May 2026 brought a number of important cosmetic regulatory developments across the UK, EU, US and Canada, with particular focus on ingredient restrictions, CMR classifications, UV filters, fragrance allergens, formaldehyde-releasing preservatives, labelling requirements and product notification data.
For brands, manufacturers and Responsible Persons, these updates are not only regulatory points to note. They may affect product formulation, raw material selection, fragrance composition, label content, packaging stock, Product Information Files, safety assessments, product notifications and market access planning.
The direction of travel across major cosmetic markets remains clear: regulators are increasing scrutiny of ingredient safety, fragrance transparency, toxicological classification, impurity control and the evidence used to support continued product compliance.
For formulation and compliance teams, the most relevant themes this month are:
- continued restrictions and prohibitions for substances classified as carcinogenic, mutagenic or toxic to reproduction;
- withdrawal of 4-MBC / Enzacamene from the EU market;
- tighter controls on specific fragrance and specialist ingredients;
- increased fragrance allergen disclosure requirements;
- formaldehyde-releaser labelling changes;
- the need to align formulation, labelling, safety assessment and notification data across multiple markets.
🇪🇺 EU: Regulatory Update
Regulation (EU) 2026/78: CMR substance restrictions from 1 May 2026
Regulation (EU) 2026/78 became fully applicable from 1 May 2026, introducing new restrictions and prohibitions for 18 substances classified as carcinogenic, mutagenic or toxic to reproduction under the CLP Regulation.
The update includes substances now prohibited in cosmetic products, including examples such as perboric acid, certain forms of silver, carbon nanotubes and acetone oxime.
Other substances, including Hexyl Salicylate and silver powder, remain permitted only under defined conditions.
Hexyl Salicylate is now restricted to a maximum concentration of 2% in hydroalcoholic fragrance products and is prohibited in products intended for children under three years old. For non-compliant products affected by this update, no sell-through period applies.
Why does it matter?
This update reinforces the EU’s automatic approach to CMR-classified substances in cosmetic products, unless a specific exemption has been assessed and included in the Cosmetics Regulation.
The absence of a sell-through period is particularly important. Where products are affected, continued supply or continued availability on the EU market may not be permitted once the application date has passed.
For formulation and compliance teams, the update highlights the need to consider not only headline INCI ingredients, but also fragrance components, specialist raw materials, silver-containing materials, nanoforms, impurity profiles and supplier documentation.
Application / Impacted Products
Potentially impacted products include:
- hydroalcoholic fragrances and fragranced cosmetic products containing Hexyl Salicylate;
- products intended for babies and children under three;
- products using silver-based ingredients or specialist functional materials;
- formulations containing complex raw material blends where restricted components may be present at low levels;
- products using advanced materials, colour systems or technologies where CMR classifications may affect continued ingredient acceptability.
4-MBC / Enzacamene fully withdrawn from the EU market
The EU transitional period for 4-Methylbenzylidene Camphor, also known as 4-MBC or Enzacamene, ended on 1 May 2026.
From this date, cosmetic products containing 4-MBC can no longer remain on the EU market. Existing stock must be withdrawn and no grace period or sell-through period applies.
4-MBC was historically used as a UV filter in sunscreens and SPF-containing cosmetic products. Its withdrawal follows ongoing concern around its potential endocrine-disrupting and reproductive toxicity profile.
Why does it matter?
This is a significant change for sun care and SPF-containing cosmetics.
Replacing a UV filter is not usually a simple ingredient substitution. Changes to a UV filter system may affect SPF performance, UVA protection, photostability, product aesthetics, compatibility, packaging interaction, claims support and the overall safety assessment conclusion.
The absence of a sell-through period also means that affected products require careful market access review where stock may still be present in supply chains.
Application / Impacted Products
Potentially impacted products include:
- sunscreens and sun protection products;
- SPF moisturisers, primers and foundations;
- daily protection skincare;
- colour cosmetics with SPF claims;
- any cosmetic product using 4-MBC as part of its UV filter system.
