CLP, REACH and PPWR: Toward Strategic Regulatory Convergence to Support Sustainable Innovation in Life Sciences

The European Union (EU) is undergoing a major overhaul of its strategy on chemical safety, product traceability and environmental sustainability. At the heart of this transformation are three key regulatory pillars: (1) the CLP Regulation(Classification, Labelling and Packaging of chemical substances and mixtures); (2) the REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals), and (3) the new PPWR (Packaging and Packaging Waste Regulation), formally known as Regulation (EU) 2025/40, published on 22 January 2025.

These texts are reshaping the regulatory landscape for placing industrial products on the EU market and have major implications for all life sciences stakeholders, including the pharmaceutical, medical device, cosmetics and biotechnology sectors.

1. CLP and REACH: New Classifications and Strengthened Chemical Requirements

Since its application in 2009, the CLP Regulation (1272/2008) has provided a harmonised framework for the classification and labelling rules for chemical substances in the EU. Regular updates to the regulation through Adaptations to Technical Progress (ATPs) ensure that it evolves alongside scientific advancements. The most recent update, Regulation (EU) 2024/2865, published in the Official Journal of the EU (OJEU) on 20 November 2024, entered into force in December 2024 and must be implemented within 18 months or 2 years, depending on the provisions concerned. It updates the classification of 28 substances^[1]. 

Table 1:  Seven substances of particular relevance to the life sciences sectors, resulting from the CLP update through Regulation (EU) 2024/2865. 

The structural revision of CLP represents an important regulatory turning point. It introduces new hazard classes to better identify and manage substances that pose long-term risks to human health and the environment. These hazard classes were formally adopted in 2023 via Delegated Regulation (EU) 2023/707, and include:

• ED HH (endocrine disruptor for human health), Category 1 and 2
• ED ENV (endocrine disruptor for the environment), Category 1 and 2
• PBT (persistent, bioaccumulative and toxic)
• vPvB (very persistent and very bioaccumulative)
• PMT (persistent, mobile and toxic)
• vPvM (very persistent and very mobile)

By integrating these categories, the EU aims to better identify and manage chemicals that pose significant risks to human health and the environment.

Transitional periods^[2] apply from the entry into force of the Delegated Regulation during which manufacturers, importers, downstream users and distributors are not yet required to classify substances or mixtures according to the new hazard classes. During these periods, the new hazard classes may be applied on a voluntary basis. Once the transitional periods end, all operators must apply the new classification rules.

For new substances placed on the EU market, companies must comply with the new hazard classes as of May 1, 2025. For substances already placed on the EU market before that date, compliance is required by November 1, 2026.

Separate transitional deadlines apply for mixtures. The new hazard classes must be applied to new mixtures from 1 May 2026, while companies have until 1 May 2028 to update the classification and labelling of existing mixtures.

From 1 May 2025, individual substances falling within these new hazard classes must be classified and labelled accordingly when placed on the EU market. Importantly, transitional provisions apply. Mixtures that have already been classified, labelled and packaged before this date and are already on the market may continue to be supplied until 1 May 2026, allowing industry some flexibility in adapting to the new requirements. However, any new placing on the market of substances or mixtures after 1 May 2025 must comply immediately with the revised classification.

Additional transitional provisions apply under Articles 61(7) and 61(8) of the CLP Regulation (2024/2865):

• Article 61(7): Provisions related to data assessment and certain labelling exemptions apply as of 1 July 2026, with a transitional period until 1 July 2028. Substances and mixtures placed on the EU market before 1 July 2026, that are already in the supply chain are exempt from these rules until 1 July 2028.
• Article 61(8): New labelling requirements apply as of 1 January 2027, with a transitional period until 1 January 2029. Products placed on the market before 1 January 2027, that are already in the supply chain may remain compliant until 1 January 2029.

Among the additional changes introduced by the revision:

• Clarification of the rules for classification of mixtures and substances with more than one constituent;
• Introduction of grouping approaches for harmonised classification (group of similar substances);
• Requirements for clearer and more legible labelling, including digital labelling provisions;
• Changes to the information submitted to and published in the classification and labelling inventory;
• Empowerment of the European Commission to mandate the European Chemicals Agency (ECHA) or the European Food Safety Authority (EFSA) to propose harmonised classifications;
• New rules for the sale of chemicals at refill stations;
• Clarification of the role of distributors as potential duty holders for poison centre notifications.

