Cosmetic: Responsibilities of the Responsible Person

Only cosmetic products for which a legal or natural person is designated within the EU as ‘responsible person’ could be placed on the market.


And what are the responsibilities of the responsible person?


1. Responsible person must ensure compliance, for each cosmetic product, with the relevant obligations set out in Cosmetic Regulation.


2. The responsible person must ensure that the manufacture of cosmetic products comply with good manufacturing practice (GMP).


3. In order to demonstrate that a cosmetic product complies with Regulation, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I of Cosmetic Regulation.


The responsible person shall ensure that:

(a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;


(b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;


(c) the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.


4. When a cosmetic product is placed on the market, the responsible person shall keep a product information file (PIF) for it.


The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.


The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.


5. Responsible person must ensure that sampling and analysis of cosmetic products are performed in a reliable and reproducible manner.


6. Prior to placing the cosmetic product on the market the responsible person must submit electronic notification into CPNP (Cosmetic Product Notification Portal).


7. When the cosmetic product is placed on the market, the responsible person shall notify the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.


8. Responsible person should ensure that the cosmetic products not contain any of the following:

(a) prohibited substances — prohibited substances listed in Annex II;

(b) restricted substances — restricted substances which are not used in accordance with the restrictions laid down in Annex III;

(c) colorants - colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;

(d) preservatives - preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex;

(e) UV-filters - (i) UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex.


9. Responsible person must notify cosmetic products containing nanomaterials by electronic means six months prior to being placed on the market.


10. Must ensure that in the market are available only cosmetic products, where the container and packaging bear the information according to article 19 Cosmetic Regulation in indelible, easily legible and visible lettering.


11. Must ensure that the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs are not used to imply that these products have characteristics or functions which they do not have.


12. Responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product are made easily accessible to the public by any appropriate means.


13. In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the competent authority of the Member State where the serious undesirable effect occurred.


Check also which documentation is required to start the sell.


If you are looking for a responsible person (OR) or company that will arrange all the necessary documentation for placing cosmetic products on the market, we are the right address for you (info@chem-consulting.si).