Chris Smith – Technical Editor, Personal Care REGULATIONS
New European Cosmetics Regulation: are you ready?
In just over a year from now, the new European Regulation on cosmetic products (full name: ‘Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products’)1
will come into force. The official
start date is 11 July 2013 and the Regulation will replace the existing Cosmetics Directive, EU 76/768/EEC. Upon reviewing the Regulation, it is clear one of the primary aims was to effectively ‘tidy up’ some of the wording from the existing Cosmetics Directive. Several of the points were previously potentially ambiguous and certainly interpreted differently across EU member states. A second key aim appeared to be to further scrutinise the safety of cosmetic products through added clarity and guidelines. The new Regulation contains several changes and new features compared to the existing Cosmetics Directive that will impact on the activities and attitudes of companies in the cosmetic industry. The aim of this article is to explore these major changes and features, providing details from the Regulation wording itself, and to discuss the significance. In particular this article will focus on the ‘information trail’ relating to cosmetic products and how the wording in the new Regulation impacts companies in the EU.
A brief overview of how to satisfy the new Cosmetic Regulation In order to satisfy the new Regulation the following steps need to be followed, most of which should sound very familiar (as they are identical to the existing Cosmetics Directive) but with some notable additions:
Cosmetic products entering the marketplace must be safe2 through a Safety Assessment3
as demonstrated and
completion of a Product Safety Report.4 A Product Information File must be kept and be made available to relevant authorities.5 Details of all cosmetic products must be logged on the new Cosmetic Products Notification Portal (CPNP).6
an EU member state. It specifically relates to collecting all data available on adverse reactions and potential health risks to consumers.
It is fair to say while the majority of these additions should be seen as ‘normal service’, some of the elements relating to the Product Information Files and the introduction of the CPNP certainly signal key changes and will have an impact on the industry. We will be exploring these elements in more detail.
It is important to note that from 11 July 2013, the new Regulation does apply to existing cosmetic products, not just new products. That specifically means safety information accordingly to Articles 10 and 11 of the Cosmetic Regulation must be readily accessible from 11 July 2013 for all cosmetic products available for sale in EU, regardless of when they were launched.
Transitional provisions until the Cosmetic Regulation comes into force
The European Commission has published a document explaining transitional provisions between now and 11 July 2013, including examples of scenarios relating to existing products and how they will be affected.7
Overview of the key changes and new elements Product Information Files and cosmetovigilance The new Regulation increases the requirements for assessing the safety of cosmetic products. A term that everyone in the industry will have become aware of during the few couple of years is ‘cosmetovigilance’.
The term ‘cosmetovigilance’ refers to the gathering and evaluation of full information about any cosmetic product manufactured in, sold in or imported into
In practical terms, cosmetovigilance ultimately relates to ensuring cosmetic products are suitable for sale and subsequently keeping detailed records of customer complaints. It is fair to say all companies selling cosmetic products should already have such systems in place, so this particular element should not raise alarm bells. The step change with the new Regulation is cosmetovigilance and will no longer be something that is done for completeness and by those most organised, it will be a legal requirement. Details and files relating to the safety of cosmetic products, plus details and files relating to any customer reactions/ complaints must be made readily available to relevant authorities.5
Responsible Person
A key development in the new Regulation is the introduction of a ‘Responsible Person’ for each product placed on the market. This will have a major impact on the way companies prepare and keep files for cosmetic product launches. This Responsible Person will be required to ensure compliance of the products to all of the stipulations in the Cosmetic Regulation, which includes all health and safety considerations. The Responsible Person must maintain a product information file that is accessible to the public authorities.
In addition to general health and safety considerations, the Responsible Person is also charged with ensuring full traceability by keeping records of distributors supplied with the products (and all other persons/ companies involved in the relevant supply chain). This traceability is required for three years from the date the product was supplied to the distributor. In a situation where a product is found to be non-compliant to one or more of the stipulations in the Cosmetic Regulation, the Responsible Person is charged with taking measures to restore the compliance of the
April 2012 PERSONAL CARE 11
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