14 May 2019
Proposal Is Tabled to Restrict Placing on the Market of Textile and Leather Articles Containing Skin Sensitising Substances
It is reported that on 29 April 2019 Sweden and France have submitted a “restriction proposal” to the European Chemicals Agency, aimed at putting in place the restriction of skin sensitising substances in textile, leather, hide and fur articles. Hong Kong’s sellers to EU customers of, for example, clothing and footwear will be directly affected by the restriction: they will have to comply with it once it is adopted and then implemented EU-wide. The restriction’s purpose would be to reduce the risk to the general public of becoming sensitised via the skin to chemical substances in finished textile, leather, hide and fur articles that are placed on the market in the European Union for the first time.
According to the text of the document, the number of individuals already sensitised to chemical substances present in finished textile and leather articles in the European Economic Area (EEA) is estimated to be between 4 and 5 million, which corresponds to 0.8%-1% of the general population of the EEA. Skin sensitisation is a health effect which leads to a lifelong sensitivity to a specific allergen.
The definition of skin sensitisation in the restriction proposal is taken from Regulation 1272/2008 (the Regulation on classification, labelling and packaging, the “CLP Regulation”), where it is stated that the development of skin sensitisation includes two phases. First, an allergenic substance primes the immune system. This induction phase is without visible symptoms and is irreversible, and is thus responsible for the lifelong sensitivity to the allergen. The second phase, the elicitation phase, takes place after re-exposure to the allergen. This phase is associated with the manifestation of the allergy, the so-called allergic contact dermatitis (ACD). The ACD is reversible, given that the exposure can be avoided.
A factor which contributes to the problem of skin sensitising substances in textile and leather articles specifically, is that the avoidance of exposure is difficult. Clothes and footwear have to be worn routinely and for life by individuals. This may be particularly problematic if the sensitised individual is unaware of which allergen he or she is reacting to.
It should be noted that the proposal’s use of the expression “textile and leather articles” also covers articles made of hides and furs.
France’s Agency for Food, Occupational and Environmental Health and Safety (“ANSES”) and Sweden’s Chemicals Agency (“KemI”) jointly contend that the risk of skin sensitising substances in textile and leather articles is currently not adequately controlled. They have concluded that a restriction of the substances under the EU’s REACH Regulation is the most appropriate risk management option.
While more than 1,000 substances are currently regarded as skin sensitisers, only 95 of these are used in textiles or leather goods. Yet, a restriction of all these sensitising substances in textiles is thought to be unrealistic, as this would create serious obstacles for the manufacturing industry.
Therefore, the chemical substances that would fall within the scope of the restriction proposal have the potential to cause allergic contact dermatitis in individuals exposed to the substances via the skin. This is because they either have harmonised classifications as skin sensitisers or are indicated to have skin sensitising properties in, for example, the scientific literature, or pursuant to patch-testing with patients with a suspected allergy to substances in textile articles.
The proposed restriction would cover substances with a harmonised classification as skin sensitisers in Category 1 or 1A or 1B in Annex VI to the EU’s CLP Regulation, as well as the substances listed in Table 2 of the restriction proposal (disperse dyes).
More specifically, proposed concentration limits include a ban on the disperse dyes, and very low tolerated thresholds for chromium VI compounds, nickel and its compounds, cobalt and its compounds, formaldehyde, 1,4 paraphenylene diamine, and other substances found to be in scope.
The proposed substance restrictions would cover any of the following articles made exclusively or partly of textile, leather, hides and furs:
i. Clothing and related accessories,
ii. Articles other than clothing which come into contact with the human skin under normal or reasonably foreseeable conditions of use to an extent similar to clothing,
There are some very limited exemptions to the restriction. These are any items of i to iii above that are deemed personal protective equipment under existing EU rules; substances that are used as active ingredients in biocidal products; and second-hand items of i to iii above which were in end-use in the EU before 31 January 2023.
Any restriction proposal must go through the approvals procedure at the European Chemicals Agency. Thereafter, the Commission must take a balanced view of the identified risks and of the benefits and costs of the proposed restriction. The final decision is taken in a comitology procedure with scrutiny involving the Member States and the European Parliament.
Once adopted, industry must comply with the restriction, which will be set out in Annex XVII of the REACH Regulation. Thus, Hong Kong’s manufacturers will have to ensure that goods being sold to EU consumers meet those requirements after they are adopted, and upon the expiration of any grace period afforded to manufacturers, giving them time to adjust to the new requirements. The Member States are responsible for enforcing the restriction.