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Cosmetic P roduct Notification in the EU

Cosmetic P roduct Notification in the EU. R. MONTIGNY Regulatory Advisor – International Scientific Regulatory Affairs , L’OREAL 2012 International cosmetic PIF, Notification and GMP practices management training - TAIPEI 4 th December 2012. Cosmetic Product Notification.

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Cosmetic P roduct Notification in the EU

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  1. Cosmetic Product Notification in the EU R. MONTIGNY Regulatory Advisor – International Scientific Regulatory Affairs , L’OREAL 2012 International cosmetic PIF, Notification and GMP practices management training - TAIPEI 4th December 2012

  2. Cosmetic Product Notification The Cosmetic Product Notification is a procedure which exists since the time when the EU Cosmetic Directive 76/768 ECC started its first implementation in the year 1976. Notification allows member states authority to become aware of the placing on the market of a new cosmetic product by its marketer (i.e. its manufacturer, distributor or importer). R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  3. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authority of the Member State of the place of manufacture or of the initial importation, of the address of the place of manufacture, or of initial importation into the Community, of the cosmetic products before the latter are placed on the Community market. (EU Cosmetic Directive 76/768 EEC Art. 7-2)

  4. Cosmetic Product Notification REGULATORS NOTIFICATION INSPECTIONS CONSUMERS INDUSTRY If we look at the EU Cosmetic regulation as the rules which governs the mechanism involving the 3 actors: Consumers, Regulators, Industry, R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  5. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Notification will trigger the Post Marketing Surveillance process leading to inspection and in-market control from the authorities side. It is therefore an important step in the process. -------- EU Cosmetic Directive 76/768 had to be transposed into each member state national law apparatus and as a result, the way notification is conducted in each countries came to be very different from one place to another.

  6. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 For this reason the reform brought in by the new regulation EC 1223/2009 changed this situation entirely and set up a modernized process common to all the member states which put away all the existing discrepancies. This process is based on a online registration through Internet at one common portal: the Cosmetic Product Notification Portal (CPNP)

  7. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 What is the Cosmetic Products Notification Portal (CPNP)? The CPNP is the online notification system created for the implementation of Regulation (EC) N° 1223/2009 of the European Parliament and of the Council on cosmetic products.

  8. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 What information needs to be entered into the CPNP? Article 13 of Regulation (EC) N° 1223/2009 lists the information that the responsible persons and, under certain circumstances, the distributors of cosmetic products shall notify through the CPNP about the products they place or make available on the European market.

  9. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Article 13 Notification 1. Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission: (a) the category of cosmetic product and its name or names, enabling its specific identification; Regulation (EC) No 1223/2009 Art. 13 - 1

  10. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 (b) the name and address of the responsibleperson where the product information file is made readily accessible; (c) the country of originin the case of import; (d) the Member State in which the cosmetic product is to be placed on the market; Regulation (EC) No 1223/2009 Art. 13 - 1

  11. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 (e) the contact details of a physical person to contact in the case of necessity; (f) the presence of substances in the form of nanomaterialsand: (i) their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this Regulation; (ii) the reasonably foreseeable exposure conditions; Regulation (EC) No 1223/2009 Art. 13 - 1

  12. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 (g) the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008; (h) the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties. Regulation (EC) No 1223/2009 Art. 13 - 1

  13. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 2. When the cosmetic product is placed on the market, the responsible person shall notify to the Commission the original labeling, and, where reasonably legible, a photograph of the corresponding packaging. Regulation (EC) No 1223/2009 Art. 13 - 2 In the new regulation this notification duty is extended to distributor under certain conditions.

  14. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 For purposes of clarification, a definition of distributor is provided in the regulation: ‘distributor’ means 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; Regulation (EC) No 1223/2009 Art. 2 – 1,(e)

  15. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 As from 11 July 2013, a distributorwho makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labeling of that product in order to comply with national law, shall submit, by electronic means, the following information to the Commission: …/… Regulation (EC) No 1223/2009 Art. 13 – 3

  16. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 (a) the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification; (b) the Member State in which the cosmetic product is made available; (c) his name and address; (d) the name and address of the responsible person where the product information file is made readily accessible. …/… Regulation (EC) No 1223/2009 Art. 13 – 3

  17. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Similar disposition exists for product which has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date, but introduced in a Member State after that date, by a distributor.

