On 22 April 2024, the European Commission adopted criteria outlining what constitutes ‘essential uses’ of the most harmful chemicals (‘Guiding Criteria and Principles for the Essential Use Concept in EU Legislation Dealing with Chemicals’). This move aims to improve health and environmental protection by accelerating the phase-out of non-essential uses while allowing time for substitution in essential cases.

What is an essential use

In the Communication published on 22 April, the Commission defines that a use of a most harmful substance is essential only if both of the following two criteria are met:

1. Its use is necessary for health or safety or is critical for the functioning of society.

2. There are no acceptable alternatives.

The concept of essential use will only have legal effect if it is included in specific legislation which is currently not the case in the EU.

Most harmful chemicals

A most harmful substance has one or more of the following hazard properties:

• Carcinogenicity Category 1A and 1B.

• Germ cell mutagenicity Category 1A and 1B.

• Reproductive/developmental toxicity Category 1A and 1B.

• Endocrine disruption Category 1 (human health).

• Endocrine disruption Category 1 (environment).

• Respiratory sensitisation Category 1.

• Specific target organ toxicity – repeated exposure (STOT-RE) Category 1, including immunotoxicity and neurotoxicity.

• Persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB).

• Persistent, mobile and toxic/very persistent and mobile (PMT/vPvM).

• Hazardous to the ozone layer Category 1.

Use necessary for health and safety

The use of a most harmful substance is necessary for health or safety if the use and the technical function of the substance in that use are necessary in order to:

• Prevent, monitor or treat disease and similar health conditions.

• Maintain essential conditions for human or animal life and health.

• Manage health crises and emergencies.

• Ensure personal safety.

• Ensure public safety.

These elements are described in the Annex to the Communication (Table 2).

Uses critical for the functioning of society

The use of a most harmful substance is critical for the functioning of society if the use and the technical function of the substance in that use are critical in order to:

• Provide resources or services that need to be maintained for society to function (e.g. ensure the supply of energy and critical raw materials or resilience to supply disruptions).

• Manage societal risks and impacts of natural crises and disasters.

• Protect and restore the natural environment.

• Undertake scientific research and development.

• Protect cultural heritage.

These elements are described in the Annex to the Communication (Table 3).

Definition of ‘use’

In the context of the essential use concept, 'use' applies to substances in various forms, including mixtures, articles, products or processes. It covers activities such as processing, formulation, consumption, storage, treatment and production. The assessment of essentiality takes into account both the technical function of the substance and the context of its use. A substance may be essential for one product, but not for another.

Integrating essential use into legislation

The Communication outlines the guiding principles and criteria for the concept of essential use, with the aim of incorporating it into EU legislation in a harmonised way. The legal effect of the concept will only be achieved through its inclusion in legislation, a process which depends on impact assessments.

At present, the essential use concept is not part of the REACH regulation and therefore does not influence initiatives such as the restriction of PFAS. Nevertheless, the Communication reaffirms the Commission's commitment to phasing out harmful substances while recognising their essential societal role, particularly in the green and digital transition.

The European Commission is in the process of amending the regulatory frameworks governing plastic materials and articles intended for food contact. A feedback period on a draft regulation ended recently and the amendments are planned to be adopted in the fourth quarter of 2024.

Aimed at improving food safety and environmental standards, these amendments will update Regulation (EU) No 10/2011 and Regulation (EC) No 2023/2006 and include provisions for the use of recycled plastics and refinement of quality control measures across the EU.

Key highlights of the draft regulations include:

- Clarification on Plastic Materials: The new regulations will address ambiguities in the current legislation by redefining "plastic layers" to ensure broader coverage of all plastic materials and articles, thereby strengthening safety measures.

- Use of Recycled Plastics: To promote sustainability, the updated rules will specify the conditions under which recycled plastics can be used in food contact materials, ensuring that they meet stringent safety standards to prevent chemical migration into food.

- Purity and Safety: The amendments emphasize the high level of purity required for materials used in food contact articles. This includes detailed purity specifications for natural and synthetic substances to protect consumer health from potential chemical contamination.

- Biocidal Products: The new framework will align with Regulation (EU) No 528/2012 which outlines the use of biocidal products in the manufacture of food contact materials, ensuring that all substances used are authorized and safe for food contact.

- Increased Transparency: Manufacturers will be required to provide detailed documentation of compliance to enforcement authorities, improving traceability and accountability in the manufacturing process.

- Consumer Information: The regulations will also enforce clearer labelling requirements to inform consumers on the safe use of plastic food contact materials, especially those intended for repeated use, to avoid deterioration and potential health risks.

Impact on Manufacturers and Consumers

Manufacturers will need to adapt to these stricter controls which may increase production costs due to higher purity standards and more rigorous testing requirements. However, these changes are expected to benefit consumers by providing greater assurance of the safety and quality of food contact materials in the EU.

Regulatory Transition and Implementation

The amendments will provide a transitional period for manufacturers and businesses to comply with the new standards, allowing products that comply with the previous regulations to be marketed until stocks are exhausted. This phased approach aims to minimize disruption to the supply chain while maintaining a high level of  public health and food safety protection.

Conclusion

This regulatory update underscores the EU's commitment to public health, environmental sustainability and the highest safety standards for food contact materials. By incorporating modernized procedures and stringent controls, the EU continues to lead in comprehensive consumer safety and environmental protection initiatives.