3. Workshop on 3^rd of September 2024

A back-to-back workshop on enforcement of PFAS in the Nordic countries was held on the 3^rd of September 2024. The aim of the workshop was to gather Nordic enforcement agencies to share experiences of enforcement projects and other activities on PFAS and to discuss challenges and opportunities for enforcement and compliance testing. Furthermore, ideas for possible future Nordic projects were discussed. A total of 21 participants from Sweden, Norway, Denmark, Finland, and Austria attended the workshop.

This section featured experiences from enforcement projects on food contact materials and outdoor textiles, a proposal for a three-step workflow for compliance testing and an overview of evaluation of analytical methods under PARC.

Anders Appelblom, enforcement officer at the Swedish Chemicals Agency, presented the results from an enforcement project on food contact materials (FCM). The project included analyses of 142 FCM products of paper and board, silicone and soft polymers, non-stick coatings, hard plastics and wood. All products were analysed for total fluorine. In addition, 105 products were analysed for target PFAS (half with prior oxidation, i.e. TOPA), and 17 products were analysed with pyr-GC/MS.

The results showed that 3 products (3%) exceeded current regulatory limit values for long-chain PFCAs. Hypothetically, if the proposed universal PFAS restriction had been in force, 10 additional products (mainly cupcake liners/baking cups) would have exceeded the proposed limit values for individual PFAS and/or sum of PFAS. It was apparent that TOPA was required to capture precursors and reach above the limit values. In addition, 43 products had a total fluorine content above 50 ppm and for these products the proposed universal PFAS restriction would require suppliers to provide proof for the origin of the measured PFAS.

Taken together, the FCM products analysed in this project rarely contain currently regulated PFAS and when these are found, the low levels indicate unintentional use. However, non-regulated PFAS are still used in FCM. Furthermore, TOPA better captures intentional non-polymeric PFAS use compared to standard (MeOH) extraction techniques. There was no correlation between the content of total fluorine and the sum of PFAS after TOPA, as no or only low levels of PFAS were detected in the products with the highest fluorine content. This probably reflects that the total fluorine analysis includes inorganic fluorine and/or fluoropolymers that are not degraded in the TOPA and subsequently captured by target analyses. Anders Appelblom believes that the implementation of a universal PFAS restriction would lower the costs for analyses and solve some of the current issues with the interpretation of “related substances”. Finally, Anders stressed that standardisation of analytical methods is needed, which is an observation that was repeated many times by the participants throughout the workshop.

Ingvild Kvien, enforcement officer at the Norwegian Environmental Agency, shared the results from a project of PFOA and PFOA-related substances in outdoor textiles, including pillows, hammocks, an umbrella, a parasol cover, and a grill cover (Miljødirektoratet 2023). The products were purchased from Norwegian, Swedish, Danish and British online shops. The samples were analysed for individual PFAS with reference standards, both with and without prior oxidation by TOPA.

The results showed that none of the products had detectable levels of PFOA or C9-C14 PFCAs before oxidation (TOPA). However, after TOPA, 6 products had detectable levels, out of which 3 products contained levels above the regulatory limit for C9-C14 PFCAs.

In conclusion, 3 out of 11 (27%) outdoor textile products did not comply with the C9-C14 PFCA restriction (however the products were bought before the restriction entered into force). Another take home message was that the use of TOPA is critical to detect precursors to regulated PFAS. However, Ingvild Kvien raised that there are uncertainties on how efficiently TOPA oxidises the precursors in a sample and how much of the remaining non-oxidised precursors that still go undetected. Furthermore, we can currently not identify which specific PFCA-related substances that are used in the products.

Robin Vestergren, scientific officer at the Swedish Chemicals agency, held a presentation about a proposal for how the systematic three-step workflow could be used for enforcement.

The presentation provided a summary of the challenges and opportunities related to compliance testing of PFAS in products described under 2.3.1 with some discussion points of particular relevance for inspectors at national agencies. The discussion that followed revolved around the regulatory acceptance of non-substance specific and non-targeted analysis for enforcement authorities. Some workshop attendees argued that it might be difficult to use the proposed methods in a court case and validated target methods remain the gold standard for compliance testing. At the same time, the chemical diversity of the proposed universal PFAS restriction, and even the current PFOA restriction, makes it impossible to have targeted methods for all included substances. Some workshop attendees emphasized that the main priority, from their view, was to get non-compliant products off the market. Although some companies may dispute analytical results generated by non-substance specific methods, the number of cases that will be taken to court are very few. It was agreed that it will be important to follow and share experiences from any court cases related to group restrictions of PFAS.

Lisa Skedung, senior researcher and project manager at RISE and Robin Vestergren, scientific officer at the Swedish Chemicals Agency, introduced the work done by PARC (Partnership for the Assessment of Risks from Chemicals) on analytical methods of PFAS.

The presentation provided an overview of the products that have been tested by TF, pyr-GC/MS, and TOP. Overall, the pyr-GC/MS offers a good complement to TF analysis for identifying PFAS above the 50 ppm limit value. So far, the method has been tested for several different fluoropolymers and fluorinated side-chain polymers providing unique markers of PFAS chemistry. For chemical products, where PFAS are sometimes used at lower levels, additional analysis by e.g. TOPA is typically needed. The following discussion touched on the availability of these new methods for companies and enforcement authorities. It was generally concluded that both the pyr-GC/MS and TOPA could be adopted by most laboratories performing PFAS analysis today with small investments and modifications of existed instruments. Further work to test and validate these methods are ongoing in PARC activity 6.4.3.

Several European countries, including Denmark and France, precede the European universal PFAS restriction by introducing national bans on PFAS. In this section, the workshop participants learned more about the Danish national restrictions on PFAS in specific products.

Kim Boesen, head of unit of the Danish Chemical Inspection Service at the Danish Environmental Protection Agency, informed the workshop attendees that a national action plan for PFAS was agreed in Denmark on 30 May 2024. The plan will run to 2027 and the implementation of the plan will be funded by more than DKK 400 million over 4 years with the aims to clean up, contain and prevent PFAS.

In regard to existing and upcoming national bans on PFAS, a Danish national ban on PFAS in firefighting foam at training sites where there is a high risk of PFAS being released directly into the environment entered into force in 2024. I addition, a Danish national ban on PFAS in clothing and impregnation agents for consumers is planned for July 2026.

Mette Holm, senior scientific adviser at the Danish Veterinary and Food Administration, talked about the Danish ban of PFAS in food contact material (FCM), which entered into force in 2020. The ban only applies to FCM products made of paper and board. Furthermore, the ban specifies that PFAS are allowed in the product if there is a functional barrier that prohibits the substances from migrating into the food. The ban has no legally binding limit values for PFAS, but there are indicator values of 20 μg total organic fluorine (TOF)/g or 10 μg TOF/dm². The indicative values are set to be low enough to capture intentionally added PFAS but high enough to exclude background contamination from e.g. water and wood pulp. In addition to chemical analysis, compliance can be proved by a statement from the provider of the raw material or intermediate material. All FCMs on the Danish market need a declaration of compliance.

Mette also informed about the upcoming ban of PFAS in food packaging in the new EU packaging and packaging waste regulation (PPWR). This EU regulation applies to all food packaging and not only paper and board. There might be FCM of paper and board that does not fall within the definition of packaging, but overall, the ban in PPWR is broader than the Danish national FCM regulation.

The third section of the workshop handled how databases, i.e. the products registers and the DK EPA consumer product surveys, can help to identify and prioritise PFAS in articles and chemical products. In addition, an example of how of cosmetic products ingredients lists can be used for enforcement was presented. Finally, the participants got introduced to a PARC project on systematic data collection on substances in products.

Erik Diurlin, chemist at the Swedish Chemicals Agency gave an overview of PFAS in the Swedish products register. The register stores information on chemical products and biotechnical organisms that are manufactured in or transferred or imported into Sweden at a volume of more than 100 kg/year. The Swedish products register currently contains about 120,000 active products and about 13,000 substances.

Since 2018 the companies need to declare if their chemical products contain intentionally added PFAS. Since then, 116 companies have registered a total of 762 products that contain PFAS, which represents 0.6% of the total number of products in the register. It can be noted that the question (yes/no) about intentionally added PFAS has not been answered for 27% of the products.

Another way to identify PFAS containing chemical products in the register is to search for PFAS in the reported composition. This approach identified nearly 1,900 products reported by a total of 269 companies. The sectors with the highest volumes of products with PFAS were plastic products, agriculture, air conditioning and motor vehicles. In total, 168 different PFAS were identified in the product register. These PFAS were not screened for regulatory status, which was identified as a possible follow-up project during the discussions at the workshop.

In conclusion, the approach of identifying PFAS containing chemical products based on the chemical composition resulted in 2.5 times more products than the approach with company notification for intentionally added PFAS (yes/no). The overlap between the two approaches was poor as only 239 products both had PFAS in the chemical composition and a PFAS notification (yes/no) by a company. This indicates that many companies are unaware of that their chemical products contain PFAS. Furthermore, even if companies notify intentionally added PFAS, these substances are rarely given in the registered chemical composition.

Product registers with information on chemical products are available in Norway, Denmark, Finland and Sweden. Based on these registers, information on the use of substances in products in the Nordic countries is publicly available in the joint database SPIN.

 http://spin2000.net/

Kim Boesen, head of unit of the Danish Chemical Inspection Service, presented the Danish Environmental Protection Agency’s surveys on chemical substances in consumer products. Since 2001, nearly 200 reports on different chemicals (not only PFAS) have been published. These reports are public and searchable on the Danish EPA homepage. Furthermore, the database is used by the Danish EPA for prioritisation of products for enforcement campaigns.

