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Cosmetic PIF, Notification, GMP Management Workshop – TAPEI 4 th December 2012 R. MONTIGNY Regulatory Advisor International Scientific Regulatory Affairs,

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Presentation on theme: "Cosmetic PIF, Notification, GMP Management Workshop – TAPEI 4 th December 2012 R. MONTIGNY Regulatory Advisor International Scientific Regulatory Affairs,"— Presentation transcript:

1 Cosmetic PIF, Notification, GMP Management Workshop – TAPEI 4 th December 2012 R. MONTIGNY Regulatory Advisor International Scientific Regulatory Affairs, L’OREAL

2 1. History 2. Regulatory provisions 3. Guidelines for PIF 2 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4 th December 2012

3 3 HISTORY -Started with implementation of the EU cosmetic Directive in Based on the principles that : Cosmetic products must be safe and safety is the responsibility of the Manufacturer Authorities should control the conformity of marketed products

4 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December mustsafe Cosmetic products must be safe: this is the main principle of this regulation. “Cosmetic products shall not damage human health under normal or reasonably foreseeable conditions of use ” (art.2 of the EU Cosmetic Directive)

5 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December survey monitor Authorities should survey or monitor marketed products: ensure Member States shall take all measures necessary to ensure that, in the labeling, putting up for sale and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs are not used to imply that these products have characteristics which they do not have. (art. 6 - § 3 of the EU Cosmetic Directive )

6 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Further in the text of the EU Cosmetic Directive 76/768 exists a provision that sets the basis of the “product Information file” although this official name is not yet adopted: responsible informationreadily accessible The manufacturer … responsible for placing … cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities … (Art. 7a of the EU Cosmetic Directive)

7 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December qualitativequantitative (a)the qualitative and quantitative composition of the product; in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier; physico-chemicalmicrobiological specifications (b) the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product; (Art. 7a of the EU Cosmetic Directive)

8 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December method of manufacture (c) The method of manufacture complying with the good manufacturing practice laid down by Community law or, failing that, laid down by the law of the Member State concerned; Assessmentsafety (d) Assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. (Art. 7a of the EU Cosmetic Directive)

9 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December (e) The name and address of the qualified person or persons responsible for the assessment referred to in (d) (f) Existing data on undesirable effects on human health resulting from use of the cosmetic product; All these information should be kept readily available specified on the label at the address specified on the label in accordance with Article 6 (1) (Art. 7a of the EU Cosmetic Directive)

10 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The Product Dossier All these information were known as “The Product Dossier” in the industry jargon. Regulation (EC) No Product Information File In 2007 a revision (or “recast”) of the EU Cosmetic Directive 76/768 EEC was undertaken by the EU authorities and achieved in It is named the Regulation (EC) No 1223/2009 it is going to enter into force next year with more detailed provisions and duties for industry and authorities. In this new regulation, The “Product Dossier” becomes the Product Information File.

11 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The spirit of the former Directive 76/768 is maintained in the new Cosmetic Regulation EC No 1223/2009 Safety Safety of cosmetic products remains always the most important principle: safe “A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use…” (EU Cosmetic Regulation No 1223/2009 Art. 3)

12 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Cosmetic products, Substance, Mixture, Manufacturer, Distributor, Making available on the market, Placing on the market, Importer, Responsible persons Harmonized Standards, Responsible persons, Safety Assessor, Undesirable effect, etc… An important set of Definitions helps to clarify the meaning of the terms used in the articles such as:

13 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market. (Art 2.1 (e)) Importer: Importer: any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market. (Art 2.1 (i)) Examples of definitions:

14 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Placing on the market: Placing on the market: the first making available of a cosmetic product on the Community market. (Art 2.1 (h)) Making available on the market: 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. (Art 2.1 (g)) Examples of definitions:

15 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December legal natural person responsible person “Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market”. (EU Cosmetic Regulation No 1223/2009 Art. 4-1) responsibility In the EU the right to market a cosmetic product in conformity to the regulation relies on the responsibility of the marketer. Responsibility is a very important burden and plays a major role. Provision for defining the layout of the responsibility frame is necessary: Examples of definitions:

