Comments for Annex XV restriction report


Skin sensitising substances

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Restriction on the placing on the market of textile, leather, hide and fur articles containing skin sensitising substances.

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as they explain both the process and the proposal itself.

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Link to the Information Note

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General Comments

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 Specific Information Requests
1:

Regarding hazards and risks:

  1. Specific information from literature or other sources is sought to confirm the skin sensitisation hazard profile or properties of the 24 disperse dyes included in Table 2 of the Annex XV report (reproduced below).

Table 2: Disperse dyes included in the scope of the proposed restriction

Substance name

CAS No.

EC No.

CI Disperse Blue 3

2475-46-9

219-604-2

CI Disperse Blue 7

3179-90-6

221-666-0

CI Disperse Blue 26

100357-99-1

13324-23-7

3860-63-7

2580-56-5

600-078-1

603-725-6

223-373-3

219-943-6

CI Disperse Blue 35

12222-75-2

56524-77-7

602-260-6

260-243-5

CI Disperse Blue 102

12222-97-8

602-282-6

Ci Disperse Blue 106

12223-01-7

602-282-2

CI Disperse Blue 124

61951-51-7

612-788-9

CI Disperse Brown 1

23355-64-8

245-604-7

CI Disperse Orange 1

2581-69-3

219-954-6

CI Disperse Orange 3

730-40-5

211-984-8

CI Disperse Orange 37 /59/76

13301-61-6

12223-33-5

51811-42-8

236-325-1

602-312-8

CI Disperse Red 1

2872-52-8

220-704-3

CI Disperse Red 11

2872-48-2

220-703-8

CI Disperse Red 17

3179-89-3

221-665-5

CI Disperse Yellow 1

119-15-3

204-300-4

CI Disperse Yellow 9

6373-73-5

228-919-4

CI Disperse Yellow 39

12236-29-2

602-641-7

Ci Disperse Yellow 49

12239-15-5

54824-37-2

235-473-4

611-202-9

CI Disperse Orange 149

85136-74-9

400-340-3

CI Disperse Blue 2911

 

 

CI Disperse Violet 1

128-95-0

204-922-6

CI Disperse Violet 93

122463-28-9

602-785-0

CI Disperse Yellow 64

10319-14-9

233-701-7

CI Disperse Yellow 23

6250-23-3

228-370-0

1For CI Disperse Blue 291 CAS and EC numbers not specified, because there are numerous CAS and EC numbers associated with this chemical.
 
  1. Regarding the risks, specific information is sought on migration data and on elicitation threshold doses for substances within the scope of the proposed restriction in textiles as well as how this migration might differ depending on the type of material (leather vs textile) and specific information on use pattern and exposure frequency of textiles.

* Compulsory Fields



2:

The Dossier Submitter has developed a list of substances that can potentially be present in finished articles made of textile, leather hides and fur.

  1. Please provide information on any substances that have been missed in the screening done by the Dossier Submitter, and listed in Table 20 in Annex E.
  2. Please provide further information regarding the availability of test methods for the substances in Table 20 in Annex E as well as the associated costs for testing.
  3. Please provide information on whether the estimated mg/kg concentrations indicated in Table 20 in Annex E are correct.
  4. In order to justify the proposed concentration limits, please provide information on the presence of the substances below the limit of concentration indicated in paragraph 3 (from I to V) of the proposed restriction, as well as any further information related to risks or socio-economic impacts.
  5. The Dossier Submitter has not been able to confirm whether the following substances are present in articles placed on the market for the general public:
    1. Benzenesulfonic acid, 3-nitro-, sodium salt (1:1)(CAS 127-68-4/EC 204-857-3) used as intermediate in dye synthesis,
    2. Tall-oil rosin (CAS 8052-10-6/EC 232-484-6), which may be used in coated, pigment printed textiles.

If they are present in articles placed on the market for the general public, please provide any information on concentrations and on possible alternatives to them.

* Compulsory Fields



3:

The Annex XV report does not identify alternatives for some of the substances, or groups of substances, that would be affected by the proposed restriction. Please provide any information you have regarding the availability and suitability of alternatives to substances that would be covered by the proposed restriction. In particular, information on alternatives to the following groups of substances would be useful:

  1. Solvents (general information on their presence and use in formulations would also be useful),
  2. Formaldehyde (CAS 50-00-0/EC 200-001-8) for leather, hide and fur applications,
  3. Glutaraldehyde (CAS 111-30-8 EC 203-856-5). Furthermore, information is sought on whether the existing supply of vegetable tanning is large enough to substitute both chromium VI and glutaraldehyde.
  4. Metals (e.g. cobalt) and inorganic compounds.
  5. Benzenamine (aniline) (CAS 62-53-3/EC 200-539-3).
  6. Industry has indicated that some of the identified alternatives may be regrettable substitutes. Please provide further information about:
    1. dioctyl sebacate (CAS 117-84-0/EC 204-214-7), dioctyl adipate (CAS 123-79-5/EC 204-652-9), dioctyl phthalate (CAS 117-84-0/EC 204-214-7) and diisononyl phthalate (CAS 28553-12-0/EC 249-079-5) for neoprene applications, which are within the intended scope of the proposed restriction,
    2. acrylics, polyurethanes and other binders for rosins,
    3. acetyl tri-butyl citrate (ATBC) (CAS 77-90-7/EC 201-067-0) and dibutyl phthalate (CAS 84-74-2; 93952-11-5/EC 201-557-4) for phthalate esters.

* Compulsory Fields



4:

For some of the substances proposed to be restricted, there is information in the Annex XV report on the identity of the most likely alternatives but further information is sought about the associated costs and hazards. In particular, information on the following:

  1. The cost of implementing best practice to reduce levels of diisocyanates in articles placed on the market for the general public. Also information on the costs of moving towards best practice for other substances would be useful.
  2. Information on whether the cost assumptions for alternative rubber accelerators are correct (e.g. the number of required reformulations and cost per reformulation). Also information of whether reformulations will be necessary for other substances, and the associated costs, would be useful.
  3. Some of the alternatives identified have a lower cost than the substances proposed  to be restricted (e.g. phthalate esters and plasticiser for neoprenes, which are both within the intended scope of the proposed restriction). Please provide information about whether there are any other impacts expected from implementing these lower cost alternatives. Please try to monetise or quantify these impacts to the extent possible.

* Compulsory Fields



5:

According to the restriction on chromium VI in leather articles (2012)[1], the use of best practice can keep the chromium VI concentration in leather articles placed on the market for the general public below 3 mg/kg. The Dossier Submitter has assumed that best practices can achieve a concentration of 1 mg/kg in leather articles. Please confirm if:

  1. It is possible to achieve a concentration of 1 mg/kg in leather articles.
  2. There are analytical methods which can enforce this limit of 1 mg/kg in the finished articles.
 

[1] https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e180d737d9

* Compulsory Fields



6:

The proposal makes reference to EN testing methods. However, it would be good to receive information regarding available analytical methods (CEN developed or otherwise, with a known limit of detection) to achieve these limits.

* Compulsory Fields



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