G/TBT/N/EU/411  
 
6 October 2016  
(16-5339) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
  NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member : EUROPEAN UNION   
If applicable, name of local government involved  (Article 3.2 and 7.2) :   
2. Agency responsible:  European Commission  
Name and  address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification  shall be indicated if different from above :  
European Commission  
EU-TBT Enquiry Point  
Fax: +(32) 2 299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/  
3. Notified under Article 2.9. 2 [X], 2.10.1 [  ], 5.6.2 [X], 5.7.1 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. 
ICS numbers may be provided in addition, where applicable):  Perfluorooctanoic acid 
(PFOA), its salts and PFOA -related sub stances as a substance on its own and as a constituent 
of other substances, in mixtures, or in articles or any part thereof, in a concentration equal 
to or greater than 25ppb of PFOA or 1000 ppb of one or a combination of related substances.  
5. Title, num ber of pages  and language(s)  of the notified document:  Draft Commission 
Regulation 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 C hemicals (REACH) as regards perfluorooctanoic acid (PFOA), its salts and 
PFOA-related substances (4 pages + Annex 4 pages, in English).     
6. Description of content:  This draft Regulation relates to a new entry in Annex XVII to 
Regulation (EC) No 1907/20 06. 
It would restrict the manufacturing, the use and placing on the market of perfluorooctanoic 
acid (PFOA), its salts and PFOA -related substances  as a substance on its own and as a 
constituent of other substances, in mixtures, or in articles or any part t hereof, in a 
concentration equal to or greater than 25ppb of PFOA or 1000 ppb of one or a combination 
of related substances.  
Exemptions are proposed for several applications as included in the Annex, paragraphs 4 
to 7.  
Application of the restriction is de ferred for 36 months to allow industry sufficient time to 
adapt and achieve compliance. Specific deferred dates are provided for the exemptions 
listed in the Annex.     G/TBT/N/EU/411  
 
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  7. Objective and rationale , including the nature of urgent problems where applicable: 
to address the risks to human health and the environment from the manufacture, placing 
on the market and use of PFOA, its salts and PFOA -related substances which may degrade 
to PFOA. The restriction proposal is based on the PBT (persistent, bioaccumulative and 
toxic substance) properties of PFOA. No relevant quantitative environmental risk 
assessment can as such be conducted for PBT substances (REACH Guidance R.11.1 
page 10, version 2.0, 2014), so the overall intention is to minimise emissions. Any 
environme ntal exposure has the potential to give rise to risks (including indirect risks to 
the general public because of potential long -term effects on the food chain).  
Human biomonitoring data can to some extent be used as a proxy for emissions, as 
indirect expos ure via food and drinking water is an important source of PFOA for humans 
(beside direct exposure via specific articles or uses).   
8. Relevant documents:   
  Regulation (EC) No 1907/2006 of the European Parliament and of the Council on 
the Registration, Eva luation, Authorisation and Restriction of Chemicals (REACH 
Regulation):  http://eur -lex.europa.eu/legal -
content/EN/TXT/?qid=1423064258789&uri=CELEX:32006R19 07 
 The opinions of the Committees for Risk Assessment (RAC) and Socio -economic 
Analysis (SEAC):  https://echa.europa.eu/documents/10162/2f0dfce0 -3dcf-4398-
8d6b-2e59c 86446be   
 Further background information is available 
at: https://echa.europa.eu/documents/10162/61e81035 -e0c5-44f5-94c5-
2f53554255a8  
 REACH Guidance: 
https://echa.europa.eu/documents/10162/13632/information_requirements_r11_e
n.pdf  
9. Proposed date of adoption: First half of 2017  
Proposed date of entry into force: 20 days from publication in the Official Journal of the 
EU 
10. Final date for comments:  60 days from notification  
11. Texts available from : National enquiry point  [ ] or address, telephone and fax 
number s and e mail and website address es, if available , of other body:   
European Commission  
EU-TBT Enquiry Point  
Fax: + (32) 2  299 80 43  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the Website: http://ec.europa.eu/growth/tools -databases/tbt/  
https://members.wto.org/crnattachments/2016/TBT/EEC/16_4205_01_e.pdf  
https://members.wto.org/crnattac hments/2016/TBT/EEC/16_4205_00_e.pdf