Science & Regulation · Regulatory Framework
EU Cosmetics Regulation 1223/2009: What Is a Cosmetic?
Key facts
- Regulation (EC) No 1223/2009 of 30 November 2009 is the EU regulation on cosmetic products, adopted as a recast.
- What makes a substance or mixture a cosmetic product is what it is intended for: contact with the external parts of the body, the teeth or the oral mucous membranes, for set purposes.
- A substance or mixture intended to be ingested, inhaled, injected or implanted into the human body is not considered a cosmetic product.
- A cosmetic product is placed on the market only if a responsible person is designated for it within the Community.
- The annexes list prohibited substances, restricted substances, and allowed colorants, preservatives and UV filters.
Under Regulation (EC) No 1223/2009, a cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body, or with the teeth and oral mucous membranes. The intended aim is exclusively or mainly to clean, perfume, protect or keep those parts in good condition, to change their appearance, or to correct body odours. Recital 6 states that the regulation relates only to cosmetic products, and not to medicinal products, medical devices or biocidal products.
Which EU text governs cosmetic products, and what does it set out to do?
The full title of the text is “Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast)”. Under its Article 1, the regulation establishes rules to be complied with by any cosmetic product made available on the market. Those rules aim to ensure the functioning of the internal market and a high level of protection of human health.
When is a product a cosmetic product?
Article 2(1)(a) of Regulation (EC) No 1223/2009 defines a “cosmetic product” as any substance or mixture intended to be placed in contact with the external parts of the human body. Those parts are the epidermis, hair system, nails, lips and external genital organs; the teeth and the mucous membranes of the oral cavity are covered as well. The contact is made 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.
For the purposes of that definition, Article 2(2) of the regulation states that a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body is not considered to be a cosmetic product.
Where does the regulation draw the line with medicinal products?
Recital 6 of Regulation (EC) No 1223/2009 states that the regulation relates only to cosmetic products, and not to medicinal products, medical devices or biocidal products. According to the same recital, the delimitation follows in particular from the detailed definition of cosmetic products. That definition refers both to their areas of application and to the purposes of their use.
What do “substance” and “mixture” mean in that definition?
In Article 2(1)(b) of Regulation (EC) No 1223/2009, a “substance” is a chemical element and its compounds, in the natural state or obtained by any manufacturing process. It includes any additive necessary to preserve its stability and any impurity deriving from the process used. It excludes any solvent which may be separated without affecting the stability of the substance or changing its composition. In Article 2(1)(c), a “mixture” is a mixture or solution composed of two or more substances.
What does EU medicines law call a medicinal product?
Directive 2004/27/EC replaces point 2 of Article 1 of Directive 2001/83/EC, which defines a “medicinal product”. In that wording, the first limb covers any substance or combination of substances presented as having properties for treating or preventing disease in human beings. The second limb covers any substance or combination of substances which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. The second limb also covers such use or administration with a view to making a medical diagnosis.
Under Article 2(1) of Directive 2001/83/EC, as replaced by Directive 2004/27/EC, the directive applies to medicinal products for human use intended to be placed on the market in Member States. The products concerned are those either prepared industrially or manufactured by a method involving an industrial process. Article 2(2), in the same wording, deals with cases of doubt. Where a product, taking into account all its characteristics, may fall within both the definition of a “medicinal product” and that of a product covered by other Community legislation, Directive 2001/83/EC applies.
What does EU medicines law call a herbal medicinal product?
Directive 2004/24/EC adds four definitions to Article 1 of Directive 2001/83/EC, as points 29 to 32. The table quotes the English text of the directive.
| Point | Term | Definition | Fact |
|---|---|---|---|
| 29 | “Traditional herbal medicinal product” | “a herbal medicinal product that fulfils the conditions laid down in Article 16a(1)” | |
| 30 | “Herbal medicinal product” | “any medicinal product, exclusively containing as active ingredients one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations” | |
| 31 | “Herbal substances” | “All mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried, form, but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety and author)” | |
| 32 | “Herbal preparations” | “preparations obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates” |
Under point 30, a herbal medicinal product is first of all a medicinal product, whose active ingredients are exclusively herbal substances, herbal preparations, or a combination of both. Point 32 names essential oils among herbal preparations within the meaning of the directive.
Directive 2004/24/EC also inserts into Title III of Directive 2001/83/EC a Chapter 2a entitled “Specific provisions applicable to traditional herbal medicinal products”. Article 16a(1), inserted by the same directive, establishes a simplified registration procedure called “traditional-use registration”. The procedure is established for herbal medicinal products which fulfil all of the criteria that the paragraph then lists.
Article 16h(3) of Directive 2001/83/EC, inserted by Directive 2004/24/EC, provides that the Committee for Herbal Medicinal Products establishes Community herbal monographs for herbal medicinal products. Those monographs are established with regard to the application of Article 10(1)(a)(ii), as well as for traditional herbal medicinal products. The directive also provides that the herbal monographs are published.
How can a herbal medicinal product reach the EU market?
According to the EMA’s “Herbal medicinal products” page, there are three main regulatory pathways for bringing a herbal medicinal product to market in EU Member States. One of them is traditional use registration, based on Article 16a(1) of Directive 2001/83/EC. Another is the well-established use marketing authorisation, based on Article 10a of the same directive.
As the EMA summarises them, the main safety and efficacy requirements of traditional use registration include use for at least 30 years, including at least 15 years within the EU. No clinical tests and trials on safety and efficacy are required, as long as sufficient safety data and plausible efficacy are demonstrated.
For a well-established use marketing authorisation, the EMA lists among the main requirements scientific literature on the active substances of the medicinal products. What that literature has to establish is well-established medicinal use of those substances within the EU for at least ten years, with recognised efficacy and an acceptable level of safety. Both pathways involve the assessment of mostly bibliographic safety and efficacy data.
