Responsabilities

Overview

The European Union Treaty and its regulations are established from the perspective of freedoms and responsibilities, a higher whole than that of rights and obligations. Taking into account the history of our consumer market, some instruments have been harmonized that guide to a responsible and honest activity in the market and the approximation of the legislation of the Member States regarding products that, appearing other than they are, could endanger the health or safety of consumers.

Thus, creative freedom is supported, including for cosmetic products, in a clean and respectful production framework, and with an honest presentation.

Definitions

In the case of our services regarding cosmetic products, Regulation (EC) no. 1223/2009 of the European Parliament and of the Council, dated November 30. 2009, on cosmetic products, aims to simplify procedures and rationalize terminology in order to reduce administrative formalities and ambiguities.

As such, the cosmetic product is that finished product, i.e. any substance or mixture intended to be put in contact with the external parts of the human body (epidermis, areas with hair, nails, lips and external genitalia) or with the teeth and mucous membranes of the oral cavity, with the aim  exclusively or mainly to clean them, perfume them, change their appearance, protect them, keep them in good condition or correct body odors.

Regarding sales, three types of marketing are defined:

  • The manufacturer, any natural or legal person who produces a cosmetic product or has the design or manufacture of such a product, and markets it under his name or brand.
  • The distributor, any natural or legal person in the distribution chain, other than the manufacturer or importer, who makes a cosmetic product available on the Community market.
  • The importer, any natural or legal person established in the Community who introduces on the Community market a cosmetic product from a third country (non-EU).

Responsible person

Only cosmetic products for which a legal or natural person is designated in the Community as the ‘responsible person’ are placed on the market. For each cosmetic product placed on the market, the responsible person ensures compliance with the relevant obligations laid down in this Regulation.

Who is the responsible person?

  • the manufacturer established (with its registered office/domicile) in the EU if the production takes place in the EU, or
  • the importer, for products from outside the EU, i.e. all importers even if they import the same product, or
  • the person designated by written mandate from the manufacturer or importer(s), or
  • the distributor placing a cosmetic product on the market under his name or trademark (private label)

Responsibility of manufacturers or private label distributors

In the creation process and always before introducing a cosmetic product to the market, any producer, small or factory, needs to pay attention to the following details, because he becomes the person legally responsible for his products:

  • arranging the work space in accordance with the Good Manufacturing Practices Guide (GMP, standardized by ISO 22716:2008 – this aspect does not require any authorization, but follows from your own responsibility;
  • to have at the premises the cosmetic product file (PIF), including the product evaluation report (CPSR) evaluated by a specialist;
  • sampling and analysis of cosmetic products;
  • cosmetic product notification in the European CPNP portal – Cosmetic Product
    Notification Portal – CPNP manufacturing notification;
  • the selection of ingredients used – in particular those prohibited or restricted substances, dyes, preservatives, UV filters, CMR – carcinogenic, mutagenic or toxic for reproduction, nanomaterials;
  • correct labeling – mandatory minimum elements must be included;
  • proof of product statements and claims.

It is also important to state that animal testing of products or their introduction to the market is prohibited in the European Community.

Information
for distributors

Those merchants who purchase cosmetic products from EU manufacturers or suppliers, with the aim of reselling them in their own stores, online or other commercial entities, are advised the following:

  • verification of the mandatory minimum requirements regarding the labeling of cosmetic products;
  • to ensure that they meet the language requirements for the country in which they will sell the respective products, respectively to ensure the translation of the label;
  • check that the minimum shelf life is not exceeded;
  • proceed to notify CPNP for distribution (optional).

It is also important to state that animal testing of products or their introduction to the market is prohibited in the European Community.

Importers' responsibility

Those traders who introduce on the European market cosmetic products originating from outside the EU, will become the persons legally responsible for those products. Thus, it is important to ensure the following aspects:

  • to have at the premises the cosmetic product file (PIF), including the product evaluation report (CPSR) evaluated by a specialist;
  • to notify the product in the CPNP portal – manufacturing notification;
  • to correctly label each product – taking into account mandatory minimum
    elements and language requirements;
  • check that the minimum shelf life is not exceeded.

It is also important to state that in the European Community it is prohibited to market cosmetic products that do not comply with the selection of ingredients used – in particular those prohibited or
restricted substances, dyes, preservatives, UV filters, CMR – carcinogenic, mutagenic or toxic for reproduction, nanomaterials, and those that have been tested on animals.

Product information file (PIF)

When a cosmetic product is placed on the market, the responsible person shall keep a product information file. The product information file (PIF) must be kept for a period of ten years from the date on which the last batch of the cosmetic product was placed on the market. The product information file shall contain the following information and data, which shall be updated whenever necessary:

  • a description of the cosmetic product allowing a clear link to be established between the product information file and the cosmetic product concerned;
  • the cosmetic product safety report (CPSR) assessed by a specialist;
  • a description of the manufacturing method of the product;
  • a declaration of compliance with good manufacturing practice (ISO 22716:2007);
  • proof of the claimed effect of the cosmetic product;
  • data on any animal testing;
  • the CPNP notification.

The responsible person shall ensure that the competent authority of the Member State where the product information file is kept has easy access to it, in electronic or other format, at its address indicated on the label.

 

The information contained in the product information file shall be accessible in a language which can be easily understood by the competent authorities of the Member State.

Applicable legislation

  • Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
  • Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures
  • Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) establishing a European Chemicals Agency
  • Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work
  • Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety
  • Commission Communication 2011/C 123/04 in the framework of the implementation of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
  • Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste