Concern over per- and polyfluoroalkyl substances (PFAS) substances is growing. A recent US study found them in a majority of food contact products, leading to calls for a ban. What regulations must industry conform to for safety and compliance?
What are PFAS?
PFAS are a diverse and expanding group of synthetic chemicals that are chemically inert and resistant to high temperatures due to their strong carbon-fluorine bonds. They are used in a wide variety of consumer products, from cosmetics to non-stick cookware, because of their water, grease and oil repellent qualities.
The inertness of these ‘forever chemicals’ means they do not degrade and are very persistent in the environment. This creates a major problem as they can be bioaccumulative, toxic to reproduction (reprotoxic) and harm the development of fetuses, and in some cases cause human cancer or have an impact on endocrine systems.
Food Contact Products
A Consumer Reports study published in March 2022 found PFAS in a variety of food contact paper and bamboo products taken from restaurants and grocery chains across the US.1 The study looked for the presence of organic fluorine – common to all PFAS but with few other sources. This methodology will detect the presence of PFAS but not identify the individual substances.
The study found that at least one product from each source contained a detectable level of organic fluorine. Of the 118 products tested, 37 had over 20 ppm and 22 exceeded 100 ppm, with the highest concentration being more than 870 ppm.
50 of the products with higher concentrations were then tested for the presence of 30 specified PFAS. These tests showed the presence of perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), two persistent organic pollutants (POP) listed under the Stockholm Convention, and perfluorobutanoic acid (PFBA).
However, the combined organic fluorine content of these 30 specified PFAS accounted for only a small quantity of the total organic fluorine found in the tested products. This meant the majority of PFAS contained in these products were not included in the 30 specified substances but are believed to be other PFAS or one of its subgroups.2
The report concluded that exposure to PFAS should be minimized, and it called on governments to prohibit their use in food packaging and restrict their use in other products.
Governments and regulatory authorities are beginning to respond to the threat from PFAS. Over the years, several jurisdictions have introduced legislation to restrict or prohibit PFAS but there is no universal approach. Stakeholders therefore need to be aware of the regulations being enforced in each of the territories in which they operate.
United States of America
Several US states and cities have introduced legislation to regulate a variety of PFAS. However, what products are regulated, which PFAS are included, and what the requirements are is dependent on the individual jurisdiction’s legislation. To see an up-to-date list of US requirements, Table 1.
The states of Maine, Oregon, Vermont and Washington also require disclosure information on hazardous chemicals, including certain PFAS, in children’s products, Table 2.
At a Federal level, the Environmental Protection Agency (EPA) has published a PFAS strategic roadmap to develop a comprehensive approach to eliminating PFAS contamination in the environment. It has also announced a research commitment to fully understand the impact and characteristics of PFAS. However, they have not, so far, approached the issue of PFAS content in consumer products.
California Proposition 65 (Prop 65)
Businesses operating in California also need to consider Prop 65, officially known as the ‘Safe Drinking and Water Toxic Enforcement Act of 1986’. This is a unique piece of legislation that requires the state to maintain a list of chemicals (Prop 65 List) known to cause cancer, birth defects or reproductive harm. The current list contains more than 900 chemicals, including several PFAS:
- PFOA – developmental toxicity (2017) and cancer (February 2022)
- PFOS – developmental toxicity (2017)
- PFOS, its salts and degradation precursors – cancer (December 2021)
- Perfluorononaoic acid (PFNA) and its salts – male toxicity (December 2021)
Once a substance is listed, companies have twelve months to comply with Prop 65 warning requirements.
European Union (EU)
At the community-wide level, the EU operates several pieces of legislation that regulate specific PFAS or categories of PFAS. In addition, Denmark has become the first country to prohibit PFAS in food contact paper and board materials and articles (Order No. 681 of May 25, 2020 ‘Executive Order on Food Contact Materials and Penal Code for Violation of Related EU Acts’).
Regulation (EC) 1907/2006 (REACH)
REACH is a comprehensive piece of legislation for the management of substances in the EU. It regulates chemical substances on their own, in mixtures and in articles. The most important restrictions applicable to articles can be found in Annex XVII of REACH, which prohibits and restricts defined substances, and the provisions relating to substances of very high concern (SVHC).
If an article contains a Candidate List SVHC above 0.1%, the supplier is obliged to provide the recipient of the article with sufficient information to allow its safe use – minimum information to be provided is the SVHC’s name. The same information must be provided to consumers at no cost within 45 days of a request.
Furthermore, producers and importers of articles are obliged to notify the European Chemicals Agency (ECHA) if a Candidate List SVHC meets both of the following conditions:
- SVHC is more than 0.1% in the article
- SVHC in (all) articles is more than 1 tonne per producer or importer per year
PFAS restrictions can be found under Annex XVII, with further PFAS on the SVHC Candidate List.
Directive 2008/98/EC ‘Waste Framework Directive’
Since January 2021, companies that produce, import or supply articles containing Candidate List SVHCs in a concentration greater than 0.1% are required to submit information via the substances of concern in articles as such or in complex objects (products) database (SCIP database). This is maintained by the ECHA and helps to support a circular economy.
Regulation (EU) 2019/1021 on Persistent Organic Pollutants (POP)
This implements the Stockholm Convention on the elimination of POP into European law. Under the terms of this regulation, PFOA and PFOS, including their salts and derivatives, are prohibited/restricted per Article 3 in conjunction with Annex I, Table 3.
Regulation (EU) 10/2011 ‘Food Contact Plastics’
Stakeholders should also be aware that several PFAS are on the union list of authorized monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. Some of these have specific migration values and some are limited by scope and specification.
Examples are tetrafluoroethylene and perfluoromethyl perfluorovinyl ether, which are authorized monomers in the production of PTFE and/or non-stick coatings and are currently restricted in food contact materials with a specific migration limit of 0.05 mg/kg of food simulants.
Globally, restrictions on PFAS continue to increase. In the EU, there are several ongoing restriction processes under REACH, including those relating to:
- Perfluorohexane-1-sulphonic acid (PFHxS), its salts and related substances
- Undecafluorohexanoic acid (PFHxA), its salts and related substances
- PFAS in firefighting foam
- PFAS broad restriction3
Manufacturers of food contact products need to find alternatives to ensure their products remain compliant with market legislation. While there are several physical and chemical alternatives to PFAS, choosing the right one for a consumer product is dependent upon the application and required functionality.
With more and more PFAS being regulated around the world, it is advisable for manufacturers considering alternatives to work with industry experts who understand the technical and regulatory requirements required for each product and market. Choosing the wrong PFAS alternative might result in a reduction in functionality or the use of a substance that may soon be regulated.
Our technical experts have extensive experience of testing materials and articles in contact with food. We ensure products meet the appropriate regulations for food contact materials, including requirements relating to PFAS. With a comprehensive range of testing services, expert advice on emerging regulations and compliance issues, and efficient documentation review solutions, SGS delivers a one-stop shop solution for all food contact material products. In the end, it’s only trusted because it’s tested.
Learn more about SGS Food Contact Material testing.
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Dr. Hing Wo Tsang
Global Information and Innovation Manager
SGS, Connectivity & Products – Hardlines
t: +852 2774 7420
Ms. Melanie Schubert
Senior Technical Manager
SGS, Connectivity & Products
t: +1 312 414 9394
Plot No. 127, Mafinga Street,
Kingsway Kinondoni Road, P.O.Box 2249, 2249,
Dar Es Salaam, Tanzania