Regulation (EU) 2026/909: further ingredient amendments
Regulation (EU) 2026/909 introduces further amendments to the EU Cosmetics Regulation relating to a range of cosmetic ingredients used across fragrance, UV filter, colourant, preservative and hair dye applications.
Substances covered by this update include, among others:
- Benzyl Salicylate;
- Triphenyl Phosphate;
- Ammonium Silver Zinc Aluminium Silicate;
- aluminium and certain aluminium compounds;
- water-soluble zinc salts;
- Acetylated Vetiver Oil;
- Citral;
- HC Blue No. 18;
- HC Red No. 18;
- HC Yellow No. 16;
- Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt;
- DHHB.
Depending on the substance, the amendments introduce revised conditions of use, concentration controls, product-type restrictions and/or impurity-related requirements.
Why does it matter?
The practical impact of this type of update can vary significantly by ingredient and product type. Some ingredients may remain permitted, but only under revised conditions. Others may require additional checks relating to concentration, product category, exposure route, impurity profile or age-related use restrictions.
For brands selling in the EU, this reinforces the importance of reviewing formulas against the latest annex requirements rather than relying only on historic formulation approvals.
Application / Impacted Products
Potentially impacted products include:
- fragranced cosmetics;
- sunscreens and products containing UV filters;
- deodorants and antiperspirants;
- hair dye and colourant systems;
- nail products and UV-cured systems;
- colour cosmetics;
- oral care cosmetics, where ingredient conditions may differ;
- products containing aluminium compounds, zinc salts, colourants or specialist functional ingredients.
EU fragrance allergen labelling deadline approaching
The first key EU deadline for the expanded fragrance allergen labelling regime is approaching.
From 31 July 2026, newly placed cosmetic products must comply with the updated fragrance allergen declaration requirements. Existing products already placed on the market have a longer transition period, with a later deadline of 31 July 2028.
The update substantially expands the number of fragrance allergens that may need to be individually declared on cosmetic product labels when present above the relevant thresholds.
Why does it matter?
This is likely to be one of the broader labelling impacts for fragranced cosmetic products.
Many products that were previously compliant using “Parfum” or “Aroma” alone may require more detailed allergen declarations. This can affect ingredient lists, artwork, packaging stock, multilingual labels, CPNP data, safety documentation and supplier fragrance data.
The change is also relevant to naturally fragranced products, as allergens may be present through essential oils, botanical extracts and aromatic raw materials, not only through conventional perfume compounds.
Application / Impacted Products
Potentially impacted products include:
- perfumes, eau de parfum and eau de toilette;
- body sprays and fragranced mists;
- fragranced skincare, body care and haircare;
- essential oil-containing products;
- botanical or naturally fragranced cosmetics;
- deodorants and antiperspirants;
- children’s products and products marketed for sensitive skin, where transparency expectations may be particularly high.
🇬🇧 UK: Regulatory update
GB amendments to cosmetic ingredient restrictions and labelling
The UK has confirmed important amendments to the Great Britain cosmetics framework through the Cosmetic Products Regulation amendment introduced under SI 2026/23.
The update introduces three key areas of change.
First, 4-Methylbenzylidene Camphor / 4-MBC / Enzacamene is being removed from permitted UV filter use and added to the list of prohibited substances in Great Britain.
Second, a group of substances classified as carcinogenic, mutagenic or toxic to reproduction is being added to the prohibited substances list.
Third, the labelling threshold for the warning “releases formaldehyde” is being lowered significantly. This may affect products preserved with formaldehyde-releasing systems, even where the preservative itself remains permitted.
The main GB transition dates are:
- 15 July 2026 – 4-MBC prohibition and revised formaldehyde-releaser labelling threshold apply to products placed on the GB market;
- 14 January 2027 – end of the sell-through period for affected 4-MBC and formaldehyde-releaser labelling products;
- 15 August 2026 – new CMR prohibitions apply to products placed on the GB market;
- 14 February 2027 – end of the sell-through period for affected CMR substances.
