EC Regulation 1223/2009 on cosmetics

Before a cosmetic product can be released on the market, proof must be provided that it is safe for human health during the course of its intended use or what is considered to be reasonable foreseeable conditions of its use. Article 3 of EC Regulation 1223/2009 builds upon Directive 87/357/EEC guidelines regarding the safety of the product in reference to its instructions for use, its disposal and most importantly, its labeling. A safety assessment must be performed and a cosmetic product safety report provided to demonstrate compliance with Article 3. Guidelines for the report are found in the Regulations Annex I.

Under Article 4 of the Regulation, a representative of the manufacturer must be named as the “responsible person” for dealing with compliance with EC 1223/2009. This responsible person is responsible for ensuring that the manufacturer remains in compliance before and after bringing their cosmetic product to market.

In the event the cosmetic product does not meet the requirements of compliance under the Regulation, the responsible person must address those issues. If the manufacturer becomes aware that the cosmetic product presents a threat to human health, the responsible person must notify the competent authorities within each Member State where the product is available. The notification would include details of the risks of using the product, non-compliance issues and what corrective actions will be performed. Corrective actions may include withdrawing the product from the market or initiating product recalls.[2]

Another responsibility of the responsible person is that they must maintain a product information file for each cosmetic product that is put on the market by his or her company under Article 11 of EC 1223/2009. This file must remain accessible by the public and government for at least 10 years after the last batch of the product was placed on the market. The product information file at minimum must contain information and data regarding the description of the cosmetic product, safety reports regarding the product, and evidence that the product performs according to manufacturer claims. Additionally, data about any product testing on animals that may have been performed by the manufacturer, agents of the manufacturer or suppliers must be included in the information file.[2]

Under Article 12 of EC 1223/2009 requires that cosmetic products must be sampled and analyzed in a reliable and reproducible manner. If local Community legislation, as what might be found in a Directive is non-existent, the assumption will be that the manufacturer will rely on methods of harmonized standards that have been published in the Official Journal of the European Union.[1]

The appointed responsible person must supply information to the EU Commission according to the guidelines provided under Article 13 of the Regulation before their cosmetic product can be placed on the market. This information includes the name and category of the product, contact information for the responsible person, the product’s country of origin, and Member State(s) where the product where be sold.[2]

Before placing cosmetic products on the market, the manufacturer must comply with container and packaging labeling guidelines under EC 1223/2009. To comply with the Regulation all required information must be presented in a legible and indelible manner.

Information to be included shall include:

• Name and address of the responsible person and country of origin for imported products
• Weight or volume of cosmetic product 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

Exceptions are made for individual labeling for smaller items that allow for product information to appear as a notice on or nearby the container where the cosmetic product is displayed for sale.[5][6]

The function, amount, precautions, and warnings must be translated into the language of the destination country. A full translation of all label elements is requested by Austria, Bulgaria, France, Poland, Portugal and Slovakia.

Certain product ingredients are prohibited under Chapter IV of EC 1223/2009 based on their threat to human health. The Annexes are lists of chemical substances that are either banned or restricted for use in specific product types or to certain limits in the final product. These are as follows:

Annex II List of substances prohibited in cosmetic products

Annex III List of substances which colour cosmetics should not contain except subject to the restrictions laid down

Annex IV List of colorants allowed in cosmetic products

Annex V List of preservatives allowed in cosmetic products

Annex VI List of UV filter allowed in cosmetic products

Chapter V addresses the prohibition of animal testing with the final formulation of cosmetic products, before being placed on the market and when testing methods are other than the alternative methods that have been validated and adopted by the EU Community.[2][5]