Your online database of sustainable policy solutions

Danish Order No 681 of 25 May 2020 on Food Contact Materials.pdf (foedevarestyrelsen.dk)

The Danish Order amends the European REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32004R1935.

The REGULATION (EU) 2019/1021 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on persistent organic pollutants (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32019R1021) regulates use of PFOS and has been amended by the COMMISSION DELEGATED REGULATION (EU) 2020/784 of 8 April 2020 […] as regards the listing of perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32020R0784).

Denmark, a comparably small but wealthy country in the European Union, is dependent on the import of paper and board food packaging material, as there is no domestic production. The DTU National Food Institute (NFI) is officially responsible for scientific assessment of risks and research-based assessment of monitoring data in the country. When researching potentially hazardous substances and their risk of migration into food contact materials around 2010, a group of scientists discovered the presence of different types of PFAS in almost all types of paper and board food packaging. These have a high risk of migrating to food.

The research led to increased awareness among consumers and retailers, such as the member-owned supermarket Coop that banned PFAS containing products and FCM from their shelfs, even before the official ban. They, together with the scientists, campaigned for legal restrictions from the government. The most important and crucially precautionary measure in these demands was that a ban should target all PFAS in food contact materials (FCM), independent of available data for specific substances.

The Order on food contact materials and on provisions for penalties for breaches of related EU legislation became effective in May 2020, creating a legal framework to implement the guideline by the NFI. The legal enforcement in Denmark has led to the industry quickly developing alternative packaging without PFAS or any significant change in costs.

In light of the recently proposed restriction of the PFAS group in the European Commission, submitted on 13 January 2023 to the European Chemicals Agency (ECHA), the ban of PFAS in paper and board food contact materials within the Danish Order must be seen as a frontrunner in taking legal action in the fight against the so-called « forever chemicals ». Complementing the European Regulation (EC) No 1935/2004 of 27 October 2004 on materials and articles intended to come into contact with food, it goes beyond the European Standards which are often regarded as the most comprehensive.

Despite the ban not applying to all products, PFAS in paper and board food contact materials present a sensible starting point: they bear a high risk of exposure for consumers. In Denmark and beyond, the ban has inspired discussions around other uses of PFAS, and there are now plans for a national ban targeting all types of products, as well as on EU level. However, threatened by industrial lobbying, delays and changes in government, it is unclear at both scales when, and even whether the ban will actually be.

Our “Best Policies” are those that meet the Future Just Lawmaking Principles and recognise the interconnected challenges we face today. The goal of principled policy work is to ensure that important universal standards of sustainability and equity, human rights and freedoms, and respect for the environment are taken into account. It also helps to increase policy coherence between different sectors.

Sustainable use of natural resources

• Supports the recycling of paper and board.
• Reduces the amount of PFAS in (disposed/recycled) paper and board.
• Offers an incentive for non-chemical solutions.

Equity and poverty eradication

• Aims to protect children and unborn from PFAS.
• Contributes to the reduction of PFAS (also called forever-chemicals) in the ecosystem and thus improving health for indigenous and rural citizens all over the world that are dependent on local farming.

Precautionary approach

• Bans all PFAS despite lack of exact data proving hazard from specific substances, based on precautionary principle and knowledge about persistence and health impacts of some substances of the group.
• By preventing the migration from FCM to the food, consumers will not face health problems from it, the functional barrier is an additional prevention measure as it prevents migration even of very low levels due to often unavoidable background contamination in recycled paper.

Public participation, access to information and justice

• Active collaboration between authorities, civil society groups, industry.
• Public communication and exchange on social media platforms.
• Public hearing as mandatory part of Danish policymaking.
• Documentation obligation for producers and suppliers on testing for PFAS – can be requested by Danish authorities.
• The next part in the supply chain always must receive adequate information about the contents of the product.

