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published on 13 february 2025 | reading time approx. 5 minutes
The EU Chemicals Strategy for Sustainability, introduced in 2020, sets new standards: tightened regulations aim to minimize and more strictly control the use of hazardous and most harmful chemicals in consumer products. For chemical and product manufacturers, this means adapting to evolving product requirements under both general chemicals legislation and product-specific regulations. The goal: minimizing health and environmental risks by promoting the use of safer and more sustainable substances. Understand the details to ensure your compliance!
The EU-Chemicals Strategy for Sustainability (CSS) aims to reduce the use of hazardous chemicals while promoting the development and application of safer and more sustainable chemicals and products. This leads to amendments and stricter requirements under the REACH & CLP Regulations. Additionally, it affects regulations for a wide range of products, including food packaging, toys, cosmetics, cleaning agents, and electronic devices.
Chemical and product manufacturers must adapt to new essentiality criteria in safety and risk assessments. In particular, the use of the most harmful chemicals in consumer products will be gradually restricted. An exception for continued use is only granted if the chemical is classified as “essential”. This applies if the substance is necessary for health or safety or plays a critical role in the functioning of society. Additionally, no viable, technically, and economically feasible alternative should be available.
The essential use category, and therefore the permitted continued use, includes, for example, the containment of public health emergencies through hygiene and cleaning products, the protection of critical infrastructure through fire protection agents and personal protective equipment, or the preservation of biodiversity through the use of pesticides against invasive species. Furthermore, manufacturers that continue to use such substances have important obligations: they must independently and continuously assess whether viable alternatives exist, which is supported by detailed substitution plans and effective market monitoring.
The “One Substance, One Assessment” approach aims to ensure transparent, consistent, and coherent chemical safety assessments and risk evaluations across various EU regulatory agencies. As part of this initiative, the European Chemicals Agency (ECHA) is increasingly involved in the risk assessment processes of the European Food Safety Authority (EFSA) for food and food packaging. Similarly, the ECHA will play a greater role in evaluating pharmaceuticals and medical devices together with the European Medicines Agency (EMA).
These changes will result in significant shifts in responsibilities for manufacturers. For instance, the responsibility for exemption applications for hazardous substances in electronic devices will shift from the European Commission to the ECHA. Additionally, ECHA will gain the authority to issue exemptions for the use of generally banned substances in toys.
The EU Chemicals Strategy aims not only to minimize the use of hazardous chemicals and improve chemical safety assessments but also to achieve further key objectives supported by a series of specific measures.
One of the first steps in this comprehensive agenda is the new approach in REACH and CLP for identifying hazardous chemicals. The most harmful substances, including endocrine-disrupting, persistent, bioaccumulative, toxic, and/or mobile substances (PBT/vPvB and PMT/vPvM), will be systematically and more comprehensively covered through the Substances of Very High Concern (SVHC) list under REACH and the hazard classifications in the CLP Regulation.
To ensure comprehensive chemicals management throughout the entire lifecycle, an EU “Chemicals Database” is to be introduced. This innovation could represent a significant expansion of existing REACH registration and information obligations for companies. In particular, additional requirements may be introduced for polymeric substances, hazardous substances produced in quantities of up to 10 tons, and the environmental footprint of chemicals. At the same time, the database will significantly improve access to substance information for downstream users, such as product manufacturers and retailers, recycling firms, and waste management companies, by providing comprehensive chemical data on a central platform.
The “Non-Toxic Material Cycles” strategy aims to enable the technical removal of hazardous chemicals and prioritize the use of recycled materials. Therefore, the threshold limits for hazardous substances in recycled materials will be aligned with those for primary materials, a principle that has already been incorporated into the new Packaging and Packaging Waste Regulation (EU) 2025/40 (PPWR) regarding heavy metals in recycled packaging materials.
The strategy also focuses on a “Zero-Tolerance Approach”, which envisions enhanced market surveillance, particularly concerning illegal chemicals in imports from non-EU countries. In this regard, the EU is pursuing a comprehensive strategy in trade, customs, and product safety, with a particular focus on direct imports via online platforms, especially from China.
The EU Chemicals Strategy implements a “preventive generic approach to risk management”, which is particularly applied to consumer products. This concept generally prohibits harmful chemicals, with only limited and strictly regulated exceptions. This development marks a significant departure from the previous risk-based approach, which considered professional user experience and actual chemical exposure levels in assessments. This shift has been met with considerable criticism from industry associations.
Consumer products should generally no longer contain chemicals classified as carcinogenic, mutagenic, endocrine-disrupting, persistent, bioaccumulative, and/or toxic. This also includes so-called “forever chemicals” or PFAS. Starting in October 2026, the use of specific PFAS in certain consumer products, including food packaging made of paper and cardboard, cosmetics, and textiles, will be gradually banned.
The new Ecodesign Framework Regulation (EU) 2024/1781 requires that information on substances of concern in consumer products (excluding i.e. food, pharmaceuticals, and vehicles) must be transparently disclosed. This information must be provided by product manufacturers, importers, or retailers in the “Digital Product Passport”. From 2025, the regulation will be expanded to include detailed sustainability requirements for products such as textiles, furniture, detergents, and electronic devices, which are expected to impose additional obligations on companies.
Chemical and product manufacturers must increasingly address so-called “combination effects”. These describe the cumulative negative impacts of mixtures of certain ubiquitous chemicals from various sources on human health and the environment. Regulatory safety and risk assessments are placing growing emphasis on these effects.
While certain product categories have successfully incorporated combination effects into safety and risk assessments, others still face uncertainty about future regulatory adaptations.
Since its introduction in 2020, the EU Chemicals Strategy has established stricter regulatory requirements, increasing the focus on safe, sustainable, and non-toxic chemicals and materials, especially in consumer products. Although implementation has been slow, far-reaching changes in chemicals and consumer goods legislation are inevitable. Companies must proactively prepare to ensure compliance and mitigate potential regulatory risks. With its multidisciplinary approach, Rödl & Partner combines legal expertise in product law and sustainability with scientific know-how, guiding businesses through complex product-specific requirements.
Ulrich Klaus
Senior Associate
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Dr. Barbara Klaus
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