The EU Cosmetics Regulation Cosmetics Europe s Guidelines on the Product Information File Manuela Coroama Cosmetics Europe
Contents The Product Information File (P.I.F.) requirement in the Cosmetics Regulation Definitions relevant to the P.I.F. Responsibilities and duties Timelines P.I.F. Contents Information to be kept by the company Information to be made public The Cosmetic Product Safety Report (CPSR) The Safety Assessment 2
The P.I.F in the new Cosmetics Regulation Legal text: Article 10 (safety assessment) Article 11 (product information file) What stays the same: - The concept and general content - Public availability of certain information 3 What is different: - Overall structure and level of detail - Product description - Statement of compliance with GMP - Cosmetic Product Safety Report (Annex I) - reasoning for the safety assessment - clearer min. qualific. for the safety assessor
Product Information File A description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product Cosmetic Product Safety Report A description of the method of manufacturing and a statement on compliance with good manufacturing practice Where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries Part A Cosmetic Product Safety Information Quantitative and Qualitative composition of the product Physical / chemical characteristics and stability of the cosmetic product Microbiological quality Impurities, traces, information about the packaging material Normal and reasonably foreseeable use Exposure to the cosmetic product Exposure to the substance Toxicological profile of the substance Undesirable effects and serious undesirable effects Information on the cosmetic product Part B Cosmetic Product Safety Assessment Assessment conclusion Labelled warnings and instructions of use Reasoning Assessor s credential and approval of part B
Definitions relevant to the P.I.F. (in the Cosmetics Regulation) 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. 5 Importer any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market
Definitions relevant to the P.I.F. (in the Cosmetics Europe Guidelines) Product Information File the information needed to meet the requirements of Article 11 of the EC Regulation. Readily accessible The P.I.F. shall be accessible to the competent authority of the Member State where the P.I.F. is kept, in electronic or other format and in a language which can be easily understood by the competent authority. The P.I.F. should be available to control officers at the address of the responsible person labelled (or, in case of several addresses, highlighted) on the product, within a 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. 6
Definitions relevant to the P.I.F. (in the Cosmetics Europe Guidelines) (cont.) Responsible person 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. 7
P.I.F.-related responsibilities The Responsible Person must: Ensure that a cosmetic product placed on the EU market is safe for human health, under normal or reasonably foreseeable conditions of use; Maintain the Product Information File; Be in a position to demonstrate, upon request, that the product he/she has placed on the market meets the requirements of the Cosmetics Regulation; Ensure that a safety assessment has been performed for each product by a qualified safety assessor; 8
P.I.F.-related responsibilities The Responsible Person must (cont.): Keep the product s safety assessment and the data upon which it is based as part of the Cosmetic Product Safety Report in the P.I.F. and update it according to relevant new data; Ensure that he/she has a P.I.F. available for answering enquiries by control authorities; Be the first point of contact for enforcement authorities, should there be any enquiry on the product he/she has placed on the market. 9
P.I.F.-related responsibilities The safety assessor must: Assess the safety of the cosmetic product before it is placed on the EU market; Depending on his/her contractual agreement with the responsible person, the safety assessor may also have to: Gather all the necessary information to document the safety assessment; Collaborate with the responsible person to ensure that the safety assessment is readily accessible to the competent authority, and is kept up-to-date. 10
P.I.F.- related duties Duties of distributors: Collaborate with the responsible person and the national competent authorities whenever necessary, to ensure compliance with the Regulation; Ensure that storage and transport conditions do not jeopardise products compliance with the Regulation. 11
P.I.F related timelines Entry into force: 11 July 2013; Retention period: 10 years after last batch of product was placed on the market; For products no longer placed on the market as of 11 July 2013, the P.I.F. must be retained until 11 July 2020; Updating: «as necessary» (no timeframe) 12
P.I.F. Contents Information to be kept by the company and to be made readily accessible to control authorities at the address on the product s label: Product description Cosmetic Product Safety Report (CPSR) Method of manufacture and statement of compliance with GMP Proof of the effect claimed Data on animal testing 13
