other considerations of relevance in case these would indicate the need for a longer transitional period or derogation”.
EUCTL advocates for this transitional period, that would allow:
- an evaluation of the relevance of the substance, in case a request for derogation is submitted;
- in absence of a request for derogation, the development of alternative products and subsequent substitution in the value chain;
- in case of lack of standard methods to assess the level of the substance in textile/leather products, a timeframe to develop suitable standard analytical methods, if possible at CEN level;
- the EU Member States to adapt their control system on the enforcement of the restriction, e.g. identifying applicable standard methods and laboratories with appropriate analytical equipment.
Bruxelles, June 2021