On June 10, 2022, the European Commission published its staff working document, and regulatory scrutiny board opinion on the evaluation of the EU food contact material (FCM) legislation, (EC) No. 1935/2004. The review found “that EU FCM Regulation is partly effective in fulfilling its two main objectives” – securing a high level of protection of human health and ensuring the functioning of the internal market, but overall, the efficiency of the FCM legislation appears to be sub-optimal.”   

Issues raised in the review include (i) a lack of safety or regulatory specificity for materials other than plastic, (ii) overlooking the nature of some substances intentionally used in plastics and additional risks posed from non-intentionally added substances (NIAS), (iii) a high uncertainty connected with the unknowns around technologies like nanomaterials, bioplastics, and chemical recycling, (iv) a scarcity of safety information being exchanged through the supply chain, and (v) a lack of efficiency and being unable to fully address safety concerns when performing risk assessments.  

According to the working document, for materials that are not plastic, the current FCM regulation is not specific enough while the rules that are in place are “technically complex.” Specifically, Article 3 of the FCM regulation, which is meant to be the principle legal requirement, “does not define the level of safety or quality expected for many [materials other than plastic], which may differ amongst stakeholders. Further, it does not state how safety should be achieved or how it can be demonstrated.” Because there are currently no EU-wide specific rules for many FCMs other than plastics, individual Member States have defined their own substance lists, migration limits, or testing regimes at the national level. Remaining compliant is therefore more time- and resource-intensive, which has made operations especially challenging for small and medium-sized businesses.  

The regulation of plastics is considered to be the most developed of any FCM type and includes a positive list of substances to be used in their manufacture (FPF reported). Still, the EC’s working document writes that even the plastic regulation “is compromised by derogations for some substances such as colorants and so-called non-intentionally added substances (NIAS).” It is also challenged by new processes or more complicated materials including bioplastics, chemical recycling, and multi-materials. 

The Commission’s review found a lack of supply chain transparency paired with a lack of resources and clarity for oversight. Together, the issues point to “a clear need to standardize, simplify and clarify rules on compliance documentation, improve the quality and exchange of information along the supply chain and reinforce the system of enforcement.”  

The Commission reviewers argue “efficiency gains could be made with a less specific [risk assessment] approach as many substances are used in more than one material type.” In the current FCM regulation, substances are assessed according to estimated exposure from a specific use while REACH “includes a more generic risk approach (GRA) with certain hazardous properties that are automatically prioritized for risk management.” The review finds, “the main consequence of this is a lack of prioritization of safety matters in the FCM approach.”  

The differences in these two current regulatory approaches can be especially confusing and concerning when one substance is restricted under REACH due to environmental concerns while still authorized for use in food contact materials. The Commission’s working document notes that “the current approach is potentially suboptimal, as it does not address the most hazardous substances migrating from all materials. Doing so could lead to greater efficiency through enhanced health gains whilst making use of existing relevant information such as that generated under the REACH Regulation.” 

The evaluation of the EU’s FCM regulation began in 2018 with a stakeholder workshop (FPF reported), followed in 2019 with a public consultation (FPF reported) and another stakeholder workshop (FPF reported).

Scientists from the Food Packaging Forum recently identified 388 intentionally used food contact chemicals that are harmful according to the EU’s Chemicals Strategy for Sustainability (FPF reported). The authors of the published study support FCM regulatory reform that moves towards generic risk assessment, allows only a defined set of safer chemicals (“positive list”), and explicitly restricts most harmful chemicals (“negative list”). They further suggest adapting the definition of FCM safety to mean that no untested substances and no hazardous chemicals are present in a finished food contact article. 

 

Reference 

European Commission (June 2022). “Evaluation of Food Contact Materials (FCM).”

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