Update to REACH legislation
Highlighting changes to fluorocarbon restrictions in REACH, which could affect manufacturers of certain products within the footwear industry.
Commission Regulation (EU) 2021/1297 was published on 4th August 2021, in order to amend REACH (EC) 1907/2006 Annex XVII entry 68. This amendment involved the addition and removal of multiple substances.
As a result of this amendment (and an amendment to the Persistent Organic Pollutants Regulation), the perflourinated substances perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) were removed from REACH (EC) 1907/2006 Annex XVII.
Several perfluorinated carboxylic acids (PFCAs) and PFCA-related substances had already been considered under REACH prior to this amendment, most significantly PFCAs with a chain of between 9 and 14 carbon atoms. Henicosafluoroundecanoic acid (PFUnDA), tricosafluorododecanoic acid (PFDoDA), pentacosafluorotridecanoic acid (PFTrDA) and heptacosafluorotetradecanoic acid (PFTDA) were included in the REACH Candidate List of Substances of Very High Concern (SVHC) as very persistent and very bio-accumulative (vPvB) in December 2012. In addition to this, perfluorononan-1-oic acid (PFNA) and nonadecafluorodecanoic acid (PFDA) were added to the SVHC list to indicate they are toxic for reproduction, and persistent, bio-accumulative and toxic (PBT) substances in December 2015 and January 2017 respectively.
Under Commission Regulation (EU) 2021/1297, any ‘C9’ to ‘C14’ PFCA-related substance must not be manufactured or placed on the market as substances from 25th February 2023.
In addition to this restriction, from 25th February 2023, any C9 to C14 PFCA-related substance cannot be used in or placed on the market in another substance, as a constituent, a mixture or articles. However, the use of PFCAs is allowed if the concentration in the substance, the mixture, or the article is below 25 parts per billion (ppb) for the sum of C9 to C14 PFCAs and their salts, or 260 ppb for the sum of C9 to C14 PFCA-related substances.
From 4th July 2023, the restriction of C9 to C14 PFCAs will be enforced in textiles for oil and water repellency for the protection of workers from dangerous liquids that comprise risks to their health and safety. This restriction will also apply to the manufacture of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF) for the production of high performance, corrosion-resistant gas filter membranes, water filter membranes and membranes for medical textiles, as well as industrial waste heat exchanger equipment and industrial sealants.
The restriction of C9 to C14 PFCAs, their salts and related substances has been derogated until 4th July 2025 for some specific applications, such as photolithography or etch processes in semiconductor manufacturing, invasive and implantable medical devices and firefighting foam.
The uses of fluorocarbon-based oligomers (which include PFCAs) documented in the ECHA Annex XV Restriction Report are in fluoropolymer production, textiles and apparel, carpets, carpet care products, cosmetics and as an additive in paints. The largest share of consumer uses was in textiles and apparel, and this accounted for approximately 50 per cent of the total use. Fluorocarbon-based polymers have been used as treatments to improve water resistance and stain resistance to textiles and leathers, hence their major use in footwear, textiles, apparel and carpet care products.
How can we help?
Please contact SATRA’s chemistry team (email@example.com) for assistance with restricted substances testing and legislation.
This article was originally published on page 16 of the March 2022 issue of SATRA Bulletin.