EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) 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 undecafluorohexanoic acid (PFHxA), its salts and PFHxA -
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 undecafluorohexanoic acid (PFHxA), its salts and PFHxA -
related substances  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functi oning 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,  
Whereas:  
(1) Undecafluorohexanoic acid (PFHxA), its salts  and PFHxA -related substances2 have a 
combination of hazardous properties. PFHx A by far exceeds  the ‘very persistent’ 
criterion set out in point 1.2.1 of  Annex XIII to Regulation (EC) No 1907/2006 , is 
mobile in the aquatic environment and ha s potential adverse effects on human health 
and the environment. PFHxA itself is not registered or used in the U nion. Several 
PFHxA -related substances as well as the ammonium salt of PFHxA  are registered in 
the Union with tonnage bands from 1 to more than 100 tonnes per annum. PFHxA -
related substances and the ammonium salt of PFHxA are widely used in many sectors, 
with large quantities used in paper and cardboard  for use  as food contact materials, in 
textiles and in firefighting foams. The continued use of PFHxA  salts and PFHxA -
related substances in wide  dispersive uses will lead to an increasing environmental 
stock and further environmental and human exposure.  
(2) On 20 Dec ember 2019 , Germany 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 , use  and placing on the 
market of PFHxA , its salts and PFHxA -related substances  on their own, and to restrict 
their use in the production of  and placing on the market in another substance, as a 
constituent, in a mixture or in an article  or the ir use in another substance, in a mixture 
                                                 
1 OJ L 396, 30.12.2006, p  1. 
2 PFHxA -related substances are substances that, based on their molecular structure, are considered to 
have the potential to degrade or be transform ed to PFHxA . A non -exhaustive list of substances 
belonging to the scope of the restriction proposal is av ailable on the website of the European Chemicals 
Agency: https://echa.europa.eu/documents/10162/7da473c1 -7f27-df34-9e6a -46152ef10d4b   
3 https://echa.europa.eu/documents/10162/c4e04484 -c989 -733d -33ed -0f023e2a200e      
EN 2  EN or in an articl e, with a general transition period of 18 months . In order to address the 
risks to human health and the environment, Germany proposed concentration limit s of 
25 ppb for the sum of PFHxA and its salts , and 1000 ppb for the sum of PFHxA -
related substances.  
(3) In addition, both t ime-limited and non -time-limited derogations were proposed by 
Germany for certain  uses taking into account the socio -economic impact and the 
availability of alternatives. For the use of PFHxA, its salts and PFHxA -related 
substances in fi refighting foams, Germany proposed a reporting obligation for a 
natural or legal person benefitting from the proposed derogations.  
(4) On 3 June  2021, the Agency’s Committee for Risk Assessment ( ‘RAC ’) adopted its 
opinion concluding that  it has not been demonstrated that the restriction on PFHxA, its 
salts and PFHxA -related substances as proposed by Germany is the most appropriate 
Union -wide measure to address the identified risk s. Nevertheless , RAC consider s that 
a broad Union-wide restriction with carefully considered targeted derogations and 
transition periods is the most  appropriate Union -wide measure to address the identified 
risks in terms of effectiveness , practicality and monitorability .  
(5) RAC support ed the restriction  as proposed b y Germany  regarding the  uses where it is 
not possible to implement risk management measures to minimise emissions, 
especially wide  dispersive consumer uses in food contact materials, in textiles as well 
as in firefighting foams used for municipal firefight ing, which comprise three major 
emission sources. However, based on the limited information available on the 
conditions of use and the effectiveness of risk management measures, RAC could not 
conclude on whether certain other uses contribute to the identif ied risk s, such as 
chrome plating and firefighting foams used at industrial installations . For th ose other 
uses, the uncertainties around the current conditions of use and effectiveness of risk 
management measures are too large to conclude that the restriction as proposed by 
Germany  was the most effective risk management option.  
(6) Furthermore, RAC d id not support the justification for most of the derogations as 
proposed by Germany as there was insufficient information  available to conclude that 
releases from those uses were minimised. Howev er, in the event that a restriction 
would be imposed , RAC support ed derogations for the following uses as credible 
information on the minimisation of releases from those uses was ava ilable:  
semiconductors and semiconductor related equipment , epilame in watches , coating for 
hearing devices , implantable medical devices  and transported isolated intermediates.  
(7) RAC agreed with the concentration limits and general transition period as propo sed by 
Germany. RAC also note d that standard analytical methods for the substances and 
matrices within the scope of restriction  as proposed by Germany  are required to be 
developed. However, RAC conclude d that, in general, analytical methods are 
commerciall y available to monitor exposures and the implementation of the restriction  
as proposed by Germany . 
