Cosmetic Products Notification Portal (CPNP) User Manual
Contents
1. Other Information Please indicate any other information of significance for the safety assessment of the nanomaterial The Responsible Person or a Delegate acting on their behalf may indicate any other information of relevance for the safety assessment of the nanomaterial either by entering the information in the dedicated free text box or by uploading a file by clicking on upload The use of English is strongly encouraged 8 MY NOTIFICATIONS Home Products gt Nanomaterials Contact persons My notifications Notify a nanomaterial Useful links gt d E me ai Both the Delegate and the RP will find two lists under the menu item My notifications New notifications and Treated notifications The Delegate and the RP will only see the notifications that they created The notifications that are created by the RP alone will not be visible to the Delegate The RP and the Delegate will also not see the notifications in which they did not participate It is the login in use to log into the system which determines to which notification the user has access Home Nanomaterials gt Useful links New notifications Treated notifications The list called New notifications shows 1 for a Delegate e all the notifications that have the status Draft and were not yet sent to the RP e all the notifications for which the Commission or the SCCS made a request for additional information and the Delegate2. material except for the Catalytic activity The Responsible Person or Delegate has two possibilities Do you want to upload a new file or make a reference to an already existing file Upload Reference The first possibility is to upload a new file containing the specifications of the nanomaterial by checking the Upload box Do you want to upload a new file or make a reference to an already existing file as Upload Reference Alternatively the Responsible Person or a Delegate acting on their behalf can make a reference to a previously uploaded file by clicking on Reference A pop up window will show all the files on Specifications uploaded by the same Responsible Person or Delegate acting on their behalf The Responsible Person or Delegate acting on their behalf can then select the relevant file In addition to the file containing the full characterization of the nanomaterial the Responsible Person or a Delegate acting on their behalf should manually fill out in the CPNP some of the parameters for identification and characterisation listed in the SCCS Guidance SCCS 1484 12 These data refer to 10 the raw material stage with the exception of point 2 7 on photocatalytic activity which refers to the final formulation 2 1 Primary particle size Primary particle sizes volume weighted median Min Number weighted median Min nm Max nm Information on primary particle size must be provided
3. mentioned when they exist Only when they do not exist the Responsible Person or a Delegate acting on their behalf should tick the box Not Available The Responsible Person or a Delegate acting on their behalf can enter this information manually or retrieve it from Cosing database If the user clicks on the button Retrieve from Cosing a pop up page will appear and the Responsible Person or a Delegate acting on their behalf will be able to search for the nanomaterial into Cosing by entering at least 5 characters A new screen will appear and display the information retrieved from Cosing However the Responsible Person is responsible for checking the completeness and the exactness of the information provided and correcting it where necessary The Responsible Person or Delegate shall add information on the class of compound the nanomaterial belongs to such as silicate fullerene etc by choosing one of the options in the drop down menu 1 2 3 Contact details Contact details SS 2eorch Responsible person Contact person Delegate Choose a contact person In this part of the screen the Delegate first needs to select the RP for which he is filling out the notification This is done by clicking on the button Search Responsible Person This will open a pop up in which the Delegate can search for the RP He needs to enter at least three characters and then click on the Search button In the list of results he ne
4. why the same toxicological profile applies to different specifications A free text box is provided for this purpose The use of English is strongly encouraged Please note that the toxicological profile for the nanomaterial provided by the Responsible Person or Delegate has to fulfil the requirements established by Scientific Committee on Consumer Safety in the Guidance on the Safety Assessment of Nanomaterials in Cosmetics SCCS 1484 12 The file to be uploaded in the form of a compressed zip file should contain The summary of the toxicological studies The relevant toxicological studies mentioned in the SCCS Guidance SCCS 1 484 12 The relevant scientific literature 5 Safety data Safety Data Do you want to upload a new file or make a reference to an already existing file o Upload Reference The safety data of the nanomaterial relating to the category of cosmetic product as used in such products must be provided Safety data means the Responsible Person s or Delegate s own assessment of the risk based on the hazard identified in the toxicological profile and the exposure conditions Here too the Responsible Person or a Delegate acting on their behalf has two possibilities The first possibility is to upload a new file containing the safety data of the nanomaterial by clicking on Upload Alternatively the Responsible Person or a Delegate acting on their behalf can make a reference to an already uploaded
