EFSA has recently carried out a new assessment of the public health risks of styrene, a substance used in plastic FCM, currently regulated in Regulation (EU) 10/2011 on plastics without a specific migration limit (SML) or other use restrictions.
In 2019, the International Agency for Research on Cancer (IARC) published a monograph classifying styrene and its main metabolite, styrene-7,8-oxide (SO), as “probably carcinogenic to humans”. As this classification could influence the inclusion of styrene in the Plastics Regulation, the European Commission asked EFSA to assess whether the evidence presented by IARC could impact the safety of using styrene in food contact materials.

In September 2020 EFSA, with a first assessment, concluded that concerns about the genotoxicity of styrene following oral exposure could not be excluded and that further data were needed to accurately assess its safety in FCM.
Considering the uncertainty about genotoxicity, the absence of an SML and the high potential for styrene to migrate into food from FCM, the European Commission proposed a draft measure setting an SML for styrene of 40 ppb, based on the tolerable daily intake (TDI) suggested by the World Health Organization (WHO) for styrene in drinking water.
The European Commission subsequently requested EFSA to review the potential genotoxicity of styrene following oral exposure and its safety for use in plastic FCM with an SML of 40 ppb.
As the WHO TDI predates the new scientific information emerging from the 2019 IARC classification and EFSA opinion in 2020, EFSA conducted a new assessment to determine whether the 40 ppb limit for styrene in food was adequate to ensure safety, evaluating, among others, the studies reported in the 2019 IARC monograph.

EFSA concluded that the reviewed studies did not show evidence of genotoxic effects of styrene following physiological exposures, including oral exposure.
For substances for which no genotoxic effects have been found, EFSA’s Note for Guidance for FCM states that an SML of up to 50 µg/kg food would not pose a health risk. Therefore, the use of styrene in the production of FCM with a migration limit set at 40 µg/kg food does not pose a health risk to consumers.

EFSA invited interested parties to submit comments on the draft opinion by 28 January 2025.

SVHC and packaging

With regard to the use of SVHC substances in packaging materials and products, packaging producers and importers must comply with some requirements set out in the REACH regulation: they must ensure that all chemical substances present in the packaging are registered, evaluated and, if necessary, authorised; if a package contains an SVHC substance in a concentration higher than 0.1% by weight, the producer or importer must inform the users of the packaging and provide information on the substance, including its identification and any risks to health and the environment.
Companies should try to reduce the use of SVHC substances in packaging, adopting safer alternatives or optimising production processes. This is to reduce the risk of damage to human health and the environment and ensure compliance with European regulations.

SVHC and food packaging

The obligations for SVHC substances must also be respected for food packaging.
Food packaging may contain SVHC substances (such as plasticizers, colorants, stabilizers or additives) which, if released into the food, could pose a risk to human health. If a SVHC substance is present in concentrations above 0.1% by weight in the packaging material and can migrate into the food product, there may be a risk to the consumer.
The risk assessment of SVHC (Substances of Very High Concern), as well as all other substances considered potentially dangerous, in food packaging is a fundamental part of safety management and compliance with European regulations, in particular food safety legislation, such as Regulation (EC) 1935/2004.

Detection and identification of SVHC substances

The first step in the risk assessment is to identify whether there are any hazardous substances in the food packaging. If there are any SVHCs among them, this involves:

• Materials Analysis:
  Examine the materials used to produce packaging, such as plastic, paper, metal, varnishes and adhesives.
• Consultation of the candidate list:
  Check whether some of the substances used in the materials are included in the candidate list, which is constantly updated by the European Chemicals Agency (ECHA).
• Migration risk assessment:
  One of the crucial steps in the risk assessment is to determine whether the SVHC substance migrates from the packaging material to the food in quantities that may be dangerous to human health. Migration is influenced by various factors, including the type of packaging, conditions of use, chemical properties of the substances.

Conclusions

Risk assessment of hazardous substances, including SVHCs, in food packaging is a complex process that requires a combination of chemical analysis, migration testing and compliance with food safety regulations. Companies must ensure that packaging does not release hazardous substances in quantities that could compromise consumer health and food, managing risks through preventive measures, such as the use of appropriate materials and continuous verification of compliance with current legislation.

Issues related to the BPA ban

Issues related to the prohibition of BPA include finding viable alternatives, some of which are already in place for materials for which it is currently prohibited, and managing its unintentional presence. BPA can be found in FCM as a contaminant from recycled waste, non-reacted monomer, vapour phase transfer or it can be present as non-intentionally added substance (NIAS) in other plastics as polystyrene. It may also be present in food as an environmental contaminant or as an alternative bisphenol (such as BPF) resulting from industrial processes.