Revision of EU Rules on FCMs
The Commission is currently working towards delivering revised EU legislation on food contact materials (FCMs), which aims to address the challenges identified in the evaluation of the current EU legislation. In line with the Commission’s better regulation process, the work on the revision includes a reality check and an assessment of the feasibility of possible new measures and approaches with a view to ensuring the goals of simplification and proportionality. The work of the revision aims to ensure new legislation will meet the expectations of all stakeholders, including those of consumers whilst also balancing the needs of businesses. The key themes and pillars of the revision of EU FCM rules can be found in the table below.
Consultation work
The basis for the revision is a roadmap (inception impact assessment) which the Commission published on its Have Your Say website. The roadmap was open for feedback from all stakeholders for six weeks and was supported by a webinar held on Wednesday 20th January 2021. The roadmap and a summary of the feedback can be found in the table below. A 14 week public consultation was also held between 5 October 2022 and 11 January 2023; a summary of the results can be found in the table below. Supporting studies have also been carried out and details of the commissioned work can be found below.
The Commission is continuing its work on the revision and aims to further consult with stakeholders. During such consultations, the Commission services may either consult with specific experts or stakeholders, or with all interested parties, as appropriate for the objective of the consultation. During the first part of these further consultation activities, the Commission services will reach out to experts who have significant knowledge and expertise on FCMs, in particular on risk assessment of chemical substances and materials as well as compliance and exchange of information in FCM supply chains. Further, wider consultation is foreseen after these initial activities. The consultation work will help to support policy developments for the revision with a view to developing a full impact assessment and an eventual legislative proposal.
If you have any questions, comments or input on the revision of EU FCM rules, please send an email to SANTE-FCM-REVISION
ec [dot] europa [dot] eu (SANTE-FCM-REVISION[at]ec[dot]europa[dot]eu).
| Description | Date | Output documents |
|---|---|---|
| Roadmap (inception impact assessment): Revision of EU rules on food contact materials | 18 December 2020 | Roadmap |
| Webinar on the evaluation and revision of the EU rules on Food Contact Materials | 20 January 2021 | Presentation |
| Recording of the event | ||
| Summary of feedback from stakeholders on the roadmap (inception impact assessment) | 25 January 2022 | Report |
| Copy of public consultation questionnaires (EN documentation tool only) | 5 October 2022 | Consumer questionnaire Stakeholder questionnaire |
| Summary report of the public consultation | 15 June 2023 | Summary report |
| Key themes and pillars of the revision of EU FCM rules | 5 May 2023 | View document |
The following studies support the ongoing activities of the revision of EU FCM rules:
| Title/Description | Indicative timing | Output documents |
|---|---|---|
Study on citizen engagement The purpose of the study was to understand citizens’ level of knowledge and understanding of FCMs and potential risks they represent; citizens’ preferences when it comes to trade-offs between safety-hygiene-sustainability; citizens’ behaviours and usage of FCMs and; citizens information needs, preferences, and proposals for what information they would like to receive and how, including alternative proposals to the current labelling scheme. | Published October 2023 | |
Study concerning information exchange, compliance and enforcement The study aimed to develop different options to support an IT infrastructure required for information exchange and then assess the impacts of these options. The study also aimed to develop options and assess the impacts of those options, for verifying compliance, controls and the role of the different actors. | Published June 2024 | Validation workshop agenda and EY presentation Executive summary final report
|
Study on sustainability in the context of food contact materials The study aimed to define the understanding of sustainability when applied to FCMs, identify gaps and opportunities for increasing sustainable development, identify the sustainable products already on the market or under development, analyse the future market trends, identify policy measures that have the potential to increase the sustainability of FCM and characterise policy measures. | Pending publication | FCM sustainability study description |
Artisanal and traditional production of FCMs
In the course of its work on developing policy and consultation activities, the Commission needs to take into account all stakeholders who may be affected by the policy, including where there would be resource implications both from a financial and technical point of view, such as for businesses. This includes SMEs as well as large businesses but also from time to time, specific types of business such as the case for artisanal producers who are often single persons or microbusinesses as well as businesses using traditional production techniques.
