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)

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.

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.

Commission decided

07-lis-2015

07-lis-2016

08-lis-2015

08-pro-2015

22-ožu-2017

01-lip-2017

22-ruj-2017

20-pro-2017

20-velj-2018

10-kol-2020

28-velj-2018