01 Sep 2020
  • Adopted
  • Very high importance
  • Europe
  • Binding legal instruments (regulations, directives and decisions)
  • Entry Into Database 01 Sep 2020
  • Last revised in database 01 Sep 2020
  • Final act signed 30 Nov 2009
  • Final act published 22 Dec 2009

Purpose

The regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health

Key definitions

  • Cosmetic product:
    Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
  • Substance:
    A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
  • Mixture:
    A mixture or solution composed of two or more substances.
  • Nanomaterial:
    An insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. Notably, the definition is different to that of European Commisions, EC 2011, which has been pointed out as being confusing by different stakeholders and academics.
  • Responsible person:
    Legal or natural person designated within the Community as ‘responsible person’ for a cosmetic product.

Data and information requirements

  • Prior to placing the cosmetic product on the market the responsible person shall provide a list of information to the European Commission, including:
    - Category of cosmetic product, the name and address of the responsible person and the Member State in which the cosmetic product is to be placed on the market, the identification of the nanomaterial including its chemical name, the specification of the nanomaterial including size of particles, physical and chemical properties and the toxicological profile of the nanomaterial (for more details see Article 16, paragraph 3).
  • When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall contain a list of information and data (including among others description of the cosmetic product and the product safety report) which shall be updated as necessary. For more details see Article 11, paragraph 2.
  • The 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.

Decision procedure

1) Prior to placing the cosmetic product containing nanomaterials on the market the responsible person shall submit, by electronic means, a list of both general and nano-specific information to the Commission (for details on the information, see section ‘Data and Info requirements’).
2) The European Commission shall, in the event that the European Commission has concerns regarding the safety of a nanomaterial, without delay, request the Scientific Committee on Consumer Safety (SCCS) to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions.
3) Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the European Commission may amend Annexes II (List of substances prohibited in cosmetic products) and III (List of substances which cosmetic products must not contain except subject to the restrictions laid down).

Decision-support tools

  • Safety assessment
    Risk assessment

Risk management procedures

  • Where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken. Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority.
  • Where the cosmetic product presents a risk to human health, distributors shall immediately inform the responsible person and the competent national authorities of the Member States in which they made the product available, giving details, in particular, of the non-compliance and of the corrective measures taken. Distributors shall cooperate with competent authorities, at the request of the latter, on any action to eliminate the risks posed by products which they have made available on the market. In particular, distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements listed under paragraph 2 of article 6, including e.g. labelling information and date of durability.
  • In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred: 1) all serious undesirable effects which are known to him or which may reasonably be expected to be known to him, 2) the name of the cosmetic product concerned, enabling its specific identification, and 3) the corrective measures taken by him, if any. The competent authority shall immediately transmit the information to the competent authorities of the other Member States.
  • In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which the member state is responsible and which contain this substance.

Monitoring requirements

  • Member States shall monitor compliance with the regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.
  • Member States shall also monitor compliance with the principles of good manufacturing practices.
  • Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the European Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means.

Enforcement

  • The competent authorities of the Member States shall cooperate with each other and with the European Commission to ensure the proper application and due enforcement of the regulation and shall transmit to each other all information necessary with a view to applying this regulation uniformly.

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Legal Requirements for different actors

  1. Safety demonstration

    Responsible person

    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. Such a report shall include ‘Cosmetic product safety information’ (with e.g. quantitative and qualitative composition of the cosmetic product and exposure to the cosmetic product) and a ‘Cosmetic product safety assessment’ (with e.g. assessment conclusion and labelled warnings and instructions of use). See more details in Annex I.

  2. Identification within the supply chain

    Responsible person

    At the request of a competent authority, responsible persons shall identify the distributors to whom they supply the cosmetic product.

  3. Product information file

    Responsible person

    When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall contain a list of information and data (including among others description of the cosmetic product and the product safety report) which shall be updated as necessary (see more details on this in Article 11, paragraph 2).

  4. Notification

    Responsible person

    Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the information to the Commission. The information includes general information including among others the category of cosmetic product, the name and address of the responsible person and the Member State in which the cosmetic product is to be placed on the market (for the full list of requirements, see Article 13, paragraph 1). When the cosmetic product is placed on the market, the responsible person shall notify to the European Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging. Cosmetic products containing nanomaterials shall, in addition to the notification described above (‘general notification’), be notified to the European Commission, six months prior to being placed on the market, except where they have already been placed on the market by the same responsible person before 11 January 2013. In the latter case, cosmetic products containing nanomaterials shall be notified to the Commission between 11 January 2013 and 11 July 2013 by electronic means, in addition to the notification in Article 13. The notification shall among others include information regarding identification of the nanomaterial (including its chemical name), the specification of the nanomaterial (including size of particles), physical and chemical properties and the toxicological profile of the nanomaterial (for the full list of requirements, see Article 16, paragraph 3).

  5. Notification

    The European Commission

    The European Commission shall, without delay, make the information provided by the responsible person (referred to in Article 13, points (a) to (g) of paragraph 1, and in paragraphs 2 and 3) available electronically to all competent authorities. For submission of notifications of cosmetic products containing nanomaterials, the European Commission shall, in the event that the European Commission has concerns regarding the safety of a nanomaterial, without delay, request the Scientific Committee on Consumer Safety (SCCS) to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions. The European Commission shall make this information public.

  6. SCCS Opinion

    Scientific Committee on Consumer Safety (SCCS)

    The SCCS shall deliver its opinion within six months of the European Commission’s request. Where the SCCS finds that any necessary data is lacking, the European Commission shall request the responsible person to provide such data within an explicitly stated reasonable time, which shall not be extended. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available. Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the European Commission may amend Annexes II (List of substances prohibited in cosmetic products) and III (List of substances which cosmetic products must not contain except subject to the restrictions laid down).

  7. Catalogue on all nanomaterials

    The European Commission

    By 11 January 2014, the European Commission shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions. The catalogue shall be regularly updated thereafter and be made publicly available. The European Commission shall submit to the European Parliament and the Council an annual status report, which will give information on developments in the use of nanomaterials in cosmetic products in the EU, including those used as colorants, UV-filters and preservatives in a separate section.

  8. Review of nanomaterial provisions

    The European Commission

    The European Commission shall regularly review the provisions of the regulation concerning nanomaterials in the light of scientific progress and shall, where necessary, propose suitable amendments to those provisions.

  9. Identification within the supply chain

    Distributors

    At the request of a competent authority, the distributor shall identify the distributor or the responsible person from whom, and the distributors to whom, the cosmetic product was supplied.

  10. Conformity with requirements

    Distributors

    Before making a cosmetic product available on the market distributors shall verify that labelling information is present, language requirements are fulfilled and where relevant, the date of minimum durability has not passed. Where distributors consider or have reason to believe that: 1) a cosmetic product is not in conformity with the requirements laid down in the regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements; 2) a cosmetic product which they have made available on the market is not in conformity with the regulation, they shall make sure that the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate, are taken. Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardize its compliance with the requirements set out in the regulation.

Cons

Notification for cosmetic products already on the market

Definition predates that of European Commission

Unclear terms in definitions of nanomaterials

Challenges of pre-market safety assessment