Allergens on the label: why the INCI list has grown and what to say at the counter

From 31 July 2026, every cosmetic product placed on the European market for the first time must list a much broader range of fragrance allergens on its label: more than 80 substances instead of 26. Products placed on the market before that date may remain on sale until 31 July 2028.

The result is that, at this moment, two generations of labels for the exact same product coexist on the same shelf.

This is the question customers will ask at the counter in the coming months, and it has a precise answer: the INCI has become longer, but the formula has not changed. Those substances were already present, included under the term parfum. What has changed is the obligation to name them individually.

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What Regulation (EU) 2023/1545 provides

The regulation, adopted by the Commission on 26 July 2023, amends Annex III to Regulation (EC) No 1223/2009 on cosmetic products. It incorporates an opinion from the Scientific Committee on Consumer Safety, which had identified 56 additional fragrance allergens capable of causing allergies in humans and, until then, not subject to the obligation of individual listing.

With that addition, the list of fragrance substances that must be declared separately in the INCI when they exceed the thresholds set out in the annex exceeds eighty entries. Until then, there were 26.

The thresholds are lower than you might think

This is the detail that makes everything else in the discussion useful: the obligation to declare an individual substance applies at 0.001% in leave-on products and 0.01% in rinse-off products.

In other words, seeing a name on the label means that a minimum quantity has been exceeded, not that the substance is present in abundance. This is exactly the opposite of the instinctive interpretation, and it is why a longer INCI does not describe a more heavily loaded formula.

The two dates, which are not the same

The technical distinction matters because it explains why both labels coexist on the shelf.

1. 31 July 2026 - placing on the market. This is the first making available of a product on the Union market. From this date, every product entering the market for the first time must comply with the new provisions. No grace period is provided.
2. 31 July 2028 - making available on the market. This means any subsequent supply for distribution, consumption or use. Products placed on the market before July 2026 may continue to circulate until this date; after that, even stock remaining on shelves must be withdrawn.

Three years to adapt formulas, labels and packaging materials, and five years to sell through products that were already in circulation: this is the transitional period chosen by the legislator precisely because of the large number of products involved.

Why this matters at the counter

Because the label is the only part of the product that customers really read, and a suddenly longer ingredient list is interpreted in only one way: they have put something in it.

The correct interpretation is the opposite. Fragrance compositions have always been declared as a group under the term parfum, which may contain dozens of different raw materials. Extracting some of them and naming them individually does not add anything to the formula: it makes visible what was already there but grouped together.

The sentence that works at the counter is short: "the cream has not changed; what has changed is how much it is allowed to keep hidden". Seeing more names on the label means more information, not a less safe product.

For people with a confirmed allergy, it changes a lot

This is why the regulation exists, and it is worth saying this first when the customer is someone who has already experienced allergic contact dermatitis.

People who know the substance they are sensitized to - typically through a dermatological patch test - could previously find it hidden under a generic parfum declaration, with no way to identify it. From now on, if it exceeds the threshold, they will find it written on the label. For that person, this is not a bureaucratic detail: it is the difference between being able to choose and not being able to.

For everyone else, the point remains the same: fragrance is the leading cause of contact sensitization in cosmetics, and on skin that is frequently irritated, it is the first variable to remove.

For reactive skin with a vascular component, the reasoning is the same, but the margin is even narrower: the more compromised the barrier, the more important it is to reduce the number of stimuli instead of adding new ones.

Three things not to say

These are the most likely oversimplifications, and each creates a different problem.

• "They are safer now." The safety of the product had already been assessed: what changes is the transparency of the information, not the formula's safety profile.
• "If an allergen is listed, it is harmful." A fragrance allergen is a problem for people sensitized to that substance, not for the general population. The percentage of people who develop allergic contact dermatitis remains limited and stable.
• "Choose the one with the shorter list." A short list may simply belong to the old labeling system, or to a product placed on the market before July 2026. At this stage, the length of the INCI is not an indicator of anything.

How to use this as an opportunity to advise

A customer who stops to look at the label is a customer who has already opened the conversation: this is when the pharmacy can do what no online channel can, namely read that label with them and explain which part concerns them.

There are three useful questions: whether they have ever had documented skin reactions, whether they have ever had a patch test, and which products they are currently using altogether - because sensitization depends on cumulative exposure, not on a single tube.

Keep the distinction clear: an allergy is diagnosed with a dermatological test, not by reading an INCI. In the event of repeated reactions, the correct advice is to see a dermatologist for a patch test, which identifies the responsible substance. The cosmetic product should be chosen afterward, based on that result.

The regulatory landscape in the coming months

This deadline does not come alone: it joins two other developments that directly affect the counter. EU Regulation 2026/78 on CMR substances and the new limits on retinol expected by May 2027 follow the same logic: gradual adjustment, with transitional periods during which products complying with different rules coexist on the shelf.

For pharmacy staff, there is only one practical consequence, and it applies to all three: during a transition period, the date of placing on the market matters more than the appearance of the packaging. A perfectly legitimate product may have a different label from its counterpart that arrived three months later.

In summary

No withdrawals, no mandatory reformulation for safety reasons, and no alarm to raise. Just a broader information requirement, a period during which labels will not be uniform, and a concrete opportunity to explain something customers genuinely need to know.

LeLang formulas are distributed through partner pharmacies precisely because this kind of conversation needs a counter and someone who knows how to lead it.

Sources for this article

01 Commission Regulation (EU) 2023/1545 of 26 July 2023 amending Regulation (EC) No 1223/2009 as regards the labeling of fragrance allergens in cosmetic products
02 Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, Annex III
03 Scientific Committee on Consumer Safety, opinion on fragrance allergens in cosmetic products, SCCS/1459/11, 26-27 June 2012

On the website: EU Regulation 2026/78 on CMR substances · why buy cosmetics at a pharmacy · what sensitive skin is