EU Chemicals Strategy: What chemical and product manufacturers need to know now | RÖDL

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!

EU-Chemicals Strategy: Key Changes for Manufacturers

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.

Essential Use Concept

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.

“One Substance, One Assessment” Approach

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.

New Approaches in REACH and CLP for Identifying Hazardous Chemicals

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.

Introduction of the EU Chemicals Database

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.

Promoting Non-Toxic Material Cycles

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.

Zero Tolerance Approach to Non-Compliance

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.

Increased Requirements for Consumer Products under the EU Chemicals Strategy

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.

Reduction and Restriction of Chemicals with Hazardous Properties

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.

New Information Obligations for Substances of Concern

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.

Combination Effects of Chemicals in Consumer Products

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.

• The proposal for the new
  Toy Safety Regulation (July 2023) explicitly requires the consideration of the “combined or cumulative presence of chemicals” in safety assessments.
• The
  EU Cosmetics Regulation (EC) No. 1223/2009 already mandates assessing the “anticipated systemic exposure to individual ingredients in final formulations”.
• However, no significant amendments have yet been proposed for food additives or food packaging to account for combination effects.
• The proposal for the revised
  Detergents Regulation (April 2023) currently does not include combination effect assessments.

While certain product categories have successfully incorporated combination effects into safety and risk assessments, others still face uncertainty about future regulatory adaptations.

Conclusion

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 combines legal expertise in product law and sustainability with scientific know-how, guiding businesses through complex product-specific requirements.