THE EU’S CHANGING SUSTAINABILITY REGULATORY LANDSCAPE: A FRAMEWORK FOR OUR FUTURE

The sustainability regulations for personal protective products in the EU are changing. In this blogpost, we’ll explore the latest developments and explain what Ansell’s doing to meet and exceed compliance around the following new regulations:

• Extended Producer Responsibility (EPR)
• European Union Deforestation-Free Products Regulation (EUDR)
• Digital instructions for use (Digital IFUs)
• Corporate Sustainability Reporting Directive (CSRD)
• Ecodesign for Sustainable Products Regulation (ESPR)

To protect people and planet, it’s important to choose a PPE provider who's compliant – but we're going beyond compliance to get in front of these changes and further improve our sustainability performance, while also supporting our customers’ own sustainability goals.

Extended Producer Responsibility (EPR)

What is it?

Extended Producer Responsibility (EPR) is an environmental policy that makes producers responsible for the entire lifecycle of their products, from production to disposal. The aim is to incentivize manufacturers to design less environmentally impactful products and EPR policies already exist in some countries. Depending on the region, EPR laws can cover different materials, but they commonly include packaging, plastic, paper, textiles, batteries and various electronics.

EPR schemes for all packaging should be established in all EU member states by the end of 2024.

What's Ansell doing?

As well as working to comply with relevant EPR schemes in all the countries we sell to and operate in, we’re going beyond standard EPR regulations. Our aim is to redefine the waste footprint of the PPE industry by rethinking our design and packaging. This includes:

• Minimizing raw material use
• Replacing fossil fuel-based materials with bio-based materials
• Incorporating more recycled materials into our products

We've already made significant progress:

• We now use 46% less paper and 35% less plastic than in 2020.
• Packaging for our Industrial products is 96% recyclable.
• 100% of healthcare segments’ outer-case and inner-dispenser packaging is recyclable, excluding plastic packaging required to protect product sterility or particulate cleanliness and all our packaging will be recyclable, reusable, or compostable by 2026.
• Alongside all this progress, through our RightCycle program, we’ve been working with recycling partners to create circular solutions to help our customers recycle or responsibly dispose of our gloves.

European Union Deforestation-Free Products Regulation (EUDR)

What is it?

The European Union Deforestation Regulation (EUDR) is an EU legislation, published in June 2023, which aims at combatting deforestation and forest degradation. The regulation is part of the EU’s efforts to help protect forests worldwide and support sustainable land-use practices to fight against climate change and biodiversity loss.

This new regulation prohibits the import and export of deforestation-linked commodities to and from the EU, unless it can be proven that they are deforestation-free by providing geolocation information on the harvesting site. Rubber, palm oil, soy, coffee, cocoa, wood, beef, and products made using these commodities are all covered by the EUDR.

What's Ansell Doing?

At Ansell, since some of our rubber PPE and medical gloves are made from natural rubber latex, they fall within the scope of the EUDR, so we see this new regulation as a great opportunity to build the EUDR into our existing commitment to sustainability and ethical practices.

We're committed to ensuring the traceability of our products and providing our customers with accurate documentation to verify EUDR compliance. This includes information about the country of production, coordinates of the plot of land where the rubber was harvested, and the date of harvesting.

We will also publicly report on our due diligence efforts, and our customers will be able to obtain our due diligence statement reference number via the EU’s Deforestation Information System to comply with the EUDR.

Digital instructions for use (IFUs)

What are they?

Instructions for use (IFUs) are the instruction documents that accompany products such as electronics, medical devices or PPE. Digital IFUs, also known as eIFUs, are non-paper versions of IFUs which allow manufacturers and distributors to provide legally required product-related instructions in a paper-free way. In October 2023, European PPE regulation guidelines were modified, removing the requirement for printed IFUs.

What's Ansell doing?

As a result, Ansell is now in the process of transitioning to digital IFUs, which are better for our customers and the environment:

• In the PPE industry alone, switching to digital IFUs should save 45,000 tonnes of paper usage every year across the EU, helping us and our customers to achieve their waste reduction goals.
• Digital IFUs are more convenient for our customers as they can be accessed easily from any device at any time and there’s no need to store them.
• They can be accessed in multiple languages and read more easily by customers with disabilities who use assistive technology.
• Lastly, customers can be confident that they always have the most up-to-date information, because digital IFUs can quickly be updated by the producer whenever needed.

Ansell’s paper IFU removal started in November 2024 for EMEA/APAC, but printed IFUs will still be available to our customers upon request and free of charge.

By the end of 2025, digital IFUs will be in place for products sold in the EU. And our packaging products will have QR codes by this time*.

Corporate Sustainability Reporting Directive (CSRD)

What is it?

The Corporate Sustainability Reporting Directive (CSRD) is EU legislation, published in December 2022, which is significantly expanding and standardizing the requirements for sustainability reporting in the EU. The aim of this change is to improve corporate transparency and promote sustainable business practices.

Under the CSRD, companies must submit a detailed report covering:

• How company operations affect environmental, social, and governance (ESG) issues
• How these issues impact the company’s development, performance and position

These disclosures must contain very specific information relating to climate-related risks, strategies for transitioning to a sustainable economy, and many other facets of ESG.

The CSRD also specifies that companies must report using European Sustainability Reporting Standards (ESRS). This is to ensure consistency and comparability of data, as the ESRS provide a standardized approach to sustainability reporting. To verify the accuracy and reliability of the information provided, reports must be audited by an independent third party.

The amount of time companies have to prepare for the CSRD depends on their size and company classification. For Ansell, CSRD reporting obligations will apply to our FY26 reporting period (1 July 2025 – 30 June 2026).

What's Ansell Doing?

We're making sure we'll be ready for the CSRD in the following ways:

• Planning for our future reporting includes a complete review of our reporting boundary against CSRD and preparation of a timeline and action plan for full CSRD and ESRS compliance.
• We already prepare our annual reports, sustainability reports, and labour rights reports in accordance with multiple mandatory and voluntary national and state legislations, as well as internationally recognized voluntary sustainability reporting standards and frameworks.
• We voluntarily prepare our sustainability and labour rights reports in accordance with the Global Reporting Initiative (GRI) Standards 2021. Plus we report in line with the recommendations of the Task Force on Climate-Related Financial Disclosures (TCFD).
• Our annual submission is always performed under UNGC CoP (Communication of Progress).

For Ansell, the CSRD has provided a great opportunity to raise our sustainability performance to the next level and we’re looking forward to its implementation.

Ecodesign for Sustainable Products Regulation (ESPR)

What is it?

The Ecodesign for Sustainable Products Regulation (ESPR) is EU legislation, published in June 2024, which establishes a framework for the ecodesign requirements with which products must comply to be sold in the EU.

This regulation applies to almost all categories of physical goods, with some exceptions such as food, animal feed and certain vehicles. It aims to make sustainable products the norm and ensure free movement of sustainable products within the EU.

As this legislation is very new, the details about how it will impact specific product categories have not yet been decided. But ecodesign requirements will eventually be introduced, and will look to improve products aspects such as durability, upgradability and recycled content.

A “digital product passport” must also be made available for each product, which will be stored by a digital product passport service provider and made easily accessible to customers and other stakeholders. The digital product passport will contain important information about the product, ensuring that actors along the value chain can easily access and understand product information relevant to them.

The ESPR officially came into force on 18 July 2024 but the first ESPR working plan is only scheduled for sometime before 19 April 2025. This working plan will identify the prioritized products for setting ecodesign requirements, and the estimated timelines for the adoption of the requirements. Currently, the first new product requirements are only set to become active in mid-2027.

What's Ansell Doing?

Although it’s not clear yet exactly how this legislation will apply to different products, that doesn’t mean companies can’t be proactive in embracing it. By making an effort now to improve our products’ ecodesign, we’re leading the way towards ESPR compliance and minimizing our product’s impact on the planet.

We are currently investing in renewable materials and sustainable packaging, and improving our manufacturing processes and the end-use of our products. Specifically, we’re aiming to:

• Use less fossil fuels and more recycled and bio-based content materials.
• Design products with reduced environmental impact.
• Make our packaging material 100% recyclable, reusable, or compostable by 2026.
• Reduce our plastic and paper packaging use by 2026.

Of the new and updated products launched this year, 60% are designed with reduced environmental impact when compared to traditional products of a similar nature.

^{*This applies to all products except in cases where local compliance and certification requirements mandate the continued use of paper.}