Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of November 30, 2009, on Cosmetic Products will come into force on July 11, 2013, and repeals the Cosmetics Directive Regulation (Directive 76/768/EEC) provisions concerning carcinogenic, mutagenic, or toxic for reproduction (CMR) substances that have applied since December 1, 2010. The European Commission (EC) states that the Cosmetics Directive “until now ensured that products circulate freely whilst guaranteeing a high level of protection for consumers.” The recast of the Cosmetics Directive includes provisions intended to protect consumers’ health and to provide additional information concerning the composition and labeling of products. The Regulation also provides for the assessment of product safety and the prohibition of animal testing. A summary of the recast is available online.
Background — Cosmetic Products
The EC’s summary of the recast states: “Cosmetic products are substances or mixtures of substances intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, etc.) 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 odors.”
Safety
“A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking in account, in particular, of the following”:
- Conformity of presentation with Directive 87/357/EEC;
- Labelling;
- Use and disposal instructions; and
- Additional information as deemed necessary by the “Responsible Person.”
Market Place Compliance and the Responsible Person
A “Responsible Person” established in the Community shall be designated for each product placed on the market. The Responsible Person must be a European Union (EU) legal entity (person or company which is registered in one of the EU Member States and which is subject to EU jurisdiction). The Responsible Person is usually the manufacturer or the EU importer. In particular, the Responsible Person shall ensure compliance with requirements relating to human health, safety, and consumer information. In addition, the Responsible Person shall ensure that a product information file is made accessible to the public authorities and is kept for ten years after the date the last batch of cosmetic product is placed onto the market for each cosmetic product placed on the market. The manufacturer may designate an established member of the community, at written request, to be their Responsible Person and who is required to accept the appointment in writing.
Responsible Person — Obligations
The Responsible Person shall take corrective measures, where necessary, to bring a product placed on the market into conformity, to withdraw it, or to recall the product. Should the cosmetic product present a risk to human health, the Responsible Person shall inform the Competent Authorities of that Member State where the product and information file is available, giving the details of the non-compliance.
Cooperation with the authorities shall be adhered to, especially when faced with non-compliance, to eliminate further potential risk. All documentation requested shall be provided in a language understood by the Competent Authority of that Member State.
Distributor Obligation
When a cosmetic product is made available, the distributor shall act with due care and shall verify that:
- Labelling information is present according to the relevant article in the Regulation text;
- Language requirements are fulfilled; and
- Specification of the date of minimum durability has not passed.
Should the distributor believe that the cosmetic product is not in conformity, it should not make the product available until it confirms conformity with the requirements. In addition, if the distributor believes that a product brought to market and available is not in conformity, it shall take appropriate corrective measures, as necessary. Further, should the cosmetic product pose a risk to human health, the distributor shall inform immediately the Responsible Person and the Competent Authority of the Member State where the product is available.
Free Movement
Free movement of these products in the internal market is permitted if compliance is met with this Regulation. “Member States shall not…refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation.” (Regulation (EC) No. 1223/2009, Chapter II, Article 9.)
Product Information File
Wherever a cosmetic product is placed on the market, the Responsible Person in that Member State shall keep a record of the product information file. The product information file shall contain the following information and be kept up to date:
- Description of said cosmetic product;
- Cosmetic Product Safety Report (Article 10 (1));
- Method of manufacture, including a statement of compliance with Good Manufacturing Practice (GMP);
- Proof of the effect claimed (if applicable) for the cosmetic product; and
- Animal testing data relating to the product development or safety assessment of the cosmetic product or individual ingredients.
The product information file shall be available electronically or another format and in a language understood by the Member State where the product will be available.
Notification
Prior to placing on the market, the Responsible Person shall submit electronically a notification to the EC. The information required in the notification includes:
- Category of cosmetic product;
- Name or names of the cosmetic product for identification purposes;
- Country of origin;
- Member State where the product will be placed;
- Contact details in case of an emergency;
- The presence of nanomaterials;
- IUPAC Chemical Name and Exposure Conditions;
- IUPAC Chemical Name and Exposure Conditions;
- Name and Chemical Abstracts Service (CAS) or EC Number if the substance is CMR of category 1A or 1B;
- Formulation in case of need for appropriate medical treatment; and
- Notification to the EC of a photograph, where possible, of the corresponding packaging.
Products Already Placed on the Market
From July 11, 2013, when a cosmetic product enters the market of more than one Member State, there will be an additional requirement for the distributor to translate any element of the labelling requirement(s) of the cosmetic product to bring it in line with the National Law of that Member State for which it is to be made available. This information, should it be necessary, must be sent electronically to the EC.
Substance Limitation
The Annexes of this Regulation contain a list of prohibited substances (Annex II) or restricted substances (Annex III) with respect to use in cosmetic products. Certain colorants (other than those in Annex IV), preservatives (other than those in Annex V), and UV-filters (other than those in Annex VI) are also prohibited. The Regulation prohibits the use of substances recognized as CMRs, apart from exceptional cases.
Nanomaterials
Under the recast, six months prior to placing a cosmetic product on the market, manufacturers, importers, or certain distributors must notify the EC of nanomaterials in the product, the nanomaterials’ specifications, toxicology and safety data, and reasonably foreseeable exposure conditions. In addition, the label’s list of ingredients must clearly indicate any ingredients in the form of nanomaterials. The recast defines nanomaterial as “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.”
Alternative Methods to Animal Testing
The Regulation prohibits the placing on the EU market of cosmetic products where the final formulation, ingredients or combinations of ingredients, and/or finished products have been the subject of animal testing. Animal testing must be replaced by alternative methods and the EC has established, after consulting the Scientific Committee for Consumer Safety (SCCS), timetables for the deadlines of phasing-out of the various tests. For those tests concerning repeated-dose toxicity, reproductive toxicity, and toxicokinetics, where no alternatives have yet been considered, a derogation on placing on the market until March 11, 2013, is granted. In exceptional circumstances, Member States may request the EC to grant derogation, after consulting the SCCS, if an ingredient in wide use, which cannot be replaced, gives rise to serious concerns.
A derogation shall only be granted where:
- The ingredient is in wide use and cannot be replaced by another ingredient capable of similar function; or
- A specific human health problem is substantiated and the need to complete animal testing is justified and supported by detailed research protocols.
Ultimately, the decision on authorization and the final result shall be part of the Annual Report presented by the EC in accordance with Article 35 of the Regulation.
Consumer Information
Product labelling contributes to consumer protection. Containers or packaging must bear written information in indelible, easily legible, and visible lettering. This information concerns:
- Name or registered name and address of the responsible person;
- Country of origin for imported products;
- Weight or volume of content at the time of packaging;
- Use-by date for products kept in appropriate conditions;
- Precautions for use, including for cosmetics for professional use;
- Function of the cosmetic product, unless clear in its presentation;
- Batch number of manufacture or the reference for identifying the cosmetic product; and
- List of ingredients, i.e., any substance or mixture intentionally used in the product during the process of manufacturing.
Additional Information
The EC has a number of materials on its website concerning the recast Cosmetics Directive. A summary of the recast is available online, and frequently asked questions are available online. Additional materials are available online.