cosmetic p roduct notification in the eu

Cosmetic Product Notification

in the EUR. MONTIGNY

Regulatory Advisor – International Scientific Regulatory Affairs , L’OREAL

2012 International cosmetic PIF, Notification and GMP practices management training - TAIPEI 4th December 2012

R. MONTIGNY PIF, GMP, Notification Management Workshop - TAIPEI 4th December 2012 2


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).


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)



If we look at the EU Cosmetic regulation as the rules which governs the mechanism involving the 3 actors: Consumers, Regulators, Industry,


INDUSTRY

REGULATORS

CONSUMERS

INSPECTION

S

NOTIFICATI

ON


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.



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)



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.



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.



Article 13 Notification1. 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



(b) the name and address of the responsible person where the product information file is made readily accessible;(c) the country of origin in the case of import;(d) the Member State in which the cosmetic product is to be placed on the market;




(e) the contact details of a physical person to 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;




(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.




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.


In the new regulation this notification duty is extended to distributor under certain conditions.



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)



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 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



(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



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.



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)



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.


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.




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)



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.



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.



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 aspectsSome 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.



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.



Product Category and Frame formula.Frame formulation‘Frame formulation’ means a formulation which lists the category or function of ingredients and their 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)



Category of cosmetic productThe 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.




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:


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 )



Level 1 Level 2 Level 3

Skin Products

Skin care Products

Face care products other than face maskFace maskEye contour productsLip care productsHand care productsFoot care productsBody care productsExternal intimate care productsChemical exfoliation productsMechanical exfoliation productsSkin lightening productsOther skin care products

Skin Cleansing Products

Soap productsBath / shower productsMake-up remover productsExternal Intimate hygiene products Other skin cleansing products

Body Hair Removal ProductsChemical depilatoriesPhysical epilation productsOther body hair removal products


Cosmetic Product NotificationLevel 1 Level 2 Level 3

Skin products (following)

Bleach for Body hair products Bleach for body hairCorrection of body odour and/or perspiration

Products with antiperspirant activityProducts without antiperspirant activity

Shaving and pre- / after- shaving products

Shaving productsPre- / after-shaving productsOther shaving and pre- / after- shaving products

Make-up products

FoundationConcealerOther face make-up productsMascaraEye shadowEye pencilEye linerOther eye make-up productsLip stickLipstick sealerOther lip make-up productsBody or face paint , including "carneval make-up"Other make-up products



Level 1 Level 2 Level 3

Skin Products (following)

PerfumesHydroalcoholic perfumesNon Hydroalcoholic perfumes

Sun and self-tanning productsBefore and after sun productsSun protection products Self-tanning productsOther sun and self-tanning products

Other skin products Other skin products

Hair and scalp products

Hair and scalp care and cleansing products

ShampooHair conditionerScalp and hair roots care productsAntidandruff productsAntihairloss productsOther hair and scalp care and cleansing products

Hair coloring products

Oxidative hair colour products Non-oxidative hair colour products Hair bleaching and dye remover products Other hair colouring products

Hair styling products

Products for temporary hair styling Permanent wave productsHair relaxer / straightener products Other hair styling products

Other hair and scalp productsHair sun protection products Other hair and scalp products


Cosmetic Product NotificationLevel 1 Level 2 Level 3

Nails and Cuticle Products

Nail varnish and remover products

Nail varnish / Nail make-upNail varnish removerNail varnish thinnerNail bleachOther nail varnish and remover products

Nail care/nail hardener productsNail care products Nail hardenerOther nail care / nail hardener products

Nail glue remover products Nail glue remover

Other nail and cuticle productsCuticle remover / softener Nail sculpting productsOther nail and cuticle products

Oral Hygiene products

Tooth care productsToothpasteTooth cleansing powder / salt Other tooth care products

Mouth wash/breath sprayMouth wash Breath sprayOther mouth wash / breath spray products

Tooth whiteners Tooth whiteners

Other oral Hygiene products Other oral Hygiene products


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.



Once the formulation name is decided, 3 types of formula notification are possible:

o Predefined frame formulationo Exact concentrationo 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.



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 …/…



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)…………………………………………………………………………………..30Silicones including volatile silicones (e.g. cyclopentasiloxane, dimethicone)………..20Humectants (e.g. glycerin, propylene glycol, PEG) ………………………………………………20Ethanol (alcohol, alcohol denat.) ……………………………………………………………………….10Additional ingredients (e.g. vitamins, antioxidants, plant extracts) ………………………10Bulking agents (e.g. talc, silica, nylon powder)………………………………………………………5UV filters …………………………………………………………………………………………………………….5Emulsifying agents, anionic / amphoteric / non-ionic surfactants(e.g. PEG stearate, ceteareth) …………………………………………………………………………….5Preservatives, antimicrobials………………………………………………………………………………2Colorants …………………………………………………………………………………………………………..2Perfume………………………………………………………………………………………………………………….1Aqua…… …………………………………………………………………………………………………..…. to 100

