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Cosmetic Products Notification Portal (CPNP) User Manual

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1. See attachment can be used to answer a specific question only when the information requested on the ingredient of concern is provided in the qualitative and quantitative composition document attached All ingredient names shall be expressed using INCI names when available The quantities of all the ingredients of concerns shall be expressed using w w The symbol w w shall not be indicated in the answering field 42 The CPNP applies the English notation for numbers Example 0 3 and not 0 3 2 If the responsible person answers no it is asked to enter the ingredients and the corresponding concentration ranges one by one by decreasing order of concentration in the product To facilitate the entry of names of ingredients a link is made to CoslIng to retrieve the information The responsible person can also type an ingredient if the name is not included in CosIng Upload a file for the qualitative and quantitative composition Yes No K INCI name Concentration range Please choose one 2 i Please choose orl iw Please choose one iw The responsible person should also mention in the dedicated field any other information on the product that would be of significance for poison centres using English only Any other information of significance for poison centres English only 11 2 2 3 Section Original labelling amp original packaging In this section the responsible person has to attach the o
2. Cosmetic Products Notification Portal CPNP User Manual This manual is intended for all CPNP users It explains the main functions of the CPNP CPNP users means Cosmetic industry responsible persons and users acting on their behalf referred to in this User Manual as responsible persons Distributors who make available in a Member State a cosmetic product already placed on the market in another Member State and translate on their own initiative any element of the labelling of that product in order to comply with national law referred to in this User Manual as distributors National Competent Authorities in charge of market surveillance market analysis evaluation and consumer information regarding cosmetic products referred to in this User Manual as competent authorities Poison Centres or similar bodies where such centres or bodies have been established by Member States referred to in this User Manual as poison centres Manual readers are kindly invited to report any remark on this User Manual to sanco cpnp ec europa eu Last update on 09 01 2012 Table of contents I INTRODUCTION AND SYSTEM REQUIREMENTS cccccscessseeseceeeceeeeeeseeesaeceaeceeeeesaecnseeseeeeeaeecsaeeeas 3 EL INTRODUGC TIONS roteert anenai a ae ean altar tee a eoe Ssi 3 L11 Key teis ann E a E beans E A R E R ans 3 1 1 2 What is the Cosmetic Products Notification Portal CPNP
3. General information Category amp formulation Product reference Product or component name Product or component name language Select a language Responsible Person name Contact Person name Select a language 7 Country of origin Country first placed on the market Select a country Select a country 2 Date From Date To Product specifically intended for children under 3 years of age Status Please choose one Choose a status gt 1 Search on dates is done on the submission date of the notification Category amp formulation TE The tab allows the users to search on the following criteria related to the category and the formulation of the product 53 Advanced search General information Categbry amp formulation Category level 1 Category level 2 Category level 3 Please choose one Please choose one Please choose one Frame formulation number Frame formulation name Please choose one Please choose one Ingredient name 2 CAS Number EC Number Contains CMR 14 or 1B Contains nanomaterials Special Applicator Please choose one Please choose one z Please choose one 2 You can enter INCI IUPAC or INN Note that attachments are not searched by the system At the bottom right of the screen the buttons Reset and Search allow either to reset the search criteria or to launch the search based on the criteria that have been filled in There are two icons at the top right of the results screen FE and 1 They allow
4. authenticates your identity on I work for a European institution European Commission websites Ido not work for a European institution Remember my choice cpnp Select requires you to authenticate EZ Last update 10 11 2011 ECAS will first ask the user if she he works for a European institution or not The user has to 1 Select I do not work for a European institution 2 Tick the checkbox Remember my choice Next time the user will try to connect to CPNP or any other Commission s application ECAS will not ask her him again if he works for the European institutions or not 3 Press the Select button 12 Contact Search Legal notice Privacy Statement Engish en v External European Commission Authentication Service ECAS EUROPA gt Authentication Service gt Login Login New password Sign Up E CAS a Login Not registered yet authenticates your identity on Is the selected domain correct European Commission websites External cpnp Username or e mail address requires you to authenticate Password More options gt Required fields Last update 10 11 2011 The user has to enter her his ECAS username and password and click on Ea The user will be then redirected to the following confirmation page External European Commission Authentication Service ECAS EUROPA gt Authentication Service gt Redirection poison ce
5. Neutralising agent e g aminomethyl propanol 10 Humectants e g glycerin 5 Additional ingredients e g vitamins plant extracts chelating agents UV filters protein hydrolysates 5 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 3 Parfum 3 Preservatives antimicrobials 2 Colorants 1 Aqua to 100 199 Frame formulation Number 1 2 4 201 1 SETTING LOTION INCLUDING COLOURED SETTING LOTIONS Ingredients Maximum levels w w Ethanol alcohol alcohol denat 80 Isopropanol isopropyl alcohol 40 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 10 Resins polymers e g polyvinyl acetate PVP 5 Parfum 2 Humectants e g propylene glycol 2 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated fatty acids 2 Neutralising agents e g aminomethy propanol 2 Additional ingredients e g UV filters vitamins 2 Preservatives antimicrobials 2 Cationic surfactants gt C42 e g cetrimonium chloride 1 Cationic polymers e g polyquaternium 11 polyquaternium 28 1 Isopropyl esters of fatty acids 1 Hair dyeing agents Colorants 1 Aqua to 100 200 Frame formulation Number 1 2 5 201 1 HAIR SHINE STYLING GEL Ingredients Maximum levels w w Ethanol a
6. There may be rare cases where the same product may be both imported and not imported In such cases the responsible person shall make two different notifications i e one notification for the imported version of the product specifying the country of origin into brackets in the product name and another notification for the non imported version of the product 11 2 1 10 Member State of first placing on the market The responsible person has to select the Member State of first placing on the market in the drop down menu Member State of first placing on the market Select a country 11 2 1 11 Save as draft Notify and Cancel There are three buttons at the top and at the bottom of the screen Save as dratt The notification is saved as draft but not notified A notification can be saved as draft without all the required fields being filled To save a notification as draft at least a product component name and the corresponding language must be filled indicated by 27 L Notity The notification is complete and will be made available to poison centres and competent authorities It will then be not possible to delete this notification from the system Only update or correction will be possible A notification can be notified only when all mandatory fields indicated by a are filled in If some mandatory information is missing the system will display a warning message and will indicate the fie
7. Your details are not complete Please contact your local administrator to complete your organisation i e Distributor or Responsible Person in SAAS Please note that at least name and address should be filled in ll 2 1 6 Contact person details For each notification the responsible person has to indicate the contact details of a physical person to contact in case of necessity In the notification form the system will display the list of all the contact persons that are linked to the responsible person Contact person R If a contact person does not yet appear in the list of contact persons this contact person can be added by clicking on the button and by entering the contact person details into the system All mandatory fields are indicated by a There are two buttons at the bottom right of the screen Adad allows the responsible person to add the new contact person to the ongoing notification This contact person will become selectable in the drop down menu for future notifications by this responsible person Cancel aborts the operation 24 Add contact person First and last name Phone Fax Street city Postcode Country Email Select a country Additional Phone Additional Phone 2 Note As soon as a new contact person is created in the CPNP an e mail will be sent to this contact person by the CPNP This email contains information on data protection aspects AN Important no
8. guanidine carbonate 30 Polymers resins hair conditioning agents 5 Additional ingredients e g humectants such as sorbitol 5 Parfum 1 Colorants 1 Aqua to 100 pH value 10 13 pH value of the mixture part A cream and part B activator 11 13 5 214 Frame formulation Number 12 21 gt 201 1 HAIR STRAIGHTENER RELAXER TYPE 3 Ingredients Maximum levels w w Emulsifying agents e g long chain alcohols ethoxylated long chain alcohols 15 Straightening agents e g ammonium thioglycolate 13 ammonium thiolactate 12 cysteine HCI 10 ethanolamine thioglycolate 1 Alkaline agents e g ammonium hydroxide ethanolamine ammonium bicarbonate 8 Diammonium dithiodiglycolate 6 Anionic non ionic amphoteric surfactants e g cocamidopropy betaine 5 Cationic surfactants gt C42 e g dicetyldimonium chloride 5 Silicones e g amodimethicone silanes e g alcoxysilanes 5 Additional ingredients e g plant extracts Thickeners 5 Anionic cationic polymers hair conditioning agents e g acrylates copolymer polyquaternium 1 1 2 5 Parfum 1 Colorants 1 Chelating agents 0 3 Aqua to 100 pH value 7 9 5 215 Frame formulation Number 1 3 1 201 1 NAIL VARNISH Ingredients Maximum levels w w Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 90 Solvents e g ethyl acetate butyl acetate diacetone alcohol PPG 2 butyl ether 90 Resins polymers e g nitrocellu
9. 201 1 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF SILICONES Ingredients Maximum levels w w Silicones including volatile silicones e g cyclopentasiloxane dimethicone 50 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 40 Ethanol a cohol alcohol denat 25 Humectants e g glycerin propylene glycol PEG 20 Additional ingredients e g plant extracts vitamins 10 Bulking agents e g starch kaolin talc 5 Emulsifying agents anionic amphoteric non ionic surfactants e g sorbitan sesquioleate sorbitan stearate 5 Thickeners e g cellulose gum 5 UV filters 5 Preservatives antimicrobials 2 Colorants 2 Parfum 1 Aqua to 100 80 Frame formulation Number 1 3 201 1 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF HUMECTANTS Ingredients Maximum levels w w Humectants e g glycerin propylene glycol PEG 50 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 40 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Ethanol a cohol alcohol denat 20 Emulsifying agents anionic amphoteric non ionic surfactants e g glyceryl stearate sodium cocoyl isethionate 10 Bulking agents e g silica talc 10 UV filters 5 Film forming polymers e g PVP 5 Additional ingredients e g vitamins plant extracts 5 Thickeners e g carbomer 5 Preservatives antimicrobials 2 Colorants 2 Parfum 1 Aqua to 100 81
10. Frame formulation Number 1 4 201 1 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF BULKING AGENTS Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 60 Thickeners e g bentonite carbomer cellulose 60 Humectants e g glycerin propylene glycol 40 Bulking agents e g starch zinc oxide kaolin 40 Emulsifying agents anionic amphoteric non ionic surfactants e g glyceryl stearate sodium laureth sulfate 25 Ethanol a cohol alcohol denat 20 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 UV filters 5 Additional ingredients e g plant extracts antioxidants chelating agents 5 Preservatives antimicrobials 2 Colorants 2 Parfum 1 Aqua to 100 82 Frame formulation Number 1 5 201 1 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF FATTY COMPOUNDS Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 95 Humectants e g glycerin propylene glycol PEG 25 Ethanol a cohol alcohol denat 25 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Emulsifying agents anionic amphoteric non ionic surfactants e g glyceryl stearate PEG stearate 15 Thickeners e g carbomer xanthan gum 12 Bulking agents e g talc silica zinc oxide nylon powder 10 Additional ingredients e g vitamins antioxidants plant ext
11. Resorcinols m Aminophenols Naphthols OH NH3 OH OH Z S s A S AN on OH N NH3 pe l CH3 O Anon 2 Amino 3 hydroxy 1 Naphthol Resorcinol 4 Amino 2 hydroxy 2 4 Diaminophenoxy pyridine toluene ethanol Some permanent hair coloring products combine oxidative dyes with a limited number of direct dyes The direct dyes are small phenylenediamines and phenols substituted with a nitro group see examples below HN wnt OQ wt S10 on ae 4 Nitro o phenylenediamine HC Yellow 2 4 Amino 3 nitrophenol Depending on the product categories the physical form and the formulation name selected additional information will be asked by the CPNP on specific ingredients of concern and or the pH value of the product The rules that the CPNP applies have been elaborated by an expert group composed of representatives from poison centres competent authorities industry trade associations and Commission services and are available for consultation in the Annex to this User Manual The following first question will be asked 36 Does the product contain any of the following ingredients Yes see below No GLYCOLS AND GLYCOL ETHERS 0 HYDROCARBON SOLVENTS 0 ALCOHOLS OTHER THAN ETHANOL AND ISOPROPANOL 0 OTHERS 0 A Please carefully go through the whole list of ingredients by clicking on the symbols The responsible person has either to click on Yes see below check the box of the relevant ingredient s and indicate its the
12. ccccccccccsssssscecececeesessssaeeeseeeens 5 1 1 3 What information needs to be entered into the CPNP 0 cc eeeceeesseceeneeceeaceceseeeceeneeceeeeeeeeneeeees 5 1 1 4 What the CPNP does with the information entered 000 0 eee ceesseceeneeceeeeeceeeeeceeeeeceeeeeeeteeeenteeeees 5 1 1 5 When information has to be entered into CPNP 0 0 eeeceeeeceecseceeceeeeeceeececeeeeeseeesneeeeneeesnseeees 5 2 SYSTEM REQUIREMEN PS ori a E ERER aa soe wate sna a eae ah se ea as 6 PSUR EGISURA TION 4 scccaGoscasestvasesscencaciyat sacs ated arteyiadeancasianuzetuat aa SE AE SEATS 6 1 3 1 General overview of the workflow ze 58 ccossssadececnta dese saaonesdeacs vais Gaensstds paves aatdvesdeias dhe Seapousedebasdeese 6 1 3 2 How do I get my ECAS login and password cescceesseceesceceescecesseeceeneeceeceecsceeceeeeecseeeeseeeeees 8 1 3 3 How can I login request an access to CPNP ecccsssecsseeeseceencecoeecseeesneeencecseecoseeeseeeeneeeneeoes 12 MASS TING PIN ope assays cate neath cased eave a eae ae ee ees 17 TEA CPNP HOME PAGE aij seccassctes ia casetecesupvasevassdundbnastacedavbetes tv dhsedtaa AR vans AAAA AA R AR i 17 H4 lConfidentiality aspects scad acs nz ceedeusscnesesnavacseucs sua E E E O EE OnE TEE IEE S 17 M 12 Navi atl on Butns eni n ited A E Sie len edison ees eae 18 II 2 NOTIFICATIONS PURSUANT TO ARTICLE 13 1 and 2 SINGLE COMPONENT PRODUCT i gesagt gh ns Na E E sig eats goo dearest Sava Ses abso bacon at arava
13. if the product imported in the Community and if so the country of origin the Member State of first placing on the market The Product details tab displays information on the category of the product the physical form of the product the special applicator or packaging if applicable information on the pH of the product if applicable the notification type e predefined frame formulations exact concentrations or concentration ranges the information on ingredients of concern contained in the product name and quantity w w Note Where not applicable is indicated the meaning is indicated in the right column i e either it means that the ingredient is not present in the product in this case 0 w w is indicated or is present in the product but under the concentration of concern in this case the concentration of concern is indicated the formulation name and formulation number in case of predefined frame formulation 57 an hyperlink to the composition of the product predefined frame formulation exact composition or composition with ranges information on CMR substances of category 1A or 1B present in the product information on substances in the form of nanomaterials present in the product any other information of significance for poison centres the original packaging of the product accessible by clicking on the original labelling of the product accessible by
14. Bulking agents e g silica nylon powder starch 10 UV filters 5 Additional ingredients e g antioxidants vitamins 5 Preservatives antimicrobials 2 Aqua to 100 85 Frame formulation Number 1 8 201 1 ZINC OXIDE BASED CREAM Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 60 Bulking agents e g titanium dioxide silica nylon powder 30 Zinc oxide 25 Humectants e g glycerin PEG 20 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 12 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Additional ingredients e g plant extracts bisabolo 10 Thickeners e g carbomer xanthan gum 5 Ethanol a cohol alcohol denat 5 Preservatives antimicrobials 1 5 Parfum 1 Aqua to 100 86 Frame formulation Number 1 9 201 1 SKIN GEL HYDRO ALCOHOL BASED Ingredients Maximum levels w w Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 70 Emollients humectants e g propylene glycol glycerin 20 Additional ingredients e g vitamins plant extracts 10 Emulsifying agents anionic amphoteric non ionic surfactants e g fatty acid polyglycolethers 6 Preservatives antimicrobials 3 5 Thickeners e g carbomer 5 Colorants 1 Parfum 1 Aqua to 100 87 Frame formulation Number 1 1 0 201 1 SKIN OIL Ingredients Maximum levels w
15. Humectants e g glycerin propylene glycol Aqua Film forming agents e g PVP hexadecene copolymer Silicones including volatile silicones e g dimethicone cyclomethicone Thickeners e g carbomer hydroxyethylcellulose UV filters Bulking agents e g silica nylon powder Emulsifying agents e g trioley phosphate Cosmetic colorants Ethanol alcohol alcohol denat Additional ingredients e g vitamins antioxidants Parfum Preservatives antimicrobials Flavouring agents 95 90 50 50 30 20 15 15 10 Frame formulation Number 2 1 201 1 FOAMING SKIN CLEANSER Ingredients Maximum levels w w Anionic surfactants e g sodium laureth sulfate 40 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 30 Amphoteric non ionic surfactants e g ethoxylated sorbitan esters 20 Humectants e g glycerin propylene glycol sorbitol 20 Abrasives e g polyethylene walnuts 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 5 Thickeners e g hydroxyethylcellulose 5 Additional ingredients e g plant extracts vitamins 5 Parfum 3 Preservatives antimicrobials 2 Colorants 1 Aqua to 100 96 Frame formulation Number 2 2 201 1 FOAMING SKIN CLEANSER WITH HIGH LEVEL OF OILS AND OR HUMECTANT Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 50 Humectants e
16. It provides the user with a login and password to connect to multiple European Commission applications This application manages specifically logins and passwords 1 1 1 13 Local administrator OJ L353 31 12 2008 p 1 http ec europa eu consumers cosmetics cosing A local administrator is the person in charge of managing the access requests of a specific organisation 1 1 1 14 Organisation An organisation means either a responsible person or its subcontractors a distributor a competent authority or a poison centre 1 1 2 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 It is important to note that the fact that a product has been succesfully notified through the CPNP does not necessarily mean that the product in question fulfills all the requirements of the Regulation EC N 1223 2009 of the European Parliament and of the Council on cosmetic products 1 1 3 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 1 1 4 What the CPNP does with th
17. Select a language Select a language gt gt OHbnrapckH BG e tina CS dansk DA Deutsch DE eesti keel ET SMnvik d EL English EN espa ol ES fran ais FR italiano IT latvie u valoda LV lietuviy Kalba LT magyar HU Malti MT Nederlands NL polski PL portugu s PT romana RO 4 gt 22 When multilingual has been selected the following warning message will be displayed The page at http s sanco apps dev sanco cec eu int says El g You will not be able to add any other translation Would you like to continue Multilingual cannot be used in case the product name is the same in some languages but different in others In this case all linguistic versions of the product name have to be entered individually in the system Even when the name is the same for some languages it has to be repeated indicating for each one the corresponding language ll 2 1 3 Shades if applicable To avoid unnecessary notifications the responsible person may notify the different shades of a product e g different shades of a lipstick into one single notification This can be done only if all these shades are fully covered by the information contained in the notification A Important notice A The different shades shall be indicated in the shades field and shall be clearly separated by a preceded and followed by a white space The translati
18. e g propylene glycol 10 Polymers thickeners e g PVP VA copolymer with carbomer gel 2 Triethanolamine 2 Preservatives antimicrobials 1 Anionic amphoteric non ionic surfactants 0 5 Aqua to 100 155 Frame formulation Number 8 1 201 1 EAU DE COLOGNE EAU DE TOILETTE FAUD PARFUM EXTRAIT DE PARFUM PARFUM Ingredients Maximum levels w w Ethanol alcohol alcohol denat 98 Parfum 40 Emollients humectants e g glycerin propylene glycol 10 Emulsifying agents e g PEG 60 hydrogenated castor oil 2 UV filters 2 Thickeners e g carbomer 2 Colorants 1 Additional ingredients e g chelating agents 1 Antioxidants 0 5 Aqua to 100 156 Frame formulation Number 8 2 201 1 PERFUMED POWDER LOOSE OR PRESSED Ingredients Maximum levels w w Mineral Bulking agents e g talc kaolin magnesium calcium carbonate 99 Other Bulking agents e g starch nylon powder sodium polyacrylate copolymer 50 Colorants colour additives e g opacifying pearlescent agents 40 Parfum 25 Binding agents e g vegetable and or mineral oils fatty acid esters 10 Additional ingredients e g UV filters vitamins antioxidants 5 Preservatives antimicrobials 1 157 Frame formulation Number 8 3 201 1 SOLID PERFUME PASTE WAXE Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 90 Silicones including volatile silicones e g cyclope
19. 1 1 1 201 1 DYE REMOVER REDUCING TYPE PART B To be mixed immediately prior to use with part A 11 10 2011 Ingredients Maximum levels w w Reducing agent e g sodium hydroxymethane sulfonate 20 Aqua to 100 pH value 10 11 187 Frame formulation Number 1 1 1 2 201 1 DYE REMOVER OXIDATIVE TYPE PARTA to be mixed immediately prior to use with Dye remover oxidative type Part B Ingredients Maximum levels w w Ammonium sodium potassium persulfate 70 Oils e g vegetable and or mineral 50 Bulking agents e g kaolin magnesium stearate 50 Alkaline agents including ammonium hydroxide liberators e g sodium magnesium silicate sodium carbonate sodium metasilicate ammonium chloride 45 Emulsifying agents e g sodium lauryl sulfate 15 Thickeners e g guar gum 5 Additional ingredients e g colorants chelating agents 5 pH value of the mixture Part A Part B 9 5 11 5 188 Frame formulation Number 1 1 1 3 201 1 DYE REMOVER OXIDATIVE TYPE PART B to be mixed immediately prior to use with Dye remover oxidative type Part A Ingredients Maximum levels w w Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 15 Hydrogen peroxide 12 Humectants e g glycerin 10 Oils e g vegetable and or mineral 5 Parfum 2 Chelating agents 0 5 Hydrogen peroxide stabilising agents e g sodium stannate 0 5 pH adjuster e g phosp
