EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards diisocyanates  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards diisocyanates  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45 /EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(1)  thereof,  
Wher eas: 
(1) Diisocyanates have a harmoni sed classification as a respiratory sensiti ser category 1 
and as a skin sensiti ser category 1 according to Regulation (EC) No 1272/2008  of the 
European Parliament and of the Council2. Diisocyanates are  used as chemical building 
block s in a wide range of sectors and applications, in particular in foams, sealants and 
coatings, inter alia , throughout the Union . 
(2) On 6 October 2016, Germany submitted to the European Chemicals Agency (‘the 
Agency’) a dossier3 pursuant to Articl e 69(4) of Regulation (EC) No 1907/2006 (‘the 
Annex XV dossier’), in order to initiate the restriction procedure set out in Articl es 69 
to 73 of that Regulation. The Annex XV dossier indicated that respiratory 
sensiti sation , due to  both dermal and inhalati on exposure to diisocyanates , leads to 
occupational asthma in workers , which  has been identified as a significant 
occupational health problem in the Union . The annual number of new occupational 
diseases caused by diisocyanates (estimated to be more than 50 00 cases) is considered 
unacceptably  high. The Annex XV dossier demonstrated that action on a Union -wide 
basis is necessary and proposed to restrict  the industrial and professional use, as well 
as the  placing on the market , of diisocyanates  on their own , and as constituent of other 
substances and in mixture s. 
(3) The restriction proposed in the Annex XV dossier aims to limit  the use of 
diisocyanates in industrial and professional applications to those cases where a 
combination of technical  and organisational measures  are implemented,  and a 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures amending and repealing Directives 
67/548/EEC and 199/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008 p.1) . 
3 https://echa.europa.eu/documents/10162/63c411e5 -cf0f-dc5e -ff83-1e8de7e4e282    
EN 2  EN minimum standardised training course  has been followed . Information  on how to get 
access to th e course  should be communicated throughout the supply chain  and it 
should be the responsibility of the operators placing these substances and mixtures on 
the market to ensure that  training courses are available to the  recipients of such  
substances or mixtures .  
(4) On 5 December 2017 , the Agency’s Commit tee for Risk Assessment (‘RAC’) adopted 
its opinion4 concluding that the pro posed restriction , as modified by RAC,  is the most 
appropriate Union -wide measure to address the identified risks arising from exposure 
to these substances in terms of effectiveness in reducing those risks.  Moreover, it  
consider ed that the implementation o f the modified proposed restriction would reduce  
as well  the number of diisocyanate -related cases of derma titis.  
(5) RAC concluded that appropriate training is a basic necessity,  and that  every worker 
handling diisocyanates should have a sufficient knowledge of the hazards of these 
substances and an awareness of the risks related with their use s, as well as sufficient 
knowledge of good working practices and appropriate risk management measures 
(RMMs), including the correct use of appropriate personal protectiv e equipment . RAC 
notes that particular training measures are needed to raise the awareness about  the 
importance of health protection by means of appropriate RMMs and safe handling 
practices . 
(6) RAC considered that the cut-off limit of 0 ,1% by weight,  set for  diisocyanates  in a 
substance or in a mixture , corresponds to the lowest concentration limit existing for 
specific diisocyanates classifi ed as respiratory sensiti sers category  1. RAC  also agreed 
with the dossier submitter  that the implementation of an indic ative or binding 
occupational exposure limit would not be sufficient to reduce the number of 
occupational asthma cases to a level as low as possible , since  currently , no threshold is 
known for the sensitising effect of diisocyanates.  
(7) On 15 March 2018 , the Agency’s Committee for S ocio-Economic Analysis (‘SEAC’)  
adopted its opinion5, in which it confirmed RAC’s conclusion that, in view of its 
socio -economic benefits and costs , the proposed restriction is the most appropriate 
Union -wide measure to address the  identified risks.  Furthermore, SEAC concluded 
that the proposed restriction is affordable for the affected supply chains.  
(8) SEAC recommended a  forty -eight month deferral of application of the restriction  in 
order to provide sufficient time to all actors for  the full implementation of the 
restriction requirements .  
(9) The Agency's Forum for Exchange of Information on Enforcement, referred to in 
Article 76(1)(f) of Regulation (EC) No 1907/2006, was consulted on the  RAC and 
SEAC opinions concerning the  proposed re striction and its recommendations have 
been taken into account.  
(10) On 9 May 2018, the Agency submitted the opinions of RAC and SEAC to the 
Commission. Based on those opinions, the Commission concludes  that an 
unacceptable risk to human health arises from the use or placing on the market of 
diisocyanates, on their own, as a constituent of other substances  and in mixtures. The 
Commission considers that those risks need to be addressed on a Union -wide basis.   
                                                 
4 https://echa.europa.eu/documents/10162/737bceac -35c3 -77fb-ba7a -0e417a81aa4a    
5 https://echa.europa.eu/documents/10162/d6794aa4 -8e3a -6780 -d079 -77237244f5f9     
EN 3  EN (11) Taking into account the Annex XV dossier as well as the opinions of RAC and SEAC, 
the Commission considers that a minimum requirement for training should be 
provided to industrial and professional users without prejudice to stricter national 
obligation s in the Member States. The Commissio n also considers that information of 
this requirement should be included in the packaging.  
(12) For the pu rpose of possible future revisions of the current restriction, Member States 
should report to the Commission the establish ed training requirements, the number of 
cases registered per year on occupational asthma and occupational respiratory and 
dermal disease, the national occupational exposure levels and information on 
enforcement activities.   
(13) Without prejudice to Union occup ation al safety and health legislation , in particular the 
Council Directive 98/24/EC on c hemical agents6, this restriction is intended to 
enhance the employers ’ capacity to achieve a higher level of risk control. Small and 
medium sized enterprises will benefit from this act, which  will further enhance  the 
implementation of the present occupational safety and health requirements  by 
providing diisocyanates -specific training programmes throughout the supply chain.  
(14) Economic operators should  be granted  a period of sufficient length to adapt to the new 
requirements. A transition period of two years is appropriate to allow  the concerned 
workforce to perform the required training . 
(15) Regulation (EC) No 1907/2006 should therefore be amended accordin gly. 
(16) The measures provided for in this Regulation are in accordance with the opinion of 
the Committee  established under Article 133 of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety  and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker  
                                                 
6 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks 
related to chemical agents at work  (OJ L 131, 5.5.1998, p.11) .