In parallel, the REACH Regulation requires registration and data sharing on the toxicological and ecotoxicological profile of substances. A substance classified as PMT under the revised CLP Regulation may be subject to restrictions or authorisations under REACH, which could lead to cascading consequences for supply chains and manufacturing, including to authorisation requests, usage restrictions, or even substitution requirements.

For stakeholders across the biotechnology, pharmaceutical, cosmetics, and medical device sectors, these changes reflect an increased emphasis on safer chemical management, transparency and sustainability. However, they also introduce operational complexities, including supply chain audits, risk assessments, and design adjustments to ensure product compliance. Preparation to address these multi-dimensional challenges is not only vital for regulatory alignment but also presents an opportunity to drive sustainable innovation within the EU.

2. PPWR: Toward Circular, Recyclable, and Traceable Packaging

The Packaging and Packaging Waste Regulation (PPWR), formally known as Regulation (EU) 2025/40, marks a significant advancement in the EU’s efforts to achieve sustainable packaging design and waste management. Adopted on 19 December 2024 and published in the OJEU on 22 January 2025, the PPWR (Regulation 2025/40) replaces Directive 94/62/EC on packaging and packaging waste. It introduces stricter rules on packaging design, recyclability and reuse, as part of the European Green Deal¹. This regulation is a major step toward reducing packaging waste, supporting the circular economy and emphasizing environmentally responsible manufacturing practices.

2.1 Tightened Design and Circularity Requirements

The regulation aims to reduce over-packaging and to phase out non-recyclable packaging. It introduces harmonized environmental labelling, including logos, pictograms, QR codes, to help consumers better understand packaging composition and sorting requirements. Ensuring digital traceability of materials is another innovative aspect, leveraging technology to track packaging flows and enhance market transparency. Lastly, the regulation bans certain hazardous substances in packaging materials, aligning with REACH and CLP requirements. Implementation has begun progressively from January 2025 onwards, depending on product categories. The regulation also establishes ambitious recycling targets aimed at reducing waste generation across multiple material categories. The EU targets an overall recycling rate of 70% by 2025 and 75% by 2030, with specific targets according to material type:

• 85% for paper and cardboard
• 80% for glass
• 75% for ferrous metals and aluminium
• 65% for plastics

These recycling goals align with broader sustainability ambitions under the European Green Deal, signaling the start of a systemic transformation in packaging production.

¹ The European Green Deal is a comprehensive EU policy framework aimed at achieving climate neutrality by 2050, fostering a circular economy, protecting biodiversity, and promoting sustainable energy, agriculture, and transport, while ensuring economic growth and social equity.

2.2     Combatting Over-Packaging: Focus on E-Commerce and Retail 

To combat over-packaging, strict measures will apply to the e-commerce and retail sectors. Manufacturers must prove that packaging is optimised and does not use excessive raw materials. Beginning in 2028, PET packaging will need to contain at least 30% recycled plastics, with progressive expansion to other materials by 2035, thus further incentivizing the integration of secondary raw materials and reducing reliance on primary resources.

The PPWR regulation also introduces binding reuse targets, an essential step toward circularity. By 2030, 40% of non-alcoholic beverage packaging must be reusable, encouraging companies to prioritize sustainable alternatives such as refillable or returnable packaging. Similar obligations will extend to the food industry and delivery platforms, urging the adoption of reusable containers within these high-waste sectors. This reuse-first approach paves the way for more durable product designs and longer material lifecycles, reducing single-use waste streams.

Another significant innovation involves harmonised labelling. To promote transparency, all packaging must include standardized harmonized labels indicating its composition, recyclability, and sorting instructions. Labels will feature pictograms, QR codes, and other user-friendly formats to simplify consumer decisions and improve recycling rates. By enhancing clarity, the regulation aims to bridge the gap between technical innovation in packaging design and real-world adoption by users.

The regulation also introduces advanced digital technologies to monitor packaging flows, enhancing traceability and accountability for manufacturers. By integrating these systems, businesses can better understand material lifecycles and ensure compliance with sustainability benchmarks. The prohibition of hazardous substances complements ongoing efforts under CLP and REACH, creating a more unified regulatory framework for chemical safety and sustainability.

The PPWR represents a major milestone in waste reduction and circular product design. By embracing ambitious recycling targets, actionable reuse strategies, and enhanced consumer engagement, it offers a model for sustainable innovation that can inspire global regulatory efforts, especially within sectors like pharmaceuticals, cosmetics, and medical devices. 

