What are Food contact materials (FCMs)?

Everything that comes in contact with food as it is produced, packaged, transported, stored, prepared and consumed needs to be safe to ensure everything we consume is safe. Materials such as plastics, paper and board, metals, ceramics are commonly used for the manufacturing of food packaging.

The European Commission's Joint Research Centre (JRC) is the European Union Reference Laboratory for Food Contact Materials (EURL-FCM). The methods and techniques for measurement of food contact materials (FCMs) are developed at the JRC and used in national laboratories across the EU, so the standards are the same in the European Union. The goal is that all European consumers should feel confident about the safety of food and the tableware they use.

The safety of FCMs relies on insuring that during contact there is no migration of unsafe levels of chemical substances from these material to the food.

Chemical partitioning from the packaging into the food is known as migration. Migration is of relevance for smaller size compounds (below 1000 Da) and the extent to which migration occurs depends on various factors (physico-chemical properties of the migrant, of the packaging material, and the food, temperature, storage time, size of the packaging in proportion to the foodstuff volume).

The types of chemicals that can migrate from packaging into food are highly diverse and depend on the type of packaging material. For inert materials (e. g. stainless steel, ceramic, glass) chemical diffusion from within the packaging material or from the outside is not possible, only chemicals from the inside surface, directly in contact with the foodstuff, can migrate. However, glass-packaged oily foods can be contaminated by migration of plasticizers (e. g. phthalates ) from the closure, but this kind of migration can be reduced by careful manufacturing or the use of specially developed low migration closures.

There are non-inert materials like paper and board or plastics that can be a direct source of migrants. Chemicals may also migrate from the outside through the packaging (e. g. printing ink). Contrast to inert materials the large pore size of paper-based materials permits smaller molecules to migrate from the outside to the food inside, but the use of barrier materials (e. g. aluminium foil, plastic) can reduce food contamination significantly.

To determine the extent of chemical transfer from packaging into food migrants are measured in food simulants. Food simulants are used as substitutes for food due to the simplification of chemical analysis. Food simulants vary in terms of their chemical properties, thus representing several different food types: hydrophilic (water-based), lipophilic (fatty foods) or amphiphilic (foods with both watery and fatty properties). For example, migration into an oily food is measured with the food simulant vegetable oil. The use of food simulants is an approximation for actual migration into foods. Their use is generally assumed to overestimate actual migration. Not only single, known substances that migrate are of interest. Overall migration assessment serves to determine the whole chemical transfer from packaging into food without necessarily knowing their chemical identity.

Concerns regarding polymers

Researchers analysed styrene (CAS 100-42-5) monomers migrating from polystyrene (PS) FCMs. They found 0.4 to 160 ng/g styrene migrating from the packages. In more than half of the dairy products and desserts, styrene concentrations exceeded 10 ng/g while the highest concentration was detected in meat packaged in foamed PS. The US State of California added styrene to its Proposition 65 list of carcinogens and in 2018 the International Agency for Research on Cancer (IARC) concluded that styrene is “probably carcinogenic to humans”. Exposure to styrene can lead to toxicity (e. g. neurotoxic, haematological, cytogenetic) has carcinogenic effects, can irritate the mucous membranes of the eyes, nose, and respiratory system, can cause confusion, dizziness, weakness, headache, even depression. It affects the central nervous system and causing neurological problems, and impairment in colour vision especially among workers exposed to high doses of styrene.

According to the European circular economy strategy, all plastic packaging placed on the market has to be recyclable by 2030. However, for recycled plastics in direct contact with food, there are still major safety concerns because (non-)intentionally added substances can potentially migrate from recycled polymers into foodstuffs. Therefore, the European Food Safety Authority (EFSA) has defined very low migration limits for recycled polymers. Thus, the use of recycles from post-consumer waste materials in direct food contact is currently only possible for PET. However, better-structured collection systems and cleaning processes, as well as more analytical methods that enable a highly sensitive detection and identification of substances, might offer the possibility of using other polymers in recycling processes in the future.

Concerns regarding natural materials

As consumers seek more sustainable options for consuming and cooking their meals, there are a growing number of food contact materials made from novel mixtures and processes that incorporate natural materials (e. g. reusable plastics with bamboo powder which is banned in the EU or single-use bowls made of compressed plant fibers). As more of these materials enter the market it is important to regularly assess the safety of the materials and any concerns that should be raised for consideration when amending regulation.