Good governance and human security

• There are regular inspections on correct documentation, and occasional as well as regular analysis of products for PFAS content.
• Regulation applies to imported products in the same way – all paper and board food packaging is imported to Denmark.
• Close collaboration with civil society (Consumer Council), science and industry (coop).
• There is no indication for misuse of power or corruption with Denmark ranked the least corrupt country globally.

Integration and interrelationship

• The ban adds to the European Directive on FCM and is integrated into a broader regulation concerning other types of packaging.
• Despite it not being the primary reasoning, there is a close exchange with the Environmental Ministry -> e.g., implications for recycling in case of a complete ban (no barrier option).
• There are plans for a PFAS ban covering all products (nationally and on EU level) which would improve the effects of the policy.
• The EU single-use plastic directive might create more demand for paper and board, making the policy even more relevant.

Common but differentiated responsibilities

• The ban reduces health risks for all consumers, and, if applied to all products could have a significant impact on environmental contamination, benefitting especially rural and indigenous people.
• Costs for substance-specific analysis must be covered by the producers. The analysis carried out by the authorities does not distinguish between substances and is thus more cost-effective.

At present, there is insufficient knowledge on the effects on human health for most PFAS, a group of over 12.000 identified substances. Some of them, however, like PFOS and PFOA, are classified as persistent organic pollutants, reproductive toxins and suspected carcinogens. There is also evidence for their immunotoxicity and effects on liver, cholesterol, as well as on the birth weight of new-born children. PFOS and PFOA are also regulated under the Stockholm Convention and EU legislation.

PFAS added to food contact materials are thus not only a problem for the environment when being produced or disposed of but can also migrate to the food and thus into the consumer’s body.

Some PFAS, but not all, are regulated by the European Commission for specific uses.

One of the first institutions to raise awareness of the issue was the Danish National Food Institute (NFI). It looked at hazardous novel substances with a high risk of migrating into food, identifying gaps in the existing legislation. Scientists from the NFI found PFAS presence in a large proportion of paper and board food packaging, particularly for contact with fatty food at high temperatures or for long-term storage. Consequently, they developed a guidance value to identify intentionally added PFAS in packaging, keeping in mind unavoidable background contamination from PFAS in the environment and recycled paper and board. The value was determined by detailed research as well as in collaboration with Nordic and international authorities and businesses. Scientists and other stakeholders also communicated their concerns about the current lack of regulation of PFAS in the Helsingør Statement and the Madrid Statement. At a national level, the Danish Consumer Council and several newspaper media continued to bring awareness on PFAS to the broader public.

In 2015, the guidance value was introduced by the Danish Minister for Environment and Food as a voluntary recommendation.

At the same time, public awareness of the issue grew, increased by the communication of the NFI and the Danish food authorities and the member-owned supermarket Coop. By 2015, Coop had already banned all PFAS from food packaging on a voluntary basis, expanding the elimination to several kinds of products in the following years. In 2017, they published a draft resolution to the parliament to ban all PFAS and bisphenols in food contact materials as well as other consumer products. Together with the report from the Nordic workshop of the Nordic Council of Ministers, this formed the basis for the order in question.

The main purpose of the policy was to protect consumers, especially developing foetuses, babies, children, and pregnant women, from PFAS accumulating in their bodies and the potential health risks associated with it. These include a suppression of the immune response and disruption of the endocrine system.

The focus of this nomination is on §8, the ban of PFAS in paper and board. This ban applies to all substances in the PFAS group, and no food contact materials made from paper or board containing any of these substances may be placed on the market. A sub-paragraph states, however, that FCM containing PFAS can be used if a function barrier is used to prevent the substances from migrating into the food.

