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Registry of restriction intentions until outcome

The registry of restriction intentions until outcome lists the intentions and Annex XV restriction proposals received by ECHA.

A restriction proposal may be prepared by a Member State or by ECHA at the request of the Commission or on its own initiative for substances in the Authorisation List. It is a legal requirement for a Member State to notify ECHA of its intention to prepare a restriction dossier. The advance notice enables interested parties to plan and prepare for commenting later on.

Interested parties can follow the progress of a proposal through the restriction process, from the notification of the intention to the adoption of the final opinions by the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC), and the adoption of the restriction by the European Commission.

Stakeholders are encouraged to submit any relevant information to the dossier submitters during the preparation of the restriction proposal and during the public consultations. Information to motivate any exemptions to the scope described in the intention is particularly useful to receive in the preparatory phase of the dossier.

Diisocyanates

EC / List no: - CAS no: -
CLP Annex VI Index number
Further substance information
Relevant Diisocyanates:

4,4'-methylenediphenyl diisocyanate (EC: 202-966-0); 2,2'-methylenediphenyl diisocyanate (EC: 219-799-4); o-(p-isocyanatobenzyl)phenyl isocyanate (EC: 227-534-9); 4-methyl-m-phenylene diisocyanate (EC: 209-544-5); m-tolylidene diisocyanate (EC: 247-722-4); 1,5-naphthylene diisocyanate (EC: 221-641-4); 3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate (EC: 202-112-7); hexamethylene diisocyanate (EC: 212-485-8); 1,3-bis(1-isocyanato-1-methylethyl)benzene (EC: 220-474-4); 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (EC: 223-861-6); 4,4'-methylenedicyclohexyl diisocyanate (EC: 225-863-2); 1,3-bis(isocyanatomethyl)benzene (EC: 222-852-4); 2,4,6-triisopropyl-m-phenylene diisocyanate (EC: 218-485-4); 2-methyl-m-phenylene diisocyanate (EC: 202-039-0); Reaction mass of 4-methyl-m-phenylene diisocyanate and 2-methyl-m-phenylene diisocyanate (CAS: 26102-02-3); 5-methyl-m-phenylene diisocyanate (CAS: 14219-05-7)
Submitter(s)
Germany
Details on the scope of restriction
1. Shall not be used as substances on their own, as a constituent in other substances or in mixtures for industrial and professional uses, unless.

a) the cumulative concentration of diisocyanates in the substance or mixture is less than 0.1 % by weight, or
b) the substance or mixture in the form in which it is supplied to the user, including the combination of such substance or mixture, its packaging and any application aid is placed on the market in accordance with paragraph 2b), or
c) the employer or self-employed worker ensures that measures and trainings are taken prior to the use of the substances or mixtures in accordance with the provisions described in Appendix 13[1] (Trainings and Measures).

Member States may implement or continue to apply own provisions for the use of these substances and mixtures as long as the minimum requirements of Appendix Trainings and Measures are met. The employer or self-employed worker shall document the compliance to the requirements of Appendix 13 (Trainings and Measures). Proof of successful completion of a training according to Appendix 13 (Trainings and Measures) shall be recognised in all other Member States.

2. Shall not be placed on the market as substances on their own, as a constituent in other substances or in mixtures for industrial and professional uses, unless

a) the cumulative concentration of diisocyanates in the substance or mixture is less than 0.1 % by weight, or
b) the substance or mixture in the form in which it is supplied to the user, including the combination of such substance or mixture, its packaging and any application aid is compliant with Appendix 12 (Exemptions), or
c) the supplier ensures that the recipient of the substance or mixture is provided with information according to paragraph 3.

3. For the purpose of 2c) manufacturers and importers of diisocyanates on their own or as a constituent in other substances and importers of mixtures containing diisocyanates shall develop a set of teaching material in accordance with the provisions of Appendix 13 (Trainings and Measures) in an official language of the Member State where the substance or mixture is placed on the market before placing the substance or mixture on the market. They shall ensure that training courses based on the training material are available to the recipients of such substances or mixtures. They shall review and update the training material after a maximum of 8 years, or without delay if new information, which may affect the risk management measures, becomes available and inform the recipients accordingly.

Natural or legal persons formulating mixtures containing diisocyanates within the EU shall provide necessary information for the development of the teaching material upon request of their substance suppliers. All downstream users may be consulted for the purpose of the development and update of the teaching material.

[1] The texts of “Appendix Trainings and Measures” and “Appendix Exemptions” are two separate documents. A short summary can be found in A.2.2. Additional information can be found in Appendix 5 to the dossier. The document on Appendix 13 attached to this proposal contains elements that should be included in the final legal text of the Appendix.
Reason for restriction
All listed diisocyanates and formulations in which they are contained at more than their generic or specific concentration limits share the classification as “Respiratory Sensitiser 1”.

Occupational respiratory diseases because of the use of diisocyanates are well known in all member states, showing that the risks of using such substances are not sufficiently controlled and should be subject to additional regulations.

It is intended to define more specifically the terms ‘realistic conditions’ and ‘acceptable risk’ as well as the nature and performance standards of suitable methods of measurement in Appendix M to the restriction text.

Specific requirements for the safe handling of these substances are already contained in the German Technical Rules for Hazardous Substances No. 430 and can serve as a basis for Appendix N to this entry.
Remarks
Status
Opinions adopted
Date of intention
07/10/2015
Expected date of submission
07/10/2016
Withdrawal date
Reason for withdrawal
Start of Call for Evidence public consultation
08/10/2015
Deadline for comments on the Call for Evidence
08/12/2015
Start of second Call for Evidence public consultation
Deadline for comments on the second Call for Evidence
Start of third Call for Evidence public consultation
Deadline for comments on the third Call for Evidence
Restriction report (and annexes)
Information note on restriction report
Start of Annex XV report public consultation
22/03/2017
1st deadline for comments on Annex XV report
01/06/2017
Final deadline for comments on Annex XV report
22/09/2017
Comments on Annex XV report
Opinion of RAC (and minority positions)
Draft opinion of SEAC
RAC & SEAC (draft) Background document (and annexes)
Start of SEAC draft opinion public consultation
20/12/2017
Deadline for comments on SEAC draft opinion
20/02/2018
Comments on SEAC draft opinion
Compiled RAC and SEAC opinion (and minority positions)
Final background document (and annexes)
Adopted restriction/Commission communication
Latest update
13/02/2019

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