On March 13, 2024 the European Commission opened the public consultation on the draft of a new regulation which will update Regulation (EU) no. 10/2011 on plastic materials intended for contact with food.
This legislative measure was necessary in particular to align with Regulation (EU) 2022/1616 on recycled plastics and Regulation (EU) No. 528/2012 on biocidal products

Main updates of the new regulation

The main changes brought by the new regulation will concern:

• Clarifications regarding the purity requirements of authorized substances and rules for the use of authorized natural materials.
• Indications on the reprocessing of plastic materials (processing waste and scraps).
• Integration into Regulation (EC) no. 2023/2006 on good manufacturing practices for MOCA, rules on quality control and management of waste and processing scraps.
• Elimination of article 7 (provisional list) and revision of the exemptions for substances not included in the Union list for biocidal products already authorized in Regulation (EU) 528/2012 for food contact (PT4), for use as additives for plastic materials.
• Review of migration testing rules for multi-material multilayer fcm: application of migration limits when the plastic material is the layer in contact with food.
• Review of tests and labelling for articles intended for repeated use.
• Review of the declaration of compliance with the addition of new points for indications on recycled plastics and the possible reprocessing of plastic material.

On February 9th 2024, the European Commission opened the public consultation on the draft of the new Regulation which will ban the use of bisphenol A (BPA, CAS 80-05-7), together with other bisphenols, in materials intended into contact with food (FCM) and will repeal Regulation (EU) 2013/2018.

Why ban BPA

This legislative measure follows the publication, in April 2023, by the European Food Safety Authority (EFSA), of a scientific update which highlights the insecurity of current dietary exposure to BPA, with a reduction in tolerable daily intake (TDI) by a factor of 20,000 (from 4 µg per kg of body weight set in 2015 to 0.2 ng per kg of body weight in 2023).
You can find more details in this article.

Transitional provisions and Derogations

The legislative proposal that introduces the ban on the use of BPA in FCM provides transitional periods to facilitate the adaptation of the industries involved. Specifically, for varnishes, coatings and final articles used as components in professional food production equipment, a period of 36 months is allowed to adapt to the new legislation, while for all other uses, the transitional period will be 18 months.

Despite the firmness of the ban, the proposal provides some significant exemptions including:

• The use of BPA disodium salt for the manufacture of polysulfonic resins used in plastic membranes in contact with food, which will be permitted by updating the annex I of Regulation (EU) 10/2011, provided that migration into the food does not occur.
• The use of BPA in the production of BADGE (CAS 1675-54-3) permitted exclusively for the creation of resistant varnishes and coatings, intended for containers with a capacity greater than 250 litres, provided that no migration of BPA into foods is found.
• A derogation of up to 10 years is granted for repeat-use final articles used in professional food production equipment.

As regards the unintentional presence of BPA in recycled materials, the proposal recognizes the impracticability and disproportionality of an absolute ban, instead providing for the establishment of a monitoring and notification system at European Union level involving business operators and Member States, focused in particular on recycled paper and board.

Other Bisphenols

To prevent BPA from being replaced with equally dangerous substances, the new regulation extends its caution to all other bisphenols used in food contact materials, which will need to be risk assessed and authorized before their use, ensuring they do not compromise human health. This measure reflects the precautionary approach already adopted for plastic materials according to Regulation (EU) 10/2011.

Consultation, Publication and Entry into Force

The Commission opened the public consultation from February 9th to March 8th 2024, inviting all interested parties to actively participate in the definition of this important legislative measure for the protection of public health and food safety within the European Union.
The adoption of the new Regulation is scheduled for the first quarter of 2024; the restriction is expected to become effective in late 2025 or early 2026.

The relationship between chemicals and materials in contact with food (FCM) and their influence on food safety and environmental protection is at the heart of an important debate.

In 2016, the European Parliament took a decisive position with the resolution “Implementation of the Food Contact Materials Regulation”, based on crucial assumptions for more effective and sustainable management.
This resolution emphasised the need for improved coordination to protect consumer health and reduce the environmental impact of packaging materials. In addition, it stressed the importance of supplementing REACH legislation, which aims to improve the protection of human health and the environment from the risks that can be posed by chemicals, with that of FCM, which aims to ensure the safety of food contact materials, especially for substances classified as CMR (carcinogens, mutagens or toxic to reproduction) or SVHC (substances of very high concern) by proposing the phasing out of harmful substances.

On December 7 2023, the European Commission, inspired also by Parliament’s resolution of 2016, presented the reform “One substance, one assessment” which aims to harmonise and simplify the assessments of chemicals in the EU.

The legislative package consists of 3 proposals:

1. Proposal for a Regulation establishing a common data platform on chemicals;
2. Proposal for a Regulation on the re-attribution of scientific and technical tasks and improving cooperation among Union agencies in the area of chemicals;
3. Proposal for a Directive on the re-attribution of scientific and technical tasks to European Chemicals Agency.

Within the “Chemicals Strategy for Sustainability (CSS)”, the 3 legislative proposals aim at a more effective management of chemical data, addressing key issues such as:

• the establishment of a common data platform,
• the redistribution of tasks among the EU agencies (ECHA, EFSA, EEA, EMA),
• the systematic collection of human biomonitoring data,
• the establishment of a monitoring and outlook framework,
• the possibility of the European Chemicals Agency (ECHA) to generate data,
• ensuring the transparency of scientific studies on chemicals, including those commissioned by companies.

Currently, there are still some critical issues. Regulation REACH (EC) 1907/2006, with its updates and amendments, still allows derogations for the use of hazardous substances, such as dibutyltin compounds, in FCM. This situation, like others, raises questions about the real effectiveness of the new legislative package in rapidly changing existing practices and about the ability to transfer chemical assessments from one legislative context to another.

Despite these misgivings, the “one substance, one assessment” package represents a significant step towards achieving the objective of more coherent and sustainable management of chemicals in the EU. This initiative lays the foundations for a future in which the information obtained from one legislative area can be applied in others, thereby promoting a more integrated and systematic approach.
Not only a paradigm shift in the management of chemicals in FCM, but also a broader vision for a future environmental and food safety policy in the EU. This vision is in line with the growing awareness of the need for more sustainable and responsible practices in the production and consumption of goods.

The next steps will include the examination of proposals by the European Parliament and the Council, following the ordinary legislative procedure. From the choices of the European institutions the EU could become a global model for the sustainable management and chemicals evaluation.