Before being placed on the European Union market, a cosmetic product must go through a series of checks covering the formula and raw materials, stability and compatibility, microbiological quality, safety assessment, manufacturing under good practices, finished-product quality and labelling. It must also have a complete technical file and be notified through the European CPNP portal.
When we use a shampoo, hair mask or colouring product, we see the finished result: a formula, its packaging and a promise of performance. Behind every cosmetic product, however, lies a much broader technical process.
In the European Union, this process is primarily governed by Regulation (EC) No 1223/2009 on cosmetic products. Its purpose is to ensure that every cosmetic product placed on the market is safe for human health when used under normal or reasonably foreseeable conditions.
Summary: the 9 Main Checks Performed on a Cosmetic Product
| Stage | What is checked? |
|---|---|
| 1. Formula | Whether the ingredients and their concentrations comply with the applicable legislation. |
| 2. Raw materials | Identity, quality, specifications and traceability. |
| 3. Stability and packaging | Whether the formula retains its properties and remains compatible with its packaging. |
| 4. Microbiology | Microbiological quality and, when appropriate, the efficacy of the preservative system. |
| 5. Safety | Whether the finished product is safe for its intended use and expected level of exposure. |
| 6. Manufacturing | Compliance with good manufacturing practices and control of the production process. |
| 7. Finished product | Whether each batch complies with the approved specifications. |
| 8. Labelling and claims | Mandatory information and evidence supporting marketing claims. |
| 9. Documentation and notification | A complete PIF and notification through the European CPNP portal. |
First, an Important Clarification: Cosmetics Are Not Authorised Like Medicines
A cosmetic product does not undergo individual prior authorisation by the authorities before it is marketed, as medicines do. Responsibility rests with the designated Responsible Person, who must ensure and document that the product complies with all applicable legislation before it is placed on the market.
This does not mean that cosmetics are subject to fewer controls. Every product requires a safety assessment carried out by a suitably qualified professional, a complete technical file, European notification, and a system that ensures traceability and post-market monitoring.
1. Reviewing the Formula and Its Ingredients
The first check takes place before the product is even manufactured. Every ingredient and its concentration must be reviewed to ensure that the formula complies with current cosmetics legislation.
This stage includes checking:
- That the formula does not contain prohibited substances.
- That restricted ingredients are used within the permitted limits.
- That colourants, preservatives and UV filters are authorised for their intended use.
- That the applicable conditions of use, warnings and target-population requirements are observed.
- That the necessary technical documentation is available for the raw materials.
This is not a one-off review. European legislation is regularly updated as new scientific evidence becomes available, making regulatory monitoring an ongoing part of a cosmetic manufacturer’s work.
2. Raw Material Checks
The quality of the finished product depends directly on the quality of its raw materials. Before they are used in manufacturing, they must therefore be correctly identified and comply with predefined specifications.
Depending on the ingredient, parameters such as appearance, colour, odour, purity, pH, density or microbiological documentation may be reviewed. Information provided by the supplier, including technical data sheets, safety data sheets and certificates of analysis, is also checked.
Correct receipt, identification, storage and traceability of every raw material also help to prevent errors and make it possible to determine which materials were used in each batch.
3. Stability and Packaging Compatibility Tests
A formula may perform well immediately after manufacture but change over time. Stability tests monitor how the cosmetic product evolves under different conditions and help determine its shelf life.
These studies monitor possible changes in:
- Colour, odour and appearance.
- pH, viscosity or density.
- Homogeneity and possible phase separation.
- The product’s functionality and overall characteristics.
Compatibility between the formula and its packaging is also assessed. Packaging is not merely an aesthetic consideration: it must protect the contents, preserve their properties and function correctly throughout the product’s expected lifetime. Checks may therefore look for leakage, deformation, blockage, loss of seal integrity or interactions between the formula and the packaging materials.
4. Microbiological Control and Preservative System Efficacy
Cosmetic products must maintain appropriate microbiological quality. This is especially important for products containing water, as they may be more susceptible to microbial growth.
Microbiological control verifies that the product remains within acceptable limits and does not contain specified microorganisms considered undesirable.
When appropriate, a challenge test, or preservative efficacy test, is also carried out. During this test, the formula is exposed to reference microorganisms under controlled conditions to determine whether its preservative system can reduce them and prevent their proliferation.
Not all cosmetics present the same microbiological risk. The type of formula, packaging, application area and method of use all influence the control strategy that should be followed.
5. Cosmetic Product Safety Assessment
Before being placed on the market, every cosmetic product must have a Cosmetic Product Safety Report (CPSR).
This report must be prepared by a person who holds the qualifications required by the legislation. To reach a conclusion, the safety assessor examines the product as a whole, including its qualitative and quantitative composition, raw-material characteristics, microbiological quality, stability, impurities, packaging materials, method of use, application area, frequency of use and level of exposure.
