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.
Food Packaging Forum, 14-06-22