Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)
Modified by
  • Commission Regulation (EU) No 344/2013of 4 April 2013amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance)Corrigendum to Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Official Journal of the European Union L 114 of 25 April 2013), 32013R034432013R0344R(01), April 25, 2013
  • Commission Regulation (EU) No 483/2013of 24 May 2013amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32013R0483, May 25, 2013
  • Commission Regulation (EU) No 658/2013of 10 July 2013amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32013R0658, July 11, 2013
  • Commission Regulation (EU) No 1197/2013of 25 November 2013amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32013R1197, November 26, 2013
  • Commission Regulation (EU) No 358/2014of 9 April 2014amending Annexes II and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32014R0358, April 10, 2014
  • Commission Regulation (EU) No 866/2014of 8 August 2014amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products(Text with EEA relevance)Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products(Official Journal of the European Union L 238 of 9 August 2014), 32014R086632014R0866R(01), August 9, 2014
  • Commission Regulation (EU) No 1003/2014of 18 September 2014amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32014R1003, September 26, 2014
  • Commission Regulation (EU) No 1004/2014of 18 September 2014amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32014R1004, September 26, 2014
  • Commission Regulation (EU) 2015/1190of 20 July 2015amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32015R1190, July 21, 2015
  • Commission Regulation (EU) 2015/1298of 28 July 2015amending Annexes II and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32015R1298, July 29, 2015
  • Commission Regulation (EU) 2016/314of 4 March 2016amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance)Corrigendum to Commission Regulation (EU) 2016/314 of 4 March 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Official Journal of the European Union L 60 of 5 March 2016), 32016R031432016R0314R(01), March 5, 2016
  • Commission Regulation (EU) 2016/621of 21 April 2016amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32016R0621, April 22, 2016
  • Commission Regulation (EU) 2016/622of 21 April 2016amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32016R0622, April 22, 2016
  • Commission Regulation (EU) 2016/1120of 11 July 2016amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32016R1120, July 12, 2016
  • Commission Regulation (EU) 2016/1121of 11 July 2016amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32016R1121, July 12, 2016
  • Commission Regulation (EU) 2016/1143of 13 July 2016amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32016R1143, July 14, 2016
  • Commission Regulation (EU) 2016/1198of 22 July 2016amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32016R1198, July 23, 2016
  • Commission Regulation (EU) 2017/237of 10 February 2017amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32017R0237, February 11, 2017
  • Commission Regulation (EU) 2017/238of 10 February 2017amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, 32017R0238, February 11, 2017
  • Commission Regulation (EU) 2017/1224of 6 July 2017amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32017R1224, July 7, 2017
  • Commission Regulation (EU) 2017/1410of 2 August 2017amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32017R1410, August 3, 2017
  • Commission Regulation (EU) 2017/1413of 3 August 2017amending Annex IV to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products(Text with EEA relevance), 32017R1413, August 4, 2017
Corrected by
  • Corrigendum to Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, 32013R0344R(01), May 29, 2013
  • Corrigendum to Commission Regulation (EU) No 866/2014 of 8 August 2014 amending Annexes III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and the Council on cosmetic products, 32014R0866R(01), August 28, 2014
  • Corrigendum to Commission Regulation (EU) 2016/314 of 4 March 2016 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, 32016R0314R(01), January 21, 2017
Regulation (EC) No 1223/2009 of the European Parliament and of the Councilof 30 November 2009on cosmetic products(recast)(Text with EEA relevance) CHAPTER ISCOPE, DEFINITIONS
Article 1Scope and objectiveThis Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.
Article 2Definitions1.For the purposes of this Regulation, the following definitions shall apply:(a)"cosmetic product" means 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;(b)"substance" means 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;(c)"mixture" means a mixture or solution composed of two or more substances;(d)"manufacturer" means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;(e)"distributor" means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;(f)"end user" means either a consumer or professional using the cosmetic product;(g)"making available on the market" means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;(h)"placing on the market" means the first making available of a cosmetic product on the Community market;(i)"importer" means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;(j)"harmonised standard" means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society servicesOJ L 204, 21.7.1998, p. 37. on the basis of a request made by the Commission in accordance with Article 6 of that Directive;(k)"nanomaterial" means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm;(l)"preservatives" means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product;(m)"colorants" means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants;(n)"UV-filters" means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation;(o)"undesirable effect" means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product;(p)"serious undesirable effect" means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death;(q)"withdrawal" means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain;(r)"recall" means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user;(s)"frame formulation" means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.2.For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.3.In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at international level. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).
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