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 as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms 
in the chain (C9 -C14 PFCAs), their salts and related substances  
(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 as regards perfluorocarboxylic acids containing 9 to 14 carbon atoms 
in the chain (C9 -C14 PFCAs), their salts and related 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 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency  (ECHA) , 
amending Direct ive 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) Linear and branched perfluorocarboxylic acids containing 9 to 14 carbon atoms in the 
chain (‘C9 -C14 PFCAs’), their salts and related substances2 currently mainly occur in 
the Union  as unavoidable by -products during the manufacture  of per fluorinated  and 
polyfluorinated substances containing a carbon chain of less than nine carbon atoms , 
such as perfluorooctanoic acid (PFOA) . Furthermore, it is possible that companies 
may consider the use of C9 -C14 PFCAs, their salts and related substances as 
substitutes for PFOA, its salts and related substances in the future, especially after the 
Union Law restrictions on PFOA become applicable. Thus, it is necessary to prevent 
future possible manufacturing and use resulting in increasing releases into the  
environment.  
(2) On 17 December 2015  and 12 January 2017, respectively , two groups  of C9-C14 
PFCAs , namely perfluorononan -1-oic acid (‘ PFNA ’) containing 9 carbon atoms in the 
chain , as well as  its sodium and ammonium salts , and nonadecafluorodecanoic acid  
(‘PFDA ’) containing 10 carbon atoms in the chain , as well as  its sodium and 
ammonium salts , were included in the Candidate List of Substances of Very High 
Concern ( ‘SVHC ’) to be potentially included  in Annex XIV to Regulation (EC) No 
1907/2006, as toxic for r eproduction in accordance with Article 57( c) of that 
Regulation , and persistent, bioaccumulative and toxic  (‘PBT’ ) substances, in 
accordance with Article 57(d) of that Regulation . Moreover, PFNA and PFDA, as well 
as their sodium and ammonium salts, are listed in Part 3 of Annex VI to Regulation 
                                                 
1 OJ L 396, 30.12.2006, p 1 . 
2 C9-C14 PFCA -related substances are substances that, based on their molecular structure are considered 
to have the potential to degrade or be transformed to C9 -C14 PFCAs.  EN 2  EN (EC) No 1272/2008 of the European Parliament and of the Council3 as carcinogenic, 
category 2  and toxic to reproduction, category 1B . On 19 D ecember 2012, 
henicosafluoroundecanoic acid (‘ PFUnDA ’) containing 11 carbon atoms in the chain , 
tricosafluorododecanoic acid  (‘PFDoDA ’) containing 12 carbon atoms in the chain , 
pentacosafluorotridecanoic acid  (‘PFTrDA ’) containing 13 carbon atoms in the ch ain 
and heptacosafluorotetradecanoic acid  (‘PFTDA ’) containing 14 carbon atoms in the 
chain  were included in th e Candidate List of SVHC , as very persistent and very 
bioaccumulative (‘vPvB’ ) substances , in accordance with Article 57(e) of Regulation 
(EC) No  1907/2006. C9-C14 PFCA -related substances are also to be regarded as PBT  
or vPvB substances , respectively,  due to their transformation  or degradation in the 
environment to C9 -C14 PFCAs.  
(3) On 6 October 2017 , Germany and Sweden  submitted to the European Chemicals 
Agency (‘the Agency’ ), a dossier4 pursuant to Article 69(4) of Regulation (EC) No 
1907/2006 (‘the Annex XV dossier ’) proposing to restrict the manufacture  and placing 
on the market of C9 -C14 PFCAs, thei r salts and C9-C14 PFCA -related substances  on 
their own, and to restrict their use in the production of, and placing on the market in, 
other substances as a constituent, mixtures and articles or parts thereof. I n order to 
reduce the release of th ose substances into the environment and to prevent them from 
being  manufactur ed, placed on the market and use d as substitutes for the  substances 
restricted by  entry 68 of Annex XVII to Regulation (EC) No 1907/20065, Germany 
and Sweden proposed a concentration limit of 25 ppb for the sum of C9 -C14 PFCAs 
and th eir salts and 260 ppb for the sum of C9 -C14 PFCA -related substances . 
Exem ptions were proposed by Germany and Sweden  for C9 -C14 PFCAs, their salts 
and C9-C14 PFCA -related substances when they occur as unintended by -products 
during the manufacturing of fluor ochemicals with a perfluoro carbon chain  equal to or 
shorter than eight  atoms or for use as   transported isolated intermediate s. 
(4) On 14 September 2018, 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 restriction on manufacture, use and 
placing on the market of C9 -C14 PFCAs, their salts and related substances, is the most 
appropriate Union -wide measure to address the identif ied risks in terms of 
effectiveness in reducing those risks. RAC agreed with the concentration limits  as 
proposed by Germany and Sweden . RAC agreed with the exemptions  proposed by 
Germany and Sweden  as the proposed restriction is not intended  to prevent t he 
manufacture of the fluorochemicals  with six or less  carbon atoms in the molecular 
chain .  RAC recommended exempting  for a limited period the use in the production  of 
pressurised metered -dose inhalers that are critical for the treatment  of lung diseases  
because of the low volumes in the order of few grams involved and the important 
medical use . RAC expressed the opinion  to grant a time -limited exemption for 
semiconductors that contain low levels of C9 -C14 PFCAs and for semi -finished and 
                                                 