The reasoning behind this exception is the unintentional background contamination stemming from recycled paper and board. A function barrier could be, for example, an inner layer of “clean” paper or plastic. Unintentional background contamination is considered any content of PFAS below the indicator value of 20 micrograms of organic fluorine per gram of paper. Although this layer does not directly protect the environment from pollution with PFAS, it does stop the substances from migrating into the food and thus protects the consumers, which is the primary focus of the policy. Indirectly, this also reduces the amount of PFAS used (intentionally or unintentionally). The migration barrier makes adding PFAS as a grease or water repellent useless. Thus, the only PFAS that may be contained in the paper result from background contamination or printing inks. This assumption is also supported by the significantly lower values in PFAS found in paper and board FCM: When added deliberately, the FCM contain around 4% of PFAS per weight, whereas the level of unintentional background contamination typically ranges around 0.0005%.

For the implementation of the policy, retailers have to provide documentation of substances contained in the FCM for the Food Administration. Food distributers must make sure that there is no PFAS contained in the FCM above the indicator value.

The official monitoring as well as the regular inspections of retailers, and the evaluation are executed by the Danish Food Administration. For testing of products, the authorities use the guiding value developed by the scientists of the National Food Institute. Further monitoring and analysis is carried out by the Danish Consumer Council, and scientists, e.g., at the National Food Institute. Non-compliance is regulated in Chapter 6 of the Order and can entail fines and imprisonment of up to two years under defined circumstances.

There is a regular exchange of the authorities with stakeholders from industry, civil society and science. They are currently advocating for a ban of PFAS for all products on a national level, as well as on a European level.

Most of the costs related to the implementation are related to testing the PFAS content in products. Producers need to conduct detailed analysis of the substances contained in their products, and document the results. The Danish authorities use a “simpler” method developed by Xenia Trier (academic informant) and her colleagues at the NFI. This method tests generally for fluorinated substances, independent of specific identification. Thus, costs on public level are relatively low, and there is no indication of budget cuts in the foreseeable future.

It is, however, unsure if the national ban on PFAS in all products will be implemented as this will probably coincide with a government change, and there is hesitancy to act before the European Union

In the process of developing the policy, new methods were established to measure the content of organic fluorine as opposed to specific PFAS substances to ease inspections and reduce the risk of missing newly developed substances. This method allows for a slightly higher value for background contamination but makes the implementation of the ban easier without it hindering the use of recycled material.

The policy prohibits the use of PFAS in paper and board FCM as stain or grease repellent. Despite having a tolerance level for background contamination, this reduced the content of PFAS in food packaging drastically, effectively preventing the migration into food and eliminating it as a direct source of contamination. Thus, the policy protects not only human health, but also reduces the input of PFAS into the environment during the production and disposal/recycling phase. However, there are still other sources of PFAS that contaminate the environment, also reaching into human foods through water, fish, meat, eggs, and vegetables.

A study by the Czech non-profit organisation Arnika showed that in 2020, Danish paper bags for French fries from Mc Donald’s contained only 5.5 mg/kg dw of total organic fluorine, whereas the the same bags in the Czech Republic and the United Kingdom contained 480 and 470 mg/kg dw respectively. This is a difference of 98.8 %.

Due to the ban, retailers had to find alternatives to PFAS-coated paper and board FCM, leading to innovation in the industry. Since it is often argued that there is no alternative to PFAS (as well as other toxic substances), this is a good example for how legal pressure can stimulate innovation and the search for other solutions in the industry.

Furthermore, the policy and the campaigns around it have inspired other governments to take similar steps. It has also brought forward the debate about the PFAS problem in the world and been part of the initial steps of the development of a universal PFAS ban in the EU brought forward by Germany, Denmark, the Netherlands, Norway, and Sweden.

The policy is transferable to many other countries as well as to other products. The PFAS testing methodology it uses does not distinguishing between different substances, making inspection easier and more cost-effective. Also, the example of Denmark showed that it is possible for industry to develop PFAS-free alternatives that do not necessarily come at a higher cost.

DTU National Food Institute (n.d.). The Danish system for food safety and nutrition. https://www.food.dtu.dk/english/about-us/the-danish-system-for-food-safety-and-nutrition.

Trier, X., Granby, K. & Christensen, J.H. (2011). Polyfluorinated surfactants (PFS) in paper and board coatings for food packaging. Environ Sci Pollut Res, 1108–1120. https://doi.org/10.1007/s11356-010-0439-3.

