FAQ – Frequently Asked Questions
Safety Assessment of Cosmetics and Placing Cosmetics on the Market in the EU and the UK
Cosmetic Product Safety Report (CPSR) is a document required by Regulation (EC) No 1223/2009. It confirms that a cosmetic product is safe for human health when used under normal or reasonably foreseeable conditions.
Yes. Every cosmetic product placed on the European Union market must have a safety assessment conducted by a qualified Safety Assessor.
A safety assessment is required before a cosmetic product is placed on the market and after any significant change to the product’s formulation.
The safety assessment must be conducted by a specialist with a background in pharmacy, toxicology, chemistry, medicine, or a related field.
The price of a CPSR depends on the type of product, the number of ingredients, and the availability of raw material documentation. An accurate quote can be provided after analyzing the cosmetic’s composition.
In most cases, preparing a safety assessment takes anywhere from a few days to about two weeks.
To conduct a safety assessment, the following information is required, among other things:
– product composition (INCI + percentages),
– raw material specifications,
– safety data sheets (SDS),
– physicochemical data for the product,
– microbiological test results,
– preservative efficacy test (challenge test),
– packaging information.
A PIF (Product Information File) is a document containing all information regarding a cosmetic product, its safety, and the manufacturing process.
The PIF documentation must be held by the person responsible for the cosmetic product (Responsible Person).
PIF documentation must be retained for 10 years from the date the last batch of the product was placed on the market.
To place a cosmetic product on the EU market, you must:
1. Conduct a safety assessment (CPSR),
2. Prepare a PIF,
3. Ensure that the label complies with the law,
4. Register the product in the CPNP system.
The CPNP (Cosmetic Products Notification Portal) is a European system for notifying cosmetic products before they are placed on the market.
Yes. Every cosmetic product sold in the EU must be notified in the CPNP system before it goes on sale.
The notification must be submitted by the person responsible for the cosmetic product (Responsible Person).
Yes. We offer support with the process of notifying cosmetics through the CPNP system.
The label of a cosmetic product should include, among other things:
– the name and address of the responsible person,
– the net content,
– the best-before date or the PAO symbol,
– the INCI list of ingredients,
– precautions.
The ingredients of a cosmetic product must be listed in accordance with the INCI (International Nomenclature of Cosmetic Ingredients).
Ingredients must be listed in descending order of concentration in the product. Only ingredients present in amounts of less than 1% may be listed in any order.
Yes. We offer label analysis to ensure compliance with EU regulations.
Yes. Microbiological testing is a standard part of a cosmetic product’s safety assessment.
A challenge test is a test of the effectiveness of a preservative system in a cosmetic product.
A stability test is required for most products containing water.
No. Testing cosmetics on animals is banned in the European Union.
Stability testing is not explicitly required by the EU Cosmetics Regulation, but in practice it is a very important part of the product safety dossier.
Stability testing allows for an assessment of whether a cosmetic product retains its physicochemical, microbiological, and performance properties throughout its declared shelf life.
Stability testing involves storing a cosmetic product under specific temperature and humidity conditions for a set period of time, and then evaluating any changes in the product.
During testing, the following are analyzed, among other things:
– the product’s appearance and color,
– smell,
– pH,
– viscosity,
– emulsion stability.
A compatibility test between the product and the packaging involves assessing the interaction between the cosmetic product and the packaging material.
The test verifies, among other things:
– whether the packaging affects the product’s stability,
– whether the cosmetic product causes degradation of the packaging material,
– whether substances migrate from the packaging into the product.
Dermatological testing involves assessing a product’s skin tolerance under the supervision of a dermatologist.
These tests are most commonly conducted as patch tests on a group of volunteers.
These tests help evaluate a product’s potential to cause irritation or allergic reactions.
Dermatological testing is not mandatory for all cosmetics, but it is often conducted to confirm a product’s safety or to support marketing claims such as “dermatologically tested.”
Application studies involve evaluating the performance and functional properties of a cosmetic product when used by a group of volunteers.
These studies allow for the assessment of, among other things:
– user experiences,
– the product’s application properties,
– subjective effectiveness.
Instrumental testing uses specialized measuring equipment to objectively assess the effects of a cosmetic product on the skin or hair.
Examples of such tests include measurements of:
– skin hydration,
– skin elasticity,
– sebum levels,
– trans-epidermal water loss (TEWL).
Yes. Dermatological, application, and instrumental studies are often used to support marketing claims such as:
– skin hydration,
– improved skin elasticity,
– reduction of skin dryness,
– improved hair condition.
Yes. We help you select the appropriate cosmetic testing based on:
– the type of product,
– marketing claims,
– safety documentation requirements,
– the target market (EU, UK).
Yes. Natural and organic cosmetics are subject to the same regulations as other cosmetics.
Yes. We offer composition analysis to ensure safety and compliance with EU regulations.
Yes. We review the ingredients to ensure they do not include any banned or restricted substances.
Yes, but a change in composition requires an update to the safety assessment.
Yes. We support new cosmetics brands from the initial product concept through to market launch.
Yes. We offer support in the development and optimization of cosmetic formulations.
Yes. We help ensure that imported cosmetics comply with EU regulations.
Yes. Cosmetics imported into the EU must have a safety assessment that complies with EU regulations.
Yes. We handle both individual projects and the management of entire cosmetic lines.
Yes. For urgent cases, we offer an expedited service.
Yes. At the client’s request, we sign a confidentiality agreement.
Yes. We offer regulatory support and consulting services related to cosmetics law.
Yes. We can review the label and identify the necessary changes.
Yes. We offer comprehensive support for the launch of new cosmetic products.
Simply contact us and send us the product specifications or a description of the project.
Yes. We offer consultations on cosmetic safety and regulatory compliance.
Yes. Analyzing the composition before production helps avoid regulatory issues and costly changes to the formula.
Not automatically. Following Brexit, the United Kingdom introduced its own regulations governing cosmetics.
Cosmetics sold in the United Kingdom must comply with the UK Cosmetics Regulation, which is based on EU Regulation (EC) No. 1223/2009 but requires a separate notification and the appointment of a UK Responsible Person.
A UK Responsible Person (UK RP) is a natural or legal person established in the United Kingdom who is responsible for ensuring that a cosmetic product complies with UK regulations.
The responsibilities of the UK Responsible Person include, among others:
– maintaining product documentation (PIF),
– ensuring the product’s compliance with regulations,
– notifying the cosmetic product in the UK system,
– cooperating with regulatory authorities.
SCPN (Submit Cosmetic Product Notification) is the UK’s cosmetic notification system.
Before a cosmetic product can be placed on the market in the UK, it must be notified through the SCPN system by the UK Responsible Person.
Yes. Even if a cosmetic product has already been notified in the European Union through the CPNP system, it must also be notified through the UK’s SCPN system before being placed on the UK market.
In most cases, a safety assessment (CPSR) prepared for the EU market can also be used in the UK. However, it must be updated to include the UK Responsible Person and translated into English.
The documentation must comply with UK regulations, and the Product Information File (PIF) must be made available to the UK Responsible Person.
This is often the case. The label should include the name and address of the UK Responsible Person.
For cosmetics imported into the UK, additional labeling requirements may also apply.
Yes. However, the product must comply with the requirements of both regulatory systems, which means:
– Responsible Person in the EU,
– UK Responsible Person,
– notification in CPNP (EU),
– notification in SCPN (UK).
Yes. We offer support to companies looking to sell cosmetics in the UK, including:
– analysis of product compliance with UK regulations,
– preparation of cosmetic safety documentation,
– assistance with notification in the SCPN system,
– verification of labels against UK market requirements.
Cosmetics intended for pregnant women do not constitute a separate regulatory category under EU law. However, during the safety assessment, the Safety Assessor must carefully analyze the product’s composition to identify any potential risks to pregnant women. Particular attention is paid to ingredients that may have reproductive toxicity and to the level of exposure resulting from the product’s intended use.
Cosmetics intended for breastfeeding women require special consideration during safety assessments, especially if they are applied to areas of the body that may come into contact with the baby (e.g., the breast area).
Safety Assessor evaluates the ingredients and method of use to ensure that the cosmetic is safe for both the mother and the baby.
Yes. Cosmetics intended for children require special attention during safety assessments, as children may be more sensitive to certain ingredients and exposed to different levels of exposure than adults.
The safety assessment analyzes, among other things:
– the age of the target group,
– the frequency of product use,
– the level of exposure to ingredients,
– the risk of irritation and allergic reactions.
Yes. Cosmetics intended for infants and young children are typically evaluated with particular care due to the greater sensitivity of their skin and the immaturity of their immune systems.
During safety assessments, special attention is paid to:
– the safety of ingredients for very young users,
– the type of product and method of application,
– the potential risk of irritation.
Yes. We conduct safety assessments of cosmetics intended for various user groups, including:
– pregnant women,
– breastfeeding women,
– infants and children,
– people with sensitive skin.
These assessments are prepared based on current scientific data and the requirements of the EU Cosmetics Regulation.
Yes. Marketing claims for cosmetics in the European Union must comply with Commission Regulation (EU) No. 655/2013, which establishes common criteria for claims made regarding cosmetic products.
Claims must be:
– lawful,
– true and supported by evidence,
– fair to the consumer,
– verifiable.
Evidence refers to data that supports the validity of a marketing claim. This may include, among other things:
– application studies,
– instrumental tests,
– literature data on ingredients,
– dermatological tests,
– Safety Assessor evaluation.
The type of evidence should be appropriate to the nature of the claim.
The claim “hypoallergenic” is permitted, but must be properly substantiated. This means, among other things:
– careful selection of ingredients with low allergenic potential,
– an analysis by Safety Assessor,
– results of dermatological tests on sensitive skin.
The claim must not imply that there is absolutely no risk of an allergic reaction.
Yes, but only if the product has actually undergone dermatological testing.
The claim should be supported by appropriate documentation from the test.
Such claims are permissible, but they must be substantiated and must not mislead consumers.
Increasing attention is being paid to the phenomenon of greenwashing, which refers to the use of claims suggesting a product’s environmental friendliness without proper justification.
Yes. Every marketing claim regarding a cosmetic product should be supported by appropriate documentation.
Yes. We offer an analysis of marketing claims with regard to:
– compliance with EU regulations,
– available scientific evidence,
– the risk of misleading consumers,
– compliance with guidelines on cosmetic claims.
Do you still have questions?
If you have any questions, please contact us. Our qualified team will be happy to assist you!