Since July 4, 2020 the manufacture, marketing and use of perfluorooctanoic acid (“PFOA”), its salts and PFOA-related compounds (collectively, “PFOAs”), and products containing them, is significantly restricted in the European Economic Area (“EU/EEA”). The restrictions were introduced by a Commission Delegated Regulation amending Annex I to the EU POPs Regulation, and are intended to implement a decision of the ninth meeting of the Conference of the Parties to the Stockholm Convention that was held from April 29 to May 10, 2019.
The new PFOA restrictions will have significant impact on a wide variety of products marketed, and businesses operating, in the EU/EEA, including semiconductors, textiles, firefighting products, pharmaceuticals, medical devices, and materials used in the life sciences industry. In effect, the new restrictions implementing the Stockholm Convention are significantly broader than the restrictions on PFOAs that were introduced under the EU REACH Regulation in 2017, and which the Commission now intends to repeal.
The new restrictions prohibit the manufacturing, placing on the market and use of PFOAs on their own, in mixtures, or in articles (i.e., objects). The restrictions only allow the unintended presence of trace contaminants up to the following thresholds:
- (i) 0,025 mg/kg for PFOA or any of its salts;
- (ii) 1 mg/kg for individual PFOA-related compounds or combination of PFOA-related compounds;
- (iii) 20 mg/kg for PFOA-related compounds where they are present in a substance to be used as a transported isolated intermediate and fulfilling the strictly controlled conditions for the product of a carbon chain equal to or shorter than six atoms; and
- (iv) 1 mg/kg for PFOA and its salts where they are present in polytetrafluorethylene (“PTFE”) micropowders produced by ionising irradiation of up to 400 kilograys or by thermal degradation as well as in mixtures in articles for industrial and professional uses containing PTFE micropowders.
These new restrictions will affect a significant variety of products, and many manufacturers may have to modify their composition or manufacturing processes, depending on their specific product formulas. In particular, products containing PTFE, which is widely used in domestic and commercial applications, may be affected, including cookware, wiper blades, fabric and carpet protection, electrical insulation, lubricants, piping systems, laboratory containers, and medical devices.
Unlike the prior PFOA restrictions under the REACH Regulation, the new restrictions only provide for a reduced number of exemptions that are also time limited. The restrictions exempt:
- (i) photolithography or etch processes in semiconductor manufacturing until July 2025;
- (ii) photographic coatings applied to films until July 2025;
- (iii) textiles for oil- and water-repellency for the protection of workers until July 2023;
- (iv) invasive and implantable medical devices until July 2025;
- (v) until July 2023, the manufacture of PTFE and PVDF for the production of high performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles, industrial waste heat exchanger equipment and industrial sealants;
- (vi) different types of fire-fighting foam products until July 2025 at the latest; and
- (vii) the use of perfluoroctyl bromide containing perfluoroctyl iodide to manufacture pharmaceutical products until December 2036 at the latest.
- (viii) The restrictions also exempt medical devices other than implantable medical devices, latex printing inks and plasma nano-coatings, but only until December 2020.
It is noteworthy that, while some of these exemptions cover manufacture, marketing and use of the PFOAs in the specified products, others only cover use.
The Commission is also considering introducing an amendment to the restrictions that would provide some additional flexibility for non-invasive and non-implantable medical devices. In particular, the amendment would exempt concentrations of PFOAs in concentrations of not more than 2 mg/kg where they are present in non-invasive and non-implantable medical devices. The amendment is intended to address the possible presence of impurities of PFOAs in short-chain PFAS alternatives used in the production of medical devices.
Are Articles in Use Before July 4, 2020 Covered?
The new restrictions also exempt the “use of articles already in use” in the EU/EEA before July 4, 2020. Moreover, the second subparagraph of Article 4(2) of the EU POPs Regulation provides an additional exemption as it states that the restrictions on the manufacture, placing on the market and use of the Regulation “shall not apply in the case of a [PFOA] present in articles already in use before or on the date” (emphasis added) the restrictions entered into force (i.e., July 4, 2020).
A Commission Note on the Implementation of Article 4(2) of the POPs Regulation confirms that the exemption of the second subparagraph of Article 4(2) of the POPs Regulation exempts from the manufacture, marketing and use restrictions articles that were produced and also used in the EU/EEA by July 4, 2020. In effect, this should not be otherwise as Article 2(6) of the POPs Regulation states that the term “use” must be defined in accordance with Article 3(24) of the REACH Regulation. That Article defines “use” as “any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation” (emphasis added).
Thus, articles that contain PFOAs will be exempted from the restrictions if their manufacturer can prove that they were produced and stored or subject to any other utilisation before July 4, 2020. Companies wishing to benefit from this exemption should have documentation readily available and at the disposal of enforcement authorities proving that the articles were in use before July 4, 2020.
The recent case law of the Court of Justice on the concept of an “article” under the REACH Regulation (and EU POPs Regulation) also means that, in practice, articles produced and used before July 4, 2020 may be used to produce complex objects after that date. This exemption would only apply as long as the exempted article is used to manufacture a complex object, and such production process does not alter the shape, surface or design of the exempted article. In other words, the exempted article should become a component of the newly produced complex object without losing its shape, surface or design.
In practice, this exclusion for articles already produced and used will only provide economic operators with some additional time to use up stocks of articles that are already present in the different stages of the supply chain.