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The responsibilities of the responsible person regarding the cosmetic products

Only cosmetic products for which a natural or legal person is designated within the EU as responsible person can be placed on the market. Hereinafter, the compliance with the course of action related to the distribution of cosmetics – specified by the applicalbe regulations – is the obligation of the responsible person.


Services related to the authorization of cosmetic products


The responsibilities of the responsible person regarding the cosmetic products

 

According to Regulation 1223/2009/EC, we can distinguish two main participants whose obligations and responsibilities are different, this is why at first it is extremely significant to determine into which category our company belongs to. 

The obligations of distributors of cosmetic products


Responsible person

 

In case if those products which were manufactured within the Community and those which were exported and not re-imported, the manufacturer established within the Community shall be the responsible person.

In case of an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market as well. The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.

If the distributor places a cosmetic product on the market under his name or trademark, or changes the product already on the market in way that it may effect the product’s compliance with the reqirements, he is considered as the responsible person.

 

The responsible person might be:


  • the manufacturer (if established within the European Union)
  • the importer (if the product manufacturer is established outside the European Union)
  • the distributor (if they place the product on the market under their own brand name)
  • appointed person or company (who is named by the manufacturer or the importer and who shell accept in writing)

 

The responsible person is obliged to ensure that the cosmetic product meets the requirements of Regulation 1223/2009/EC.

 

According to the regulation, acosmetic product can only be distributed if:


  • with safety evaluation and safety report
  • with Product information file (PIF)
  • appropriate labelling
  • and production is made according to the guidance of ISO 22716, appropriate to the good manufacturing practise (GMP).

 

Preparation of safety evaluation and report

 

The safety assessment and the report based on it intended to prove that cosmetic products are safe for the human health when applied under normal or reasonable, foreseeable conditions.

Before distributing the cosmetic product, the responsible person ensures that the product’s safety report is done, and that it is updated in case any further relevant information is received after the start of the distribution.

The safety assessment of the cosmetic product is an essential part of the product information documentation (TID) needed for the distribution of the cosmetic product.

Service compiling the Safety Assessment’ of cosmetic products

 

Compilation of product information file

 

Compilation of the product information file is the criterium of the distribution and EU report in accordance with Regulation 1223/2009/EC of cosmetic products (cosmetics).

 

The product information dossier (TID) has to contain the following:


  • the description of the cosmetic product
  • the safety assessment
  • description of the manufacturing method
  • the statement of the introduction of GMP (Good Manufacturing Practice)
  • confirmation of the cosmetic produst’s expected effect, if its nature or effect justifies it
  • data on animal experiments, which were carried out during the manufacture of cosmetic products (development of components) or made during the safety evaluation

 

The responsible person must make the PIF readily accessible at the physical address indicated on the product label to the competent authority of the Member State in which the file is kept. The information contained in the PIF must be available in a language which can be easily understood by the competent authorities of the Member State.

 

The product information dossier has to be retaind for 10 years from the distribution date of the last cosmetic product item.

 

Label elements

 

A cosmetic product can be distributed only if the following label information can be found on the packaging and container – in an indelible, easily legible and visible way:

 

1. Name of the responsible person or registered company name and address. The country of origin in the case of import

2. The nominal content by weight or volume at the time of packaging.

(Exception: Prepacked products, many products for which the weight or volume is not relevant, packaging which contains less than 5 g or 5 ml of the product, free samples and disposable products.)

3. Shelf life

a, the shelf life on the less than 30 months shelf life products

Appropriate format: after the date of minimum durability symbol or the period-after-opening must be followed by month/year or day/month/year order

b, in the case of cosmetic products with a shelf-life of more than 30 months, those time period must be indicated after opening in which the product is safe and can be used by the consumer without any negative consequences. The " Period-after-opening" symbol is followed by the time indicated in months and / or years, unless the period of usability after opening is not relevant: in case of disposable products, non-perishable products or decomposed product.

4. Special precautions for user:

5. The batch number or identification number of the cosmetic product.

6. The designation of the cosmetic product, unless it can be stated by its appearance.

7. List of ingredients according to INCI (International Nomenclature Cosmetic Ingredient). This information shall be provided only on the outer packaging (if applicable).

 

The labeling information must be provided in the language of the Member State where the product is distributed for the end user (except: "Ingredients").

If it is not possible to indicate the listed information on the label due to practical reasons, the information must be indicated on an leaflet, label, tape or card enclosed or attached to the product.

Our service on the preparation and translation of the label plan of cosmetic products

 

Reporting the product:

 

The responsible person, before starting the distribution, is obliged to report electronically the following information regarding the cosmetic product via the CPNP portal:

  • the name and/or identificator of the product
  • the name and address of the responsible person, where the product information file is available
  • the country of origin
  • those member states where the product was placed on the market
  • the contact details of a natural person who is possible to contact with in the case of necessity
  • the identificators, chemical names and expected effects of substances present in nanosubstance form
  • the name, CAS number or EC number of substances that are carcinogenic, mutagenic or toxic for reproduction (CMR)
  • the frame formulation
  • the original labelling
  • photo of the packaging

 

In case of change of information, the responsible person is obliged to supervise the data reported via CPNP portal immediately.

Our service on CPNP notification

 


 

Tags:  cosmetic productobligationregulation 1223/2009/ECresponsible person


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