Cosmetic products are regulated by Regulation (EC) No. 1223/2009. It establishes that cosmetics made available on the market must be safe for human health when used under normal or reasonably foreseeable conditions of use, with safety ascertained through a specific evaluation process.
In general, products that meet the definition of a cosmetic product, as indicated in the following paragraph, are expressly excluded from the application of CLP Regulation 1272/2008 and REACH Regulation 1907/2006 “if in their finished state and intended for the end user.”
The definition of “finished state” is unfortunately missing in the CLP and REACH regulations and is understood to refer to the final formulation of the cosmetic as placed on the market and made available to the end user, that is, its prototype. The end user, as defined by the cosmetics regulation, may be either the consumer or the professional user.
What Is the Definition of a Cosmetic Product Under the Legislation?
This is clarified by Regulation (EC) No. 1223/2009 itself, which identifies a cosmetic product as “any substance or mixture intended to be applied to the external surfaces of the human body (epidermis, hair system and hair, nails, lips, external genital organs) or to the teeth and mucous membranes of the mouth for the sole or predominant purpose of cleaning, perfuming, changing their appearance, protecting them, keeping them in good condition or correcting body odours”.
Comparison with this definition is essential to clearly identify which products must comply with the obligations of this regulation, and, above all, to determine the appropriate supply chain.
Examples of Products That Do Not Meet the Definition of a Cosmetic
Among the finished products intended for the end user, there are products for animal care, such as shampoo or conditioner to detangle the hair, which do not fall within the definition of a cosmetic product.
Products that are not in a finished state include, for example, semi-finished products, which cannot yet be considered cosmetics.
Focus 1: Assessing products that do not meet the definition of a cosmetic or are not in the finished state
These are substances or mixtures that must be assessed based on their hazard profile, considering their chemical-physical, toxicological, and eco-toxicological properties according to the criteria set out in the CLP Regulation.
Finally, manufacturers and importers must also assess any registration obligations under REACH.
Focus 2: How to manage bulk products
For bulk products supplied to third parties (e.g. where packaging is carried out by an external company), the applicability of CLP and REACH regulations may be excluded from a regulatory perspective.
For REACH, this applies specifically to the obligation of providing a Safety Data Sheet (SDS), which must be prepared in accordance with the relevant annex of the REACH Regulation, as currently amended by Regulation 878/2020.
However, suppliers are still required to provide the necessary information to ensure safe handling, in order to protect the health and safety of workers involved in completing the production process.
Therefore, particularly when the product or its components present hazards, it is strongly recommended that the product be accompanied throughout the supply chain by a label and an SDS that address these information requirements.
These SDS must include a detailed description of the product, structured into 16 sections:
1. Identification of the substance or mixture and the company/company
- Product name and relevant identifiers.
- Recommended and discouraged uses.
- Name, address, and contact details of the supplier/manufacturer.
- Emergency phone number.
2. Hazard identification
- Product classification according to GHS/REACH.
- Hazard pictograms, warnings, hazard statements and precautionary statements.
- Other hazards (e.g. risk of explosion, sensitization, etc.).
3. Composition/ingredient information
- Main components and their concentration.
- CAS number, CE number and other chemical identifications.
4. First aid measures
- Actions to be taken in case of exposure (inhalation, skin contact, eye contact, ingestion).
- More serious symptoms and effects, both acute and delayed.
- Specific instructions for rescuers.
5. Fire Prevention Measures
- Appropriate and inappropriate means of extinguishing.
- Specific risks from the substance/mixture (e.g. toxic gases).
- Protective equipment for firefighters.
6. Measures in case of accidental release
- Personal precautions, protective equipment and emergency procedures.
- Environmental Precautions.
- Methods and materials for containment and cleaning.
7. Handling and storage
- Precautions for safe handling.
- Conditions for safe storage (temperature, incompatibility).
8. Exposure control/personal protection
- Occupational exposure limit values.
- Personal protective measures (goggles, gloves, masks, etc.).
- Technical controls.
9. Physical and chemical properties
- Specific data such as physical state, color, odor, boiling point, flash point, solubility, etc.
10. Stability and responsiveness
- Chemical stability and conditions to avoid.
- Incompatible materials.
- Hazardous decomposition products.
11. Toxicological information
- Data on health effects (acute toxicity, irritation, sensitization, mutagenicity, carcinogenicity, etc.).
- Likely routes of exposure.
12. Ecological information
- Ecotoxicity.
- Persistence and degradability.
- Bioaccumulation.
- Mobility in the soil.
13. Disposal considerations
- Appropriate disposal methods for the product and container.
- Applicable Regulations.
14. Transportation Information
- Classification for transport purposes (ADR, IMDG, IATA).
- Specific risks during transport.
- Packaging group and UN number.
15. Regulatory Information
- Specific EU or applicable national regulations.
- Chemical safety assessment.
16. Other information
- Additional Disclaimers and Warnings.
- Sources of the data used to compile the form.
- Revision date and changes from previous version.
In addition, it is recommended that companies consider adopting a precautionary approach and, for mixtures classified as hazardous to human health or physical properties, proceed with the notification of the composition as required by Article 45 of the CLP Regulation (PCN notification).
For further details on this obligation, which every responsible person must take into account when placing products on the market, please refer to our article on General Product Safety Regulation GPSR.
Why SDS and Labelling Matter
SDS and labelling are extremely useful tools:
- for employers in the supply chain, as they provide information on the safe and effective management of hazards
- for the cosmetics safety assessor, as they contain the necessary data for evaluating the formulated product, including the safety data sheets for the packaging components
There are many obligations and requirements under the relevant regulations. Contact us to ensure your product is never stopped at customs or seized.
