EU & UK Fragrance Allergen Rules What Cosmetic Brands Must Know (Thumbnail)
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Anagha

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 what industry sources describe as 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.”

Great Britain applies its own cosmetics law, so the expanded EU list does not apply there automatically. Check the current GB requirements before you finalise UK labels. Industry bodies have already published joint guidance on the new allergen labelling deadlines.

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 a much longer list of 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 Regulation does not state a total. It adds new entries to Annex III, amends others and deletes some, and some entries cover families of related substances, so the exact count depends on how groups are counted. 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).

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 the footnotes in Annex III of the Regulation:

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:

  • The 31 July 2026 date has passed. New batches placed on the EU market must now 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.

The 2028 sell-through date may sound a long way off, but with artwork updates, PIF revisions and coordination with suppliers, your remaining stock needs planning now.

EU vs UK: Are the Rules the Same for Fragrance Allergens?

EU position
The EU’s position is straightforward: Regulation (EU) 2023/1545 is in force. The first deadline (31 July 2026) has passed, and the sell-through period for older stock runs to 31 July 2028. It applies to all cosmetic products in the EU/EEA, including imported goods and online sales aimed at EU consumers.

UK position
Great Britain applies the UK Cosmetics Regulation, which was retained after Brexit and is separate from EU law. Regulation (EU) 2023/1545 does not apply in Great Britain automatically. As far as we can find, Great Britain has not added the new EU allergen entries to its law. Confirm with OPSS or CTPA before you finalise UK labels.

However:

  • UK industry bodies are paying close attention to the EU changes.
  • A joint communication from CTPA and IFRA UK explains “placing on the market” and “making available” under the EU and UK Cosmetics Regulations, in the context of the new allergen labelling deadlines.

In short:

  • EU: The 80+ allergen labelling rules are already in place with set deadlines.
  • UK: Great Britain has its own rules, so check the current GB requirements. The EU list does not apply there automatically.

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?

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:

  1. Multiply the concentration of each allergen in the fragrance or ingredient by the percentage of that ingredient in the finished formula.
  2. 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:

  • Add any allergen above the threshold to the list of ingredients, in addition to the term “parfum” or “aroma” (Article 19(1)(g)). Keep the list in descending order of weight; ingredients below 1% may be listed in any order after those above 1%.
  • Use the names given in the Common Ingredients Glossary column of the updated Annex III (these follow the INCI system).
  • 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 any information you notified changes after relabelling or reformulation:

  • Ensure that EU CPNP entries are updated without delay (Article 13(7) of the EU Cosmetics Regulation)
  • Update your UK SCPN notification immediately if any notified information changes (OPSS guidance on Article 13)

In the EU, the Responsible Person or the distributor must provide any update to notified information without delay (Article 13(7)). Agree with your Responsible Person who handles this.

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.
  • 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

How Euverify Can Help 1

The move from 26 to what industry calls 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 document verification in line with current EU and UK cosmetics regulations
  • Submission and tracking of your CPNP and SCPN notifications
  • A verifiable certificate confirming your representation
  • A compliance dashboard to keep all your compliance data in one place

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.