EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) 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 1 -methyl -2-pyrrolidone  
(Text with EEA relevance)   EN 2   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 1 -methyl -2-pyrrolidone  
(Text with EEA relevance)  
THE EUROPEAN C OMMISSION,  
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 
Directiv es 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(1) thereof,  
Whereas:  
(1) On 9 August 2013 , the Netherlands  submitted to  the  European Chemicals Agency 
(‘the Agency’)  a dossier pursuant to Article 69(4) of Regulation (EC) No 1907/2006  
(‘the Annex XV dossier’2), proposing to restrict  1-methyl -2-pyrrolidone (NMP). The 
Annex XV dossier demonstrated that action on a Union -wide basis was necessary to 
address risks to the health of  workers exposed to NMP . 
(2) The Netherlands based its h azard assessment of NMP on the effects of the substance 
on several human health endpoints. Developmental toxicity was considered the most 
critical of th ose endpoints and was used to determine a level (the derived no -effect 
level or ‘DNEL’) above which work ers should not be exposed to NMP by inhalation.   
(3) Regulation (EC) No 1272/2008  of the European Parliament and of the Council3 
provides that, where  NMP is present in mixtures in a concentration of 0 ,3 % or higher, 
they are to  be classified as   toxic for reproduction, category 1B . The restriction  should 
apply in relation to such mixtures , as well as to the substance on its own . 
(4) On 5 June 2014, the Agency’s Risk Assessment Committee ( RAC ) adopted its 
opinion , con firming  that developmental toxicity was the most critical health endpoint . 
RAC consider ed, however, that a different assessment factor  from that used by The 
Netherlands should be applied  to calculate the DNEL  for NMP . This resulted in a level 
twice as high as  that propose d by The Netherlands  for exposure of workers to NMP 
                                                 
1 OJ L 396, 30.12.2006, p 1.  
2 https://echa.europa.eu/documents/10162/ee4c88a9 -d26f-4872 -98fd-fb41646cc9e1  
3 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 and repealing Directives 67/548/EEC 
and 1999/45/EC, and amending Regulation (EC) No 1907/20 06 (OJ L353, 31.12.2008, p.1).  EN 3   EN via the inhalation route . RAC also calculated a DNEL  for exposure of workers to 
NMP via the dermal route , which had not been  proposed by T he Netherlands . 
(5) RAC  confirmed  that overall exposure to NMP above those two DNEL s poses a risk to 
the health of  workers and that the proposed restriction , based on th ose two DNEL s, is 
the most appropriate Union -wide measure to reduc e that risk in terms of its 
effectiveness .  
(6) On 25 November 2014 , the Agency’s Socio -Economic Assessment Committee 
(SEAC ) adopted its opinion , conclud ing that the proposed restriction , as modified by 
RAC,  is the most appropriate Union -wide measure to reduce  the risk to the health of 
workers arising from NMP in terms of  its socio -econ omic benefits and socio -
economic costs.  
(7) SEAC recommended a five year general deferral of application of the restriction, in 
line with the period propose d in the Annex XV dossier, to allow stakeholders to take 
the necessary compliance measures. SEAC conside red that a longer deferral period 
might be appropriate for the wire coating sector , which was  identified by The 
Netherlands  as the sector on which the proposed restriction could have the greatest 
impact in relation to cost s. 
(8) 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 during the 
restriction process and its recommendations have been  taken into account.  
(9) On 9 December 2014 , the Agency submitted the opinions of RAC and SEAC4 to the 
Commission.  
(10) On becoming aware of a discrepancy between  the DNEL for exposure to NMP via the 
inhalation route  proposed by RAC in its opinion and the indicative occupational 
exposure limit for NMP established under  Council Directive 98/24/EC5 following a 
scientific opinion of the Scientific Committee on Occupational Exposure Limits for 
chemical substances (SCOEL) , the Commission asked RAC and SCOEL to work 
together to resolve the issue  in accordance with Article  95(3) of Regulation (EC) No 
1907/2006 . As a result of this, on 30 November 2016 RAC proposed a modified 
DNEL  for exposure of workers to NMP via the inhalation route . 
(11) Based on the opinions of RAC and SEAC, t he Commission considers that t here is an 
unacceptable risk to the health of workers during the manufacture and use of NMP  
which  needs to be  addressed on a Union -wide basis . A restriction establishing DNEL s 
for exposure of workers to NMP via both the inhalation and the dermal routes  is the 
most  appropriate Union -wide measure to address th at risk . Such a restriction would be 
more appropriate than the indicative occupational exposure limit for NMP established 
under Directive 98/24/EC  for the following reasons : the overall risk characterisation  
ratio is based on quantified DNELs for inhalation and dermal exposure  to NMP ; the 
harmonisation of the chemical safety report in the registration dossier via harmonised 
DNELs can only be established under Regulation (EC) No 1907/2006 ; downstream 
users wil l have the same time period as manufacturer s and importers to put in place  
the appropriate risk management measures and operational conditions in order to 
                                                 
4 http://echa.europa.eu/documents/10162/9ce0977b -3540 -4de0 -af6d-16ad6e78ff20  
5 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  (fourteenth individual Directive within the meaning of 
Article 16(1) of Directive 89/391/EEC)  (OJ L 131, 5.5.1998, p. 11. ) EN 4   EN ensure that exposure of workers to NMP is below the two DNELs; the safety data 
sheets will include th ose DNELs in the appropriate  specific  sections.  
(12) Therefore , the proposed restriction is the most appropriate Union -wide measure to 
address the risk to the health of workers  from exposure to NMP .   
(13) DNEL s are to be applied  when conducting the chemical safety  assessment of a 
substance under Regulation (EC) No 1907/2006  in order to help determine the 
measures that need to be taken to manage the risk presented by the substance in 
particular exposure scenarios. Where manufacturers, importers or downstream users 
intend to place NMP as a substance on the market on its own or in mixtures in a 
certain concentration, t hat assessment  should  be made available  to users of the 
substance by means of chemical safety reports and safety data sheets.  Manufacturers 
and downstrea m users should  ensure that the DNELs are complied with when the 
substance is manufactured or used, on its own or in a mixture.  
(14) Stakeholders should be allowed sufficient time to take appropriate measures to comply 
with the proposed restriction, particularly  in the wire coating sector , where the costs of 
implementing the restriction will be particularly high . Therefore, t aking into account 
the SEAC recommendation , the application of the restriction should be deferred . The 
deferral period should have  regard to the delay in the restriction process due to the 
collaboration between RAC and SCOEL .  
(15) Regulation (EC) No 1907/2006 should therefore be amended accordingly . 
(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