Remaining Stocks of TPO-containing Nail Products – Do Professional Users Have to Discard Everything?
Interview with Dr. Beate Pfundstein, state-certified food chemist, ICADA Head of EU Department, ICADA e.V., and Dr. Andreas Reinhart, lawyer specializing in cosmetics law, REINHART Rechtsanwälte Partnerschaft mbB law firm
ICADA e.V. | REINHART Rechtsanwälte Partnerschaft mbB
Dr. Pfundstein, Dr. Reinhart, the ban on products containing TPO is causing considerable uncertainty in the industry. Can you briefly explain what TPO is all about?
Dr. Pfundstein: TPO stands for trimethylbenzoyl diphenylphosphine oxide (CAS No. 75980-60-8). It serves as a photoinitiator used in UV-curing nail polishes and modeling gels. It ensures that the products cure under UV light.
What is the legal background?
Dr. Pfundstein: TPO was not previously subject to EU Cosmetics Regulation (EC) No. 1223/2009. However, the substance was already classified as a Category 2 CMR substance (reproductive toxicity) in 2012 in accordance with Commission Regulation (EU) No. 618/2012 adapting Regulation (EC) No. 1272/2008 (CLP Regulation) to technical and scientific progress. At that time, the ECHA's Committee for Risk Assessment (RAC) concluded in its opinion that the testes are a target organ for TPO in rats and may cause reduced male fertility. These adverse effects occurred without significant general toxicity.
Dr. Reinhart: According to Article 15(1) of the EU Cosmetics Regulation (1223/2009), the use of substances classified as CMR substances in category 2 is prohibited in cosmetic products. However, such a substance may be used if it has been evaluated by the Scientific Committee on Consumer Safety (SCCS) and found to be safe for use in cosmetic products. In September 2013, the Commission received a dossier from Cosmetics Europe on the safety assessment of TPO. The SCCS concluded that 5% TPO in topically applied artificial nail systems is safe. TPO was then included in Annex III of the EU Cosmetics Regulation and approved with the restrictions "for professional use only," "avoid skin contact," and "read instructions carefully" and a maximum concentration of 5% (entry 311 in Annex III, old version).
What other toxicological assessments were carried out?
Dr. Pfundstein: In 2018, local lymph node assay (LLNA) tests for sensitization, a screening test for reproductive and developmental toxicity (OECD 421), and an extended one-generation reproductive toxicity study (OECD 443) were conducted. These studies clearly demonstrated sensitization and adverse effects on the testes and epididymides in rats, leading to reduced fertility – again without pronounced general toxicity.
In 2021, the ECHA's Committee for Risk Assessment (RAC) issued a further opinion. This led to the adoption of the 21st ATP as Delegated Regulation (EU) 2024/197. TPO was thus classified as toxic to reproduction (1B) and a skin sensitizer (1B), with the hazard statements H360Fd and H317.
Dr. Reinhart: This new classification means that TPO now falls under Article 15(2) of the EU Cosmetics Regulation, which—compared to Article 15(1)—imposes stricter requirements for exceptional authorization. No application for an exemption was therefore submitted, as maintaining the entry in Annex III would require not only a safety dossier for the SCCS, but also evidence of alternatives and food safety. As a result, TPO was (also) banned for cosmetic products. For reasons of uniform implementation and legal certainty, CMR substances prohibited under Article 15 are included in the list of prohibited substances in Annex II to the EU Cosmetics Regulation, which, with regard to TPO, was done by Regulation (EU) 2025/877 of May 12, 2025. TPO is now included in Annex II (entry 1731) and deleted from Annex III. The ban has been in force since September 1, 2025.
What does this mean for the industry in concrete terms?
Dr. Pfundstein: Since September 1, 2025, TPO has been a banned substance in cosmetic products. Cosmetics companies process chemicals, and this has been official knowledge since the publication of the 21st ATP Regulation in October 2023. The RAC opinion in 2021 should have been reason enough to start looking for alternatives.
Dr. Reinhart: According to Article 14(1)(a) of the EU Cosmetics Regulation, cosmetic products must not contain prohibited substances. This means that since September 1, 2025, products containing TPO may no longer be manufactured or placed on the market in the EU. Their provision—i.e., sale or free distribution—is also prohibited. Commercial suppliers, nail salons, and hairdressers will therefore not be allowed to sell or give away products containing TPO after this date.