Guan and co-authors published a study focused on chemicals in FCMs containing or made from wood and bamboo. They also summarized that most of the potentially hazardous chemicals detected in these kinds of products are from melamine-formaldehyde-resins, paints, and coatings, as well as preservatives and bleaching agents. Melamine and formaldehyde have been found to migrate from bamboo-containing plastic which is of high concern. Melamine could cause developmental or anthropometric problems, it is endocrine disruptor, neurotoxic and can damage the kidney. Paints and coatings would be problematic due to heavy metals, which can cause many symptoms and have serious health effects. Furthermore, pesticides are used to grow plants which are the resources of these materials, and it could become problematic when still present in the final product. The authors said, “there is still a lack of relevant research on bamboo and wood FCM/FCA (food contact articles), for example, more scientific evidence is strictly required to support safety assessment of those materials”.

Wrona and co-authors analysed four types of ‘natural’ dishware (bamboo, palm leaf, wood, and wheat pulp) and identified 25 non-volatile compounds in total. The migration was highest from bamboo and in the bamboo dish three oligomers exceeded specific migration limits (SMLs). The authors find “that manufacturing FCMs from natural materials does not guarantee food safety, since they may be manufactured with additives and are also susceptible to cross-contamination”. It is recommended that tableware from different origins and of different brands should be studied and clear rules for these FCMs established.

Scientists from Brazil investigated seven dry foods packaged in cellulose (main components of wood and bamboo) for the presences of phthalates and 2,6-diisopropylnaphthalene (DIPN). They reported that five of the seven samples from foods contained all targeted substances, while the remaining two contained at least one of the analysed phthalates. These plastic plasticizers (phthalates) have been associated with several human health outcomes such as lower semen quality, neurodevelopmental effects, childhood asthma, Type 2 diabetes, as well as breast and uterine cancer.

European Commission’s Working Group concluded that bamboo-based additives are not authorized per se for use in plastic FCMs in the EU and launched an EU Enforcement Action Plan to ensure that bamboo and other illegal plant-based additives are not marketed in the EU.

Concerns regarding other materials

In a Chinese study scientists analysed photoinitiators (PIs) in paper FCMs. The primary source of PIs in FCMs is printing inks, which can be found in paper straws and other paper and board food packaging. They detected several PIs and amounts of the individual compounds ranged from 1 to 195 mg/kg, although some of the detected PIs are strictly prohibited for use since they may cause a severe threat to health because PIs are carcinogenic, endocrine disrupts and toxic to reproductive organs.

Other scientists investigated several green tea and tea packaging samples for the presence and migration of short-chain chlorinated paraffins (CAS 85535-84-8) and medium-chain chlorinated paraffins (CAS 85535-85-9). They detected high level of chlorinated paraffins both in green tea and tea packaging. EFSA published its risk assessment of chlorinated paraffins in feed and food finding insufficient data to complete robust risk characterization such that a non-health-based guidance value was defined. However, in 2021 medium-chain chlorinated paraffins were added to the European Chemicals Agency’s (ECHA) Candidate List for substances of very high concern (SVHCs).

Regulations

In November 2017, the EC published a roadmap to assess the EU’s approach to regulating FCMs. In 2019, the EC launched a public consultation for consumers and another for stakeholders. The assessment identified eight fundamental issues with current FCM legislation. These include concerns like the absence of specific EU rules for most sectors other than plastics. Other concerns include poor exchange of information in the supply chain and generally poor enforcement of rules on FCMs, in addition lack of prioritization of hazardous substances. The European Union (EU) is currently evaluating its legislation on food contact materials. Currently Framework Regulation (EC) No. 1935/2004 is the cornerstone. There is Regulation (EC) No. 2023/2006 for the good manufacturing practices and are also specific legislations for material groups and components. Additionally national regulation 152/2009 (XI. 12.) FVM is also in place in Hungary.

Summary

The health of consumers is a priority regarding FCMs, which is being achieved through research conducted by EURL-FCM in the EU. However, ever-changing consumer needs require constant attention, revision, and assessments in this area, where decision-makers have a major task.

Within the EU, there are several legislations in place for FCMs, including sector-specific ones. However, there are several sectors (other than plastics) for which there is no specific legislation. There is also a lack of information exchange within the food supply chain, enforcement, and prioritisation of hazardous substances.

Many recycled polymers may pose a health risk due to their carcinogenic or neurotoxic effects. It is important to know that plant fibres and other natural materials can also pose risks, as many chemicals used during their manufacture that can leach out later when food is stored in counters made from natural materials. Several of these compounds are carcinogenic, endocrine disruptors, can cause developmental problems, and damage the kidneys and nervous system.