EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) XXX  draft  
ANNEX 1  
  
ANNEX  
 
to the  
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    
 ANNEX  
In Annex XVII to Regulation (EC) No 1907/2006, the following entry is added:  
“68. Perfluorooctanoic acid (PFOA ) 
CAS  No 335-67-1 
EC No 206-397-9  
and its salts.  
 
Any related substance (including its salts 
and polymers) having a linear or 
branched  perfluoroheptyl group with the 
formula  C7F15- directly attached to 
another carbon atom, as one of the 
structural  elements . 
 
Any related substance (including its salts 
and polymers) having a linear or 
branched  perfluorooctyl group with the 
formula C 8F17- as one of the structural 
elements . 
 
 
The following substances are ex cluded 
from this designat ion: 
 C8F17-X, where X= F, Cl, Br.  
 C8F17-C(=O)O -X' or C 8F17-CF2-
X' (where X'=any group, 
including salts).  
______________________________  
 
 
 
 
 
 
 
 
 
 
 1. Shall not  be manufactured , or placed on the 
market as substance s on their own from [ date – 
3 years after date of entry into force  of this 
Regulation ]. 
 
2. Shall not, from [date – 3 years after date of 
entry into force of this Regulation ], be used in 
the production of, or p laced on the market  in: 
(a) another substance, as a  constituent ; 
(b) a mixture ;   
(c) an article , or any part thereof  
in a concentration equal to or above 25 ppb of 
PFOA including  its salts  or 1000  ppb of one or a 
combination of  PFOA -related substances . 
 
3. Paragraph s 1 and 2 shall apply from : 
(a) [date - 5 years after entry into force  of 
this Regulation ] to:  
(i) equipment used to manufacture semi -
conductor s; 
(ii) latex printing inks . 
 
(b) [date – 6 years after entry into force  of 
this Regulation ] to: 
(i) textiles for the protection of workers  
that must meet  durable water 
repelle ncy (DWR) performance  
standards ; 
(ii) membranes intended for  use in  
medical textiles, filtration in water 
treatment, production processes and 
effluent treatment;  
(iii) plasma nano -coating s. 
 
(c) [date – 15 years after entry into force  of 
this Regulation ] to medical devices  other 
than implantable medical devices within 
the scope of Directive 93/42/EEC . 
 
4. Paragraph s 1 and 2 shall not apply to  any of 
the following : 
(a) perfluorooctane sulfonic acid and its 
derivatives, which are listed in Part A of 
Annex I to Regulation (EC) No 
850/2004;  
(b) the manufacture of a substance w here  
 this occurs as an unavoidable by -product 
of the manu facture of fluorochemicals 
with a carbon chain eq ual to or shorter 
than 6 atoms;  
(c) a substance that is to be used, or is used  
as a transported isolated intermediate, 
provided that the conditions in points (a) 
to (f) of Article 18(4)  of this Regulation  
are met ; 
(d) a substance, constituent of another 
substance or  mixture that is to be used, 
or is used :  
(i) in the production of implantable 
medical devices within the scope of 
Directive 93/42/EEC;   
(ii) in photogra phic coatings applied to 
films, papers or printing plates;  
(iii) in semiconductor photo -lithography 
processes or in etching processes for 
compound semiconductors ;  
(e) concent rated fire -fighting foam  mixture s 
that were placed on the market before  
[date – 3 years  after date of entry into 
force  of this Regulation ] and are to be 
used, or are used in the production of 
other fire -fighting foam  mixtures . 
 
5. Paragraph 2 (b) shall not apply to fire -
fighting foam mixtures  which were : 
(a) placed on the market before [ date – 3 
years after entry into force  of this 
Regulation ]; or 
(b) produced in accordance with paragraph 
4(e), 
provided that, where they are used for 
training purposes, emissions to the 
environment  are minimised and effluents 
collected are safely disposed of . 
 
6. Paragraph  2(c) shall not apply to :  
(a) articles placed on the market before  
[date – 3 years after date of entry into 
force  of this Regulation ]; 
(b) implantable medical devices produced 
in accordance with point (i) of 
paragraph 4(d); 
(c) articles coated with the photographic 
coatings referred to in point (ii) of 
paragraph 4(d); 
(d) compound semiconductors referred to  
 in point (iii) of paragraph 4(d).”