Are studios allowed to continue using such products that were purchased before the deadline?
Dr. Pfundstein: This is precisely where the controversy lies. In a Q&A statement on August 19, 2025, the EU Commission clarified that commercial users may no longer use products containing TPO from September 1, 2025, as this is considered "making available on the market" in the context of a commercial activity. This applies regardless of when the products were purchased. The first version of the Q&A statement indicated that consumers may continue to use products purchased before the deadline for private use, even though it would be advisable to switch to alternatives (these lines were deleted in the second version).
Dr. Reinhart: This statement by a Commission department is incorrect. It is undisputed that private end users may continue to use products containing TPO that they received before September 1, 2025. However, according to Article 2(1)(f) of the EU Cosmetics Regulation, a person who uses cosmetic products for professional purposes is also considered an "end user." Accordingly, private end users and professional or commercial end users are fundamentally treated equally under the EU Cosmetics Regulation. In addition to the term "end user," the binding definition of "making available on the market" also contradicts the Commission's view. According to Article 2(1)(g) of the EU Cosmetics Regulation, this means "any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge." According to the clear wording, this requires a "supply." This means that a professional user does not commit "making available on the market" when using the product, but uses the product like a consumer. Thus, the use of the product will still be legally permissible after September 1, 2025, if the product was obtained before September 1, 2025.
Dr. Pfundstein: The TPO-containing products placed on the market and made available on the market before September 1, 2025, are expressly intended for commercial use only, so that only professional users will use them up. Professional users are trained to avoid skin contact in particular, so that the risk can continue to be controlled. In any case, this only concerns remaining stocks. The reclassification from Category 2 to 1B merely means a shift from "some evidence" to "clear evidence" of reproductive toxicity. Remaining stocks may therefore be used up. At the same time, the discussion is helping to raise awareness of the reproductive toxicity potential of TPO.
Dr. Reinhart: The publication of the Q&A document by the Commission, which is not legally binding and should not be regarded as an official statement by the EU Commission, was intended to serve as a guide and provide clarity. Instead, however, it presents a legal opinion that is, at the very least, idiosyncratic and incompatible with the wording of the EU Cosmetics Regulation. This is problematic and could ultimately require legal proceedings to correct this misinterpretation. It is not the EU Commission but the Court of Justice of the European Union (CJEU) that is responsible for interpreting EU law. This is not about the substance TPO, but about the fundamental question of whether the mere application or use of cosmetic products by persons who use them professionally falls under the provisions of the EU Cosmetics Regulation.
A final word on the classification of TPO in the general development?
Dr. Pfundstein: TPO is just one example of substances that are classified as CMR. As an industry association, ICADA is monitoring these developments very closely. Since the restructuring in 2023, we have been informing our members at an early stage about intended classifications, both via internal platforms and via newsletters and events.
ICADA e. V. represents the interests of small and medium-sized cosmetics companies at EU and national level. We support our members with regulatory expertise, market access, training, and networking events. With quality seals, consulting services, and innovation promotion, we strengthen the competitiveness of our members—today and in the future.
Note: Source language German, translated into English using AI.
Dr. Beate Pfundstein
State-certified food chemist, advises on issues relating to quality assurance/toxicology/food and cosmetics law and works for ICADA e.V. as head of the EU department, represents the association in the EU Commission's working group on cosmetic products in Brussels and is responsible for providing information and advice to ICADA members.
Dr. Andreas Reinhart
Attorney at law in Munich and partner at the law firm REINHART Rechtsanwälte Partnerschaft mbB. He advises and represents clients from the food, cosmetics, and pharmaceutical industries on product-specific and competition law issues.
Lecturer in food law at the Technical University of Munich in Weihenstephan.
He is a member of the Legal Committee of the German Food Association (Lebensmittelverband Deutschland e.V.), the GRUR Expert Committee on Pharmaceutical and Food Law, and the Scientific Advisory Board of the Scientific Society for Food Law (WGfL), as well as an active member of the LChG's Cosmetics Working Group.
Author of numerous scientific publications, including co-editor of the journal “Lebensmittel & Recht” (Food & Law) and editor of the commentary on the EU Cosmetics Regulation and the practical handbook on cosmetic products.
