Non-harmonised FCM laws – a reason for concern

A new CHEM Trust briefing, Non-harmonised FCM laws – a reason for concern, highlights the chaotic situation of legislation on food contact materials (FCMs) in the EU.

Harmonised legislation, including restrictions on harmful substances, exists for four types of materialsat the EU level; active and intelligent materials, plastics (incl. recycled plastics), cellulose film and ceramics.

However, no EU-wide provisions exist for all other types of FCMs, including paper and board, metals, textiles, adhesives or printing inks. This new briefing outlines the negative impacts of this lack of harmonised legislation, such as increased compliance costs for companies and differing levels of protection across the EU, and makes recommendations for action.

 

Over 100 national provisions on FCMs

The general safety requirement of the FCM regulation – “[…] do not transfer their constituents to food in quantities which could a) endanger human health; or […]” – needs to be interpreted, and Member States have therefore developed national provisions to specify it’s meaning and to make implementation possible.

There are 118 national provisions for 14 different FCMs. Twenty Member States have at least one national provision, while the remaining countries have none. In total, these provisions cover 8,000 different substances. The specific national provisions include bans, concentration thresholds, migration limits, and measurement standards.

National provisions have several negative impacts

As a consequence of this patchwork of FCM legislation, the level of protection citizens receive from harmful chemicals and contaminants in FCMs differs across the EU.

If FCM producers place their products on the market in different Member States, they must comply with several pieces of legislation. Due to the “mutual recognition principle,” enforcement authorities also have to consider different legal provisions.

In its 2016 impact assessment report, the European Parliament stated that the lack of harmonised provisions:

  • increases compliance costs for companies;
  • creates internal market barriers,
  • hinders innovation;
  • prevents uniform safety standards for consumers across the EU.

Chemicals enter the human body via food contact materials

FCMs are a key pathway through which hazardous chemicals can enter the human body.Studies have found harmful chemicals in different types of FCMs, including endocrine disrupters in silicone baking cups, PFAS in fast food packaging, and brominated flame retardants in kitchen utensils. These chemicals can migrate from the FCM into food, be ingested, and may contribute to negative health effects.

In 2023, the European Food Safety Authority (EFSA) stated that the health of people in all age groups is at risk from bisphenol A (BPA) in their diets. A regulation banning BPA and other hazardous bisphenols in FCMs was published in December 2024. Read more about this ban here.

The EU FCM framework must urgently be revised

The EU FCM framework legislation has not been revised since it entered into force in 2004. Its key provisions, which stem from the first FCM Directive of 1976, are more than 40 years old.

A revision of the FCM legislation was promised in the EU strategy for a sustainable agriculture and food sector (the Farm to Fork Strategy). However, since the end of the open public consultation in January 2023, to which CHEM Trust contributed, the Commission has not taken any further action. The existence of non-harmonised legislation is another reason for the revision of the FCM legislation to start as soon as possible.

Antonia Reihlen, policy expert at CHEM Trust says:

“It is incredible that legislation on FCMs, which we know are very relevant for the uptake of harmful chemicals, has never been revised. What makes it even more astounding is that many stakeholders agree on the need for a revision, particularly regarding non-harmonised provisions. It is high time the EU Commission ensures safe FCMs across the EU and tables an ambitious, protective, and harmonised FCM legislation.”

CHEM Trust recommendations

The EU FCM regulation needs a fundamental overhaul. The provisions to protect human health and the environment, and support a circular economy, must include:

  • A ban of the most hazardous chemicals from FCMs, as promised in the Chemicals Strategy for Sustainability. The “most hazardous chemicals” should include carcinogenic, mutagenic and reprotoxic chemicals (CMRs) and endocrine disrupting chemicals (EDCs) (Category 1 and 2) as well as persistent substances (PBT/vPvB and PMT/vPvM), as a minimum.
  • Consideration of mixture effects of chemicals in the human body by applying a mixture assessment factor in any risk assessment.
  • A regulatory approach that covers all FCMs at the EU level rather than a patchwork of national provisions.

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Read more about harmful chemicals in FCMs here, or on the Toxic-Free Food Packaging website.