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- Cosmetic toxicologist at Euverify, specialising in cosmetic product safety, PIF and CPSR preparation, and regulatory compliance with EU and UK Cosmetic Regulations. Conducts toxicological assessments of cosmetic ingredients and formulations, reviews product safety reports and manages CPNP and SCPN product notifications. Dedicated to supporting brands in achieving compliance with EU and UK cosmetic standards.
From 26 to 80+ Fragrance Allergens: What EU & UK Cosmetic Brands Must Do Next
Fragrance is one of the things people love most about a cosmetic product. It is also one of the areas regulators watch most closely.
For a long time, brands in the EU only had to call out 26 fragrance allergens on their labels when the amounts passed certain limits. That has now changed in a big way. Under Regulation (EU) 2023/1545, the list has been expanded to more than 80 individual allergens and groups. This update applies to everything from perfume and moisturiser to deodorant, baby care and even products that are marketed as gentle or “clean.”
The UK has not officially adopted the expanded list yet. Even so, the industry and regulators are clearly getting ready for some kind of shift. Joint guidance and early communication have already started, which is a good sign that similar rules may follow.
In this guide, you will find a simple walkthrough of what to look out for, including:
- What changed in the EU
• What is happening now in the UK
• Which products are affected
• How to review your formulas, labels and documentation
• How to plan ahead without stressing or guessing
This gives you a clear starting point so you can update your products with ease and stay ahead of upcoming rules.
Why Fragrance Allergens Are Back in the Spotlight
Fragrance allergies are more common than many people realise. EU regulators estimate that somewhere between 1 and 9 percent of people are sensitised to fragrance allergens. Once someone is sensitised, even tiny amounts can lead to contact dermatitis.
For a long time, the EU followed a simple framework. Some allergens were restricted under Annex III, which set limits and usage rules. On top of that, brands had to list 26 specific allergens on the label whenever they passed 0.001 percent in leave-on products or 0.01 percent in rinse-off products.
Over time, new scientific work from the Scientific Committee on Consumer Safety showed that the original list did not go far enough. More fragrance ingredients were linked to allergic reactions, which meant consumers needed clearer information on labels.
Regulation (EU) 2023/1545 is the outcome of that research. It expands the allergen list, updates several entries and aims to make labelling more transparent so people who are sensitised can avoid the substances that affect them.
What Exactly Changed: Regulation (EU) 2023/1545
From 26 to 80+ allergens
Regulation (EU) 2023/1545:
- Amends Annex III of the EU Cosmetics Regulation (EC) 1223/2009
- Expands the number of allergens that must be individually listed on labels from the historic “26” to more than 80 substances and groups (often referred to as “80+ fragrance allergens”)
- Updates several existing entries to include isomers, harmonise INCI names, and refine CAS/EC numbers
The exact total can vary depending on how groups are counted, since some entries cover families of related substances. This is why many expert sources refer to “80+ allergens” rather than a fixed number.
Thresholds: what triggers labelling?
The concentration thresholds for when allergens must appear on the label remain the same as before:
- Leave-on products: 0.001%
- Rinse-off products: 0.01%
This is confirmed directly in the updated Annex III wording for multiple entries (for example benzyl alcohol, citral, citronellol, limonene, methyl salicylate and others). EUR-Lex+1
In simple terms: more substances are now on the list, but the trigger level for when they must be declared has not changed.
Key types of substances added
The new entries include:
- Additional terpenes and citrus-derived compounds (e.g. limonene isomers, terpinolene)
- Components of essential oils (e.g. cedarwood, pine, verbena derivatives)
- “Rose ketones” and other complex fragrance molecules
- Substances found in complex natural extracts (e.g. Peru balsam)
The overall principle is that if a substance has been identified as a contact allergen and is likely to be present in cosmetics, consumers should be able to see it on the ingredient list.
Timelines: When Do You Need to Comply?
The EU added transition periods to acknowledge how much work relabelling and reformulation involve. According to Article 2 and the footnotes in Annex III:
Non-compliant products (those that only meet the old rules):
- May continue to be placed on the EU market until 31 July 2026
- May continue to be made available (sold) until 31 July 2028
“Placed on the market” generally refers to the first time a product is supplied, whether sold or given away. “Made available” refers to the ongoing supply of that product to distributors or consumers. The CTPA/IFRA UK joint note explains how these ideas work in practice for both the EU and UK.
What this means for brands:
- You have until mid-2026 to make sure new batches placed on the EU market comply with the expanded allergen list.
- You have until mid-2028 to sell through older stock that was placed on the market before the deadline.
