Electronic Product Notification Dr. Gerald Renner Colipa Director Technical Regulatory Affairs Bologna – April 2010 - Notification 1 Electronic Product Notification The main drivers Bologna – April 2010 - Notification 1 Clean-up & Codification After 30 years of European Cosmetics Directive One core text with seven amendments and more than 40 technical adaptations The Cosmetics Directive had become a regulatory patchwork, although a well functioning one… Bologna – April 2010 - Notification Simplification First discussions of a legislative overhaul date back to 2003 (SLIM initiative) The European Commission included Cosmetics in its ‘better regulation’ initiative. Technical discussions with stakeholders started fully in Q4 2006 Bologna – April 2010 - Notification EU - Harmonisation Move towards a Regulation Single piece of legislation instantly and directly enforced across the whole territory of the EU. Æ Harmonisation across Europe Æ But also an important contribution / nucleus for international alignment 5 Electronic Product Notification Legal / Regulatory Aspects Bologna – April 2010 - Notification 1 Notification – Current Obligations under the Cosmetics Directive ¾ Notification to the Competent Authority Requirement laid down in Article 7(a)(4) – all Member States ¾ Notification to Poison Centres Option laid down in Article 7(3) – at discretion of Member States Unharmonised & multiple notifications throughout EU Bologna – April 2010 - Notification 3 Notification – New Cosmetics Regulation Art. 13 : Establishes Harmonised EU System Central notification at European Commission level Notification required for new products and existing products still on the market Responsible person and distributor obligations Bologna – April 2010 - Notification 4 Who needs to notify – and to whom ? i. Responsible Person - Article 13(1& 2): Prior to placing new product on the market and for existing products ii. Distributors – Article 13(3): When distributor translates the labelling on his own initiative for sale in another Member State iii. Responsible Person - Article 13(4): When a distributor re-introduces a product no longer placed on the market by the responsible person In all cases : Notification to central EU portal Bologna – April 2010 - Notification 7 What needs to be notified ? Only new products Product category Product name(s) Responsible person - name and address Country of origin (import only) Member State where product is placed on the market Details of physical contact person in case necessity Nanomaterials – identification, exposure conditions CMRs (1A & 1B) – identification Frame formulation Existing & new products Art. 13 (1&2) Original labelling (only once) Photograph of original packaging -if reasonably legible (only once) Bologna – April 2010 - Notification 8 What needs to be notified ? Art. 13 (3) distributor translates the labelling Distributor is required to notify: • The category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification • The Member State in which the cosmetic product is made available • Its name and address • The name and address of the responsible person where the product information file is made readily accessible Still a lot of practical details to be discussed ! Bologna – April 2010 - Notification 9 What needs to be notified ? Art. 13 (4) distributor re-introduces a product Product placed on the market by RP Product no longer under on the market the Cosmetics Directive Product re-introduced by distributor after implementation date Distributor informs the responsible person in which member state he will make the product available Responsible person has to notify to the EC portal like a new product only if the product has not previously been notified in this Member State (under the old Cosmetics Directive) Bologna – April 2010 - Notification 10 Poison Control Centres Product category Product name(s) Responsible person - name and address Country of origin (import only) Member State where product is placed on the market Details of physical contact person in case necessity Nanomaterials – identification, exposure conditions CMRs (1A & 1B) – identification Original labelling (only once) Photograph of original packaging -if reasonably legible (only once) Competent Authorities Who has access to the notified Information? Frame formulation Bologna – April 2010 - Notification 11 8 Timeline - Transition Period 11 January 2010 Cosmetics Regulation entered into force 11 July 2013 11 January 2012 24 months Continued national notification requirements under Cosmetics Directive 18 months Possibility to use EU central notification under the new Regulation on both, new and existing products. Use of EU system exempts from national requirements under the Cosmetics Directive Bologna – April 2010 - Notification New notification requirement for new products Obligation that all existing products are notified in the new EU system Obligation to notify all new products in the new EU system Obligation for distributors when translating labelling or reintroducing products 13 Electronic Product Notification Practical Implementation Aspects Bologna – April 2010 - Notification 1 Colipa Strategy for Implementation • Provide strong and credible industry position during discussions in the Commission stakeholder groups • Collaborate on interpretation of the final text with the Commission and stakeholders. Prioritise the subjects to be taken up • (Co-)develop Implementation Guidelines. • Help Member States in the passage from previous legislation to new legislation. (moving towards application) Bologna – April 2010 - Notification How do we proceed on Notification ? Colipa Expert Task Force Stakeholder group with European Commission, Industry, Authorities and Poison Control