16 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Responsible person: shall ensure compliance Responsible person: is 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. The responsible person shall ensure compliance with the relevant obligations set out in the Regulation. (Art.4 1 and 4.2). The responsible person can be one of the following: Manufacturer within the EU Person designated by a manufacturer from outside the EU Examples of definitions:

17 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Responsible person can be: Distributor A Distributor if he modifies a product already on the market in such a way that compliance with the Regulation may be affected (according to Article. 4.6) or if he places a cosmetic product on the Community market under his name or trademark Importer( An Importer(s) (according to Article 4.5) A Third party with a written mandate from manufacturer or importer. Additional information on the identification of the Responsible Person can be found in Cosmetics Europe’s Guidance Document on Roles & Responsibilities along the supply chain.

18 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Responsible persons Responsible persons shall cooperate with authorities … first point of contact all the information and documentation Is the first point of contact for the enforcement authorities should there be any enquiry on the product he has placed on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority. (EU Cosmetic Regulation No 1223/2009 Art. 5-3)

19 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The new EU Cosmetic Regulation (EC) No 1223/2009 has dedicated a specific chapter for Product Information file, under the article 11: product information file ten years last batch “When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.” (EU Cosmetic Regulation No 1223/2009 Art. 11-1)

20 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The product information file shall contain the following information and data which shall be updated as necessary: description (a)a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product; cosmetic product safety report (b) the cosmetic product safety report referred to in Article 10(1);… (EU Cosmetic Regulation No 1223/2009 Art. 11-2)

21 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December method of manufacturing statement on compliance (c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8; proof of the effect claimed (d) where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product; (EU Cosmetic Regulation No 1223/2009 Art. 11-2)

22 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December animal testing to meet third countries (e) 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. (EU Cosmetic Regulation No 1223/2009 Art. 11-2)

23 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The responsible person readily accessible electronic The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept. The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State. (EU Cosmetic Regulation No 1223/2009 Art. 11-3)

24 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Readily accessible: e.g. 72 hours The P.I.F. should be available to control officers at the address of the responsible person labeled (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.

25 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The Regulation requires the P.I.F. to be kept in electronic format or any other format (e.g. paper), as long as it is readily accessible to the competent authority in the Member State where the P.I.F is kept. The text concerning the language used for the P.I.F. states that the information should be easily understood by the controlling officer when he/she comes to verify the P.I.F. in the country where it is kept. Format and language of the P.I.F.

26 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December where the P.I.F is held Therefore, it is obviously in the interest of the company concerned to make the P.I.F. available in the national language(s) for the country where the P.I.F is held, unless it has been previously established that the competent authority is equally willing to accept another language. In many Member States, English will be “a language easily understood by the competent authorities”. Format and language of the P.I.F.

27 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Location of and access to the P.I.F. Thus, the point of access to the P.I.F. for the competent authorities is the address of the responsible person specified on the packaging of the marketed product. This address must be indicated on the product, as required under Article 19.1a of the Regulation: need not Each company may choose a single place within the EU where the complete P.I.F. is accessible. This place need not be a manufacturing site.

28 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Location of and access to the P.I.F. Where there is more than one address on the packaging of a marketed product, the single point of access to the P.I.F. must be highlighted (e.g. underlined). In the case of a product manufactured outside the EU, the P.I.F. must be accessible within the EU at the address on the label. If an abbreviated address is used on the label, it must be sufficient to allow the identification of and the access to the undertaking. The address may be abbreviated to a well- known city or town such that the normal postal service will deliver a letter to that address.

29 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Example of address: This address (underlined) Location of and access to the P.I.F.

30 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December As the P.I.F. must be “readily accessible”, authorities will expect that it is made available within a reasonable period of time even if it does not have to be physically kept at the point of access Should the authorities request additional information, such as further supporting documentation, this may take a few days to be made available. The support documentation for the P.I.F. may also not necessarily be on company premises, e.g. it could be at the office of a contract laboratory or consultant. It can also be kept outside the EU. Location of and access to the P.I.F.

31 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The accessibility of the documentation has to be assured. The P.I.F. is accessible in one of the Member States, at the discretion of the responsible person. Should a justified request for information be made by another Member State, such a request is transmitted through the competent authorities of the country where the P.I.F. is accessible. These competent authorities will report the results of their consultation to the competent authority of the EU Member State which made the request. Location of and access to the P.I.F.

