Cosmetic Product Notification in the EU R MONTIGNY

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 4 th December 2012

Cosmetic Product Notification The Cosmetic Product Notification is a procedure which exists since the time when procedure 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 aware market of a new cosmetic product by its marketer (i. e. its manufacturer, distributor or importer). R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 2

Cosmetic Product Notification 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 notify State of the place of manufacture or of the initial place of manufacture importation, of the address of the place of place manufacture, or of initial importation into the of initial importation Community, of the cosmetic products before the latter are placed on the Community market. (EU Cosmetic Directive 76/768 EEC Art. 7 -2) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 3

Cosmetic Product Notification If we look at the EU Cosmetic regulation as the rules which governs the mechanism involving the 3 actors: Consumers, Regulators, Industry, TI CA FI TI N NO O ON TI EC SP S IN REGULATO RS CONSUME RS INDUSTRY R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 4

Cosmetic Product Notification will trigger the Post Marketing trigger 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 5

Cosmetic Product Notification 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) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 6

Cosmetic Product Notification 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 7

Cosmetic Product Notification What information needs to be entered into the CPNP? Article 13 of Regulation (EC) N° 1223/2009 Article 13 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 8

Cosmetic Product Notification 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 category name or names, enabling its specific identification; Regulation (EC) No 1223/2009 Art. 13 - 1 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 9

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

Cosmetic Product Notification (e) the contact details of a physical person to physical person contact in the case of necessity; (f) the presence of substances in the form of nanomaterials and: (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 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 11

Cosmetic Product Notification (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 1 A or CMR 1 B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008; (h) the frame formulation allowing for prompt frame formulation and appropriate medical treatment in the event of difficulties. Regulation (EC) No 1223/2009 Art. 13 - 1 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 12

Cosmetic Product Notification 2. When the cosmetic product is placed on the market, the responsible person shall notify to the Commission the original labeling, and, original labeling 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 distributor conditions. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 13

Cosmetic Product Notification For purposes of clarification, a definition of distributor is provided in the regulation: ‘distributor’ means any natural or legal distributor 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) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 14

Cosmetic Product Notification As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his translates 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 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 15

Cosmetic Product Notification (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 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 16

Cosmetic Product Notification 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 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 17

Cosmetic Product Notification 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, surveillance market analysis, evaluation and market analysis consumer information in the context of Articles 25, 26 and 27. (Regulation (EC) No 1223/2009 Art. 14 – 5) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 18

Cosmetic Product Notification 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 -R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 7 19

Cosmetic Product Notification 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) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 20

Cosmetic Product Notification 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 21

Cosmetic Product Notification 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 22

Cosmetic Product Notification All CPNP users should be part of what is called an 'organization'. An organization means either 'organization a 'responsible person' (or its sub-organizations), 'responsible person a 'distributor', a 'competent authority' or a distributor 'poison center'. Confidentiality aspects Some of the data contained in CPNP are business confidential information thus a warning confidential information 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 23

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

Cosmetic Product Notification Product Category and Frame formulation ‘Frame formulation’ means a formulation which lists the category or category function of ingredients and their function maximum concentration in 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) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 25

Cosmetic Product Notification Category of cosmetic product The responsible person has to select three responsible person 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 'functions under different categories. In these cases, it is the primary function that has to be considered primary function for the categorization of the cosmetic product. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 26

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 4 th December 2012 27

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

Level 1 Level 2 Level 3 Face care products other than face mask Face mask Eye contour products Lip care products Hand care products Skin care Products Foot care products Body care products External intimate care products Chemical exfoliation products Mechanical exfoliation products Skin Products Skin lightening products Other skin care products Soap products Bath / shower products Skin Cleansing Products Make-up remover products External Intimate hygiene products Other skin cleansing products Chemical depilatories Body Hair Removal Products Physical epilation products Other body hair removal products R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 29

Cosmetic Product Notification Level 1 Level 2 Bleach for Body hair products Correction of body odour and/or perspiration Shaving and pre- / after- shaving products Skin products (following) Make-up products Level 3 Bleach for body hair Products with antiperspirant activity Products without antiperspirant activity Shaving products Pre- / after-shaving products Other shaving and pre- / after- shaving products Foundation Concealer Other face make-up products Mascara Eye shadow Eye pencil Eye liner Other eye make-up products Lip stick Lipstick sealer Other lip make-up products Body or face paint , including "carneval make-up" Other make-up products R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 30

Cosmetic Product Notification Level 1 Level 2 Perfumes Skin Products (following) Sun and self-tanning products Other skin products Level 3 Hydroalcoholic perfumes Non Hydroalcoholic perfumes Before and after sun products Sun protection products Self-tanning products Other sun and self-tanning products Other skin products Shampoo Hair conditioner Hair and scalp care and cleansing Scalp and hair roots care products Antidandruff products Antihairloss products Other hair and scalp care and cleansing products Oxidative hair colour products Hair and scalp Non-oxidative hair colour products Hair coloring products Hair bleaching and dye remover products Other hair colouring products Products for temporary hair styling Permanent wave products Hair styling products Hair relaxer / straightener products Other hair styling products Hair sun protection products Other hair and scalp products R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 31

Cosmetic Product Notification Level 1 Level 2 Nail varnish and remover products Nails and Cuticle Products Nail care/nail hardener products Nail glue remover products Other nail and cuticle products Tooth care products Oral Hygiene products Mouth wash/breath spray Tooth whiteners Other oral Hygiene products Level 3 Nail varnish / Nail make-up Nail varnish remover Nail varnish thinner Nail bleach Other nail varnish and remover products Nail care products Nail hardener Other nail care / nail hardener products Nail glue remover Cuticle remover / softener Nail sculpting products Other nail and cuticle products Toothpaste Tooth cleansing powder / salt Other tooth care products Mouth wash Breath spray Other mouth wash / breath spray products Tooth whiteners Other oral Hygiene products R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 32

Cosmetic Product Notification 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 33

Cosmetic Product Notification Once the formulation name is decided, 3 types of formula notification are possible: o Predefined frame formulation o Exact concentration o 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 34

Cosmetic Product Notification Categories, Categories sub categories definitions as well as sub categories predefined frame formulations were compiled predefined frame formulations 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 …/… R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 35

Frame formulation Number: 1. 1 – 2011 SKIN CARE CREAM, LOTION, GEL Ingredients Maximum 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 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 36

Frame formulation Number: 7. 8 - 2011 LIP COLOUR and GLOSSER/BALM Ingredients w/w) Maximum levels (% Oils (e. g. vegetable and/or mineral), waxes and fats(e. g. long chain alcohols). . . 90 Film forming polymers (e. g. stearalkonium hectorite, 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 (C 11 -C 16), 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 37 Photoprotective products contain UV filters (e. g.

Frame formulation Number: 7. 22 - 2011 MASCARA - REGULAR Ingredients w/w) Maximum levels (% 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 38 Fibres (e. g. cellulose, nylon fibres) ……………………………

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

Cosmetic Product Notification • • 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 <C 12 • (INCI name to be specified if non preservative function) • • Products containing propellants (INCI + %) Products containing H 2 O 2 (% or INCI for H 2 O 2 • Products containing reducing agents (INCI + %) Product containing persulfates (INCI + %) • releasers) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 40

Cosmetic Product Notification • • • 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 p. H <3 or >10 Etc… R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 41

Cosmetic Product Notification 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 R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 42

Cosmetic Product Notification 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 ETHERS (not polymers) (above 1%) METHOXYISOPROPANOL (above 10%) METHOXYISOPROPYL ACETATE (above 10%) PPG-2 METHYL ETHER ACETATE (above 10%) PROPYLENE GLYCOL (above 10%) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 43 PROPYLENE GLYCOL BUTYL

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

Cosmetic Product Notification • 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%) R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 45

Cosmetic Product Notification 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%) …/… R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 46

Cosmetic Product Notification …/… 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%). R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 47

Cosmetic Product Notification If Exact concentration declaration is selected Exact concentration by the responsible persons, a pfd file can be pfd uploaded. All ingredients are to be expressed in INCI names, by decreasing order of %. If Concentration range declaration is selected, Concentration range declaration a pdf file can also be uploaded, no handpdf 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 4 th December 2012 48

