Cosmetici sul banco della farmacia e normativa europea

EU Regulation 2026/78: the new CMR rules in pharmacies

of Elisa Avalle , founder of LeLang

5 min read

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From 1 May 2026, Regulation (EU) 2026/78 is fully applicable in all Member States. For pharmacies, parapharmacies and professional operators, this means that non-compliant products may no longer be sold or held for professional use: no transitional period was provided.

If you have not yet completed your product range review, this article is intended to help you do so now — because the rule is in force and the penalties provided for under Italian law are not merely symbolic.

What Regulation (EU) 2026/78 provides

The Regulation was published on 13 January 2026 in the Official Journal of the European Union and amends Regulation (EC) No 1223/2009, the European framework legislation on cosmetic products. It concerns the use of certain substances classified as CMR: carcinogenic, mutagenic or toxic to reproduction.

This is an important clarification: the "R" in CMR stands for reproduction, not "toxicity" in general. In the case of silver, reproductive toxicity is precisely the reason for the restriction.

The starting point is Delegated Regulation (EU) 2024/2564, which updated the list of CMR substances. The Scientific Committee on Consumer Safety (SCCS) then assessed whether some of them could be used in cosmetics within safe limits: for CMR substances, the general principle is prohibition, but Regulation 1223/2009 provides for an exception when safe use is demonstrated within defined parameters.

The measure is part of a gradual process, launched with Regulation (EU) 2025/877 of May 2025.

The bans are directly applicable in all Member States, without the need for national transposition. There is no need to wait for any Italian decree: the rule already applies.

The three substances involved

Silver (CI 77820)

A mineral colorant used to create metallic, mirrored or glossy effects in nail polishes, eyeshadows, lipsticks and some creams. It has been classified as toxic to reproduction in certain forms and particle sizes.

Use in powder form (with a diameter between 100 nm and 1 mm) remains permitted, for example up to 0.2% in lip products and eyeshadows. The areas most exposed are nail products, including nail polishes and gels.

Hexyl Salicylate (hexyl 2-hydroxybenzoate)

A very common synthetic fragrance ingredient. It is found in floral fragrances, shampoos, shower gels, lotions, creams, toothpastes and mouthwashes. For pharmacies, it is the substance with the widest distribution, and therefore the one requiring the most extensive checks.

o-Phenylphenol (biphenyl-2-ol) and Sodium o-Phenylphenate

Antibacterial preservative used in shampoos, cleansers, lotions, and professional hair care products. Its use as a preservative is confirmed, but within precise limits:

0,2% (expressed as phenol) in rinse-off products;
0,15% in leave-on products;
prohibited in products involving inhalation exposure, such as aerosols and sprays;
prohibited in oral care products, including toothpastes and mouthwashes;
it is recommended to avoid contact with the eyes.

The presence of one of these substances in the INCI does not automatically prove non-compliance: the product category and percentage matter, and this information is not always legible on the label. For this reason, the check necessarily involves the supplier. For information on how to read a label, see the cosmetic ingredients guide.

How to check the product range: the procedure

Identify the references at risk. Start with the categories most exposed: nail products with metallic effects, fragranced lines, shampoos and cleansers, and oral care products.
Request written confirmation from the supplier of compliance with Regulation (EU) 2026/78, retaining the batch reference and a photograph of the INCI.
Physically separate the products being checked from those displayed to the public, to prevent accidental sales during the assessment.
Define with the supplier the procedures for returns, replacement, or disposal.
Document the process. In the event of an inspection, being able to demonstrate that the check was carried out is part of the required diligence.

One point on which the Regulation says nothing: it does not establish whether non-compliant products must be returned to the supplier or disposed of by the operator. The matter is left to the contractual agreements between the parties, which is why it is advisable to address it in writing rather than verbally.

Penalties in Italy

In Italy, the penalty framework for the Cosmetics Regulation is already established by Legislative Decree 204/2015. Article 10 covers violations concerning prohibited substances, limits in the annexes, and CMR substances.

In the cases specified by the decree, and except in more serious cases, violation of Article 15 on CMR substances may result in imprisonment from six months to two years and a fine of between 2,000 and 15,000 euros.

It is worth reading carefully: this is not just about administrative penalties. For violations involving CMR substances, Italian law also provides for criminal liability. This is the most concrete reason why checking the product range is not a mere formality.

Why this also matters for in-pharmacy advice

There is an aspect that goes beyond compliance. A customer who asks whether a product is safe deserves an informed answer, and knowledge of the regulatory framework is exactly what distinguishes in-pharmacy advice from an online search.

The case of these three substances also shows how the European system works: new scientific evidence leads to reclassification, the SCCS assesses safety limits, and the Commission updates the annexes. This is not a sign that cosmetics were dangerous, but that monitoring is an ongoing process. We discuss this in greater depth in the article on PFAS and European regulations, and in the article on how a cosmetic product is created, which describes the validation process behind every formula.

Finally, we would like to remind you that LeLang formulations do not contain any of the three substances covered by Regulation 2026/78: our research is based on essential ingredient lists and active ingredients of natural or biotechnological origin.

Are you a pharmacist?

If you collaborate with us or would like to, we can provide you with the compliance documentation for our product lines and training support for in-pharmacy consultations. You can find the information on the page dedicated to LeLang partners, or you can apply to become a partner pharmacist.

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Frequently asked questions

When does EU Regulation 2026/78 apply?
From May 1, 2026, with no transitional period and no need for national transposition.

Which substances are involved?
Silver (CI 77820), Hexyl Salicylate and o-Phenylphenol, together with its sodium salt.

If one of these substances appears in the INCI, is the product non-compliant?
Not necessarily. It depends on the product category and concentration: confirmation from the supplier is required.

Who is responsible for disposing of non-compliant products?
The Regulation does not establish this: the matter depends on the contractual agreements with the supplier.