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Europe - REACh: final opinion on the proposed restriction of allergens in articles (Annex XVII)

Posted in Innocuousness on 2021-05-11 by CTC
Following the public consultation organized in summer 2020 (see CTC article on the subject), the European Committee for Socio-economic Analysis (SEAC) adopted its final opinion in September 2020 (see article CTC) on the proposed restriction aiming to include a new requirement in Annex XVII of the REACh Regulation for skin sensitizing substances (allergens) in certain consumer articles.

This final SEAC opinion, consolidated with the Risk Assessment Committee’s (RAC) opinion, was posted on the website of the European Chemicals Agency (ECHA) on April 21, 2021, as well as the relevant final documents associated with the project ("final background document" and appendices).

As a reminder, this project submitted by France and Sweden in April 2019 aims to restrict the presence of all substances officially classified as skin sensitizers of category 1 / 1A / 1B according to the European CLP regulation (hazard statement "H317"), as well as a few not officially classified substances, but with known allergenic properties (disperse dyes).

In its final opinion, the SEAC proposes the following restriction conditions:

 

Scope

The proposed restriction concerns the following categories of articles:

  • (1) clothing and related accessories.
  • (2) Textile, leather, fur, hide and synthetic leather articls, other than clothing which, under normal or reasonably foreseeable conditions of use, comes into contact with human skin to a similar extent to that of clothing (example: handbag, backpack, watch strap, necklace, bed linen, sleeping bag, etc.).
  • (3) Disposable sanitary towels, napkins, tissues and nappies
  • (4) footwear
  • Without further clarification of the text, all the materials of articles of clothing or footwear fall in the scope (rubber, polymers, etc.),
  • As for the articles’ components, the SEAC considers that they are all within the scope (inaccessible, accessible, with or without contact with the skin), to be consistent with the scope of entry 72 of the Annex XVII of the REACh regulation (restriction on CMRs substances, see article CTC).
  • The exemptions cited in the project are as follows:
    • Personal protective equipment (PPE) covered by regulation 2016/425
    • Active substances in the context of biocidal use, as defined in regulation 528/2012
    • Second-hand items placed on the market before January 31, 2023
    • Metal parts of articles.

 

Restriction thresholds

​The table below lists the thresholds proposed in the document. Some highlights as a preamble:

  • The threshold applicable to Chromium 6 in leather is maintained at 3 mg/kg for 5 years after the entry into force of the text, then will be lowered to 1 mg/kg.
  • The proposed thresholds for compounds of Nickel and Cobalt will apply 5 years after the entry into force of the text.
  • The threshold applicable to formaldehyde finally returns to 75 mg/kg, whereas it was proposed at 30 mg/kg in the provisional opinion of the SEAC.
  • Substances newly classified as category 1 / 1A / 1B allergens in Annex VI of the CLP regulation, will be covered by the restriction within 3 years after their official classification date.
  • The scope of application covers in theory all materials of articles of clothing or footwear type, but in fact, most of the proposed thresholds are only explicitly defined for leather and textile materials. Only the application of the threshold for formaldehyde is not restricted to a category of material. The comments made during the public consultation phases, which suggested to include other types of materials, have apparently not been heard.

 

 

Substances

Textiles

Leather, fur, hide

Other materials

Disperse dyes
(officially classified as skin sensitizers according to CLP regulation, or listed in the table appended to the restriction)

Prohibited Prohibited Prohibited

Chromium 6 compounds
(expressed in extractable Cr6)

1 mg/kg 3 mg/kg
threshold lowered to 1 mg/kg five years after entry into force of the restriction
-

Formaldehyde

75 mg/kg 75 mg/kg 75 mg/kg

1,4 paraphenylene diamine

250 mg/kg

50 mg/kg

-

Nickel compounds
(expressed in extractable Ni)

125 mg/kg

25 mg/kg

-

Cobalt compounds
(expressed in extractable Co)

70 mg/kg

15 mg/kg

-

Other substances classified as skin sensitizers (official classification according to CLP regulation)

130 mg/kg

30 mg/kg

-

 

It is the turn of the European Commission to prepare the draft text amending Annex XVII of the REACh regulation to include an entry on these substances, based on the opinions of the RAC and SEAC committees. The Commission will submit it to the World Trade Organization to ensure that it does not create technical barriers to international trade. The Council and the European Parliament will also take note of the text: if they do not oppose the restriction, it will be adopted and published in the European Official Journal. All these stages can take place over several months; precise deadlines are not known.

Weblink to the documents related to the restriction project

 

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