Food contact materials and objects

Updates, revisions, and new developments in European MOCA legislation: from the current regulatory framework to emerging trends that place greater emphasis on the end product, prioritising the evaluation and control of the substances used, as well as the promotion of safer and more sustainable alternatives.

Edited by Marinella Vitulli, Food Contact Centre

Note: On 19 December 2024, the 26th edition of the seminar “Materials and Objects in Contact with Food” was held, organised by the Istituto Italiano Imballaggio in collaboration with the Istituto Superiore di Sanità.

The much-anticipated seminar organised by the Istituto Italiano Imballaggio took place in December 2024, marking the conclusion of numerous activities dedicated to the safety of food contact materials. The event featured the participation of Dr Maria Rosaria Milana, former head of the ISS National Reference Laboratory for Food Contact Materials, along with her entire team. Once again, the seminar generated significant interest, drawing a large audience of specialists in the field.

The morning session of the seminar focused on current legislation, highlighting recent regulatory updates, and upcoming regulations expected in the near future.

Presentations by the ISS team outlined the current state of the European and Italian regulatory framework for Food Contact Materials (MOCAs), with particular emphasis on emerging trends and new standards, including the latest updates on the regulation governing the use of recycled plastics in contact with food.

The afternoon was dedicated to a Q&A session, during which numerous questions were raised by companies, with the goal of providing operational answers to the many experts in attendance.

Current status and ongoing legislative developments

The seminar opened with a presentation by Dr Milana, who provided a comprehensive overview of current legislation related to MOCAs. She outlined the basic criteria set out in Framework Regulations (EC) No. 1935/2004 and No. 2023/2006 (Good Manufacturing Practices - GMP), pointing out that MOCAs fall under the scope of food safety. As such, they are subject to the same official control regulations that govern the food industry. The review of the European Commission's “Farm to Fork” Strategy, aimed at making the food system fairer, safer and more sustainable, was announced in 2020.  In this context, Member States are required to implement regulations and laws in line with EU policy, while adhering to the objectives set out by the Commission. With regard to changes in MOCA legislation, it is highly likely that future strategies will focus more on the end product, prioritising the evaluation and control of substances used, as well as promoting safer and more sustainable alternatives.

Changes under discussion for MOCA legislation

Future legislative strategies on MOCAs are expected to focus more on the end product, strengthening the evaluation of the substances used and promoting safer and more sustainable alternatives.
The European Commission will:

• Establish more targeted rules for end products and materials intended to come into contact with food;
• Strengthen regulations on Good Manufacturing Practices (GMP);
• Prioritise the evaluation and management of substances, with particular attention to:
• NIAS (Non-Intentionally Added Substances),
• CMR (Carcinogenic, Mutagenic and Reprotoxic) substances,
• EDs (Endocrine Disruptors) and substances classified as Persistent, Bioaccumulative and Toxic (PBT),
• Substances in nanoform and other high-concern categories.

In addition, the EU aims to encourage more sustainable alternatives by promoting safe reuse and broadening the recognition of recycling technologies that comply with environmental regulations.

Current activities and next steps

In 2024, several initiatives were launched:

• The Scoping Paper, which sets out guidelines for revising the regulations;
• A Sustainability Study, aimed at analysing the market to identify eco-friendly solutions;
• The Reassessment of Priorities in coordination with the newly appointed European Commission.
• The roadmap includes:
• Publication of the Policy Paper by the end of 2025;
• Impact Assessment by mid-2026;
• Legislative Proposal in early 2027.

A key aspect of the revision is to improve the quality and accessibility of information throughout the supply chain, particularly through the digitalisation of compliance documentation to support businesses. Finally, the possibility of involving delegated bodies (as per EU Regulation No. 625/2017) is being considered to expand the scope of official controls beyond the current competent authorities. The evolution of MOCA regulations is expected to continue in the coming years, necessitating that all stakeholders in the industry adapt to ongoing changes.

Evolution of specific EU activities: state of the art

The conference then delved into the activities carried out by various institutional technical working groups.

1) Regarding the future 18th amendment to Regulation (EU) No. 10/2011, there is a need to align with Regulation (EU) No. 2022/1616, which will involve substantial revisions to the articles.
In this case, the main proposed changes include:

• Revision of Article 2: introduction of new definitions, such as “plastic rework” and “UVCB substances” (substances of unknown or variable composition);
• Amendment to Article 4: clarification that plastic materials placed on the market must comply with Regulation (EU) No. 2022/1616 when applicable;
• Revision of Article 5: confirmation that only substances included in the EU List may be used, with the possibility of consulting EFSA when substance identity is unclear;
• Amendment to Article 6: authorisation for the use of substances with biocidal properties, provided they are approved under  the Biocidal Products Regulation (EU) 528/2012;
• Deletion of Article 7: removal of the provisional list of new substances;
• Revision of Article 8: strengthening of purity requirements for substances used in MOCAs, with the addition of a new Article 3a defining the “high degree of purity”.
• Amendment to Article 14: introduction of specific migration testing for multi-material, multi-layer materials;
• Revision of Chapter IV: introduction of a new Article 14a regulating the repeated use of plastic materials to prevent degradation that could increase the migration of substances into food;
• Amendment to Article 16: updates to the requirements for the Declaration of Conformity.

