Cosmetic products

Cosmetic products

Outline of the Community (European Union) legislation about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal welfare

Cosmetic products (from 2013)

Document or Iniciative

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (Text with EEA relevance).

Summary

Cosmetic products are substances * or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) 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.

Free movement of these products in the internal market is permitted if they comply with this Regulation.

Market surveillance

A responsible person established in the Community shall be designated for each product placed on the market. This person shall ensure compliance of the products with the rules set out in the Regulation. In particular, they shall ensure compliance with requirements relating to human health, safety and consumer information. They shall maintain a product information file accessible to the public authorities.

In order to ensure product traceability, responsible persons shall identify the distributors to whom they supply the cosmetic product: for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. The same applies to all other persons involved in the supply chain.

In case of product non-compliance, the responsible person shall take measures to render it compliant, withdraw it from the market or recall it to the manufacturing company in all Member States where the product is available. Where the responsible person does not take all appropriate measures, the competent national authorities may take the necessary corrective measures.

If a product which complies with the requirements of the Regulation presents or could present a serious risk to human health, the competent national authority shall take all necessary provisional measures to withdraw, recall or restrict the availability of the product on the market.

Limitations for certain substances

The Annexes of this Regulation give a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V) and UV-filters (other than those in Annex VI) are also prohibited.

The Regulation prohibits the use of substances recognised as carcinogenic, mutagenic or toxic for reproduction (classified as CMR), apart from in exceptional cases. It provides for a high level of protection of human health where nanomaterials are used in cosmetic products.

Consumer information

Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible and visible lettering. This information concerns:

  • the name or registered name and the address of the responsible person;
  • the country of origin for imported products;
  • the weight or volume of the content at the time of packaging;
  • a use-by date for products kept in appropriate conditions;
  • precautions for use, including for cosmetics for professional use;
  • the batch number of manufacture or the reference for identifying the cosmetic product;
  • the list of ingredients, i.e. any substance or mixture intentionally used in the product during the process of manufacturing.

The language of the information shall be determined by the Member State where the product is made available to the end user.

Animal testing

Animal testing must be replaced by alternative methods. The Regulation prohibits the performance of animal testing in the European Union for:

  • finished products,
  • ingredients or combinations of ingredients.

The Regulation also prohibits the placing on the European Union market of:

  • products where the final formulation has been the subject of animal testing;
  • products containing ingredients or combinations of ingredients which have been the subject of animal testing.

A derogation from the ban relating to placing products on the market shall be granted until 11 March 2013 in order to test repeated-dose toxicity, the effects of certain substances on reproduction and to study toxicokinetics *.

In exceptional circumstances, Member States may request the Commission to grant a derogation, after consulting the Scientific Committee for Consumer Safety (SCCS), if an ingredient in wide use which cannot be replaced gives rise to serious concerns.

Committee procedure

The Commission shall be assisted by the Standing Committee on Cosmetic Products.

Context

This Regulation recasts Directive 76/768/EEC due to the many amendments made to it and the new amendments that were required.

The new Regulation shall apply in 2013. However, some of its provisions will apply from 1 December 2010: they concern substances which are carcinogenic, mutagenic or toxic for reproduction (classified as CMR).

Key terms
  • 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.
  • Toxicokinetics: study of the long-term effects of toxic substances in the body.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1223/2009

11.7.2013

1.12.10 (Articles 15 paragraphs 1 and 2, Articles 14, 16, 31 and 32)

11.1.2013 (Article 16, paragraph 3, second section)

OJ L 342 of 22.12.2009


Another Normative about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Food safety > Animal welfare

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/ECof 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC 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 [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].


Another Normative about Cosmetic products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic

Internal market > Pharmaceutical and cosmetic products

Cosmetic products (until 2013)

Document or Iniciative

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Cosmetics Directive) [See amending act(s)].

Summary

The free movement of cosmetic products within the European market cannot be restricted or prohibited by Member States if these products are not dangerous to human health under normal or foreseeable conditions of use.

However, if a cosmetic product conforming to this Directive constitutes a danger to human health, the Member State of the territory on which the product is marketed may take restrictive or prohibitive measures. In this instance, it informs the other Member States and the Commission so that appropriate measures can be taken throughout the European Union (EU).