(8) On 8 December 2021 , the Agency’s Committee for Socio -Economic Analys is 
(‘SEAC’) adopted its opinion  concluding that it has not been demonstrated that the 
restriction on PFHxA, its salts and PFHxA -related substances as proposed by 
Germany is the most appropriate Union -wide measure to address the identified risks , 
taking into account its socio -economic benefits and costs . SEAC consider ed that a 
restriction on  PFHxA, its salts and PFHxA -related substances is, in general, an 
appropriate measure to address the identified risks. However, based on the limited 
available information on socio -economic impacts and emission estimates, SEAC could  
EN 3  EN not conclude whether the  conditions of the restriction, as modified by SEAC, are , as a 
whole , the most appropriate measure s to address the identified risks. Nevertheless, 
SEAC concluded on the socio -economic benefits and costs of a restriction  for certain 
uses, where information on socio -economic impacts was less uncertain. SEAC took  
into account RAC ’s conclusions on effectiveness  of risk management measures  and 
the minimisation of emissions , the irreversibility of emissions of PFHxA to the 
environment,  the information available o n alternatives , the possible functional losses  
and socio -economic impacts . SEAC concluded that restricting the uses in consumer 
apparel textiles, firefighting foams in municipal and mobile firefighting, paper and 
cardboard as food contact materials and consumer mixtures is likely not an 
inappropriate  measure , in terms of its socio -economic benefits and its costs, to address 
the risk , and that restricting the use in cosmetic products  is likely an appropriate  
measure , in terms  of its socio -economic benefits and its costs, to address the risk . 
(9) SEAC d id not agree with the proposed general transition period of 18 months. SEAC 
consider ed that the transition period should be long enough to ensure that producers, 
importers and users of substances, mixtures and arti cles are able to comply with the 
restriction and adapt their operations to allow for the phasing -out and substitution of 
PFHxA, its salts and PFHxA -related substances and to allow for adaptations within the 
affected supply chains . Therefore , SEAC proposed a general transition period of 36 
months.  
(10) The Agency’s Forum for Exchange of Information on Enforcement, referred to in 
Article 76(1) , point (f), of Regulation  (EC)  No 1907/2006 , was consulted during the 
restriction process and its opinion has been taken into account.  SEAC note d the 
Forum’s opinion that the restriction  as proposed by Germany  can be regarded as 
enforceable, as long as it is clear which substances are in the scope  of the restriction 
and that reliable normative test methods are defined covering all types of regulated 
substances.  
(11) On 10 May 2022 , the Agency submitted the opinions of RAC and SEAC4 to the 
Commission.   
(12) Taking into account the Annex XV dossier and the opini ons of RAC and SEAC , the 
Commission considers that an unacceptable risk to human health and the environment 
arises from the use and placing on the market of PFHxA, its salts and PFHxA -related 
substances in certain mixtures and in certain articles , which  need s to be addressed on a 
Union -wide basis .  
(13) The Commission considers that it is not demonstrated that the proposed restriction, as 
modified  by RAC and SEAC, is the most appropriate Union -wide measure to address 
the identified risks, taking into account t hat the d ata presented on emissions , risk 
reduction and socio -economic impacts  are uncertain and important data are missing . 
RAC clearly indicate d that the reported quantitative release estimates are unreliable 
due to numerous inconsistencies between diffe rent sections of the Background 
Document  to the Opinion on the Annex XV dossier5, insufficient  justifications for the 
assumptions made and significant gaps in the information presented or in the reporting 
of the underlying calculation methodology for the d ifferent use sectors .  
                                                 
4 https://echa.europa .eu/documents/10162/97eb5263 -90be -ede5 -0dd9 -7d8c50865c7e   
5 https://echa.europa.eu/documents/10162/5c011606 -5891 -d26a -03e7 -ceba0a35126f    
EN 4  EN (14) Despite the existing uncertainties on the data available, the Commission concurs with 
RAC that r eleases to the environment and exposure to humans have been confirmed 
by a large set of environmental and human monitoring data , and that  the manufacture 
of PFHxA, its salts and PFHxA -related substances , and the uses of th ose substances 
that result in releases to the environment that are not adequately controlled , should be 
minimised . Instead of a broad  restriction, t he Commission considers  a targeted  
restriction as the most appropriate Union -wide measure to address the identified risks. 
The Commission considers that the restriction should be targeted to those uses for 
which RAC concluded that it is not possible to implement risk management measures 
to minimise emissions and SEAC concluded that restrictin g that specific use is likely 
appropriate or likely not inappropriate in terms of socio -economic benefits and costs . 