5. Cosmetic Products Notification Portal CPNP User Manual for the Notification of Cosmetic Products Containing Nanomaterials Table of Contents A nts sued erica eaeeenacee tector yueansenas 1 1 CREATE A NOTIFICATION OF A PRODUCT CONTAINING NANOMATERIAL Saro 5 AA EG 6 12 IDENTPIGATION iosscoperss roporasdnioonop pornp e T TT TO TNES 6 aro EIA TON eee nee ee E oi io ttabias 9 2 Puimay Darlici IZ isis 10 22 SeECOMOaly Parce SIZE a is a a e 10 MM das 11 2 A Slnmace CNAFACICNISUCS 554 265 cra 12 O 8 0 enema ete eee o ae ee eee 12 20 AAA o o 13 A tere E er renee renter tecnere tren mee ne ements tener cree 13 e CO CO EE S 14 4 TOXIGOIOGIC Al DTOM O scssantao clics 14 or Oo fs cleaner nr ner Rete E PU eee een ne nea eee 15 6x EXOOSULE GC OMCIIOMS esa iodo 16 nn A E E EET EE S A 17 SMN NO IFICA THONS cerrar 17 JEDINO TRIG AGN ON Ss oc ccctecpenten ce poe 19 10 HOW TO DUPLICATE A NOTIFICATION cece eeeceeeeeeeee es 19 11 REQUEST FOR ADDITIONAL INFORMATION eee eee eee 19 2 EMAIL NO TEFISGATMONS cosita 21 The Notification of Cosmetic Products Containing Nanomaterials According to Article 16 of Regualtion EC No 1223 2009 Article 16 of Regulation EC No 1223 on cosmetic products requires that in addition to the notification under Article 13 cosmetic products containing nanomaterials shall be notified to the Commission by the Responsible Person by electronic means six months prior to bei
6. Delegate will only have access to the module for Article 16 in CPNP A Delegate will not see the menu items on the screen that are needed to notify products under Article 13 in CPNP As mentioned above a Delegate can also not enter the estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year The field to enter this information is only visible to the RP The notification of cosmetic products containing nanomaterials is mandatory for those products containing nanomaterials that have not undergone a full risk assessment by the Scientific Committee on Consumer safety SCCS The notification of safety information allows the Commission to request a full risk assessment in case it has concerns related to the safety of the nanomaterails for human health This means that if the product contains nanomaterials included in such form in Annexes Ill IV V or VI to Regulation EC No 1223 2009 it does not need to be notified under Article 16 If a product is available in several shades each shade containing a different nanomaterial should be notified under Article 16 If a product contains more than one nanomaterial there should be one Article16 notification per nanomaterial This assessment is done in different steps That is why in the system the notification will follow certain predefined steps The following flow charts show what these steps are The first flow chart explains how a notification
7. The Responsible Person or a Delegate acting on their behalf has to provide the lowest size cut off value the volume weighted median and the number weighted median all three values expressed in nanometres nm For both the volume weighted and number weighted median ranges can be indicated corresponding to the minimum and the maximum value of the different measurements with the same method As per the SCCS Guidance on the Safety Assessment of Nanomaterial in Cosmetics SCCS 1484 12 the particle size has to be measured with more than one method The particle size values to be registered in the CPNP are those obtained with the method which gives the lowest particle size in terms of volume weighted or number weighted median The results obtained with other measurement methods should be provided in the attached file preferably in a table comparing the results obtained with the different methods used to determine particle size The CPNP applies the English notation for numbers Example 0 3 and not 0 3 2 2 Secondary particle size Secondary particle size Yolume weighted median hin nm Max nm Information on secondary particle sizes should be provided where appropriate The parameters requested are the minimum and the maximum volume weighted median expressed in nanometres nm As for the primary particle size ranges can be provided The CPNP applies the English notation for numbers Example 0 3 and not 0 3 11 2 3 Morphology Mor
8. did not yet reply 2 for a RP e all the notifications that have the status Draft and were not yet notified to the Commission e all the notifications for which the Commission or the SCCS did make a request for additional information and for which the Delegate did already formulate a reply but the RP did not yet reply The list called Treated notifications shows all the notifications that are notified and for which there is no request for additional information or a reply was already given to such a request These two lists also give the user the possibility to follow the status of each notification to which he has access The status of each notification is updated automatically in these lists The status of a notification is identified by a name and a colour 2 Draft AE ON RP 2 eee ee 4 Additional info requested by EC to Delegate 5 Additional info requested by EC to RP Fe E E fee oe ers 6 Final reply to EC request Final reply to EC request 8 Sent to SCCS Sent to SCCS 9 Additional info requested by SCCS to Additonal info requested by SCCS to Delegate Delegate 10 Additional info requested by SCCS to RP Additonal info requested by SCCS to RP Final reply to SCCS request Final reply to SCCS request 12 Opinion given by SCCS A 13 Deadline 13 Deadline Expired Note that the status Notification Treated does not mean that no concern may arise regarding the safety of the nanomaterial and it can b
