On May 1, 2024, the UK Department for Environment, Food and Rural Affairs (DEFRA) notified to the European Union (EU) and the World Trade Organisation (WTO) the draft Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024. The introduction of this regulation is a crucial step towards the implementation of Extended Producer Responsibility (EPR) for packaging across the UK and provides clarity across the supply chain, helping stakeholders prepare for the EPR coming into force next year.

Objective

The aim of the new regulation is to provide consumers with clear and consistent information on recycling through the introduction of a specific label, thereby improving recycling rates and reducing environmental impact, thereby supporting the country’s environmental objectives.

Development of the Regulations

The Regulations have been developed following extensive consultations in May 2019, March 2021 and July 2023, incorporating feedback from a wide range of stakeholders. These Regulations aim to reform the UK’s packaging producer responsibility system and align it with wider environmental objectives.

New Regulation (EU) no. 2055/2023 marks a decisive turning point in the fight against microplastic pollution, an environmental problem of growing concern. This regulation represents a significant step towards achieving the objectives of the European Green Deal and the new action plan for the circular economy, placing the European Union at the forefront of environmental protection and food safety.

Context and Objectives

The EU aims to reduce (intentional and unintentional) microplastic releases by 30% by 2030, an ambitious target that reflects a commitment to a zero pollution action plan. Regulation (EU) 2055/2023 amends Annex XVII of the REACH Regulation, introducing new restrictions for entry 78, which concerns synthetic polymer microplastics, thus limiting the intentional addition of these substances in a wide range of products.

What are Microplastics?

Microplastics are defined as microparticles of synthetic polymers that can be contained in particles, constituting at least 1% by weight, or create a continuous surface coating. Those with dimensions equal to or less than 5 mm, or with a length less than 15 mm and a length/diameter ratio greater than 3, are particularly regulated.

Significative Exclusions

The regulation specifically excludes:

• Natural polymers not chemically modified
• Degradable polymers, according to the criteria of Appendix 15
• Water-soluble Polymers beyond a certain threshold, as defined in Appendix 16
• Polymers without carbon atoms in their chemical structure.

Impact on Products and Market

With the entry into force of the regulation, there is a ban on the manufacture, use and marketing of various products containing microplastics. This will affect sectors such as artificial sports surfaces, cosmetics, detergents and others, with variable deadlines depending on the product.

Supplier Responsibilities

Suppliers of synthetic polymer microparticles are now required to provide detailed instructions for use and disposal from October 17, 2025, to prevent their release into the environment.

Degradability and Solubility Standards and Tests

The Regulation establishes rigorous standards for demonstrating the degradability and solubility of polymers, requiring tests conducted by laboratories compliant with good laboratory practices or accredited according to ISO 17025.
Regulation (EU) no. 2055/2023, which entered into force on October 17, 2023, represents a clear signal of the EU’s commitment to environmental sustainability and public health. It is essential that companies begin to evaluate and adapt their practices to ensure they are in full compliance with these important new provisions.

The path towards the elimination of microplastics is complex and requires a joint commitment from companies, consumers and institutions With this new regulation, the EU is laying the foundations for a cleaner and safer future, where citizens’ health and environmental protection are undisputed priorities.

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.