New Cosmetic Products Regulation

On 30 November 2009, the new cosmetics products regulation was adopted, EU Regulation 1223/2009, replacing the Cosmetics Directive. With the new Cosmetics Regulation Europe is having a robust, internationally recognised regime, which reinforces product safety taking into consideration the latest technological developments, including the possible use of nanomaterials.

Most of the provisions of this new regulation will be applicable as from 11 July 2013. The ban and the strict regime aiming at phasing out animal testing were not modified.

In view of the above kindly submit any comments to Audrey Anne Anastasi on fax: 21 242406. For more information contact 23952000.

Document can be downloaded from MSA's Cosmetics web page: www.msa.org.mt/rad/cosmetics/consultations/2010/Ongoing/

Introduction

Council Directive 76/768/EEC relating to cosmetic products, transposed to national legislation by Legal Notice 424 of 2004 (as amended), has been significantly amended on several occasions. Since further amendments are to be made, in this particular case it should be recast as one single text in the interests of clarity. A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Community.

This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. This Regulation 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.

The environmental concerns that substances used in cosmetic products may raise are considered through the application of 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) and establishing a European Chemicals Agency, which enables the assessment of environmental safety in a cross-sectoral manner.

Who's responsible?

The presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs, in accordance with Council Directive 87/357/EEC concerning products which, appearing to be other than they are, endanger the health or safety of consumers. In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community.

An efficient traceability system facilitates market surveillance authorities' task of tracing economic operators.

It is necessary to determine under which conditions a distributor is to be considered as the responsible person. All legal or natural persons in the wholesale trade as well as retailers selling directly to the consumer are covered by reference to the distributor. The obligations of the distributor should therefore be adapted to the respective role and part of the activity of each of these operators.

To ensure their safety, cosmetic products placed on the market should be produced according to good manufacturing practice. For the purpose of effective market surveillance, a product information file (PIF) should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located. The

PIF shall be made available in at least one of the following languages: Maltese, English, Italian.

The general principle of the responsibility of the manufacturer or importer for the safety of the product is also supported by restrictions of some substances in Annexes II and III. Moreover, substances which are intended to be used as colorants, preservatives and UV-filters should be listed in the Annexes IV, V and VI to Regulation (EC) 1223/2009 respectively in order to be allowed for these uses. To avoid ambiguities, it should be clarified that the list of allowed colorants contained in Annex IV includes only substances which colour through absorption and reflection and not substances which colour through photoluminescence, interference, or chemical reaction.