3. Why Connect CLP, REACH, and PPWR?

CLP, REACH, and PPWR are mutually reinforcing regulatory texts that, together, create a cohesive framework to address chemical safety, environmental sustainability, and product lifecycle management. For instance, a substance reclassified according to the new hazard classes introduced by the revised CLP (such as endocrine disruptors or PMT substances) must be reassessed under REACH to evaluate its health, safety, and environmental profile. This could lead to restrictions or conditions imposed on its usage. If the substance is present in packaging materials, the implications extend to compliance with PPWR, as these materials must meet strict sustainability and substance requirements, including recyclability and the prohibition of certain hazardous chemicals. Companies must therefore adopt an integrated regulatory management approach, combining substance compliance with packaging and sustainability requirements.

For manufacturers in the biotechnology, pharmaceutical, cosmetics and medical devices sectors, this interconnectedness of the regulatory texts necessitates an integrated regulatory management approach. Companies must align chemical compliance with packaging sustainability while navigating complex supply chains. Adopting a proactive strategy—anticipating regulatory changes rather than reacting to them—can minimize compliance risks while unlocking opportunities for innovation in product design, material use, and environmental stewardship.

4. Key Dates and Regulatory Milestones

The regulatory roadmap includes several significant dates that mark the implementation of these changes:

For the industry, this means:

• 2024–2025: Major compliance deadline for classification (CLP) and packaging traceability (PPWR).
• 2026: Last year for legacy products under transitional CLP rules.
• 2028: Begin using recycled content in plastics to meet PPWR targets.
• 2030–2035: Prepare for high-circularity packaging systems and possible REACH authorisation expansions.

Businesses must familiarize themselves with these dates and act swiftly to ensure their products and processes align with evolving requirements.

5. Impacts on non-EU companies

The impacts of CLP, REACH, and PPWR extend far beyond the borders of the EU, influencing manufacturers, distributors, and Marketing Authorization Holders (MAHs) or legal manufacturers of medical devices outside of the EU.

Non-EU Companies:

• CLP Compliance: Products must comply with hazard classifications under CLP, and organizations are required to provide EU-compliant Safety Data Sheets (SDSs).
• REACH Compliance: Companies must appoint an Only Representative within the EU who can manage obligations such as registration, data submission, and handling authorizations or restrictions under REACH.
• PPWR Compliance: Packaging must meet strict design, labeling, and chemical composition requirements, reflect sustainability goals and align with circular economy strategies.

The ripple effects of these regulations are increasingly shaping international standards, influencing regulatory approaches in countries like Canada and South Korea. This creates both challenges and opportunities for global businesses to align their practices with emerging norms and demonstrate leadership in sustainable innovation.

6. Conclusion

The convergence of CLP, REACH and PPWR is transforming how health-related products are designed, labelled, and brought to market, both in the EU and beyond. While navigating this multifaceted regulatory landscape may seem complex, it offers unique opportunities for companies to:

• Accelerate compliance with international standards, enhancing market access and trust.
• Unlock sustainable innovation, incorporating environmentally conscious materials, designs, and manufacturing processes.
• Strengthen transparency, fostering trust across supply chains and with consumers.

Health-related industries, including pharmaceuticals, medical devices, and biotechnology, are at a pivotal moment to embrace these regulatory shifts not only as obligations but as catalysts for growth and meaningful contributions to global sustainability.

Need help?

At Efor, we support our clients in navigating this complex regulatory environment by combining regulatory affairs expertise, toxicology expertise, product quality know-how, and sustainability strategies.

Whether you are adapting to CLP hazard reclassifications, REACH restrictions, or PPWR packaging rules, our experts can assist with:

• Regulatory gap assessments and audits of your existing documentation, processes, and data flows
• Support for your EU market access strategy (substances registration, labelling, packaging compliance, notification procedure)
• Technical assistance with toxicological and biological assessments
• Help in preparing your compliance files (SDS, labelling, SCIP declarations, PCN notifications)
• Expertise in packaging qualification and validation
• Customised training for your teams (regulatory, sustainable innovation)

Contact us at TechnicalDivision@efor-group.com to transform compliance into a lasting competitive advantage.

^[1] 🔗 Full ATP 2024/2865 list (Annex VI CLP) : https://echa.europa.eu/information-on-chemicals/annex-vi-to-clp

^[2] https://echa.europa.eu/fr/new-hazard-classes-2023