Why does it matter?
The GB changes are commercially important because they affect both formulation and artwork timelines.
The 4-MBC change is particularly relevant for sun care and SPF-containing cosmetic products. Where 4-MBC is present, replacement may require reformulation, compatibility review, stability assessment and SPF or UVA performance testing.
The formaldehyde-releaser labelling change may have wider reach, as it can affect preserved leave-on and rinse-off cosmetics across a broad range of categories. Products may become label-non-compliant if the finished product exceeds the new free formaldehyde threshold and the appropriate warning is absent.
The CMR restrictions also reinforce the need for updated ingredient screening, particularly where raw materials, photoinitiators, colour systems, nail technologies or complex supplier blends are used.
Application / Impacted Products
Potentially impacted product categories include:
- sunscreens and cosmetic products containing UV filters;
- SPF moisturisers, primers, foundations and daily protection products;
- preserved leave-on skincare and body care;
- rinse-off products using formaldehyde-releasing preservative systems;
- professional nail products and UV/LED curing systems;
- colour cosmetics and hair colour products using specialist colour or polymer chemistry;
- products using complex raw material blends where minor components may not be immediately visible from headline INCI listings.
🇺🇸 US: Regulatory update
MoCRA implementation and fragrance allergen disclosure watch point
In the United States, the key cosmetic regulatory focus remains the continuing implementation of the Modernization of Cosmetics Regulation Act.
During May 2026, one of the most relevant watch points was the expected FDA proposed rule on fragrance allergen disclosure in cosmetic labelling. This rulemaking is intended to identify fragrance allergens that must be disclosed individually on cosmetic labels.
Although the detailed list and final compliance dates will depend on the rulemaking process, the direction is consistent with the wider international move towards more transparent fragrance allergen declaration.
The US framework also continues to place emphasis on:
- cosmetic product facility registration;
- cosmetic product listing;
- annual product listing updates;
- serious adverse event reporting;
- safety substantiation;
- responsible person obligations;
- developing GMP expectations for cosmetic facilities.
Why does it matter?
The US is moving from a historically lighter-touch cosmetics framework towards a more data-driven and regulator-visible system.
For businesses placing products on the US market, product listing and facility registration obligations mean that formula, facility and responsible person data must be accurate and maintained. The expected fragrance allergen rule is likely to add a further labelling and formulation-data requirement, particularly for fragranced products and products using complex perfume compositions.
Even before final fragrance allergen rules are in place, brands should expect greater scrutiny of whether safety substantiation, ingredient data and adverse event systems are robust and accessible.
Application / Impacted Products
Potentially impacted product categories include:
- fragranced skincare, body care and haircare;
- perfumes and fine fragrance products;
- deodorants and body sprays;
- products using essential oils, botanical extracts or fragrance blends;
- products manufactured by third-party or overseas facilities for sale in the US;
- brands with multiple product listings requiring annual data maintenance;
- product categories that may fall outside certain small business exemptions, including products intended for use around the eye, products intended for internal use, products intended to be injected, and products intended to alter appearance for more than 24 hours.
🇨🇦 Canada: Regulatory update
Fragrance allergen disclosure and Cosmetic Notification Form requirements
Canada’s updated fragrance allergen disclosure requirements are now an active compliance consideration.
From 12 April 2026, certain fragrance allergens must be disclosed when present above the relevant thresholds:
- greater than 0.001% in leave-on products;
- greater than 0.01% in rinse-off products.
These allergens must also be reflected in the Cosmetic Notification Form where applicable. Fragrance allergens present above the disclosure threshold should be listed individually rather than only under “fragrance” or “parfum”.
Further expansion is expected from 1 August 2026 for new products, with a longer transition for existing products.
Why does it matter?
This is a significant labelling and notification change for the Canadian market.
The update affects both product packaging and the information submitted to Health Canada. Fragrance allergens may be present not only through perfume compounds but also through essential oils, botanical extracts and naturally derived aromatic materials. This means that the impact may extend beyond traditionally fragranced products.
