The European Commission notified a new draft amendment to the EU Cosmetics Regulation on 8 July 2026.
The proposal would prohibit or restrict several cosmetic ingredients based on new classifications and scientific assessments.
The consultation period is scheduled to remain open until 6 September 2026.
The measure is still a draft and should not be presented as final adopted law.
Nevertheless, cosmetic manufacturers, responsible persons, safety assessors and raw-material suppliers should begin screening their portfolios now.
Why has the new draft been proposed?
Part of the proposal is intended to reflect new classifications of substances as carcinogenic, mutagenic or toxic for reproduction under the EU Classification, Labelling and Packaging framework.
The relevant CLP amendment is scheduled to apply from 1 February 2027.
The draft Cosmetics Regulation amendment also addresses several substances following opinions from the Scientific Committee on Consumer Safety.
Which ingredients are included in the proposal?
According to the Commission notification, the draft notably proposes prohibitions for:
- Benzophenone-1
- Benzophenone-2
- Basic Brown 16
- Basic Blue 99
- prostaglandin analogues
It also proposes new or revised restrictions for:
- Butylated Hydroxyanisole, commonly known as BHA
- Butylparaben
- Cannabidiol, or CBD
- Hydroxyapatite in nano form
The draft would additionally remove existing derogations concerning certain mercury-containing preservatives.
The final regulatory conditions may differ from the notified draft. Businesses should therefore track the final adopted text before making definitive legal conclusions.
Which cosmetic products may be affected?
The relevance depends on the ingredient and its function.
Potentially affected product categories may include:
- UV-related and sun-care formulations
- hair-colouring products
- eyelash and eyebrow products
- products positioned around lash or hair growth
- preserved cosmetic formulations
- oral-care products containing hydroxyapatite
- CBD cosmetics
- products using butylparaben
- formulations containing BHA
- imported cosmetics using non-EU raw-material standards
A product should not be classified as affected based only on its marketing category. The actual INCI formula, raw-material composition and impurity profile must be assessed.
Why should companies act before the regulation is final?
Early screening does not mean relabelling or reformulating immediately.
It means determining:
- which products contain potentially affected ingredients
- at what concentrations they are used
- which function the ingredient performs
- whether alternatives are available
- how long reformulation and testing would require
- whether existing stock and packaging could be affected
- which supplier documents need updating
Waiting for the final publication may leave insufficient time for reformulation, stability testing, compatibility studies, safety reassessment and new packaging production.
Recommended steps for cosmetic companies
1. Screen the full product portfolio
Search formulas and raw-material specifications for the substances named in the draft.
The review should include:
- current products
- products under development
- discontinued products still on the market
- regional variants
- fragrance and colour variants
- raw materials with complex compositions
2. Contact suppliers
Request current information on:
- INCI composition
- substance concentration
- impurities
- particle characteristics
- nano status
- safety data
- planned reformulations
- availability of compliant alternatives
Supplier trade names may hide ingredients that are not obvious from internal product lists.
3. Assess substitution impact
Replacing an ingredient can affect:
- preservation
- colour
- stability
- texture
- sensory properties
- product performance
- packaging compatibility
- microbiological safety
- claims
Reformulation should therefore be treated as a controlled development project, not only an ingredient-list update.
4. Review the safety documentation
A formulation change may require updates to:
- the Cosmetic Product Safety Report
- the Product Information File
- stability data
- microbiological assessments
- challenge testing
- packaging compatibility
- CPNP information
- the ingredient list and artwork
The necessary scope depends on the significance of the change.
5. Monitor the final regulation
The draft should not be treated as the final legal text.
Companies should track:
- the end of the comment period
- the final adopted substances and conditions
- publication in the Official Journal
- application dates
- transition periods
- sell-through provisions
Special attention for imported products
Non-EU manufacturers may continue using ingredients permitted in their home market but restricted or prohibited in the EU.
Importers and EU responsible persons should not rely exclusively on a foreign-market compliance statement.
The complete formulation and relevant raw-material data must be assessed against the applicable EU requirements.
How Makrolife can support portfolio screening
Makrolife can support cosmetic companies with:
- ingredient and formula portfolio screening
- identification of potentially affected products
- supplier-document reviews
- safety and toxicological assessments
- testing strategies for reformulated products
- CPSR and PIF updates
- label and INCI reviews
- coordination of stability and microbiological testing
- regulatory monitoring
The immediate objective is not to predict the final wording. It is to identify where regulatory changes could create time, cost or launch risks.
Identify affected products early
Companies using potentially affected ingredients should complete an initial portfolio screen while the proposal is still under review.
Request an EU Cosmetic Ingredient Portfolio Screening from Makrolife.
