Cosmetic CPSR in the European Union: requirements and safety assessment under Regulation 1223/2009

Before a cosmetic product can be placed on the European Union market, a cosmetic CPSR must demonstrate that it is safe for human health when used under normal or reasonably foreseeable conditions.

This conclusion cannot be based solely on the fact that the ingredients are commonly used, that the formulation resembles another product already on the market or that the product has passed a basic stability test.

Safety must be assessed individually and documented in the Cosmetic Product Safety Report (CPSR).

The CPSR is one of the fundamental elements required to comply with Regulation (EC) No 1223/2009 on cosmetic products. It forms part of the Product Information File (PIF) and must be completed before the cosmetic product is placed on the European market.

Preparing a CPSR correctly involves integrating the formulation, the characteristics of the raw materials, consumer exposure, toxicological information, analytical results, packaging, conditions of use and data generated after the product has been placed on the market.

What is a cosmetic CPSR and why is it mandatory?

The CPSR is the scientific document through which a qualified safety assessor determines whether a cosmetic product can be considered safe under its intended conditions of use.

Under Article 10 of Regulation (EC) No 1223/2009, the Responsible Person must ensure that the product has undergone a safety assessment based on the relevant information and that the corresponding report has been prepared in accordance with Annex I.

Among other aspects, the CPSR provides justification for:

• Compliance with the restrictions applicable to the ingredients.
• The safety of the exposure levels.
• The microbiological quality of the product.
• The effectiveness of the preservative system.
• Stability and shelf life.
• Compatibility between the formulation and its packaging.
• Warnings and conditions of use.
• The adequacy of the available toxicological information.

It is not an authorisation issued by an authority or a generic certificate that can be applied to any product variant. It is an assessment linked to a specific formulation, raw materials, packaging, target population and conditions of use.

Regulatory and technical framework

Regulation (EC) No 1223/2009 establishes the obligations relating to safety, the Responsible Person, the PIF, good manufacturing practices, labelling, CPNP notification and market surveillance.

The minimum content of the CPSR is set out in Annex I of the Regulation. Commission Implementing Decision 2013/674/EU provides guidelines for its correct application and explains the information and scientific reasoning that should be included in each section.

The guidance issued by the Scientific Committee on Consumer Safety (SCCS) is also an important technical reference for assessing ingredient exposure and toxicological profiles.

The assessment must always consider the legislation and restrictions applicable when the product is placed on the market. A CPSR may need to be updated if the legislation changes or if relevant new scientific information becomes available.

Relationship between the CPSR, PIF and CPNP

The cosmetic CPSR forms part of the Product Information File (PIF), which must also include:

• A description of the product.
• The manufacturing method.
• A declaration of compliance with good manufacturing practices.
• Evidence supporting the claimed effects, where appropriate.
• Available information on animal testing.

The PIF must remain available to the competent authorities for ten years after the last batch of the product has been placed on the market.

Before placing the product on the market, it must also be notified through the Cosmetic Products Notification Portal (CPNP).

The formulation, label, CPSR, PIF and notified information must be consistent with one another. If the marketed composition, packaging or instructions for use differ from those assessed, the safety conclusion may no longer be valid.

Structure of the cosmetic CPSR

The report is divided into two parts:

• Part A: Cosmetic product safety information.
• Part B: Cosmetic product safety assessment.

Part A brings together the available technical information. Part B contains the scientific assessment and the conclusion signed by the safety assessor.

Part A of the cosmetic CPSR: safety information

1. Qualitative and quantitative composition

The complete formulation must be provided, including the identity and concentration of every ingredient.

The information may include:

• INCI name.
• Chemical name.
• CAS and EC numbers, where applicable.
• Cosmetic function.
• Concentration.
• Supplier.
• Identity of fragrances, flavours or mixtures.

Providing only the INCI list used on the label is not sufficient. When a commercial raw material is a mixture, the safety assessor must know its composition, including preservatives, solvents, antioxidants, impurities and other relevant substances.

2. Physicochemical characteristics and stability

The properties of the raw materials and finished product must be assessed, including appearance, odour, pH, viscosity, density or water activity, where relevant.

It must also be demonstrated that the cosmetic product maintains acceptable characteristics throughout its shelf life.

The stability study should support:

• Minimum shelf life.
• Period after opening, or PAO.
• Special storage conditions.
• Integrity of the formulation.
• Compatibility with the packaging.

There is no single protocol applicable to every cosmetic product. The study should be adapted to the formulation, packaging, distribution conditions and intended use.

3. Microbiological quality

The cosmetic CPSR must consider the microbiological specifications of the raw materials and the finished product.