20. 11 6 pH value of the mixture with oxidative part 8 11 6 maximum concentration of ammonium hydroxide permitted is 6 180 Frame formulation Number 1 1 6 201 1 HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 3 THREE COMPONENTS COLORANT PART PART A Part A 11 6 2011 and Part B 11 7 2011 to be mixed immediately prior to use with oxidative part 11 8 2011 or 11 9 2011 Ingredients Maximum levels w w Alkaline agents e g ammonium hydroxide ethanolamine 22 Solvents e g propylene glycol glycerin 20 Hair dyeing agents Primary intermediates e g p phenylenediamines such as p phenylenediamine and toluene 2 5 diamine p aminophenols such as p aminophenol and 4 amino m cresol heterocyclic diamines such as 1 hydroxyethyl 4 5 diamino pyrazole sulfate 10 Couplers e g m aminophenols such as m aminophenol and 4 amino 2 hydroxytoluene m phenylenediamines such as 2 amino 4 hydroxyethylamino anisole resorcinols such as resorcinol and 4 chlororesorcinol pyridines such as 2 6 dihydroxy 3 4 dimethylpyridine naphtols such as 7 o naphthalenediol 10 Directs e g HC red no 3 2 amino 6 chloro 4 nitrophenol basic yellow 87 10 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 16 Thickeners e g cellulose derivatives 10 Cationic surfactants gt C42 e g dicetyldimonium chloride PEG 2 oleamine 5 Cationic polymers e g polyquaternium 6 5 Additional ingredients e g hair conditi
21. 6 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 5 Emulsifying agents e g ceteary palmitate 5 Polymers e g carbomer 5 Colorants 2 Parfum 1 Preservatives antimicrobials 1 Aqua to 100 163 Frame formulation Number 9 5 201 1 SUNSCREEN GEL OIL BASED Ingredients Maximum levels w w Silicones including volatile silicones e g cyclopentasiloxane dimethicone 40 UV filters 25 Film forming polymers e g PVP 10 Thickeners e g bentonite 10 Additional ingredients e g plant extracts vitamins 6 Colorants 2 Parfum 1 Preservatives antimicrobials 2 Antioxidants 0 5 Oils e g vegetable and or mineral to 100 164 Frame formulation Number 9 6 201 1 SELF TAN LOTION CREAM Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 50 Ethanol alcohol alcohol denat 25 Emulsifying agents e g glyceryl stearate PEG stearate 25 Humectants e g glycerin PEG 25 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Anionic amphoteric non ionic surfactants e g sodium cocoyl isethionate sodium laureth sulfate 20 UV filters 15 Dihydroxyacetone 10 Additional ingredients e g plant extracts vitamins bisabolol 6 Thickeners e g carbomer 5 Colorants 5 Preservatives antimicrobials chelating agents 2 Parfum 1 Aqua to 100 165 Frame formulation Number 9 7 201 1 SELF
22. ECAS password This password should only be used when prom ECAS is identified by a distinctive logo and you connection padiock for internet Explorer Ne Confirm new ECAS password f The user has then to type the password of her his choice following these specific recommendations keeping in mind that the password may not include his username and must contain at least 10 characters chosen from at least three of the following character groups no other characters are permitted apart from the white space Upper case A to Z Lower case a to z Numeric 0 to 9 Special character amp Q lt gt _ l Once the user has entered her his password and clicked on the submit button a confirmation page will be displayed gt gt EUROPA gt Authentication Service gt Password initialisation ECAS password initialisation success our ECAS password was successfully initialised 11 1 3 3 How can login request an access to CPNP 1 3 3 1 Login to CPNP using your ECAS credentials The user has to open a new browser and connect to CPNP at the following address https webgate ec europa eu cpnp The system will automatically redirect the user to the ECAS login page Contact Search Legal notice Privacy Statement v European Commission European Commission Authentication Service ECAS Intracomm gt Authentication Service gt Where Are You From ECAS a Where Are You From
23. Other Ingredients In addition to the rules above a number of substances have been identified by European Poison Control Centres 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 An updated notification is required when the concentration changes by more than 20 of the value declared previously 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 68 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 solvents CYCLOHEXANE above 5 HYDROGENATED DIDODECENE above 5 ISOPENTANE above 5 PENTANE above 5 TOLUENE above 5 TURPENTINE above 5 Alcohols other than ethanol and isopropanol BENZYL ALCOHOL above 1 FURFURYL ALCOHOL above 1 HEXYL ALCOHOL above 5 N BUTYL ALCOHO
24. are presented in aerosol spray Rule 10 Products containing or releasing hydrogen peroxide The concentration of hydrogen peroxide and or the INCI name and concentration of the compounds releasing hydrogen peroxide must be specified An updated notification is required when the concentration changes by more than 20 of the value declared previously If hydrogen peroxide and compounds releasing hydrogen peroxide are not present in the product then not applicable must be checked This rule concerns hair colorant products hair bleach products permanent wave products and hair straighteners Rule 11 Products containing reducing agents The INCI name and the concentration of each reducing agent must be specified An updated notification is required when either of these concentrations changes by more than 20 of the value declared previously This rule concerns depilatories hair dyes dye removers and permanent wave products 65 Examples for reducing agents typically used are thioglycerin thioglycolic acid and its salts ammonium thioglycolate ethanolamine thioglycolate ammonium thiolactate cysteine HCI sodium sulfite sodium metabisulfite sodium hydroxymethane sulfonate sodium hydrosulfite alkaline and earth alkaline sulphides If reducing agent s are not present in the product then not applicable must be checked Rule 12 Products containing persulfates The INCI name and the concentration of each persulfa
25. be specified An updated notification is required when either of these concentrations changes by more than 20 of the value declared previously Examples for alkaline agents typically used are sodium potassium hydroxide sodium potassium carbonate sodium potassium metasilicate calcium oxide ammonium hydroxide 67 e ethanolamine A typical ammonium hydroxide liberator is ammonium chloride Rule 17 Products containing essential oils camphor menthol or eucalyptol Except for perfume and some limited other product categories when a manufacturer introduces in a formula essential oils camphor menthol or eucalyptol with a total level higher than 0 5 the total level concentration must be indicated If essential oils camphor menthol or eucalyptol are not present in the product or if the level of essential oils camphor menthol or eucalyptol does not exceed 0 5 then not applicable must be checked For each individual essential oil camphor menthol or eucalyptol with a level higher than 0 5 0 15 in case of camphor the manufacturer must state the name and quantity of this essential oil essential oil derivative If no individual essential oil camphor menthol or eucalyptol are present with a level higher than 0 5 0 15 in case of camphor then not applicable must be checked An updated notification is required when the concentration changes by more than 20 of the value declared previously Rule 18
26. carbomer hydroxyethylcellulose 10 Additional ingredients e g proteins chelating agents pearlescent agents 10 Cationic surfactants gt C42 e g behentrimonium chloride 5 Polymers resins e g polyquaternium 10 polyquaternium 1 1 butyl ester of PVM MA copolymer 5 Parfum 3 UV filters 1 Preservatives antimicrobials 1 Colorants 1 Aqua to 100 170 Frame formulation Number 1 0 5 201 1 HAIR CONDITIONER SILICONE BASED Ingredients Maximum levels w w Aqua 20 Additional ingredients e g UV filters polymers 10 Emulsifying agents e g ethoxylated long chain alcohols 6 Ethanol a cohol alcohol denat 5 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone to 100 171 Frame formulation Number 1 0 6 201 1 HAIR SCALP CARE LOTION Ingredients Maximum levels w w Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 60 Polymers e g PVP 10 Hair conditioning agents e g cationic polymers cellulose derivatives 5 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 5 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 5 Humectants e g glycerin 5 Additional ingredients e g vitamins plant extracts chelating agents UV filters protein hydrolysates 5 Emulsifying agents e g ethoxylated long chain alcohols 3 Parfum 3 Preserva
27. denat 25 Emulsifying agents e g glyceryl stearate PEG 100 stearate 10 Bulking agents e g talc silica nylon powder 10 Additional ingredients e g bisabolol vitamins 6 Film forming polymers e g PVP 5 Thickeners e g carbomer xanthan gum 5 Parfum 3 Preservatives antimicrobials 2 Colorants 2 Aqua to 100 160 Frame formulation Number 9 2 201 1 SUNSCREEN OIL Ingredients Maximum levels w w Ethanol alcohol alcohol denat 70 UV filters 35 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 30 Film forming agents e g PVP 10 Additional ingredients e g bisabolo 6 Parfum 3 Colorants 2 Thickeners e g bentonite 1 Preservatives antimicrobials 1 Oils e g vegetable and or mineral to 100 161 Frame formulation Number 9 3 201 1 SUNSCREEN STICK Ingredients Maximum levels w w Waxes fats e g theobroma cacao seed butter polyethylene 60 UV filters 35 Bulking agents e g kaolin nylon powder 20 Emollients e g ceteary octanoate 15 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Additional ingredients e g bisabolol Colorants 6 Antioxidants 1 Oils e g vegetable and or mineral to 100 162 Frame formulation Number 9 4 201 1 SUNSCREEN HYDROGEL Ingredients Maximum levels w w Ethanol a cohol alcohol denat 60 UV filters 25 Humectants e g sorbitol 10 Additional ingredients e g plant extracts vitamins
28. either ingredient or the sum of both ingredients changes by more than 5 if the value declared previously is lt 30 or by more than 10 if the value declared previously is 2 30 For the other ingredients an updated notification is required when the concentration of an ingredient changes by more than 20 of the value declared previously when a new ingredient enters in the composition of the product or when an ingredient no longer enters the composition of the product 2 If the responsible person answers no it is asked to enter the ingredients one by one To facilitate the entry of names of ingredients a link is made to Coslng to retrieve the information The responsible person can also type an ingredient if its name is not included in Cosing 39 Here too it is recommended that the responsible person starts by mentioning the ingredients of concern and their concentration according to the rules set out in Annex to this User Manual and then lists all other ingredients by decreasing order of concentration in the product The responsible person should also mention in the dedicated field any other information on the product that would be of significance for poison centres using English only Any other information of significance for poison centres English only Depending on the product categories and formulation name selected additional information may be asked by the CPNP on the pH value 11 2 2 2 5 3 Concentrat
29. ethanolamine oleates 30 Solvents e g propylene glycol glycerin 20 Thickeners e g carbomer long chain alcohols 20 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 16 Alkaline agents e g ammonium hydroxide ethanolamine 10 Cationic surfactants gt C42 e g dicetyldimonium chloride PEG 2 oleamine 5 Cationic polymers e g polyquaternium 6 5 Additional ingredients e g hair conditioning agents pearlescent agents 5 Parfum 2 Chelating agents e g EDTA 1 Aqua to 100 pH value 8 11 6 pH value of the different mixtures 9 5 11 5 maximum concentration of ammonium hydroxide permitted is 6 195 Frame formulation Number 1 1 20 z 201 1 HAIR COLOUR RESTORER Ingredients Maximum levels w w Waxes e g petrolatum cetearyl alcohol 35 Oils e g vegetable and or mineral 20 Humectants e g sorbitol glycerin 10 Emulsifying agents e g ceteth 12 sorbitan sesquioleate 10 Sulfur 3 Parfum 1 Aqua to 100 196 Frame formulation Number 1 2 1 a 201 1 HAIR STYLING CREAM PASTE GUM POMADE PASTE WAX Ingredients Maximum levels w w Oils e g vegetable and or mineral and waxes 60 Humectants e g propylene glycol glycerin 50 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated fatty acids 30 Hair conditioning agents e g cellulose derivatives cationic polymers 20 Silicones including volatile silicones e g cyclopentasiloxane dime
30. evaluate the corrected dataset R Modification type Update Correction Modified items Product name s Responsible person details Contact person details Member State of first placing on the market Country of origin Component name s CMR 14 or 1B Nanomaterial Formulation and or categories Original labelling and or original packaging Product not manufactured anymore Product ready to go on the market or product already on the market Comment The responsible person has the possibility to add a comment using English only in the free text box should it wish to provide further details on the modification Save Once the information has been entered the responsible person has to click on to notify the change in the system This change will be made available to competent authorities and poison centres A Important notice A Only an update not a correction of the formulation and or category will create a new version of the notification All other changes will result into a new time stamp of the same version of the notification Should the responsible persons want to cancel the modification it has to clickon 9 Il 6 3 Duplicate a product 61 This function allows the responsible person to duplicate an existing notification This is a useful function when very similar products have to be notified separately since it avoids retyping all identical information The system duplicates all data except the answers to
31. g glycerin propylene glycol 50 Anionic surfactants e g sodium laureth sulfate disodium laureth sulfosuccinate 30 Non ionic amphoteric surfactants e g ceteth 20 ethoxylated long chain alcohols 20 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Abrasives e g polyethylene walnuts 10 Thickeners e g carbomer 6 Additional ingredients e g pearlescent agents such as glycol distearate 5 Preservatives antimicrobials 2 Parfum 1 Colorants 1 Aqua to 100 97 Frame formulation Number 2 3 201 1 MAKE UP REMOVER NON FOAMING CLEANSER INCLUDING TWO PHASE PRODUCTS Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 80 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 50 Humectants e g glycerin propylene glycol 20 Emulsifying agents anionic amphoteric non ionic surfactants e g glyceryl stearate polysorbate 60 15 Ethanol a cohol alcohol denat 10 Thickeners e g hydroxyethylcellulose 5 Additional ingredients e g chelating agents plant extracts antioxidants 5 Preservatives antimicrobials 2 Parfum 1 Colorants 1 Aqua to 100 98 Frame formulation Number 2 4 201 1 MAKE UP REMOVER NON FOAMING OIL CLEANSER Ingredients Maximum levels w w Silicones including volatile silicones e g cyclopentasiloxane dimethicone 50 Humectants e g glycerin 20 Ethanol a c
32. in the product in this case 0 w w is indicated or is present in the product but under the concentration of concern in this case the concentration of concern is indicated an hyperlink to the composition of the component predefined frame formulation exact composition or composition with ranges the formulation name of the component information on CMR substances of category 1A or 1B present in the component information on substances in the form of nanomaterials present in the component other information of significance por poison centres optionally the original packaging of the component accessible by clicking on optionally the original labelling of the component accessible by clicking on optionally the original labeling of the component text only 59 The Previous version s tab indicates into brackets the number of versions and displays information on these different versions of the notification dates of validity type of change update or correction and reason for change see section II 6 2 The Distributed tab is only available to competent authorities and poison centres This tab shows the contact details of the distributors At the bottom right up to four buttons may appear poe Export Edit Back The button por allows the user to create a PDF document for the notification The button Export allows the user to export the notification using XML files The button E
33. ingredient of concern specific questions attached labelling and packaging where appropriate and the checkbox Product ready to go on the market or already on the market I 7 VIEW AND EDIT NOTIFICATIONS PURSUANT ARTICLE 13 3 Once a search for notifications pursuant Article 13 3 has been performed the following screen will be displayed Show 10 v entries Filter Product name in the Product name in the Member State in Member State in which the Status Member State of dispatch which the product is made available product is made available Kit test 20111910 Translation in French France Notified le Showing 1 to 1 of 1 entries First Previous 1 Next Last If the distributor wants to update or correct one of the displayed notifications he has to click on The CPNP will then display the notification screen and the distributor can update or correct the information that was submitted Two buttons are available Notity to notify the change correction or Cancel to cancel the operation 62 ANNEX I Rules on specific ingredients of concern and or the pH value Rule 1 Ethanol and or isopropanol The percentage weights w w of ethanol and or isopropanol must be specified for all products An updated notification is required when the content of either ingredient or the sum of both ingredients changes by more than 5 ifthe value declared previously is lt 30 Examples A change from 20 of ethanol to 26 etha
34. interface language Trade Mark Brand Repair amp Shine smoothing shampoo lemon Responsible Person name SANCO DDG1 B 2 CPNP Reference 849 Date first notification 04 11 2011 10 09 45 Current version 3 Previous version s 2 1 The header allows the direct consultation of some important information on the product the product name the product name in the interface language the responsible person name the CPNP reference e the reference given by the CPNP to the product the current version number indicating the formula version not the dataset version see below the date of the first notification 56 the access to the previous versions 11 6 1 1 Single component products General information Product details Versions 1 Distributed The General information tab displays some general information on the product e g the CPNP reference the industry reference only for industry s internal use the version of the notification the last modification date and time stamp the product name s shades if applicable and corresponding language s given by the responsible person and by the distributors the information on whether the product is specifically intended for children under 3 years of age the responsible person details at least name and address the contact person details the information on whether the product is ready to go on the market or already on the market
35. name Login Request date Organisation Access Profile poison center CPNP nepnpcpo 11 11 2011 POISON INFORMATION Acting under Poison poison_center_cpnp CENTRES Centre profile te for ae First Previous i Next Last Your active and locked access tokens show 10 Y entries Search edr E Last name Login Status Access Start Date End Date Organisation Access Profile poison center CPNP ncpnpcpo locked 10 06 2011 Poison Acting poison_center_cpnp Information under Centre PIC Poison Centre profile On this page the user can see all her his current access requests concerning CPNP but also a summary of all her his previous access requests active or locked 1 3 3 3 Delegation mechanisms in SAAS 16 A Responsible Person can decide to delegate the notification of its products to suborganisations via the subdelegation mechanism implemented into SAAS This function is useful for instance when notifications are to be done by another entity e g a consultant on behalf of the Responsible Person or when a Responsible Person wants to separate its notifications by brands or type of products Organisations in SAAS are structured as follows The level 1 is the parent organisation It is always the Responsible Person Below level 1 there is the possibity to have suborganisations linked to the Responsible Person These suborganisations can enter notifications into the CPNP on behalf of that Responsible Person The notific
36. on B 34 Formulation name Liquid Soap K Please choose the notification type Predefined frame formulation Frame Formulation Number 2 9 2011 A Important notice A A notification via predefined frame formulation can be done only if the composition of the cosmetic product completely falls within the concentration ranges mentioned in this frame formulation In particular if any ingredient concentration is higher than the maximum levels indicated in the predefined frame formulation or if any ingredient is not covered by the predefined frame formulation content this predefined frame formulation must not be used for the notification Specific information for Poison Centres regarding hair colouring products 90 of total hair color market consists of permanent hair coloring products based on oxidative dyes Permanent hair coloring products are typically two component products which are mixed by the consumer immediately before application to the hair they are typically left on the hair for 30minutes before rinsing and drying of the hair Component 1 is usually labelled color cream or color gel and is usually an off white or yellow orange cream or liquid containing the oxidative dyes and the alkali ammonia or mono ethanolamine Component 2 is usually labelled developer cream or lotion and is a white liquid containing the oxidant hydrogen peroxide Oxidative dyes themselves are small colorless
37. or an advanced search has been performed the CPNP will display the list of results 55 Show 0 iv entries Search Component Responsible Category Formulation Version ist Status name Person Name notification date To shorten the list of results the Search filter tool can be used on the top right of the results list A possibility to see more results on the same page is available by using the drop down menu and selecting Show 10 25 50 or 100 entries on one page 11 6 1 View product The accessible information depends on the user profile The responsible person and the poison centres 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 In the results list the symbol 9 may appear in the column product name for some notifications It means that the original labelling and the photograph of the packaging if reasonably legible of the product have not yet been notified and indicates therefore that the product is not yet placed on the market After having clicked on a header is available for consultation Product name Trade Mark Brand Repair amp Shine smoothing shampoo lemon Product name
38. s shades if applicable and corresponding language s given by the responsible person and by the distributors the information on whether the product is specifically intended for children under 3 years of age the responsible person details at least name and address the contact person details the information on whether the product is ready to go on the market or already on the market if the product imported in the Community and if yes the country of origin the Member State of first placing on the market the pH of the mixed product if appropriate the original packaging of the product accessible by clicking on the original labelling of the product accessible by clicking on the original labeling of the product text only Each Component tab s display s information on the component name s shades if applicable and corresponding language s given by the responsible person and by the distributors if any the category of the component the physical form of the component the special applicator or packaging if applicable the notification type e predefined frame formulations exact concentrations or concentration ranges the information on ingredients of concern contained in the component name and quantity w w Note Where not applicable is indicated the meaning is indicated in the right column i e either it means that the ingredient is not present
