New Environmental EU Regulations

The EU recently introduced two new Regulations aimed at protecting the environment. They are the Microplastics Regulation and the Batteries Regulation. Both are in force now but are designed so that their measures will be introduced over a phased period. We review some of the highlights of these Regulations and how they apply to the life sciences sector.

Microplastics Regulation

The intentional use of microplastics is to be restricted under EU law. Microplastics are all synthetic polymer particles (SPMs) below five millimetres that are organic, insoluble and resist degradation. They are used in a wide array of products across a range of life sciences, including amongst others:

• Medicine
• Pharmaceuticals
• Biomechanics
• Horticulture

However, the EU recognises the environmental damage caused by microplastics. By a recent amendment to the REACH Regulation[1] , the EU aims to restrict the use of microplastics. This will be achieved by prohibiting the placing on the EU market of microplastics designed to be used on their own or as additives in products which release microplastics when used.

The amendment to the law entered into force on 20 October 2023. However, the restrictions will take effect on a phased basis between 2023 and 2035, as set in our previous article. An exemption will apply to a limited range of medicinal and veterinarian products, in vitro diagnostic devices, and fertilisers. However, manufacturers of exempted products will have to provide instructions on how to use and dispose of the product to prevent microplastic emissions.

This legislative amendment is a significant step towards the reduction of plastic pollution in line with the European Green Deal, Circular Economy Action Plan and Zero Pollution Action Plan. Owing to the current widespread use of microplastics, these restrictions are likely to have a profound impact on the life sciences industry. Although the restrictions are to be introduced over a 12 year period, manufacturers and suppliers of products containing microplastics should become familiar with the regulations now, so they have ample time to adjust their processes and plan for the future.

Batteries Regulation

By 2030, battery demand is expected to rise by 140%. The EU's new Batteries Regulation[2]entered into force on 17 August 2023. It applies to all manufacturers, importers and distributors of all battery types on the EU market. The Regulation mandates the collection, reuse, and recycling of batteries to the highest standard. This aims to minimise their carbon impact and enable Member States to achieve the targets set under the European Green Deal. The targets aim to make Europe the world’s first carbon-neutral continent by 2050.

The Batteries Regulation lays down requirements on sustainability, safety, labelling, due diligence, and green public procurement of all types of batteries placed, made available or put into service on the EU market. For example, this means that any entity that imports from non-EU countries batteries for use in medical devices or imports medical devices containing batteries, will be subject to the Batteries Regulation. The Regulation also lays down minimum requirements for extended producer responsibility, the collection and treatment of waste batteries and for reporting. Some of the headline measures are:

• A restriction on the use of mercury, cadmium, and lead in batteries.

• The introduction of an electronic 'battery passport' and QR codes for all batteries. The battery passport must provide information on the performance, durability and chemical composition of the battery for which it is created.

• All economic operators, excluding SMEs, who place or bring batteries into service on the EU market must carry out due diligence to ensure materials used in their production are sourced and processed responsibly. Large economic operators will have to verify the source of raw materials used in the manufacture of batteries and provide this information to the relevant national authority. The national authority will periodically perform audits on due diligence records and policies.

• Economic operators must incorporate this due diligence into contracts with suppliers. They must also implement mitigating measures to address any adverse effects on the environment which emanate from their supply chain.

• All waste batteries will have to be collected free of charge from the end user by economic operators placing them on the market.

Some of the dates for introduction of measures under the Batteries Regulation include:

• Producers of portable batteries must achieve 45% collection of waste batteries placed on the market from 31 December 2023.
• An EU declaration of conformity must be provided to confirm compliance with the requirements laid down in articles 6 - 10 and articles 12 – 14 from 18 February 2024. CE marking must be affixed visibly, legibly and indelibly to the battery.
• Conformity assessment of batteries must be carried out in accordance with the procedures set out in Part A, Part B and Part C of Annex VIII to the Batteries Regulation from 18 August 2024.
• Economic operators must on an annual basis review and make publicly available, including on the internet, a report on its battery due diligence policy from 18 August 2025.

Conclusion

The Microplastics Regulation and Batteries Regulation exemplify the circular economy objectives underpinning the European Green Deal and they reflect the EU’s commitment to ensuring a safer and more sustainable economy. For manufacturers, importers, producers, and suppliers of batteries and microplastics, it is important to be familiar with the requirements of these Regulations. There is a broad range of matters that must be complied with. These will be introduced incrementally in the coming years.

For more information on the Microplastics Regulation or the Batteries Regulation, please contact a member of our Planning & Environment team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.

[1] Commission Regulation (EU) 2023/2055 of 25 September 2023 amending Annex XVII to Regulation (EC) No 1907/2006

[2] Regulation (EU) 2023/1542 of 12 July 2023 concerning batteries and waste batteries