Finally, the new amendment introduces stricter requirements for multi-material, multi-layer plastic materials, specifying that if the food contact layer is made of plastic, it must comply with the migration limits established by Regulation No. 10/2011. The Declaration of Compliance is also being updated to include more detailed information on the duration and temperature of treatment and storage of plastic objects intended for repeated use.

2) Regarding the new regulation on Bisphenol A (BPA), the introduction of stricter measures was anticipated, including a ban on the use of BPA as a monomer or starting substance in adhesives, rubbers, plastics, paints, silicones and other food contact materials. Limited exemptions are foreseen for specific industrial applications, but these will be subject to stringent requirements for undetectable content. This regulatory update is part of an ongoing process, with further changes expected by 2025.

3) A presentation then focused on Regulation (EU) No. 2022/1616 on recycled plastics, a key issue in the context of the circular economy. Effective as of 10 October 2022, the new regulation establishes a legal basis for all recycling processes, covering technologies already recognised as suitable (such as mechanical recycling of PET) and new technologies still under development. A key requirement is that recycling processes must reduce any initial contamination to levels that pose no risk to human health, with particular emphasis on the decontamination phase.
A quality assurance system in accordance with Regulation (EC) No. 2023/2006 has been implemented to ensure the safety of the materials produced. The regulation governs the placing on the market of recycled plastics intended for food contact, establishing conditions and restrictions of use, which must be documented through a specific Declaration of Conformity. In addition, suitable recycling technologies must be evaluated by EFSA and authorised by the European Commission and Member States. The regulation also mandates the recording of all information necessary for official controls and compliance documentation, including the preparation of Compliance Monitoring Sheets (CMSS). For new technologies, the regulation establishes an evaluation process that includes notification to the Competent Authority at least six months prior to the decontamination facility becoming operational, publication of periodic reports, and, if the collected data is deemed sufficient, submission of a request for evaluation by EFSA. Lastly, the implementation of a Community Registry is currently underway, aimed at managing information on recycling facilities and technologies.

4) The findings correlated to official controls were then explained. In 2024, the Rapid Alert System for Food and Feed (RASFF) recorded 170 alerts concerning Materials and Objects intended to come into Contact with Food (MOCAs), a figure that remains stable compared to the previous year, yet lower than the 2021-2022 period, which saw approximately 200 alerts.  The main critical issues reported involved the migration of hazardous substances, with 40% of alerts concerning the presence of primary aromatic amines, melamine, and formaldehyde, particularly from items containing bamboo. Metals, such as chromium, nickel, manganese, arsenic, aluminium and cobalt accounted for 19% of the alerts, while lead, mostly found in pizza boxes and ceramic items, accounted for 12.5%. Other issues reported included bisphenol A (10 alerts), phthalates in pizza boxes (16 alerts), and non-compliant overall migration levels (13 alerts). One noteworthy aspect was the considerable number of alerts (24) concerning false declarations of conformity or insufficient documentation, which highlights the need for stricter oversight of the traceability and regulatory compliance of MOCAs. There was also evidence of a sharp decline in alerts involving MOCAs containing bamboo and other unauthorised plant-based fibres (such as rice, corn, and cotton), which had accounted for 60% of alerts in 2021 but dropped to just 5% in 2024, thanks to a coordinated action plan implemented by Member States.

5) Subsequent presentations covered ongoing activities of the European EURL FCM laboratory, which provides scientific and technical support to Member States and assists the European Commission during the pre-regulatory and revision phases of MOCA legislation.  The collaborative efforts between National Reference Laboratories (NRLs) and the EURL were highlighted, as well as training programmes (workshops and courses) and interlaboratory comparison exercises aimed at ensuring consistent and harmonised criteria for the conformity assessment of food contact materials and objects (MOCAs). Particular attention was given to the current regulations governing plastics, paper and cardboard, metals and alloys, as well as to the harmonisation of testing methodologies. The Joint Research Centre (JRC) is conducting targeted studies to improve the reliability of migration testing, particularly on parameters such as oven temperature, item placement, stability of testing conditions, and temperature monitoring using calibrated instruments. In addition, work is underway to define the maximum expected lifespan of a MOCA, with the aim of providing detailed guidance on instructions to slow material degradation, as well as on the observable changes that indicate the end of the material's life. Future initiatives include the publication of guidelines for the design of migration tests and the assessment of compliance of plastic MOCAs intended for repeated use, along with the organisation of new Proficiency Testing (PT) schemes focused on substances of concern such as PFAS and BPA.

Question Time: the answers to companies

A question time session was held on the afternoon of 19 December, during which the team from the Istituto Superiore di Sanità addressed questions submitted by participants earlier in the day. The session was followed by comments on the practical aspects of implementation. One of the issues raised concerned multi-material, multi-layer materials. In response to a specific question, it was confirmed that if the food contact layer is made of plastic, it must comply with the migration limits established by Regulation (EU) No. 10/2011. Other questions focused on Declarations of Conformity, with participants seeking clarification on whether the recent changes will introduce new requirements for their preparation and completion. ecycling was also a topic of discussion, given that current legislation could significantly affect the extent to which companies in the sector will need to adapt. Additional topics raised by participants included the presence of contaminants such as bisphenols and perfluorinated compounds. As always, it was a lively and engaging debate, underscoring the importance of participating in industry events of this kind.