On April 29, 2019, Sweden and France submitted a “restriction proposal” to the European Chemicals Agency (ECHA), aiming to restrict the use of Skin sensitizing substances are restricted. Sellers targeting the EU (such as clothing and footwear) will be directly affected by this restriction: they will have to comply with the restriction once the recommendations are adopted and implemented across the EU. The purpose of the recommendations is to reduce the risk of sensitization to the public due to skin contact with chemicals in finished textiles, leather and fur products sold on the EU market for the first time. According to the document, the number of people in the European Economic Area (EEA) who are allergic to chemicals present in finished textile and leather products is estimated to be between 4 and 5 million, equivalent to 0.8-1% of the total EEA population. Skin allergy is a physiological reaction that results in lifelong sensitivity to a specific allergen.
The proposal uses the expression “textile and leather goods” to cover items made of hides and skins. The French Agency for Food, Occupational and Environmental Health and Safety (ANSES) and the Swedish Chemicals Agency (KemI) jointly stated that the risk of skin sensitizing substances in textiles and leather products has not yet been fully controlled. They concluded that restricting substances under EU REACH regulations was the most appropriate risk management option.
Although there are currently more than 1,000 substances considered skin sensitizers, only 95 of them are used in textiles or leather products. However, it is unrealistic to limit all allergenic substances in textiles and will seriously hinder the development of manufacturing industry.
The proposed restrictions would cover substances with harmonized classifications such as skin sensitizers in Category 1 or Category 1A or Category 1B in Annex VI of the EU CLP Regulation , and substances listed in Table 2 of the proposed restriction (disperse dyes).
More specifically, the recommended concentration limits include the ban on disperse dyes, and on hexavalent chromium compounds, nickel and its compounds, cobalt and its compounds, formaldehyde, 1 , extremely low tolerance threshold for 4-p-phenylenediamine and other substances.
The proposed substance restrictions would cover the following items made in whole or in part from textiles, leather and fur:
1. Clothing and related accessories;
2. Items other than clothing that come into contact with the skin under normal or reasonably foreseeable conditions of use, and Similar clothing;
3. Footwear.
Limited exemptions to this restriction exist. Under existing EU regulations, equipment from 1 to 3 above are considered personal protective equipment; substances used as active ingredients in antiseptic products; second-hand items 1 to 3 used within the EU before 31 January 2023 thing.
Any proposal for restrictions must go through the ECHA approval process. Thereafter, the Commission must take a balanced view of the risks identified and the benefits and costs of the proposed restrictions. The final decision is determined during a review process by member states and the European Parliament.
Once adopted, industry must comply with restrictions, which will be set out in Annex XVII of the REACH Regulation. Therefore, after the restrictions come into effect, manufacturers must ensure that goods sold to EU consumers comply with these requirements, and manufacturers must adapt to the new requirements within a grace period. Each member state is responsible for enforcing the restrictions.
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