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EU : ECHA Launched SECOND Public Consultation on Restriction on Skin Sensitising Substances

JUNE 2020 – RELEVANT FOR: ELECTRICAL AND ELECTRONICS, HARDLINES, SOFTLINES, CHILDREN'S PRODUCTS

The European Chemicals Agency (ECHA) launched the 2nd public consultation1 on the proposal to restrict skin sensitising substances in textiles and leather under REACH Annex XVII. 

After the 1st public consultation, the original proposal2 was modified by the Socio-Economic Assessment Committee (SEAC). Major modifications3 include:

  • Expand the product scope;
  • Disposable sanitary towels, napkins, tissues and nappies are also newly added to the scope;
  • Provide a non-exhaust list of examples for articles which come into contact with skin to an extent similar to clothing, e.g. bed line, blankets, upholstery, child care articles and children’s products other than toys, bags, carpets, fashion accessories;
  • Modify the limits of restricted substances.

Table A shows the details of the proposed restriction which were modified by the SEAC.

The consultation will end on 24 August 2020. After the 2nd public consultation, the ECHA will submit the final opinions to the European Commission (EC) to see if it is needed to amend Annex XVII.

Table A. Proposed restriction on skin sensitising substances modified by SEAC

Parameter Details of the proposal
Target substances 
  • Disperse dyes which are classified as skin sensitisers in category 1, 1A or 1B in Annex VI to Regulation (EC) No 1272/2008, or listed in Table B;
  • Chromium VI;
  • Formaldehyde;
  • 1,4 paraphenylene diamine;
  • Nickel compounds;
  • Cobalt compounds;
  • Other compounds which are classified as skin sensitisers in category 1, 1A or 1B in Annex VI to Regulation (EC) No 1272/2008 
Proposed scope of the restriction  

The following articles made exclusively or partly of textiles, leather, hides and furs:

  • Clothing and related accessories;
  • Textile, leather, fur, hide and synthetic leather 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;
  • Disposable sanitary towels, napkins, tissues and nappies;
  • Footwear
Proposed limit
  • Disperse dyes: Not detected
  • Chromium VI: < 1 mg/kg (extractable, leather, fur and hide: < 3 mg/kg of total dry weight);
  • Formaldehyde: < 30 mg/kg;- 1,4 paraphenylene diamine: < 250 mg/kg in textiles, < 50 mg/kg in leather, hides and fur;
  • Nickel compounds: < 125 mg/kg in textiles; < 25 mg/kg in leather, hides and fur (extractable);
  • Cobalt compounds: < 70 mg/kg in textiles; < 15 mg/kg in leather, hides and fur (extractable);
  • Other compounds: < 130 mg/kg in textiles; < 30 mg/kg in leather, hides and fur
Proposed exemption
  • Personal Protective Equipment (PPE) within the scope of Regulation (EU) 2016/425;
  • Medical devices within the scope of Regulation (EU) 2017/745;
  • Substances that are used as active ingredients in biocidal products within the
    scope of Regulation (EU) 528/2012;
  • The second-hand articles which were in end-use before 31 January 2023.
Proposed transitional period
  • 36 months

 

Table B. List of disperse dyes restricted in the proposal

 Substance name CAS No.  Substance name CAS No. 
CI Disperse Blue 3 2475-46-9 CI Disperse Red 11  2872-48-2
CI Disperse Blue 7
3179-90-6 CI Disperse Red 17
3179-89-3
CI Disperse Blue 26 3860-63-7 CI Disperse Yellow 1
119-15-3
CI Disperse Blue 35
12222-75-2
CI Disperse Yellow 9
6373-73-5
CI Disperse Blue 102
12222-97-8 CI Disperse Yellow 39
12236-29-2
CI Disperse Blue 106
68516-81-4
CI Disperse Yellow 49
54824-37-2
CI Disperse Blue 124
15141-18-1 CI Disperse Orange 149
85136-74-9
CI Disperse Brown 1
23355-64-8
CI Disperse Blue 291
56548-64-2
CI Disperse Orange 1
2581-69-3
CI Disperse Violet 1
128-95-0
CI Disperse Orange 3
730-40-5
CI Disperse Violet 93
268221-71-2
CI Disperse Orange 37/59/76

13301-61-6
12223-33-5
51811-42-8

CI Disperse Yellow 64
10319-14-9
CI Disperse Red 1
2872-52-8
CI Disperse Yellow 23
6250-23-3

 

[1] Public consultation on skin sensitising substances

[2] Report submitted for the restriction proposal (containing the proposed text on p.11)

[3] Draft opinion of SEAC

 

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