The toxicological profile of the ingredients is also examined, and the safety of the formula is assessed under the intended conditions of use. The purpose is not simply to verify whether each ingredient is permitted, but to determine whether the finished product, with that specific formula, use and exposure, is safe.
6. Manufacturing in Accordance with Good Practices
A properly designed formula must be reproduced consistently on an industrial scale. Cosmetic good manufacturing practices establish guidelines covering personnel, premises, equipment, cleaning, raw materials, production, filling, storage, documentation and incident management.
Their purpose is to minimise the risk of errors, contamination or mix-ups and ensure that every batch meets its established specifications.
Manufacturing operations and the materials used are documented throughout the process. These records maintain traceability from the raw materials through to the finished product.
7. Finished-Product Control and Batch Release
Once manufactured and packed, the finished product undergoes quality control before the batch can be released for distribution.
Depending on the type of cosmetic product, physicochemical and organoleptic parameters such as appearance, odour, colour, pH, viscosity or density may be checked. Microbiological tests, fill-volume checks, packaging inspections, batch-code verification and label reviews may also be carried out.
The results are compared with the approved specifications. A batch can only be released for marketing once it meets the established criteria.
8. Reviewing Labelling and Claims
Safety also depends on users receiving accurate information. For this reason, the label must be reviewed before the product is placed on the market.
Among other information, it must include the Responsible Person’s details, nominal content, minimum durability or period after opening where applicable, precautions for use, batch number, product function and list of ingredients.
Marketing claims—such as “hydrates”, “repairs” or “adds shine”—must also comply with the common criteria established in the European Union. They must be truthful, understandable and supported by appropriate evidence. Communicating a product effectively is not simply about making it appealing; its benefits must also be described responsibly.
9. Product Information File and European Notification
Before a product is placed on the market, the Responsible Person must hold a Product Information File (PIF). This contains essential documentation including the cosmetic product description, safety report, manufacturing method, statement of compliance with good manufacturing practices and, where necessary, evidence supporting the claimed effects.
The product must also be electronically notified through the European Commission’s Cosmetic Products Notification Portal (CPNP). This notification makes certain information available to competent authorities and poison centres.
Notification does not constitute administrative approval of the product. It is one of the requirements that must be met before the cosmetic product is marketed.
Control Continues After the Product Reaches the Market
The work does not end when a cosmetic product leaves the factory. The Responsible Person must keep the product information up to date, manage complaints and monitor undesirable effects.
This cosmetovigilance system, together with market surveillance carried out by the authorities, makes it possible to identify incidents and take action when necessary. In Spain, the Spanish Agency for Medicines and Health Products (AEMPS) may conduct document reviews, inspections and laboratory analyses to verify compliance with the applicable legislation.
Frequently Asked Questions About Cosmetic Product Checks
Who ensures that a cosmetic product is safe?
The Responsible Person designated in the European Union must ensure that the product complies with Regulation (EC) No 1223/2009. Before placing it on the market, they must hold a safety assessment prepared by a suitably qualified professional and the corresponding Product Information File.
Does a cosmetic product require prior authorisation before it can be sold?
No. In the European Union, cosmetic products do not receive individual prior authorisation equivalent to that required for medicines. They must, however, meet all legal requirements, have the required technical documentation and be notified through the CPNP before they are placed on the market.
What is a cosmetic product CPSR?
The CPSR is the Cosmetic Product Safety Report. It examines the product’s composition, physicochemical and microbiological characteristics, stability, packaging, intended use, exposure and the toxicological profile of its ingredients to conclude whether the product is safe.
What is a PIF?
The PIF is the Product Information File. It contains the product description, safety report, manufacturing method, statement of compliance with good manufacturing practices and documentation supporting the claimed effects, among other information.
What is a challenge test?
It is a test that assesses how effectively the preservative system acts against reference microorganisms. It is performed when appropriate based on the product’s characteristics and microbiological risk.
Do all cosmetic products undergo exactly the same tests?
No. All cosmetic products must be safe and comply with the legislation, but the testing strategy is adapted to the formula, packaging, application area, target population and conditions of use. A shampoo, an anhydrous product and a hair colourant do not present the same risks and do not require an identical assessment.
Cosmetic Quality: a Process That Accompanies the Product at Every Stage
The quality of a cosmetic product is not established by a single final test. It is built from the selection of ingredients and development of the formula through to manufacturing, documentation, labelling and post-market monitoring.
At Global Cosmetic Technology, we understand quality control as an integral part of cosmetic development and manufacturing. From our headquarters in Valencia, we transform technical knowledge into professional haircare solutions manufactured to European standards and designed to meet the real needs of salons.
Because behind every effective product there must be a robust, traceable process committed to safety.
Hair Specialists, Quality Manufacturers
At Global Cosmetic Technology, we develop and manufacture professional haircare solutions in Valencia, combining technical knowledge, quality control and industry experience.
Contact Us