On September 24, 2018 the European Commission’s Directorate General for Health and Food Safety (DG SANTE) held a stakeholder meeting on the evaluation of the Food Contact Materials (FCM) regulation (FPF reported). The meeting’s purpose was to start the evaluation process, inform participants about the twelve months evaluation period, and to collect input for the evaluation process and its content. All presentation slides along with materials related to the ongoing evaluation are available at DG SANTE’s evaluation website.
Sabine Juelicher, Director of DG SANTE’s Food and feed safety, Innovation (unit E), set the frame for the evaluation, stating that the “FCM scope is wide and actually quite challenging”. The economic relevance of this sector is estimated at about 100 billion € annually, or 0.5% of the EU’s Gross Domestic Product (GDP). The current EU FCM regulation dates back more than 40 years and has two main objectives: (1) to protect public health from harmful chemicals originating from FCMs and (2) to ensure the functioning of the free EU market. The purpose of the evaluation exercise is to assess how the existing legislation is performing in meeting its two main objectives. This step will serve as basis for reflections on what needs to be done to improve legislation, “if anything”, as Sabine Juelicher stated. Further, she asked for facts and evidence, and emphasized that all contributions were welcome.
Jonathan Briggs is leading the evaluation process within DG SANTE’s unit E2, Food processing technologies and novel foods. A roadmap for the evaluation was published by DG SANTE in November 2017 (FPF reported), and stakeholder feedback on the roadmap was received (FPF reported). In his overview of the EU FCM regulation Jonathan Briggs pointed out that some issues raised by stakeholders are known, for example the “non-harmonized” FCMs for which EU-wide specific measures are absent. Further issues relate to the risk assessment of plastic FCMs, the positive list for chemicals in plastic FCMs, as well as information exchange in the supply chain. He also stated the need to assess coherence with other EU legislations.
Details on the evaluation process were shared by Michael Lasch of DG SANTE’s unit A1, Better regulation. The evaluation will be carried out using Better Regulation Guidelines. Michael Lasch stated that “stakeholder input is at the core” of this process, where a fitness check will be carried out to assess how the regulation performs. The timeframe for the evaluation is twelve months, starting in September 2018. Publication of the final report is foreseen for October 2019, and a staff working document will be prepared at the beginning of 2020.
Further speakers included Eddo Hoekstra, European Commission’s (EC) Joint Research Centre and head of the EU Reference Laboratory for FCMs, who reviewed the so-called baseline study which provides an overview of the non-harmonized materials (FPF reported). He stated that around 8,000 substances are intentionally used in non-plastics FCMs across the EU, with specific legislation in different Member States. Notably, many substances included in national legislation have not been risk assessed. Eric Barthelmy, European Food Safety Authority (EFSA), reviewed risk assessment tasks performed by EFSA’s Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel). The guidelines for risk assessment of chemicals to be used in plastic FCMs were published in 2001 and apply to date. In 2016, EFSA’s CEF Panel published a scientific opinion on the safety assessment of FCMs (FPF reported), and the Food Packaging Forum has commented on it (FPF reported).
Non-governmental organizations (NGO) representatives Michael Warhurst, CHEM Trust, Pelle Moos, The European Consumer Organisation (BEUC), Sophie Perroud, Health and Environment Alliance (HEAL), and Alice Bernard, ClientEarth presented their views of the EU FCM regulation in a joint NGO statement, noting that the current system is not fit for purpose and that it is unfortunate that DG SANTE sees the need to spend another twelve months to evaluate it. A further conclusion was that “consumers worry about chemicals of concern” in FCMs. The NGO speakers stressed the fact that issues relating to FCM regulations have been raised in the past, for example in the EU Parliament’s report in 2016 (FPF reported). All FCMs should have EU-wide regulation, non-intentionally added substances (NIAS) as well as mixtures need to be addressed appropriately, and all levels of endocrine disrupting chemicals (EDC) should be removed from FCMs. For this purpose, already existing information, for example from the EU chemicals regulation REACH, should be integrated into new FCM regulation. Further, the realities of the circular economy need to be appropriately addressed, for example in adequate measures for paperboard recycling into FCMs. In addition, the need for transparency in the FCM regulatory process was stressed. At present, the expert group working together with DG SANTE consists exclusively of industry members. This group’s tasks are extensive, and its activities are not publicly disclosed. Another way is possible, according to Alice Bernard, as the example of REACH shows.