It might sound like plenty of time, but with artwork updates, PIF revisions, and coordination with suppliers, it’s really not.
EU vs UK: Are the Rules the Same for Fragrance Allergens?
EU position
The EU’s position is straightforward: Regulation (EU) 2023/1545 is already in force, and the transition timelines are active. It applies to all cosmetic products in the EU/EEA, including imported goods and online sales aimed at EU consumers.
UK position (as of late 2025)
The UK has kept the core UK Cosmetics Regulation after Brexit, and for now it still follows the original list of 26 allergens. The UK has not formally adopted Regulation (EU) 2023/1545.
However:
- UK industry bodies and regulators are paying close attention to the EU changes.
- A 2025 joint communication from CTPA and IFRA UK explains “placing on the market” and “making available” in the context of future allergen labelling changes, which signals that additional requirements are likely to affect UK products as well.
In short:
- EU: The 80+ allergen labelling rules are already in place with set deadlines.
- UK: Still using the original allergen list for now, but alignment or similar changes are very likely in the medium term.
For many brands, the easiest approach will be to apply EU-level labelling across all SKUs, instead of managing separate allergen strategies for the EU and UK.
Which Products Are Affected?
It’s easy to think this is only a “perfume issue”, but the scope is much wider.
Any cosmetic product covered by Regulation (EC) 1223/2009 that contains fragrance or perfuming compounds can be affected, including:
- Fine fragrances (Eau de Parfum, Eau de Toilette, body mists)
- Facial skincare (serums, moisturisers, anti-ageing creams)
- Body care (lotions, oils, butters, scrubs)
- Hair care products (shampoos, conditioners, styling products)
- Deodorants and antiperspirants
- Hand creams and leave-on hand products
- Baby and children’s cosmetics
- Soaps, shower gels, bath foams
- Wet wipes and intimate care products
It’s also worth remembering that allergens don’t only come from perfuming “parfum” mixtures. They can also come from:
- Essential oils
- Plant extracts
- “Active” ingredients that happen to be aromatic
- Complex botanical blends used for marketing or sensorial appeal
If a listed allergen is present above the threshold in the finished product, it must be declared, no matter whether it comes from a “fragrance”, an “aroma”, or any other ingredient source.
How to Audit Your Products for the New Allergen Rules
This is where brands tend to feel overwhelmed: multiple suppliers, incomplete data, legacy formulas. The best way forward is a structured audit.
Step 1 – Build an allergen-focused ingredient map
Start by listing all products that contain:
- Parfum / Fragrance / Aroma
- Essential oils
- Botanical or natural extracts with aromatic properties
Then, for each product:
- Extract the full formula from your internal system or your PIF.
- Identify ingredients that could be potential allergen sources (perfume bases, essential oils, flavored actives, etc.).
This gives you a shortlist of SKUs likely to be impacted.
Step 2 – Request technical data from fragrance and raw-material suppliers
Ask suppliers for updated, nano-level data aligned with Regulation (EU) 2023/1545. At a minimum, you’ll need:
- Full breakdown of any fragrance composition, including:
- Names of listed allergens present
- Concentrations in the fragrance compound
- IFRA certificates and safety assessments
- Updated INCI names, especially where the Regulation has clarified or grouped substances
For essential oils and botanicals, clarify:
- How they were standardised
- Whether specific allergen content is known from analysis
Step 3 – Calculate allergen levels in the finished product
Using supplier data:
- Multiply the concentration of each allergen in the fragrance or ingredient by the percentage of that ingredient in the finished formula.
- Compare the resulting level to the allergen thresholds:
- 0.001% (leave-on)
- 0.01% (rinse-off)
Any allergen above the threshold must appear in the ingredient list.
Step 4 – Update your PIF and CPSR
Under the EU (and UK) Cosmetics Regulations, your Product Information File (PIF) and Cosmetic Product Safety Report (CPSR) must reflect:
- The presence and level of each allergen
- Exposure scenarios (leave-on vs rinse-off, body area, target population)
- The toxicologist’s assessment of sensitisation risk
If new allergens appear or levels change, your Responsible Person may need to update the CPSR and document the risk evaluation based on the expanded SCCS allergen data.
Step 5 – Update labels and artwork
Once allergen calculations are done:
- Update the INCI list on packs to include any allergen above the threshold, in descending order after other ingredients.
- Use the exact INCI names specified in the updated Annex III and Cosmetics Europe guidance.
- Ensure that label space, font size, and legibility still comply with general labelling requirements.