  18. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 5. The Commission shall, without delay, make the information referred to in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3 available electronically to all competent authorities. That information may be used by competent authorities only for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27. (Regulation (EC) No 1223/2009 Art. 14 – 5)

  19. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 information referred to in paragraphs 1, 2 and 3 will be made available electronically to poison centers or similar bodies, where such centers or bodies have been established by Member States. These information may be used by those bodies only for the purposes of medical treatment. Regulation (EC) No 1223/2009 Art. 13 - 6 Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay. Regulation (EC) No 1223/2009 Art. 13 - 7

  20. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 What the CPNP does with the information entered? The CPNP makes some of this information available electronically to the competent authorities (for the purposes of market surveillance, market analysis, evaluation and consumer information) and to the poison centers, or similar bodies established by Member States (for the purposes of medical treatment)

  21. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 When does information have to be entered into CPNP? As from 11 January 2012, a responsible person will have the possibility to notify through CPNP, by way of derogation from Directive 76/768/EEC, the information referred to in Article 13(1) and (2) of Regulation (EC) No 1223/2009. As from 11 July 2013, the use of CPNP will become mandatory.

  22. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Two systems are needed: - The European Commission Authentication Service (ECAS). This system provides the user with a login and password to connect to multiple European Commission applications. - The SANCO Authentication and Authorization System (SAAS). This system provides the user with a profile and access rights for a specific European Commission application, in this case the CPNP.

  23. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 All CPNP users should be part of what is called an 'organization'. An organization means either a 'responsible person' (or its sub-organizations), a 'distributor', a 'competent authority' or a 'poison center'. Confidentiality aspects Some of the data contained in CPNP are business confidential information thus a warning message is displayed on the home page for the competent authorities and for the poison centers, when they connect to the CPNP for enhancing this point.

  24. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 A responsible person or a distributor can search for and display only the products it (or a user acting on its behalf) has entered into the system. Products of one responsible person or of one distributor are not accessible to another responsible person or distributor. A responsible person or a distributor can search for its draft and submitted notifications.

  25. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Product Category and Frame formula. Frame formulation ‘Frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentrationin the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indication for the establishment of frame formulation and adapt them regularly to scientific and technical progress. Regulation (EC) No 1223/2009 Art. 2 – 1 - (s)

  26. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Category of cosmetic product The responsible person has to select three category levels, starting by the level 1, followed subsequently by level 2 and 3. In some rare cases, products may have several 'functions' that may make them fall under different categories. In these cases, it is the primary function that has to be considered for the categorization of the cosmetic product.

  27. Cosmetic Product Notification The choice of a category at level 1 determines the categories available at level 2; the choice of a category at level 2 will determine the categories available at level 3. Example: R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  28. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 There are 4 level-one defined categories: • Skin products (with 10 level-two categories ) • Hair and scalp products (with 4 level-two categories ) • Nails and Cuticle products (with 4 level-two categories ) • Oral hygiene products (with 4 level-two categories )

  29. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  30. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  31. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  32. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  33. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 The total number of level-three categories is 82; All existing categories can be found in Annex III of the CPNP User Manual. To complete the procedure, input of a Formulation name is necessary. Depending on the category selected, CPNP proposes a list of possible formulation names in a dropdown menu. This information provides a more detailed product categorization and is made available to Poison centers only.

  34. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 • Once the formulation name is decided, 3 types of formula notification are possible: • Predefined frame formulation • Exact concentration • Concentration ranges • If the responsible person selects 'predefined frame formulation', the CPNP will automatically propose the corresponding predefined frame formulation on the basis of the category and formulation name selected by the responsible person.

  35. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Categories, sub categories definitions as well as predefined frame formulations were compiled by the members of an expert group composed of representatives from EU authorities and industry association and Poison Centers. Notification via predefined frame formulation can be done only if composition falls completely within the concentration ranges proposed in this frame. Examples of some predefined frame formula …/…