P.I.F. Information to be made public Information to be made publicly available (www.european- Cosmetics.info): Product identification (product name and company name) Qualitative and quantitative composition of the product: Qualitative: INCI list Quantitative: only for substances classified as dangerous under Regulation 1272/2008, may be expressed as «<x%» or «x-y %» Perfume and aromatic compositions: name & code number, identity of supplier. Data on undesirable effects and serious undesirable effects that are very likely or likely to be attributable to the use of the product. 14
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. 15
The Cosmetic Product Safety Report: Annex I of the Regulation, Part B Cosmetic Product Safety Assessment: Assessment conclusions Labelled warnings and instructions for use Reasoning Assessor s credentials and approval 16
The Cosmetic Product Safety Report, Parts A and B: Annex I of the Regulation European Commission Guidelines on Annex I to Regulation (EC) No 1223/2009 on the Cosmetic Product Safety Report: Publication delayed but now imminent. 17
The Safety Assessment: what changes? Existing P.I.F. (Cosmetics Directive) New P.I.F. (Cosmetics Regulation) d) assessment of the safety for human health of the finished product ( ) Cosmetic product safety assessment, consisting of: 1 Assessment conclusion 2 Labelled warnings and instructions of use 3 Reasoning 4 Assessor s credentials and approval of part B To be included in the Cosmetic Product Safety Report, Part B, Cosmetic Product Safety Assessment (see Annex I of the CPR, Part B). 18
The Safety Assessment: what changes? Existing P.I.F. (Cosmetics Directive) d) ( ) taking into account the general toxicological profile of the ingredients, their chemical structure and their level of exposure New P.I.F. (Cosmetics Regulation) - Impurities, traces, information about the packaging material - Normal and reasonably foreseeable use - Exposure to the cosmetic product - Information on the cosmetic product. To be included in the Cosmetic Product Safety Report (see Annex I, Part A). e) the name and address of the qualified person or persons responsible for the assessment. Name and address of the safety assessor. Proof of qualification of safety assessor. Date and signature of safety assessor. 19 To be included in the Cosmetic Product Safety Report, Part B, Cosmetic Product Safety Assessment (see Annex I of the CPR, Part B, 4).
The Safety Assessment includes: Ingredient characterisation (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. 20
Safety Assessment: reasoning The reasoning contains, but is not limited to, the following elements: Exposure assessment and calculation Selection of the appropriate toxicological endpoints as the driver for the safety assessment and justification for waiving of endpoints Weight of evidence approach 21
Reminder : Safety Assessments are based on Weight of Evidence! Structural information, (Q)SAR) Physicochemical properties Data from in vitro methods Animal data Exposure/use conditions Human experience (clinical studies, history of use, postmarket surveillance)
Safety Assessment: alternatives to animal testing (AAT) Alternatives to Animal Testing for cosmetics are not an exclusive EU topic. The legal, scientific, business and ethical drivers towards AAT are of international relevance. Cosmetics Europe s AAT Research Programme is among the largest programmes of this kind in the world it has brought significant results, but full replacement of all animal studies is not possible yet. One-on-one replacements of an animal study with one alternative method works only in few cases; future successes will be built on Intelligent Testing Strategies (ITS) approaches 23
Safety Assessment: alternatives to animal testing (AAT) Valid(ated) alternative approaches are routinely and successfully used in regulatory safety assessments : Phototoxicty Dermal penetration Skin corrosivity/skin irritation Genotoxicity Eye irritation Skin sensitisation Validation and regulatory acceptance are broad concepts that may have different practical meanings in different contexts (e.g. in-house method vs. OECD Guideline) 24
Safety Assessment Conclusions Based on all the available data, the conclusion of the safety assessment may be: The product is safe for the proposed use without restrictions or The product is safe with restrictions and may need specific warnings or precautions (risk reduction measures). 25
The Safety Assessor Is responsible for assessing the safety of a cosmetic product; His/her qualifications are defined in the Regulation: Diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State; Note: EC Guidelines on Annex I: recognition of safety assessors from third countries complying with the above. The credentials and contact address of the safety assessor have to be part of the safety assessment. 26
The Safety Assessor (cont.) He/she also must: Have recognised competence in the analysis, evaluation and interpretation of toxicological data, as well as ethics in the field of cosmetology; Have access to both the toxicological and analytical information relevant to safety (e.g. purity of raw materials and control procedures applied, detailed information on a test, or information referred to by a supplier); Consider the safety of the product impartially and objectively; Carry out the safety assessment based on a thorough analysis of all available data and conditions of exposure. 27
Further information: Cosmetics Europe: www.cosmeticseurope.eu The European Commission: www.ec.europa.eu/consumers/sectors/cosmetics/ 28