The adoption of Regulation (EU) 2023/988 on May 10, 2023, marks a significant update to the EU's general product safety framework, replacing Directive 2001/95/EC. This new legislation establishes comprehensive safety requirements for non-food products, including chemicals, to ensure consumer protection in a rapidly evolving market.
For chemical manufacturers, the regulation introduces specific obligations that must be addressed to maintain compliance and market access. This article highlights critical aspects of the regulation, including new rules regarding economic operators and their responsibilities.
Economic Operators: A Key Role in Ensuring Safety
One of the key features of Regulation (EU) 2023/988 is the requirement for a responsible economic operator established within the EU for any product placed on the market. This provision aims to enhance accountability and streamline communication between manufacturers, importers, and market surveillance authorities.
Key Requirements for Economic Operators
Presence in the Union: A product cannot be placed on the EU market unless an economic operator is established in the Union to fulfill the obligations set out in Article 4(3) of Regulation (EU) 2019/1020.
References in Article 4(3) to "Union harmonization legislation" or "applicable Union harmonization legislation" are references to Regulation (EU) 2023/988.
Regular Compliance Checks: The economic operator must regularly ensure that the product meets the following requirements:
Compliance with the technical documentation outlined in Article 9(2) of Regulation (EU) 2023/988.
Adherence to the product requirements specified in Articles 9(5), (6), and (7).
These checks are vital to mitigate potential risks associated with the product. The operator must also provide documented evidence of these checks to market surveillance authorities upon request.
Clear Identification of the Economic Operator: To facilitate traceability, the following details must be provided on the product, its packaging, parcel, or accompanying document:
Name
Registered trade name or trade mark
Contact details, including postal and electronic addresses.
Implications for Chemical Manufacturers
1. Responsibility for Safety
Chemical manufacturers must establish clear accountability within the EU, either by acting as the economic operator themselves or by designating one. This operator will take on significant responsibility for verifying product compliance and safety, making it essential to establish robust documentation and testing processes.
2. Technical Documentation Compliance
Manufacturers must ensure that their products comply with the technical documentation requirements of Article 9(2). For chemicals, this includes:
Providing accurate safety data sheets (SDS)
Adhering to REACH and CLP guidelines alongside the general safety requirements of Regulation (EU) 2023/988
3. Market Surveillance Readiness
With enhanced enforcement powers, market surveillance authorities may request evidence of compliance checks at any time. Manufacturers must work closely with their economic operators to maintain accurate and accessible records.
4. Labelling and Traceability
The inclusion of economic operator details on product packaging or accompanying documentation is critical. Chemical manufacturers must revise their labelling practices to incorporate this information seamlessly, ensuring it is visible and consistent across all products.
Preparation Steps for Compliance
To meet these new requirements, chemical manufacturers should:
Appoint or Establish an Economic Operator: Identify a qualified economic operator within the EU and define their responsibilities clearly. Ensure they are equipped to perform regular compliance checks and maintain communication with authorities.
Update Technical Documentation: Review and update all product documentation to ensure alignment with the new regulation. This includes SDS, test reports, and any supporting compliance records.
Revise Labelling and Packaging: Include the required economic operator details on all products, packaging, and accompanying documents.
Develop a Monitoring System: Implement a system for regular compliance checks and document these efforts thoroughly to respond effectively to potential market surveillance inquiries.
Conclusion
Regulation (EU) 2023/988 introduces significant changes to the EU’s approach to product safety, emphasizing accountability, traceability, and consumer protection. For chemical manufacturers, the requirement to designate an EU-based economic operator represents both a challenge and an opportunity to strengthen compliance frameworks.
By taking proactive steps to align with the new requirements, manufacturers can safeguard their market access and demonstrate their commitment to product safety.
Stay ahead of the curve and ensure your products meet the new standards. Compliance is not just a legal obligation—it’s a competitive advantage.
For further details, consult the full text of Regulation (EU) 2023/988 or seek expert regulatory advice (info@chem-consulting.si).
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