  36. Frame formulation Number: 1.1 – 2011SKIN CARE CREAM, LOTION, GEL IngredientsMaximum levels (% w/w) Oils (e.g. vegetable and/or mineral), waxes and fats (e.g. long chain alcohols)…………………………………………………………………………………..30 Silicones including volatile silicones (e.g. cyclopentasiloxane, dimethicone)………..20 Humectants (e.g. glycerin, propylene glycol, PEG) ………………………………………………20 Ethanol (alcohol, alcohol denat.) ……………………………………………………………………….10 Additional ingredients (e.g. vitamins, antioxidants, plant extracts) ………………………10 Bulking agents (e.g. talc, silica, nylon powder)………………………………………………………5 UV filters …………………………………………………………………………………………………………….5 Emulsifying agents, anionic / amphoteric / non-ionic surfactants (e.g. PEG stearate, ceteareth) …………………………………………………………………………….5 Preservatives, antimicrobials………………………………………………………………………………2 Colorants …………………………………………………………………………………………………………..2 Perfume………………………………………………………………………………………………………………….1 Aqua…… …………………………………………………………………………………………………..…. to 100 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  37. Frame formulation Number: 7.8 - 2011 LIP COLOUR and GLOSSER/BALM IngredientsMaximum levels (% w/w) Oils (e.g. vegetable and/or mineral), waxes and fats(e.g. long chain alcohols)......................... 90 Film forming polymers (e.g. stearalkoniumhectorite, polybutene) ………………………………… 80 Emollients (e.g. glycerin, propylene glycol) ……………………………………………………… 50 Silicones including volatile silicones (e.g. cyclopentasiloxane, dimethicone) ………………………… 50 Liquid paraffin and isoparaffin(e.g. branched-chain isoparaffin (C11-C16), isododecane, isohexadecane)….. 40 Aqua ………………………………………………………………………………………. 40 Colorants, colour additives (e.g. opacifying / pearlescent agents) ……………………………… 30 Bulking agents (e.g. talc, silica, nylon powder) ………………………………………………….. 20 Emulsifying agents (e.g. trioleyl phosphate) ……………………………………………………. 5 Photoprotective products contain UV filters (e.g. titanium dioxide, zinc oxide) ………………….. 10 Thickeners (e.g. carbomer, hydroxyethylcellulose) ………………………………………………… 10 Ethanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol) ……………………………. 5 Additional ingredients (e.g. vitamins, proteins, antioxidants) ………………………………….. 5 Parfum ……………………………………………………………………………………… 2 Preservatives, antimicrobials ……………………………………………………………….. 1 Flavouring agents …………………………………………………………………………… 1 Oral care-sweetening agents (e.g. saccharin) …………………………………………………… 0.02

  38. Frame formulation Number: 7.22 - 2011 MASCARA - REGULAR IngredientsMaximum levels (% w/w) Film forming polymers (e.g. ammonium acrylates copolymer, cellulose derivatives, acetyl trihexyl citrate) ………………………………………………… 45 Oils (e.g. vegetable and/or mineral), waxes and fats (e.g. long chain alcohols)……………. 30 Colorants, colour additives (e.g. opacifying / pearlescent agents) ……………………….. 25 Emulsifying agents (e.g. TEA-stearate) …………………………………………………… 20 Silicones including volatile silicones (e.g. cyclopentasiloxane, dimethicone) …………………… 20 Humectants (e.g. propylene glycol, glycerin) ………………………………………………. 15 Thickeners (e.g. magnesium silicate, aluminum silicate, PEG derivatives) ..................................... 15 Ethanol (alcohol, alcohol denat.) …………………………………………………………. 11 Fibres (e.g. cellulose, nylon fibres) ………………………………………………………… 10 Emollients (e.g. isopropylmyristate) ……………………………………………………… 5 Additional ingredients (e.g. vitamins, plant extracts) ……………………………………. 5 Preservatives, antimicrobials …………………………………………………………… 2.5 Parfum…………………………………………………………………………………. 1 Aqua …………………………………………………………………………………. to 100

  39. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 • Depending on the product categories, the physical form and the formulation frame name selected, additional information may be asked by CPNP on specific ingredients of concern. • These ingredients are for example: • Ethanol/ isopropanol (%W/W) • Antidandruff products active agents (INCI,%) • Skin lightening products active agents (INCI,%)

  40. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 • Chemical exfoliating agents (INCI+ %) • Vitamin A or its derivatives (% as retinol if >0,2%) • Xanthine derivatives (INCI + % if >0,5%) • Cationic surfactants with 2 or + chains <C12 • (INCI name to be specified if non preservative function) • Products containing propellants (INCI + %) • Products containing H2O2 (% or INCI for H2O2 releasers) • Products containing reducing agents (INCI + %) • Product containing persulfates (INCI + %)

