Informative Notice
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Cosmetic product notification
A distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following information to the European Commission:
(a) the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;
(b) the Member State in which the cosmetic product is made available;
(c) his name and address;
(d) the name and address of the responsible person where the product information file is made readily accessible.
The electronic notification of a cosmetic product is done through the online notification portal for cosmetic products (Cosmetic Products Notification Portal, CPNP).
Conditions
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Only cosmetic products for which a responsible legal entity or natural person is appointed can be placed on the market. A person responsible for a cosmetic product produced in the European Union is a manufacturer with a head office in the EU.
A manufacturer must:
- prepare a safety assessment and a report on safety of the cosmetic product;
- keep documentation with information on the cosmetic product (10 years);
- submit an electronic notification of the cosmetic product to the European Commission;
- submit an electronic notification of the cosmetic product which contains substances in the form of nanomaterials to the European Commission;
- label the cosmetic product as per the applicable legislation, and report on any serious adverse effect of the cosmetic product.
Legal basis
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The person responsible is obliged to ensure that a safety assessment has been implemented and a report on the safety of the cosmetic product drafted before the placement of the product on the market in accordance with Annex I to Regulation (EC) on cosmetic products.
The person responsible ensures that:
- the purpose of the use of the cosmetic product and expected systemic exposure to individual components in the final formulation are observed in the safety assessment;
- suitable analysis is used in the safety assessment, based on the relevance of evidence for the discussion of suitable data obtained from all existing sources;
- the report on the safety of the cosmetic product is updated as per suitable additional information collected after the placement of the product on the market.
The safety assessment may only be prepared by a safety assessor with suitable formal qualifications.
Legal basis
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Safety assessment provider is an individual who prepares a safety assessment. This person must have an appropriate education.
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The documentation with information on the product encompasses the following data which are updated accordingly:
- description of the cosmetic product which reveals that documentation with information clearly refers to the relevant cosmetic product;
- report on the safety of the cosmetic product;
- description of the production method and statement of compliance with good manufacturing practice;
- evidence on the effect of the cosmetic product when this is justified by the nature or effect of the cosmetic product;
- data on any animal testing implemented by the manufacturers, their representatives or suppliers relating to the development or safety assessment of the cosmetic product or its ingredients, including animal testing implemented due to compliance with regulations of third countries.
The information included in the documentation on the product must be available in a language which is easily understood by the competent authorities in a member state.
Legal basis
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The presence of substances in the form of nanomaterials in a cosmetic product must be declared by the responsible person within the notification of the cosmetic product. In addition to a declaration, the person responsible must inform the Commission in electronic form about cosmetic products containing nanomaterials six months before their placement on the market, unless the responsible person placed them on market before 11 January 2013.
The notification is not necessary if nanomaterials are used as dyes, UV-filters or preservatives.
Information submitted to the Commission for notification must at least include:
- identification of the nanomaterial, including its chemical name (IUPAC);
- nanomaterial specification, including the size of particles and physical and chemical properties;
- quantity assessment of nanomaterial in cosmetic products intended to be placed on the market annually;
- toxicological profile of the nanomaterial;
- safety data on nanomaterial related to the category of cosmetic products in which they are used, and reasonably foreseeable exposure conditions.
Legal basis
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Sampling and analysis are implemented in order to test the composition of cosmetic products. Cosmetic products are sampled by taking samples from original packaging which are sent to a laboratory without prior opening.
Every basic sample being taken must be accompanied by the following data:
- date, place and time of sampling;
- name of the inspector or the unit of the inspectorate conducting the sampling; name of the person responsible present at the sampling, and data on the sample.
Minutes are drafted after each sampling. The minutes must also include trials which have to be conducted in the laboratory.
Evidence
Minutes on implementation of trials
Legal basis
- REGULATION (EC) No 1223 /2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products (2009/1223)
- Rules on cosmetic product sampling and laboratory testing
- FIRST COMMISSION DIRECTIVE of 22 December 1980 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products (1980/1335)
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Cosmetic products in samples of 0.1 g or 0.1 ml must not contain the following microorganisms: Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans.
Cosmetic products in samples of 0.5 g or 0.5 ml intended for the care of children under the age of three or for use on skin in the area of the eyes or mucous membranes must not contain the microorganisms referred to in the preceding paragraph.
The total number of living aerobic mesophilic microorganisms in samples of cosmetic products of 1 g or 1 ml must not exceed 1,000.
The total number of living aerobic mesophilic microorganisms in samples of cosmetic products of 1 g or 1 ml intended for the care of children under the age of three or for use on skin in the area of the eyes or mucous membranes must not exceed 100.
Evidence
Analysis of microbiological conditions
Legal basis
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Cosmetic products must not contain any of the following:
- prohibited substances from Annex II to Regulation (EC) No 1223/2009;
- restricted substances not being used as per the restrictions under Annex III to Regulation (EC) No 1223/2009;
- colourants with the exception of colourants provided in Annex IV to Regulation (EC) No 1223/2009;
- preservatives except the preservatives provided in Annex V to Regulation (EC) No 1223/2009;
- UV filters with the exception of those provided in Annex VI to Regulation (EC) No 1223/2009.
Legal basis
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It is prohibited to:
- place on the market cosmetic products whose final formulation was tested on animals with a method which was not an alternative method after such an alternative method had already been scientifically approved;
- place on the market cosmetic products which contain ingredients or combinations of ingredients which were tested on animals with a method which was not an alternative method after such an alternative method had already been scientifically approved;
- implement trials of finished cosmetic products on animals, and implement testing of ingredients or combinations of ingredients on animals after the date requiring that such testing be substituted by one or more scientifically approved alternative methods.
Legal basis
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When a cosmetic product which has been sold in a certain member state since 11 July 2013 is to be placed on a market in another member state, the following information must be submitted in electronic form to the Commission:
- category of the cosmetic product, its name in the member state from which the cosmetic product was shipped and its name in the member state where it is accessible on the market, which enables its accurate identification;
- a member state in which the cosmetic product is accessible;
- the distributor’s name and address, and the name and address of the responsible person providing constant access to the documentation with information on the product.
When a cosmetic product was placed on the market before 11 July 2013, but was no longer being placed on the market after the relevant date, the distributor placing this product in a member state after this date must submit to the responsible person the following data:
- category of the cosmetic product, its name in the member state from which the cosmetic product was shipped and its name in the member state where it is accessible on the market, which enables its accurate identification;
- a member state in which the cosmetic product is accessible, and the distributor’s name and address.
Legal basis
Competent Authority
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When a cosmetic product which has been sold in a certain member state since 11 July 2013 is to be placed on a market in another member state, the following information must be submitted in electronic form to the Commission:
- category of the cosmetic product, its name in the member state from which the cosmetic product was shipped and its name in the member state where it is accessible on the market, which enables its accurate identification;
- a member state in which the cosmetic product is accessible;
- the distributor’s name and address, and the name and address of the responsible person providing constant access to the documentation with information on the product.
When a cosmetic product was placed on the market before 11 July 2013, but was no longer being placed on the market after the relevant date, the distributor placing this product in a member state after this date must submit to the responsible person the following data:
- category of the cosmetic product, its name in the member state from which the cosmetic product was shipped and its name in the member state where it is accessible on the market, which enables its accurate identification;
- a member state in which the cosmetic product is accessible, and the distributor’s name and address.
Legal basis
Competent Authority
Procedures
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Notification of a cosmetic product
Legal basis
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