Published on February 27, 2014
How to easy manage the Product Information File for the EU cosmetic regulation Dr. Giulio Pirotta Neovita consulting – firstname.lastname@example.org
PIF legal basis – regulation 1223/09 • Article 10 (safety assessment) • Article 11 (product information file) DIRECTIVE REGULATION Concept - General content- Public availability of certain information concept - general content - Public availability of certain information Info available Structure and level of detail Safety Statement Reasoning for safety assessment Collection of data Cosmetovigilance G. Pirotta - email@example.com
Definitions Cosmetic product • any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. Making available on the market • any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge. Placing on the market • the first making available of a cosmetic product on the Community market. Importer • any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market G. Pirotta - firstname.lastname@example.org
Definitions Product Information File • information to meet the requirements of Article 11 of the EC Regulation. • minimum set of information listed ANNEX I Readily accessible • • • • accessible to the competent authority of the Member State electronic or other format language easily understood by the competent authority. available at the address of the responsible person labelled on the product • within reasonable time period (e.g. 72 hours). • Whilst many items may be rapidly accessible through electronic media, there may be a short delay when information is accessed by other means. G. Pirotta - email@example.com
Responsible person Definitions • a legal or natural person based within the Community who is responsible for the placing on the EU market of a cosmetic product and who has been designated as such. Safety assessor • a natural person who carries out the cosmetic product Safety Assessment, and who is in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or similar discipline, or a course recognised as equivalent by a Member State. Cosmetic Product Safety Report (CPSR) • part of the Product Information File, documentation showing that a safety assessment has been conducted. The CPSR shall, as a minimum, contain the information requested in Annex I of the Cosmetics Regulation G. Pirotta - firstname.lastname@example.org
The Responsible Person must • Ensure that a cosmetic product placed on the EU market is safe for human health • Maintain the Product Information File • demonstrate, upon request, that the product placed on the market meets the requirements of the Regulation; • Ensure safety assessment performed by qualified safety assessor G. Pirotta - email@example.com
The Responsible Person must • Keep the product’s safety assessment and the data as part of the Cosmetic Product Safety Report in the P.I.F. and update it according to relevant new data; • Ensure the P.I.F. available for control authorities; • Be the first point of contact for authorities G. Pirotta - firstname.lastname@example.org
The safety assessor must • Assess the safety of the cosmetic product before it is placed on the EU market; • may also have to gather all the necessary information to document the safety assessment; • May cooperate with the responsible person to ensure the safety assessment is readily accessible to the competent authority and up-to-date. G. Pirotta - email@example.com
PIF – expiry date Retained 10 years after last batch of product was placed on the market; products no longer on the market as of 11 July 2013, the P.I.F. must be retained until 11 July 2020; G. Pirotta - firstname.lastname@example.org Updating: «as needed» no timeframe
THE PIF THIS IS THE MOST ADVANCED VERSION ! G. Pirotta - email@example.com
G. Pirotta - firstname.lastname@example.org Source- Cosmetics Europe (COLIPA) guidelines
Cosmetic product safety assessment Cosmetic product safety info PRODUCT INFORMATION FILE Other manufacturing data R&D data G. Pirotta - email@example.com
Definizione prodotto Identificare fonti dati Valutazione sicurezza Stesura finale Elaborazione bozza Product Information File G. Pirotta - firstname.lastname@example.org
Product information file • Description of the product • Cosmetic safety report – Part A – Part B • Manufacturing process – GMP ISO 22716 • Proof of claims (ECO/Organic) • Data animal testing • (Eco/sustainability data) ? G. Pirotta - email@example.com
The Cosmetic Product Safety Report Annex I of the Regulation, Part A • • • • • • • • • • Cosmetic Product Safety Information Qualitative / quantitative composition of the product Physical/chemical characteristics and stability Microbiological quality Impurities, traces, information about the packaging material Normal and reasonably foreseeable conditions of use Exposure to the cosmetic product Exposure to the substances contained in the product Toxicological profile of substances Undesirable effects and serious undesirable effects Information on the cosmetic product G. Pirotta - firstname.lastname@example.org
The Cosmetic Product Safety Report Annex I of the Regulation, Part B Cosmetic Product Safety Report • • • • • Cosmetic Product Safety Assessment: Assessment conclusions Labelled warnings and instructions for use Reasoning (calculation) Assessor’s credentials and approval • EU Guidelines? G. Pirotta - email@example.com
detailed • general toxicological profile of the ingredients • chemical structure and their level of exposure • Impurities, traces, information about the packaging material • Normal and reasonably foreseeable use • Exposure to the cosmetic product • Information on the cosmetic product. G. Pirotta - firstname.lastname@example.org
detailed • The Safety Assessment includes: • Ingredient characterization – phys-chem data – purity and profile of impurities, – chemical structure of ingredients (structural alerts) • Exposure assessment and considerations – (target users) • Assessment of all relevant hazard information; – Calculation of safety or exposure margins, as appropriate; • Product stability and microbiological quality • Cosmetovigilance to support continued product safety. G. Pirotta - email@example.com
Safety Assessment: reasoning • Exposure assessment and calculation – (MOS-NOAEL) • Selection of the appropriate toxicological endpoints for the safety assessment and justification for waiving of endpoints • Weight of evidence approach • WHY THE PRODUCT IS SAFE ? G. Pirotta - firstname.lastname@example.org
Frequency critical points Source : presentazione “Valutazione dei dossier informativi e segnalazione Reazioni avverse – Isabella De Angelis – Dip. Ambiente e connessa prevenzione Primaria – Istituto Superiore di Sanità – Roma – 20 giugno 2013 G. Pirotta - email@example.com
TIPS and TRICKS Clear structure of documents Simple and clear wording data not available? >> clear statement Point not needed? >> clear statement Shared data – identify the source G. Pirotta - firstname.lastname@example.org
TIPS G. Pirotta - email@example.com
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