37

Frame formulation Number: 7.8 - 2011LIP COLOUR and GLOSSER/BALM

Ingredients Maximum levels (% w/w)

Oils (e.g. vegetable and/or mineral), waxes and fats(e.g. long chain alcohols)......................... 90Film forming polymers (e.g. stearalkonium hectorite, polybutene) ………………………………… 80Emollients (e.g. glycerin, propylene glycol) ……………………………………………………… 50Silicones including volatile silicones (e.g. cyclopentasiloxane, dimethicone) ………………………… 50Liquid paraffin and isoparaffin(e.g. branched-chain isoparaffin (C11-C16), isododecane, isohexadecane)….. 40Aqua ……………………………………………………………………………………….

40Colorants, colour additives (e.g. opacifying / pearlescent agents) ……………………………… 30Bulking agents (e.g. talc, silica, nylon powder) ………………………………………………….. 20Emulsifying agents (e.g. trioleyl phosphate) ……………………………………………………. 5Photoprotective products contain UV filters (e.g. titanium dioxide, zinc oxide) ………………….. 10Thickeners (e.g. carbomer, hydroxyethylcellulose) ………………………………………………… 10Ethanol and/or isopropanol (alcohol, alcohol denat., isopropyl alcohol) ……………………………. 5Additional ingredients (e.g. vitamins, proteins, antioxidants) ………………………………….. 5Parfum ………………………………………………………………………………………

2Preservatives, antimicrobials ……………………………………………………………….. 1Flavouring agents ……………………………………………………………………………

1Oral care-sweetening agents (e.g. saccharin) …………………………………………………… 0.02

38

Frame formulation Number: 7.22 - 2011MASCARA - REGULAR

Ingredients Maximum levels (% w/w)

Film forming polymers (e.g. ammonium acrylates copolymer,cellulose derivatives, acetyl trihexyl citrate) ………………………………………………… 45Oils (e.g. vegetable and/or mineral), waxes and fats (e.g. long chain alcohols)……………. 30Colorants, colour additives (e.g. opacifying / pearlescent agents) ……………………….. 25Emulsifying agents (e.g. TEA-stearate) …………………………………………………… 20Silicones including volatile silicones (e.g. cyclopentasiloxane, dimethicone) …………………… 20Humectants (e.g. propylene glycol, glycerin) ………………………………………………. 15Thickeners (e.g. magnesium silicate, aluminum silicate, PEG derivatives) ..................................... 15Ethanol (alcohol, alcohol denat.) ………………………………………………………….

11Fibres (e.g. cellulose, nylon fibres) ………………………………………………………… 10Emollients (e.g. isopropyl myristate) ……………………………………………………… 5Additional ingredients (e.g. vitamins, plant extracts) ……………………………………. 5Preservatives, antimicrobials ……………………………………………………………

2.5Parfum…………………………………………………………………………………. 1Aqua …………………………………………………………………………………. to 100


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,

%)



• 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 + %)



• 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…



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



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%)



•Hydrocarbons solventsCYCLOHEXANE (above 5%)HYDROGENATED DIDODECENE (above 5%)ISOPENTANE (above 5%)PENTANE (above 5%)TOLUENE (above 5%)TURPENTINE (above 5%)



•Alcohols other than ethanol and isopropanolBENZYL 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%)



Following Other ingredients:

ACETONE (above 5%)BENZYL BENZOATE (above 1%)BRUCINE SULFATEBUTYL 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%)

…/…



…/…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 NotificationIf 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 pdf file 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


Another mandatory information that must be declared is the original labeling and packagingOriginal 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.



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.



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 multi-component products provided that all components that compose this set have been notified individually.



The component name is a crucial element of the notification as it might be used bycompetent 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.



Notification by distributor:A distributor who makes available in a Member State a cosmetic product already marketed 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 must notify some information in the CPNP.To enter a distribution notification the distributor has to select 'notify a product' in the 'Distributors‘ tab proposed on the Portal



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.



The CPNP will then ask the distributor to enter the product name in the Member State ofdispatch.On the basis of the information entered by the distributor, the CPNP will display a limited list ofresult of product names matching.The distributor has to select one of the proposed results.



The CPNP will display (in read only mode) the category of the cosmetic productassociated 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.



Search toolsCNPN proposes also a convenient search tool for its users. A responsible person can search only for the 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.



Search toolsCompetent 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.



View productThe 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 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 category 1A or 1B and of substances in the form of nanomaterials.



CNPN started its function since almost one year (11 January 2012 by derogation of the Directive 76/768). It will become mandatory from July 11th 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.



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 massive notification. Naming of product in each language, date of placing product on the market will help for their identification



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.



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


cosmetic p roduct notification in the eu

Documents

new cosmetic product

international cosmetic

eu cosmetic regulation

imported cosmetic products

eu cosmetic directive

way notification

montigny pif

online notification