REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products
With this article, we will take a detailed look together at what the European Cosmetics Regulation (EC) No. 1223/2009 consists of, what its main purpose is, and what the most important points are.
FOR WHICH EUROPEAN STATES IS THE COSMETICS REGULATION VALID
This regulation is valid for all 27 countries that are part of Europe and came into force on July 11, 2013. Following Brexit, England drafted its own regulation, Regulation 2009/1223 and the Cosmetic Products Enforcement Regulations 2013: Great Britain, to date very similar to the European regulation.
WHAT DOES COSMETICS REGULATION CONSIST OF
Cosmetics regulation is the “appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States”. The rules of the regulation must be met by all brands selling their cosmetics in the European territory, otherwise the products are considered as non-compliant.
WHAT IS ITS PURPOSE
The ultimate purpose of the regulation is to regulate the cosmetics market and ensure the protection of human health at an appropriate level. “This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health”. Thus, the regulation harmonizes the market and establishes a high safety of cosmetics for all states for which it is valid.
DEFINITION OF COSMETIC PRODUCT
From the regulation, “cosmetic product” means “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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 odours”.
WHICH COSMETIC PRODUCTS ARE SUBJECT TO THE REGULATION
All cosmetics placed on the European market, by which is meant also samples not subject to sale, must be in line and compliant with the regulation, thus safe under normal or reasonably foreseeable conditions of use.
THE MAIN POINTS OF THE REGULATION
Let us briefly review the main articles of the regulation, namely:
- Article 4, Article 5: Role and obligations of the Responsible Person;
- Article 11: Content of the PIF;
- Article 13: Cosmetic Product Notification;
- Article 19, Article 20 (and COMMISSION REGULATION (EU) No 655/2013): Mandatory elements to be included on the label and how to express claims (marketing communications);
- Annex I: What must be included in the CPSR.
CHAPTER II SAFETY, RESPONSIBILITY, FREE MOVEMENT
Article 4 Responsible Person
“Only cosmetic products for which a legal or natural person is designated within the Community as ‘Responsible Person’ shall be placed on the market”. This is the Responsible Person also called Legal Representation and must be based in Europe.
Only cosmetic products are placed on the market for which a natural or legal person has been designated by written mandate as the “Responsible Person” within the Community.
For each cosmetic product placed on the market, the Responsible Person must ensure compliance with the obligations under these Regulations. The Responsible Person’s address must appear on the label of the cosmetic product for which he or she is responsible.
Article 5 Obligations of Responsible Persons
The Responsible Person is responsible for the compliance of the cosmetic product for which have been designated for this role. If the product is non-compliant, the Responsible Person must immediately take necessary corrective measures (make it compliant, withdraw it or recall it).
“Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken”.
The Responsible Person must therefore cooperate with the competent authorities, and in the event of an inspection, provide all requested documents and information “in a language that can be easily understood by the authority.”
Here more information on the role of the Responsible Person and how Biorius can help.
CHAPTER III SAFETY ASSESSMENT, PRODUCTINFORMATION FILE, NOTIFICATION
Article 11 Product Information File
The Cosmetic Product Information File, abbreviated as PIF is a very structured dossier that contains all the information about a particular cosmetic product. Here more information about which documents the PIF must imperatively include. Please note that the Cosmetic Product Safety Report CPSR, or Safety Assessment, is included in the PIF.
Article 13 Notification
Regulation (EC) No 1223/2009 stipulates that all cosmetic products that will be placed on the market in the European Union must be notified to the CPNP Cosmetic Product Notification Portal, prior to being placed on the market. The notification can be performed by the Responsible Person or by a regulatory consultant such as Biorius.
CHAPTER VI CONSUMER INFORMATION
Article 19 Labelling
Labelling requirements for cosmetics in the EU, such as the name or company name and address of the Responsible Person, the nominal content at the time of packaging, the “date of minimum durability” or PAO Period After Opening, etc., are listed in this article and summarized at our blog article.
In addition, some states require full translation into official languages. There are, moreover, some states’ own national requirements that must be met, such as recent EPR and recycling instruction requirements.
Article 20 Product claims
Beware with the use of advertising, claims and images used: “in the labelling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have”. In addition, regarding the claims that may be used, a list of common criteria has been adopted.
COMMON CRITERIA AND REGULATION (EU) No 655/2013
According to Annex I “Common Criteria” of COMMISSION REGULATION (EU) No. 655/2013 of July 10 2013 laying down common criteria for the justification of claims used in relation to cosmetic products, cosmetic products and claims must meet the following requirements:
- Conformity to standards
- Evidentiary support
- Informed decisions
More information can be found here.
THE ANNEXES OF REGULATION (EC) No. 1223/2009
Following on from these articles, the Regulation also stipulates several annexes.
Annex I includes more information on the Cosmetic Product Safety Report listing in detail all the documents it must contain. In English, the CPSR is a synonym of Safety Assessment.
At the following link you will find our article on the CPSR.
As we could see in this article, the purpose of Cosmetic Regulation is to regulate the market and protect the consumer.
In addition, since the regulation is an ever-changing and amending document, it is important to rely on a regulatory consultant who can keep you up-to-date and compliant your products.
For any information, please do not hesitate to contact us.