For brands selling in Canada and the EU, the Canadian changes also increase the importance of harmonised fragrance allergen data. However, Canadian labelling, bilingual requirements and Cosmetic Notification Form obligations still need to be considered in their own right.
Application / Impacted Products
Potentially impacted product categories include:
- perfumes and fragrance-led products;
- leave-on skincare, body lotions, creams and balms;
- shampoos, conditioners, shower gels and cleansers;
- deodorants and body sprays;
- essential oil products and aromatherapy-positioned cosmetics;
- botanical or naturally fragranced products;
- products sold in small packs where ingredient presentation may need practical label review;
- products requiring updated Cosmetic Notification Form submissions.
Cross-Market Themes for Formulation and Compliance Teams
Ingredient acceptability is becoming more dynamic
Ingredients that were historically permitted may become restricted, subject to tighter conditions, or prohibited as new toxicological opinions and classifications are adopted.
This is particularly relevant to UV filters, fragrance materials, colourants, preservatives, specialist raw materials, silver-containing ingredients and substances affected by CMR classifications.
Fragrance transparency is now a global issue
The EU, Canada and US are all moving towards greater fragrance allergen disclosure.
This places more importance on obtaining detailed allergen breakdowns from fragrance houses and ensuring that formula, label, safety assessment and notification data remain aligned.
Labelling changes need longer lead times
Many of the current updates affect artwork, ingredient order, multilingual requirements, warning phrases and packaging stock.
Regulatory review should therefore happen before packaging commitments are made, particularly where products are sold across multiple territories with different transition dates.
Reformulation may trigger further testing
Where an ingredient must be removed, reduced or replaced, additional work may be required to confirm product stability, microbiological robustness, preservation, packaging compatibility, claims support, SPF performance or safety assessment conclusions.
This is especially relevant where UV filters, preservatives, fragrance components or specialist functional ingredients are changed.
Documentation must reflect the final marketed product
Regulators increasingly expect formula data, safety documentation, product notifications and labels to match the product being sold.
Gaps between supplier data, formulation records, safety documentation and market-facing information can create compliance risk, particularly during periods of regulatory transition.
Conclusion
May 2026 reinforces the importance of proactive cosmetic compliance management across all major target markets.
For brands operating in the UK, EU, US and Canada, the practical challenge is not simply understanding each regulatory update in isolation. The real challenge is translating those updates into product-level decisions: whether a formula remains compliant, whether a label needs revision, whether supporting data is sufficient, whether a notification must be updated, and whether reformulation or testing may be required before a deadline is reached.
The most immediate areas of focus are EU CMR substance restrictions under Regulation (EU) 2026/78, the full EU withdrawal of 4-MBC / Enzacamene, UK ingredient prohibitions and formaldehyde-releaser labelling changes, EU and Canadian fragrance allergen disclosure deadlines, and the continued development of the US MoCRA framework.
Businesses that address these changes early will be better placed to manage artwork timelines, stock planning, testing schedules, reformulation programmes and market access continuity.
How ADSL Can Help
ADSL supports cosmetic brands, manufacturers and Responsible Persons with practical technical and regulatory services to help manage cosmetic regulatory change.
Our services include:
- formula review against UK, EU, US and Canadian requirements;
- regulatory gap analysis for affected ingredients and product categories;
- reformulation support where restricted or prohibited ingredients are present;
- cosmetic safety assessment and CPSR support;
- Product Information File review and updates;
- label and artwork review;
- fragrance allergen review and INCI declaration support;
- preservative and microbiological testing;
- SPF and performance testing support;
- claims support and substantiation review;
- product notification and compliance documentation support.
If your product portfolio includes fragranced products, UV filters, formaldehyde-releasing preservatives, hair dyes, nail products, colour cosmetics, children’s products or products sold across multiple territories, ADSL can help assess the impact of these updates and support a route to continued compliance.
ADSL – Advanced Development & Safety Laboratories
Technical Team | Paignton, UK
