EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2020) 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 N,N-dimethylformamide  
(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 N,N-dimethylformamide  
(Text with EEA relevance)  
THE EUR OPEAN 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 a nd 
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,  
Whereas:  
(1) N,N–dimethylformamide is an aprotic medium polar organic solvent classified as toxic 
to reproduction 1B , acute tox icant  4 (inhalation and dermal r oute) and as an eye 
irritant 2 in accordance with  Regulation (EC) No 1272/20082. N,N–
dimethylformamide  is a high production volume substance used in many industrial 
settings  and professional activities across Europe . 
(2) On 5 October 2018 , Italy (hereinafter ‘the dossier submitter’) submitted to the 
European Chemicals Agency (‘the Agency’) a dossier3 pursuant to Article 69(4) of 
Regulation (EC) No 1907/2006 (‘the Annex XV dossier’), in order to initiate the 
restriction proce ss set out in Articl es 69 to 73 of that Regulation. The Annex XV 
dossier demonstrated tha t action on a Union -wide basis wa s necessary and proposed to 
restrict  the industrial and professional use, as well as the  placing on the market  of 
N,N–dimethylformamide  on its own or in mixture s. 
(3) The dossier submitter  based its hazard assessment  of N,N–dimethylformamide  on the 
systemic effects of the substance on several endpoints . This resulted in  a long-term 
inhalation derived no -effect level  (‘DNEL ’) and a long-term dermal DNEL bas ed on 
animal data on decreased body weights, clinical chemistry changes and liver injury.  
(4) On 20 September 2019 , the Agency’s Commit tee for Risk Assessment (‘RAC’) 
adopted its opinion4 concluding that the proposed restriction , as modified by RAC,  is 
the most appropriate Union -wide measure to address the identified risks arising from 
                                                 
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/d3feb838 -3c17 -bcf9-db88 -92b83f5a43fc   
4 https://echa.europa.eu/documents/10162/44ad5cd9 -1143 -0072 -0550 -5860846ffbb4   EN 2  EN exposure to N,N–dimethylformamide  in terms of its effectiveness in reducing the risk, 
its practicality and monitorability .  
(5) As the dossier submitter ’s assessment consid ered several contributing scenarios for 
N,N–dimethylformamide  containing substances at low concentrations,  RAC proposed 
to clarify the wording of the scope by including the presence of the substance, 
regardless of whether N,N–dimethylformamide  is a constit uent, a main constituent, an 
impurity or a stabiliser.   
(6) The dossier submitter proposed a  long-term inhalation DNEL  of 3,2 mg/m3 based on 
hepatic effects  in animals. However, RAC recommended a  long-term inhalation 
DNEL of 6 mg/m3 based on a combination of human data and animal data, taking into 
account liver toxicity and developmental toxicity, respectively.  
(7) For the long -term dermal DNEL, RAC recommen ded a DNEL based on a  dermal 
study rather than making a route -to-route extrapolation from an oral 28 -day stu dy as 
proposed by the dossier submitter. T herefore , RAC propose d to use the value of 
1,1 mg/kg/day as the long-term dermal DNEL . 
(8) On 5 Dec ember 2019 , the Agency’s Committee for S ocio-Economic Analysis 
(‘SEAC’)  adopted its opinion5, concluding 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 N,N–dimethylformamide , taking into account its  socio -
economic benefits and costs.  SEAC recomme nded a  24-month deferral of application 
of the restriction  for all sectors , in line with the Annex XV dossier, t o provide 
sufficient time to stakeholders  to fully implement the restriction requirements .  
(9) The Forum for Exchang e of Information on Enforcement  was consulted on  the 
proposed restriction and its recommendations have been taken into account.  
(10) On 1 April 2020 , the Agency submitted the opinions of RAC and SEAC to the 
Commission . The said opinions  confirmed  that the  risk to the health  of workers in all  
occupational setting s during the manufacture and use of N,N–dimethylformamide  is 
not adequately controlled .  
(11) Taking into account the Annex XV dossier  and the RAC and SEAC opinions , the 
Commission considers  that there is an unacceptable risk to workers ari sing from  
exposure to  N,N–dimethylformamide  above specific DNEL values and that the 
proposed r estriction establishing a DNEL  for exposure of workers to DMF  via both 
the inhalation and the dermal routes is the most appropriate Union -wide measure to 
address that risk.  
(12) The Commission considers that the  proposed  restriction , as modified by RAC and 
SEAC, is appropriate for the following reasons: the overall risk characterisation ratio 
is based on quantified DNELs for inhalation and dermal exposure to DMF ; 
harmon isation of  chemical safety report s in the registration dossier s via harmonised 
DNELs can only be achieved under  Regulation (EC) No 1907/2006; the safety data 
sheets will include those DNELs in the appropriate  specific sections.   
(13) Stakeholders should be allowed sufficient time to comply with the proposed 
restriction , and  downstream users , in particular,  should  have the same time period as 
manufacturers and importers to implement the appropriate risk management measures 
and operational conditions in order to ensure that exposure of workers to N,N–
                                                 
5 https://echa.europa.eu/documents/10162/b6644298 -54a4 -052a -9bbc -6824966d151e  (compiled version 
of final RAC and SEAC opinions)  EN 3  EN dimethylformamide  is below the DNELs . The Commission therefore considers, in line 
with the Annex XV dossier and the opinion of SEAC, that the application of the 
restriction should be deferred for 24 months.   
(14) Regula tion (EC) No 1907/2006 should therefore be amended accordingly.  
(15) The measures provided for in this Regulation are in accordance with the opinion of 
the Committee  established by Article 133 (1) 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 Un ion. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen