Do Finished Cosmetic Products Require a Safety Data Sheet in the EU an

Finished cosmetic products placed on the market in the European Union and the United Kingdom do not require a Safety Data Sheet under REACH, because they are instead governed by cosmetic legislation that mandates safety assessment, a Product Information File, and oversight by a Responsible Person.

Questions about Safety Data Sheets (SDS) are common in the cosmetic sector, particularly among professionals working with nail products, distributors, and regulatory authorities. In chemical legislation, SDS documentation is a standard safety communication tool. However, finished cosmetic products placed on the market in the European Union and the United Kingdom follow a different legal framework.

This article explains why finished cosmetics do not require an SDS under the REACH Regulation, how safety is instead ensured through the Cosmetic Product Regulation, and how ingredient transparency and labeling obligations are maintained in practice.

The REACH Regulation and the SDS Exemption for Finished Cosmetics

Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) generally requires suppliers of hazardous substances or mixtures to provide a Safety Data Sheet to downstream users. The SDS communicates hazards, handling precautions, and emergency measures.

However, Article 2(6) of REACH establishes a specific exemption for finished cosmetic products that fall within the scope of cosmetic legislation. Where a product is correctly classified and placed on the market as a cosmetic product, the obligation to supply an SDS at finished-product level does not apply.

The absence of an SDS does not indicate an absence of safety oversight. Instead, cosmetic products are governed by a dedicated regulatory system designed specifically for products intended for application to the human body.

Regulation of Cosmetics in the EU and the UK

In the European Union, cosmetic products are regulated by Regulation (EC) No. 1223/2009 on cosmetic products. In the United Kingdom, an equivalent framework is implemented through Schedule 34 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, commonly referred to as the UK Cosmetics Regulation.

Although operating in separate jurisdictions, both systems impose substantially identical core obligations before a cosmetic product may be placed on the market:

Each product must have a designated Responsible Person established in the relevant jurisdiction.
Compliance with safety, composition, labeling, and notification requirements must be ensured prior to market placement.
A complete Product Information File (PIF) must be compiled and kept available for competent authorities.
The PIF must contain a Cosmetic Product Safety Report (CPSR) prepared by a qualified safety assessor.

These legally defined mechanisms replace the need for a Safety Data Sheet for the finished cosmetic product.

The Role of the Responsible Person

The Responsible Person is the legal entity that ensures a cosmetic product complies with the applicable Regulation before it is placed on the market. This role may be fulfilled by the manufacturer, the importer, or a specifically designated third party established within the EU or the UK.

Among the central duties of the Responsible Person is the maintenance of the Product Information File. The PIF must be readily accessible at the address of the Responsible Person for inspection by competent authorities and must be retained for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

The Product Information File and Cosmetic Product Safety Report

The Product Information File forms the technical and scientific foundation of cosmetic compliance. It must contain, at minimum:

A description of the cosmetic product enabling clear identification.
The Cosmetic Product Safety Report as defined in Annex I of Regulation (EC) No. 1223/2009.
A description of the manufacturing method and confirmation of compliance with Good Manufacturing Practice.
Where justified by the nature or effect of the product, proof supporting claimed effects.
Data relating to animal testing, where applicable.

The CPSR itself consists of two parts. Part A compiles all safety-relevant data, including ingredient composition, toxicological profiles, exposure assessment, and margin-of-safety calculations. Part B provides the formal safety conclusion and conditions of use determined by the safety assessor.

Qualified Safety Assessor Requirement

Article 10 of Regulation (EC) No. 1223/2009 requires that the cosmetic product safety assessment be carried out by a safety assessor in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine, or a similar discipline, or a course recognised as equivalent.

This requirement ensures that the safety of finished cosmetic products is evaluated through a scientifically rigorous and product-specific assessment rather than through general chemical hazard documentation such as an SDS.

Ingredient Disclosure and Label Transparency

Even though finished cosmetic products do not require a Safety Data Sheet, transparency toward users remains a fundamental legal principle. Cosmetic legislation therefore mandates full disclosure of ingredients on the product label using the International Nomenclature of Cosmetic Ingredients (INCI).

To maintain consistency between regulatory documentation and publicly available information:

The ingredient lists presented on our website correspond exactly to the ingredients declared on the product packaging.
Labels are provided in the official language or languages required in the countries to which the product is supplied.
No simplified or alternative ingredient summaries replace the legally required INCI declaration.

This approach ensures that professionals, consumers, and authorities all refer to the same verified ingredient information.

Why Cosmetic Products Follow a Different Safety System

The regulatory model for cosmetics differs from general chemical legislation because cosmetic products are intended for direct application to the human body under defined conditions of use. Instead of hazard communication through an SDS, cosmetic law requires:

Pre-market safety assessment by a qualified expert.
Continuous legal accountability through the Responsible Person.
Comprehensive technical documentation maintained within the PIF.
Strict ingredient control through regulatory annexes and restrictions.
Full public ingredient disclosure via labeling.

Together, these measures provide a structured and product-specific safety framework tailored to the nature of cosmetic use.

Conclusion

In both the European Union and the United Kingdom, finished cosmetic products are exempt from the requirement to provide a Safety Data Sheet under the REACH Regulation because they are governed by dedicated cosmetic legislation.

Safety is instead ensured through the obligations imposed by the Cosmetic Product Regulation, including the appointment of a Responsible Person, the maintenance of a Product Information File, the preparation of a Cosmetic Product Safety Report, assessment by a qualified safety assessor, and accurate ingredient labeling in the appropriate official languages.

Publishing ingredient information exactly as declared on product labels supports transparency while remaining fully aligned with the regulatory framework that governs cosmetic safety in the EU and UK.

Cosmetic products supplied from outside the EU or UK

Special attention is required when cosmetic products are supplied into the European Union or the United Kingdom from countries outside these jurisdictions. The presence of a Safety Data Sheet is neither required for finished cosmetic products nor sufficient to demonstrate legal compliance. Instead, products must fully comply with the applicable cosmetic legislation before being placed on the market. This includes correct labeling in the official language(s) of the destination country, identification of the Responsible Person established in the EU or UK, full ingredient disclosure using INCI nomenclature, and the availability of a compliant Product Information File supported by a Cosmetic Product Safety Report.

Where these legal requirements are not fulfilled, competent authorities may take enforcement action in accordance with applicable market surveillance legislation. Such measures can include restrictions on sale, withdrawal from the market, seizure of non-compliant products, and, where necessary, destruction of the goods. Compliance prior to placing a cosmetic product on the market is therefore a fundamental legal obligation for suppliers distributing products into the EU or UK.

Do Finished Cosmetic Products Require a Safety Data Sheet in the EU and UK?