ECHA (2023, November). ECHA publishes PFAS restriction proposal. Retrieved April 14, 2023, from https://echa.europa.eu/-/echa-publishes-pfas-restriction-proposal.

KEMI (2023). PFAS. https://www.kemi.se/en/chemical-substances-and-materials/pfas.

Susman, H.P., Schaider L.A., Rodgers, K.M. & Rudel, R.A. (2019, October 9). Dietary Habits Related to Food Packaging and Population Exposure to PFASs. Environmental Health Perspectives. Volume 127, Issue 10. https://doi.org/10.1289/EHP4092.

Trier, X., Granby, K. & Christensen, J.H. (2011). Polyfluorinated surfactants (PFS) in paper and board coatings for food packaging. Environ Sci Pollut Res, 1108–1120. https://doi.org/10.1007/s11356-010-0439-3.

Trier,X., Tavxig, C., Vinggaard, A.M. & DTU Fødevareinstituttet (2015), Notat, Forslag til grænseværdi for indhold af totalt organisk fluor i papir og pap fødevareemballage. https://www.foedevarestyrelsen.dk/SiteCollectionDocuments/Kemi%20og%20foedevarekvalitet/FKM/Notat-graensevaerdiforslag-for-fluorstoffer-i-papir-og-pap-emballage-FINAL.pdf.

Ministry of Environment and Food of Denmark, Danish Vetenary and Food Administration (2020, June). Ban on fluorinated substances in paper and board food contact materials (FCM), Fact sheet, June 2020. https://www.foedevarestyrelsen.dk/english/SiteCollectionDocuments/Kemi%20og%20foedevarekvalitet/UK-Fact-sheet-fluorinated-substances.pdf. N

Scheringer, M., Trier, X., Cousins, I.T., de Voogt,P., Fletcher, T., Wang, Z. & Webster, T.F. (2014). Helsingør Statement on poly- and perfluorinated alkyl substances (PFASs). Chemosphere, Volume 114, pp. 337-339. https://doi.org/10.1016/j.chemosphere.2014.05.044.

Blum, A., Balan, S.A., Scheringer, M., Trier, X., Golcenman, G., Cousins, I.T., Diamond, M., Fletcher, T., Higgins, C., Lindeman, A.E., Peaslee, G., de Voogt, P., Wang, Z. & Weber, R. (2015). The Madrid Statement on Poly- and Perfluoroalkyl Substances (PFASs). Environmental Health Perspective. Vol. 123, No. 5. https://doi.org/10.1289/ehp.1509934.

COOP Danmark A/S (21 September 2017). Coop vil have Folketinget med i kampen mod farlig kemi Retrieved April 19, 2023 from https://csr.dk/coop-vil-have-folketinget-med-i-kampen-mod-farlig-kemi-3.

Trier, X., Taxvig, C., Rosenmai, A.K., Pedersen, G.A. (2017). PFAS in paper and board for food contact: Options for risk management of poly- and perfluorinated substances. Nordisk Ministerråd. http://dx.doi.org/10.6027/TN2017-573.

Straková, J., Schneider, J., Cingotti, N., et al. (2021). Throwaway Packaging, Forever Chemicals: European-wide survey of PFAS in disposable food packaging and tableware. Retrieved 21 March 2023 from https://chemtrust.org/wp-content/uploads/PFASreport_FCM_May2021.pdf.

ECHA (2023, 11 April). Registry of restriction intentions until outcome. Retrieved April 14, 2023, from https://echa.europa.eu/en/registry-of-restriction-intentions/-/dislist/details/0b0236e18663449b.

ECHA (2023, March 22). Annex to the Annex XV Restriction Report, Proposal for a Restriction. Version No. 2. Retrieved April 14, 2023, from https://echa.europa.eu/documents/10162/8de11d7c-c56f-e204-5072-e89f11071219.