The cosmetics regulation 2025 cycle in the EU has brought new bans, SCCS opinions, and restrictions that require urgent reformulation strategies.
Between new bans, stricter restrictions, and updated scientific opinions from the Scientific Committee on Consumer Safety (SCCS), the industry faces a scenario in which reformulation is no longer an exception, but a structural necessity.
At the same time, the European Commission has progressed with proposals that will begin to take effect in 2026, including new additions to the Annexes of Regulation (EC) 1223/2009, adjustments to UV filters and impurities, and an increasing emphasis on raw material purity and the protection of vulnerable consumer groups.
This article summarises, in a structured and visual way, what happened during 2025 and what to expect in 2026, including tables that provide at-a-glance information on the regulations, affected substances, and key compliance deadlines.
EU Cosmetics Regulation: Core Legal Structure
Regulation (EC) 1223/2009 remains the legal foundation for cosmetic products in the EU. However, its actual content evolves through frequent annex updates, Omnibus Regulations arising from CLP reclassifications, and the SCCS scientific opinions that reassess ingredient safety.
In 2025, three major areas of change have dominated the regulatory landscape:
- Reinforcement of Annex II (prohibited substances), primarily through Regulation (EU) 2025/877 – Omnibus VII.
- New restrictions added to Annex III, impacting fragrances, hair dyes, and core raw materials.
- Final SCCS opinions on key ingredients such as Tea Tree Oil (TTO) and the UV filter DHHB, redefining concentration limits and permitted impurity thresholds.
Additionally, a new mandate has been issued to the SCCS regarding the assessment of Titanium Dioxide (TiO₂) in oral-care products, an area that is expected to evolve significantly between 2026 and 2027.
2025 Cosmetics Regulation: Key Changes
Omnibus VII And New CMR Bans
The adoption of Regulation (EU) 2025/877 (Omnibus VII) introduced over 20 CMR substances into Annex II, with a prohibition effective from 1 September 2025, with no transitional period. Any non-compliant product must be withdrawn immediately.
One of the most notable cases:
- Trimethylbenzoyl Diphenylphosphine Oxide (TPO)
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- Previously: restricted for UV-cured nail systems
- Now: prohibited (Annex II)
- Impact: requires alternative photoinitiators in nail enhancement technologies
Other Measures Approved in 2025
In addition to Omnibus VII, several other regulatory and scientific decisions now affect cosmetic formulations:
1. Newly Prohibited Substances (Annex II)
- Silver Zinc Zeolite (with the exception of the specific form authorised as a preservative in Annex V)
- Triphenyl Phosphate (TPhP)
These substances were banned due to toxicological concerns and chronic exposure risks.
2. Newly Restricted Substances (Annex III)
Substances now listed with conditions of use include:
- Acetylated Vetiver Oil (Vetiveria zizanioides)
- Aluminium-containing compounds
- Fragrance allergens: benzyl salicylate, citral, geranial, neral
- Hair dye substances: HC Blue 18, HC Yellow 16, HC Red 18
- Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt
- Water-soluble zinc salts
These restrictions reflect accumulating evidence of sensitisation, systemic toxicity, and environmental risks, requiring updates to raw material inventories and CPSR documentation.
3. Preservatives and UV Filters
- New preservative authorised (Annex V):
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- Ammonium Silver Zinc Aluminum Silicate, under strict purity and concentration conditions
- UV filter DHHB (Diethylamino Hydroxybenzoyl Hexyl Benzoate)
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- SCCS sets a maximum limit of 0.026% (260 ppm) for the impurity DnHexP, provided the UV filter does not exceed 10% in the formula
4. Tea Tree Oil (TTO)
According to the SCCS, Tea Tree Oil is considered safe when meeting ISO specifications and following strict concentration limits:
- 2.0% in shampoos
- 1.0% in shower gels and facial cleansers
- 0.1% in facial creams
Only TTO compliant with ISO 4730:2017 is acceptable, and aerosol applications are excluded due to inhalation risks.
5. Methyl Salicylate and Child-care Products
In 2025, the SCCS strengthened its recommendation limiting methyl salicylate to 0.02% in products intended for children aged 0–3 years (excluding toothpaste), reinforcing the EU’s conservative stance on early-life exposure.
Summary Table: Key Measures Implemented in 2025
| Measure / Source | Type of Change | Substances Affected | Application Deadline |
| Regulation (EU) 2025/877 – Omnibus VII | New Annex II prohibitions (CMR) | >20 CMR substances incl. TPO | 01-09-2025, no transition |
| Annex II amendments | Additional prohibitions | Silver Zinc Zeolite, TPhP | Effective 2025 |
| Annex III amendments | Restrictions | Vetiver oil, aluminium compounds, fragrance allergens, hair dyes, zinc salts, PPD derivatives | Progressive application 2025–2026 |
| SCCS – TTO | Category limits | 2.0%, 1.0%, 0.1% | Immediate for new CPSR |
| SCCS – DHHB/DnHexP | Impurity limit | Max. 0.026% | Integration into QC 2025–2026 |
| SCCS – Methyl Salicylate | Children’s limit | Max. 0.02% | Applies in safety reports from 2025 |
What’s Coming in 2026: New Bans, Restrictions, and Deadlines
Several upcoming amendments to the Annexes of Regulation 1223/2009 are expected to enter into force from Q1 2026, with significant impact on reformulation and market compliance.
New Prohibitions (Annex II) With 2026 Deadlines
- Silver Zinc Zeolite
- Prohibited as a general ingredient, except for the specific form included in Annex V.
