Per- and polyfluoroalkyl substances (PFAS) are often described as “forever chemicals” due to their persistence. Rising concern over detrimental health effects and accumulation in the environment has led to tightening PFAS restrictions over the years, culminating in a recent European Chemicals Agency (ECHA) proposal calling for a gradual ban of over 10,000 PFAS compounds in Europe.1
While the full PFAS ban is unlikely to pass in the near future due to industry pressure2, existing regulations limit the presence of selected PFAS compounds in various products and materials, including food, drinking water, and consumer products. PFAS testing of water, fish, and other environmental samples will also remain important due to the compounds' persistence.
This article contains an overview of European PFAS regulations that apply to different product groups, along with recommendations for compliance testing. Do not hesitate to contact us if you need testing to ensure your product's or material's compliance with any of the discussed legislation.
Table of contents
What are PFAS?
PFAS are man-made organic compounds that have been used in consumer products since the 1940s due to their effectiveness in repelling water, dirt, and grease. Some common PFAS-containing products include non-stick frying pans, firefighting foams, water-proof textiles, and paper and board food packaging with grease-resistant coatings.
Due to their chemical structure, PFAS degrade very slowly. This leads to their accumulation in nature due to industrial waste and the degradation of consumer products. Humans get exposed to PFAS mainly through food and drinking water, although exposure can also occur through the air and using products containing the chemicals.
What are the health effects?
The impacts of PFAS on human health have been increasingly studied since the beginning of the 2000s. Exposure to elevated amounts has been linked to detrimental effects including increased risk of certain types of cancer, reduced response to vaccines, and increased cholesterol levels.3 Bulk of the research has focused, however, on a few of the most well-known compounds (mostly PFOS and PFOA). This means that very little is known about the effects of the thousands of other chemicals within the group.
PFAS restrictions under EU chemicals legislation
The use of the most harmful PFAS compounds has been restricted both globally and within the EU for over a decade. The Stockholm Convention on Persistent Organic Pollutants (POPs) forbids the use of PFOS, PFOA, PFHxS, and related compounds, apart from specific applications where they may not be effectively replaced. Temporary exemptions have been granted for products including firefighting foams and medical devices, but many of these are about to expire in the upcoming years.4
Several groups of PFAS have also been added to the REACH Regulation Candidate List.5 If chemicals included in the Candidate List are used in products or materials, the producer or importer has to notify ECHA and provide customers with sufficient information on the safe use of the product.
What complicates compliance assessments is the large number of substances related to the restricted PFAS. As these are included in the regulations as part of a restricted group (i.e. PFOA-related compounds, derivatives of PFOS, etc.) rather than being listed individually, it can be difficult for companies to determine whether a given substance is currently prohibited. Considering this and the plans for a full ban, it may be preferable to avoid using PFAS altogether in applications where they can be replaced.
Maximum PFAS concentrations in food
Commission Regulation (EU) 2023/915 on food contaminants sets maximum concentrations for high-profile PFAS in food. The limits apply to four compounds (PFOS, PFOA, PFNA, and PFHxS) and their sum in certain high-risk food categories.6 If higher concentrations than those listed in Table 1 are discovered in laboratory tests, the product has to be removed from the market.
Table 1: Maximum levels of PFAS per food category
Foodstuff | PFOS, μg/kg | PFOA, μg/kg | PFNA, μg/kg | PFHxS, μg/kg | Sum of the 4 PFAS, μg/kg |
Eggs | 1 | 0.3 | 0.7 | 0.3 | 1.7 |
Anchovy, babel, bream, char, eel, pike-perch, perch, roach, smelt, and whitefish | 35 | 8 | 8 | 1.5 | 45 |
Baltic herring, bonito, burbot, pike, plaice, sardine, seabass, wild salmon and trout, etc.* | 7 | 1 | 2.5 | 0.2 | 8 |
Other species of fish & all fish intended for young children | 2 | 0.2 | 0.5 | 0.2 | 2 |
Crustaceans and molluscs | 3 | 0.7 | 1 | 1.5 | 5 |
Meat of bovines, pigs, and poultry | 0.3 | 0.8 | 0.2 | 0.2 | 1.3 |
Meat of sheep | 1 | 0.2 | 0.2 | 0.2 | 1.6 |
Offal of sheep, pigs, poultry, and bovine animals | 6 | 0.7 | 0.4 | 0.5 | 8 |
Meat of game animals | 5 | 3.5 | 1.5 | 0.6 | 9 |
Offal of game animals | 50 | 25 | 45 | 3 | 50 |
* In addition to these, the category covers European sprat, flounder, grey mullet, horse mackerel, pilchard, sea catfish, sea lamprey, tench, vendace, silverly lightfish, and wolf fish.