According to the EMA, the HMPC focuses on two main tasks to support EU Member States. The first is establishing EU monographs for herbal substances and preparations. The second is drafting an EU list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
The EMA states that EU herbal monographs are distinct from monographs of the European Pharmacopoeia. Those Pharmacopoeia monographs cover the quality requirements for a wide range of substances, including herbal substances and preparations. However, general quality matters are also addressed in scientific guidelines issued by the HMPC.
According to the EMA, companies seeking a traditional use registration for their product can use EU monographs and list entries as reference material for their application. The monographs can also be used by companies seeking a well-established use marketing authorisation. If applicants can demonstrate that their traditional medicinal product complies with the EU list, no further evidence of the safe and traditional use is required.
How does REACH define substances which occur in nature, and what do its Annex V and Article 2(6) cover?
In Regulation (EC) No 1907/2006 (REACH), as published by the corrigendum in OJ L 136 of 29.5.2007, Article 3(39) defines “substances which occur in nature”. The term means a naturally occurring substance as such, either unprocessed or processed only by the means that the definition lists. Those means are manual, mechanical or gravitational means, dissolution in water, flotation, extraction with water, steam distillation, or heating solely to remove water. A naturally occurring substance which is extracted from air by any means also falls within the definition.
In the same text, Article 3(40) defines a “not chemically modified substance” as a substance whose chemical structure remains unchanged. This holds even if the substance has undergone a chemical process or treatment, or a physical mineralogical transformation, for instance to remove impurities.
Commission Regulation (EC) No 987/2008 (OJ L 268 of 9.10.2008) has an Annex II which replaces Annex V of REACH. In that wording, Annex V of REACH is entitled “Exemptions from the obligation to register in accordance with Article 2(7)(b)”. Point 7 of that annex covers the following substances which occur in nature, if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal.
In the Annex V text given by Regulation (EC) No 987/2008, point 8 covers substances which occur in nature other than those listed under paragraph 7, if they are not chemically modified. The point first leaves out (“unless”) a substance which meets the criteria for classification as dangerous according to Directive 67/548/EEC. It also leaves out a substance which is persistent, bioaccumulative and toxic, or very persistent and very bioaccumulative, in accordance with the criteria set out in Annex XIII. Lastly, it leaves out a substance identified in accordance with Article 59(1) at least two years previously as giving rise to an equivalent level of concern as set out in Article 57(f).
Article 58 of Regulation (EC) No 1272/2008 (CLP) orders that REACH be amended from 1 December 2010. Its point 10 provides that, in Annex V, point 8, the words “Directive 67/548/EEC” are to be replaced by “Regulation (EC) No 1272/2008”.
Under Article 2(6) of REACH, as published by the corrigendum in OJ L 136 of 29.5.2007, the provisions of Title IV “shall not apply” to certain “preparations in the finished state, intended for the final user”. Point (a) covers medicinal products within the scope of Regulation (EC) No 726/2004 and Directive 2001/82/EC and as defined in Directive 2001/83/EC. Point (b) covers cosmetic products as defined in Directive 76/768/EEC.
Article 57 of Regulation (EC) No 1272/2008 orders that REACH be amended as from the entry into force of that regulation. Its point 11 provides that the word “preparation” or “preparations”, within the meaning of Article 3(2) of REACH, is to be replaced by “mixture” or “mixtures” respectively throughout the text.
Who answers for a cosmetic product before it reaches the market?
Under Article 4(1) of Regulation (EC) No 1223/2009, only cosmetic products for which a legal or natural person is designated within the Community as “responsible person” are placed on the market. Article 10(1), on the safety assessment, serves to demonstrate that a cosmetic product complies with Article 3. Before placing the product on the market, the responsible person ensures that it has undergone a safety assessment on the basis of the relevant information. The same person ensures that a cosmetic product safety report is set up in accordance with Annex I.
Which lists do the annexes set out?
The annex titles are given below as the stored English text writes them; no entry or limit is reproduced.
| Annex | Title | Fact |
|---|---|---|
| Annex II | “List of substances prohibited in cosmetic products” | |
| Annex III | “List of substances which cosmetic products must not contain except subject to the restrictions laid down” | |
| Annex IV | “List of colorants allowed in cosmetic products” | |
| Annex V of Regulation (EC) No 1223/2009 | “List of preservatives allowed in cosmetic products” | |
| Annex VI | “List of UV filters allowed in cosmetic products” |
How does the ingredient list name perfume and aromatic compositions?
Under Article 19(1)(g) of Regulation (EC) No 1223/2009, the labelling particulars include a list of ingredients. This information may be indicated on the packaging alone. The list is preceded by the term “ingredients”. Perfume and aromatic compositions and their raw materials are referred to by the terms “parfum” or “aroma”.
See also: Essential oil quality control, Toxicology of essential oils, Analytical chemistry of essential oils.
References
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) — https://publications.europa.eu/resource/celex/32009R1223
- Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30/04/2004, p. 34-57) — https://publications.europa.eu/resource/celex/32004L0027
- Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30/04/2004, p. 85-90) — https://publications.europa.eu/resource/celex/32004L0024
- Corrigendum to 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, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 136, 29.5.2007, p. 3) — https://publications.europa.eu/resource/celex/32006R1907R%2801%29
- Commission Regulation (EC) No 987/2008 of 8 October 2008 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V (Official Journal of the European Union L 268, 9.10.2008, p. 14) — https://publications.europa.eu/resource/celex/32008R0987
- 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, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 — https://publications.europa.eu/resource/celex/32008R1272
- European Medicines Agency (EMA), « Herbal medicinal products », web page, consulted 03/11/2026 — https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products