As part of the overall work revising rules on FCMs, the Commission will take into account the specificities of such businesses and in particular, those producing ceramic FCMs such as tableware and kitchenware like plates, cups, glasses, bowls or oven trays and vitreous materials include glass, crystal and enamelled metals. The production of these materials involves the use of metals such as lead and cadmium, which are often used for technical (e.g. give shine, durability) or decorative purposes (e.g. colours).
Recent scientific evidence and enforcement data indicate that current exposure from those metals may be of concern and that those metals are sometimes released in significant amounts from both ceramic and vitreous FCMs. The Commission has therefore initiated action to lower migration limits for lead and cadmium as well as introducing limits for aluminium, arsenic, barium, cobalt, chromium and nickel from ceramic and vitreous food contact materials to ensure consumer safety.
In achieving the reduction and establishment of limits for these metals, additional challenges faced by traditional and artisanal producers need to be overcome, some of which are more generic to food contact compliance work and extend beyond the scope of the issue described above. Therefore, this work and the wider consideration of specific industries such as traditional and artisanal producers, is being taken forward in the work of the overall revision of EU FCM rules.
You can read more about the issue affecting ceramic and vitreous FCMs below.
Based on current health data including opinions published by the European Food Safety Authority (EFSA), there is a need to significantly lower the limits of lead, cadmium and introduce limits for aluminium, arsenic, barium, cobalt, chromium and nickel. The aim of the Commission is to expand the scope of the current EU rules – Directive 84/500/EEC – to include not only ceramic but also vitreous FCMs – glass, crystal and enamelled metals.
Considering this would affect EU producers, in particular smaller artisans, hobbyists and producers of cultural and traditional value, the Commission is also looking at ways to mitigate the impact of updating the limits on those producers.
Three types of "mitigating provisions" are being assessed:
Tailored transition plans to address the situation where a manufacturer would have significant costs, for example to replace their ovens, or need additional time and resources to change their materials and production methods in order to comply with the new limits. The legislation would set a transition period after which all articles placed on the market will need to comply. However, this may not be sufficient for some producers.
To prevent operators from having to stop their production and close their businesses, such producers would be able to agree with their national competent authorities tailored transition plans during which they can continue sell their articles while they make the necessary changes to comply. They would also need to label that their articles are under "transition" and inform customers on the adequate use and care needed.
- Quality control through the supply chain to control the quality of raw materials supplied to manufacturers and reduce their need to test final articles. Supplies will be required to know and communicate the composition of their supplies (labelling, declaration of compliance). Those selling to hobbyists and artisan must also provide adequate instructions on how to use those raw materials, the labels to put on final articles, and an explanation of legal requirements to produce and sell articles for food contact.
- Conditional derogation for artisanal and traditional products. This will enable artisans and producers of articles of traditional or cultural value to continue produce and place on the market articles that exceed by a certain maximum amount the new limits but under certain conditions: 1) mandatory labelling and adequate use and care instructions for end-users and 2) for traditional producers, mandatory application to the national competent authority.
Indeed, it may be more difficult for artisans to ensure the constant quality of their production and for some traditional and cultural articles to comply with the new limits because the value of their products depends directly on the use of those metals and/or production methods.
On 29 May 2019, the Commission published an Inception Impact Assessment, laying out the problem the initiative aims to address. It included a 4-week public feedback period, providing a first opportunity for stakeholders to give feedback.
As part of the work to assess the impacts, the Commission will carefully assess the proposed policy options and form the evidence base for a possible decision on future policy.
To support this process, the Commission will continue its close dialogue with all relevant stakeholder groups, which includes:
- The ceramics and glass industries including individual businesses, professional associations, artisans and hobbyists, and producers of articles of cultural and traditional value.
- Citizens and consumers,
- NGOs and other public-interest organisations,
- National competent authorities and EU bodies.
A study has also been undertaken, which aimed to gather data enabling the Commission to further develop policy on this issue and to help make a first assessment of expected impacts and develop the mitigating provisions under consideration.
Further consultation will provide further opportunity for the Commission to present more details of the future policy and how the mitigating provisions would work, and to get relevant feedback from all stakeholders.