Ingredients and composition

The Directive determines the list of substances which are prohibited in the composition of cosmetic products (Annex II) and the substances which are subject to restrictions or specific conditions of use (Annex III).

The Directive also contains lists of authorised colourings (Annex IV), preservatives (Annex VI) and UV filters (Annex VII).

Labelling

Containers and/or packaging must specifically mention, in indelible, easily legible and visible characters:

  • the name and address of the manufacturer or of the person responsible for marketing the product;
  • the nominal contents at the time of packaging, by weight or by volume;
  • the date of minimum durability indicated for products with a minimum durability of less than 30 months;
  • the period of time after opening for which the product can be used for products with a minimum durability of more than 30 months (indicated with the symbol representing an open pot of cream);
  • the function of the product and particular precautions for use;
  • the batch number.

This information must be in the official language(s) of the respective Member State.

Moreover, the labelling must contain a list of ingredients. Perfume and aromatic compositions are designated by the words “perfume” or “aroma”, except where these have been identified as a significant cause of allergic reactions.

Market surveillance

Member States are responsible for monitoring their market. To this end, they check the safety of products manufactured or imported in the EU. Furthermore, they also ensure that the characteristics attributed to cosmetic products are not deceptive.

The manufacturer, the importer or the person responsible for marketing the product must inform the national competent authorities when a product is imported into the EU for the first time.

Animal testing

The Directive puts an end to animal testing by imposing bans on:

  • testing finished cosmetic products and ingredients on animals (testing ban);
  • marketing finished cosmetic products which have been tested on animals or which contain ingredients that have been tested on animals (marketing ban).

With regard to repeated-dose toxicity tests, reproductive toxicity tests, and toxicokinetics, the marketing prohibition applies from 11 March 2013. This prohibition is applicable regardless of the availability of alternative test methods.

Context

This Directive is replaced by Regulation (EC) No 1223/2009 from 11 July 2013.

References

Act Entry into force Deadline for transposition in the Member States Official Journal

Directive 76/768/EEC

30.7.1976

30.1.1978

OJ L 262 of 27.9.1976

Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal

Directive 79/661/EEC

26.7.1979

30.7.1979

OJ L 192 of 31.7.1979

Directive 82/368/EEC

19.5.1982

31.12.1983

OJ L 167 of 15.6.1982

Directive 83/574/EEC

4.11.1983

31.12.1984

OJ L 332 of 28.11.1983

Directive 88/667/EEC

14.1.1989

31.12.1989

OJ L 382 of 31.12.1988

Directive 89/679/EEC

3.1.1990

3.1.1990

OJ L 398 of 30.12.1989

Directive 93/35/EEC

23.6.1993

14.6.1995

OJ L 151 of 23.6.1993

Directive 2003/15/EC

11.3.2003

11.9.2004

OJ L 66 of 11.3.2003

Successive amendments and corrections to Directive 76/768/EEC have been incorporated in the basic text. This consolidated version  has a purely documentary value”.

Related Acts

Non-inclusion of ingredients on labelling

Commission Directive 95/17/EC

of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non- inclusion of one or more ingredients on the list used for the labelling of cosmetic products.

Inventory and common nomenclature of ingredients

Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common nomenclature of ingredients employed in cosmetic products [Official Journal L 132 of 1.6.1996].

Checking the composition of cosmetic products

First Commission Directive 80/1335/EEC 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 [Amended by Directive 87/143/EEC, Official Journal L 57 of 27.2.1987].

Second Commission Directive 82/434/EEC of 14 May 1982 on the approximation of the Laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [Amended by Directive 90/207/EEC, Official Journal L 108 of 28.4.1990].

Third Commission Directive 83/514/EEC of 27 September 1983 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 291 of 24.10.1983].

Fourth Commission Directive 85/490/EEC of 11 October 1985 on the approximation of the laws of the Member States relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 295 of 7.11.1985].

Fifth Commission Directive 93/73/EEC of 9 September 1993 on the methods of analysis necessary for checking composition of cosmetic products [OJ L 231 of 14.9.1993].

Sixth Commission Directive 95/32/EC of 7 July 1995 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 178 of 28.7.1995].

Seventh Commission Directive 96/45/EC of 2 July 1996 relating to methods of analysis necessary for checking the composition of cosmetic products [OJ L 213 of 22.8.1996].

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