NEW COSMETIC PRODUCT.
FORMULATION, PRODUCTION AND PLACING ON THE MARKET
Legal framework
The EU Cosmetics Regulation governs how cosmetics and personal care products are made and placed on the market. It is a very comprehensive set of laws, requiring cosmetics to be safe for human health when applied under normal or reasonably foreseeable conditions of use.
Regulation 1223/2009 on cosmetic products is the main regulatory framework for finished cosmetic products when produced and placed on the EU market. It strengthens the safety of cosmetic products and streamlines the framework for all operators in the sector. Regulation 1223/2009 has general application, it is binding in its entirety and directly applicable in all Member States.
Alongside the EU legal framework, each Member State has its own national legislation that transposes certain requirements of EU legal acts. The main Bulgarian legal acts that set issues for cosmetic production and trade are Health act, Ordinance 14/ 28.07.2014 laying down rules for the application of art.19, par. 4 of Regulation 1223/2009 on cosmetic products. There are also a great variety of legal acts that should be taken into account when cosmetics are produced or traded in Bulgaria.
Regulation 1223/2009 comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health. Another important EU legal act is Regulation 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products.
Legal definitions:
- “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;
- “manufacturer” means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;
- “distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;
- “importer” means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;
- „preservatives” means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product;
- „colourants” means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain part thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colourants shall be deemed colourants;
- „UV-filters” means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation;
- „nanomaterial” means 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.
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.
For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in Regulation 1223/2009.
Good manufacturing practice (GMP)
The manufacture of cosmetic products shall comply with Good manufacturing practice (GMP) with a view to ensuring the objectives of Article 1, Regulation 1223/2009.
Compliance with good manufacturing practice shall be presumed where the manufacturer is in accordance with the relevant harmonised standards – ISO 22716:2007. Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices.
Labelling
Cosmetic products shall be made available on the market only if the container and packaging of cosmetic products bear an information in indelible, easily legible and visible lettering.
Transparency is needed regarding the ingredients used in cosmetic products. Such transparency should be achieved by an indication of the ingredients used in a cosmetic product on its packaging. Where for practical reasons it is impossible to indicate the ingredients on the packaging, such information should be enclosed so that the consumer has access to this information.
In order to inform consumers, cosmetic products should bear precise and easily understandable indications concerning their durability for use. Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability, i.e. the date by which it is best to use the product. Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer. However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open.
Product claims
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.
The Commission shall, in cooperation with the Member States, establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use of a claim.
Safety assessment of cosmetic products
In order to demonstrate that a cosmetic product complies with Article 3 to Regulation 1223/2009, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I to Regulation 1223/2009.
The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.
Product information file (PIF)
When a cosmetic product is placed on the market, the responsible person shall keep a Product information file (PIF) for it. The Product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.
The product information file shall contain the following information and data which shall be updated as necessary:
- a description of the cosmetic product which enables the Product information file to be clearly attributed to the cosmetic product;
- the cosmetic product safety report referred to in Article 10(1) to Regulation 1223/2009;
- a description of the method of manufacturing and a statement on compliance with Good manufacturing practice referred to in Article 8 to Regulation 1223/2009;
- where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;
- data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.
- The responsible person shall make the Product information file readily accessible in an electronic or another format at his address indicated on the label to the competent authority of the Member State in which the file is kept.
- The information contained in the Product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.
Notification of cosmetic product
Prior to placing the cosmetic product on the market the responsible person and, under certain circumstances, the distributor of a cosmetic product shall notify, by electronic means, the Commission about the product.
Notification is done through Cosmetic Products Notification Portal (CPNP). CPNP is free of charge online notification system created for the implementation of Regulation (EC) 1223/2009 on cosmetic products. When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.
The CPNP is not open to the public. Information submitted to the CPNP is made available through the portal only to the relevant Competent Authorities (enabling market surveillance, analysis and evaluation, as well as to safeguard against the grey market or counterfeit products) and to Poison Control Centers (for medical treatment and consumer safety purposes).
It is important to note that the fact that a product has been successfully notified through the CPNP does not necessarily mean that the product in question fulfils all the requirements of the Regulation (EC) 1223/2009 on cosmetic products.
CPNP reference number
CPNP reference is a unique number generated for each successfully notified cosmetic product.
This number should be given to the competent controlling bodies (for Bulgarian that is Regional Health Inspection) and the customs.
Health certificate
Health certificate is issued by Ministry of Health. With this document, the Ministry states that certain cosmetic product is duly produced according to the requirements of Regulation 1223/2009 and the product is or shall be placed on the EU market.