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Product Information File

R. MONTIGNY Regulatory Advisor International Scientific Regulatory Affairs , L’OREAL. Product Information File. Cosmetic PIF, Notification, GMP Management Workshop – TAPEI 4 th December 2012. Product Information File. History Regulatory provisions Guidelines for PIF.

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Product Information File

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

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

  3. Product Information File • HISTORY • Started with implementation of the EU cosmetic Directive in 1976 • - 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 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  4. Product Information File Cosmetic products must be safe: this is the main principle of this regulation. “Cosmetic products shall not damage human healthunder normal or reasonably foreseeable conditions of use ” (art.2 of the EU Cosmetic Directive) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  5. Product information file Authorities shouldsurvey or monitor marketedproducts: 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 ) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  6. Product Information File 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: The manufacturer … responsiblefor placing … cosmetic product on the Community market shall for control purposes keep the following informationreadily accessible to the competent authorities … (Art. 7a of the EU Cosmetic Directive) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  7. Product information file 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; (b) the physico-chemical and microbiologicalspecifications 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  8. Product information file (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; (d) Assessmentof the safetyfor 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  9. Product information file (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 at the address specified on the label in accordance with Article 6 (1) (Art. 7a of the EU Cosmetic Directive) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  10. All these information were known as “The Product Dossier” in the industry jargon. In 2007 a revision (or “recast”) of the EU Cosmetic Directive 76/768 EEC was undertaken by the EU authorities and achieved in 2009. 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  11. Product information file The spirit of the former Directive 76/768 is maintained in the new Cosmetic Regulation EC No 1223/2009 Safety of cosmetic products remains always the most important principle: “A cosmetic product made available on the market shall be safefor human health when used under normal or reasonably foreseeable conditions of use…” (EU Cosmetic Regulation No 1223/2009 Art. 3) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  12. Product information file An important set of Definitions helps to clarify the meaning of the terms used in the articles such as: Cosmetic products, Substance, Mixture, Manufacturer, Distributor, Making available on the market, Placing on the market, Importer, Harmonized Standards, Responsible persons, Safety Assessor, Undesirable effect, etc… R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  13. Product information file Examples of definitions: 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: 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)) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  14. Examples of definitions: 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: 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)) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  15. Product information file Examples of definitions: 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: “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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  16. Product information file Examples of definitions: • 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 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  17. Product information file • Responsible person can be: • 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 • 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  18. Product information file Responsible persons shall cooperate with authorities … 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 documentationnecessary 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  19. Product information file The new EU Cosmetic Regulation (EC) No 1223/2009 has dedicated a specific chapter for Product Information file, under the article 11: “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 often yearsfollowing 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  20. Product information file The product information file shall contain the following information and data which shall be updated as necessary: a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product; (b) the cosmetic product safety report referred to in Article 10(1);… (EU Cosmetic Regulation No 1223/2009 Art. 11-2) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  21. Product information file (c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8; (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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  22. Product information file (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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  23. Product information file The responsible person shall make the product information file readily accessible in electronicor 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  24. Product information file Readily accessible: 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  25. Product information file Format and language of the P.I.F. 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  26. Product information file Format and language of the P.I.F. 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”. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  27. Product information file 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: 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  28. Product information file 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  29. Product information file Location of and access to the P.I.F. This address (underlined) Example of address: R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  30. Product information file Location of and access to the P.I.F. 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  31. Product information file Location of and access to the P.I.F. 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  32. Location of and access to the P.I.F. 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  33. Product information file Location of and access to the P.I.F. 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  34. Product information file 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. The elements of the PIF include but are not limited to: R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  35. Product information file • Product description and category • Safety report • Method of Manufacturing • Evidence of Compliance with GMP • Data on animal testing • Labeling • Data on serious undesirable health effects R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  36. Product information file • Product description and category : • 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: R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  37. Product information file Product description and category : ‘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 ) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  38. Product information file 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  39. Product information file • Product description and category : • Creams1, Emulsions2, Lotions3, Gels and Oils for the skin4, Face masks5, Tintedbases (liquids, pastes, powders)6, Make-up powders7, After-bath powders8, Hygienic powders9, Toilet soaps10, Deodorant soaps11, Perfumes12, Toiletwaters and Eau de Cologne13, Bath and Showerpreparations (salts, foams, oils, gels)14, Depilatories15, Deodorantsand Antiperspirants16, Hair colorants17… (EU Cosmetic Regulation No 1223/2009 Preamble 7) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  40. Product information file Product description and category : …products for Waving18, Straightening and Fixing hair19, Hair-setting products20, 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-up25, products intended for application to the Lips26, … (EU Cosmetic Regulation No 1223/2009 Preamble 7) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  41. Product information file Product description and category : products for Care of the Teeth and the Mouth27 , products for Nail care and Make-up 28, products for External Intimate hygiene29 , Sunbathing products 30, products for Tanning without sun31 , Skin-whitening products32and Anti-wrinkle products33. (EU Cosmetic Regulation No 1223/2009 Preamble 7) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  42. Product information file Product description and category : 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 codeor 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  43. Product information file 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  44. Product information file Access to information for the public • 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. R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  45. Product information file • Safety report: • The second set of information to consider for the product information file is the Safety report. • 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 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  46. Product information file 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 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  47. Product information file Safety report PART A – Cosmetic product safety information 2. 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 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  48. Product information file Safety report PART A – Cosmetic product safety information 3. Microbiological quality 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 R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  49. Product information file Safety report PART A – Cosmetic product safety information 4. 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. The relevant characteristics of packaging material, in particular purity and stability. (This provision did not exist in the Directive EU 76/768) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

  50. Product information file Safety report PART A – Cosmetic product safety information 5. 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) R. MONTIGNY Cosmetic PIF Notification GMP Management Workshop TAIPEI - 4th December 2012

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