The authorities of France and Sweden have jointly submitted a restriction proposal for skin sensitising substances under the European Chemicals Regulation (REACH), with the intent to restrict skin allergens in articles made of textiles, leather, fur and hides.

SAFEGUARDS | Softlines NO. 150/19

Ladies clothing hanging on rack

The European Chemicals Agency (ECHA) opened a public consultation [1] on the proposal to restrict placing textile, leather, hide and fur articles in the market that contain skin sensitising substances. The proposed restriction covers substances with harmonized classification as skin sensitizers in Categories 1 or 1A or 1B in Annex VI under the Classification, Labelling and Packaging (CLP) Regulation (EC) No. 1272/2008, as well as a list of disperse dyes that are indicated to have skin sensitising properties [2]. The comment period is open until the 19th December 2019.

Articles in the scope of the restriction proposal are: any clothing and related accessories, as well as articles other than clothing which come into contact with the skin under normal or reasonably foreseeable condition of use, such as bed linens, blankets, throws, upholstery (fabric covering chairs, armchairs and sofas, car seats etc.), cushion covers, bathrobes, towels, re-usable nappies and sanitary towels, sleeping bags, yarn and fabrics intended for use by the final consumer, bags (e.g. handbags, backpacks, briefcases), carpets, mats and rugs, fashion accessories (e.g. wristwatch straps, necklaces, bracelets, etc.), and footwear (including inner soles).

As part of the restriction dossier, a risk assessment was carried out to determine the maximum concentration limit of listed substances in order to protect consumers from the risks of skin allergies. The limit of concentration for sensitising substances are proposed as following:

Substance/Group of Substances Textile Leather, Fur and Hides
Disperse dyes Not Detected Not Detected
Chromium VI compounds 1 mg/kg 1 mg/kg
Nickel and its compounds 130 mg/kg 110 mg/kg
Cobalt and its compounds 70 mg/kg 60 mg/kg
Formaldehyde 75 mg/kg 75 mg/kg
1,4 paraphenylene diamine 250 mg/kg 210 mg/kg
Other substances in scope* 130 mg/kg 110 mg/kg

*Substances with harmonized classification as skin sensitizers in Category 1, 1A or 1B listed in Annex VI to Regulation (EC) No 1272/2008 or with skin sensitizing concern (Restriction Proposal, Table 5 [2])

Articles excluded from the restriction proposal are: jewellery, glasses and sunglasses, curtains, textile lampshades and wall decorations, filling materials in chairs, armchairs and sofas, second hand articles, articles within the scope of Regulation 2016/425/EU on personal protective equipment, articles within the scope of Regulation 2017/745/EU on medical devices, and parts of footwear that do not come into contact with human skin under normal or reasonably foreseeable conditions of use (e.g. underside of footwear).

The European Commission (EC) will decide whether to adopt the restriction on skin sensitising substances in textile, leather, fur and hides, and include them in Annex XVII of Regulation (EC) No. 1907/2006 (REACH), based on the submitted opinions by ECHA after the public consultation.

Recently, a textile product of underwear was recalled under the Rapid Alert System for Non-Food Products (RAPEX) due to the excessive amount of nickel with a measured value of 130 mg/kg by weight [3]. Nickel is commonly known as a strong skin sensitizer and can cause allergic reactions if present in articles that come into direct and prolonged contact with skin. The voluntary withdrawal of certain products from the market importers has aroused public awareness of exposure to sensitising chemicals that found in textile articles.


  1. ECHA Public Consultations Information and ECHA Newsletter
  2. Restriction Proposal
  3. RAPEX Recall Products

For enquiries, please contact:

Louann Spirito
Consumer and Retail — Softlines
US & Canada Softlines Business Head
t: +1 973 461 7919

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