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SAFEGUARDS | Consumer Products NO. 097/17

SafeGuardS Scientist with laboratory background and concept

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 [1] 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 [2] 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 [3])
  • Perfluorooctane sulfonic acid (PFOS) and its derivatives under Part A of Annex I to Regulation (EC) 850/2004 on persistent organic pollutants (POPs [4])

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 [5]’ & persistent, bioaccumulative and toxic (PBT). It has been on the Candidate List of Substances of Very High Concern (SVHCs) since June 2013 [6].

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
Entry 68
Substance   Scope Requirement         Effective Date                                          
  • PFOA and its salts
  • PFOA-related substances with a perfluoroheptyl group (C7F15-) directly attached to another carbon atom or perfluorooctyl group (C8F17-)* as one of the structural elements
Substance Prohibited

July 4, 2020

July 4, 2022 for:

  • Equipment used to produce semi-conductors
  • Latex printing inks

July 4, 2023 for:

  • Textiles for worker protection
  • Membranes in medical textiles, filtration in water treatments, production processes and effluent treatments
  • Plasma nano-coatings

July 4, 2032 for medical devices other than implantable medical devices

Constituent of another substance
  • < 25 ppb (PFOA) or
  • < 1000 ppb (PFOA-related substances)
Mixture
Article

*The following substances are excluded from this designation:

  • C8F17-X where X = F, Cl or Br
  • C8F17-C(O)OH, C8F17-C(O)O-X’ or C8F17-CF2-X’ where X’ = any group, including salts

According to the opinion of the Committee for Risk Assessment (RAC [7]) dated September 8, 2015, the excluded substances above are considered to contain a molecular structure that is expected to prevent transformation to PFOA.

SGS will follow up and inform interested parties as developments on REACH regulation occur. Our expertise combined with consultancy services and experience in consumer product supply chains provides a central point of contact for global solutions. If you would like to learn more about how SGS can support your REACH compliance activities please visit www.sgs.com/reach

For enquiries, please contact:

Hingwo Tsang
Global Information and Innovation Manager
t: +852 2774 7420

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