Link to the page: Simplification: Council approves ‘stop-the-clock’ mechanism on chemicals to provide legal certainty to businesses – Consilium
On 24 April 2025, the EU Council approved its negotiating position on the Commission’s proposal under the Omnibus VI package, covering the “stop-the-clock” mechanism for chemicals under the CLP Regulation (EU) 2865/2024, as well as proposed amendments to the Cosmetics Regulation (EU) 1223/2009 and the Fertilising Products Regulation (EU) 2019/1009.
This is very good news for the cosmetics industry. If the legislative process is completed successfully (the next steps include a positive reading by the European Parliament and trilogue negotiations between the Parliament, the Council and the Commission), the sector will not only gain breathing space thanks to the postponement of CLP implementation deadlines to 1 January 2028, but—most importantly—will benefit from a number of key amendments to the Cosmetics Regulation proposed under COM(2025) 531. The most important changes include:
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Introduction of a new Article 14a CPR, establishing a procedure for adding colourants, preservatives and UV filters to Annexes IV, V and VI, with a 12-month SCCS opinion deadline—a long-awaited opportunity for new cosmetic ingredients.
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Deletion of Article 33 and amendments to Article 19, removing the obligation to publish a “paper” version of the Ingredient Glossary and replacing it with a more up-to-date digital version, based on internationally recognised nomenclature systems (CosIng and PCPC).
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Harmonisation of nanomaterial notification obligations (currently duplicated under Article 13 (CPNP) and Article 16), including the removal of the prenotification requirement under Article 16 and the introduction of an obligation to include nanomaterial specifications and a detailed description in the Cosmetic Product Safety Report, prepared by a qualified safety assessor (which, for CosmetoSAFE Consulting, is very much business as usual 😊).
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Amendment of Article 22, removing the obligation for Member State authorities to submit market surveillance reports to the European Commission.
And most importantly:
Changes to Article 15(2) finally introduce common-sense regulatory tools, ensuring that situations like the Lilial or TPO cases no longer catch the industry off guard—like a tax audit at 8 a.m. on a Monday 😉:
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A new deadline for submitting a derogation application—no later than 3 months from the entry into force of an ATP to the CLP Regulation.
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Removal of the requirement for compliance with food safety legislation as a prerequisite for obtaining a derogation.
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Introduction of a definition of an alternative substance, making it realistically applicable and recognisable as suitable.
Alternative substance means a substance that:
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does not increase the overall risk to human health or the environment;
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performs an equivalent function to the classified substance in the finished cosmetic product, with comparable performance and the same level of effectiveness;
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is technically feasible and economically viable to substitute;
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is freely available (not subject to restrictions or patent protection), in sufficient quantities to meet market demand.
Additional key clarifications include:
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CMR classification linked to a specific route of exposure, ensuring that the ban under Article 15(1) and (2) does not apply to substances classified as CMR solely via oral or inhalation exposure routes—such substances will be subject to SCCS assessment upon request of the Commission.
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Clarification of the approach to Natural Complex Substances (NCS)—the ban under Article 15(1) and (2) does not apply to NCS, which will also be subject to SCCS assessment upon Commission request.
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Introduction of transitional periods to allow stock sell-off: 12 months to place products on the market and 24 months to make them available on the market from the entry into force of the amendment to the Cosmetics Regulation, regardless of whether a derogation dossier has been submitted.
We particularly welcome the route-specific approach to CMR derogations, which finally acknowledges how crucial it is—in the context of cosmetics—to focus on the actual route of exposure. After all, for cosmetic products, dermal exposure is key, while oral and inhalation exposure are always of secondary relevance.
A simplified derogation procedure, transitional periods, and hazard assessment aligned with real dermal exposure—these changes are especially important for fragrance ingredients such as hydroxycitronellal, p-cymene, peppermint oil or carvone, which are currently under pressure due to potential bans based on CLH classifications. Such bans could otherwise lead to the withdrawal of a vast number of fragrance formulations, including perfumes, body lotions and personal care products.
These legislative changes also move the industry further away from the “worst-case scenario” looming over the ongoing CMR classification (oral route) of ethanol. If the European Parliament were not to approve the Commission’s proposed deregulation, ethanol would automatically be excluded from use in cosmetics. We will be closely monitoring the Parliament’s decisions.
And you— which simplifications and regulatory changes do you value the most?
