On July 1, 2020, the European Commission (EC) published the final report supporting the ongoing evaluation of the food contact material (FCM) legislation in the EU. Carried out by the consultancy Ecorys, the evaluation’s “objective is to provide the Commission with factual, quantitative and qualitative data and a comprehensive analysis to answer 10 evaluation questions” and to serve as input in the development of a Commission Staff Working Document that will provide “evidence-based conclusions and prioritization of the areas that require action” within the FCM legislation.

The evaluation by Ecorys focused on five criteria, namely effectiveness, efficiency, relevance, coherence, and EU added-value provided by the current legislation:

  • In terms of effectiveness, the report concludes that the positive list for plastic FCMs “is seen as offering a generally effective approach to protecting human health.” However, it finds that gaps remain due to the complexity of polymers, many migrating substances, and a lack of consideration for non-intentionally added substances (NIAS) and the cocktail effects of migrating substances. The lack of EU-wide regulation on currently non-harmonized materials is seen to “lead to lack of clarity (e.g. on risk assessment, testing approaches), need for specific legal advice (both internal and external), obstacles to trade, language barriers, lack of transparency (i.e. national legislation that disregards the EU nature of supply chains and only addresses national circumstances).”
  • In terms of efficiency, the report offers estimates of benefits provided by the FCM regulations based on available (but notably incomplete) information. It reports a “considerably” underestimated benefit to human health valued at exceeding 1 billion Euro per year along with a likely overestimated annual cost for industry of over 3 billion Euro per year. The study, however, finds that “overall, the benefits for human health arising from the safety of FCM outweigh the costs of the legislation for the industry.” There is a strong unified call for more harmonization across industry sectors, also “suggesting that harmonization leads to reduced costs.”
  • In terms of relevance, the report finds that the regulation “reflects the needs for protection of human health and preservation of organoleptic properties of food.” It notes that there are (i) growing consumer interests in environmental issues covered by other pieces of legislation, (ii) a desire for harmonized measures covering all FCMs in the form of a Union list and/or harmonized guidelines, (iii) and a call from authorities for “more capacity and expertise to carry out inspections and controls” including analytical methods.
  • In terms of coherence, the report finds again that a lack of harmonized regulations has led to challenges and additional compliance burden, including complex national regulations on certain materials. Coatings, inks, adhesives, and paper and board were mentioned most often as needing harmonized legislation across EU member states. Civil society groups also highlighted a lack of current legislation considering combined effects from mixtures of migrating substances, a lack of measures to address recognized substances of very high concern (SVHCs), and overall a lack of coherence (especially in risk management) between FCM regulations and other chemicals legislation (such as REACH).
  • In terms of EU added-value, the study finds that “the harmonization introduced by Regulation (EC) 1935/2004 provides EU added-value but its impact is reduced by incomplete implementation: fifteen years after the entry into force of the legislation, specific measures are in place for only four [out of 17] materials.” The harmonization that has been achieved for plastics was found to provide added-value and be more efficient compared to a non-harmonized approach. Several overall factors limiting the legislation’s effectiveness include “difficulties of official control bodies to adequately enforce the legislation and difficulties encountered by companies in complying with requirements regarding declarations of compliance” as well as small and medium-sized enterprises (SMEs) being disadvantaged compared to larger companies.

A roadmap for the evaluation was first published in November 2017 (FPF reported). As part of the evaluation, a first stakeholder event was held in September 2018 (FPF reported), and a public consultation was open from February to May 2019 (FPF reported). Many stakeholders provided input during the public consultation period (FPF reported), including a position paper submitted by the Food Packaging Forum. A second stakeholder workshop took place in September 2019 (FPF reported), and the outcomes from a workshop with policy and enforcement officials on FCMs in June 2019 have also recently been published.

Read More

European Commission (July 2, 2020). “Evaluation of Food Contact Materials (FCMs).”

Chemical Watch (July 16, 2020). “Key study highlights weaknesses of EU FCM legislation.”


European Commission (July 2, 2020). “Study supporting the Evaluation of Food Contact Materials (FCM) legislation – (Regulation (EC) No 1935/2004).”