39. salts 30 Humectants e g propylene glycol 25 Liquid paraffin and isoparaffin e g branched chain isoparatfin C11 C 16 isododecane isohexadecane 20 Emollients e g long chain alcohols 20 Emulsifying agents e g ceteareth 30 PEG stearate 10 Additional ingredients e g plant extracts EDTA 5 Deodorants e g zinc ricinoleate 5 Parfum 3 Preservatives antimicrobials 0 5 Aqua to 100 122 Frame formulation Number 6 1 201 1 SHAVING CREAM Ingredients Maximum levels w w Soaps e g mixed sodium and potassium stearate laurate and cocoate 60 Humectants e g glycerin propylene glycol 30 Thickeners emulsifying agents e g fatty acid glycol esters long chain alcohols 15 Emollients e g oils vegetable and or mineral fatty acid esters 15 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Anionic amphoteric non ionic surfactants e g sodium laureth sulfate betaine derivatives 5 Parfum 2 Additional ingredients e g vitamins 3 Opacifying agents e g titanium dioxide 1 Anticorrosives e g sodium metasilicate 0 5 Chelating agents 0 5 Antioxidants 0 1 Aqua to 100 123 Frame formulation Number 6 2 201 1 BRUSHLESS SHAVING CREAM Ingredients Maximum levels w w Fatty acids 40 Oils e g vegetable and or mineral 20 Soaps e g TEA stearate and TEA laurate 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Additional ingr
40. should include the trade mark brand the product line and the specific name of the product as they appear on the product The complete name should include the function unless it is part of the specific name of the product Example 1 Trade Mark Brand 2 Product Line 21 3 Specific name function included The complete name of the product is Trade Mark Brand Product Line specific name function included e g Trade Mark Brand Repair amp Shine smoothing cream Trade Mark Brand Repair amp Shine smoothing conditioner Trade Mark Brand Repair amp Shine smoothing shampoo lemon Trade Mark Brand Repair amp Shine smoothing shampoo orange Trade Mark Brand Repair amp Shine smoothing shampoo vanilla 11 2 1 2 Language When the product is made available on the market with a name translated in different languages each of these names has to be mentioned in the notification together with the corresponding language selected via the drop down menu The symbol next to the language drop down menu allows the responsible person to add product name translation s and to select the corresponding language s If the responsible person wants to delete a product name translation it has to click on the button next to the corresponding translation If the product name is the same in_all languages the responsible person can indicate this name only once and select multilingual in the drop down menu Language
41. sodium lauroyl sarcosinate sodium laureth sulfate disodium laureth sulfosuccinate 25 Non ionic amphoteric surfactants e g betaine derivatives glucose derivatives 20 Foam boosting agents e g ethoxylated long chain alcohols alkyl polyglucose 10 Emulsifying agents e g PEG 6 laurate glyceryl cocoate 10 Thickeners e g hydroxypropyl methylcellulose sodium chloride 10 Additional ingredients e g pearlescent agents plant extracts 10 Parfum 6 Cationic polymers e g po yquaternium 7 3 Colorants 1 Preservatives antimicrobials 1 Aqua to 100 105 Frame formulation Number 2 1 1 201 1 SLIGHTLY FOAMING SHOWER CREAM MILK Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 60 Humectants e g glycerin hexylene glycol 30 Anionic surfactants e g sodium lauroyl sarcosinate sodium laureth sulfate disodium laureth sulfosuccinate 10 Non ionic amphoteric surfactants e g betaine derivatives glucose derivatives 10 Foam boosting agents e g ethoxylated long chain alcohols alkyl polyglucose 10 Emulsifying agents e g PEG 6 laurate glyceryl cocoate 10 Thickeners e g hydroxypropyl methylcellulose sodium chloride 10 Additional ingredients e g pearlescent agents plant extracts 10 Parfum 6 Cationic polymers e g po yquaternium 7 3 Colorants 1 Preservatives antimicrobials 1 Aqua to 100 106 Frame formulation Number 2 1
42. to be added A new screen will appear and display the information retrieved from CoslIng i e INCI IUPAC INN XAN CAS number EINECS and or ELINCS Here too the responsible person remains responsible for checking the completeness and the exactness of the information provided and changing it where necessary Add nanomaterial At least one of those fields is required INCI K IUPAC K INN XAN CAS number K EINECS ELINCS A Important notice A When retrieving information from Coslng please note that there is no filter intended to display only nanomaterials 30 If the responsible person clicks on Laaa the nanomaterial will be added to the notification If the responsible person clicks on Back the nanomaterial will not be added to the notification and the responsible person will be redirected to the search screen By clicking on new nanomaterials the responsible person can also type a nanomaterial if the name is not included in Coslng Search nanomaterials New naggatenals Please encode at least 5 characters INCI IUPAC INN CAS or EC Number 1 2 2 2 Section Category amp Frame formulation In this section the responsible person has to enter information on 11 2 2 2 1 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 A Important notice A In some rare cases products may have sever
43. to select the future new local administrator in the list of active access profiles in the main page of SAAS click on the login of the the future new local administrator and tick the checkbox Local admin As any other local administrator the new local administrator s will be able to accept or refuse access requests designate other local administrators create new suborganisations etc For security reasons only local administrators who have been formally nominated by the Member States beforehand will be allowed to create an organisation Competent Authority or an organisation Poison Centre in SAAS A User enters the CPNP url A User must fill in the registration form A B User is redirected to the ECAS login page B ECAS will send a confirmation email l C User registers his ECAS password l C User enters his ECAS login password D User is redirected to CPNP er has no valid access profile E User is redirected to the CPNP homepage F User goes to the Profile page E CPNP displays an Access denied page F User goes to the SAAS access request form A User completes the access request form I Organisation does not exist m M M M A M M M M M aM aM aM aM aM ae B User enters details of the new organisation Organisation exists i B User submits his access request form l seca 1 3 2 How do I get my ECAS login and pa
44. 0 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 30 Resins Film forming polymers e g a uminum distearate PVP hexadecene copolymer 30 Colorants colour additives e g opacifying pearlescent agents 25 Emulsifying agents e g cera alba 20 Bulking agents e g talc kaolin zinc stearate 15 Thickeners e g stearalkonium hectorite 12 Ethanol alcohol alcohol denat 10 Aqua 10 Humectants e g propylene glycol glycerin 5 Additional ingredients e g vitamins plant extracts silk powder 5 Parfum 1 Antioxidants 1 Preservatives antimicrobials 1 153 Frame formulation Number 7 24 201 1 MASCARA CAKE Ingredients Emulsifying agents anionic amphoteric non ionic surfactants e g TEA stearate Waxes e g ozokerite cera alba carnauba Colorants colour additives e g opacifying pearlescent agents Film forming polymers e g ammonium acrylates copolymer cellulose derivatives Thickeners e g polyethylene derivatives stearalkonium hectorite Aqua Additional ingredients e g vitamins plant extracts Preservatives antimicrobials 154 Maximum levels w w 50 50 25 25 20 20 Frame formulation Number 7 25 201 1 BODY GLITTER Ingredients Maximum levels w w Colorants colour additives e g opacifying pearlescent agents coloured aluminium foil polyester film or laminates of both 30 Ethanol a cohol alcohol denat 15 Humectants
45. 0 Aluminium salts e g aluminum chlorohydrate 30 Emollients humectants e g isopropyl myristate glycerin propylene glycol derivatives 25 Oils and waxes e g vegetable and or mineral isoparaffin 15 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 15 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 15 Additional ingredients e g plant extracts EDTA 5 Deodorants e g zinc ricinoleate 4 Parfum 3 Preservatives antimicrobials 1 Aqua to 100 120 Frame formulation Number 5 8 201 1 DEODORANT LIQUID SQUEEZE PACK OR PUMP SPRAY Ingredients Maximum levels w w Ethanol alcohol alcohol denat 95 Emollients humectants e g propylene glycol glycerin 25 Oils and waxes e g vegetable and or mineral isoparaffin 15 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 15 Liquid paraffin and isoparaffin e g branched chain isoparatfin C11 C 16 isododecane isohexadecane 15 Additional ingredients e g plant extracts 5 Deodorants e g zinc ricinoleate 4 Parfum 3 Preservatives antimicrobials 1 Aqua to 100 121 Frame formulation Number 5 9 201 1 ANTIPERSPIRANT CREAM Ingredients Maximum levels w w Oils and waxes e g vegetable and or mineral isoparaffin 30 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 30 Antiperspirant salts e g aluminium or zirconium
46. 1 1 FOUNDATION ANHYDROUS Ingredients Maximum levels w w Oils e g vegetable and or mineral 70 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 60 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 40 Bulking agents e g nylon talc kaolin silica 30 Colorants colour additives e g opacifying pearlescent agents 30 Waxes e g cera alba carnauba 20 Thickeners emulsifying agents e g sodium stearate potassium stearate 20 Humectants e g glycerin 10 Emollients e g anolin 10 UV filters 10 Additional ingredients e g vitamins antioxidants 5 Preservatives antimicrobials 1 Parfum 1 132 Frame formulation Number 7 3 201 1 CONCEALER CREAM Ingredients Maximum levels w w Colorants colour additives e g opacifying pearlescent agents 40 Oils e g vegetable and or mineral 20 Emollients humectants e g oleyl alcohol 20 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Bulking agents e g nylon talc starch kaolin 20 Ethanol alcohol alcohol denat 15 Emulsifying agents e g glyceryl stearate 10 Additional ingredients e g vitamins antioxidants 6 Thickeners 3 UV filters 3 Preservatives antimicrobials 2 Aqua to 100 133 Frame formulation Number 7 4 201 1 CONCEALER STICK Ingredients Maximum levels w w Ethanol a cohol alcohol denat 70 Additional ingredi
47. 1 4 Placing on the market Placing on the market means the first making available of a cosmetic product on the Community market 1 1 1 5 Importer Importer means any natural or legal person established within the Community who places a cosmetic product from a third country on the Community market 1 1 1 6 Nanomaterial Nanomaterial means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions or an internal structure on the scale from 1 to 100 nm 1 1 1 7 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 1 1 1 8 Responsible person For a cosmetic product manufactured within the Community and not subsequently exported and imported back into the Community the manufacturer established within the Community shall be the responsible person The manufacturer may designate by written mandate a person established within the Community as the responsible person who shall accept in writing Where for a cosmetic product manufactured within the Community and not subsequently exported and imported back into the Community the manufacturer is established outside the Community he shall designate by written ma
48. 16 Hair dyeing agents Primary intermediates e g p phenylenediamines such as p phenylenediamine and toluene 2 5 diamine p aminophenols such as p aminophenol and 4 amino m cresol heterocyclic diamines such as 7 hydroxyethyl 4 5 diamino pyrazole sulfate 6 Couplers e g m aminophenols such as m aminophenol and 4 amino 2 hydroxytoluene m phenylenediamines such as 2 amino 4 hydroxyethylamino anisole resorcinols such as resorcinol and 4 chlororesorcinol pyridines such as 2 6 dihydroxy 3 4 dimethylpyridine naphtols such as 7 o naphthalenediol 6 Directs e g HC red no 3 2 amino 6 chloro 4 nitrophenol basic yellow 87 6 Alkaline agents e g ammonium hydroxide ethanolamine 10 Cationic surfactants gt C42 e g dicetyldimonium chloride PEG 2 oleamine 5 Cationic polymers e g polyquaternium 6 5 Additional ingredients e g hair conditioning agents pearlescent agents 5 177 Antioxidants reducing agents e g ascorbic acid sodium metabisulfite Parfum Chelating agents e g EDTA Aqua pH value 8 11 6 pH value of the mixture with oxidative part 8 11 6 maximum concentration of ammonium hydroxide permitted is 6 178 Frame formulation Number 1 1 5 201 1 HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 2 TWO COMPONENTS COLORANT PART WITH HIGH LEVEL OF OILS To be mixed immediately prior to use with oxidative part 11 8 2011 or 11 9 2011 Ingredients Maximum levels w w Oils e g vegetab
49. 2 201 1 BATH SALTS CUBES Ingredients Maximum levels w w Sodium salts e g sodium carbonate sodium bicarbonate sodium sesquicarbonate sodium chloride 99 Parfum 5 Emollients e g glycerin 5 Anionic amphoteric non ionic surfactants e g sodium dodecylbenzenesulfonate 1 Oils e g vegetable and or mineral 1 Colorants 1 Binding agents e g silica 0 5 NB for cubes desintegrating agents e g talc starch 6 107 Frame formulation Number 2 1 3 201 1 BATH AND SHOWER OIL INCLUDING BATH BEADS Ingredients Maximum levels w w Emulsifying agents anionic amphoteric non ionic surfactants e g PEG stearate ethers of oley alcohol 15 Parfum 10 Plant extracts e g ivy extract rosemary extract 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 5 Additional ingredients e g vitamins UV filters 1 5 Colorants 1 Antioxidants 0 1 Oils e g vegetable and or mineral and emollients e g glycerin PEG isopropyl myristate to 100 In case of capsules or beads Nature of the capsule e g caprolactone and cellulose derivatives agar and plasticisers such as glycerin sorbitol 108 Frame formulation Number 2 1 4 201 1 FOOTBATH Ingredients Maximum levels w w Anionic amphoteric non ionic surfactants e g sodium laureth sulfate 20 Emollients humectants e g glycol stearate butylene glycol 10 Emulsifying agents e g ethoxylated long chain al
50. 3 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF BULKING AGENTS 1 4 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF FATTY COMPOUNDS 1 5 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF UV FILTERS 1 6 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF PERFUME 1 7 ZINC OXIDE BASED CREAM 1 8 SKIN GEL HYDRO ALCOHOLIC BASED 1 9 SKIN OIL 1 10 TONIC COSMETIC WATER 1 12 CHEMICAL EXFOLIATION PRODUCTS 1 13 SKIN CARE SILICONE BASED 1 14 PETROLEUM JELLY 1 15 TALCUM POWDER LOOSE OR PRESSED 1 16 LIP CARE STICK CREAM GEL 1 17 2 SKIN CLEANSING FOAMING SKIN CLEANSER1 2 1 FOAMING SKIN CLEANSER WITH HIGH LEVEL OF OILS AND OR HUMECTANT 2 2 71 MAKE UP REMOVER NON FOAMING CLEANSER INCLUDING TWO PHASE PRODUCTS 2 3 MAKE UP REMOVER NON FOAMING OIL CLEANSER 24 GENTLE CLEANSING GEL 25 SKIN CLEANSING CREAM LOTION SCRUB GEL 26 BODY SCRUB GEL CREAM 27 SOAP TOILET 28 LIQUID SOAP 2 9 BATH AND SHOWER GEL CREAM MILK PASTE 2 10 SLIGHTLY FOAMING SHOWER CREAM MILK 2 11 BATH SALTS CUBES 2 12 BATH AND SHOWER OIL INCLUDING BATH BEADS 2 13 FOOTBATH 2 14 3 HAIR REMOVAL CHEMICAL DEPILATORY CREAM GEL 3 1 PHYSICAL DEPILATORY WAX RESIN BASED 3 PHYSICAL DEPILATORY WAX SUGAR BASED F 4 BLEACH FOR BODY HAIR BLEACH FOR BODY HAIR 4 1 5 CORRECTION OF BODY ODOUR AND OR PERSPIRATION ANTIPERSPIRANT AEROSOL SPRAY WITH ANTIPERSPIRANT S
51. 5 193 Frame formulation Number 1 1 1 8 201 1 HAIR BLEACH OXIDATIVE PART TYPE 2 TO BE MIXED IMMEDIATELY PRIOR TO USE WITH HAIR BLEACH POWDER 11 15 2011 OR HAIR BLEACH POWDER ALKALINE PART 11 15 2011 11 19 2011 HAIR BLEACH PASTE 11 16 2011 OR HAIR BLEACH PASTE ALKALINE PART 11 16 2011 11 19 2011 Ingredients Maximum levels w w Oils e g vegetable and or mineral 80 Thickeners e g long chain alcohols acrylates copolymer 15 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 15 Hydrogen peroxide 12 Humectants e g glycerin 10 Additional ingredients e g hair conditioning agents 5 Parfum 2 Chelating agents 0 5 Hydrogen peroxide stabilising agents e g sodium stannate 0 5 pH adjuster e g phosphoric acid qs pH 2 3 Aqua to 100 pH value of the different mixtures 9 5 11 5 194 Frame formulation Number 1 1 1 9 201 1 HAIR BLEACH ALKALINE PART TO BE MIXED IMMEDIATELY PRIOR TO USE WITH HAIR BLEACH POWDER 11 15 2011 OXIDATIVE PART 11 17 2011 OR 11 18 2011 HAIR BLEACH PASTE 11 16 2011 OXIDATIVE PART 11 17 2011 OR 11 18 2011 Ingredients Maximum levels w w Anionic surfactants e g ammonium laureth sulfate 20 Non ionic surfactants e g aureth 12 deceth 3 20 Amphoteric surfactants e g betaine derivatives 20 Emulsifying agents e g ethoxylated long chain alcohols 30 Soaps e g ammonium hydroxide
52. ALT 5 1 12 DEODORANT AEROSOL SPRAY WITHOUT ANTIPERSPIRANT SALT 5 2 ANTIPERSPIRANT ROLL ON WITH ANTIPERSPIRANT SALT 5 3 DEODORANT ROLL ON WITHOUT ANTIPERSPIRANT SALT 5 4 ANTIPERSPIRANT STICK WITH ANTIPERSPIRANT SALT 5 5 DEODORANT STICK WITHOUT ANTIPERSPIRANT SALT 5 6 ANTIPERSPIRANT LIQUID SQUEEZE PACK OR PUMP SPRAY 5 7 DEODORANT LIQUID SQUEEZE PACK OR PUMP SPRAY 5 8 ANTIPERSPIRANT CREAM 5 9 6 SHAVING PRODUCTS SHAVING CREAM 6 1 BRUSHLESS SHAVING CREAM 6 2 SHAVE GEL 6 3 SHAVING GEL POST FOAMING 6 4 SHAVING FOAM AEROSOL 6 5 SHAVING SOAP STICK 6 6 AFTERSHAVE BALM 6 7 AFTERSHAVE LOTION 6 8 7 MAKE UP FOUNDATION AND BLUSHER LIQUID CREAM FOAM 7 1 FOUNDATION ANHYDROUS 7 2 CONCEALER CREAM 7 3 CONCEALER STICK 7 4 73 FOUNDATION CONCEALER SOLID 7 5 FACE POWDER 7 6 LIPSTICK LIP CREAM INCLUDING CONCEALER STICK CREAM 7 7 LIP COLOUR AND GLOSSER BALM 7 8 LIP PENCIL 7 9 LIPSTICK SEALER LIP COAT 7 10 LIP AND EYE FIX 7 11 EYE FIX ANHYDROUS 7 12 LIP INK PENCIL 7 13 LIP INK LIQUID 7 14 EYE SHADOW BLUSHER AND LINER POWDER 7 15 EYE SHADOW AND BLUSHER CREAM 7 16 EYE SHADOW AND BLUSHER ANHYDROUS CREAM STICK POWDER 7 17 EYE PENCIL 7 18 EYE LINER REGULAR LIQUID CREAM 7 19 EYE LINER WATERPROOF LIQUID CREAM PAST
53. Additional ingredients e g UV filters vitamins antioxidants 5 Emulsifying agents e g non ionics such as polysorbate 60 PEG 6 sorbitan stearate 5 Preservatives antimicrobials 1 Parfum 0 5 139 Frame formulation Number 7 1 0 201 1 LIPSTICK SEALER LIP COAT Ingredients Maximum levels w w Ethanol a cohol alcohol denat 95 Resins e g PVP 10 Plasticisers e g diisopropyl adipate 5 Thickeners e g hydroxyethylcellulose 1 140 Frame formulation Number 7 1 1 201 1 LIP AND EYE FIX Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 90 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 50 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 40 Humectants e g glycerin propylene glycol 25 Emulsifying agents thickeners e g polysorbate 25 Bulking agents e g talc zinc stearate silica 15 Emollients e g long chain alcohols isopropyl myristate 10 Polymers resins e g nylon PVP 10 Additional ingredients e g vitamins UV filters plant extracts 5 Preservatives antimicrobials 1 Parfum 1 Aqua to 100 141 Frame formulation Number 7 1 2 201 1 EYE FIX ANHYDROUS Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 70 Liquid paraffin and isoparaffin e g branched chain isop
54. C 16 isododecane isohexadecane 45 Emollients e g isopropyl myristate cetyl alcohol fatty esters 30 Antiperspirant salts e g aluminum chlorohydrate aluminum zirconium tetrachlorohydrate 25 Soaps emulsifying agents e g sodium stearate 20 Bulking agents e g stearalkonium bentonite perlite nylon powder talc 20 Additional ingredients e g plant extracts EDTA 5 Deodorants e g zinc ricinoleate 5 Parfum 3 Preservatives antimicrobials 1 Aqua to 100 118 Frame formulation Number 5 6 201 1 DEODORANT STICK WITHOUT ANTIPERSPIRANT SALT Ingredients Maximum levels w w Ethanol a cohol alcohol denat 80 Humectants e g propylene glycol glycerin 80 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 50 Oils and waxes e g vegetable and or mineral isoparaffin 45 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 45 Emollients e g isopropyl myristate cetyl alcohol fatty esters 30 Soaps emulsifying agents e g sodium stearate 25 Bulking agents e g stearalkonium bentonite perlite nylon powder talc 20 Additional ingredients e g plant extracts EDTA 5 Deodorants e g zinc ricinoleate 5 Parfum 3 Preservatives antimicrobials 1 Aqua to 100 119 Frame formulation Number 5 7 201 1 ANTIPERSPIRANT LIQUID SQUEEZE PACK OR PUMP SPRAY Ingredients Maximum levels Y w w Ethanol alcohol alcohol denat 8
55. E 7 20 EYE LINER CAKE 7 21 MASCARA REGULAR 7 22 MASCARA WATERPROOF 7 23 MASCARA CAKE 7 24 BODY GLITTER 7 25 8 PERFUMES PERFUME EAU DE COLOGNE EAU DE TOILETTE EAU DE PARFUM EXTRAIT DE 8 1 PARFUM PARFUM PERFUMED POWDER LOOSE OR PRESSED 8 2 74 SOLID PERFUME PASTE WAXE 8 3 PERFUMED SKIN OIL 8 4 9 SUN PRODUCTS AND SELF TANNING PRODUCTS SUNSCREEN CREAM LOTION 9 1 SUNSCREEN OIL 9 2 SUNSCREEN STICK 9 3 SUNSCREEN HYDROGEL 9 4 SUNSCREEN GEL OIL BASED 9 5 SELF TAN LOTION CREAM 9 6 SELF TAN LOTION GEL 9 7 10 HAIR AND SCALP CARE PRODUCTS SHAMPOO LIQUID CREAM PASTE 10 1 SOAP SHAMPOO 10 2 SHAMPOO PLUS CONDITIONER 10 3 HAIR CONDITIONER 10 4 HAIR CONDITIONER SILICONE BASED 10 5 HAIR SCALP CARE LOTION 10 6 HAIR SCALP BIPHASE LOTION 10 7 11 HAIR COLOURING PRODUCTS HAIR COLORANT TEMPORARY SHAMPOO 75 HAIR COLORANT TEMPORARY FOAM LOTION HAIR COLORANT TEMPORARY OR SEMI PERMANENT LIQUID CREAM FOAM HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 1 TWO COMPONENTS COLORANT PART HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 2 TWO COMPONENTS COLORANT PART WITH HIGH LEVEL OF OILS HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 3 THREE COMPONENTS COLORANT PART A HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 3 THREE COMPONENTS COLO
56. G ethers 25 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 20 Bulking agents e g perlite nylon powder 10 Additional ingredients e g plant extracts 5 Deodorants e g zinc ricinoleate 5 Parfum 3 Preservatives antimicrobials 1 5 Aqua to 100 116 Frame formulation Number 5 4 201 1 DEODORANT ROLL ON WITHOUT ANTIPERSPIRANT SALT Ingredients Maximum levels w w Ethanol alcohol alcohol denat 65 Oils and waxes e g vegetable and or mineral isoparaffin 30 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 30 Thickeners e g starch emollients e g glycerin emulsifying agents e g steareth PPG ethers 25 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C16 isododecane isohexadecane 20 Bulking agents e g perlite nylon powder 20 Additional ingredients e g plant extracts EDTA 5 Deodorants e g zinc ricinoleate 5 Parfum 3 Preservatives antimicrobials 1 5 Aqua to 100 117 Frame formulation Number 5 5 201 1 ANTIPERSPIRANT STICK WITH ANTIPERSPIRANT SALT Ingredients Maximum levels w w Ethanol a cohol alcohol denat 80 Humectants e g propylene glycol glycerin 80 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 50 Oils and waxes e g vegetable and or mineral isoparaffin 45 Liquid paraffin and isoparaffin e g branched chain isoparatfin C11
57. L above 1 PROPYL ALCOHOL above 1 T BUTYL ALCOHOL above 1 Others 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 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 69 MIBK above 5 POTASSIUM CHLORATE above 0 1 SODIUM CHLORATE above 0 1 TRIETHYL PHOSPHATE above 0 1 The user should also notify in the dedicated field any other information on the product that would be of significance for poison centres or similar bodies where such centres or bodies have been established by Member States using English only Note Frame formulations mentioning AQUA also cover products in which water is not added as such as an ingredient but through carry over from aqueous plant extracts fruit juices etc 70 ANNEX II Frame formulations 1 SKIN CARE SKIN CARE CREAM LOTION GEL 1 1 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF SILICONES 1 2 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF HUMECTANTS 1
