CMR Substances in Cosmetics: Regulatory Similarities and Differences Between the EU and ASEAN

Ingredient safety serves as the foundation of overall cosmetic product safety. To safeguard consumers, regulatory frameworks worldwide strictly restrict the use of hazardous substances in cosmetics. Among these, CMR substances—those classified as carcinogenic, mutagenic, or toxic for reproduction—have become a particular concern, increasingly drawing the attention of regulatory authorities as scientific knowledge and consumer awareness grow.

This article examines how EU and ASEAN manage CMR substances in cosmetics, highlighting similarities in classification, differences in regulatory approaches, and zinc pyrithione (ZPT) as a case study of regulatory application.

Classification of CMR Substances

The EU's Regulation 1272/2008 on Classification, Labelling and Packaging of Substances and Mixture (CLP Regulation) provides a harmonized system for classifying hazardous chemicals, including CMR substances, across the EU. In the cosmetics sector, these classifications serve as a key reference when determining prohibitions or restrictions on CMR substances.

By comparison, when reviewing the safety of CMR substances in cosmetics, ASEAN authorities generally consider EU regulatory updates and CLP classification as part of their evaluation. As a result, the classification of CMR substances in both regions is largely aligned. Based on their hazardous properties, these substances are further divided into three categories, which are outlined below:

Approaches to Regulating CMR Substances

1. EU Rules

EU adopts a hazard-based approach to CMR substances. Article 15 of Regulation (EC) No 1223/2009 (Cosmetics Regulation) provides that CMR substances are prohibited in cosmetics, unless a derogation has been granted by the European Commission. Accordingly, once a substance is classified as CMR under the CLP Regulation, this classification automatically triggers a ban on its use in cosmetics.

An exemption from this prohibition may be granted only if the industry submits an application to the Commission, and demonstrates that all exemption criteria set out in the Cosmetics Regulation are fulfilled. These criteria vary depending on the category of CMR substances, listed as follows.

2. ASEAN Rules

In comparison, ASEAN follows a risk-based approach in managing CMR substances, where decisions to ban or restrict a substance are primarily guided by risk assessment and exposure analysis.

Following discussions at the 38th and 39th ASEAN Cosmetic Scientific Body (ACSB) meetings, preliminary criteria for the continued use of CMR substances in cosmetics were developed. These criteria apply only to substances with specific cosmetic uses in ASEAN. Substances not used in cosmetics may be included into the prohibited ingredients list of the ASEAN Cosmetic Directive (ACD).

Under the criteria, when a CMR substance is used in cosmetics marketed within ASEAN, its use shall be reviewed to confirm compliance with specified criteria (see table below). In contrast to the EU, ASEAN does not mandate proof of food safety compliance for Categories 1A and 1B. It further differentiates criteria for these categories, reflecting their classification basis—human evidence for 1A and animal evidence for 1B.

Case Study: Application of CMR Criteria to ZPT

ZPT (CAS No. 13463-41-7) is commonly used in anti-dandruff shampoos for its fungistatic and bacteriostatic properties. In September 2018, the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) proposed classifying it as a CMR Category 1B substance. This classification was subsequently integrated into the CLP Regulation by the Commission in August 2020.

1. EU Evaluation of ZPT

Before being classified as a CMR substance, ZPT was regulated in the EU as a preservative in rinse-off cosmetics (excluding oral hygiene products), with maximum concentrations of 1% in hair products and 0.5% in all other products. For non-preservative uses, it was permitted at concentrations up to 0.1% in leave-on hair products.

Following the CMR classification proposed by RAC, an application for an exemption from the CMR prohibition was submitted for ZPT. Evaluated against the corresponding exemption criteria, ZPT was deemed to meet the food safety requirements, and the application specified its use as an anti-dandruff ingredient in rinse-off products. Moreover, SCCS confirmed in its opinion SCCS/1614/19 that ZPT could be considered safe for use as an anti-dandruff ingredient in rinse-off hair products at concentrations up to 1%. However, as it had not been demonstrated that no suitable alternative substances were available for this use, EU ultimately decided to prohibit ZPT in cosmetics under Commission Regulation (EU) 2021/1902, effective March 1, 2022.

2. ASEAN Evaluation of ZPT

Prior to discussion on its CMR classification, ZPT was authorized in ASEAN as a preservative under the same use conditions as in the EU. For non-preservative uses, it was allowed at concentrations up to 0.1% in leave-on hair products, and 2% in rinse-off hair products.

At the 35th ACSB meeting held in May 2022, the question of whether to follow the EU in prohibiting ZPT in ASEAN was raised for the first time. During the meeting, the ASEAN Cosmetics Association (ACA) provided an initial defense of ZPT's safety, highlighting both its long safe-use history and the comprehensive safety reviews conducted by EU SCCS. In subsequent ACSB meetings, ACA submitted additional safety data and more detailed assessment calculations to support ZPT's various applications. These evaluations demonstrated that ZPT use in cosmetics is not anticipated to pose risks to the health and well-being of consumers. Even under the worst-case exposure scenario, where consumers are exposed daily to both leave-on and rinse-off products (including rinse-off products other than hair products) containing ZPT, the Margin of Safety (MoS) remains above 700, well above the commonly accepted threshold of 100 in cosmetics.

Guided by the ASEAN CMR criteria and supported by safety data and MoS calculations, ASEAN member states agreed at the 39th ACSB meeting to maintain ZPT's use in cosmetics under revised conditions. This outcome also established a precedent for risk-based decision-making in ASEAN, helping ensure that other similar safe cosmetic ingredients are not removed from the ASEAN market due to non-safety reasons. The revised use conditions for ZPT, presented in the following below, will take effect on May 14, 2026.

Further Reading

• Updates to ASEAN Cosmetic Directive (ACD)'s Ingredient Annexes: 15 Revised and 1 Added

• EU Clarifies Key Points of Upcoming TPO Ban in Cosmetics

• EU Unveils Proposal for Cosmetics Regulation Revision