The Council of the EU, the European Parliament and the European Commission reached a political agreement on the Omnibus VI package, which includes simplifications m.in the CLP Regulation and the Cosmetics Regulation. For the industry, this means both operational facilitation and the need to adapt to the new rules within certain deadlines.
The Omnibus VI package is part of the European Union’s broader efforts to simplify and unify the rules governing the chemical and cosmetics market. The agreement reached in the trilogue (Council-Parliament-Commission) sets the direction for future changes that will have a direct impact on manufacturers, importers and distributors of chemical and cosmetic products. In the course of the work, special attention was paid to reducing excessive administrative burdens, while maintaining a high level of protection of human health and the environment.
Changes to the CLP Regulation
In the area of CLP (Classification, Labelling and Packaging), a significant part of the simplifications proposed by the European
Commission has been maintained. Key arrangements include:
• simplifying the rules for formatting labels – the new requirements will only apply to mandatory CLP information and consumer products;
• Maintaining a minimum font height:
o 0.9 mm for ≤125 ml packages,
o 1.2 mm for larger packages,
• Extension of the deadline for updating labels after the change of classification from 6 to 15 months,
• simplification of advertising requirements – only the hazard pictogram and the message: “Always read the label and product information before use” remain mandatory,
• the possibility of using digital labels (e.g. QR) for small packages, while maintaining full information on the outer packaging.
However, the postulate to extend the possibility of using a smaller font (0.9 mm) for packaging to 500 ml was not accepted – the threshold of 125 ml remains unchanged.
Changes to the Cosmetics Regulation
An important part of the package are changes to the cosmetics regulation, which address the industry’s long-standing problems related to the automatic linking of CLP classification to ingredient bans. Key findings include:
• A new process for including substances in the Annexes (Article 14) – a formal procedure has been introduced with a 12-month assessment period by the SCCS;
• amendments to Article 15 (CMR 1A/1B):
o simplification and clarification of the process of obtaining exemptions,
o the ability to submit one dossier for multiple applications,
o moving away from food safety criteria,
o introduction of clear rules for assessing the availability of alternatives,
• new criteria for assessing substitutions, covering safety, efficacy, technical and economic feasibility and market availability;
• a commitment by the European Commission to develop guidelines on the analysis of alternatives within 12 months;
• transition periods depending on the outcome of the SCCS assessment (from 6 to 36 months),
• special approach to natural compound substances (NCS) – no automatic ban despite CMR classification,
• administrative changes (removal of part of the reporting and publication obligations),
• distance selling – a new obligation to share product information (except for batches and durability) with a 12-month implementation period.
In addition, the rules for notifying nanomaterials have been modified – the notification obligation has been maintained, but the requirement of 6 months in advance has been removed.
Actions required of businesses
In connection with the new regulations, companies should:
• Analyze the impact of changes on labels and marketing communications (CLP)
• prepare for the prolonged, but still mandatory processes of updating documentation,
• assess the cosmetic ingredient portfolio against the new rules on CMR substances and alternatives;
• adapt online sales processes to the new information requirements,
• plan the implementation of changes within the designated transition periods.
Importance for the industry
The Omnibus VI agreement is an important step towards more proportionate and predictable regulation in the EU. The changes reduce excessive administrative burdens, especially in the area of labelling and advertising, while maintaining a high level of consumer protection. For the chemical and cosmetics industry, this means greater operational flexibility, but also the need to adapt to new substance assessment processes and information requirements. It will be crucial to prepare early for the implementation of changes and to monitor the next stages of the legislative process, including the publication of the final acts and guidelines of the European Commission.
Ekotox website: https://ekotox.eu/changes-to-the-clp-regulation-2024-2027-and-new-obligations/