For th ose uses, the Commission considers that the risk is not adequately c ontrolled, 
alternatives are available and socio -economic costs are likely to be limited in 
comparison to the human health and environmental benefits.   
(15) Therefore, the Commission considers it necessary to adopt a Union -wide restriction 
for placing on the market or use of PFHxA, its salts and PFHxA -related substances in 
textiles , leather , furs and hides  in clothing  (such as  outdoor clothing  like rain jackets ); 
related accessories (such as handbags) and footwear for  the general public ; paper a nd 
cardboard used as food contact materials ; mixture s for the general public ; cosmetic 
products ; and some firefighting foams applications .  
(16) Although SEAC could not conclude on the magnitude of socio -economic costs in 
relation to the benefits  for textiles , leather , furs and hides  other than in clothing  and 
related accessories  for the general public , including upholstery , the Commission 
considers th at the use in those materials  should also be restricted because there are 
indications that considerable amounts of PFHxA -related substances might be used; it 
is a wide  dispersive use where  the risk is not adequately controlled ; emissions cannot 
be minimised by the application of risk management measures , as concluded by RAC ; 
and alternatives for water repellent prop erties appear to be available. For th ose product 
types, it has not been well established that the lack of oil and stain repellent properties 
would lead to functional losses with significant negative impacts . Given the possible 
socio -economic impact s relate d to functional losses where alternatives do not provide 
sufficient oil and stain repellence , a longer transition period for textiles other than in 
clothing  and related accessories  for the general public is considered to be justified.  
(17) On 14 January  2022, the Agency submitted on behalf of the Commission a dossier6 
pursuant to Article 69( 1) of Regulation (EC) No 1907/2006, proposing to restrict the 
manufacture, placing on the market and use of p er- and polyfluoroalkyl substances  
(PFAS) in firefighting  foams. PFHxA, its salts and PFHxA -related substances are in 
the scope of that restriction proposal. The Commission considers that a decision on 
restricting the use of PFHxA, its salts and PFHxA -related substances in most 
firefighting foams uses is more ap propriate ly reached  based on the restriction dossier 
for all PFAS in firefighting foams . However, given that alternatives are widely 
available and already in use for PFHxA, its salts and PFHxA -related in firefighting 
foams used for  training and  testing, fo r municipal fire services and for civil aviation , 
the Commission consider s that  restricting  those uses should not be delayed.  
(18) The Commission agrees with the concentration limits as proposed by Germany, RAC 
and SEAC.  
                                                 
6 https://echa.europa.eu/documents/10162/4524f49c -ae14 -b01b -71d2 -ac3fa916c4e9    
EN 5  EN (19) The Commission considers that a derogation for any substance having a perfluoroalkyl 
group C 6F13-directly attached to a sulphur  atom  (PFHxS, its salts and related 
substances) should be provided for , since th ose substances are restricted by  Regulation 
(EU) 2019/1021  of the European Parliament and of the Council7. 
(20) The Commission agrees with RAC and SEAC  that substances having a perfluoroalkyl 
group C 6F13- directly attached to an oxygen atom at one of the non -terminal carbons  
should  be excluded from the scope of substa nces subject to the restriction since  those 
substances cannot  be transformed into PFHxA. Their chemical structure is such that a 
degradation to a carboxylic acid or to a carboxylate would form two separate shorter 
fluoroalkyl chains, the hazards a nd risks  of which  were not assessed in the Annex XV 
dossier . 
(21) Stakeholders  should be allowed sufficient time to take appropriate measures to comply 
with the restriction. Therefore, taking into account the suggestion s from the Annex XV 
dossier , as well as  RAC’s and SEAC’s considerations, the application of the restriction 
should be deferred for 18 months for  firefighting foams used in training , testing and 
municipal fire services ; 24 months  for textiles, leather, furs and hides in clo thing and 
related accessories and footwear for  the general public , paper and cardboard used as 
food contact materials, mixtures for  general public and cosmetic products ; 36 months 
for textiles, leath er, furs and hides other than in clothing  and related accessori es for the 
general public ; and 5 years for firefighting foams used in civil aviation .  
(22) The restriction should not apply to articles placed on the market prior to the respective 
date of application of the restriction , for practicality and enforceability rea sons.  
(23) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(24) 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 RE GULATION:  
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.  
                                                 
7  Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 201 9 on 
persistent organic pollutants (OJ L 169, 25.6.2019, p. 45 ).  
EN 6  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen