The Council Directive 76/768/EEC for the safety of cosmetic products introduced in July 1976 was recast as the Cosmetic Products Regulation (EC) No. 1223/2009, which entered into force on 11 January 2010 and takes full effect from 11 July 2013.
Intertek experts told CosmeticsDesign-Europe.com that "the main drivers for change has been simplification, to strengthen product safety and reducing costs for businesses, removing legal uncertainties and inconsistencies to avoid the divergence in national transposition whilst establishing a framework to ensure that cosmetic products placed on the EU market are safe in the light of innovation in this sector.”
Improvement and clarification
“The recast has given improvement and clarification, especially in regards to the ‘responsible person’ definition, Good Manufacturing Practice (GMP), and safety reporting,” the company stated.
For nanomaterials, notification, labelling, definition and safety assessment will be necessary. Substances classified as carcinogenic, mutagenic or toxic for reproduction are prohibited and new criteria will be developed for product claims, the company explained.
In terms of the information provided in the safety assessment on ingredients, the regulation is far more prescriptive, said Intertek, explaining that cosmetics companies will look to their suppliers for information required to complete Section 8.
“Therefore, ingredient suppliers should have the relevant information on hand to support their customers in a structured and well documented manner. In effect, each ingredient will need a cosmetic ingredient safety assessment.”
Questions answered...
Companies want to know how they are affected by the recast Intertek said it expects most questions put to its experts in-cosmetics to focus on how industry players are affected by the recast “Many hot topics will be on the table during In-cosmetics such as raw materials characterisation, in vitro testing, GMP (ISO 22716) nanomaterial or packaging studies.”
The company noted that the question of safety testing and how it can be achieved is of particular concern to the cosmetics industry, and its clients are also seeking advice on the presence of contaminants such as NDELA and other controlled ingredients such as formaldehyde.
Intertek is also running a series of webinars to provide further guidance. The first webinar, ‘Understanding Cosmetic Regulation & Attaining Compliance’, is taking place on 2 May, and the second, ‘Analytical testing to give you confidence that your product satisfies the cosmetic regulations’ is programmed for 9 May.