Environmental sustainability and ESG compliance in the life sciences industry

Jay Sattin
Mason Hayes & Curran, Dublin
jsattin@mhc.ie

Jenny Kelehan
Mason Hayes & Curran, Dublin
jkelehan@mhc.ie

Introduction

As the life sciences sector continues to evolve, so too do the sustainability laws that regulate it. From the batteries powering medical devices to the chemicals used in cosmetics, environmental sustainability rules impact the core elements of businesses operating across the life sciences sector. In a complex and changing legal landscape, compliance is a significant challenge. In this article, we provide an overview of some of the laws in five key areas affecting the life sciences sector and provide advice for industry on how to prepare for compliance.

Batteries

Batteries are crucial components of medical technology. Implantable medical devices are powered by batteries. Substantial volumes of other medical equipment also rely on batteries, either as their main or back-up power source. The European Union’s Batteries Regulation^[1] aims to ensure that batteries placed for sale on the EU market are sourced and manufactured in a sustainable manner. The Regulation sets out, among other things, rules on the sustainability, performance, safety, collection, recycling and second life of batteries. Specific obligations apply depending on an operator’s role in the supply chain, for example:

• manufacturers need to carry out a conformity assessment, provide technical documentation and apply CE marking;
• importers need to verify the CE marking and technical documentation provided by the manufacturer, and ensure that the manufacturer has complied with certain information requirements; and
• distributors need to verify that a battery bears the CE marking and is marked and labelled correctly, and ensure that both the manufacturer and importer have complied with certain information requirements.

Companies placing batteries on the EU market may also need to register with an extended producer responsibility (EPR) scheme.

The Regulation also provides for an electronic ‘passport’ and quick response (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.

Medical devices exemption

The Batteries Regulation applies to all batteries placed on the EU market, including ‘portable’ batteries, which are most commonly used in medical devices. However, there is an exemption for ‘professional medical imaging and radiotherapy devices’ and ‘in vitro diagnostic medical devices’.

Due diligence requirements

The Regulation imposes stringent due diligence (DD) requirements on economic operators that place batteries onto the EU market or supply batteries for particular services and have a turnover of over €40m. It should be noted that the European Commission has proposed increasing this threshold limit to €150m, in order to exempt ‘small mid-cap’ companies.^[2]

The application date has recently changed, and the rules will now apply from 18 August 2027.^[3]

Broadly speaking, applicable ‘economic operators’ must implement a DD system to reduce the risk of environmental and human rights abuses arising from their supply chain. This includes preparing DD policies that:

• assess the social and environmental risks associated with the raw materials used to make that operator’s batteries;
• communicate these risks to the relevant supply chain operators and the public more generally; and
• be verified by a notified body, noting that they may be subject to an audit by the relevant enforcement authorities.

Next steps

Batteries are regularly used in devices in life sciences. If a business’s device uses a battery, it is important for that business to understand its role and obligations under the Regulation, including whether an exemption applies.

If a business is subject to DD obligations, it should look out for the guidance issued by the European Commission, which is required to be published one year before the DD obligations take effect. Although this delay gives businesses significantly more time to comply, the DD requirements can be onerous and preparation for compliance should start now.

Chemicals and per- and polyfluoroalkyl substances (PFAS)

Chemicals play a critical role in the life sciences sector, particularly for pharmaceuticals, cosmetics and healthcare organisations. The chemicals industry is undergoing significant regulatory change at the EU level. For example, the European Commission announced an Action Plan for the chemicals industry in July 2025. The Action Plan sets out concrete measures, designed to strengthen global competitiveness and modernise the sector. The move is part of a wider simplification package known as the 6th Omnibus Package, which aims to simplify EU laws and cut administrative burdens.

The Action Plan includes five key areas. We outline the two areas most relevant to the life sciences sector below.

PFAS

A key element of the Action Plan concerns restricting PFAS. Prior commitments to minimise PFAS emissions will remain in place. Under the Action Plan, the European Commission will consider banning PFAS, also known as ‘forever chemicals’, in regard to consumer uses, such as cosmetics. However, the use of PFAS will be permitted to continue in critical applications, for eg, medicinal products. Their use will be subject to strict conditions and will only be allowed in instances where no viable alternatives are available.

The European Chemicals Agency (ECHA) will play a pivotal role in the regulation of PFAS, which includes the substances that fall within the scope of the Revised Urban Wastewater Treatment Directive (Directive (EU) 2024/3019), discussed below. The European Commission will also invest in innovation, promote remediation based on the ‘polluter pays principle’ and prioritise the development of safer alternatives.

Regulatory simplification

The European Commission has proposed the 6th Omnibus Package to simplify EU chemicals legislation and enhance the governance of the ECHA. The package includes measures to:

• simplify labelling rules for hazardous chemicals;
• clarify EU cosmetics regulations;
• introduce a delegated act on low-carbon hydrogen; and
• ease the registration requirements for EU fertiliser products.

As part of the Omnibus Package, the European Commission has proposed new rules to strengthen and modernise the governance of the ECHA. The proposed ECHA Basic Regulation aims to equip the ECHA with better resources, flexibility and structures that are necessary to carry out its growing mandate.

Looking forward

Life sciences businesses should ensure that they keep up to date with updates from the European Commission on chemicals regulation, particularly in relation to PFAS. One item to look out for is the ECHA’s proposal to restrict PFAS under the EU’s chemicals regulation, REACH.^[4] The ECHA has carried out risk assessments for several sectors, including medical applications like immediate packaging and excipients for pharmaceuticals. Ultimately, the European Commission will decide on any PFAS restrictions in consultation with Member States.

Micropollutants extended producer responsibility (EPR)

Producers of medicinal and cosmetics products will have to pay for the removal of micropollutants from urban wastewater under an amendment to the Urban Wastewater Treatment Directive (UWWTD).^[5] Under the revised UWWTD, Ireland will be required to establish an EPR scheme by 31 December 2028 to fund its enhanced treatment of micropollutants from urban wastewater. At least 80 per cent of the cost of this enhanced quintenary treatment will be recovered from ‘producers’ who place on the Irish market certain medicinal products for human use and certain cosmetic products.

‘Producers’ include:

• manufacturers;
• importers;
• distributors; and
• distance sellers.

The revised UWWTD covers a greater amount and more types of pollutants. It includes:

• heavy metals;
• microplastics;
• micropollutants; and
• other chemicals, such as PFAS.

Exemptions

Ireland will be obliged to provide an exemption from the EPR scheme for certain producers. This will include producers who can demonstrate, for the products they place on the EU market, that:

• the quantity of the substances contained in the products is below one tonne per year; and
• the substances contained in the products are rapidly biodegradable in wastewater or do not generate micropollutants in wastewater at the end of their life.

Looking forward

Ireland will have until 31 July 2027 to transpose the provisions set out in the revised UWWTD into national legislation. As EU directives do not have direct effect, Ireland has a certain level of discretion in regard to how to transpose the revised UWWTD into national law.

Producers should:

• engage with government to discuss the implementation of the EPR scheme;
• avail of any opportunities or guidance issued by the European Commission to try to ensure the costs they are required to pay do not have the effect of endangering the affordability, availability or accessibility of these products on the EU market; and
• consider assessing their ‘contribution’ to the EPR scheme, which is based on the quantities and hazardousness of the substances in urban wastewater, and whether this can be reduced, for example by substituting hazardous substances for alternatives that do not give rise to the accumulation of the applicable micropollutants.

Packaging

Strict rules already apply to the packaging and labelling of medicinal products. Since 11 February 2025, new rules on the sustainability of packaging apply to all types of packaging, regardless of the material used, and to all packaging waste. The EU’s new Packaging and Packaging Waste Regulation (PPWR)^[6] imposes requirements for the entire lifecycle of packaging, from its manufacture to its use and disposal. It imposes new and more stringent obligations on multiple different operators involved in that packaging lifecycle, including manufacturers, importers and distributors.

The core objectives of the PPWR include:

• reducing packaging waste;
• introducing enhanced recyclability and reusability requirements; and
• reducing substances of concern in packaging, especially in food packaging.

Like in relation to batteries, life sciences businesses need to identify their role in the supply chain and whether they are placing the packaging or packaged products on the EU market, as the obligations vary accordingly. For example, importers and distributors are prohibited from placing packaging on the market that does not conform with the PPWR. This means that, in order to comply with their own obligations, importers and distributors must also check that the relevant manufacturers have complied with their obligations. The PPWR sets out some specific elements of compliance that importers and distributors must verify have been complied with.

Manufacturers are subject to extensive obligations under the PPWR. Key obligations relate to:

• limiting harmful substances in packaging, particularly food packaging;
• recyclability and recycled content requirements;
• packaging minimisation;
• labelling; and
• conformity assessments.

Exemptions

While the PPWR applies to all packaging, including that for medical devices and pharmaceuticals, certain exemptions apply to packaging that is considered to be essential to a product’s integrity, safety and function. Exemptions include, among others:

• packaging that directly holds medicines;
• packaging required by law to preserve the quality of the product; and
• contact-sensitive plastic packaging for medical devices and in vitro diagnostic medical devices.

Next steps

The PPWR is long, detailed and complex. It applies from 12 August 2026, with obligations coming into effect on a phased basis. This gives life sciences businesses some time to get to grips with their new obligations and make any necessary to changes to their packaging and supply chains.

Manufacturers should take immediate steps to familiarise themselves and ensure appropriate procedures are put into place to comply with the Regulation. Importers and distributors should start getting their operations and supply chain ready for compliance now. Cooperation with all of the players involved in a company’s supply chain and comprehensive, accurate data collection will be critical to successfully achieving compliance.

Green claims

The Green Claims Directive (GCD) was proposed by the EU in 2023 to protect consumers from misleading environmental marketing practices, often known as ‘greenwashing’. A key element of the rules is the requirement that evidence provided by companies to substantiate green claims is verified by national accredited third parties.

The European Commission announced the withdrawal of the proposed GCD in June 2025, but later clarified that its formal withdrawal had not occurred. Whether the GCD will be adopted remains to be seen.

The existing framework

Regardless of whether the GCD is withdrawn, life sciences businesses producing products in the EU need to comply with the existing anti-greenwashing legislative framework, which includes laws like:

• the Unfair Commercial Practices Directive (2005/29/EC);
• the Consumer Protection Act 2007; and
• the Green Transition Directive (Directive (EU) 2024/825) (which is due to apply from 27 September 2026).   

Next steps

Life sciences businesses making environmental claims about goods and services should be aware of the risk of litigation and regulatory scrutiny. The industry should monitor updates on the status of the GCD.

Conclusion

Sustainability laws significantly impact the life sciences sector. Despite the EU’s simplification agenda, complying with complex sustainability regulations remains a challenge. Now, more than ever, it is important for the industry to stay informed about the evolving regulatory landscape, familiarise itself with key laws and implementation dates and prepare for compliance early.

Notes