32 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December providing copies Any authority that is given access to such information must keep it confidential. Making the P.I.F. readily accessible does not imply providing copies of any part of the information to control officers. Under Article 5.3, in the exceptional case of a reasoned (i.e. motivated) request from a national competent authority, the responsible person shall provide it with particular pieces of information and documentation necessary to demonstrate that specific aspects of the product are in compliance with the Regulation. Location of and access to the P.I.F.

33 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Ownership of all data comprising the PIF, either as hard copy or electronically, remains the property of the responsible person. It should not be expected that an enforcement officer removes from the premises of the responsible person any documents of the P.I.F.. However, if there are reasonable grounds to suspect an offence has been committed the officer may have the power to require the responsible person to produce any records relating to his business and seize and detain goods or records. (EU Cosmetic Regulation No 1223/2009 Art. 11-4) Location of and access to the P.I.F.

34 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December In short, the PIF is the mandatory compilation of technical documentation required for each cosmetic product to be placed on the market. According to the EU Cosmetic Regulation 1223/2009/EC. but are not limited The elements of the PIF include but are not limited to:

35 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December o Product description and category o Safety report o Method of Manufacturing o Evidence of Compliance with GMP o Data on animal testing o Labeling o Data on serious undesirable health effects

36 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Product description and category Product description and category : definition of the cosmetic -It should match the definition of the cosmetic product laid in the regulation art.2 – (a). Actually this definition did not change from that in the previous EU Cosmetic Directive 76/768:

37 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December substancemixture ‘cosmetic product’ means 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 odors’ (EU Cosmetic Regulation No 1223/2009 Art. 2-1 ) Product description and category Product description and category :

38 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Product description and category Product description and category : The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by- case assessment, taking into account all characteristics of the product. The cosmetic products may include the following : (EU Cosmetic Regulation No 1223/2009 Preamble 7)

39 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Product description and category Product description and category : Creams 1, Emulsions 2, Lotions 3, Gels and Oils for the skin 4, Face masks 5, Tinted bases (liquids, pastes, powders) 6, Make-up powders 7, After-bath powders 8, Hygienic powders 9, Toilet soaps 10, Deodorant soaps 11, Perfumes 12, Toilet waters and Eau de Cologne 13, Bath and Shower preparations (salts, foams, oils, gels )14, Depilatories 15, Deodorants and Antiperspirants 16, Hair colorants 17 … (EU Cosmetic Regulation No 1223/2009 Preamble 7)

40 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Product description and category Product description and category : …products for Waving 18, Straightening and Fixing hair 19, Hair-setting products 20, Hair-cleansing products (lotions, powders, shampoos) 21, Hair-conditioning products (lotions, creams, oils) 22, Hairdressing products (lotions, lacquers, brilliantines )23, Shaving products (creams, foams, lotions) 24, Make-up and products removing Make-up 25, products intended for application to the Lips 26, … (EU Cosmetic Regulation No 1223/2009 Preamble 7)

41 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Product description and category Product description and category : products for Care of the Teeth and the Mouth 27, products for Nail care and Make-up 28, products for External Intimate hygiene 29, Sunbathing products 30, products for Tanning without sun 31, Skin-whitening products 32 and Anti-wrinkle products 33. (EU Cosmetic Regulation No 1223/2009 Preamble 7)

42 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Product description and category Product description and category : product name, code name, identifying code formula numbers The text of Article 11.2 of the Regulation differs from the text in the Cosmetics Directive. The emphasis of Article 11.2 is on clearly relating the finished product with the P.I.F. The P.I.F. should include the product name, code name, identifying code or any other product identifier that would enable the responsible person or competent authority to attribute the P.I.F. to the cosmetic product placed in market. For example, formula numbers or code numbers used during the development of the product should be cross-referenced with the product name or other identifier.

43 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Product description and category Product description and category : in the case where a product notification has been made, it is recommended to include this product notification reference number in the product description. Companies may wish to include any local language names for the product if marketed in other countries, and a description of the product function if it is not obvious from the product name. The product name should be consistent with the name used for notification according to Article 13.

