The legal framework for regulating chemicals in the EU is Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). REACH came into force on 1 June 2007.
REACH requires registration of chemical substances that are manufactured or imported into the EU in quantities of 1 Tonnes per Annum (TPA) or more, unless the substance is exempted from the scope of registration. This applies to substances on their own, in mixtures, or in articles when the chemicals are intended to be released under normal or reasonably foreseeable conditions of use of the article. Registered substances can in principle circulate freely on the internal market.
Cosmetics Directive - The Directive 76/768/EC has been governing the composition, labelling and packaging of ﬁnished cosmetic products in the European Union since 1976 and is now replaced by the Cosmetics Regulation (EC) 1223/2009.
Cosmetics Regulation - Regulation (EC) 1223/2009, on cosmetic products, entered into force on 11 January 2010. From 11 July 2013, it completely replaced Directive 76/768/EEC, on the approximation of the laws of the Member States relating to cosmetic products. Being common to all Member States, the Regulation sought to address the remaining gaps among national transpositions of the Directive and to streamline procedures.
This law was created to establish standards for cosmetic products that would be applicable in the EU-27 and 4 EFTA countries: Norway, Switzerland, Lichtenstein, and Iceland.
Regulation (EC) 1223/2009 on cosmetic products covers cosmetics defined as:
Regulation (EU) 655/2013 is provided in Regulation (EC) 1223/2009, and therefore covers claims made in relation to cosmetics according to the same definition.
Main requirements under Regulation (CE) 1223/2009
Obligations under the regulation fall on a Responsible Person (RP), who must ensure compliance. The RP must be established within the European Union (must be a natural or legal person within the Union).
Thus, RPs have obligations in relation to the product itself (including labelling and claims) and relative to market placement notification and follow-up.
Products available on the market must be safe for human health when used under normal or reasonably foreseeable conditions of use.
To this end, RPs must comply with the ingredient obligations set out in the Regulation, as set out in its annexes (which are regularly updated)
Good manufacturing practice
Cosmetic products must be manufactured in accordance with the ISO 22716 standard (or any other equivalent standard). This is self-certified, but third-party certification is possible.
Labelling and claims
Labelling in the container and packaging must include the following information
Where it is impossible to include the precautions and ingredients in the label, they must be included in an attached leaflet, label, tape, tag or card.
The language of the information (except the product name, ingredients and batch number) is determined by national legislation.
Claims must comply with Regulation (EU) 655/2013, which establishes common criteria for claims. These must be :
Claims referring to the fact that no animal testing has been carried out may only be done if no animal testing has been used to develop the finished cosmetic product, its prototype, or its ingredients.
Under Regulation (EC) 1223/2009, a RP must compile information relevant to the product in a Product Information File (PIF), notify Competent Authorities when placing said product on the market, and develop a system to monitor and report on undesirable effects. A list of Competent Authorities for every Member State may be found here.
The Product Information File
The Product Information File is the key document needed before placing a product on the European market since it serves as evidence that the product is compliant to the Regulation. It gathers technical documents related to the finished product and its raw material for a Safety Assessor to perform a thorough analysis. The PIF is divided into 6 sections:
The PIF must be kept by the RP for 10 years after the date of the last batch of the cosmetic product was placed on the market. The PIF shall be available to the Competent Authorities of the Member State where it is kept.
Notification on the CPNP
Prior to placing a product on the market, the following information must be submitted by the RP to the European Commission, using the Commission’s Cosmetic Products Notification Portal (CPNP) :
In the case of serious undesirable effects, the RP and distributors must notify the Competent Authority of the Member State where the effect occurred, providing the following information:
A list of Competent Authorities for every Member State may be found here
The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure proper application and due enforcement of this Regulation and shall transmit to each other, all information necessary with a view to applying this Regulation uniformly.
The Cosmetic Products Notiﬁcation Portal (CPNP) is a free of charge online notiﬁcation system created for the implementation of Regulation (EC) No 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 accessible to :
The term ‘manufacturer’ has a wide definition under the cosmetics legislation and includes the entity which has a product designed or manufactured, and markets the cosmetic product under its name or trademark. Therefore, unless it has explicitly been mandated as such in writing, a contract manufacturer / filler will normally not be considered as the Responsible Person as it is providing services for a third party and not in its own name.
It is the responsibility of the Responsible Person (RP) to ensure that every product placed on the EU market complies with the requirements of the Cosmetics Regulation (EC) 1223/2009. The RP's duties relate to all aspects regulated under the EU cosmetics legislation:
Regulation (EC) No. 1223/2009 Article 8 establishes ISO 22716 or equivalent as the requirements for good manufacturing practice (GMP).
ISO 22716 is the GMP standard and provides organisational and technical guidance on the management of the human, technical and administrative factors affecting cosmetic product manufacture and product quality.
The documentation system implemented should incorporate the following (this list is not exhaustive):
Animal Testing Prohibited :
The Cosmetics Directive provides the regulatory framework for the phasing out of animal testing for cosmetics purposes. Speciﬁcally, it establishes:
Responsible person has an obligation to communicate within supply chain on behalf of EU manufacturer and importer. Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.
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.
Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of speciﬁc aspects of the product, in a language which can be easily understood by that authority.
GPC can :