If your products are sold in both the EU and UK, it is usually simpler to:
- Adopt a single, EU-compliant allergen listing approach globally
- Rather than maintaining separate “26 allergen” vs “80+ allergen” labels by region
Step 6 – Check CPNP and SCPN notifications
If you materially change your formula or label:
- Ensure that EU CPNP entries reflect the updated formula information
- Update UK SCPN notifications where relevant
Your Responsible Person for cosmetics (under the EU and UK Cosmetics Regulations) is responsible for keeping these notifications up to date.
Reformulation: When Labelling Alone May Not Be Enough
For some brands, especially those positioned for “sensitive skin” or “baby” use, simply adding more allergens to the INCI list may not feel acceptable from a marketing or safety point of view.
Situations where reformulation may be needed:
- Leave-on face or eye products that contain several new allergens at or near the threshold
- Products aimed at children or users who are known to be allergy-prone
- Lines marketed as “allergen-reduced” or “for sensitive skin”
Possible strategies:
- Work with fragrance houses to create “allergen-light” or reduced-allergen fragrance bases
- Replace certain essential oils with more controlled, standardised alternatives
- Review long lists of botanical extracts to identify which ones actually contribute to the allergen load
Whatever route you take, keep a clear paper trail:
- Supplier correspondence
- The rationale behind any reformulation
Updated CPSR and stability or microbiological testing where required
Marketing and Claims: “Free From” and “Hypoallergenic”
Fragrance allergens are not only a labelling issue. They also have a real impact on claims and advertising.
Across the EU and UK:
- Cosmetic claims must be truthful, honest, fair, and backed by evidence, in line with the EU common criteria for cosmetic claims and local advertising standards. CTPA+1
- Claims like “hypoallergenic”, “dermatologist tested”, or “for sensitive skin” need proper substantiation, not just lower fragrance levels.
- “Free from [X]” claims can cause issues if they:
- Suggest that legal, allowed ingredients are unsafe
- Play on consumer fears
- Go against the principles in the EU common criteria or UK advertising codes
Both EU authorities and the UK Advertising Standards Authority (ASA) have made it clear that “free from” claims and similar wording must not mislead or imply that lawful competing products are inferior.
With the expanded allergen list, brands should:
- Avoid blanket statements like “fragrance-free” if the product still contains any perfuming ingredients.
- Make sure “allergen-free” claims are only used when they are strictly and demonstrably true based on the full expanded allergen list.
Keep marketing and regulatory teams aligned so that claims and the INCI list are consistent and tell the same story.
What Non-Compliance Looks Like (and Why it Matters)
If products do not meet the new requirements, authorities can:
- Request corrective actions such as re-labelling or reformulation
- Restrict or withdraw products from the market, especially if there is a clear risk for people who are already sensitised
- Highlight non-compliant products through public channels or enforcement reports
Regulators have already indicated that fragrance allergens will stay a priority in market surveillance, inspections, and testing programmes, especially for products used by more vulnerable groups such as babies, children, and users of leave-on facial care.
For brands, the main risks are:
- Expensive relabelling efforts and possible product withdrawals
- Loss of consumer trust, particularly among those who value transparency
Conflicts between “clean” or “safe” marketing messages and what the regulations actually require
How Euverify Can Help
The move from 26 to more than 80 fragrance allergens is more than just an updated list. It affects formulas, labels, safety assessments, and marketing claims across both EU and UK markets. If you’re selling cosmetics into Europe or the UK, you’ll need:
- Accurate checks on ingredients and potential allergens in each formula
- Updated PIFs and CPSRs that reflect the new regulatory requirements
- Clear, compliant labelling for both regions
- An EU and UK Responsible Person who can work with authorities and maintain your documentation
Euverify supports cosmetic brands and private-label owners with:
- EU and UK Responsible Person services, acting as your regulatory contact and keeping your documentation compliant
- PIF and CPSR reviews and updates in line with current EU and UK cosmetics regulations
- Ingredient, labelling, and compliance checks built into their RP and documentation processes
- Practical guidance on claims and labelling, so you stay compliant without losing your brand’s tone of voice
- A streamlined compliance platform to organise, store, and maintain your technical files
If your range includes fragranced products, now is the right time to get ahead of the new requirements, rather than waiting for regulatory deadlines to collide with your artwork timelines.
Final Takeaway
The move to 80+ fragrance allergens is a major shift, but it’s one you can navigate smoothly with the right preparation. Understanding what’s changing, reviewing your formulas and labels early, and keeping your documentation up to date will make the transition far easier. Taking a proactive approach now means fewer surprises later and ensures your products stay compliant, trusted, and ready for both EU and UK markets.
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