The perspectives of the FCM manufacturing industries were presented in two talks given by Michel Cassart, Plastics Coordination Group and Plastics Europe, and John Dixon, Cross Sector Group and Flexible Packaging Europe. For plastics manufacturers, the main issues relate to what needs to be measured exactly in terms of chemicals migration, and how measurements are to be performed. A technical guidance document detailing migration assessment has so far not been published by the European Commission. Further, Michel Cassart stated that current risk assessment requirements set a high barrier for new product development which limits innovation. Improvements in the risk assessment process, which is very time consuming at present, are necessary. In addition, he stated that any new rules and migration limits need to be controllable, in the sense that low migration limits technically can be measured. The Plastics Coordination Group has prepared a proposal for new FCM regulation and is ready to share it once the evaluation process has been concluded. Speaking on behalf of the non-harmonized FCMs, John Dixon shared advantages and disadvantages of the existing FCM regulation. In the FCM framework regulation (EU 1935/2004), Article 3 is the cornerstone for ensuring compliance and “the best way of” protecting public health. However, no harmonized, official guidelines exist for how industry needs to demonstrate compliance with Article 3, which makes it very challenging for industry, also in their communication with other participants in the supply chain.
Gregor McCombie of the Official Food Control of the Canton of Zurich gave an overview of enforcement of the EU FCM regulation, which is also applied in the non-EU member country Switzerland. Three elements are important for enforcement, (1) Inspection, where processes at businesses are checked, (2) product control, where chemical analyses of retail products are performed, and (3) documentation controls, where Supporting Documentation and Declarations of Compliance are assessed for their completeness. McCombie stated that at present, enforcement of FCMs in Europe mostly does not work. Reasons for this are, according to him, the large number of substances, with around 100,000 different chemicals expected to be present in all different types of FCMs, of which only around 10,000 are intentionally added, about 1000 are specifically regulated, and less than 100 are effectively controlled by enforcement. In many EU countries, no chemical analysis of FCMs is performed at all. An example of successful enforcement is Denmark, where all businesses in the FCM sector need to register and regular inspections are carried out. According to McCombie, many businesses lack the knowledge on the risks associated with chemical migration from FCMs. In order to enforce the FCM regulations, severe EU-wide fines as they are foreseen in other areas of EU legislation would be necessary.
Addressing the evaluation process and study, representatives of Ecorys, the contractor running the evaluation, described the five evaluation criteria according to which the FCM regulation will be assessed: Effectiveness (i.e. does the regulation deliver as expected), Efficiency (i.e. cost vs benefits), Relevance (i.e. addressing the needs and problems), Coherence (i.e. overlaps with or discrepancies to other EU regulations), and EU added value (i.e. compared to EU not intervening). A subset of pre-defined questions will be asked for each criterion, and sub-topics for the evaluation will be set. Starting by the end of November 2018, stakeholders will be contacted and asked to join focus groups, give expert interviews, and respond to surveys. Additionally, an SME panel will be established, and an open public consultation is foreseen for the beginning of 2019 with the aim to solicit input from the general public. A draft final report is expected to be circulated in summer 2019, with a second stakeholder workshop planned for September 2019, and a final report scheduled for October 2019. Ecorys will be managing the evaluation process and all input can be sent to fcm(a)ecorys.com . It was stressed that input from all stakeholders is welcome.
European Commission (2018). “Evaluation of Food Contact Materials (FCMs).” Evaluation website.
Luke Buxton (October 4, 2018). “EU Commission begins evaluation of FCM regulation.” Chemical Watch
IBE-BVI (October 2018). “Evaluation of Food Contact Materials (FCMs).”
Sidsel Dyekjaer (October 16, 2018). “Finally, a review of Europe’s ineffective laws on chemicals in food contact materials has begun.” CHEM Trust
Jonathan Kleimark (October 18, 2018). “What’s the difference between a take-away cup and a receipt?” International Chemical Secretariat
CHEM Trust, BEUC, HEAL, ClientEarth (September 24, 2018). “EU laws on chemicals in food contact materials: a system in dire need of reform.” (pdf)