EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) 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 perfluorooctanoic acid (PFOA), its salts 
and PFOA -relat ed substances  
(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 perfluorooctanoic acid (PFOA), its salts 
and PFOA -relat ed substances  
(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 concernin g 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 a s 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) Perfluorooctanoic acid  ('PFOA '), its salts  and PFOA -related substances2 have  some 
specific  properties such as high friction  resistance, dielectrical ity, resistance to heat 
and chemical agents, and low surface energy . They are used in a wide variety of 
applications such as in the fluoropolymer and fluoroelastomer production, as 
surfactants in fi re-fighting foams, and in textile  and paper  production to provide water, 
grease, oil and /or dirt repellency.  
(2) On 14 June 2013 , the Member State Committee,  referred to in Article 76(1)(e) of 
Regulation (EC) No 1907/2006,  identified PFOA  as a persistent, bioa ccumulative and 
toxic substance ('PBT') in accordance with Article 57(d) of that Regulation. On 20 
June 2013, PFOA was included in the Candidate List of Substances of Very High 
Concern ('SVHC') for possible inclusion in Annex XIV  to Regulation (EC) No 
1907 /2006 .  
(3) On 17 October 2014, Germany and Norway 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'), proposing to restrict the manufacture, placing on 
the market and use of PFOA, its salts and PFOA -related substances , in order to 
address the risks to human health and the environment. Germany and Norway  
proposed a concentration limit of 2 ppb for the presence of these substances in  other 
substances, mixtures or articles, and did not propose exemptions except for second -
                                                 
1 OJ L 396, 30.12.2006, p 1.  
2  PFOA -related substances are substances that, based on their molecular structure, are considered to have 
the potential to degrade or be transformed to PFOA.  
3  http://echa.europa.eu/documents/10162/e9cddee6 -3164 -473d -b590 -8fcf9caa50e7  EN 3   EN hand articles for which an end -use in the Union can be demonstrated before the date of 
application of the restriction.  
(4) On 8 September 2015, the  Agency's  Committee for  Risk Assessment ('RAC') adopted 
its opinion concluding that subject to modification  of the scope and conditions  
proposed in the Annex XV dossier, a general restriction on manufacture, use and 
placing on the market of PFOA , its salts and PFOA -related substances , is the most 
appropriate Union -wide measure  to address the identified risks in terms of 
effectiveness in reducing  those risks. RAC proposed two different concentration 
limits, namely 25 ppb for PFOA and its salts and 1000 ppb for one or a combin ation of 
PFOA -related substances, in other substances, mixtures or articles, reflecting the 
possible presence of unavoidable impurities and unintended contaminants, and taking 
account of the capabilities of analytical methods.  RAC proposed to exempt from t he 
restriction photographic coatings applied to films, papers or printing plates, 
implantable medical devices and substances or mixtures used in semiconductor and 
photolithography processes,  considering the relatively low environmental impact and 
long subs titution timeframes. RAC also proposed to exempt the use of substances as 
transported isolated intermediates  in order to allow the manufacture of alternatives, as 
well as the placing on the market of second -hand articles.  
(5) On 4 December 2015, the  Agency's  Committee for Socio -Economic Analysis ('SEAC') 
adopted its opinion, indicating that the restriction proposed in the Annex XV dossier, 
as modified by RAC and SEAC, is the most appropriate Union -wide measure to 
address the identified  risks in terms of its so cio-economic benefits and socio -economic 
costs.  
(6) SEAC agreed with the exemptions proposed by RAC. In addition , SEAC suggested a 
three year deferral of the restriction, instead of the eighteen months proposed in the 
Annex XV dossier, to allow stakeholders to  take the necessary compliance measures.  
Based on socio -economic considerations, such as high costs, significant economic 
burden, lack of alternatives, relatively low emissions to the environment, critical uses 
with high societal benefits, SEAC suggested l onger deferrals of the restriction for latex 
printing inks, textiles for the protection of workers, membranes intended for medical 
textiles, filtration in water treatment, production processes, and effluent treatment, 
certain plasma nano -coatings and non -implantable medical devices .  
(7) SEAC also suggested to exempt  from the proposed restriction  fire-fighting foams 
already placed on the market before the date of application of the restriction , and 
semiconductor manufacturing equipment.  
(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 opinion has been  taken into account.  
(9) On 12 January 2016, the Agency submitt ed the opinions of the RAC and the SEAC4 to 
the Commission.  
(10) Based on those opinions, the Commission concluded  that an unacceptable risk to 
human health and the environment arises from the manufacture, use or placing on the 
market of PFOA, its salts and PFOA-related substances on their own, as a constituent 
of other substances, in mixtures and in articles . The Commission considers that those 
risks need to be addressed on a Union wide basis.  
                                                 
4 https://e cha.europa.eu/documents/10162/2f0dfce0 -3dcf-4398 -8d6b -2e59c86446be   EN 4   EN (11) Perfluorooctane sulfonic acid ( 'PFOS ') and its derivatives should be  exempted from  
the proposed restriction , since those  substances are already regulated  by Regulation 
(EC) No 850/2004 of the European Parliament and of the Council5. The unavoidable 
production of PFOA during the manufacture of fluorochemicals with a carbon chain 
equal to or shorter than six atoms should also be exempted from the proposed 
restriction.  
(12) As advised  by SEAC, the application of the restriction should be deferred generally for 
a period of three  years  and for longer periods in relation to specified sectors in order to 
enable s takeholders  to comply with the proposed restriction .  
(13) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(14) The measures provided for in this Regulation are in acco rdance 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  
                                                 
5 Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on 
persistent organic pollutants and amending Directive 79/117/EEC ( OJ L 158, 30.4.2004, p. 7 ).