Centers Issues to be worked on: ¾ Key principles required for the industry ¾ Specific areas of work : 9Categorisation of cosmetics products 9Review of Frame Formulations 9IT database (CPNP – Cosm. Products Notification Portal) Bologna – April 2010 - Notification 5 Industry Key Principles • Single centralised system (no national notification) • Full confidentiality/security of submitted information • Ease of use • Product definition (linked to profuct information file) • Product categories (develop harmonised classification system) • Product name(s) (include national variants in one notification) • Only one Member State identified in notification (i.e. where the product is placed on the market) • Physical contact person (not 24 / 7 accessibility) • Frame formulations updated to suit industry needs • Original labelling& packaging notification (only to be submitted once) 18 Industry Key Principles Colipa prepared, submitted & communicated a Position Paper of the key principles Largely accepted by EC, Member States and PCC Bologna – April 2010 - Notification 6 Building the IT Data Model for the EU Notification Portal and Database A product can be made up from: • • • • One component (e.g: cream, shampoo … Several components possibly used separately (e.g: make-up palettes) A collection of components intended to be used as a mix or sequentially (e.g; hair colouring kit, skin peeling kit, permanent styling product) A range of products, as described above, that are only differentiated by colour shade, smell, or strength can be notified under one notification Bologna – April 2010 - Notification 14 Examples of scenarios by Increasing complexity 1) Simple product 1a) Shampoo Cream Skincare gift sets 3) Composite products Palette lips, eyes, cheeks Professional Hair colour 1b) 21 2) Shaded /fragrance variant products Lipstick Eye Shadow 4) Kit products Hair colour Plus the additional complexity of multilingual names 16 Some principles for the datamodel One notification is linked to one cosmetic product One cosmetic product is linked to one product information file One product covered in one product information file may be comprised of several components One product information file may, in some cases, be linked to several variants (e.g: shades, smells, etc.) Æ One notification maybe comprise of several components (e.g. oxidative hair dye) and several variants (e.g: shades, smells, etc.) Bologna – April 2010 - Notification 15 Scenario for a simple one-component product, e.g. shampoo Scenario: One single Product covered by one notification and one product information file. One Product Category One frame formulation One EU‐wide product name or national/regional names 23 17 Possible Representation in Database (mock-up) Notification # ‐ version # Name / address of responsible person: Contact details of a physical person (in case of necessity): Notification status (if renovation, previous notification #) : Brand, Product line, Name(s) : Shade, fragrance, flavour or strength GARNIER Fructis Shampooing fortifiant Hydra‐Boucles GARNIER Fructis Szampon wzmacniajacy sprezyste loki GARNIER Fructis Champu fortificante hidra‐rizos Country of origin (in case of import) : First marketing country : France Packaging picture Component name (for multi‐component products) Component Name GARNIER Fructis Shampooing fortifiant Hydra‐Boucles GARNIER Fructis Szampon wzmacniajacy sprezyste loki GARNIER Fructis Champu fortificante hidra‐rizos + Shade, fragrance, flavour or strength Category : Shampoo FrameForm. Type I/II Type III 2.1 ‐ 2000 Shampoo liquid and cream Add formula … Nano Identification Exposition CMR 1A or 1B Other information CAS INCI Artwork : Add artwork document … 24 This box should be filled in automatically from product name if there are no components 18 Impact of Product Reformulation on Notifications Declaration Form 1 : If the product falls into a new FF : Update the notification & indicate the date of formulation change. The database will keep a history of changes for PCC Declaration Form 2 : In addition to the above : Update the notification if the content of the specific ingredient (e.g. alcohol, isopropanol, Vit. A …) changes by more than X % (*) Declaration Form 3 : In addition to the above : Update the notification if the concentration of another ingredient changes to an extent that contributes in a significant way to the toxicity profile of the cosmetic product. (*) see Frame Formulation Book for specific concentration thresholds Bologna – April 2010 - Notification 20 Electronic Product Notification Next Steps Bologna – April 2010 - Notification 1 A busy schedule … • 16 March 2010 CPNP ad-hoc group on IT related issues • 13 April CPNP ad-hoc group on categorisation of Cosmetic Products • 11 May 2010 CPNP ad-hoc group on Frame Formulations (FF) related issues • 22 June 2010 CPNP ad-hoc group on Frame Formulations related issues • 13 Sept 2010 CPNP ad-hoc group on IT related issues • 17 Nov 2010 CPNP Working Group Database – Beta version availability expected at the end of 2010 with draft guidance manual Bologna – April 2010 - Notification 22 Colipa TF Notification – Members • • • • • • • • • • • • • • • • Vincent Belin, L’Oréal Nathalie Cachin, LVMH Dominique Castelli, Johnson & Johnson Isabelle Dermigny, Chanel Anne Dux, FEBEA Carmen Esteban, STANPA Peter Freunscht, Unilever Mark Griffiths, Procter & Gamble Birgit Huber, IKW Marie Kennedy, Elizabeth Arden Isabelle Orquevaux, FEBEA Brigitte Trzaska, Coty Sue Wemyss, Estée Lauder Bertrand Du Puy de Goyne, L’Oréal (IT ad-hoc WG) David Brands, Unilever (IT ad-hoc WG) Gerald Renner, Colipa * Thanks to M. Kennedy for the use of some slides Bologna – April 2010 - Notification 23
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