The application of PFAS legislation

Investigating the restrictions on per-and polyfluoroalkyl substances within Europe.

Per-and polyfluoroalkyl substances (PFAS) are molecules that contain at least one fully fluorinated carbon atom. This is a very broad definition and, as such, there are thousands of substances in the PFAS ‘family’. This diversity, and the chemical properties common to PFAS, make them very useful for a wide range of applications, including non-stick coatings, waterproof and stain-resistant treatments, and protective workwear.

However, there are growing concerns about the use of PFAS in these industries. PFAS are highly resistant to degradation, and persist for a long period of time within the environment. Several PFAS are known to be harmful to humans, and scientists do not yet fully understand the potential effects that continued exposure could have upon human health or our planet. This pollution is a global issue, and many nations have now imposed legislation aimed at limiting the release of PFAS in an attempt to address this.

PFAS restrictions within Europe

In Europe, there are restrictions upon the use of PFAS within both REACH Regulation (EC) 1907/2006 and the Persistent Organic Pollutants Regulation (EU) 2019/1021 (POPs). REACH Annex XVII entry 68 imposes restrictions upon a group of substances within the PFAS family, specifically C9 to C14 perfluorocarboxylic acids (PFCAs).

This restriction came into force in February 2023, and it prohibits the placing on the market of these substances on their own, or as constituents of substances, mixtures or consumer articles above certain concentrations. The restrictions in the UK version of REACH are slightly different. These place limits upon a specific PFAS chemical – perfluorooctanoic acid (PFOA) – as well as its salts and related substances. The specific restrictions for PFAS in the EU and UK are summarised in table 1.

Table 1: Requirements for these substances
Legislation	PFAS chemicals	Permitted amount
REACH Annex XVII entry 68	C9 to C14 – PFCAs and PFCA-related substances	< 25 parts per billion (ppb) sum of C9 to C14 PFCAs and their salts < 260 ppb sum of C9 to C14 PFCA-related substances
UK REACH Annex XVII entry 68	Perfluorooctanoic acid (PFOA)	< 25 ppb of PFOA and its salts < 1,000 ppb of PFOA-related substances
Persistent Organic Pollutants Regulation	Perfluorooctanoic acid (PFOA)	< 25 ppb of PFOA and its salts < 1,000 ppb of PFOA-related substances
	Perfluorooctane sulfonate (PFOS)	< 1 mg/m2 in coated textiles < 1,000 ppb in all other articles
	Perfluorohexane-1-sulphonic acid (PFHxS)	< 25 ppb of PFHxS and its salts < 1,000 ppb of PFHxS-related substances

In addition to REACH and UK REACH, companies operating within Europe will also need to be aware of the restrictions on PFAS under the Persistent Organic Pollutants Regulation (EU) 2019/1021 (POPs). These are global restrictions implemented under the Stockholm Convention, and all nations which have signed the treaty have the responsibility to enforce compliance. The POPs Regulation imposes restrictions upon three specific PFAS chemicals: perfluorooctanoic acid (PFOA), perfluorooctane sulfonate (PFOS), and perfluorohexane-1-sulphonic acid (PFHxS).

These pose a particular concern to human health, as PFOA and PFOS are suspected carcinogens and have been shown to affect the endocrine system. This means that they can be detrimental to reproduction, and PFHxS has adverse effects upon the nervous system. The requirements for these substances are summarised in table 1.

Companies must ensure they are compliant with the restrictions of REACH, UK REACH and POPs in order to fulfil their legal obligations. These restrictions apply to all types of material which may be used within protective gloves, including textiles, plastics and rubbers. Products to which a water-resistant or stain-resistant treatment has been applied should be considered as an especially high-risk, but PFAS can also be used in manufacturing processes or be introduced as contaminants.

Future PFAS restrictions

With growing concern over the impact that consumerism is having upon the future of our planet, and studies demonstrating the persistence and accumulation of PFAS chemicals within the environment, there is growing pressure upon regulatory bodies to act.

Although regulations such as REACH and POPs impose restrictions upon the use of certain PFAS to limit their release, there is concern that the existing requirements will not be sufficient to reduce the impact caused by these substances. This has led to several recent proposals to impose more stringent restrictions upon the supply and use of PFAS chemicals.

In February 2024, EU member states approved a proposal to introduce restrictions on undecafluorohexanoic acid (PFHxA) under REACH Annex XVII. This restriction is currently being drafted by the European Chemicals Agency (ECHA), and will be reviewed by European Parliament before being adopted.

There has also been a proposal by five EU member states to expand the scope of the current restrictions within entry 68 of REACH Annex XVII to apply to all substances containing a fully fluorinated carbon atom. This would prohibit the use of all PFAS. Such action is intended to avoid ‘regrettable substitutions’ of alternative PFAS chemicals that are allegedly less harmful, but which could still have detrimental effects on the environment.

This proposal is currently under review, and the details of the restrictions it will introduce if approved are not yet known. However, it seems likely that we can expect to see further restrictions on PFAS being implemented in the near future. For this reason, it is recommended that companies are aware of the use of PFAS within their production processes, and consider the impact that such restrictions may have. SATRA can assist by advising on the legislation and requirements with which companies should comply, and by arranging for testing for the presence of PFAS within consumer goods.

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