ISO 17516 is a commonly used reference for establishing microbiological limits for cosmetic products.

When the formulation may support microbial growth, the effectiveness of the preservative system must be evaluated. ISO 11930 is commonly used to conduct the challenge test.

Products presenting a low microbiological risk may justify a different approach, but this decision must be based on the characteristics of the formulation and sufficient technical data.

4. Impurities, traces and packaging

The assessment must consider impurities that may be present in the raw materials or generated during manufacturing and storage.

Relevant substances may include:

• Heavy metals.
• Residual solvents.
• Pesticides.
• Nitrosamines.
• Allergens.
• Restricted substances present as traces.
• Degradation products.

It must also be assessed whether the packaging could cause migration, loss of components, contamination or changes to the formulation.

From a safety perspective, the product and its packaging form a single system.

5. Normal and reasonably foreseeable use

The way in which the consumer will use the product must be described, including:

• Area of application.
• Amount used.
• Frequency of use.
• Duration of contact.
• Rinse-off or leave-on use.
• Method of application.
• Type of consumer.
• Possible inhalation or ingestion exposure.

Reasonably foreseeable use is not limited to the manufacturer’s ideal instructions. It must also take into account behaviours that can realistically be expected from consumers.

For example, a lip product may be partially ingested, while a spray product may result in inhalation exposure.

6. Exposure to the product and its ingredients

Consumer exposure to the finished product and the substances it contains must be estimated.

The assessment may consider:

• Amount applied.
• Frequency of use.
• Body surface area exposed.
• Duration of contact.
• Route of exposure.
• Population group.
• Body weight.
• Ingredient concentrations.
• Dermal, oral or inhalation absorption.

One of the parameters used is the systemic exposure dose (SED).

The scenarios must be representative of the product being assessed. Where specific data are unavailable, a suitably justified conservative approach may be used.

7. Toxicological profile

The safety assessor must review the toxicological information available for the relevant ingredients.

Depending on the product and route of exposure, the assessment may cover:

• Skin and eye irritation.
• Sensitisation.
• Repeated-dose toxicity.
• Genotoxicity.
• Carcinogenicity.
• Reproductive toxicity.
• Phototoxicity.
• Dermal absorption.
• Endocrine activity.
• Toxicokinetics.

The information may come from experimental studies, human data, scientific publications, SCCS opinions, regulatory assessments, in silico models, alternative methods and read-across approaches.

Safety data sheets may be useful, but they do not normally contain all the information required to assess a cosmetic ingredient.

Margin of Safety

For certain ingredients, it may be necessary to calculate the Margin of Safety (MoS).

This calculation relates a toxicological point of departure to the estimated systemic exposure.

Its interpretation depends on factors such as:

• The quality of the toxicological data.
• The route of exposure.
• The absorption value used.
• The exposed population.
• The selection of the point of departure.
• Existing uncertainties.

The calculation should not be performed automatically. A numerical result is only valid when the input data and assumptions used are scientifically justified.

8. Undesirable effects

The cosmetic CPSR must include the available information on undesirable effects and serious undesirable effects associated with the product.

After the product has been placed on the market, complaints and cosmetovigilance data must be reviewed to determine whether they affect the safety assessment.

Signing the initial report does not close the process. The CPSR must be updated whenever relevant information becomes available.

9. Additional information

Part A may include other studies required to support the assessment, such as:

• Skin compatibility tests.
• Ocular tolerance studies.
• Patch tests.
• Use studies.
• Clinical data.
• Instrumental assessments.
• Information on similar products.
• Justification of warnings and claims.

These studies must be interpreted according to their design and scope. A statement such as “dermatologically tested” does not replace a safety assessment.

Part B of the cosmetic CPSR: safety assessment

1. Assessment conclusion

The safety assessor must state whether the product is safe for human health under normal or reasonably foreseeable conditions of use.

The conclusion must refer to the specific formulation, presentation, packaging and conditions that have been assessed.

2. Warnings and instructions

The warnings and conditions of use that must appear on the label should be specified.

These may arise from:

• The Annexes to the Regulation.
• The concentration of certain ingredients.
• The route or area of application.
• The target population.
• The toxicological assessment.

Warnings must not be used to compensate for a product that is not safe under reasonably foreseeable conditions of use.

3. Scientific reasoning

The report must explain how the safety conclusion was reached.

The reasoning should integrate:

• Exposure.
• Toxicological profiles.
• Margins of safety.
• Stability.
• Microbiological quality.
• Impurities.
• Packaging.
• Vulnerable populations.
• Identified uncertainties.

Collecting information alone is not enough. The safety assessor must evaluate its quality, relevance and relationship to the finished product.

4. Safety assessor’s credentials and approval

Part B must be dated and signed by a qualified person.

Article 10.2 of the Regulation establishes that the assessment must be carried out by a person holding a university qualification in:

• Pharmacy.
• Toxicology.
• Medicine.
• A similar discipline.
• Studies recognised as equivalent by a Member State.

In addition to the qualification, the assessor must have the knowledge required to interpret toxicological, regulatory and exposure information.

Products requiring specific assessment

Some products require particular attention:

• Cosmetics intended for children under three years of age.
• External intimate hygiene products.
• Aerosols, sprays and fine powders.
• Products intended for the eyes, lips or mucous membranes.
• Cosmetics intended for damaged skin.
• Products containing nanomaterials.
• Products intended for vulnerable populations.

In these cases, the exposure scenarios, microbiological requirements, potential for inhalation or ingestion and necessary warnings may differ.

Studies that may be required

Depending on the product, the following studies may be required:

• Microbiological testing.
• Challenge test.
• Stability studies.
• Packaging compatibility testing.
• Physicochemical studies.
• Skin or eye tolerance testing.
• Patch tests.
• Use studies.
• Analysis of impurities or contaminants.

Not every study is required for every cosmetic product. Their selection should address a specific safety question and be based on the formulation, packaging, intended use and target population.

Common mistakes when preparing a cosmetic CPSR

The most common mistakes include:

• Assessing only the INCI list.
• Failing to obtain the complete composition of the raw materials.
• Relying only on safety data sheets.
• Failing to consider the actual commercial formulation.
• Applying absorption data without justification.
• Copying toxicological profiles without assessing their relevance.
• Omitting impurities, traces or degradation products.
• Failing to evaluate packaging compatibility.
• Using a label or instructions that differ from those assessed.
• Failing to update the report when the product or legislation changes.

An extensive collection of documents does not guarantee a correct assessment. The quality of the cosmetic CPSR depends on the analysis carried out and the consistency between all its elements.

When should the cosmetic CPSR be updated?

The cosmetic CPSR must be reviewed whenever information becomes available that could affect product safety.

This may occur when changes are made to:

• The formulation or concentration of an ingredient.
• The supplier or specifications of a raw material.
• The fragrance, flavour, colourant or preservative.
• The packaging.
• The method or area of application.
• The target population.
• The shelf life or PAO.
• The instructions or claims.

It must also be updated when new toxicological data, regulatory changes, relevant stability results or undesirable effects associated with the product become available.

Not every change requires the CPSR to be completely rewritten, but its impact must be assessed and documented.

Integrating the CPSR into product development

Requesting the safety assessment after the formulation, packaging, label and production process have already been finalised may lead to reformulation, repeated studies and delays.

An early review can identify:

• Prohibited or restricted ingredients.
• Concentrations that are not permitted.
• Missing documentation.
• High exposure levels.
• The need for additional testing.
• Microbiological or stability problems.
• Warnings that affect the product label.

The safety assessment should form part of product development rather than being added at the end as a separate administrative requirement.

The role of the Responsible Person

The Responsible Person must ensure that the product complies with European cosmetic legislation.

Their main obligations include:

• Ensuring that a valid safety assessment is available.
• Keeping the PIF up to date.
• Ensuring compliance with labelling requirements.
• Completing the CPNP notification.
• Verifying compliance with good manufacturing practices.
• Managing cosmetovigilance.
• Taking corrective action when necessary.

The safety assessor’s signature does not remove the responsibilities of the Responsible Person. The product placed on the market must correspond to the product that was assessed.

How SHAPYPRO can help

At SHAPYPRO, we help manufacturers, brands and importers prepare the documentation required to place cosmetic products on the European Union market.

Our services include:

• Regulatory review of formulations and ingredients.
• Preparation and review of the CPSR and PIF.
• Microbiological testing and challenge testing.
• Stability and compatibility studies.
• Review of labelling, claims and CPNP documentation.

This approach helps identify deficiencies before the product is placed on the market and keeps the formulation, testing and regulatory documentation properly aligned.

Conclusion

The cosmetic CPSR is the document that demonstrates that a cosmetic product is safe under its normal or reasonably foreseeable conditions of use.

Its preparation must integrate the actual composition, exposure, toxicological profile, microbiological quality, stability, packaging and labelling.

It must also be kept up to date whenever changes are made to the product, the legislation or the available information.

Preparing the assessment during product development makes it possible to identify problems early, avoid reformulations and reduce delays before the product is placed on the market.