58. PONENT BASED ON REDUCING AGENTS Ingredients Maximum levels w w Reducing agents e g ammonium thioglycollate 13 ammonium thiolactate 12 cysteine HCI 10 sodium metabisulfite 8 sodium sulfite 8 Alkaline agents e g ammonium hydroxide ethanolamine ammonium bicarbonate 8 Diammonium dithiodiglycolate 6 Silicones e g amodimethicone silanes e g alcoxysilanes 5 Additional ingredients e g Thickeners emulsifying agents 3 Anionic non ionic amphoteric surfactants e g cocamidopropy betaine 3 Cationic surfactants gt C42 e g dicetyldimonium chloride 3 Anionic cationic polymers e g acrylates copolymer polyquaternium 11 2 5 Hair conditioning agents e g proteins 2 5 Parfum 1 Colorants 1 Opacifying agents e g styrene PVP copolymer 0 5 Chelating agents 0 3 Aqua to 100 pH value 7 9 5 206 Frame formulation Number 1 2 1 3 201 1 PERMANENT WAVE LOTION TWO COMPONENTS BASED ON HYDROGENPEROXIDE AND REDUCING AGENTS PART A To be mixed prior to use with part B 12 14 2011 the mixing of parts A and B is exothermic Ingredients Maximum levels w w Hydrogen peroxide 12 Non ionic surfactants 5 Hair conditioning agents e g proteins 1 Stabilising agents 0 5 Aqua to 100 pH value 2 5 3 5 pH value of the ready to use mixture parts A and B 7 9 5 Frame formulation Number 1 2 1 4 S 201 1 PERMANENT WAVE LOTION TWO COMPONENTS BASED ON HYDROGEN PEROXIDE AND RED
59. R CAKE Ingredients Bulking agents e g talc Colorants colour additives e g opacifying pearlescent agents Emulsifying agents binding agents e g fatty acid esters Additional ingredients e g vitamins plant extracts Parfum Preservatives antimicrobials 151 Maximum levels w w 70 50 10 Frame formulation Number 7 22 201 1 MASCARA REGULAR Ingredients Maximum levels w w Film forming polymers e g ammonium acrylates copolymer cellulose derivatives acetyl trihexy citrate 45 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 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 isopropyl myristate 5 Additional ingredients e g vitamins plant extracts 5 Preservatives antimicrobials 2 5 Parfum 1 Aqua to 100 152 Frame formulation Number 7 23 201 1 MASCARA WATERPROOF Ingredients Maximum levels w w Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 80 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 8
60. R BLEACH PASTE TO BE MIXED IMMEDIATELY PRIOR TO USE WITH OXIDATIVE PART 11 17 2011 OR 11 18 2011 OR WITH OXIDATIVE AND ALKALINE PARTS 11 17 2011 OR 11 18 2011 AND 11 19 2011 Ingredients Maximum levels w w Ammonium sodium potassium persulfate 70 Oils e g vegetable and or mineral 50 Bulking agents e g kaolin magnesium stearate 50 Alkaline agents including ammonium hydroxide liberators e g sodium magnesium silicate sodium carbonate sodium metasilicate ammonium chloride 45 Emulsifying agents e g sodium lauryl sulfate 15 Thickeners e g guar gum 5 Additional ingredients e g Colorants chelating agents 5 pH value of the different mixtures 9 5 11 5 192 Frame formulation Number 1 1 1 T E 201 1 HAIR BLEACH OXIDATIVE PART TYPE 1 TO BE MIXED IMMEDIATELY PRIOR TO USE WITH HAIR BLEACH POWDER 11 15 2011 OR HAIR BLEACH POWDER ALKALINE PART 11 15 2011 11 19 2011 HAIR BLEACH PASTE 11 16 2011 OR HAIR BLEACH PASTE ALKALINE PART 11 16 2011 11 19 2011 Ingredients Maximum levels w w Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 15 Hydrogen peroxide 12 Humectants e g glycerin 10 Oils e g vegetable and or mineral 5 Parfum 2 Chelating agents 0 5 Hydrogen peroxide stabilising agents e g sodium stannate 0 5 pH adjuster e g phosphoric acid qs pH 2 3 Aqua to 100 pH value of the different mixtures 9 5 11
61. RANT PART B HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 1 TWO OR THREE COMPONENTS OXIDATIVE PART HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 2 TWO OR THREE COMPONENTS OXIDATIVE PART WITH HIGH LEVEL OF OILS DYE REMOVER REDUCING TYPE PART A 11 10 DYE REMOVER REDUCING TYPE PART B 11 11 DYE REMOVER OXIDATIVE TYPE PARTA 11 12 DYE REMOVER OXIDATIVE TYPE PART B 11 13 SKIN DYE REMOVING CLEANSER REDUCING TYPE 11 14 HAIR BLEACH POWDER 11 15 HAIR BLEACH PASTE 11 16 HAIR BLEACH OXIDATIVE PART TYPE 1 11 17 HAIR BLEACH OXIDATIVE PART TYPE 2 11 18 HAIR BLEACH ALKALINE PART 11 19 HAIR COLOUR RESTORER 11 20 12 HAIR STYLING PRODUCTS HAIR STYLING CREAM PASTE GUM POMADE PASTE WAXE 12 1 HAIR SHINE WAX OR BRILLIANTINE 12 2 HAIR STYLING LOTION 12 3 76 SETTING LOTION INCLUDING COLOURED SETTING LOTIONS 12 4 HAIR SHINE STYLING GEL 12 5 HAIR FOAM 12 6 HAIR SPRAY AEROSOL 12 7 HAIR SPRAY PUMP SPRAY 12 8 HAIR SHINE SPRAY AEROSOL 12 9 PERMANENT WAVE LOTION SINGLE COMPONENT BASED ON REDUCING AGENTS 12 10 PERMANENT WAVE LOTION TWO COMPONENT BASED ON HYDROGEN 12 13 PEROXIDE AND REDUCING AGENTS PART A i PERMANENT WAVE LOTION TWO COMPONENT BASED ON HYDROGEN PEROXIDE 12 14 AND REDUCING AGENTS PAR
62. Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Thickeners e g carbomer xanthan gum 12 Bulking agents e g talc silica zinc oxide nylon powder 10 Abrasives e g polyethylene walnuts 10 Additional ingredients e g vitamins antioxidants plant extracts 10 Cationic polymers e g polyquaternium 7 polyquaternium 24 Parfum 5 Preservatives antimicrobials 2 Colorants 1 Aqua to 100 101 Frame formulation Number 2 7 201 1 BODY SCRUB GEL CREAM Ingredients Maximum levels w w Anionic surfactants e g sodium lauroyl sarcosinate sodium laureth sulfate disodium laureth sulfosuccinate 30 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 30 Humectants e g glycerin hexylene glycol 30 Abrasives e g polyethylene walnuts 20 Non ionic amphoteric surfactants e g betaine derivatives glucose derivatives 20 Foam boosting agents e g ethoxylated long chain alcohols alkyl polyglucose 10 Emulsifying agents e g PEG 6 laurate glyceryl cocoate 10 Thickeners e g hydroxypropyl methylcellulose sodium chloride 10 Parfum 6 Additional ingredients e g pearlescent agents plant extracts 6 Cationic polymers e g polyquaternium 7 3 Colorants 1 Preservatives antimicrobials 1 Aqua to 100 102 Frame formulation Number 2 8 201 1 SOAP TOILET Ingredients Maximum levels w w Soap vegetable base palm oil and coconut oil fat
63. T B i PERMANENT WAVE LOTION TWO COMPONENT BASED ON REDUCING AGENTS 12 15 PART A PERMANENT WAVE LOTION TWO COMPONENT BASED ON REDUCING AGENTS 12 16 PART B PERMANENT WAVE NEUTRALISER LIQUID CREAM 12 17 HAIR STRAIGHTENER RELAXER TYPE 1 12 18 HAIR STRAIGHTENER RELAXER TYPE 2 PART A 12 19 HAIR STRAIGHTENER RELAXER TYPE 2 PART B 12 20 HAIR STRAIGHTENER RELAXER TYPE 3 12 21 13 NAIL VARNISH AND REMOVER NAIL VARNISH 13 1 NAIL WHITE PENCIL 13 2 14 NAIL CARE NAIL CONDITIONER OIL BASED 14 1 11 16 TOOTH CARE TOOTHPASTE 16 1 17 MOUTH WASH BREATH SPRAY MOUTHWASH 17 1 MOUTHWASH CONCENTRATE 17 2 BREATH SPRAY PUMP SPRAY 17 3 78 Frame formulation Number 1 1 201 1 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 Preservatives antimicrobials 2 Colorants 2 Parfum 1 Aqua to 100 79 Frame formulation Number 1 2
64. TAN LOTION GEL Ingredients Maximum levels w w Ethanol a cohol alcohol denat 60 UV Filters 15 Humectants e g glycerin propylene glycol 10 Emulsifying agents e g PEG 40 hydrogenated castor oil 10 Additional ingredients e g plant extracts allantoin vitamins 6 Dihydroxyacetone 10 Thickeners e g carbomer 10 Colorants 5 Preservatives antimicrobials 2 Parfum 0 5 Chelating agents 0 5 Aqua to 100 166 Frame formulation Number 1 0 1 201 1 SHAMPOO LIQUID CREAM PASTE Ingredients Maximum levels w w Anionic surfactants e g sodium ammonium TEA lauryl sulfates sodium ammoniun TEA laureth sulfates 30 Amphoteric surfactants e g betaine derivatives 20 Non ionic surfactants e g fatty alkanolamides 15 Thickeners e g propylene glycol PEG 10 Cationic surfactants gt C42 e g stearamidopropy l dimethylamine behentrimonium chloride 5 Hair conditioning agents e g silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes cysteine derivatives cellulose derivatives fatty acid esters 15 Additional ingredients e g UV filters pearlescent agents opacifying agents 10 Parfum 2 Preservatives antimicrobials 1 Chelating agents e g disodium EDTA 0 5 Aqua to 100 167 Frame formulation Number 1 0 2 201 1 SOAP SHAMPOO Ingredients Maximum levels w w Soap base e g mixed sodium potassium stearate and sodi
65. The European Commission s Identity Management Service IMS provides a common way for users to register or be registered for access to a number By checking this box you acknowledge that you have read and understood the privacy statement Security check PEFREEPLIPEIPEETELIBLTEHE PEL Try a different image Please type in the characters in the above image upper and lower case may be used fiorchasnoativ Once the registration is sent the system will display the following confirmation page opean Commission Authentication Service cy Statement Contact ECASHelp Registration Help Thank you for registering you will receive an e mail allowing you to complete the registration process This website is managed by the European Commission s Informatics DG 1 3 2 2 Register a password After the submission of the ECAS registration form an e mail will be sent to the user e mail address This e mail will allow the user to complete the registration process by choosing a password Your password Message HTML File Edit view Insert Format Tools Actions Help SEE Please treat this as Private From European Commission Authentication Service ecas admin ec europa eu Sent jeu 17 06 2010 10 26 To c D Subject Your password gt You have been registered in ECAS the European Commission Authentication Servi
66. UCING AGENTS PART B To be mixed prior to use with part A 12 13 2011 the mixing of parts A and B is exothermic Ingredients Maximum levels w w Reducing agent Ammonium thioglycolate 20 Alkaline agents e g ammonium hydroxide ethanolamine ammonium bicarbonate 8 Anionic non ionic amphoteric surfactants e g betaine derivatives 3 Cationic surfactants 2 C12 e g adicetyldimonium chloride 3 Parfum 1 Colorants 1 Opacifying agents 0 5 Aqua to 100 before exothermic reaction with hydrogen peroxide pH value 7 9 5 pH value of the ready to use mixture parts A and B 7 9 5 208 Frame formulation Number 1 2 1 5 S 201 1 PERMANENT WAVE LOTION TWO COMPONENTS BASED ON REDUCING AGENTS PART A To be mixed prior to use with part B 12 16 2011 Ingredients Maximum levels w w Reducing agent Thioglycolate ester e g glyceryl thioglycolate 99 Glycerin 50 pH value of the ready to use mixture parts A and B 6 5 9 209 Frame formulation Number 1 2 1 6 201 1 PERMANENT WAVE LOTION TWO COMPONENTS BASED ON REDUCING AGENTS PART B To be mixed prior to use with part A 12 15 2011 Ingredients Maximum levels w w Reducing agents e g ammonium thioglycolate 5 cysteine HCI 10 ethanolamine thioglycolate 1 Anionic non ionic amphoteric surfactants e g betaine derivatives 10 Cationic surfactants C42 e g dicetyldimonium chloride 5 Alkaline agents e g ammonium h
67. acts 5 Deodorants e g zinc ricinoleate 4 Parfum 3 Preservatives antimicrobials 0 1 114 Frame formulation Number 5 2 201 1 DEODORANT AEROSOL SPRAY WITHOUT ANTIPERSPIRANT SALT Ingredients Maximum levels w w Ethanol a cohol alcohol denat 95 Propellants e g dimethyl ether hydrocarbons compressed gas 90 Humectants emollients e g isopropyl myristate glycerin propylene glycol 25 Oils and waxes e g vegetable and or mineral isoparaffin 15 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 15 Liquid paraffin and isoparaffin e g branched chain isoparatfin C11 C 16 isododecane isohexadecane 15 Thickeners e g stearalkonium bentonite 10 Bulking agents e g perlite nylon powder 5 Additional ingredients e g plant extracts 5 Deodorants e g zinc ricinoleate 4 Parfum 3 Preservatives antimicrobials 1 Aqua to 100 NB includes aerosol spray compressed gas e g air nitrogen carbon dioxide 115 Frame formulation Number 5 3 201 1 ANTIPERSPIRANT ROLL ON WITH ANTIPERSPIRANT SALT Ingredients Maximum levels w w Ethanol a cohol alcohol denat 65 Oils and waxes e g vegetable and or mineral isoparaffin 30 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 30 Antiperspirant salts e g aluminium salt or aluminium zirconium complex 25 Thickeners e g starch emollients e g glycerin emulsifying agents e g steareth PP
68. al functions that may make them fall under different categories In these cases it is the primary function that has to be considered for the categorisation 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 31 Category of cosmetic product Level 1 Skin products Level 2 Skin cleansing products Level 3 Soap products gt All existing categories are available for consultation in Annex III to this User Manual 11 2 2 2 2 Physical form The responsible person has to select the physical form of the product in the drop down menu Physical form EERE choose one N TIENT powder Is the product preseiLoose powder Cream paste gel Liquid Foam 4 z Spray Formulation name Bother 11 2 2 2 3 Special applicator packaging When the product is not presented in a typical non pressurised cosmetic packaging e g bottle jar or sachet but in a special applicator or packaging the responsible person has to mention it This information might allow poison centres to modulate their risk assessment in case of emergency medical treatment By clicking on e the responsible person can see the possible choices in terms of special applicators and packagings If the answer is yes the responsible person has to select the applicator packaging from the drop down menu Is the product pres
69. amphoteric non ionic surfactants e g ethoxylated long chain alcohols 15 Hydrogen peroxide 12 Humectants e g glycerin 10 Parfum 2 Chelating agents 0 5 Hydrogen peroxide stabilising agents e g sodium stannate 0 5 pH adjuster e g phosphoric acid qs pH 2 3 Aqua to 100 pH value of the mixture with colourant part 8 11 6 184 Frame formulation Number 1 1 9 201 1 HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 2 TWO OR THREE COMPONENTS OXIDATIVE PART WITH HIGH LEVEL OF OILS To be mixed immediately prior to use with colourant part 11 4 2011 or 11 5 2011 or 11 6 2011 11 7 2011 Ingredients Maximum levels w w Oils e g vegetable and or mineral 80 Thickeners e g long chain alcohols acrylates copolymer 15 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 15 Hydrogen peroxide 12 Humectants e g glycerin 10 Additional ingredients e g hair conditioning agents 5 Parfum 2 Chelating agents 0 5 Hydrogen peroxide stabilising agents e g sodium stannate 0 5 pH adjuster e g phosphoric acid qs pH 2 3 Aqua to 100 pH value of the mixture with colourant part 8 11 6 185 Frame formulation Number 1 1 1 0 z 201 1 DYE REMOVER REDUCING TYPE PARTA To be mixed immediately prior to use with part B 11 11 2011 Ingredients Maximum levels w w Acid citric acid 13 Aqua to 100 pH value 1 5 2 186 Frame formulation Number 1
70. anaes mata eat eee otro 20 Th 2 1 General miformation tabeatna a a aE NE EE E E R R 21 M2 2 Product Metals tab zren e a coerce a E E aA EAIA 27 II 3 NOTIFICATIONS PURSUANT TO ARTICLE 13 1 and 2 MULTI COMPONENT PRODUCT E gu esy ad ey A T E E leds E E one reauhs 46 II 4 NOTIFICATIONS PURSUANT ARTICLE 13 3 DISTRIBUTION 1 0 0 cece cesceeeeeeeeteeeneees 48 MESA TOOLS a sts ats Ba Ni ly ae al tn a Sg ashe ue es BuO sc Da ce TAO Ty he a 49 MS lSimple seathar nre ny crane er eer te reer eter nd a ate Sie heer Sie tert et ee Neer Weert UrePece de Met So 49 M5 2Ady nced SEARO UN yasiestois corte esha catia ini tent oeiescaleted cnet entre fat des Taki oiet hat cabices Gaeimiats 50 TES 3 Distribution Search sacs ssccciesesescanvcsuadasnsoaedssuaecauesassaceasonccade E AE EE dagenedoedyseonsecesateses 52 TESA Responsible PETS ON SE AEC I 3h 5 5S soe sins ssiecaalop bec nacise ss taes a ds h gu deena uceue R Ra seasn ees 53 II 6 VIEW EDIT or DUPLICATE NOTIFICATIONS PURSUANT ARTICLE 13 1 and 2 53 M6 L View producten nenun n a a a a a a a a a a aiaa a a e 54 I 6 1 1 Single component products sssesssessseeeesseesseesseesseresseesssetssresseresseesseeesseresseesseesseesseeessseesseese 55 M 6 1 2 Multicomponent prodUCtS ceina a a E R E a ERA E 56 EAA IG Or OCU TO AAE EEE EAEE E EEE 58 M63 D plicate a Pr OCU cess sch s ree a E E EE a a i air irigis 59 I 7 VIEW AND EDIT NOTIFICATIONS PURSUANT ARTICLE 13 3 eccee
71. and poison centres can search for all submitted notifications contained in the system Draft notifications are not accessible to competent authorities and poison centres The Simple search searches on product name component name responsible person name distributor name for competent authorities and poison centres only category level 3 formulation name for responsible person and poison centres only and CPNP reference Simple search formulation name CPNP reference In order to reduce the amount of data returned please enter words of at least three characters Keyword search cream Show 10 v entries Filter CPNP Product Name Component Responsible Category Formulation Version ist Ref name Person Name notification date 218 KANEBO Skin 1 14 06 2011 products 219 KANEBO Skin 1 14 06 2011 products 220 KANEBO Cream KANEBO Skin 1 14 06 2011 As shown above the keyword s used for the simple search will be highlighted in the list of results 11 5 2 Advanced search The Advanced search is intended for the responsible persons the competent authorities and the poison centres It allows these users to search a product into the CPNP using cumulative search criteria The advanced search criteria are spread over two different tabs 52 General information Category amp formulation General information f f The tab allows the users to search on the following general information criteria about the product
72. araffin C11 C 16 ea isohexadecane Silicones including volatile silicones e g cyclopentasiloxane dimethicone 50 Bulking agents e g talc silica nylon powder 40 Thickeners e g stearalkonium hectorite 15 Additional ingredients e g vitamins plant extracts antioxidants 5 Preservatives antimicrobials 1 Parfum 1 142 Frame formulation Number 7 1 3 201 1 LIP INK PENCIL Ingredients Maximum levels w w Humectants e g glycerin propylene glycol 20 Ethanol alcohol alcohol denat 20 Polymers resins e g PVP dimethicone copolyol 15 Emulsifying agents e g polysorbate 10 Colorants colour additives e g opacifying pearlescent agents 10 Additional ingredients e g vitamins UV filters antioxidants 5 Preservatives antimicrobials 1 Parfum 1 Aqua to 100 143 Frame formulation Number 7 1 4 201 1 LIP INK LIQUID Ingredients Maximum levels w w Humectants e g glycerin propylene glycol 20 Ethanol a cohol alcohol denat 10 Emulsifying agents e g trioley phosphate sodium lauryl phosphate 10 Polymers resins e g xanthan gum carbomer 10 Colorants colour additives e g opacifying pearlescent agents 10 Oils e g vegetable and or mineral and fats 5 Additional ingredients e g vitamins antioxidants 5 Preservatives antimicrobials 2 Parfum 1 Aqua to 100 144 Frame formulation Number 7 1 5 201 1 EYE SHADOW BLUSHER and LINER POWDER Ingredients Maximum le
73. ated in the answering field The CPNP applies the English notation for numbers Example 0 3 and not 0 3 For ethanol and or isopropanol an updated notification is required when the content of either ingredient or the sum of both ingredients changes by more than 5 if the value declared previously is lt 30 or by more than 10 if the value declared previously is 30 For all other ingredients of concern an updated notification is required when the concentration of the ingredient changes by more than 20 of the value previously declared see Annex to this User Manual for further details An updated notification is also required when the product does not fall anymore in the predefined frame formulation when a new ingredient of concern enters in the composition of the product or when an ingredient of concern no longer enters the composition of the product 11 2 2 2 5 2 Exact concentration declaration If the responsible person selects Exact concentration the CPNP will ask whether he wants to upload a file for the qualitative and quantitative composition Please choose the notification type Exact concentrations Upload a file for the qualitative and quantitative composition Yes No 1 If the responsible person answers yes he is asked to attach the corresponding file Only PDF format is allowed Upload a file for the qualitative and quantitative composition Yes No Qualitative and quantitative comp
74. ations done by a user belonging to a suborganisation are visible and editable by any user of this suborganisation These notifications are also visible but not editable by the Responsible Person How to create a sub organisation in SAAS There are two possibilities to create a suborganisation in SAAS when a user request an access to CPNP she he has the possibility to select an existing suborganisation or to create a new one The local administrator of the parent organisation will have to accept or refuse the creation of the new suborganisation and any access to that suborganisation A local administrator of an organisation also has the possibility to create new suborganisations by clicking on the Create new button ll USING CPNP I 1 CPNP HOME PAGE Depending on the user profile i e responsible person distributor competent authority or poison centre the home pages and subsequent screens may differ This is detailed throughout this user manual 11 1 1 Confidentiality aspects Some of the data contained in CPNP are business confidential information For this reason the following warning message is displayed on the home page for the competent authorities and for the poison centres when they connect to the CPNP 17 Welcome to the Cosmetic Products Notification Portal I understand that by logging into the Cosmetic Products Notification Portal I am given access to information which is business confidential by natu
75. ats 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 C11 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 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 02 138 Frame formulation Number 7 9 201 1 LIP PENCIL Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 90 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 50 Colorants colour additives e g opacifying pearlescent agents 50 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 40 Bulking agents e g talc silica 30 Polymers e g nylon PVP 20 Thickeners e g stearalkonium hectorite 10
76. authorities industry trade associations and Commission services and are available for consultation in the Annex to this User Manual The following first question will be asked Does the product contain any of the following ingredients Yes see below No GLYCOLS AND GLYCOL ETHERS 0 HYDROCARBON SOLVENTS 0 ALCOHOLS OTHER THAN ETHANOL AND ISOPROPANOL 0 HOTHERS 0 I Please carefully go through the whole list of ingredients by clicking on the symbols The responsible person has either to click on Yes see below check the box of the relevant ingredient s and indicate its their concentration s in the product on Yes see attachment if the answer is provided in the attachment or on No if the product contains none of the ingredients listed For the other questions the responsible person will usually have three options i e to answer the question in the dedicated fields answer not applicable or answer see attachment Please specify the percentage weight of ethanol Not applicable See attachment A Important notice A Not applicable means in the case of ethanol and or isopropanol that these ingredients are not present in the product Not applicable means in the case of all other ingredients of concern that the ingredient is either not present in the product or is present in the product but under the concentration of concern according to the rules set out in the Annex to this User Manual
77. cceeseeesseeeteceeeeeeeeeeneees 60 ANNEX I Rules on specific ingredients of concern and or the pH value eee ees eeseceeeeeseeseseenseeeeeeeenees 61 ANNEX M Frame formulations sceni hans etre T E tu iva E Neeanes eh E eared geo 69 ANNEX III Categories of Cosmetic products ecccecsscceesseceesseceessecesaecesaaecesaaeceeaeecssacecseneeceeneeceseeeeesaeers 222 I INTRODUCTION AND SYSTEM REQUIREMENTS 1 1 INTRODUCTION 1 1 1 Key terms Some key terms used in this User Manual are reproduced here for ease of reference 1 1 1 1 Cosmetic product 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 odours 1 1 1 2 Distributor 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 1 1 1 3 Making available on the market Making available on the market means 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 1 1
78. ce Click on the link and you will be automatically redirected to the Password registration page Your user name is fabreca To create your password click You have a maximum of 1h30 starting from the time that this message was sent to create your password but you are encouraged to do so immediately if possible After this time you can make another request by following the same link you will then need to re enter your username and confirm your request F the above link does not work you can copy the following address make sure the complete address is copied and paste it into your browser s address bar https webgate ec europa_eu ecas init initialisePasswordLogin do wayf domain external amp wayf remember checked amp wayf submit Select amp uid nfabrece amp resetCode dtlOw7opCFPjyTD Whenever you login please choose the domain External not European Commission Instead of replying to this message if you have a problem please follow the help or contact information on the site where you were trying to register Sent to you by ECAS European Commission Authentication Service Once the user has clicked on the link specified in the e mail the following page will be displayed 10 gt gt EUROPA gt Authentication Service gt Password initialisation Create your new password and login Domain External Username en This page allows you to reset your ECAS passy original request New
79. clicking on the original labeling of the product text only The Previous version s tab indicates into brackets the number of versions and displays information on these different versions of the notification period of validity type of change update or correction and reason for change see section II 6 2 The Distributed tab is only available to competent authorities and poison centres This tab shows the contact details of the distributors At the bottom right up to four buttons may appear PoF LExport Edit Back The button Por allows the user to create a PDF document for the notification The button Export allows the user to export the notification using XML files The button Edit is only available for responsible persons It allows the responsible person to edit its notification The button Back allows the user to go back to the search screen 11 6 1 2 Multi component products General information Component component Previous versions 1 For the multi component products the tabs available are slightly different The General information tab displays some general information on the product e g the CPNP reference e the reference given by the CPNP to the product the industry reference e the reference given by the industry to the product only for industry internal use the version of the notification 58 the last modification date and time stamp the product name
80. cohols 10 Foam boosting agents e g cocamide MEA 10 Ethanol alcohol alcohol denat 5 Additional ingredients e g plant extracts 5 Preservatives antimicrobials antioxidants 1 Parfum 1 Colorants 1 Aqua to 100 109 Frame formulation Number 3 1 201 1 CHEMICAL DEPILATORY CREAM GEL Ingredients Maximum levels w w Alkaline agents e g calcium sodium potassium carbonate sodium potassium silicate sodium hydroxide calcium oxide 15 Thickeners e g propylene carbonate 15 Emulsifying agents e g ethoxylated long chain alcohols esters 15 Emollients humectants and waxes e g glycerin long chain alcohols 15 Reducing agents e g thioglycerin thioglycolic acid and its salts 8 Additional ingredients e g plant extracts colorants chelating agents 5 Parfum 1 Aqua to 100 less than 5 calculated as thioglycolic acid pH 11 12 7 110 Frame formulation Number 3 2 201 1 PHYSICAL DEPILATORY WAX RESIN BASED Ingredients Tackifying agents and thickeners e g triethylene glycol rosinate glyceryl rosinate polyethylene ethylene VA copolymer hydrogenated microcrystalline wax paraffin colophonium beeswax silica Emollients humectants e g paraffinum liquidum glycerin Emulsifying agents anionic amphoteric non ionic surfactants e g PEG 40 hydrogenated castor oil Aqua Additional ingredients e g plant extracts skin conditioning agents opacifying agents antioxidants Colo
81. dit is only available for responsible persons It allows the responsible person to edit its notification The button Back allows the user to go back to the search screen Il 6 2 Edit product The Edit product function is only available for the responsible person It allows the responsible person to edit a notification it has previously entered in the system A Important Notice A Where any of the information set out in paragraphs 1 3 and 4 of Article 13 of Regulation 1223 2009 changes the responsible person or the distributor shall update its notification without delay Once the change s made the system will ask the responsible person for the modification type update or correction and the modified items A Important Notice A It is important to make a clear distinction between an update and a correction It is particularly important to make this distinction when it concerns the formulation An update of the formulation means a change of previously valid information The original data are related to the older product formulation while the updated dataset relates to the new 60 formulation Poisons centre must evaluate both formulations in case they cannot reliably decide which formulation version is involved in an exposure case A correction of the formulation means change of erroneous or incomplete product information without changing the real world formula Poisons centre need only
82. e 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 centres or similar bodies established by Member States for the purposes of medical treatment 1 1 5 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 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 labelling of that product in order to comply with national law OJ L342 22 12 2009 p 59 will have to submit into CPNP the information referred to in Article 13 3 of Regulation EC N 1223 2009 Where a cosmetic product has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date and a distributor introduces that product in a Member State after that date that distributor will have to communicate the information referred to in Article 13 4 of Regulation EC N 1223 2009 to the responsible person On the basis of that comm
83. edients e g vitamins plant extracts 3 Parfum 2 Antioxidants chelating agents 0 5 Aqua to 100 124 Frame formulation Number 6 3 201 1 SHAVE GEL Ingredients Maximum levels w w Humectants e g glycerin 15 Film forming polymers e g glyceryl polymethacrylate 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Thickeners e g hydroxyethylcellulose 3 Emulsifying agents anionic amphoteric non ionic surfactants e g sodium laureth sulfate 3 Additional ingredients e g vitamins plant extracts 3 Parfum 1 Colorants 1 Preservatives antimicrobials 1 Aqua to 100 125 Frame formulation Number 6 4 201 1 SHAVING GEL POST FOAMING Ingredients Maximum levels w w Soaps e g potassium salts of fatty acids triethanolamine salts of fatty acids 30 Humectants e g glycerin 15 Emulsifying agents anionic amphoteric non ionic surfactants e g PEG 150 distearate 10 Additional ingredients e g vitamins plant extracts 6 Post foaming agents e g hydrocarbon 5 Thickeners e g cellulose derivatives 2 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 2 Parfum 2 Skin conditioning agents e g polyquaternium 7 2 Colorants 1 Preservatives antimicrobials 0 2 Aqua to 100 126 Frame formulation Number 6 5 201 1 SHAVING FOAM AEROSOL Ingredients Maximum levels w w Soaps e g potassium salts of fatty acids triethanolamine sal
84. ented in a special applicator packaging oe v Yes No Applicator packaging Please choose one 7 Please choose one Wipe sponge patchipad Capsule Pressurised spray container If the responsible person selects other in the drop down menu the responsible person is invited to suggest an applicator packaging denomination preferably in English All applicator packaging suggested names will be taken into consideration by the CPNP maintenance group in order to create new applicator packaging names or update the existing ones where necessary 32 Is the product presented in a special applicator packaging in v Yes No applicator packaging Other Please suggest an applicator packaging denomination 11 2 2 2 4 Formulation name Depending on the categories selected at levels 1 2 and 3 the CPNP will propose a list of possible formulation names in a drop down menu The responsible person has to select the relevant formulation name The formulation name provides a more detailed product categorisation which is made available to poison centers only Formulation name Select a formulation name Select a formulation name Soap Toilet Please choose the notification type a Liquid Soap Other Soap Products A Important notice A Choosing a formulation name does not mean that the responsible person will notify his product using a predefined frame formulation After having selected a formulation name
85. ents e g UV filters antioxidants 5 Humectants e g glycerin 2 Smoothing agents anti blemish agents e g salicylic acid 2 Preservatives antimicrobials 2 Thickeners 1 Chelating agents 0 1 Aqua to 100 134 Frame formulation Number 7 5 201 1 FOUNDATION CONCEALER SOLID Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 55 Emollients e g lanolin oil isopropyl myristate 50 Opacifying agents e g calcium carbonate 40 Colorants colour additives e g pearlescent agents 40 Aqua 40 Ethanol alcohol alcohol denat 15 Bulking agents e g talc 15 Thickeners e g stearalkonium hectorite propylene carbonate 10 UV filters 10 Emulsifying agents e g PEG derivatives PPG derivatives 6 Additional ingredients e g plant extracts vitamins antioxidants 5 Preservatives antimicrobials 2 135 Frame formulation Number 7 6 201 1 FACE POWDER Ingredients Maximum levels w w Mineral Bulking agents e g talc mica kaolin zinc oxide titanium dioxide magnesium calcium carbonate 95 Other Bulking agents e g starch nylon powder polyethylene powder 50 Binding agents e g vegetable and or mineral oils fatty acid esters Silicones including volatile silicones e g cyclopentasiloxane dimethicone is Colorants colour additives e g opacifying pearlescent agents 30 Anticaking agents e g zinc magnesium stearate zinc magnesium laura
86. epilation products Other body hair removal products Bleach for body hair products 224 Bleach for body hair Correction of body odour and or perspiration Products with antiperspirant activity Products without antiperspirant activity Shaving and pre after shaving products Shaving products Pre after shaving products Other shaving and pre after shaving products Make up 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 Perfumes Hydroalcoholic perfumes Non hydroalcoholic perfumes Sun and self tanning products Before and after sun products Sun protection products Self tanning products Other sun and self tanning products Other skin products 225 Other skin products Hair and scalp products Hair and scalp care and cleansing products Shampoo Hair conditioner Scalp and hair roots care products Antidandruff products Antihairloss products Other hair and scalp care and cleansing products Hair colouring 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 temp
87. exporting the results list in a PDF or XLS format 11 5 3 Distribution search The Distribution search is intended for the distributors only It allows a distributor to search for its notifications Home Products Contact persons Distributors Useful links 7 Notify a product This search tool allows the distributor to search on the product name in the Member State where the distributor has made the product available on the Member State where the product was made available by the distributor and on the status of the notification i e draft or notified 54 Product name in the Member State in which the product is made available Member State in which the product is made available Status Choose a country gt Chooseas The two following buttons are available at the bottom right of the screen Reset to reset the search criteria Search to launch the search 11 5 4 Responsible person search The Responsible person search is intended for the competent authorities and poison centres only It allows these users to search for a responsible person in the CPNP by its name the postal code or the country of its address It then allows for the consultation of all notifications of this responsible person Responsible person search Responsible person name Postal code Country Choose a country 11 6 VIEW EDIT or DUPLICATE NOTIFICATIONS PURSUANT ARTICLE 13 1 and 2 Once a simple search
88. factants e g glyceryl stearate Parfum 5 Thickeners e g carbomer 1 Colorants 1 Preservatives antimicrobials 1 Chelating agents antioxidants 0 5 Aqua to 100 129 Frame formulation Number 6 8 201 1 AFTERSHAVE LOTION Ingredients Maximum levels w w Ethanol alcohol alcohol denat 90 Emollients humectants e g glycerin propylene glycol isopropyl myristate 15 Parfum 10 Additional ingredients e g plant extracts astringents such as hamamelis 10 Colorants 1 Chelating agents antioxidants 0 5 Aqua to 100 130 Frame formulation Number 7 1 201 1 FOUNDATION and BLUSHER LIQUID CREAM FOAM Ingredients Maximum levels w w Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 60 Oils e g vegetable and or mineral 40 Emollients e g propylene glycol lanolin 30 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 30 Bulking agents e g talc kaolin silica starch 30 Colorants colour additives e g opacifying pearlescent agents 30 Humectants e g glycerin PEG 25 Thickeners emulsifying agents e g glyceryl stearate PEG stearate 20 Ethanol alcohol alcohol denat 15 UV filters 10 Anionic amphoteric non ionic surfactants e g sodium lauroyl sarcosinate 5 Additional ingredients e g vitamins plant extracts 5 Parfum 1 Preservatives antimicrobials 1 Aqua to 100 131 Frame formulation Number 7 2 20
89. for the first time need to follow a 3 step procedure 1 Create his ECAS login password 2 Request an access to CPNP 3 Connect to CPNP All CPNP users should be part of what is called an organisation An organisation means either a responsible person or its sub organisations a distributor a competent authority or a poison centre There are two situations that a new user may face 1 The organisation she he belongs to already exists in SAAS In this situation the user only needs to ask for an access to this organisation The local administrator s of this organisation will have the possibility to accept or refuse the access request 2 The organisation does not yet exist in SAAS In this situation the user has to create the organisation in SAAS The Commission services have to validate this new organisation and to accept or refuse the access request submitted by the user The user who creates a new organisation becomes automatically a local administrator of this organisation and in the future he will be able to manage all access requests related to that organisation Note A local administrator can designate additional local administrator s for her his organisation and for each of its sub organisations see section 1 3 3 3 for further details provided that these future new local administrator s already exist in SAAS and have access to CPNP for the sub organisation To do so the local administrator has
90. h 20 5 Hair texturizing agents e g kaolin starch 3 Plasticisers e g triacetin 2 Preservatives antimicrobials 2 Additional ingredients e g UV filters vitamins 2 Colorants 1 Parfum 0 2 Aqua to 100 202 Frame formulation Number 1 2 7 z 201 1 HAIR SPRAY AEROSOL Ingredients Maximum levels w w Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 95 Propellants e g dimethyl ether hydrocarbons 90 Solvents e g volatile silicones e g cyclopentasiloxane dimethicone liquid paraffin and isoparaffin e g branched chain isoparatfin C11 C 16 isododecane isohexadecane 40 Humectants e g glycerin propylene glycol 30 Resins polymers e g PVP VA copolymer VA crotonates copolymer butyl ester of PVM MA copolymer Neutralising agent e g aminomethy propanol Alkoxylated glucose derivatives 8 5 Additional ingredients e g UV filters vitamins 2 Plasticisers e g polyglycol ethers alcohol esters 2 Preservatives antimicrobials 1 Parfum 1 Aqua to 100 203 Frame formulation Number 1 2 8 201 1 HAIR SPRAY PUMP SPRAY Ingredients Maximum levels w w Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 95 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 50 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 50 Liquid paraffin and isoparaff
91. he contact persons associated to their organisation on a bulk basis 1 1 2 4 Distributors tab This tab is displayed for distributors only It allows the distributors to enter distribution notifications and to search for the notifications they have already entered in the system 11 1 2 5 Useful links tab This tab is displayed for all users It shows links to CPNP User Manual the CosIng database and the Regulation on cosmetic products 19 1 1 2 6 Privacy Statement This item is displayed for all users It shows the CPNP privacy statement 1 1 2 7 Contact This item is displayed for all users It allows the user to send an email to the CPNP functional mailbox 1 1 2 8 Profile This item is displayed for all users It allows the users to check their profile in CPNP 1 1 2 9 Language This item is displayed for all users It allows the users to change the interface language Note The CPNP interface has been initially created in English and then translated Therefore in case of doubt please use the English version as reference and do not hesitate to report to sanco cpnp ec europa eu any inconsistency you would find in any other language 11 1 2 10 Log out This item is displayed for all users It logs the user out of the system Il 2 NOTIFICATIONS PURSUANT TO ARTICLE 13 1 and 2 SINGLE COMPONENT PRODUCT This function is only accessible to the responsible persons A s
92. horic acid qs pH 2 3 Aqua to 100 pH value of the mixture Part A Part B 9 5 11 5 189 Frame formulation Number 1 1 14 S 201 1 SKIN DYE REMOVING CLEANSER REDUCING TYPE Ingredients Maximum levels w w Ethanol alcohol alcohol denat 30 Emulsifying agents anionic amphoteric non ionic surfactants e g sodium laureth sulfate ethoxylated long chain alcohols 20 Solvents e g propylene glycol PPG 2 butyl ether 10 Humectants e g glycerin 10 Reducing agents e g sodium sulfite 5 Additional ingredients e g bisabolol 5 Parfum 2 Aqua to 100 190 Frame formulation Number 1 1 1 5 S 201 1 HAIR BLEACH POWDER TO BE MIXED IMMEDIATELY PRIOR TO USE WITH AQUA FOR USE ALONE OR WITH OXIDATIVE PART 11 17 2011 OR 11 18 2011 OR WITH OXIDATIVE AND ALKALINE PARTS 11 17 2011 OR 11 18 2011 AND 11 19 2011 Ingredients Maximum levels w w Ammonium sodium potassium persulfate 70 Bulking agents e g kaolin magnesium stearate 50 Alkaline agents including ammonium hydroxide liberators e g sodium carbonate sodium magnesium silicate sodium metasilicate ammonium chloride 45 Emulsifying agents e g sodium lauryl sulfate 15 Thickeners e g guar gum 5 Oils e g vegetable and or mineral 5 Additional ingredients e g Colorants chelating agents 5 pH value at 1 powder in water 10 11 pH value of the different mixtures 9 5 11 5 191 Frame formulation Number 1 1 1 6 E 201 1 HAI
93. in e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 40 Humectants e g glycerin propylene glycol 20 Resins polymers e g PVP VA copolymer VA crotonates copolymer butyl ester of PVM MA copolymer Neutralising agent e g aminomethy propanol Alkoxylated glucose derivatives 8 Plasticisers e g polyglycol ethers alcohol esters 2 Additional ingredients e g UV filters vitamins 2 Hair texturizing agents e g silica 1 Preservatives antimicrobials 1 Parfum 1 Aqua to 100 204 Frame formulation Number 1 2 9 201 1 SHINE HAIR SPRAY AEROSOL Ingredients Maximum levels w w Propellants e g dimethyl ether hydrocarbons 90 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 50 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 50 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 40 Resins polymers e g PVP VA copolymer VA crotonates copolymer butyl ester of PVM MA copolymer Neutralising agent e g aminomethy propanol Alkoxylated glucose derivatives 10 Additional ingredients e g UV filters vitamins Colorants 5 Preservatives antimicrobials 1 Parfum 1 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol to 100 205 Frame formulation Number 1 2 1 0 z 201 1 PERMANENT WAVE LOTION SINGLE COM
94. in more than 0 5 xanthine derivatives the INCI name and the concentration of the derivative s must be specified An updated notification is required when the concentration changes by more than 20 of the value declared previously If xanthine derivatives are not present or present below 0 5 in the cosmetic product then not applicable must be checked Rule 8 Products containing cationic surfactants with two or more chain lengths below C12 64 The INCI name and the concentration of cationic surfactants with two or more chain lengths below C12 must be specified if the surfactant is used for non preservative purpose An updated notification is required when the concentration changes by more than 20 of the value declared previously Typical examples for cationic surfactants covered by this rule behentrimonium chloride distearyldimonium chloride cetrimonium chloride dicetyldimonium chloride If cationic surfactants with two or more chain lengths below C12 are not present in the product then not applicable must be checked Rule 9 Products containing propellants The INCI name and the concentration of each propellant must be specified An updated notification is required when either of these concentrations changes by more than 20 of the value declared previously If propellants are not present in the product then not applicable must be checked This rule concerns aerosol spray products and any other product which
95. including volatile silicones e g cyclopentasiloxane dimethicone 20 Chemical exfoliating agents e g lactic acid glycolic acid salicylic acid 10 Additional ingredients e g hydrolysed proteins plant extracts vitamins 10 Thickeners e g carbomer 5 Preservatives antimicrobials 1 Parfum 1 Aqua to 100 maximum concentration of salicylic acid permitted is 2 91 Frame formulation Number 1 n 1 4 a 201 1 SKIN CARE SILICONE BASED Ingredients Maximum levels w w Silicones including volatile silicones e g cyclopentasiloxane dimethicone 90 Emollients e g squalane 25 Additional ingredients e g vitamins plant extracts 10 92 Frame formulation Number 1 1 5 201 1 PETROLEUM JELLY Ingredients Maximum levels w w Petrolatum 100 Parfum 0 5 93 Frame formulation Number 1 1 6 201 1 TALCUM POWDER LOOSE OR PRESSED Ingredients Talc Bulking agents e g starch nylon powder sodium polyacrylate copolymer kaolin magnesium calcium carbonate Colorants colour additives e g opacifying pearlescent agents Binding agents e g vegetable and or mineral oils fatty acid esters Parfum Additional ingredients e g UV filters vitamins antioxidants Preservatives antimicrobials 94 Maximum levels w w 99 80 40 10 10 Frame formulation Number 1 1 T S 201 1 LIP CARE STICK CREAM GEL Oils e g vegetable and or mineral waxes and fats e g fatty alcohols
96. ing composition document cannot exceed 2 MB 45 AN Important notice A The labelling can also be submitted by using the free text box This is however limited to the very specific cases where the labelling is exclusively composed of text Original labelling text 46 I 3 NOTIFICATIONS PURSUANT TO ARTICLE 13 1 and 2 MULTI COMPONENT PRODUCT A notification that relates to products composed of several components e g hair dye sets make up sets that are not marketed separately will be different from that of a single component product Note Sets do not need to be notified as multi component products provided that all components that compose this set have been notified individually To create a notification for a multi component product the responsible person has to click on Notify a multi component product in the Products tab Home Products Contact persons Distributors Useful links v N Notify a single component product Notify a multi me to component product Simple search Your det Advanced search The general form for the notification of that multi component product will be displayed oducts Notification Portal Three different tabs are available one titled General information and two titled Component k Addcomnonent aSaveesdott Nota iango General information kit Component Component The General information tab allows the resp
97. ingle component product refers to a product that is composed of one single element e g a single bottle of shampoo To create a notification for a single component product the responsible person has to click on Notify a single component product in the Products tab 20 Distributors Useful links 9 oducts Notification Portal Products Contact persons y Notify a single Home component product Welcome to Notify a multi component product Simple search Your det Advanced search T Please Responsible person ator to complete your organisation i e Distributor or Responsible Person in SAAS search Pleasen2 address should be filled in The general form for the notification of a single component product will be displayed Two different tabs are available General information and Product details General information Product details 11 2 1 General information tab The General information tab allows the responsible person to enter the following information about the product 1 2 1 1 Product name product Name Language Shades if applicable The product name is a crucial element of the notification since it will be often used by competent authorities or by poison centres to search for a product in the CPNP The product name must be detailed enough to enable the specific identification of the cosmetic product The product name
98. ion ranges declaration If the responsible person selects Concentration ranges the CPNP will ask whether he wants to upload a file for the qualitative and quantitative composition 1 If the responsible person answers yes it is asked to attach the corresponding file Only PDF format is allowed Upload a file for the qualitative and quantitative composition Yes No K sas Qualitative and quantitative composition document The page at http s sanco apps dey sanco cec eu int says No hand written Formulation can be submitted only clear and legible electronic text Format document is allowed A Important notice A No hand written document is allowed Only clear and legible electronic PDF text format documents are allowed For ingredients that are not of special concern only the following concentration ranges are allowed 40 0 0 1 10 1 1 11 5 15 10 110 25 125 50 150 75 175 100 In order to facilitate poison centres reading in emergency situations it is recommended that the concentration ranges document starts by mentioning the ingredients of concerns and their exact concentration according to the rules set out in the annex to this User Manual and then lists all other ingredients by decreasing order of their concentration range in the product Where the information on pH is required and the pH could not be measured in the product direc
99. ir concentration s in the product or to click on No For the other questions the responsible person will usually have two choices i e to answer the question in the dedicated fields or answer not applicable Please specify the percentage weight of ethanol N Not applicable To facilitate the entry of names of ingredients a link is made to Coslng to retrieve the information The responsible person can also type an ingredient name if the name is not included in Coslng A Important notice A Not applicable means in the case of ethanol and or isopropanol that these ingredients are not present in the product Not applicable means in the case of all other ingredient of concern that the ingredient is either not present in the product or is present in the product but under the concentration of concern according to the rules set out in the Annex to this User Manual All ingredient names shall be expressed using INCI names when available Where the information on pH is required and the pH could not be measured in the product directly but through an aqueous solution extract or dispersion e g for solid formulations the user should mention this in the field dedicated to Any other information of significance for poison centres using the expression pH aqueous extract solution dispersion in English only All ingredient quantities shall be expressed using w w The symbol w w shall not be indic
100. itives e g opacifying pearlescent agents 60 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 50 Bulking agents e g talc silica nylon powder 40 Thickeners e g stearalkonium hectorite 15 Film forming polymers e g PVP hexadecene copolymer 15 Additional ingredients e g vitamins plant extracts antioxidants UV filters 5 Preservatives antimicrobials 1 Parfum 1 147 Frame formulation Number 7 1 8 201 1 EYE PENCIL Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 70 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 ee isohexadecane Colorants colour additives e g opacifying pearlescent agents 50 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 50 Bulking agents e g talc 30 Polymers resins e g nylon 20 Anionic amphoteric non ionic surfactants e g polysorbate 60 PEG 6 sorbitan stearate 5 UV filters 5 Additional ingredients e g vitamins plant extracts antioxidants 5 Preservatives antimicrobials 1 Parfum 0 3 148 Frame formulation Number 7 1 9 201 1 EYE LINER REGULAR LIQUID CREAM Ingredients Maximum levels w w Film forming polymers e g acrylic resin ammonium acrylates copolymer 40 Colorants colour additives e g opacifying pearlescent agents 25 Oils e g vegetable and or mineral wa
101. lIng If there is more than one CMR substance of category 1A or 1B in the product they can be added by clicking on the button A Important notice A When retrieving information from Coslng please note that there is no filter intended to display only CMR 1A or 1B 1 2 2 1 2 Nanomaterials If the responsible person answers Yes to the second question Does the product contain nanomaterials the following screen will be displayed Does the product contain nanomaterials Yes No aaa Rinse off Leave on Rinse off Leave on Exposure route Dermal Oral Inhalation Show 10 y entries Search INCI IUPAC CAS number EINECS ELINCS No matching records found Showing 0 to 0 of 0 entries First Previous Next Last The CPNP will first ask the responsible person to answer two questions on the exposure conditions Is the product a rinse off or a leave on product What is the exposure route dermal oral and or inhalation To add a nanomaterial to the notification the responsible person has to click on add A pop up page will appear and the responsible person can then search for the nanomaterial into CosIng by entering at least 5 characters 29 te New nanomaterials Search nanomaterials Please encode at least 5 characters INCI IUPAC INN CAS or EC Number x lt The responsible person can then select one of the proposed nanomaterials by clicking onthe button next to the nanomaterial
102. lcohol alcohol denat 80 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 25 Humectants e g glycerin propylene glycol 20 Resins polymers e g PVP polyquaternium 11 VA crotonates copolymer butyl ester of PVM MA copolymer Neutralising agent e g aminomethy propanol triethanolamine 15 Colorants colour additives e g opacifying pearlescent agents 15 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated fatty acids 5 Isopropanol isopropyl alcohol can be present in resins 5 Thickeners e g carbomer 2 Additional ingredients e g UV filters vitamins 2 Preservatives antimicrobials chelating agents 1 5 Parfum 1 Aqua to 100 201 Frame formulation Number 1 2 6 201 1 HAIR FOAM Ingredients Maximum levels w w Ethanol alcohol alcoho denat 30 Propellants e g hydrocarbons dimethyl ether compressed gas 30 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 25 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 25 Film forming agents polymers resins e g polyvinyl acetate PVP polyquaternium 4 and neutralising agent e g aminomethy propanol 10 Humectants e g glycerin 10 Polyglycol ethers 5 Cationic surfactants gt C42 e g cetrimonium chloride 5 Non ionic surfactants e g olet
103. ld s that still needs to be filled in Cancel The ongoing operation is aborted 11 2 2 Product details tab The product details tab is composed of three different sections 1 2 2 1 Section CMR amp Nanomaterials v CMR amp Nanomaterials Does the product contain CMR of category 1A or 1B Yes No Does the product contain nanomaterials Yes No In this section the responsible person has to indicate if the product contains 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 and Substances in the form of nanomaterials 11 2 2 1 1 CMR If the responsible person clicks yes to the question Does the product contain CMR substances of category 1A or 1B he has to indicate the Name of the CMR substance of category 1A or 1B and its CAS or EC Number v CMR amp Nanomaterials Does the product contain CMR of category 1A or 1B Yes No Name CAS number EC Number To help the responsible person the name and information on CAS and EC numbers will be retrieved from CoslIng when available but the responsible person remains 28 responsible for checking the completeness and the exactness of the information provided and changing it where necessary The responsible person can also manually type a CMR substance of category 1A or 1B and its CAS and or EC number if it is not included in Cos
104. le and or mineral 80 Anionic surfactants e g ammonium laureth sulfate 20 Non ionic surfactants e g aureth 12 deceth 3 20 Amphoteric surfactants e g betaine derivatives 20 Emulsifying agents e g ethoxylated long chain alcohols 30 Soaps e g ammonium hydroxide ethanolamine oleates 30 Solvents e g propylene glycol glycerin 20 Thickeners e g carbomer long chain alcohols 20 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 16 Hair dyeing agents Primary intermediates e g p phenylenediamines such as p phenylenediamine and toluene 2 5 diamine p aminophenols such as p aminophenol and 4 amino m cresol heterocyclic diamines such as 7 hydroxyethyl 4 5 diamino pyrazole sulfate 6 Couplers e g m aminophenols such as m aminophenol and 4 amino 2 hydroxytoluene m phenylenediamines such as 2 amino 4 hydroxyethylamino anisole resorcinols such as resorcinol and 4 chlororesorcinol pyridines such as 2 6 dihydroxy 3 4 dimethylpyridine naphtols such as 7 o naphthalenediol 6 Directs e g HC red no 3 2 amino 6 chloro 4 nitrophenol basic yellow 87 6 Alkaline agents 10 Cationic surfactants gt C42 e g dicetyldimonium chloride PEG 2 oleamine 5 179 Cationic polymers e g polyquaternium 6 5 Additional ingredients e g hair conditioning agents pearlescent agents 5 Antioxidants e g ascorbic acid 3 Reducing agents 3 Parfum 2 Chelating agents e g EDTA 1 Aqua to 100 pH value 8
105. le silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes cysteine derivatives cellulose derivatives fatty acid esters 15 Additional ingredients e g UV filters pearlescent agents opacifying agents 10 Hair dyeing agents Directs dyes e g disperse violet 1 acid violet 43 basic brown 17 3 Preservatives antimicrobials 1 Chelating agents e g disodium EDTA 0 5 Parfum 1 Aqua to 100 174 Frame formulation Number 1 1 2 201 1 HAIR COLORANT TEMPORARY FOAM LOTION Ingredients Maximum levels w w Ethanol a cohol alcohol denat 60 Anionic non ionic amphoteric surfactants e g sodium laureth sulfate 10 Foam boosting agents e g cocamide MIPA 5 Additional ingredients e g plant extracts pearlescent agents 5 Polymers resins e g acrylates copolymer carbomer 4 Hair dyeing agents Directs dyes e g disperse violet 1 acid violet 43 basic brown 17 2 Preservatives antimicrobials 1 Cationic surfactants 2 C42 e g cetrimonium chloride 0 2 pH adjuster e g citric acid triethanolamine qspH 3 9 Aqua to 100 175 Frame formulation Number 1 1 3 201 1 HAIR COLORANT TEMPORARY or SEMI PERMANENT LIQUID CREAM FOAM Ingredients Maximum levels w w Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 50 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 20 Emulsifying agents e g aureth 11 Silic
106. ley alcohol and their ethoxylates 15 Additional ingredients e g plant extracts 5 Straightening agents e g sodium hydroxide potassium hydroxide lithium hydroxide calcium hydroxide 4 5 Hair conditioning agents e g proteins polymers 2 Parfum 1 Aqua to 100 pH value 11 0 13 5 212 Frame formulation Number 1 2 1 9 201 1 HAIR STRAIGHTENER RELAXER TYPE 2 PARTA Part A No lye type cream base to be mixed prior to use with part B activator 12 20 2011 Ingredients Maximum levels w w Straightening agents e g calcium hydroxide 10 potassium citrate 10 Oils e g vegetable and or mineral waxes and fats Humectants emollients e g lanolin cholesterol 30 Anionic non ionic amphoteric surfactants e g betaine derivatives 10 Emulsifying agents e g long chain alcohols and their ethoxylates 10 Hair conditioning agents e g proteins polymers 5 Additional ingredients e g plant extracts 5 Parfum 1 Aqua to 100 the mix with part B activator generates an alkaline mix of up to 5 alkali calculated as calcium hydroxide pH value 11 13 pH value of the mixture part A cream base and part B activator 11 13 5 213 Frame formulation Number 12 20 z 201 1 HAIR STRAIGHTENER RELAXER TYPE 2 PART B Part B Activator to be mixed prior to use with part A cream base 12 19 2011 Ingredients Maximum levels w w Straightening agents e g calcium hydroxide 40
107. lose acrylates copolymer phthalic anhydride buty benzoic acid propylene glycol copolymer 50 Plasticisers e g triethyl citrate 15 Colorants colour additives e g opacifying pearlescent agents 15 Additional ingredients e g vitamins proteins plant extracts 10 Thickeners e g stearalkonium hectorite silica 5 UV filters 2 216 Frame formulation Number 1 3 2 201 1 NAIL WHITE PENCIL Ingredients Maximum levels w w Bulking agents e g kaolin magnesium carbonate chalk 80 Colorants colour additives e g opacifying agents titanium dioxide 30 Binding agents e g waxes stearic acid 25 Thickeners e g bentonite 5 217 Frame formulation Number 1 4 1 a 201 1 NAIL CONDITIONER OIL BASED Ingredients Maximum levels w w Unsaturated fatty acids proteins vitamins 10 Colorants 1 Antioxidants preservatives antimicrobials 0 5 Parfum 0 5 Vegetable oils e g sesame oil to 100 218 Frame formulation Number 1 6 1 201 1 TOOTHPASTE Ingredients Maximum levels w w Sorbitol Abrasives e g dicalcium phosphate dihydrate and or alumina and or calcium carbonate and or silica and silicates Glycerin Insoluble metaphosphate IMP Ethanol alcohol alcohol denat Sodium pyrophosphate potassium pyrophosphate PEG PPG Oral care protecting agents e g strontium chloride Anionic surfactants e g sodium lauryl sulfate Thickeners e g cellulose derivatives Additional ingredien
108. mber 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 Product name pte Member State of dispatch Step 4 The CPNP will display in read only mode the category of the cosmetic product associated to this product in the CPNP Step 5 The CPNP will ask the distributor to select in the drop down menu the Member State in which he makes the product available Member State in which it is made available Choose a country s 50 The distributor has to enter the product name in the Member States in which the distibutor makes the product available and to select the corresponding language in the drop down menu Product name in the Member State in which the product is made Language available Select a language co R Step 6 If the product is a multi component product the distributor has to enter the component name in the Member States in which the distributor makes the product available and to select the corresponding language in the drop down menu Component name in the Member State in which the component is made Language available Three buttons are available at the bottom right of the screen If the distributor wants to save the notification as draft the distributor has to click on If the distributor wants to abort the ongoing operation the distributo
109. molecules which diffuse into the hair together with hydrogen peroxide whereupon they start to couple with each other to form larger colored molecules inside of the hair see SCCS opinion on reaction products in oxidative products 1311 10 Oxidative dyes can be split into two groups Primary Intermediates or Precursors such as p phenylenediamines and p aminophenols Couplers or Color Modifiers such as resorcinols and m aminophenols The types of precursors and couplers found in commercial products in the EU are relatively limited 35 There are three classes of Oxidative Primary intemediates By far the most commonly used are the p phenylenediamines e g p phenylenediamine p toluenediamine and p aminophenols There are five classes of Oxidative Couplers The most commonly used are resorcinols m aminophenols and m phenylenediamines Concentrations in precursors and couplers vary depending on the shades and the way they are formulated It is worth mentioning that concentrations are often restricted and the maximum level allowed are available in the annexes of the Directive or via the CosIng database 1 Precursors Primary Intermediates 3 main chemical classes p Aminophenols Heterocyclic Diamines NH NH3 S NH3 SS N N A 2 NH OH OH p Phenylenediamine p Aminophenol 1 Hydroxyethyl 3 4 diaminopyrazole p Phenylenediamines
110. must be checked Rule 16 Products with a pH lower than 3 or higher than 10 and pH of hair coloring products gt The pH of single component products or individual component except for hair dyes must be specified in the pH field if it is lower than 3 or higher than 10 gt In the case of multiple component products except for hair dyes that are mixed prior to use the pH of the mixed product must be specified in the respective pH field if it is lower than 3 or higher than 10 It is acknowledged that different mixing ratios of components e g to achieve different strengths can lead to pH variations In case the exact pH cannot be determined for the mixed product then the pH can be expressed in range form of no more than one unit e g 9 5 10 5 gt For the case of single component or multi component hair dyes the pH must always be indicated even if it is within the range of pH 3 to pH 10 However given pH variations between color shades of the same product the indication of an exact pH may not be relevant For these products the pH of the components and the mixed products can be expressed in range form of no more than one unit e g 8 5 9 5 In all cases above an updated notification is required when the pH declared previously changes by more than 0 5 For any product or component with a pH higher than 10 the INCI name and concentration of each alkaline agent and if applicable ammonium hydroxide liberator must
111. n the user has to select an organisation in the list of existing organisations for CPNP If the organisation she he belongs to is not yet created in SAAS she he can create it by clicking on the Create organisation button The user has then to select the access profile she he is entitled to have 15 Competent Authority Distributor Poison Centre Responsible Person When the user clicks on the Submit button his request is sent to 1 the local administrator s of the selected organisation if is not a new organisation and the European Commission services 2 the European Commission services only if it is a new organisation Note access can be granted also for a limited period of time Note all organisations created in SAAS are visible to all SAAS users Once the registration request has been completed the user sees the following page ison center CPNP logout Cosmetic Products Notification Portal Home Request access Dear poison center CPNP ur request Access for the organization POISON INFORMATION CENTRES on the application Cosmetic Products Notification Portal was e sa dei ji s Welcome on SAAS II Click in Request access tab to apply on a new application or select the application in the list below To see the details of your own account please Click here Select an application Cosmetic Products Notification Portal K Your requested access tokens Show 10 Y entries Search Last
112. ndate a person established within the Community as the responsible person who shall accept in writing For an imported cosmetic product each importer shall be the responsible person for the specific cosmetic product he places on the market The importer may by written mandate designate a person established within the Community as the responsible person who shall accept in writing The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected 1 1 1 9 CMR substances Substances classified as carcinogenic mutagenic or toxic for reproduction pursuant to Regulation EC No 1272 2008 1 1 1 10 Cosing It is a European Commission database that contains information on cosmetic substances and ingredients 1 1 1 11 SAAS It is the Sanco Autentication and Authorisation System It provides the user with a profile and access rights for a specific European Commission application This application manages specifically the access rights 1 1 1 12 ECAS It is the European Commission Authentication Service
113. nol constitutes a change of 6 in the ethanol content in the formulation and therefore requires an updated notification A change from 20 of ethanol and 20 isopropanol to 23 of ethanol and 24 of isopropanol constitutes a change of 7 of the sum of ethanol and isopropanol in the formulation and therefore requires an updated notification 10 if the value declared previously is gt 30 If ethanol or isopropanol are not present in the cosmetic product then not applicable must be checked Note declarations of percentage weights may be rounded to the nearest whole number Note if the percentage weight is below 1 it can be specified as 1 Rule 2 Antidandruff products The INCI name and the concentration of the antidandruff agent s must be specified An updated notification is required when the concentration of the antidandruff agent changes by more than 20 of the value declared previously Rule 3 Anti hair loss products The INCI name and the concentration of the anti hair loss agent s must be specified An updated notification is required when the concentration of the anti hair loss agent changes by more than 20 of the value declared previously Rule 4 Skin lightening products containing anti pigmenting and or depigmenting agent s 63 The INCI name and the concentration of anti pigmenting and depigmenting agent s must be specified An updated notification is required when the concentration of at least one age
114. nt changes by more than 20 of the value declared previously If anti pigmenting and depigmenting agent s are not present in the cosmetic product then not applicable must be checked Rule 5 Chemical exfoliation products containing chemical exfoliating agent s e g lactic acid glycolic acid salicylic acid The INCI name and the concentration of chemical exfoliating agent s must be specified An updated notification is required when the concentration changes by more than 20 of the value declared previously Rule 6 Products containing vitamin A and derivatives e g retinol retinyl esters The exact content of vitamin A or any of its derivatives must be specified if the level exceeds 0 20 calculated as retinol or if the amount exceeds 0 09 grams calculated as retinol for the whole product An updated notification is required when the concentration of vitamin A or derivatives changes by more than 20 of the value declared previously If the level of vitamin A or any of its derivatives does not exceed 0 20 calculated as retinol or if the amount does not exceed 0 09 grams calculated as retinol or if vitamin A or any of its derivatives are not present in the product then not applicable must be checked Rule 7 Products containing xanthine derivatives e g caffeine theophylline theobromine plant extracts containing xanthine derivatives e g Paulinia cupana guarana extracts powders Should a product conta
115. ntasiloxane dimethicone 30 Colorants colour additives e g opacifying pearlescent agents 50 Humectants e g glycerin propylene glycol 30 Parfum 25 Bulking agents e g silica nylon powder starch 20 Thickeners e g carbomer hydroxyethylcellulose 10 Film forming polymers e g acrylic resin ammonium acrylates copolymer 5 Additional ingredients e g vitamins proteins antioxidants 5 Preservatives antimicrobials 1 158 Frame formulation Number 8 4 201 1 PERFUMED SKIN OIL Ingredients Maximum levels w w Ethanol alcohol alcohol denat 80 Colorants colour additives e g opacifying pearlescent agents 40 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 30 Parfum 25 Bulking agents e g silica nylon powder starch 15 Humectants e g glycerin propylene glycol 10 Emulsifying agents anionic amphoteric non ionic surfactants e g glyceryl stearate PEG stearate 5 Thickeners e g dextrin palmitate 5 Additional ingredients e g antioxidants plant extracts 5 UV filters 2 Oils vegetable and or mineral to 100 159 Frame formulation Number 9 1 201 1 SUNSCREEN CREAM LOTION Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 70 UV filters 40 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 30 Humectants e g glycerin propylene glycol 30 Ethanol a cohol alcohol