Danish EPA Surveys of chemical substances in consumer products:

Sunitha Vijayalekshmi, enforcement officer at the Swedish Chemicals Agency, presented a FORUM enforcement pilot project of PFCAs in cosmetic products. The project was performed in 13 European countries with the aim to enforce the legal requirements by setting a harmonized approach and establishing common enforcement methods for checking such obligations.

In the project, cosmetic products were first checked for 5 specified restricted PFAS substances on the ingredient lists and one product per restricted substance was purchased from each company. In total, 627 products from 47 companies were checked. Out of these, 77 products were non-compliant with the restrictions of PFOA and C9-C14 PFCAs and their related substances.

Taken together, the project indicates that some companies do not have sufficient information and/or knowledge to decide if PFAS are present in their products. Other experiences include that ingredients lists that are presented at online shops often are poorly updated, and that companies need to be reminded that restrictions apply to the entire supply chain including distributors.

Finally, it was proposed that a possible follow-up project could be to confirm the listed PFAS ingredients in the cosmetics by chemical analysis.

Robin Vestergren, scientific officer at the Swedish Chemicals agency, held a presentation about the work performed under PARC to review databases and information structures related to chemicals in chemical products and articles. A better understanding of substances in chemical products and articles is needed for, enforcement of restricted substances but also to set up for early warning systems, promote substitution actions and the transition to a circular economy. As part of the landscaping activities performed under PARC 6.4.3. a comprehensive review identified and evaluated available databases on chemicals in chemical products and articles from literature using a defined protocol and from European national market surveillance authorities, non-governmental agencies, and industrial sector groups using questionnaires. Among the 57 identified databases, 49 identified specific substances, and only 30 reported their concentration in their products. The analysis highlights the lack of comprehensive or accessible data on chemicals in chemical products and articles for most categories of products and jurisdictions. The limitations of existing databases were attributed to scattered regulatory information requirements, lack of data for unregulated substances, complexity of supply-chain communication and confidentiality issues.

At the workshop, the main challenges with enforcement of PFAS were brought up and discussed. Some of the identified challenges are listed below.

The workshop participants all agreed that there are uncertainties in the available analytical methods of PFAS and the interpretation of the results in relation to the restrictions. For example, TOPA can be applied prior to targeted analysis to catch the precursors to regulated PFAS. However, it is uncertain to which extent the precursors are oxidised. Most likely, there is an underestimation of the actual PFAS content in the samples even after TOPA.  

It was pointed out that the laboratories need incentives and large budgets to develop new methods. Thus, large and transnational enforcement projects are more likely to put pressure on laboratories to develop new methods, compared to small national projects. The participants at the workshop found it surprising that commercial laboratories are not more eager to develop analytical methods for PFAS in products, as such analytical methods are expected to be increasingly requested by companies and agencies. In contrast, there are cheap and fast methods for PFAS analysis in water due to a large demand on such analyses. However, it is recognized that articles and chemical products are more diverse and difficult matrices compared to water.

It was also acknowledged that it is difficult to use academic laboratories for chemical analyses as the researcher often need results that are interesting enough to publish. At the same time, commercial laboratories do not have all the equipment that for example are proposed by the three-step workflow that has been introduced at the conference and workshop (2.3.1). However, Lisa Skedung believes that the pyr-GC/MS could be installed at more laboratories to reasonable costs as the method builds om standard methods (i.e. GC/MS) together with a pyrolysis unit. Several labs most probably have a pyr-GC/MS instrument already to study microplastics.

One participant raised that FORUM

Forum for Exchange of Information on Enforcement (Forum) is an ECHA body that coordinates a network of agencies responsible for the enforcement of the REACH, CLP, and PIC, POP and Biocidal Product regulations.

and the European Commission need to do more to ensure that the restrictions are enforceable. Otherwise, they leave the agencies with an impossible task. For example, the European Commission could assign laboratories to develop standardised methods for enforcement of the PFAS restrictions. 

There are several examples of Nordic enforcement projects of PFAS in different products groups. Overall, existing restrictions of specific PFAS and their related compounds often require TOPA to elucidate if a product in non-compliant with these restrictions due to the presence of precursors. It was believed that a universal PFAS restriction may simplify enforcement if appropriate and validated methods are available.

Overall, it was agreed that standardised analytical methods for PFAS analysis in articles and chemical products are urgently needed for efficient enforcement. Methods should be developed both for currently restricted PFAS, and for the broader group of PFAS that will be restricted in the future. Agencies, academia, commercial laboratories and companies should collaborate to develop analytical methods for PFAS.

Large transnational enforcement projects on PFAS. Such collaboration projects have the size to make demands on the involved laboratories, e.g. in terms of method development.

A guidance on procurement of PFAS analyses in articles and chemical products, including how to find laboratories, request analyses and interpret the relevant analyses. This would include communication with commercial laboratories.

Development and evaluation of a testing strategy suitable for enforcement.

Use the Nordic product registers as a source to prioritise product groups. The product registers could also be used to examine if there are restricted PFAS in the registers.

A possible follow-up to the cosmetics project could be to analyse the non-compliant products to confirm the presence of the PFAS that are listed in the ingredients list.