How to Ensure Compliance of Cosmetic Products with REACH and CLP: A Guide for Manufacturers and Formulators

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The cosmetics industry is one of the most strictly regulated sectors in the European Union. In addition to the Cosmetics Regulation (EC) No 1223/2009, manufacturers must also comply with the requirements of REACH and CLP, which apply to chemical substances and mixtures. This means that every raw material used in a formulation must be registered, classified, and labelled in accordance with the applicable regulations. Non-compliance can lead not only to product withdrawal from the market but also to substantial fines. How should raw materials be assessed? How can safety data sheets be correctly compiled? And how can you ensure that your products meet all legislative requirements?

REACH and Cosmetics: What Manufacturers Need to Know About Substance Registration and Evaluation

Cosmetic products fall under the scope of the REACH regulation, even though the final products themselves are not subject to registration. The key point is that all chemical substances contained in cosmetics in quantities exceeding 1 tonne per year must be registered with the European Chemicals Agency (ECHA). This applies to active ingredients as well as excipients, preservatives, emulsifiers, or fragrances. Manufacturers and importers of cosmetics are obliged to verify whether their suppliers have fulfilled their registration obligations; otherwise, the product may be withdrawn from the market or penalties may be imposed.

For formulators, it is crucial to be aware of so-called SVHC substances (substances of very high concern) listed on the REACH Candidate List. These substances are subject to authorisation, and their use in cosmetics may be restricted or prohibited. For example, certain phthalates or perfluorinated compounds are already banned or heavily regulated in cosmetics. It is recommended to regularly check updates to the Candidate List and the list of restrictions under Annex XVII of the REACH Regulation to avoid unintentional non-compliance with the regulations.

Classification and Labelling under CLP: How to Correctly Prepare a Cosmetic Product Label

The CLP Regulation (Classification, Labelling and Packaging) sets out the rules for the classification, labelling, and packaging of chemical substances and mixtures, including cosmetic products. Although cosmetics are governed by their own specific legislation (EU Regulation 1223/2009), CLP applies to them in cases where the product contains substances with hazardous properties. This concerns, for example, certain preservatives, solvents, or fragrance ingredients that may be classified as irritants, sensitisers, or toxic substances.

The label of a cosmetic product must include standard CLP elements if the product is classified as hazardous: hazard pictograms, signal words ("Danger" or "Warning"), standard hazard statements (H-phrases), and safety instructions (P-phrases). For example, a product with a high alcohol content may require a flammability pictogram and corresponding H-phrases. Manufacturers must ensure that the label is clear, durable, and placed in a visible location on the packaging. It is also important to verify that the classification complies with the current harmonized lists of substances under CLP.

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Safety Data Sheets (SDS) for cosmetic raw materials: When and how to request them from suppliers

The Safety Data Sheet (SDS) is a key document for ensuring the safe handling of chemical substances and mixtures, including cosmetic raw materials. Under the REACH regulation, suppliers must provide an SDS for all substances and mixtures classified as hazardous or if they contain hazardous components in concentrations above the specified limits. Cosmetic manufacturers should request an SDS from their suppliers for each raw material, even when not mandatory, to have an overview of potential risks and measures for safe use.

The SDS must contain 16 mandatory sections, including information on substance identification, hazard classification, composition, first aid measures, fire-fighting instructions, accidental release measures, handling and storage, exposure controls, and personal protective equipment. For cosmetic formulators, Sections 8 (exposure controls) and 11 (toxicological information) are particularly important, as they help assess risks for workers and end users. It is recommended to regularly update the SDS in line with changes in legislation or new scientific findings.

Practical Steps to Ensure Compliance: From Raw Material Selection to Documentation for Regulatory Authorities

Ensuring compliance of cosmetic products with REACH and CLP requires a systematic approach from the formulation development stage. The first step is careful raw material selection—substances with complete REACH registration, without SVHC substances, and with clear CLP classification should be preferred. Manufacturers should collaborate with verified suppliers who provide transparent documentation, including SDS and declarations of conformity. It is also important to monitor updates to REACH restriction lists and the candidate list to avoid using prohibited or regulated substances.

