Search Legislation

Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilShow full title

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)

 Help about what version

What Version

 Help about advanced features

Advanced Features

 Help about UK-EU Regulation

Legislation originating from the EU

When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.

Close

This item of legislation originated from the EU

Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).

Changes to legislation:

There are currently no known outstanding effects for the Regulation (EC) No 1223/2009 of the European Parliament and of the Council, Article 2. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.

Article 2U.K.Definitions

1.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 F1... person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under [F2their] name or trademark;

(e)‘distributor’ means any F3... person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the F4... 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 [F5market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge [F6and related expressions are to be construed accordingly];

[F7(h)placing on the market' means the first making available of a cosmetic product on the market of Great Britain on or after IP completion day and related expressions are to be construed accordingly;]

[F8(i)importer” means a person who—

(aa)is established in the United Kingdom and places a cosmetic product from a country outside of the United Kingdom on the market; or

(bb)is established in Northern Ireland and places a cosmetic product on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;]

F9(j). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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. F10...

[F11(t)‘Regulation (EC) No 1272/2008’ means Regulation (EC) 1272/2008 of the European Parliament and of the Council of 16th December 2008 on classifications, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC and amending Regulation (EC) 1907/2006;

(u)‘EU Regulation (pre-exit)’ means Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November on cosmetic products (recast)F12, as it has effect immediately before IP completion day;

(v)‘Enforcement Regulations’ means the Cosmetic Products Enforcement Regulations 2013;

(va)‘CMR’ means carcinogenic, mutagenic or toxic for reproduction;

(w)‘competent authority’ has the meaning given to it in regulation 4 of the Enforcement Regulations;

(x)‘enforcement authority’ has the meaning given to it in regulation 2(1) of the Enforcement Regulations;

(y)‘finished cosmetic product’ means the cosmetic product in its final formulation, as placed on the market and made available to the end user, or its prototype;

(ya)‘historic animal testing data’ means data from any animal testing that was carried out before the date on which such testing was prohibited in accordance with Article 18 of the EU Regulation (pre-exit);

(z)‘prototype’ means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed;

(za)the transitory period” means the period of 90 days beginning on the day after the day on which IP completion day falls.]

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.

[F133.

(1)Subject to subparagraphs (6) and (7), in this Regulation a “designated standard” means a technical specification which is—

(a)adopted by a recognised standardisation body [F14or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

(b)designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2)For the purposes of subparagraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a)the characteristics required of a cosmetic product, including—

(i)levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii)the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(b)production methods and processes relating to the product, where these have an effect on the characteristics of the product.

(3)For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (Cenelec);

(c)the European Telecommunications Standards Institute (ETSI);

(d)the British Standards Institution (BSI).

[F15(3A)In this paragraph “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).]

(4)When considering whether the manner of publication of a reference is appropriate in accordance with subparagraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5)Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [F16such] technical specifications adopted by the other recognised standardisation bodies [F17or by international standardising bodies as the Secretary of State considers to be relevant].

(6)The Secretary of State may remove from publication the reference to a standard which has been published in accordance with subparagraph (1)(b).

(7)Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.]

Textual Amendments

F12OJ L 342, 22.12.2009, p.59.

Back to top

Options/Help

Print Options

You have chosen to open the Whole Regulation

The Whole Regulation you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

You have chosen to open Schedules only

The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.

Would you like to continue?

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

See additional information alongside the content

Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.

Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources