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EU Restricts PFOA and Related Substances under REACH



In it official journal on June 14, 2017, the European Commission (EU), has released measures to regulate Perfluorooctanoic acid (PFOA) with its salts and certain PFOA related substances. This newly published Regulation (EU) 2017/1000 amended the EU REACH Annex XVII by including a new entry 68 to it and will be applicable from July 4, 2020 though with certain exemptions.

PFOA, its salts and related substances have been recognized as been used in a variety of applications including the Fluoropolymer and Fluoroelastomer production for non-stick coatings in cookware, used in fire-fighting as surfactants, as well as used in textile and paper production. However, PFOA has since June, 2013, been on the Candidate List of Substances of Very High Concern (SVHCs).

The SVHC are often determined based on if the substance meets one or more of certain criteria such as

  • If substance is carcinogenic
  • If substance is mutagenic
  • If substance is toxic for reproduction
  • If substance persists or bioaccumulates or toxic

PFOA, its salts and other related substances have been identified as reprotoxic (toxic to reproduction), carcinogenic; and persistent, bioaccumulative and toxic (PBT) which had put it on an important position on the Candidate list.

Implementation of the new Regulation

The implementation of this new law for PFOA, its salts, and other PFOA-related substances will commence from July 4, 2020 and will happen in phases as shown below:

 

  • July4, 2020: for all applications except for those stated below
  • July 4, 2022: for equipments used in manufacturing semi-conductors; for Latex printing inks
  • July 4, 2023: for textiles providing safety for workers against health risks; for membranes used in medical textiles, filtration in water treatment; for plasma nano-coatings
  • July 4, 2032: for medical devices other than implantable medical devices found within the scope of Directive 93/42/EEC.

 

Exemptions to the regulation

 

However, there are some certain exemptions with Regulation (EU) 2017/1000 when it comes to the use of these substances and articles, which include:

  • Articles placed on the market before July 4, 2020
  • Photographic coatings applied to films, paper, or printing plates
  • Implantable medical devices that fall within the scope of Directive 93/42/EEC
  • Perfluorooctane sulfonic acid (PFOS) and its derivatives under Part A of Annex I to Regulation (EC) No 850/2004 on persistent organic pollutants (POPs)
  • Substances or mixtures being used in semi-conductor and photolithography processes
  • By-products from manufacturing substances
  • Manufacture of a substance where it is produced as an unavoidable by-product of the manufacture of fluorochemicals with a carbon chain equal to or shorter than 6 atoms