44 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Some of information contained in PIF are linked to another provision existing in the regulation: which stipulate that it should be made accessible for the public, one of it is Product identification- product name & company name, This obligation is with the responsible person. Its presentation may be specifically adapted for the public, and thus differ from that of the product information. Access to information for the public

45 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Safety report: The second set of information to consider for the product information file is the Safety report. Annex I Annex I of the Regulation 1223/2009 provides the list of documents necessary to assemble the Safety report. It is composed of two parts: Part A - The safety information Part B - The safety assessment

46 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Safety report PART A – Cosmetic product safety information 1. Quantitative and qualitative composition of the cosmetic product. The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. This provision already existed in the Directive EU 76/768

47 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Physical/chemical characteristics and stability of the cosmetic product The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product. The stability of the cosmetics product under reasonably foreseeable storage conditions. This provision already existed in the Directive EU 76/768 Safety report PART A – Cosmetic product safety information

48 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Microbiological quality around the eyes damaged skin children under three years of ageelderly people The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses. Results of preservation challenge test. This provision already existed in the Directive EU 76/768 Safety report PART A – Cosmetic product safety information

49 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Impurities, traces, information about the packaging material The purity of the substances and mixtures. In the case of traces of prohibited substances, evidence for their technical unavoidability. packaging material puritystability The relevant characteristics of packaging material, in particular purity and stability. (This provision did not exist in the Directive EU 76/768) Safety report PART A – Cosmetic product safety information

50 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Normal and reasonably foreseeable use The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light of warnings and other explanations in the product labeling. (This provision did not exist in the Directive EU 76/768) Safety report PART A – Cosmetic product safety information

51 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Exposure to the cosmetic product Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to: 1) The site(s) of application; 2) The surface area(s) of application; 3) The amount of product applied; This provision already existed in the Directive EU 76/768: Art 7a-(d) Safety report PART A – Cosmetic product safety information

52 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December ) The duration and frequency of use; 5) The normal and reasonably foreseeable exposure route(s); 6) The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account. Similar provision already existed in the Directive EU 76/768: Art 7a-(d) …/… Safety report PART A – Cosmetic product safety information

53 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.). Particular consideration shall be given to any possible impacts on exposure due to particle size …/… Safety report PART A – Cosmetic product safety information

54 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Exposure to the substances Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6. Similar provision already existed in the Directive EU 76/768: Art 7a-(d) Safety report PART A – Cosmetic product safety information

55 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Toxicological profile of the substances Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made Similar provision already existed in the Directive EU 76/768: Art 7a-(d).…/… Safety report PART A – Cosmetic product safety information

56 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified. Similar provision already existed in the Directive EU 76/768: Art 7a-(d) …/… Safety report PART A – Cosmetic product safety information

57 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Particular consideration shall be given to any possible impacts on the toxicological profile due to particle sizesnanomaterials — particle sizes, including nanomaterials, impurities — impurities of the substances and raw material used, and — interaction of substances. read-acrosssubstantiated Any read-across shall be duly substantiated and justified. The source of information shall be clearly identified. Similar provision less detailed already existed in the Directive EU 76/768: Art 7a-(d) …/… Safety report PART A – Cosmetic product safety information

58 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Undesirable effects and serious undesirable effects serious All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data. “Undesirable effects” already existed in the Directive EU 76/768: Art 7a-(d) Serious undesirable effect is a new requirement This information has to be also accessible to public Safety report PART A – Cosmetic product safety information

59 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Information on the cosmetic product Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas. (new requirement) Safety report PART A – Cosmetic product safety information

60 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Assessment conclusion Statement on the safety of the cosmetic product in relation to Article Labeled warnings and instructions of use Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d). (new requirement) Safety report PART B – Cosmetic product safety assessment

61 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Reasoning Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed. (new requirement) Safety report PART B – Cosmetic product safety assessment

62 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene. Possible interactions of the substances contained in the cosmetic product shall be assessed. Safety report PART B – Cosmetic product safety assessment

63 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December duly justified The consideration and non-consideration of the different toxicological profiles shall be duly justified. Impacts of the stability on the safety of the cosmetic product shall be duly considered. Safety report PART B – Cosmetic product safety assessment

64 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Assessor’s credentials and approval of part B Name and address of the safety assessor. Proof of qualification of safety assessor. Date and signature of safety assessor. Safety report PART B – Cosmetic product safety assessment

65 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guidelines on CPSR (Cosmetic product Safety Report) CPSR represents the main element of PIF. all It is an expert report made of several components or modules which may be stored in different databases. The report should contain as a minimum all information indicated in the headings mentioned here above. Retrievable under the same headings or similar for ease of the competent authorities. clear reference It is, however, also understood that it may be sufficient that under each heading a clear reference is made to the document, in electronic or other format, which contains the information and which is directly available.

66 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guideline on Cosmetic product Safety Report Guideline on Cosmetic product Safety Report (following): safety assessor duly justified The CPSR must be drawn up in a transparent way; it must be well-argued and easily understandable. The structure and the content of the CPSR should reflect the requirements of Annex I. However, if the information is not directly presented in the document, a reference to another readily available source should be provided. The safety assessor can, of course, use any additional data, when relevant. If any of the information required by Annex I is not provided, this should be duly justified in the CPSR (e.g. preservation challenge test)

67 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guideline on Cosmetic product Safety Report Guideline on Cosmetic product Safety Report (following): identifyquantify risks Part A of the CPSR aims at gathering the data necessary to clearly identify and quantify, from the identified hazards, the risks that a cosmetic product may present to human health. The hazard may arise, for example, from the raw materials, the manufacturing process, the packaging, the conditions of use of the product, microbiology, quantities used, the toxicological profile of the substances, etc. If data are inadequate to make a proper assessment, the safety assessor may require additional tests to be carried out.

68 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guideline on Cosmetic product Safety Report Guideline on Cosmetic product Safety Report (following): Good Laboratory Practices (GLP The official text requires that non-clinical studies used for the assessment of safety should be carried out in accordance with the principles of Good Laboratory Practices (GLP). However, an existing safety study should not be rejected purely on the grounds that it has not been carried out to GLP standards. It is not necessary to repeat such studies merely to meet P.I.F. requirements.

69 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guidelines on Cosmetic product Safety Report Guidelines on Cosmetic product Safety Report (following): statement Part B of the CPSR is a safety assessment leading to a conclusion about the safety of the product. The assessment conclusion should be a statement on the safety of the cosmetic product in relation to the safety requirement of Article 3 of the Regulation. In his or her reasoning, the safety assessor must take into account all hazards identified and the intended exposure conditions of the product.

70 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guidelines on Cosmetic product Safety Report Guidelines on Cosmetic product Safety Report (following): This reasoning is based on the data compiled in part A and takes into account the safety evaluation of substances and/or mixtures (done by the Scientific Committee for Consumer Safety, in case the substances appear in the annexes to the Cosmetics Regulation, by other competent scientific committees or panels or by the safety assessor himself), and the safety evaluation of the cosmetic product.

71 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guidelines on Cosmetic product Safety Report Guidelines on Cosmetic product Safety Report (following): Products intended for children under three years of age and products intended exclusively for external intimate hygiene do require special attention, particularly in light of their specific exposure characteristics. not necessarily The safety assessor may be a company employee or a consultant. The safety assessor need not necessarily be based within the EU. Responsible person and safety assessor should work closely together to ensure that the safety of the product is properly assessed, documented and kept up-to-date.

72 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guidelines on Cosmetic product Safety Report Guidelines on Cosmetic product Safety Report (following): responsible person essential independence objectivity structures and processes The responsible person should gather all the necessary information, as required by either Annex I – Part A or the information should be gathered by the safety assessor himself, at the request of the responsible person. Safety assessors would generally be expected to report to the senior management of a company to preserve the essential independence and objectivity of the safety function. The responsible person must establish structures and processes in order to ensure that the safety assessor is aware of possible changes and information on undesirable effects, as listed above.