116. nter CPNP poison center cpnp External Logout Change password Account information ECAS a authenticates your identity on European Commission websites You are now logged in to ECAS You are about to be redirected to cpnp You are being redirected to cpnp Last update 10 11 2011 After a few seconds ECAS will redirect the user to CPNP If the user has no access to the CPNP or if her his access request has not yet been validated by a local administrator she he will see the following screen CPNP Home Useful links Click on the link to submit anew access request form Access denied You are not authorized to access this page You are not authorized to access this application CPNP Please foll w this link to submit an access request form Legal notice The system you are trying to access is the property of the European Commission and is provided solely for use by those which have been granted explicit authorization for it If you are not yet a user of the system but would like to request access to it you should contact the system administrator following the provided link Your attention is drawn to the legal consequences that any false fictitious or fraudulent statement or representation made by you when submitting an access request for this system may entail If the user already has access to CPNP she he will be redirected to the CPNP homepage 1 3 3 2 Request an acces
117. nts Maximum levels w w Ethanol alcohol alcohol denat 80 Humectants e g glycerin propylene glycol 80 Flavour mostly essential oils e g mint 7 5 Additional ingredients e g vitamins 5 Colorants 3 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 2 Preservatives antimicrobials 1 Oral care sweetening agents e g sodium saccharin 0 2 Aqua to 100 222 Frame formulation Number 1 7 3 201 1 BREATH SPRAY PUMP SPRAY Ingredients Maximum levels w w Ethanol a cohol alcohol denat 99 Humectants e g propylene glycol glycerin 30 Flavour mostly essential oils e g mint 2 Oral care deodorant e g zinc chloride 0 5 Preservatives antimicrobials 0 2 Oral care sweetening agents e g sodium saccharin 0 2 Aqua to 100 223 ANNEX Ill Categories of cosmetic products Skin products Skin care products Face care products other than face mask Face mask Eye contour products Lip care products Hand care products Foot care products Body care products External intimate care products Chemical exfoliation products Mechanical exfoliation products Skin lightening products Other skin care products Skin cleansing products Soap products Bath shower products Make up remover products External Intimate hygiene products Other skin cleansing products Body hair removal products Chemical depilatories Physical
118. ohol alcohol denat 10 Emulsifying agents anionic amphoteric non ionic surfactants e g steareth 2 steareth 4 10 Additional ingredients e g antioxidants plant extracts aqua 10 Thickeners e g dextrin palmitate 5 Preservatives antimicrobials 1 5 Parfum 1 Colorants 1 Oils e g mineral and or vegetable to 100 99 Frame formulation Number 2 5 201 1 GENTLE CLEANSING GEL Ingredients Maximum levels w w Anionic surfactants e g sodium lauroyl sarcosinate disodium laureth sulfosuccinate 20 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 20 Humectants e g glycerin propylene glycol 20 Non ionic amphoteric surfactants e g betaine derivatives glucose derivatives 15 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Foam boosting agents e g cocamide MEA 5 Additional ingredients e g pearlescent agents plant extracts 5 Thickeners e g hydroxypropyl methylcellulose 5 Preservatives antimicrobials 2 Parfum 1 Colorants 1 Aqua to 100 100 Frame formulation Number 2 6 201 1 SKIN CLEANSING CREAM LOTION SCRUB GEL Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 95 Humectants e g glycerin propylene glycol PEG 25 Anionic amphoteric non ionic surfactants e g sodium cocoyl isethionate sodium laureth sulfate 25 Ethanol a cohol alcohol denat 25
119. on to enter the information on each of the components separately see section II 2 2 for further details A Important notice A The component name is a crucial element of the notification as it might be used by competent authorities or by poison centres to search for a specific component in the database The component name must be detailed enough to enable its specific identification Only in cases where the component has no name e g certain make up set components the component name shall be understood as the description of the component that enables its specific identification By default two component tabs are Eia but additional component tab s can be added to the notification by clicking on The user can 48 L Save as dratt The notification is saved as draft but not notified A notification can be saved as draft without all the required fields being filled To save a notification as draft at least a product component name and the corresponding language must be filled indicated by a Natty The notification is complete and will be made available to poison centres and competent authorities It will then be not possible to delete this notification from the system Only update or correction will be possible A notification can be notified only when all mandatory fields indicated by a are filled in If some mandatory information is missing the system will not accept the notification and will displa
120. ones including volatile silicones cyclopentasiloxane dimethicone amodimethicone 10 Anionic non ionic amphoteric surfactants e g ether of oley alcohol 10 Hair dyeing agents Direct dyes e g HC red no 3 4 amino 3 nitrophenol 3 nitro p hydroxyethylaminophenol 10 Solvents e g propylene glycol benzyl alcohol 10 Cationic surfactants gt C12 e g dicetyldimonium chloride 5 Additional ingredients e g plant extracts protein derivatives 5 Hair conditioning agents e g cationic polymers 5 Resins e g acrylates copolymer 3 Thickeners e g cellulose derivatives 2 Parfum 1 Preservatives antimicrobials 1 pH adjuster e g citric acid or alkaline e g ethanolamine sodium hydroxide ammonium hydroxide qs pH 2 10 Aqua to 100 176 Frame formulation Number 1 1 4 201 1 HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 1 TWO COMPONENTS COLORANT PART To be mixed immediately prior to use with oxidative part 11 8 2011 or 11 9 2011 Ingredients Maximum levels Y w w Anionic surfactants e g ammonium laureth sulfate 20 Non ionic surfactants e g aureth 12 deceth 3 20 Amphoteric surfactants e g betaine derivatives 20 Emulsifying agents e g ethoxylated long chain alcohols 30 Soaps e g ammonium hydroxide ethanolamine oleates 30 Solvents e g propylene glycol glycerin 20 Thickeners e g carbomer long chain alcohols 20 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol
121. oning agents pearlescent agents 5 Antioxidants reducing agents e g ascorbic acid sodium metabisulfite 3 Parfum 2 Chelating agents e g EDTA 1 Aqua to 100 181 pH value 8 11 6 pH value of the mixture Part A Part B and oxidative part 8 11 6 maximum concentration of ammonium hydroxide permitted is 6 182 Frame formulation Number 1 1 yf 201 1 HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 3 THREE COMPONENTS COLORANT PART PART B Part A 11 6 2011 and Part B 11 7 2011 to be mixed immediately prior to use with oxidative part 11 8 2011 or 11 9 2011 Ingredients Maximum levels w w Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated long chain alcohols 20 Emollients humectants e g octyldodecanol 20 Thickeners e g bentonite fatty esters 20 Cationic surfactants gt C42 e g dicetyldimonium chloride PEG 2 oleamine 5 Additional ingredients e g hair conditioning agents antioxidants 5 Parfum 2 Chelating agents e g EDTA 1 Oils e g vegetable and or mineral to 100 pH value of the mixture Part A Part B and oxidative part 8 11 6 183 Frame formulation Number 1 1 8 201 1 HAIR COLORANT PERMANENT OXIDATIVE TYPE TYPE 1 TWO OR THREE COMPONENTS OXIDATIVE PART To be mixed immediately prior to use with colourant part 11 4 2011 or 11 5 2011 or 11 6 2011 11 7 2011 Ingredients Maximum levels w w Emulsifying agents anionic
122. ons of these shades in the different languages have to be indicated in the shades field just below the corresponding linguistic version of the product name When some shades of a cosmetic product are not fully covered by the information contained in the notification e g different composition information these shades must be notified separately 11 2 1 4 Product specifically intended for children under 3 years of age The responsible person must indicate whether the product is specifically intended for children under 3 years of age Is the product specifically intended for children under 3 years of age Yes 11 2 1 5 Responsible person details 23 No The notification shall contain at_least_the name and the address of the responsible person These data appear on the left part of the screen under Responsible person They are automatically retrieved from SAAS on the basis of the login of the user When the responsible person needs to update or correct its details it has to be done in SAAS Access to SAAS is available from the profile item located at the top right of the CPNP screen Only local administrators can modify the responsible person details A Important notice A In case the name and the address of the responsible person are not complete in SAAS the following warning message will be displayed and the responsible person will not be allowed to enter any notification in the system until the information is complete
123. onsible person to enter some general information about the product e g kit set etc see section II 2 1 for further details Additional question on pH will be asked by the CPNP In particular the CPNP will ask if the components of the products are intended to be mixed Do the components of the product need to be mixed Yes No If the responsible person answers yes the CPNP will ask if the produc is a hair dye Do the components of the product need to be mixed Yes No Is the product a hair dye Yes No If the responsible person answers No the CPNP will ask if the pH is lower than 3 or higher than 10 47 Do the components of the product need to be mixed 2 Yes No Is the product a hair dye Yes No Is the pH lower than 8 or higher than 10 Yes No If the responible person answers Yes the CPNP will ask to indicte the pH range The pH range cannot exceed 1 pH unit Do the components of the product need to be mixed Yes No Is the product a hair dye Yes No Is the pH lower than 3 or higher than 10 Yes No 4 Please indicate the pH min and max values If the responsible person indicates that the product is a hair dye the CPNP will directly ask the pH range The pH range cannot exceed 1 pH unit Do the components of the product need to be mixed 2 Yes No Is the product a hair dye Yes No Please indicate the pH min and max values The Component tabs will allow the responsible pers
124. orary hair styling Permanent wave products Hair relaxer straightener products Other hair styling products Other hair and scalp products Hair sun protection products Other hair and scalp products Nail and cuticle products Nail varnish and remover products Nail varnish Nail make up Nail varnish remover Nail varnish thinner Nail bleach Other nail varnish and remover products Nail care nail hardener products Nail care products Nail hardener Other nail care nail hardener products Nail glue remover products 226 Nail glue remover Other nail and cuticle products Cuticle remover softener Nail sculpting products Other nail and cuticle products Oral hygiene products Tooth care products Toothpaste Tooth cleansing powder salt Other tooth care products Mouth wash breath spray Mouth wash Breath spray Other mouth wash breath spray products Tooth whiteners Tooth whiteners Other oral hygiene products Other oral hygiene products 227
125. ose two options i e exact concentrations or concentration ranges A Important notice A Upon specific and individual request whatever is the notification type chosen by a responsible person for the notification of a cosmetic product pursuant Article 13 1 of Regulation EC No 1223 2009 additional information should be provided to poison centres or similar bodies where such centres or bodies have been established by Member States to allow prompt and appropriate treatment in the event of difficulties 11 2 2 2 5 1 Predefined frame formulation A set of predefined frame formulations have been elaborated by an expert group composed of representatives from poison centres competent authorities industry trade associations and Commission services and are available for consultation in the Annex II to this User Manual These frame formulations will be regularly updated in light of technical and scientific progress in accordance with Article 2 s of Regulation EC No 1223 2009 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 This predefined frame formulation will be linked to the notification as a PDF document This PDF document can be opened by the responsible person in order to check its relevance for the product being notified by clicking
126. osition document f Browse The page at http s sanco apps dey sanco cec eu int says No hand written Formulation can be submitted only clear and legible electronic text Format document is allowed 38 A Important notice A No hand written document is allowed Only clear and legible electronic PDF text format documents are allowed In order to facilitate poison centres reading in emergency situations it is recommended that the exact concentration document starts by mentioning the ingredients of concerns and their concentration according to the rules set out in Annex to this User Manual and then lists all other ingredients by decreasing order of their concentration in the product All ingredient names shall be expressed using INCI names when available All ingredient quantities shall be expressed using w w The symbol w w shall not be indicated in the answering field The CPNP applies the English notation for numbers Example 0 3 and not 0 3 Where the information on pH is required and the pH could not be measured in the product directly but through an aqueous solution extract or dispersion e g for solid formulations the user should mention this in the field dedicated to Any other information of significance for poison centres using the expression pH aqueous extract solution dispersion in English only For ethanol and or isopropanol an updated notification is required when the content of
127. r has to click on cancel When the information on the distribution notification is complete the distributor can click on The information will be made available to competent authorities and poison centres It will be linked to the original notification of the product being distributed It will then be not possible to delete this notification from the system Only update will be possible IL5 SEARCH TOOLS 11 5 1 Simple search The Simple search is intended for the responsible persons the competent authorities and the poison centres It allows these users to quickly search for a notification in the database using key words To reduce the amount of data returned at least three characters must be entered Simple search R This field allows you to search for a product on product name component name responsible person distributor name category level 3 formulation name CPNP reference In order to reduce the amount of data returned please enter words of at least three characters Keyword search 51 The data that is accessible though the simple search depends on the user profile 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 Competent authorities
128. r 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 If the notification covers several pack sizes or shades the most legible original labelling amp original packaging are to be attached to the notification usually the biggest pack size Original labelling image Add document Show 10 entries Search No matching records found Showing O to 0 of 0 entries First Previous Next Last 44 Original packaging photograph Add document Show 10 Y entries Search No matching records found Showing O to O of 0 entries First Previous Next Last To add an image of the original P ora a of the original packaging the responsible person has to click on A pop up will appear where the documents can be uploaded Add Document Name x The responsible person has then to click on Save to attach the document to the notification or on The button gives the possibility to add more than one document The responsible person can view the documents it has attached by clicking the view button or delete them by clicking in the delete button A Important notice A The size of all attached documents labelling photograph of the packag
129. racts 10 Cationic polymers e g polyquaternium 7 polyquaternium 24 5 UV filters 5 Parfum 5 Preservatives antimicrobials 2 Colorants 2 Aqua to 100 83 Frame formulation Number 1 6 201 1 SKIN CARE CREAM LOTION GEL WITH HIGH LEVEL OF UV FILTERS Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 60 UV filters 30 Humectants e g glycerin propylene glycol PEG 25 Ethanol a cohol alcohol denat 25 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Emulsifying agents anionic amphoteric non ionic surfactants e g glyceryl stearate PEG stearate 15 Thickeners e g carbomer xanthan gum 12 Bulking agents e g talc silica nylon powder 10 Preservatives antimicrobials 2 Colorants 2 Aqua to 100 84 Frame formulation Number 1 f 201 1 SKIN CARE CREAM LOTION GEL WITH HIGH LEVELS OF PERFUME Ingredients Maximum levels w w Ethanol alcohol alcohol denat 80 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 60 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Humectants e g glycerin propylene glycol PEG 30 Parfum 25 Emulsifying agents anionic amphoteric non ionic surfactants e g glyceyl stearate PEG stearate 25 Colorants colour additives e g opacifying pearlescent agents 20 Thickeners e g carbomer hydroxyethylcellulose 15
130. rants Parfum Preservatives antimicrobials 111 Maximum levels w w to 100 25 10 Frame formulation Number 3 3 201 1 PHYSICAL DEPILATORY WAX SUGAR BASED Ingredients Maximum levels w w Tackifying agents e g sucrose 90 Aqua 12 Additional ingredients e g plant extracts antioxidants colorants 3 pH adjuster e g citric acid 2 Parfum 1 112 Frame formulation Number 4 1 a 201 1 BLEACH FOR BODY HAIR Ingredients Maximum levels w w Emollients e g isopropyl myristate petrolatum 15 Emulsifying agents e g glyceryl stearate ethoxylated alcohols 15 Hydrogen peroxide 4 Hydrogen peroxide stabilising agents 0 5 pH adjusters qs pH 2 3 Aqua to 100 113 Frame formulation Number 5 1 201 1 ANTIPERSPIRANT AEROSOL SPRAY WITH ANTIPERSPIRANT SALT Ingredients Maximum levels w w Propellants e g dimethyl ether hydrocarbons 90 Emollients humectants e g isopropyl myristate glycerin propylene glycol 20 Oils and waxes e g vegetable and or mineral isoparaffin 20 Silicones including volatile silicones e g dimethicone cyclopentasiloxane 20 Liquid paraffin and isoparaffin e g branched chain isoparatfin C11 C 16 isododecane isohexadecane 20 Aluminium salts e g aluminum chlorohydrate 10 Thickeners e g stearalkonium bentonite 10 Ethanol a cohol alcohol denat 5 Bulking agents e g perlite nylon powder 5 Additional ingredients e g vitamins plant extr
131. re and may be covered by trade secret or intellectual property rights I commit to treat this information with the highest level of confidentiality and to use it solely for the purposes assigned to it by Regulation EC No 1223 2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products I also commit not to disclose such information further to unauthorized users or otherwise use it for unauthorized purposes I understand that liabilities may be incurred under EU and or national law in case of breaches of my obligation to give such information the appropriate confidential treatment Competent authorities and poison centres will have to click on agree with the above to be able to proceed further 11 1 2 Navigation buttons The following tabs may be displayed on the home page depending on the user profile Home Products y Contact persons v Distributors y Useful links 9 11 1 2 1 Home tab It allows the users to go back to the homepage Privacy statement contact profile logout English EN 1 1 2 2 Products tab Notify a single component product This menu item is only displayed for the responsible persons It allows the responsible persons to create notifications for single component products Notify a multi component product This menu item is only displayed for responsible persons It allows the responsible persons to create notifications for produc
132. riginal labelling and a photograph of the original packaging where reasonably legible Only PDF JPG or JPEG format are accepted Original means the one corresponding to the first placing on the market in the EU The submission of the original labelling and of a photograph of the original packaging where reasonably legible is mandatory at the latest when the product is placed on the market 43 Various situations may occur Example 1 a single component product without any secondary packaging e g a standalone bottle of shampoo The original labelling of the bottle and if reasonably legible the photograph of the bottle shall be submitted Example 2 a single component product with a secondary packaging e g a bottle of shampoo in a box The original labelling of the box outer packaging and if reasonably legible the photograph of the box shall be submitted Optionally the original labelling and the photograph of the bottle can also be submitted Example 3 a multi component product e g a set composed of three bottles The original labelling of the set and if reasonably legible the photograph of the set shall be submitted Optionally the original labelling of each bottle and the photograph of each bottle can also be added to the notification at the component level A Important notice A The labelling shall include any text symbols pictures etc e g art work It shall cove
133. s to CPNP On the Access denied page there is a link that allows the user to be redirected to SAAS and submit a new access request form Once redirected to SAAS the user will see the following screen allowing her him to submit a new access request 14 disclaimer support poison center CPNP logout Cosmetic Products Notification Portal The Commission shall process personal data information pursuant to Regulation 45 2001 EC on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data An other disclaimer will be added here soon New application access application a Cosmetic Products Notification Portal 4 aans When you search on an Organization name the result will be displayed as a list Show 10 entries c COMPETENT AUTHORITIES C Demo 20311027 K DISTRIBUTORS C perez amp Co c POISON INFORMATION CENTRES Cc RESPONSIBLE PERSONS viengies First Previous Next Last Comments Access Profiles not selected Access Profiles Acting under Competent Authority profile Acting under Distributor profile Acting under Poison Centre profile Acting under Responsible Person profile sanco In a first dropdown the user will see that the Cosmetic Products Notification Portal application has been selected by default Please do not select another application The
134. sible person will be allowed to submit its notification without the original labelling and corresponding packaging being attached However the following warning message will be displayed According to Art 13 2 of Regulation 1223 2009 concerning cosmetic products the original labelling and where reasonably legible a photograph of the corresponding packaging shall be submitted at the latest when the cosmetic product is placed on the market A Important notice A To fulfil its legal obligations the responsible person has to notify once the original labelling and where reasonably legible a photograph of the corresponding packaging at the latest when the product is placed on the market 11 2 1 9 Product imported in the Community The responsible person has to indicate if the product is imported in the Community and if so it has to select the country of origin in the drop down menu Is this product imported in the Community e Yes No Country of origin Select a country 26 A Important notice A There may be rare cases where the same product is imported from several countries In such cases the responsible person shall make one notification per country of origin and shall mention the country of origin into brackets in the product name Examples Trade Mark Brand Repair amp Shine smoothing cream United States Trade Mark Brand Repair amp Shine smoothing cream China A Important notice A
