Cosmetics certification in Europe
CE Certification of cosmetic products. Cosmetic Product Safety Report/ CPSR (Cosmetics safety assessment) Cosmetic Product Safety Report. 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
– 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.
I. MSDS compilation for cosmetic product (required for customs and carrier);
II. CPSR compilation for cosmetic product (the guarantee the safety of the product for the consumer);
III. CPNP registration for cosmetic product (for the sale of products on the territory of the European Union);
VI. PiF preparation for cosmetic product (mandatory for Responsible Person to have);
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.
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;
• Bimatoprost, Latanoprost, PGE1 (in the form of alprostadil), PGF2a/ Prostaglandin F2alpha, Travoprost, Dechloro Dihydroxy Difluoro Ethylcloprostenolamide >> Based on MZDR 25268/2019/OVZ;
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/ Responsible Person.
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.
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:
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;
– 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.
If there are restrictions specified in CosIng (Cosmetics Ingredients & Substances), the substance that is part of the cosmetic mixture is additionally checked according to:
• 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 €.
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:
– List of substances prohibited in cosmetic products;
– List of substances which cosmetic products must not contain except subject to the restrictions laid down;
– List of colorants allowed in cosmetic products;
– List of preservatives allowed in cosmetic products;
– List of UV filters allowed in cosmetic products;
– Commission Directive 95/45/EC;
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.
– List of substances which cosmetic products must not contain except subject to the restrictions laid down;
– List of colorants allowed in cosmetic products;
– List of preservatives allowed in cosmetic products;
– List of UV filters allowed in cosmetic products;
– Commission Directive 95/45/EC;
A Sample for initial verification of cosmetic products.
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
– 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%;
• 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
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
CE Certification of cosmetic products in EU - Full information
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