73 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December To stress the importance of the “responsible persons” his duties can be summarized as follows: ensure that a cosmetic product placed on the EU market is safe for human health under normal or reasonably foreseeable conditions of use; maintain specific information on the product that he places on the market, as specified under Article 11 of EU Cosmetic legislation P.I.F.; Duties of the responsible person with regard to the P.I.F.:

74 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Duties of the responsible person with regard to the P.I.F.: be in a position to demonstrate upon request that the product he has placed on the market meets the requirements laid down by the EU cosmetics legislation (Article 5.3); ensure that the Cosmetic Product Safety Assessment has been performed by a safety assessor, i.e. a person with appropriate qualifications and expertise considering the specific requirements described in Annex I of the Regulation;

75 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Duties of the responsible person with regard to the P.I.F.: update keep the product’s safety assessment as well as the data upon which it is based as part of a “Cosmetic Product Safety Report” in the P.I.F. and update it in view of additional relevant information generated subsequent to placing the product on the market (Article 10.1(c) of the Regulation); ensure that he has a P.I.F. available in order to answer the enquiries made by the competent authority where the P.I.F. is kept and to bring evidence that the product is in compliance with the Regulation;

76 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Duties of the distributor with regard to the P.I.F: Duties of the distributor with regard to the P.I.F: collaborate with the responsible person and the national competent authorities whenever necessary to ensure compliance with the Regulation (Articles 6(3), 23 and 26); for further details, please refer to the Colipa guidelines on Roles & Responsibilities along the supply chain.

77 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guidelines on Cosmetic product Safety Report Guidelines on Cosmetic product Safety Report (following): In order to enable undertakings, in (SMEs), to comply with the requirements laid down in Annex I, the Commission, will publish appropriate guidelines, as stipulated by Article 10 (1) in its last subparagraph. Further guidance on the safety assessment of cosmetic ingredients and finished products is provided by the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation (7th revision, SCCS/1416/11) and the forthcoming Commission guidance on the Cosmetic Product Safety Report.

78 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Safety Assessor Qualifications of the Safety Assessor soundsupportable He or she should be a qualified person with a diploma in a “similar discipline” could be, for example, a veterinarian, a biochemist or a chemist with appropriate background and experience. Further guidance on this is expected from the European Commission. It is most obviously in a company’s interest that the safety assessment should be sound and supportable. Safety assessor needs not to be in Europe.

79 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Safety Assessor Safety Assessor (following): It is recommended that substantial experience – in addition to formal qualifications – may be appropriate for this function to be adequately fulfilled. Training programs on risk assessment exist at European as well as at Member States ‟ national level, some of them particularly focusing on cosmetic products.

80 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Duties of the safety assessor with regard to the P.I.F.: Assess the safety of the cosmetic product before it is placed on the market; depending on his contractual agreement with the responsible person, the safety assessor may also have to: gather all the necessary information to document the safety assessment as laid down in the Cosmetics Regulation (Annex I) collaborate with the responsible person to ensure that the safety assessment is readily accessible to the competent authority and kept up to date.

81 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Other elements of the PIF : Method of manufacture, This would be expected to be a brief overview of the method of manufacture including bulk storage and filling and should be generally applicable to the manufacturing site(s) concerned. There should be a summary of the process and a cross-reference to the detailed manufacturing documentation within any specific manufacturing site.

82 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Other elements of the PIF : Statement of compliance with GMP: at the manufacturing site Regulation requires that the manufacture of cosmetic products shall comply with cosmetic Good Manufacturing Practices (GMP). The cosmetic GMP and aspects of manufacture should be addressed and cross reference should be made to the full cosmetic GMP documentation at the manufacturing site concerned.

83 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Other elements of the PIF : Statement of compliance with GMP: presumed Compliance will be presumed if GMP is in accordance with an established harmonized standard published in the Official Journal of the European Union. A harmonized standard is defined in Article 2.1.j of the Regulation as a standard adopted by one of the European standardization bodies listed in Annex I to Directive 98/34/EC. ISO One such example is the CEN ISO 22716

84 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Other elements of PIF: Statement of compliance with GMP: Compliance may also be demonstrated in other ways, for example via a reference to industry-recognized standards and codes. However, in such cases, there is no automatic presumed compliance.

85 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Other elements of PIF: Statement of compliance with GMP: does not require a certification to be obtained The Cosmetics Regulation does not require a certification to be obtained; only compliance is expected. Member States are explicitly monitor compliance Companies must confirm compliance by including a statement in the P.I.F. Furthermore, in Article 22 of the Cosmetic Regulation, Member States are explicitly required to monitor compliance with the principles of GMP.

86 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Other elements of the PIF: Proof of effect claimed substantiatingclaimed effect(s The P.I.F. should contain the technical data (or cross- references, if the data are not part of the P.I.F.) necessary for substantiating the claimed effect(s). This concerns any claim made for a cosmetic product, irrespective of the communication medium or type of marketing tool used and irrespective of the target audience (consumers, professionals, etc.).

87 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December The choice of the adequate and appropriate way to substantiate a claim remains with the responsible person and depends on the type of product, the packaging, the claims and their context, etc. In cases where the effect is obvious (e.g. lipsticks to colour the lips or shampoos to wash the hair), there is no need to include data on performance in the P.I.F.. Other elements of the PIF: Proof of effect claimed

88 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Guidelines for the Evaluation of the Efficacy of Cosmetic Products In order to assist the cosmetics industry in its compliance with the requirements of the Cosmetics Regulation regarding the efficacy evaluation of cosmetic products, Cosmetics Europe has issued Guidelines for the Evaluation of the Efficacy of Cosmetic Products (2nd rev., 2008). Because the methodologically sound research is essential for the efficacy evaluation, these Efficacy guidelines provide an overview of established testing methodologies. Other elements of the PIF: Proof of effect claimed

89 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Specific requirements existing for sunscreen products: Commission recommendation on the efficacy of sunscreen products and the claims made relating thereto. 22 September 2006 (2006/647/EC) In vivo determination of Sun Protection Factor (SPF) : ISO Standard – ( ISO ). This International Standard is applicable to products that contain any component able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin. Proof of effect claimed

90 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Cosmetics Europe In vitro Method for Determination of UVA protection, March 2011 Proof of effect claimed Other elements of the PIF: Data on animal testing: Data on animal testing The 7th Amendment of the Cosmetic Directive established a regulatory framework with the aim of phasing out animal testing (see now Article 18 of the Regulation). “Data on animal testing” should be interpreted as a list of tests carried out, including information on the type of test.

91 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Data on animal testing: 11 September 2004 is not restricted The provision applies to any animal tests performed on cosmetic products and ingredients after 11 September 2004, relating to the development or safety evaluation of the product or its ingredients regardless of whether the testing was carried out within the European Union. The information is to be included in the Product Information and is therefore open to inspection by the competent authorities. The scope of this requirement is not restricted to testing carried out in order to meet the requirements of the Cosmetics Directive.

92 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Data on undesirable effect and serious undesirable effect related to the product. These are on a European basis information on the frequency and nature of undesirable effects linked to the product. Undesirable effect is an adverse reaction for human health attributable to the normal or foreseeable use of a cosmetic product.(Article 2 -1 (o)) Access to information for the public

93 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Data on undesirable effect and serious undesirable effect related to the product. demonstrable There should be a demonstrable link between the affected person and the product; undesirable effects do not include anecdotal or ambiguously reported effects or those resulting from abuse or misuse of the product, and do not include those related to associated items, such as the packaging. Access to information for the public

94 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Data on undesirable effect and serious undesirable effect related to the product. A ”serious undesirable effect” means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death (Article 2.1(p) of the Regulation). Access to information for the public

95 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Data on undesirable effect and serious undesirable effect related to the product. In order to ensure consistent information to the public, companies should generally compute a value for the number of (serious) undesirable effects per million units placed on the market (including all member states but excluding non-EU markets). However, in situations where the actual number of items placed on the market is small (such as a recent launch or sale through selective distribution), the actual number of undesirable effects may be provided. Access to information for the public

96 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December Conclusion responsible person post marketing surveillance As one can understand, PIF in the EU is a comprehensive set of information which can hardly take the shape of a common “file”. Information are disseminated in various places and accessible by electronic means. PIF is a concept which is intimately linked to the spirit of the legislation where the responsibility of compliance to the regulation lays entirely in the hands of the responsible person. It is fit to work in a regulatory system based on the principle of post marketing surveillance.


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