CE Certification of cosmetic products. Cosmetic Product Safety Report/ CPSR (Cosmetics safety assessment). CPNP registration. PiF compilation
European CE Certification of cosmetic products. Preparation of Cosmetics safety assessment / Cosmetic Product Safety Report. CPNP registration. PiF Compilation
CE Certification/ notification of cosmetic products in Europe is a comprehensive package of permits and tests confirming the quality of cosmetics
How to certify cosmetics in Europe?
Cosmetic products entering the EU (European Union) market must have:
– SDS/ MSDS adapted to cosmetic regulations;
– Label according to the provisions of the European Cosmetic Regulation No. 1223/2009;
– Cosmetic Product Safety Report/ CPSR (Cosmetics safety assessment/ SR) in accordance with the Rules for the assessment of the safety of cosmetic products, Part A and Part B of Annex I of Regulation (EC) No 1223/2009;
– CPNP registration with the receipt of a referral number for each cosmetic product supplied to the European market;
– PiF (Product Information File/ Dosser) for each supplied product in the EU.
The supplier company, which is not a resident of the European Union, is obliged to have its own representative on the territory of the EU. Any legal entity of the European Union can be a representative.
Preparation of a package of documents for cosmetic products for sale in the EU countries
Preparation of a package of documents for cosmetic products for sale in the EU is conditionally divided into 4 stages. Each stage finishes with the obtaining of a certain authorization document for a cosmetic product.
Fee for the production of each document takes place separately, under a separate contract.
Detailing the cost, time and conditions of notification, laboratory testing of cosmetic products is conditionally free, only if our MSDS for cosmetic products are available.
The cost of notifying one cosmetic product on the territory of the European Union, according to Regulation (EC) No. 1223/2009 – from 500 eur.
The exact cost for the European certification of cosmetics is formed from many factors, some of which become known only in the next steps. In particular, the price depends on: the composition of the cosmetic product; the number of components in the cosmetic mixture; the characteristics of the product declared by the manufacturer; the presence or absence of certain documents from the manufacturer.
We do not carry out any kind of work with cosmetic products containing the following substances: • Bimatoprost, Latanoprost, PGE1 (in the form of alprostadil), PGF2a/ Prostaglandin F2alpha, Travoprost, Dechloro Dihydroxy Difluoro Ethylcloprostenolamide >> Based on MZDR 25268/2019/OVZ; • Any cosmetic products with intentionally added microplastics. For example, cosmetics with loose glitter, nail cosmetics with colored plastic microgranules, and the like this. From October 15, 2023, the EU will introduce a ban on the sale of products containing microplastics. >> Based on C(2023) 6419 - Commission Regulation (EU);
Before starting all work on the preparation of permits for cosmetic products, the manufacturer / supplier of cosmetics is required to have a Cosmetics Responsible Person in Europe.
Cosmetics Responsible Person according to the cosmetic regulations of the European Union
All cosmetic products available for sale in the European Union must have a representative (legal entity) geographically located in the EU. According to Cosmetic Regulation (EC) No 1223/2009 Cosmetics Responsible Person is responsible for the cosmetic product of a non-European manufacturer on the EU market.
Cosmetics Responsible Person must store a PiF (Product Information File)/ Dosser file of product information and strictly observe the confidentiality of storing the information file.
The name and contact details of the responsible person must be on the label of the cosmetic product.
The best option when Cosmetics Responsible Person is a third-party company, and is not related to the producer's commodity network in the European Union. In this case, changing the dealer/ distributor/ sales agent will not lead to changes on the label and in the CPSR, CPNP, PiF file. The task of a professional responsible person is to ensure compliance of cosmetic products with the European Regulations, which does not affect commercial interests outside the European cosmetics manufacturer in any way.
Availability of Cosmetics Responsible Person/ The responsible Person of the manufacturer on the territory of the European Union. The responsible person can be any legal entity, a resident of any EU country. The task of Cosmetics Responsible Person is to ensure compliance of cosmetic products with the European Regulations.
Possible options with the presence of a Responsible Person when registering a cosmetic product:
– registration of your own company in Latvia or Spain, with full legal and accounting services from our side;
– conclusion of an agreement with our company to represent your interests on the territory of the European Union – from 300 €/ year;
– selection of Cosmetics Responsible Person on their own;
MSDS/ Material Safety Data sheet (first stage)
Material Safety Data Sheet is a mandatory document when trading with cosmetic products on the territory of the European Union, when transporting cosmetic products, their customs clearance, storage or disposal. The document is required for the European CE certification of cosmetic products and for obtaining other permits.
