EU Regulates PFOA and Related Substances under REACH
SAFEGUARDS | Consumer Products NO. 097/17
The EU has recently published measures to regulate PFOA, its salts and related substances in a wide range of products under Annex XVII of REACH. The new law will be implemented in phases, starting July 4, 2020.
In October 2016, we  informed you that the World Trade Organization (WTO) had circulated a proposal from the EU to regulate perfluorooctanoic acid (PFOA) and similar substances under REACH.
On June 14, 2017, the European Union (EU) published Regulation (EU) 2017/1000  to regulate PFOA (CAS 335-67-1), its salts and certain related substances as a completely new entry 68 to Annex XVII of REACH.
The new measures provide a number of exemptions, including the following:
- Articles placed on the market before July 4, 2020
- By-products from manufacturing substances
- Applications in photo-lithography processes for semi-conductors or etching processes for compound semiconductors.
- Applications in photographic coatings for films, paper or printing plates
- Manufacture of implantable medical devices (Directive 93/42/EEC )
- Perfluorooctane sulfonic acid (PFOS) and its derivatives under Part A of Annex I to Regulation (EC) 850/2004 on persistent organic pollutants (POPs )
PFOA has been classified as reprotoxic (toxic to reproduction) category 1B and carcinogenic category 2 in Regulation (EC) 1272/2008 on the classification, labelling and packaging of substances and mixtures, the so-called ‘CLP Regulation ’ & persistent, bioaccumulative and toxic (PBT). It has been on the Candidate List of Substances of Very High Concern (SVHCs) since June 2013 .
PFOA, its salts and related substances have a wide variety of applications, such as in the manufacture of fluoropolymers and fluoroelastomers, as surfactants in fire-fighting foams, and in the production of textiles and paper with anti-water, grease, oil and/or dirt properties.
The provisions in the new law will be implemented in phases starting July 4, 2020.
Highlights of certain provisions in new entry 68 to Annex XVII of REACH are summarized in Table 1.
|Regulation (EU) 2017/1000 amending Annex XVII of REACH
July 4, 2020
July 4, 2022 for:
July 4, 2023 for:
July 4, 2032 for medical devices other than implantable medical devices
|Constituent of another substance||
*The following substances are excluded from this designation:
According to the opinion of the Committee for Risk Assessment (RAC ) dated September 8, 2015, the excluded substances above are considered to contain a molecular structure that is expected to prevent transformation to PFOA.
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