All cosmetics marketed with the European Union are regulated under Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
Cosmetics are regulated differently across the globe. The EU cosmetic regulation is the ‘golden standard’ of cosmetic regulations, from which many other global cosmetic regulations take inspiration from. The regulation was brought into force to maintain a high level of consumer protection, it does so by forty (40) articles. On this page we have outlined the seven (7) most important articles from the regulation, providing you with a concise snippet of what the regulation is about. We cover product safety, who’s responsible, animal testing, cosmetic product labelling, notification and cosmetic claims.
What is a Regulation?
A regulation is a binding legislative act. It is mandatory that entities concerned by any regulation strictly abide by the rules set out by the legislation. Regulations state what the goal is and provide structure for achieving the goals for all entities in a standardised way. This minimises confusion and allows for a clearer monitoring of the market/sector.
A directive is not a regulation. A directive is a legislative act which sets out a goal for entities concerned to achieve. The ways in which the needs of a directive are met are left to the entities concerned themselves to decide upon, therefore, multiple methods may be implemented by different entities to achieve the same end goal set out by the directive.
Legislation relating to cosmetics today comes in the form of regulation, not a directive. However, this has only been a somewhat recent change to help manage the cosmetics market more effectively.
Do you want to learn more about regulations including other cosmetic regulations? Click the button to our ‘Cosmetic Regulatory & Safety‘ articles
EU Cosmetic Regulation
All cosmetics marketed with the European Union are regulated under Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. All member states part of the European Union are obligated by law to conform with this regulation.
The main scope of the regulation is to ensure a high level of consumer protection. It concerns all products which fall under the definition of a cosmetic product (any substance or mixture intended to be placed on the human body to deliver cosmetic benefits). The regulation is written, reviewed and updated by the European Commision. The European Commision is responsible for implementing and maintaining all legislative acts.
Regulation No 1223/2009 on cosmetic products replaced Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products. The transition from directive to regulation standardised the approach for cosmetic product legislation.
UK Cosmetic Regulation
In the UK cosmetics are regulated under The Product Safety and Metrology etc. (Amendment etc). (EU Exit) Regulations 2019.
This regulation was formed due to Brexit (the withdrawal of the United Kingdom from the European Union), when the UK had to establish their own regulations as they left the authority of the European Commission. By large, the UK remained in-line with the EU cosmetic regulation by simply adopting Regulation 1223/2009 and amending it as required. Since January 2020 the UK’s cosmetic regulation has diverged from the EU’s as the EU cosmetic regulation continued to update their annexes, leaving the UK behind.
What are the Regulations about Cosmetics?
The EU Cosmetic Regulation regulates all aspects of cosmetic products to ensure consumer protection in terms of safety, informed decision making and information made available to the public.
The main articles regarding consumer protection are:
- Article 3 – Safety
- Article 4 – Responsible Person
- Article 10 – Safety Assessment
- Article 14 – Restrictions for Substances Listed in the Annexes
- Article 18 – Animal Testing
- Article 19 – Labelling
- Article 20 – Product Claims
These main articles listed in Regulation EC No. 1223/2009 outline the safety standards, how the safety of a cosmetic product is established, who is responsible for the safety and branding of the products, as well as what ingredients are/aren’t permitted, guidance on animal testing, labelling and product claims.
The cosmetic regulation also contains ten (10) annexes, most notably annexes two to six (2 – 6) which provide negative and positive lists for ingredients prohibited, restricted and allowed in cosmetic products.
Other Regulations Concerning Cosmetics
Other more general regulations are also applicable to cosmetics (especially cosmetic ingredients) such as 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 (CLP Regulation) and 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 Regulation). These are chemical regulations which are applicable to any chemical based product including cosmetics.
These regulations are managed by an agency of the European Union called European Chemicals Agency (ECHA)
Article 3 - Safety
All cosmetic products must be safe for human health when used under normal and reasonably foreseeable conditions of use; taking into account labelling, instructions for use and branding. The safety of each product is ensured by an individual safety assessment carried out by a qualified toxicologist.
The safety of each cosmetic product is determined by a safety assessment outlined in article ten (10). Annex I of the cosmetic regulation outlines the requirements for a cosmetic products safety report (CPSR).
Article 4 - Responsible Person
Each cosmetic product must have a designated ‘responsible person’. A responsible person is a business or agency which takes on the responsibilities of placing the product on the market. They are in charge of ensuring product compliance in terms of safety, labelling, advertising and administration. If anything was to go wrong, or local competent authorities questioned the compliance of a product, the responsible person (RP) would be contacted.
The responsible person can be the manufacturer, distributor, importer or a third party organisation (RP service consultancy). The responsible person will be indicated on the labelling of each product by an EU address.
The responsible person (RP) is tasked with compiling and keeping on file a product information file (PIF), with all relevant product information. This includes the product cosmetic product safety report, manufacturing method, animal testing information, claims substantiation and data on raw materials used. More information on the product information file (PIF) is outlined in article eleven (11).
Article 10 - Safety Assessment
A safety assessment carried out by a qualified toxicologist acts as proof of product safety. Each cosmetic should hold a unique safety assessment in their product information file (PIF). Annex I of the cosmetic regulation lays out the format for all safety assessments. A safety assessment is often referred to as a cosmetic product safety report (CPSR). The safety report is made up of two parts (part A & part B).
Part A contains cosmetic product safety information, including;
- Quantitative and qualitative composition of the cosmetic product.
- Physical/chemical characteristics and stability of the cosmetic product.
- Microbiological quality.
- Impurities, traces, information about the packaging material.
- Normal and reasonably foreseeable use.
- Exposure to the cosmetic product.
- Exposure to the substances.
- Toxicological profile of the substances.
- Undesirable effects and serious undesirable effects.
- Information on the cosmetic product.
Part B contains cosmetic product safety assessment, including;
- Assessment conclusion.
- Labelled warnings and instructions of use.
- Reasoning.
- Assessor’s credentials and approval of part B.
Article 13 - Notification
All cosmetic products must be notified through an online portal Cosmetic Products Notification Portal (CPNP) to the EU Commission.
The following information is required to notify a cosmetic product:
- Product name & identifiers.
- Product category.
- Name and address of responsible person (RP).
- Country of origin.
- Regions of sale.
- Responsible person contact details.
- Presence of nanomaterial substances.
- Names and chemicals abstract services (CAS) or EC numbers of substances classified as carcinogenic, mutagenic or reprotoxic (CMR).
- Frame formulation of product.
- Product labelling.
Article 14 - Restrictions for Substances Listed in the Annexes
To ensure consumer safety, the regulation lists prohibited and restricted substances. It also lists colourants, preservatives and UV-filters allowed in cosmetics. If a cosmetic contains a substance classified as a colourant, preservative or UV-filter but is not listed in the annexes, it is not permitted.
The Scientific Committee on Consumer Safety (SCCS) is consulted when ingredients are added to the annexes. This is frequently reviewed and maintained.
The annexes which list the restrictions on substances are:
- 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 Colourants Allowed in Cosmetic Products
- Annex V – List of Preservatives Allowed in Cosmetic Products
- Annex VI – List of UV Filters Allowed in Cosmetic Products
Article 18 - Animal Testing
Cosmetic products and their ingredients are prohibited to be tested on animals when there is a suitable non-animal testing alternative method established by the Organisation for Economic Co-operation and Development (OECD).
The process of implementation of non-animal testing (on both ingredients and final products), when alternative methods are available was 11th March 2009.
Repeat-dose toxicity, reproductive toxicity and toxicokinetic studies for which there are no alternatives to animal testing were permitted until the implementation date of 11th March 2013. Any updates on animal testing are provided under Article thirty-five (35) ‘Annual Report on Animal Testing’.
Existing cosmetic ingredients (but not finished products) can be tested on animals if they arise serious concerns regarding the safety of the ingredient. A Member State (country in the EU) may request a derogation (exemption) from animal testing from the Commision. The derogation may be granted after the Commission consults the Scientific Committee on Consumer Safety (SCCS).
Article 19 - Labelling
Cosmetics must be labelled in accordance with the cosmetic regulation. The legislation sets out the labelling requirements for every product to be placed on the EU market. There are seven labelling requirements outlined in the cosmetic regulation. It is also important to consider legibility, minimum font sizes, claims, logos and barcodes when labelling cosmetic products.
Labelling requirements for products sold in the European Union:
- Name & address of responsible person & country of origin.
- Nominal content given by weight or volume.
- Durability – typically expressed as period after opening (PAO).
- Precautions.
- Batch number or reference for identification.
- Function of cosmetics, unless the function is clear from presentation.
- A list of ingredients following the international nomenclature of cosmetic ingredients (INCI) system.
The international nomenclature of cosmetic ingredient (INCI) names can be found in the Commision implementing decision (EU) 2022/67 of 31 March 2022 laying down rules of the application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards to the glossary of common ingredient names for use in labelling of cosmetic products. INCI names can also be found through an online search portal COSING – Cosmetic Ingredients.
As with every rule, there are exceptions. Some smaller or niche products are exempt from some aspects of product labelling, we will cover these in a future article which goes more in-depth into the labelling of consumer goods.
Article 20 - Product Claims
Cosmetics, like any other products on the EU market, shall not be misbranded, misrepresented or misleading. A claim is regarded as any text, name, trademark, picture/diagram/illustration, logo or other features which explicitly or implicitly speaks about the product’s nature. These claims are regulated the same regardless of what marketing tools are used, whether the product claim is on the packaging, advertised on a commercial or through social media.
The European Commission has published a separate regulation entitled Commission Regulation (EU) No 655/2013 laying down the common criteria for the justification of claims used in relation to cosmetic products which helps in the decision making of classifying claims as compliant or noncompliant and deciding what substantiation is required for each claim.
The common criteria of cosmetic claims is listed in six main sections:
- Legal compliance.
- Truthfulness.
- Evidential support.
- Honesty.
- Fairness.
- Informed decision making.
The criteria talk about how every claim must be legally compliant and not denigrate other products on the market. The claims must not be misleading and provide the benefits the product claims to have, these benefits must also be adequately substantiated through forms of testing or literary review. The claims must also be fair to other brands on the market, making them easily understandable to the end consumer.