MSDS informs consumers in detail on the special conditions of storage of products, their safe use. It must contain information necessary to ensure the safety of people's lives and the safety of health, property and the environment.
The presence of correct MSDS, with the most described data in all sections is very important, both during the initial review of the product and for obtaining CPRS in a short time.
Before manufacturing MSDS for a cosmetic product, all its components are pre-checked for the presence of a substance in CosIng data base CosIng (Cosmetics Ingredients & Substances) and ECHA.
If there are restrictions specified in CosIng (Cosmetics Ingredients & Substances), the substance that is part of the cosmetic mixture is additionally checked according to:
Independent verification of the composition of a cosmetic product using the specified databases is free of charge. Verification procedures with the involvement of our company – from 25 €. The time of verification by our company depends on the amount of substances in one cosmetic product and the total number of products taken into operation.
If the substance is not registered in the CosIng (Cosmetics Ingredients & Substances), then when preparing the Cosmetic Product Safety Report you will need to provide additional information from the manufacturer of the substance (for example, MSDS/SDS for the substance), which contains data on the applicability of this substance in the cosmetic industry.
Preparation of MSDS for each registered cosmetic product. The cost of manufacturing one MSDS depends on the number of cosmetic products declared in the work. (with more – the cost of one MSDS decreases);
– the EC Cosmetic Regulation requires that the names of the components of a cosmetic product be indicated on the label in the INCI (International Nomenclature of Cosmetic Ingredients);
– according to Regulation (EC) 1223/2009 in MSDS for many cosmetic products, the maximum deviation of the concentration of substances in the mixture is allowed by 0.1 – 0.2%. This means that in the MSDS of cosmetic products, it is required to specify the exact concentrations of components in the product, without intervals of 5 – 10%;
Additional options in the preparation of MSDS for cosmetic products • When preparing MSDS, we can inform the client that the product is classified as dangerous and indicate which substances the concentration should be reduced to avoid this. The cost of the service is 55 €, if the preliminary calculation of the components of the mixture is carried out simultaneously with the preparation of MSDS.
• Adjustment of ready-made MSDS to reduce the hazard class of the product during transportation – the cost of the service is 125 €.
All new substances for the cosmetics industry that do not have a cas # / ec # registration number, or whose safety has not yet been evaluated and confirmed by the relevant structures, are required to confirm the safety and suitability of such substances for use as a cosmetic ingredient.
To do this, the manufacturer of the new substance must submit an application to the Scientific Committee on Consumer Safety (SCCS), provide relevant documentation, and obtain an expert opinion. And then wait for the result from SCCS. SCCS guidelines for testing Cosmetic Ingredients and evaluating their Safety
CPSR is the main part of the Product Information File (PIF) and is a scientific review of the safety of a cosmetic product. CPSR (Cosmetic Product Safety Report) consists of two parts: Part A – Information on the safety of cosmetic products and Part B – Assessment of the safety of cosmetic products
Cosmetics safety assessment should contain the following information:
1. Quantitative and qualitative composition of cosmetic product;
2. Physical/ chemical properties and stability of cosmetic product;
– Physical/ chemical characteristics of substances or mixtures;
– Physical/ chemical properties of the finished cosmetic product;
3. Microbiological quality (checking the effectiveness of preservatives in cosmetics and skin care products);
4. Impurities, packaging material information;
5. Description of use;
6. The effect of cosmetic product;
7. Exposure to constituents/ substances;
8. Toxicological profile of substances;
9. Undesirable effects and serious undesirable effects when using cosmetic products;
10. Information about the cosmetic product.
The report is generated strictly based on the results of laboratory tests or on the basis of valid MSDS/ SDS
Example CPSR >> The cost of CPSR includes: a) Preparation of a dossier (package of documents) for CPSR compilation – from 150 € for all cosmetic products provided.
the dossier (package of documents) for the preparation of CPSR includes:
– Cosmetics Responsible Person data;
– correct MSDS data;
– label layouts for a Cosmetic product that meet the requirements of European legislation; Example of required data >> – the results of testing cosmetic product, from a verified European laboratory;
– photo of cosmetic product in primary packaging/ packaging with label;
– test-report of the primary packaging (packaging) of a cosmetic product; Example of test-report for primary packaging/container >> – some other non-public documents.
b) Laboratory tests in a notified European laboratory (if necessary according to the cosmetic regulations) – from 200 € for one cosmetic product;
c) The cost for preparation of a multi-page Cosmetic Product Safety Report/ CPSR from 200 € for one product (the cost depends on the amount of substances included in the cosmetic product);
Clarifications of the legislative acts of the European Union on the need to provide the requested documents for certification/ notification of cosmetic products for export to EU countries.
All cosmetic substances must be registered in the ЕU CPNP database To register cosmetic products on the CPNP portal, you need:
– the presence of the Representative of the manufacturer on the territory of the European Union. A Representative can be any legal entity, a resident of any EU country;
– e-mail for CPNP registration. To which both a Legal Representative and a manufacturer of cosmetic products will have access;
– photos of cosmetic products;
– the original layout of the label / sticker of cosmetic products. The label must contain complete data according to the requirements of the European Union in English or in the national language of the first sale of the cosmetic product;
– MSDS/ SDS for each registered cosmetic product;
Information that is submitted to the European Cosmetic Portal CPNP:
– composition and description of the cosmetic product (from CPSR);
– photo of the cosmetic product (from the package of documents for CPSR);
– graphic sticker of a cosmetic product (from the package of documents for CPSR);
Notification of a cosmetic product on the CPNP Cosmetic Portal takes up to 3 days.
The fee for registering one cosmetic product on the CPNP portal is from 18 eur (depending on the quantity and complexity of the composition of cosmetic products).
PiF (Product Information File) – Dosser for Cosmetics product (fourth stage)
PiF is a package of all permits for the sale of cosmetic products in Europe, this information package also includes Safety Report/ CPSR.
Each cosmetic product should have its own product information file containing precise information on the product.
The PiF should include a product description, a report on the safety of cosmetic products, information on manufacturing methods in accordance with good manufacturing practices and confirmation of the claimed effect.
Formal requirements for a PiF file The competent authority should be able to freely access the PiF file at the address indicated on the product label. It should be possible to submit the PIF file within 72 hours to any inspection body of the European Union. The PiF file for each cosmetic product should be kept for ten years as of the time when the last batch of a certain cosmetic product was released to the EU market.
The contents of the PiF file about the cosmetic product must contain:
1. Clear description of the cosmetic product;
2. All existing information about the responsible person (RP);
3. CPNP notification;
4. The recipe and the exact composition of the cosmetic product – a detailed list of ingredients (a confidentiality agreement is possible);
5. Physico-chemical properties and stability:
– for each ingredient or component: Material safety data sheets, microbiological tests and certificates of analysis;
– INCI declaration (if required for perfume oil – IFRA certificates);
– if available, toxicological profiles of raw materials from the manufacturer;
Information for the final product:
– physico-chemical data (pH, viscosity, color, particle size, etc.);
– information on micro biological tests;
– stability test of the physical product (for example, 3 months at 40 °C);
– if available, tests of the effectiveness of the cosmetic product;
– a detailed description of the impact (levels of use);
– if there is information about environmental pollution;
– toxicological tests (in vivo, in vitro tests or patch tests) and others;
– documentation regarding packaging (EU declaration of conformity in accordance with 1935/2004 and (EU) 10/2011 and SVHC declaration) and labeling of cosmetic product packaging;
6. If there is a GMP certificate (or confirmation of good manufacturing practices of the manufacturer);
7. Information about undesirable consequences;
8. Information about animal testing in relation to raw materials and finished cosmetic product;
9. Information about the manufacturing process of the cosmetic produc.
The PiF file is created in a free form, in the format .pdf or presentations
The cost of creating a PiF (Product Information File/ Dossier) dossier for a cosmetic product is from 110 € to 150 € for one product (the price depends on the amount of information included in it);
Safety assessment and laboratory testing of cosmetics
Safety assessment of cosmetic products Based on the documents (Information on the safety of a cosmetic product) submitted by the manufacturer of cosmetic products (Annex I to the EU Regulation No. 1223/2009), we make an assessment of the safety of cosmetic products in accordance with Part B, Annex I, Regulation EC No. 1223/2009.
Laboratory tests of cosmetic products In accordance with Annex I to Regulation EC No. 1223/2009, the following tests/tests are carried out in laboratories:
• organoleptic: appearance, smell/aroma, color, taste;
• physico-chemical: pH, percentage of dry matter, determination of acids and determination of the acid number of ethanol, humidity, etc.;
• biological: detection of specific microorganisms (Staphylococcus, C. Albicans, E. coli, etc.), determination of the number and identity of non-specific microorganisms (mesophilic bacteria, yeast, etc.)
• microbiological:
Price list for CE Certification/ safety assessment of cosmetic products
The cost of notifying one cosmetic product on the territory of the European Union, according to Regulation (EC) No. 1223/2009 – from 500 eur.
Methodological recommendations to Annex I of Regulation No. 1223/2009 on the formation (production) Cosmetic Product Safety Report/ Cosmetic Product Safety Report / CPSR