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 , amending and repealing Directive s 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006   (OJ L 353, 31.12.2008, 
p.1). 
4 https://www.echa.europa.eu/documents/10162/2ec5dfdd -0e63 -0b49 -d756 -4dc1bae7ec61   
5 Commission Regulation (EU) 2017/1 000 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 related 
substances (OJ L 130, 14.6.2017, p. 14 ).  EN 3  EN finished electronic equipment containing specialty semiconductors to be used as 
replacement parts for finished electronic equipment.  
(5) Furthermore, RAC recommended to apply to the restriction of C9-C14 PFCAs, their 
salts and related substances the same exem ptions which apply to the PFOA restriction  
in entry 68 to Annex XVII of Regulation (EC) No 1907/2006 . 
(6) On 29  November 2018, the Agency’s Committee for Socio -Economic Analysis 
(‘SEAC’) adopted its opinion, indicating that the restriction proposed in the Anne x 
XV dossier, as modified by RAC and SEAC,  is the most appropriate Union -wide 
measure to address the identified risks in terms of its socio -economic benefits and 
socio -economic costs.  
(7) Based on the socio -economic elements provided in the Annex XV dossier a nd 
submitted during the public consultations, SEAC agreed with the exemptions pro posed 
in the Annex XV dossier  and recommended by RAC. SEAC concurred with the 
proposed eighteen -month  deferral of the restriction.  In addition, SEA C suggested 
higher limit value s for fluoropolymers  that contain perfluoropropoxy -groups or 
perfluoromethoxy -groups and are used in specific product gr oups in order to allow 
their production. Nonetheless, t he generic threshold  of 25 ppb remains  appli cable  to 
the final articles manu factured from th ose materials.  
(8) The Agency’s Forum for Exchange of Information on Enforcement, referred to in 
Article 76(1)(f) of Regulation No 1907/2006 , was consulted during the restriction 
process and its opinion has been taken into account.  
(9) On 16 Janu ary 2019, the Agency submitted the opinions of the RAC and SEAC6 to the 
Commission.  
(10) Regulation  (EU) 2019/1021 of the European Parliament and of the Council7 was 
amended in accordance with the decision adopted by the Conference of the Parties 
(SC-9/12) of t he Stockholm Convention on Persistent Organic Pollutants  for PFOA8 
which contains some but not all derogations included in entry 68 of Annex XVII of 
Regulation (EC) No 1907/2006. Entry 68 of that Annex should  effectively be replaced 
by the above mentioned amendment of the Regulation (EU) 2019/1021.  The 
exemptions which apply to the use of PFOA , its salts and PFOA -related compounds in 
the amendment of the Regulation (EU) 2019/1021 should also apply to C9-C14 
PFCAs and related substances under the same conditions because of the 
manufacturing process of fluorochemicals in which both group of substances are 
present as impurities.  
(11) The Commission received t wo addi tional requests for exemptions to allow the  
fluoropolymers and fluoroelastomers production as well as the production of PTFE 
micro powders and use in mixtures and articles for industrial and professional 
applications. The Comm ission asked  ECHA for a supplementary opinion as the final 
products are u sed in high value applications9. [To be adapted in light of the opinion of 
RAC and SEAC as requested in a letter to ECHA , additional place holder s in the 
Annex  for derogations granted by RAC/SEAC supplementary opinion .]  
                                                 
6 https://echa.e uropa.eu/documents/10162/13641/rest_pfcas_compiled_racseac_opi_en.pdf/b06db225 -
3995 -13fd-d89a -a9b73ef6bfc2   
7 OJ L 1 88I, 15.6.2020, p. 1.  
8 http://www.pops.int/TheConvention/ConferenceoftheParties/Meetings/COP9/tabid/7521/Default.aspx   
9 https://echa.europa.eu/documents/10162/034d97c3 -7975 -19f5-3739 -76c288ad2b0c  EN 4  EN (12) Taking into account the Annex XV do ssier, the opinions of RAC and SEAC , the 
Commission considers that an unacceptable risk to human health and the environment 
arises from the manufacture, use or placing on the market of linear and/or branched 
C9-C14 PFCAs, their salts and related substances  on their own, as a constituent of 
other substances, in mixtures and in articles , which  need s to be addressed on a Union -
wide basis . The Commission considers that the proposed restriction, as amended by 
RAC and SEAC, taking into account its socio -economic impact and availability of 
alternatives  as well as  the alignment of some of the exemptions  in this restriction to 
the exemptions in  the amendment of Regulation (EU) 2019/1021 is an appropriate 
Union -wide measure to address the identified risk.   
(13) Stakeholder s should be allowed sufficient time to take appropriate measures to comply 
with the restriction. Therefore, taking into account the suggestion from the Annex XV 
dossier as  well as  RAC’s and SEAC’s considerations, the application of the restriction 
should b e deferred for 18 months . Longer deferral s or overall exemptions  should apply 
to addres s the particular cases of specific sectors.  
(14) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(15) The measures provided for in this Regulation are in ac cordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006 ,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Article 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 Bru ssels,  
 For the Commission  
 The President  
 Ursula von der Leyen