Another key step is maintaining complete documentation that demonstrates compliance with legislation. This includes technical data sheets for raw materials, safety data sheets, cosmetic product safety assessment reports (CPSR), and records of classification and labelling according to CLP. In the event of an inspection by regulatory authorities, the manufacturer must be able to prove that all substances used meet REACH requirements and that the product label complies with the CLP Regulation. It is also recommended to regularly train employees in chemical safety and maintain an internal system for tracking changes in legislation.

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Impact of REACH Regulation on the Development of New Cosmetic Formulations

When developing new cosmetic formulations, it is crucial to consider REACH regulation requirements already at the initial stage of raw material selection. Manufacturers should prioritise substances that are properly registered in the ECHA database and meet all conditions for use in cosmetics. This includes verifying whether the substance is not listed on the authorisation list (REACH Annex XIV) or restrictions list (Annex XVII). For example, some preservatives, UV filters, or dyes may be restricted or prohibited, which can affect the stability and safety of the final product. It is recommended to collaborate with suppliers who provide transparent information on the registration status of their raw materials and their compliance with REACH.

Another important aspect is the risk assessment associated with exposure to individual substances during the manufacturing process and consumer use. REACH requires manufacturers and importers to conduct a Chemical Safety Assessment (CSA) for substances produced or imported in quantities exceeding 10 tonnes per year. Although cosmetic products themselves are not subject to registration under REACH, the raw materials they contain are. Therefore, it is essential to have up-to-date Safety Data Sheets (SDS) and technical specifications confirming that the raw materials are safe for the intended use and do not contain prohibited impurities.

CLP and cosmetic packaging: How to correctly combine labelling requirements

Labelling of cosmetic products in accordance with the CLP Regulation (Classification, Labelling and Packaging) must comply with the requirements of the EU Cosmetics Regulation (Regulation (EC) No 1223/2009). This means that the label must include both mandatory elements under CLP (e.g., hazard pictograms, signal words, standard hazard statements, and safety instructions) and specific cosmetic information, such as the list of ingredients (INCI), minimum durability date, or storage conditions. Manufacturers must ensure that this information does not conflict and is easily readable for consumers.

Special attention must be paid to products that may be classified as hazardous under CLP, such as certain shampoos with a high surfactant content, nail polish removers containing acetone, or preparations with a high alcohol concentration. In these cases, the packaging must display the relevant pictograms (e.g., the warning symbol for irritancy or flammability) and standard hazard statements (H-phrases). At the same time, it is necessary to comply with cosmetic legislation requirements, which may demand additional warnings, such as those for allergens or restrictions on use in children. For complex cases, consultation with a chemical legislation expert is recommended.

Documentation for Supervisory Authorities: How to Prepare a Complete Technical File for a Cosmetic Product

Every cosmetic product placed on the market must be accompanied by a technical file (Product Information File, PIF), which contains all the information required to assess its safety. This file must include the Cosmetic Product Safety Report (CPSR), which is divided into two parts: Part A (safety information) and Part B (safety assessment). Part A contains data on the product composition, physico-chemical properties, microbiological quality, impurities, and stability, while Part B includes exposure assessment, toxicological profiles of raw materials, and the final safety assessment.

In addition to the safety report, the technical file must include a description of the manufacturing process, a declaration of conformity with Good Manufacturing Practices (GMP), and evidence of the effects claimed on the packaging. An important part of the file is also data on the compliance assessment of raw materials with REACH and CLP, including Safety Data Sheets (SDS) and technical specifications from suppliers. Supervisory authorities, such as the National Institute of Public Health or the Czech Trade Inspection Authority, may request the submission of the technical file for verification. It is recommended to retain this documentation for at least 10 years from the last placing of the product on the market and to update it regularly in line with legislative changes or new scientific findings.

Do you have questions about regulatory compliance?

GCG Group provides complete Safety Data Sheets (SDS) and technical documentation for every supplied raw material in accordance with REACH and CLP. Our experts will advise you on raw material selection, risk assessment, and formulation optimization to ensure full regulatory compliance. Contact us – or browse our catalog of over 1,300 products right away.