Restrictions under the Drinking Water Directive
The revised EU Drinking Water Directive specifies two ways in which PFAS concentrations can be measured. These are:
PFAS Total, defined as "the totality of per- and polyfluoroalkyl substances". The maximum for this parameter is 0.5 μg per liter.
Sum of PFAS, calculated as the sum of 20 individual substances listed in Annex III of the Directive. The sum must not exceed 0.1 μg per liter.7
Restrictions on PFAS in cosmetics
Several PFAS compounds are listed as prohibited substances in the consolidated version of the EU Cosmetics Regulation. If any of these substances are found, even in trace quantities, the manufacturer has to prove that their presence is technically unavoidable. Otherwise, the product may not be sold in the EU.
The prohibited substances include:8
Perfluorooctane sulfonic acid (PFOS)
Perfluorooctanoic acid (PFOA)
Perfluorononanoic acid (PFNA), its sodium, and its ammonium salts
Perfluoroheptanoic acid (PFHpA)
In addition, it is important to note that the PFAS restrictions outlined in the POP and REACH regulations also apply to cosmetics. In a recent enforcement project, ECHA found over 150 cosmetic products that contained prohibited PFAS compounds. Most of these were flagged for perfluorononyl dimethicone, which is a PFOA-related substance and thus restricted under both POP and REACH.9
Proposed ban on PFAS in food packaging
The upcoming EU Packaging and Packaging Waste Regulation (PPWR) is set to introduce a full ban on PFAS in food contact materials. Once the PPWR is passed, manufacturers will have 18 months to ensure that PFAS is not present in food packaging in concentrations exceeding the following limits:10
25 ppb for any compound measured with targeted PFAS analysis
250 ppb for the sum of PFAS measured with targeted analysis
50 ppm for total fluorine, unless it can be shown the fluorine is derived from non-PFAS sources
PFAS analysis for assessing regulatory compliance
Targeted PFAS analysis is typically performed using a combination of liquid chromatography and (tandem) mass spectrometry (LC-MS or LC-MS/MS). With advanced LC-MS/MS techniques, it is possible to detect dozens of PFAS compounds in water with a detection limit as low as 0.0002 µg/l. The detection limit for other matrices can be somewhat higher, but it is well within the range required for compliance testing by EU regulations.
Measurlabs offers PFAS testing for plastic materials, firefighting foams, food, drinking water, cosmetics, consumer products, and environmental samples. Other sample types can be analyzed upon request, and we can also provide total organic fluorine (TOF) testing to estimate the overall presence of PFAS in different materials. A combination of TOF and targeted analysis is recommended to assess the credibility of PFAS-free claims.
In addition to EU regulations, testing can be performed to assess compliance with US laws. For this, we recommend PFAS analysis based on EPA Method 1633. Do not hesitate to ask our experts for more information or a quote through the form below.
References:
1 ECHA’s draft proposal recommends a full ban on PFAS compounds with an application-dependent transition period from 18 months to 12 years. The proposal was submitted by Germany, the Netherlands, Sweden, Norway, and Denmark. The European Commission’s decision on the possible adoption of the proposal is expected in 2025.
2 The Guardian reported in October 2023 that the European Commission had dropped the PFAS ban proposal from its 2024 work program following intense industry pressure.
3 The European Environment Agency provides a summary of current knowledge on the health effects of PFAS.
4 List of substances restricted by the Stockholm Convention. See also Annex I to the POP Regulation (EU) 2019/1021, which outlines the exemptions and derogations for using PFOA, PFOS, PFHxS, their salts, and related compounds.
5 ECHA’s Candidate List of substances of very high concern
6 These limits are outlined in the Annex of Regulation (EU) 2022/2388.
7 The maximum concentrations for PFAS Total and Sum of PFAS are listed in Part B of Annex I to Directive (EU) 2020/2184.
8 Prohibited substances are listed in Annex II of Regulation (EC) 1223/2009. PFOS is listed under reference number 1493, PFOA under 1561, PFNA under 1636, and PFHpA under 1705.
9 ECHA: Pilot project report on: enforcement of restrictions of PFCAs and related substances focusing on cosmetics, 25 October 2024
10 The proposed restrictions are listed in Chapter II, Article 5, Paragraph 2a. of the provisional political agreement on the Packaging and Packaging Waste Regulation.