  41. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 • Products containing hair straightening agents (INCI, % active agent) • Bath salt cubes with inorganic sodium salts (Total salt % ) • Toothpastes and mouthwashes with Fluoride compounds (% as Fluorine) • Product with pH <3or >10 • Etc…

  42. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 In addition to the rules above, a number of substances have been identified by European Poison Control Centers as posing a particular concern with regard to an acute poisoning emergency. The concentration, above the indicated threshold, of any of these ingredients in a formulation must be specified. If no threshold is indicated, the concentration must always be specified

  43. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 These ingredients are: Glycols and Glycol ethers: BUTETH-2 ACETATE (above 1%) BUTOXYDIGLYCOL (above 1%) BUTOXYETHANOL (above 1%) BUTOXYETHYL ACETATE (above 1%) DIETHOXYDIGLYCOL (above 1%) DIPROPYLENE GLYCOL (above 10%) DIPROPYLENE GLYCOL DIMETHYL ETHER (above 10%) DIPROPYLENE GLYCOL ISOBORNYL ETHER (above 10%) ETHOXYDIGLYCOL (above 1%) ETHOXYDIGLYCOL ACETATE (above 1%) GLYCOL (above 1%) GLYCOL ETHERS (not polymers) (above 1%) METHOXYISOPROPANOL (above 10%) METHOXYISOPROPYL ACETATE (above 10%) PPG-2 METHYL ETHER (above 10%) PPG-2 METHYL ETHER ACETATE (above 10%) PROPYLENE GLYCOL (above 10%) PROPYLENE GLYCOL BUTYL ETHER (above 10%)

  44. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 • Hydrocarbons solvents • CYCLOHEXANE (above 5%) • HYDROGENATED DIDODECENE (above 5%) • ISOPENTANE (above 5%) • PENTANE (above 5%) • TOLUENE (above 5%) • TURPENTINE (above 5%)

  45. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 • Alcohols other than ethanol and isopropanol • BENZYL ALCOHOL (above 1%) • FURFURYL ALCOHOL (above 1%) • HEXYL ALCOHOL (above 5%) • N-BUTYL ALCOHOL (above 1%) • PROPYL ALCOHOL (above 1%) • T-BUTYL ALCOHOL (above 1%)

  46. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Following Other ingredients: ACETONE (above 5%) BENZYL BENZOATE (above 1%) BRUCINE SULFATE BUTYL ACETATE (above 1%) BUTYROLACTONE (above 0,1%) BUTOXYETHYL ACETATE (above 1%) CHLOROPLATINIC ACID (above 0,1%) COPPER SULFATE (above 0,1%) CYCLOHEXANONE (above 5%) DIMETHYLTOLYLAMINE (above 0,1%) …/…

  47. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 …/… ETHYL ACETATE (above 1%) ETHYL ETHER (above 5%) FORMALDEHYDE (above 0,2%) HYDROXYLAMINE HCL; HYDROXYLAMINE SULFATE(above 1%) M-CRESOL, O-CRESOL, P-CRESOL, MIXED CRESOLS (above 0,1%) MEK (above 5%) METHYL ACETATE (above 0,1%) METHYL PYRROLIDONE (above 5%) MIBK (above 5%) POTASSIUM CHLORATE (above 0,1%) SODIUM CHLORATE (above 0,1%) TRIETHYL PHOSPHATE (above 0,1%).

  48. Cosmetic Product Notification If Exact concentration declaration is selected by the responsible persons, a pfd file can be uploaded. All ingredients are to be expressed in INCI names, by decreasing order of %. If Concentration range declaration is selected, a pdffile can also be uploaded, no hand-written document is allowed. To facilitate the reading of Poison Centers, one should start by mentioning the ingredients of concern and their exact % . R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012

  49. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 Another mandatory information that must be declared is the original labeling and packaging Original means here the labeling of the first placing on the market in the EU. A photograph of the original packaging can be upload as a PDF format or JPG or JPEG.

  50. Cosmetic Product Notification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 The labeling shall include any text, symbols, pictures etc (e.g. art work). It shall cover notably all the mandatory elements mentioned in Article 19 of Regulation (EC) N°1223/2009. In cases where, in accordance with Article 19(2), some mandatory information is mentioned on an enclosed or attached leaflet, label, tag or card, this leaflet, label, tag or card shall also be included in the notification.

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