Cosmetics

What are cosmetic products?

Cosmetic product means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

Cosmetic products are regulated in the EU by the Cosmetic Products Regulation (Regulation (EU) 1223/2009).

Legislation

Prohibition of TPO in Cosmetic Products

On 12 May 2025, the EU Commission published a legislation, known as the 7th CMR Omnibus Regulation, to add 22 new substances to the list of ingredients prohibited for use in cosmetics.

The list includes Trimethylbenzoyl diphenylphosphine oxide (TPO). TPO is used in some UV gels and hybrid nail polishes helping product to harden and cure under UV light. It was previously permitted for professional use only but now will be prohibited in all settings.

The 7th CMR Omnibus Regulation will take effect on 1 September 2025. From 1 September 2025, both placing and making available on the market of cosmetic products containing TPO are prohibited. This means that:

  • New products containing TPO cannot be placed on the market from that date.
  • Products already placed on the market before that date cannot continue to be supplied, transferred, or otherwise made available to another person in the course of commercial activity. In other words, professionals in the cosmetic businesses may not sell these products in the EU, nor may they give these products away.

Background to the inclusion of TPO in Annex II

The Classification, Labelling and Packaging (CLP) Regulation in the EU aims to ensure a high level of protection of human health and the environment by identifying the hazardous properties of substances and mixtures.

Under the EU CLP Regulation (Regulation (EC) No 1272/2008), substances deemed carcinogenic, mutagenic, or reprotoxic (CMR) are classified into three categories based on the strength of evidence for their hazardous effects:

  • CMR1A: substances for which there is clear evidence that they are carcinogenic, mutagenic or toxic to reproduction.
  • CMR1B: substances for which these effects are possible but for which there is a need for further research for confirmation of the effects.
  • CMR2: substances suspected of having carcinogenic, mutagenic or reprotoxic effects. The risk assessment requires further studies.

Under the CLP, TPO is now classified as belonging to the CMR Category 1B, resulting in its inclusion in Annex II of the European Cosmetics Regulation, prohibiting its use in cosmetic products.

Further information about the TPO  ban can be found on the Commission website.

Placing on the market

Any cosmetic product should comply with Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products. Each cosmetic product must be notified accordingly on the Cosmetic Product Notification Portal (CPNP).

The CPNP is a free of charge online notification system created for the implementation of the cosmetics regulation. When a product has been notified in the CPNP there is no need for any further notification at national level in the European Union.

When the notification process is complete, the system will assign a notification number for each product. Kindly give this notification number to Customs as proof that you have performed the notification, along with the correct label which will be used.

The label should include the correct particulars and requirements as established within Article 19 of the same regulation. These includes an EU address (of the responsible person who notified the product), the country of origin for products imported into the EU, the nominal content at the time of packaging (given by weight or volume), the date of minimum durability, particular precautions to be observed, the batch number, the function of the cosmetic product and the list of ingredients. The ingredients list should be written using the International Nomenclature for Cosmetic Ingredients (INCI) nomenclature. With respect to the ingredients, one may consult the COSING website to check whether the substances in the formulation are restricted or banned. The labelling elements listed above should be made available in either English or Maltese as per Legal notice 323 of 2011.

Furthermore, cosmetic products should not contain any claims relating to the treating or curing, etc. of a disease or medical condition.

Also, according to Article 11, the responsible person is obliged to keep a Product Information File (PIF) for each cosmetic product placed on the market. Amongst the information to be included in the PIF is a cosmetic product safety report, for which further information can be found under Annex I of the Cosmetic Products Regulation.

Contact Us

Need further information or assistance?

Feel free to send us an email – rad@mccaa.org.mt or give us a call at +356 23952000.

Further Information