135. ssword 1 3 2 1 Connect to the ECAS registration website The user has to connect to https webgate ec europa eu aida selfreg and complete the following fields Username First name Last name E mail Preferred language To submit his request the user has to 1 Tick the checkbox to aknowledge that he has read and understood the privacy statement 2 Type the security characters displayed in the image i opean Commission 4 Authentication Service English en Contact ECAS Help Registration Help European Commission Authentication Service ECAS User Registration Form Please fill in and submit the information requested below to register as a user of European Commission Information Systems The username you choose or the one assigned to you may be used to log into any system using the ECAS authentication service that you are authorised to access When you login you will see an ECAS page with a banner similar to the one on this page If you are asked to specify your domain when logging in choose External Fields marked are mandatory Choose a username optional First name Last name j E mail Re enter your e mail address Email preferred language English en vis Privacy statement Privacy statement for users registered with the European A Q Commission s Identity Management Service 1 What is the Identity Management Service
136. te 15 UV Filters 10 Additional ingredients e g antioxidants humectants vitamins 5 Anionic amphoteric non ionic surfactants e g polysorbate 3 Preservatives antimicrobials 1 5 Parfum 1 5 136 Frame formulation Number lf 201 1 LIPSTICK LIP CREAM INCLUDING CONCEALER STICKS CREAMS Ingredients Maximum levels w w Oils e g vegetable and or mineral esters and fatty acids 65 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 65 Colorants colour additives e g opacifying pearlescent agents 65 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 40 Emollients e g glycerin oleyl alcohol cetyl acetate lanolin derivatives 40 Waxes e g carnauba candelilla cera paraffin 35 Film forming polymers e g PVP hexadecene copolymer 25 Thickeners e g qguaternium 18 20 Bulking agents e g talc silica nylon powder 20 Photoprotective products contain UV filters e g titanium dioxide zinc oxide 10 Additional ingredients e g vitamins hydrolysed proteins antioxidants 10 Emulsifying agents e g trioley phosphate 5 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 5 Parfum 2 Preservatives antimicrobials 1 Flavouring agents 1 Aqua to 100 137 Frame formulation Number 7 8 201 1 LIP COLOUR and GLOSSER BALM Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and f
137. te must be specified An updated notification is required when either of these concentrations changes by more than 20 of the value declared previously If persulfate s are not present in the product then not applicable must be checked Rule 13 Products containing hair straightening agents The INCI name and the concentration of straightening agents must be specified An updated notification is required when either of these concentrations changes by more than 20 of the value declared previously Examples for straightening agents typically used are sodium hydroxide potassium hydroxide lithium hydroxide potassium citrate calcium hydroxide guanidine carbonate reducing agents ammonium thioglycolate ammonium thiolactate cysteine HCI ethanolamine thioglycolate O O O O Rule 14 Bath salts cubes containing inorganic sodium salts The total concentration of sodium salts must be specified An updated notification is required when the total concentration of inorganic sodium salts changes by more than 20 of the value declared previously 66 Rule 15 Toothpastes and Mouthwashes containing Fluoride compounds The concentration of fluoride compounds calculated as Fluorine must be specified An updated notification is required when the fluorine concentration changes by more than 20 of the value declared previously If fluoride compounds are not present in the product then not applicable
138. the responsible person will still have the choice to notify using a predefined frame formulation an exact concentration declaration or a concentration ranges declaration If the responsible person selects other the responsible person is invited to suggest a formulation name preferably in English All suggested names will be taken into consideration by the CPNP maintenance group in order to create new formulation names or update those existing where necessary Formulation name Other Soap Products gt Please suggest a formulation name Only in cases where the responsible person has no suggestion for any formulation name the responsible person may simply repeat the name selected for the level 3 category 11 2 2 2 5 Notification type 33 In the majority of the cases the drop down menu will propose 3 options i e predefined frame formulations exact concentrations or concentration ranges The symbol o reminds the responsible persons that all ingredients names shall be expressed using INCI names when available and that all ingredients quantities shall be expressed using w w Formulation name Soap Toilet a Please choose the notification type Please choose one Predefined frame formulation Exact concentrations Concentration ranges In some cases depending on the categories of cosmetic products selected there may be no existing predefined frame formulation In these cases the CPNP will only prop
139. thicone amodimethicone silanes e g alcoxysilanes 20 Hair texturising agents e g kaolin starch 20 Resins polymers e g PVP VA copolymer acrylates copolymer Neutralising agent e g aminomethy propanol 10 Additional ingredients e g UV filters vitamins Colorants chelating agents 5 Parfum 1 Preservatives antimicrobials 1 Aqua to 100 197 Frame formulation Number 1 2 2 201 1 HAIR SHINE WAX OR BRILLIANTINE Ingredients Maximum levels w w Oils e g vegetable and or mineral and waxes 99 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 99 Emulsifying agents e g ethoxylated fatty acids 3 Parfum 3 Additional ingredients e g UV filters vitamins 2 Preservatives antimicrobials antioxidants 1 Colorants 1 198 Frame formulation Number 1 2 3 201 1 HAIR STYLING LOTION Ingredients Maximum levels w w Liquid paraffin and isoparaffin e g branched chain isoparatfin C11 C 16 isododecane isohexadecane 90 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 80 Hair conditioning agents e g cationic polymers cellulose derivatives 20 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 15 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 15 Resins polymers e g polyvinyl acetate PVP
140. tice A All phone and fax numbers entered in the CPNP must include the international prefix Example 0032 2 296 93 62 A specific module has been created in the CPNP for the management of contact person details on a bulk basis To access this module the responsible person has to click on the Contact persons tab on the top left of the screen Home Products vy Contact persons Distributors Useful links v o New contact o By selecting List in the Contact persons tab the responsible person can then either search for one contact person using the search field or display all contact persons by clicking on All contact persons The responsible person can then edit the contact person details by clicking on or delete them by clicking onfi 25 The responsible person can create new contact person s by selecting New contact person in the Contact persons tab 11 2 1 7 Product no longer manufactured When a product is no longer manufactured the responsible person may indicate it Product no longer manufactured N ll 2 1 8 Product ready to go on the market or already on the market If the product is ready to go on the market or is already on the market the responsible person has to tick the box Product ready to go on the market or product already on the market N If all mandatory fields are filled and the product is not indicated as being ready to go on the market or already on the market the respon
141. tives antimicrobials 2 Colorants 1 Aqua to 100 172 Frame formulation Number 1 0 7 201 1 HAIR SCALP BI PHASE LOTION Ingredients Maximum levels w w Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane 90 Ethanol alcohol alcohol denat 80 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 50 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 50 Isopropanol isopropyl alcohol 40 Polymers e g PVP 10 Hair conditioning agents e g cationic copolymers cellulose derivatives 10 Humectants e g propylene glycol 10 Additional ingredients e g UV filters vitamins 5 Emulsifying agents anionic amphoteric non ionic surfactants e g ethoxylated fatty acids 3 Parfum 3 Preservatives antimicrobials 2 Colorants 1 Aqua to 100 173 Frame formulation Number 1 1 1 201 1 HAIR COLORANT TEMPORARY SHAMPOO Ingredients Maximum levels w w Anionic surfactants e g sodium ammonium TEA lauryl sulfate sodium ammoniun TEA laureth sulfate 30 Amphoteric surfactants e g betaine derivatives 20 Non ionic surfactants e g fatty alkanolamides 15 Thickeners e g propylene glycol PEG 10 Cationic surfactants gt C42 e g stearamidopropy l dimethylamine distearyldimonium chloride 5 Hair conditioning agents e g silicones including volati
142. tly but through an aqueous solution extract or dispersion e g for solid formulations the user should mention this in the field dedicated to Any other information of significance for poison centres using the expression pH aqueous extract solution dispersion in English only For ethanol and or isopropanol an updated notification is required when the content of either ingredient or the sum of both ingredients changes by more than 5 if the value declared previously is lt 30 or by more than 10 if the value declared previously is 2 30 For all other ingredients of concern an updated notification is required when the concentration of an ingredient changes by more than 20 of the value previously declared see Annex to this User Manual for further details An updated notification is also required when an ingredient falls in a concentration range different from the one previously declared when a new ingredient of concern enters in the composition of the product or when an ingredient of concern no longer enters the composition of the product As for predefined frame formulations depending on the product categories the physical form and the formulation name selected additional information will be asked by the CPNP on specific ingredients of concern and or the pH value of the product The rules that the CPNP applies have been elaborated by an expert group composed of representatives 41 from poison centres competent
143. ts e g pH stabilisers such as sodium potassium phosphate vitamins Flavour mostly essential oils e g mint Titanium dioxide Colorants Preservatives Oral care antiplaque e g Zinc citrate Oral care sweetening agents e g aspartame Calcium glycerophosphate Fluoride compounds calculated as Fluorine Aqua to 219 70 55 40 35 30 15 10 10 0 5 0 15 0 15 100 actual weight present will depend on M Wt of fluorine donor e g 0 15 fluorine 1 14 MFP monofluorophosphate or 0 333 NaF sodium fluoride 220 Frame formulation Number 1 7 1 201 1 MOUTHWASH Ingredients Maximum levels w w Ethanol alcohol alcohol denat 25 Humectants e g sorbitol 20 Additional ingredients e g vitamins 5 Flavour mostly essential oils e g mint 3 Anionic amphoteric non ionic surfactants e g sodium lauryl sulfate polysorbate 3 Colorants 3 Emulsifying agents e g PEG 60 hydrogenated castor oil 1 Preservatives antimicrobials 1 Oral care deodorant e g zinc chloride 0 5 Thickeners e g cellulose derivatives 0 5 Oral care sweetening agents e g sodium saccharin 0 2 Fluoride compounds calculated as Fluorine 0 15 Aqua to 100 s actual weight present will depend on M Wt of fluorine donor e g 0 15 fluorine 1 14 MFP monofluorophosphate or 0 333 NaF sodium fluoride 221 Frame formulation Number 1 7 2 201 1 MOUTHWASH CONCENTRATE Ingredie
144. ts of fatty acids 30 Anionic Amphoteric Non ionic surfactants e g sodium laureth sulfate betaine derivatives polysorbate 15 Humectants e g glycerin 15 Propellants e g hydrocarbons 15 Emollients e g waxes 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Emulsifying agents e g PEG derivatives 5 Additional ingredients e g plant extracts vitamins 3 Parfum 1 Preservatives antimicrobials 1 Thickeners e g cellulose derivatives 1 Aqua to 100 127 Frame formulation Number 6 6 201 1 SHAVING SOAP STICK Ingredients Maximum levels w w Mixed sodium and potassium stearate and laurate 90 Humectants e g glycerin 15 Non ionic surfactants e g polysorbate 5 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 5 Additional ingredients e g vitamins plant extracts chelating agents 3 Parfum 2 Opacifying agents e g titanium dioxide 1 Preservatives antimicrobials 1 Antioxidants 0 1 128 Frame formulation Number 6 7 201 1 AFTERSHAVE BALM Ingredients Maximum levels w w Ethanol a cohol alcohol denat 40 Oils e g vegetable and or mineral and fats 20 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Emollients humectants e g propylene glycol glycerin 20 Additional ingredients e g UV filters vitamins bisabolol plant extracts 10 Emulsifying agents anionic amphoteric non ionic sur
145. ts that contain several components Advanced search This menu item is displayed for responsible persons competent authorities and poison centres It allows these users to search for products or components on the basis of several criteria Simple search 18 This menu item is displayed for responsible persons competent authorities and poison centres It allows these users to search for products or components using key words Responsible person search This menu item is displayed for competent authorities and poison centres only It allows these users to search for the responsible persons existing in the system and then to see all their submitted notifications A Important notice A 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 This means that the products of one responsible person or of one distributor are not accessible to another responsible person or distributor in the system A responsible person or a distributor can search for its draft and submitted notifications Competent authorities and poison centres can search for all submitted notifications contained in the system Draft notifications are not accessible to competent authorities and poison centres ll 1 2 3 Contact persons tab This tab is displayed for responsible persons onl It allows the responsible persons to manage the contact details of t
146. ty acids 99 Glycerin 20 Emollients humectants e g propylene glycol 10 Amphoteric anionic surfactants e g cocamidopropy betaine 5 Oils e g vegetable and or mineral 5 Parfum 5 Colorants 2 5 Titanium dioxide 2 Cationic polymers e g polyquaternium 7 2 Additional ingredients e g plant extracts 2 Preservatives antimicrobials antioxidants chelating agents 1 Aqua to 100 103 Frame formulation Number 2 9 201 1 LIQUID SOAP Ingredients Maximum levels w w Anionic amphoteric surfactants e g laureth sulfate betaine 40 Non ionic surfactants e g glucose derivatives 40 Soaps sodium potassium or triethanolamine 20 Emollients e g PEG 7 glyceryl cocoate 20 Humectants e g glycerin propylene glycol sorbitol 20 Thickeners e g sodium chloride hydroxycellulose derivatives 5 Additional ingredients e g plant extracts UV filters 5 Pearlescent agents e g glycol distearate glycol stearate 5 Skin conditioning agents e g cationic cellulose 5 Parfum 5 Preservatives antimicrobials 2 Colorants 1 Aqua to 100 NB liquid soaps may be soap based totally synthetic based or a combination of both soap and synthetic 104 Frame formulation Number 2 1 0 201 1 BATH AND SHOWER GEL CREAM MILK PASTE Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 30 Humectants e g glycerin hexylene glycol 30 Anionic surfactants e g
147. um potassium laurate 70 Ethanol alcohol alcohol denat 30 Plant extracts 10 Parfum 2 Essential oils 1 168 Frame formulation Number 1 0 3 201 1 SHAMPOO PLUS CONDITIONER Ingredients Maximum levels w w Anionic surfactants e g sodium laureth sulfate 20 Non ionic surfactants e g alkyl polyglucosides 20 Amphoteric surfactants e g betaine derivatives 20 Thickeners e g long chain alcohols steary alcohol 10 Oils e g vegetable and or mineral and waxes 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 10 Cationic surfactants gt C42 e g behentrimonium chloride 5 Cationic polymers e g polyquaternium 1 1 5 Humectants emollients e g glycerin 5 Additional ingredients e g UV filters pearlescent agents 5 Parfum 2 Preservatives antimicrobials 1 Colorants 1 Chelating agents 0 5 Aqua to 100 169 Frame formulation Number 1 0 4 201 1 HAIR CONDITIONER Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 20 Silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes 20 Ethanol alcohol alcohol denat 15 Amphoteric surfactants e g betaine derivatives 15 Emulsifying agents e g ceteth 30 cetyl alcohol 10 Emollients humectants e g glycerin propylene glycol 10 Thickeners e g
148. unication the responsible person shall notify through CPNP the information referred to in paragraph 1 of Article 13 of Regulation EC N 1223 2009 where notifications according to Article 7 3 and Article 7a 4 of Directive 76 768 EEC have not been carried out in the Member State in which the cosmetic product is made available 1 2 SYSTEM REQUIREMENTS The following items are required to connect to the CPNP An Internet connection Acomputer screen resolution of at least 1024 X 768 pixels The CPNP is optimized for Microsoft Internet Explorer 7 or Mozilla Firefox 2 Internet Explorer with JavaScript and cookies enabled Note this User Manual explains the online use of the CPNP In the future there will be also the possibility for Responsible Persons to notify directly from machine to machine This will be further detailed in this User Manual once this functionality is implemented 1 3 REGISTRATION In order to access the CPNP the user needs a user login and password 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 Authorisation System SAAS This system provides the user with a profile and access rights for a specific European Commission application in this case the CPNP 1 3 1 General overview of the workflow A user that accesses the CPNP
149. vels w w Colorants colour additives e g opacifying pearlescent agents 80 Binding agents oils e g vegetable and or mineral waxes and fats e g long chain alcohols 20 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 20 Anticaking agents e g zinc magnesium stearate zinc magnesium laurate 10 Additional ingredients e g humectants vitamins UV filters 5 Parfum 1 Preservatives antimicrobials 1 Bulking agents e g talc silica starch nylon powder polyethylene powder to 100 145 Frame formulation Number 7 1 6 201 1 EYE SHADOW and BLUSHER CREAM Ingredients Maximum levels w w Oils e g vegetable and or mineral and waxes 70 Colorants colour additives e g opacifying pearlescent agents 50 Bulking agents e g talc silica nylon powder 20 Emulsifying agents e g PEG stearate polysorbate 10 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 10 Thickeners e g carbomer 5 Additional ingredients e g vitamins plant extracts UV filters antioxidants 5 Parfum 1 Preservatives antimicrobials 1 Aqua to 100 146 Frame formulation Number 7 1 T 201 1 EYE SHADOW and BLUSHER ANHYDROUS CREAM STICK POWDER Ingredients Maximum levels w w Oils e g vegetable and or mineral waxes and fats e g long chain alcohols 70 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 70 Colorants colour add
150. w Ethanol alcohol alcohol denat 90 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 30 Humectants e g glycerin 20 Plant extracts e g rosemary camomile 10 Emulsifying agents anionic amphoteric non ionic surfactants e g steareth 2 steareth 4 10 Thickeners e g dextrin palmitate 5 Parfum 5 Additional ingredients e g antioxidants colorants aqua 5 Preservatives antimicrobials 1 5 Colorants 1 Oils e g vegetable and or mineral to 100 88 89 Frame formulation Number 1 1 2 201 1 TONIC COSMETIC WATER Ingredients Maximum levels w w Ethanol alcohol alcohol denat 70 Humectants e g glycerin PEG 25 Plant extracts 10 Oils e g vegetable and or mineral 5 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 5 Bulking agents e g silica nylon powder 5 Additional ingredients e g vitamins UV filters 5 Emulsifying agents anionic amphoteric non ionic surfactants e g sorbitan stearate 5 Thickeners e g carbomer 2 Preservatives antimicrobials 2 Parfum 1 5 Colorants 1 Aqua to 100 90 Frame formulation Number 1 1 3 201 1 CHEMICAL EXFOLIATION PRODUCTS Ingredients Maximum levels w w Emollients humectants e g glycerin 40 Oils e g vegetable and or mineral 30 Emulsifying agents anionic amphoteric non ionic surfactants e g sorbitan stearate TEA stearate 25 Ethanol alcohol alcohol denat 25 Silicones
151. xes and fats e g long chain alcohols 30 Silicones including volatile silicones e g cyclopentasiloxane dimethicone 30 Humectants e g propylene glycol glycerin 20 Emulsifying agents e g polysorbate PEG oleate TEA oleate 10 Thickeners e g carbomer magnesium aluminium silicate cellulose 10 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 10 Additional ingredients e g vitamins plant extracts 5 Preservatives antimicrobials 1 Parfum 1 Aqua to 100 149 Frame formulation Number 7 20 201 1 EYE LINER WATERPROOF LIQUID CREAM PASTE Ingredients Maximum levels w w Resins film forming polymers e g acrylic resin ammonium acrylates copolymer 30 Oils e g vegetable and or mineral waxes and fats e g long chain alcohols Silicones including volatile silicones e g cyclopentasiloxane dimethicone 30 Colorants colour additives e g opacifying pearlescent agents 20 Thickeners e g stearalkonium hectorite propylene carbonate 15 Ethanol and or isopropanol alcohol alcohol denat isopropyl alcohol 10 Additional ingredients e g vitamins plant extracts aqua 10 Humectants e g propylene glycol glycerin 8 Bulking agents e g talc kaolin zinc stearate 5 Preservatives antimicrobials 1 Parfum 1 Liquid paraffin and isoparaffin e g branched chain isoparaffin C11 C 16 isododecane isohexadecane to 100 150 Frame formulation Number 7 21 201 1 EYE LINE
152. y a warning message indicating how many fields are missing The system will indicate the tab s where the information is missing and will show the message this field is required next to the field s that still needs to be filled in Cancel The ongoing operation is aborted 49 Il 4 NOTIFICATIONS PURSUANT ARTICLE 13 3 DISTRIBUTION 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 labelling 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 Home Products Contact persons P Distributors Useful links v Notify a Pjgduct Search Step 1 The CPNP will first ask the distributor to provide the name of the responsible person of the product that the distibutor wants to distribute Product responsible person name Step 2 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 Step 3 The CPNP will then ask the distributor to enter the product name in the Me
153. ydroxide ethanolamine ammonium bicarbonate 5 Silicones e g amodimethicone silanes e g alcoxysilanes 5 Diammonium dithiodiglycolate 4 Hair conditioning agents e g proteins polymers 2 Opacifying agents 1 Parfum 1 Aqua to 100 pH value 8 9 5 pH value of the ready to use mixture parts A and B 6 5 9 210 Frame formulation Number 1 2 1 T E 201 1 PERMANENT WAVE NEUTRALISER LIQUID CREAM Ingredients Maximum levels w w Emulsifying agents anionic amphoteric non ionic surfactants wetting agents e g ceteary alcohol 8 Hydrogen peroxide 2 6 Thickeners e g carbomer 2 Hair conditioning agents e g silicones including volatile silicones e g cyclopentasiloxane dimethicone amodimethicone silanes e g alcoxysilanes po yquaternium 6 2 Parfum 1 Colorants 1 Hydrogen peroxide stabilising agents e g sodium stannate oxyquinoline sulfate 0 5 Opacifying agents e g styrene PVP copolymer 0 5 Preservatives antimicrobials 0 2 Chelating agents 0 2 pH adjuster e g citric acid qs pH 2 5 3 5 Aqua to 100 211 Frame formulation Number 1 2 1 8 201 1 HAIR STRAIGHTENER RELAXER TYPE 1 Cream type based on lye Ingredients Maximum levels w w Oils e g vegetable and or mineral and waxes 80 Emollients humectants e g lanolin cholesterol 30 Anionic non ionic amphoteric surfactants e g polysorbate 60 15 Emulsifying agents e g cetyl alcohol stearyl alcohol o

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