EC Regulation 1223/2009 on cosmetics

The objective of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 is to establish standards for cosmetic products that are available on the market. Compliance to these standards help ensure the functioning of the internal market, but more importantly, a high-level of protection for the health and safety of citizens of the European Union.

Regulation (EC) No 1223/2009 supersedes previous Directives that applied to cosmetic manufacturers. All member states are required to abide by the guidelines set by the Regulation as of its effective date.

Safety and Responsibility

Article 3 of EC No 1223/2009 states that before releasing a cosmetic product on the market, the cosmetic product must be safe for human health during its intended use or what would be considered reasonably foreseeable conditions of its use. Factors that would support the safety of the product would include its presentation in regards to Directive 87/357/EEC, its labelling, and its instructions for use and disposal. Furthermore, information that is supplied through the named manufacturer’s representative, referred to as the “responsible person” under Article 4 of the Regulation is also taken into consideration.

The responsible person is charged with the obligation of ensuring that the cosmetic product is in compliance with the standards laid out in EC No 1223/2009. If for any reason a cosmetic product is found to present a threat to human health, the responsible person must immediately notify competent national authorities within each of the Member States where the product has been made available. Included in this notification would be the details of the risks of using the product, issues of non-compliance to the Regulation, and what corrective measures will be taken.

Before placing a cosmetic product on the market, the responsible person must demonstrate compliance with Article 3. This is accomplished through the performance of a safety assessment that is based on the product’s relevant information and providing a cosmetic product safety report that is in accordance with Annex I of the EC No 1223/2009.

Maintaining a Product Information File

Article 11 of the Regulation stipulates that the responsible person must keep a product information file for each cosmetic product that is placed on the market. This file must be kept on file for at least 10 years after the last batch of the cosmetic product was put on the market. The product information file shall consider of information and data regarding the:

Description of the cosmetic product
Safety report for the cosmetic product
Proof of the effect that the cosmetic product claims to do
Data on animal testing that has been performed by the manufacturer or any agents or suppliers

Access to the product information file must be made readily accessible by the responsible person in electronic or other formats via the address provided on the product’s label to the authority of the Member State where the file is stored.

Sampling and Analysis of Cosmetic Products

Article 12 of Regulation 1223/2009 stipulates that cosmetics be sampled and analyzed in manner that is reliable and reproducible. When local Community legislation regarding sampling and analysis is non-existent, it will be presumed that the manufacturer will use methods of harmonized standards that have been published in the Official Journal of the European Union.

Notification of the EU Commission

Before a cosmetic product can be placed on the market, the responsible person must follow the guidelines given under Article 13 of Regulation 1223/2009 for supplying information to the Commission including:

Identifiable name and category of the product
Name and address of the responsible person who can provide the product’s information file
Country of origin if the cosmetic product is imported
Member State(s) where the product will be placed on the market
Contact information for a physical person in the event contact is necessary
Ingredient information, including presence on nanomaterials and information pertaining to Chemicals Abstracts Service (CAS) for ingredients classified as carcinogenic or toxic.

Restrictions for Certain Substances

Chapter IV of Regulation 1223/2009 states that cosmetic products shall not contain:

Prohibited substances that are listed in Annex II
Restricted substances listed in Annex III
Any colorants than those listed in Annex IV
Preservatives other than those listed in Annex V
UV-filters other than listed in Annex VI

Chapter V refers to the prohibition of animal testing of the final formulation of cosmetics to be placed on the market using methods other than alternative methods that have been validated and adopted by the EU community.

Requirement for Labelling Cosmetic Products

Cosmetic products may only be made available on the market if their container and packaging meet the guidelines for providing information to the consumer. The law of the Member States where the cosmetic product is made available to consumers will determine the language that the required labeling information will need to be provided in.

The following information must be presented in a legible format, with visible lettering and of an indelible nature:

Name and address of the responsible person and country of origin for imported products
Weight or volume of cosmetics at time of packaging
Expiration date of product when stored under appropriate conditions
Precautions to be followed in the use of the cosmetic product
Identifying batch number for the manufacture of the product
Explanation of the function of the cosmetic product if its use is unclear
Ingredients listed in descending order of the weight of each when added to the product; ingredients that are present in concentrations of less than 1% can be listed in any order after the main ingredients

When it is impractical or impossible to print this required information on the container or packaging of the cosmetic product, the information may be supplied via attached leaflet, tag, card or label. In instances, such as with soaps, bath balls or other small cosmetics, this information is required to appear on a notice on or in immediate proximity to the container where said cosmetics are presented for sale.

Consequences of Non-Compliance

The named responsible person is charged with the responsibility of taking all appropriate measures to ensure that the cosmetic product complies with the standards provided under Regulation 1223/2009. When a product has been found to be in non-compliance, the competent authorities will require the responsible person to take corrective actions to bring the cosmetic product to conformity, withdraw the product from the market, or recall the product within a prescribed time limit that will commensurate with level of risk to the health and safety of the public. The responsible person is required to report the measures that he or she has taken in efforts to remedy non-compliance issues.

In circumstances where non-compliance is not remedied, the competent authority shall inform the competent authority of the Member State from which the responsible person is established. If the competent authority has reasonable grounds for concern or ascertains that a cosmetic product is a serious risk to human health, they shall move forward instituting appropriate provisional measures to withdraw, recall or restrict the availability of the product.