Cosmetic Product Notification 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 49

Cosmetic Product Notification 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. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 50

Cosmetic Product Notification A notification that relates to products composed of several components (e. g. hair dye sets, makeup sets) that are not marketed separately will be different from that of a single component product. Sets do not need to be notified as multicomponent products provided that all components that compose this set have been notified individually. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 51

Cosmetic Product Notification The component name is a crucial element of the notification as it might be used by competent authorities or by poison centers to search for a specific component in the database. The component name must be detailed enough to enable its specific identification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 52

Cosmetic Product Notification by distributor: A distributor who makes available in a distributor Member State a cosmetic product already marketed in another Member State and translates, on his own initiative, any element translates of the labeling of that product in order to comply with national law must notify some information in the CPNP. information To enter a distribution notification the distributor has to select 'notify a product' in 'notify a product' the 'Distributors‘ tab proposed on the Portal R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 53

Cosmetic Product Notification The CPNP will first ask the distributor to provide the name of the responsible person of the product that the distributor wants to distribute. On the basis of the information entered by the distributor, the CPNP will display a limited list of result of matching responsible person names. The distributor has to select one of the proposed results. The system will then display (in read only mode) the address associated to this responsible person. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 54

Cosmetic Product Notification The CPNP will then ask the distributor to enter the product name in the Member State of dispatch. On the basis of the information entered by the distributor, the CPNP will display a limited list of result of product names matching. The distributor has to select one of the proposed results. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 55

Cosmetic Product Notification The CPNP will display (in read only mode) the category of the cosmetic product associated to this product in the CPNP. Then it will ask the distributor to select in the drop down menu the Member State in which he makes the product available. The distributor has to enter the product name in the Member States in which the distributor makes the product available and to select the corresponding language in the drop down menu. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 56

Cosmetic Product Notification Search tools CNPN proposes also a convenient search tool for its users. A responsible person can search only for the responsible person notifications it (or users acting on its behalf) has entered into the system. A responsible person that has given access to several users to act on his behalf can see all notifications entered by these users. A responsible person can search for draft and submitted notifications. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 57

Cosmetic Product Notification Search tools Competent authorities and poison centers can search for all submitted notifications contained in the system. Draft notifications are not accessible to competent authorities and poison centers. The 'Advanced search' is intended for the responsible persons, the competent authorities and the poison centers. It allows these users to search a product into the CPNP using cumulative search criteria. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 58

Cosmetic Product Notification View product The accessible information depends on the user profile: The responsible person and the poison centers can see all the information contained in the notification. The competent authorities do not have access to do not have information related to the formulation name, frame formulation number and qualitative and quantitative composition information, except the information concerning the presence of CMR substances of CMR category 1 A or 1 B and of substances in the form of nanomaterials R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 59

Cosmetic Product Notification CNPN started its function since almost one year (11 January 2012 by derogation of the Directive 76/768). It will become mandatory from July 11 th next year. It is too early yet to provide information on whether the functioning of this complex tool developed with the collaboration of the EU administration, Industry and Poison Centers is running smoothly or not. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 60

Cosmetic Product Notification For multinational companies launching hundreds of products every year in the 27 member states and its 23 official languages, notification represents a complex challenge. One issue of concern is the management of Information System and its adaptation to a Information System massive notification. Naming of product in each language, date of placing product on the market will help for their identification R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 61

Cosmetic Product Notification Another challenge is the upload of the packaging photos provided they remain documents sufficiently legible. Heavy documents may slow considerably processes. How good will the categorization proposed in the present system prove adapted to the variety of products, and what will be the consequences of their update on the already registered records? Same question regarding update of Frame formulation. R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 62

Cosmetic Product Notification on-line is in deed a challenging objective and the tool developed is essentially aimed at fitting the provisions of the EC Regulation 1223/2009. Let’s hope that the proposed result of this pragmatic approach will not reveal as a huge labyrinthine system in the reality… Thank you R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4 th December 2012 63