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EU REACH restriction on PFOA published

June, 2017

On 14 June 2017, the European Union’s restriction on perfluorooctanoic acid (PFOA) (CAS no. 335-67-1), its salts and PFOA-related substances, was published in the Official Journal as Regulation (EU) No 2017/10001, amended the Annex XVII to REACH Regulation as a newly added entry – entry 68.

PFOA, its salts and PFOA-related substances have some specific properties, such as high friction resistance, dielectricality, resistance to heat and chemical agents, and low surface energy. These substances are used in many applications, such as special finishing to textiles and paper to give water, grease, oil and/or dirt repellency, as surfactants in fire-fighting foams. In 2013, PFOA was identified as a Substances of Very High Concern (SVHC) because of its persistence, bioaccumulative and toxic property (PBT), and was included in the Candidate List.

In 2014, Germany and Norway submitted a report, proposed to amend REACH Annex XVII to restrict the manufacturing, use and placing on the market of PFOA, its salts and PFOA-related substances. After 1st and 2nd public consultation, the European Chemicals Agency (ECHA) submitted the final opinions to the European Commission (EC) in January 2016. Based on the opinions, the EC concluded that an unacceptable risk to human health and the environment arises from the manufacture, use or placing on the market of PFOA, its salts and PFOA-related substances, and those risks need to be addressed in the EU. REACH Annex XVII should be amended accordingly.

Regarding the analytical method for PFOA and PFOA-related substances, currently, there is no standard method available for extraction and chemical analysis of those substances. CEN/TS 15968:2010 which is available for the determination of extractable perfluorooctane sulfonic acid and its derivatives (PFOS), most likely can be adjusted to also include PFOA and PFOA-related substances with the relevant detection limit. And the suitable analytical methods may be further developed during the deferral period of the restriction.

The new restriction will apply from 4 July 2020, and some specific items can enjoy longer transition periods.

Table A (below). Entry 68 - Restriction on PFOA, its salts and PFOA-related substances

Scope of restriction Substances, mixtures and articles
Limits

Substances: Not used (Not detected)
As constituents of other substances, as a component of mixtures, articles:

  • PFOA or its salts: < 25 ppb;
  • One or a combination of PFOA-related substances: < 1000 ppb
Exemptions

Substances and mixtures

  • Perfluorooctane sulfonic acid and its derivatives (PFOS) covered by the Regulation (EC) No 850/2004;
  • The manufacture of a substance where this occurs as an unavoidable by-product of the manufacture of fluorochemicals with a carbon chain equal to or shorter than 6 atoms;
  • Substances used as transported isolated intermediates where the conditions in Article 18(4) of REACH Regulation are met;
  • Substances and mixtures used in
    • the production of implantable medical devices within the scope of Directive 93/42/EEC;
    • photographic coatings applied to films, papers or printing plates
    • semiconductor photo-lithography processes or etching processes for compound semiconductors;
  • Concentrated fire-fighting foam mixtures that were placed on the market before 4 July 2020 and are used in the production of other fire-fighting foam mixtures.

Articles

  • Perfluorooctane sulfonic acid and its derivatives (PFOS) covered by the Regulation (EC) No 850/2004;
  • Articles placed on the market before 4 July 2020;
  • Implantable medical devices as defined by Council Directive 93/42/EEC;
  • Articles coated with photographic coatings;
  • Semiconductors or compound semiconductors.
Application date
  • 4 July 2020: Substances, mixtures and articles except the below applications
  • 4 July 2022:
    • Equipment used to manufacture semi-conductors;
    • Latex printing inks.
  • 4 July 2023:
    • Textiles for the protection of workers;
    • Membranes intended for use in medical textiles, filtration in water treatment, production processes and effluent treatment;
    • Plasma nano-coatings.
  • 4 July 2032: medical devices other than implantable medical devices within the scope of Directive 93/42/EC

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