- Triphenyl Phosphate (TPhP)
- Removed as a plasticizer and component in certain cosmetic formulas.
Although some bans took effect in 2025, 2026 consolidates the final withdrawal of remaining non-compliant products.
New Restrictions (Annex III) Starting in 2026
Key ingredients:
- Fragrance allergens (e.g., benzyl salicylate, citral, geranial, neral)
- Aluminium compounds in deodorants and other categories
- Specific hair dye substances and PPD derivatives
- Water-soluble zinc salts
This requires:
- Reformulation in fine fragrance, hair colour, deodorants, multifunctional products
- Full review of allergen labelling and CPNP updates
New Restrictions on Silicones D4, D5, and D6 (Regulation (EU) 2024/1328)
The use of cyclic siloxanes D4, D5, and D6 continues to tighten across the European Union due to their classification as PBT/vPvB substances. Regulation (EU) 2024/1328 introduces significant new restrictions that will take full effect between 2026 and 2027, strongly limiting the allowed concentration of D5 and D6 in cosmetic products.
Current regulatory status
- D4 (Octamethylcyclotetrasiloxane) → Banned in cosmetics (Annex II)
- D5 (Decamethylcyclopentasiloxane) → Restricted to ≤ 0.1 %
- D6 (Dodecamethylcyclohexasiloxane) → Restricted to ≤ 0.1 %
Compliance deadlines
- Rinse-off products containing D6
- Must not be placed on the market above 1 %
- Deadline: 6 June 2026 (two years after the Regulation enters into force)
- Leave-on products containing D5 and D6
- Must not be placed on the market above 1 %
- Deadline: 6 June 2027 (three years after entry into force)
Impact on formulation 2026–2027
- Necessity to replace D5 and D6 with linear silicones or alternative volatile emollients.
- Adjustments in claims and technical documentation.
- Review of raw material purity to ensure minimal residual cyclic siloxane content.
This is especially relevant for categories such as:
- Deodorants
- Leave-on and rinse-off haircare
- Primers and makeup
- Products relying on volatile sensorial performance
Early reformulation during 2025–2026 is strongly recommended to maintain market continuity.
2026 Summary Table: Proposed Amendments and Timelines
| Expected Amendment (2026) | Type | Key Substances | Indicative Timeline |
| Annex II & III updates (EC proposal) | Bans + new restrictions | Silver Zinc Zeolite, TPhP, fragrance allergens, aluminium compounds, zinc salts, hair dyes | Entry into force expected Q1 2026 |
| Annex V (preservatives) | New preservative | Ammonium Silver Zinc Aluminum Silicate | No extended transition expected |
| TiO₂ in oral-care (new SCCS mandate) | Future restrictions possible | Titanium Dioxide | SCCS opinion expected 2026–2027 |
Practical Steps for Cosmetics Regulation Compliance
1. Accelerated Reformulation
Companies will need to:
- Replace prohibited ingredients (TPO, TPhP, some silver-zinc zeolites)
- Adjust fragrance allergen levels
- Control aluminium and zinc content
- Ensure preservatives and UV filters meet both maximum concentration and impurity limits
2. Expanded Toxicological Assessment
CPSRs must now include:
- Updated concentration limits
- Assessment of critical impurities (e.g., DnHexP in DHHB)
- Combined exposure models, especially for children
- Verification of ingredient purity (e.g., ISO 4730 for TTO)
3. Supply Chain and Traceability
2025–2026 demands a more rigorous approach to raw material specifications:
- Detailed impurity data
- Toxicological profiles
- Nano-fraction information (e.g., TiO₂)
4. Labelling and Notification
Changes to restrictions and fragrance allergens require:
- Updated INCI lists and allergen declaration under articles 19 and 21
- Review of marketing claims (e.g., “free-from”, “hypoallergenic”)
Strategic Planning for Cosmetics Regulation 2026
A structured strategy is essential:
1. Regulatory impact mapping:
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- List all formulas affected by: CMR, new prohibitions, new restrictions, SCCS changes.
2. Risk-based prioritization:
- Priorizar productos con TPO, filtros UV afectados, alérgenos de fragancia de alto uso, aluminio y zinc.
3. Internal 2025–2026 roadmap:
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- Internal “last production” and “last sale” dates, aligned with legal deadlines.
4. Continuous regulatory monitoring:
- Monitorizar nuevas opiniones del SCCS (TiO₂, futuros filtros, ingredientes “naturales” cuestionados).
In this context, specialised regulatory expertise becomes a strategic advantage — ensuring correct interpretation, planning, and adaptation.
Conclusion: Adapting to Cosmetics Regulation 2025–2026
The 2025–2026 period marks one of the most intense regulatory cycles for the European cosmetics industry since the implementation of Regulation 1223/2009. The combination of new bans, restrictions, annex updates, and SCCS opinions requires companies to thoroughly review formulations, quality control systems, technical documentation, and market positioning strategies.
This is not a temporary challenge, but a structural shift: heightened focus on impurities, stricter limits for widely used ingredients, and reinforced protection of vulnerable consumers. Companies that anticipate these changes will navigate the transition smoothly and maintain portfolio continuity.
In this evolving environment, technical regulatory support is essential.
SHAPYPRO assists with regulatory interpretation, safety assessment, ingredient review, documentation management, and dossier updates, helping companies maintain compliance and adapt to new European requirements with scientific rigour and full traceability.
Regulation evolves. Preparedness is key.