Regulations - A new framework

On 22 December 2009 a new regulatory framework for cosmetics ^[1] was published in the Official Journal of the European Union and entered into force 20 days later, on 11 January 2010.

Regulation (EC) No 1223/2009, of the European Parliament and of the Council on cosmetic products is a recast of Council Directive 76/768/EEC, the Cosmetics Directive^[2] which will be repealed on 11 July 2013. The key goals for the recast were to simplify the rules and the procedures whilst ensuring a higher level of consumer protection.

The previous Directive, which had been in place since 1976, had become an incoherent patchwork due to numerous amendments and adaptations. This in addition to the 27 different national frameworks which were created as a result of the required translation into national legislation for the EU member states, paved the way for simplification.

Contrary to a directive, a regulation becomes immediately enforceable as law in all EU Member States. As such the new Regulation represents a common European code of law that is clearly structured into 40 articles and 9 annexes, and applies in all 27 EU Member States and the States of the European Economic Area (EEA).

A recast however is a legal technique based on the EU treaties where the provisions of a directive are conversed into a regulation, and with this, significant amendments are made to all provisions of the earlier act^[3]. With the new Cosmetics Regulation changes have been introduced concerning various organisational structures, ingredient provisions and higher safety standards.

The role of the ‘responsible person’ was created. The responsible person has to ensure compliance with all relevant obligations set out in the Regulation. Amongst the obligations, it is the ‘responsible person’s’ duty to notify the competent authorities about serious undesirable effects, such as adverse reactions to cosmetic products that leave a temporary or permanent functional incapacity, and this information will be communicated to all member states.

Higher safety standards have also been addressed by strengthening in-market control and performing appropriate checks on products and sales channels. In addition controls of manufacturing sites will target compliance with good practice principles. Member States are also now requested to provide the market surveillance authorities with the necessary resources and knowledge.

Changes on provisions for substances focus mainly on two product classes; nanomaterials and CMRs. For nanomaterials, labelling and notification provisions were extended so cosmetic products containing nanomaterials need to be notified six months prior to their marketing. Also in the list of ingredients all nanomaterials have to be clearly indicated by adding the word ‘nano’ (in brackets).

New provisions also apply to the use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) according to the classification criteria given in Regulation (EC) No 1272/2008 (CLP).^[4] CMRs of category 2 may be used in cosmetic products if the substance has been evaluated by the SCCS (Scientific Committee on Consumer Safety) and was found safe for use. Category 1A and 1B CMR substances are prohibited for use in cosmetic products, however it may be granted by way of exception under certain preconditions.

A central function for assuring the safety of cosmetic products is assigned to the safety assessment. While the Cosmetics Directive did require an assessment and its documentation in information files, there was no specific requirement in terms of performance and of the necessary database. With the new Regulation requirements have been laid down in a written format with a systematic outline. Product safety information and product safety assessment must form part of a Product Information File (PIF), together with a description of the cosmetic product, the method of manufacturing, a statement on compliance with good manufacturing practice, proof of the claimed effects and data on any animal testing performed.

The PIF then has to be kept for a period of ten years following the date when the last product batch was placed on the market. Compliance with these safety requirements is a challenge per se. Further complicating this is the fact that toxicity studies are invariably requested for the safety assessment. It is therefore important to be aware that the provisions on the animal testing ban according to the 7th Amendment to the Cosmetics Directive and the respective deadlines specified on 1 October 2004^[5] have been fully resumed for the Regulation.

In line with the new legal format that represents a common European code of law, the notification provisions have also been harmonised and a central electronic platform will be created. This new notification platform will replace all existing national notification procedures. The information from notification of products will be communicated to the national competent authorities of all EU member states where it may be used for in-market surveillance, market analysis, evaluation and consumer information. The information will also be provided to poison centres or similar bodies, where it will be used as background on appropriate medical treatments in the case of adverse reactions.

The majority of the provision for the new Regulation will apply as of 11 July 2013, but different deadlines apply for the two cases of rules for substance classes as mentioned above. As such, the provisions on use of substances classified as CMR will apply from 1 December 2010, whereas the notification provisions for nanomaterials will apply from 11 January 2013. During transitional periods cosmetic products that already comply with the new Regulation may be marketed. Notifications performed according to Article 13 of the Regulation will be compliant from 11 January 2012.

Contact
CONUSBAT, Aachen, Germany
info@conusbat.com

References
1. Regulation (EC) No 1223/2009 on cosmetic products (recast)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF

2. Council Directive 76/768/EEC - Cosmetics Directive
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20080424:en:PDF

3. EU Council Statement 12682/09 ADD 1 REV 1
http://register.consilium.europa.eu/pdf/en/09/st12/st12682-ad01re01.en09.pdf

4. Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP)
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:353:0001:1355:EN:PDF

5. Timetables for the phasing-out of animal testing - 7th Amendment to the Cosmetics Directive
http://ec.europa.eu/enterprise/sectors/cosmetics/files/doc/antest/sec_2004_1210_en.pdf