9. e changed into Sent to SCCS at any time In addition the status Notification Treated does not mean that the product can be placed on the market before the expiration of the six month standstill 19 9 EDIT NOTIFICA TIONS All notifications that have the status Draft can still be edited It is important to note that once a notification is notified to the Commission it can no longer be edited To edit a notification the following has to be done 1 go to My nanomaterials 2 in the list of New notifications find the notification that needs to be edited 3 click on the Edit button El and the notification will open 4 edit all the information that needs to be changed or completed 5 either save as draft or click the Send to RP button for a Delegate or the Notify button for an RP Note that an RP can always edit the data entered by a Delegate if this Delegate did not lock his information All information that is locked by a Delegate is not visible to the RP and can thus not be edited by the RP 10 HOW TO DUPLICATE A NOTIFICATION The Duplicate function allows a user to copy all the information except for the Foreseen Cosmetic Product Name from a notified notification to a new notification The information that is copied into the new notification can be edited It is important to note that this duplicate function is linked to the lock function described above There are different scenarios 1 A Delegat
10. e fills out a notification and does not use the lock function The RP will be able to duplicate this notification after notifying All the information is copied in this new notification including the contact details of the Delegate When the RP clicks the Notify button for this new notification the Delegate will receive an e mail notification The Delegate did not participate in the creation of this new notification but given that his information is being reused it is necessary that he is aware of this This also means that if the Commission or the SCCS make a request for additional information concerning this second notification this request will first be sent to the Delegate 2 A Delegate fills out a notification and uses the lock function After the information is notified to the Commission the RP will not be able to duplicate this notification The fact that the RP cannot see part of the information prevents him from being able to duplicate In this case only the Delegate can duplicate the notification and he will have to pass on the draft notification to the RP when he is finished filling out his part 11 REQUEST FOR ADDITIONAL INFORMATION Both the Commission and the SCCS have the possibility to make a request for additional information This functionality can only be used once by each of them There are two possible scenarios 1 There is a Delegate The request will be sent to the Delegate first He needs to give his informati
11. ecification Quantity Tox Profile Safety Data Expraemar Other At the end of each section the Responsible Person has the possibility to click on e Save as draft in case he wants to save the data but not submit them e Notify if the notification is complete and he wishes to submit it to the Commission or e Cancel in case he wants to cancel the on going operation It is important to note that the Delegate is not able to notify to the Commission At the end of each section the Delegate has therefore the possibility to click on e Save as draft in case he wants to save the data but not submit them e Send to RP if the Delegate estimates that he did provide all the information or e Cancel in case he wants to cancel the on going operation Note The SCCS works in English Therefore the use of English for the information submitted into CPNP is strongly encouraged The CPNP interface for Article 16 notifications is in English However to facilitate the use of the system translations of the labels used in the interface are available under Useful links 1 1 LOCK function A Delegate has the possibility to lock part of the information he enters into a notification Identification Specification ias Safety Data esi Gils Other Notification information Lock Unlock The Delegate can at any moment before sending the notification to the RP lock or unlock some information By clicking the c
12. eds to select the correct RP The contact details of the RP will then we shown in the notification itself The Responsible Person or a Delegate acting on their behalf has then to provide details of a physical contact person that may be contacted if necessary The Responsible Person or a Delegate acting on their behalf can either select an existing contact person in the drop down list or click on button to insert the details of a new physical contact person 2 SPECIFICATION The User Manual for this section should be read in conjunction with the SCCS s Guidance on the Safety Assessment of Nanomaterials in Cosmetics SCCS 1484 12 available at 9a eu health scientific_committees consumer_safet The specifications of the nanomaterial including size of particles physical and chemical properties must be provided A full characterization of the nanomaterial at different stages of the manufacturing process as recommended by the SCCS section 4 1 of SCCS 1484 12 taking into account all the parameters listed in Table 1 of the above mentioned Guidance should be carried out This information should be provided by the Responsible Person or a Delegate acting on their behalf under the Specification Tab in the form of a specific pdf or Zip file Specification The requirements provided in the SCCS Guidance on the safety assessment of nanomaterials in cosmetics SCOCS 1464 12 should be followed All measurements need to be done on the raw
13. file by clicking on Reference The reference of an uploaded file can be searched among the files containing Safety Data already uploaded by the same Responsible Person or a Delegate acting on their behalf by clicking on the button Search file 16 When the Responsible Person or a Delegate acting on their behalf makes reference to an already uploaded file he must indicate if the specifications are the same In case the specifications are not the same the Responsible Person or a Delegate acting on their behalf has to explain why the same safety data apply to different specifications The use of English is strongly encouraged It should be noted that the safety data file provided by Responsible Person has to be in line with the criteria established by Scientific Committee on Consumer Safety in the latest the SCCS s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation SCCS 1416 12 and the Guidance on the Safety Assessment of Nanomaterials in Cosmetics SCCS 1484 12 6 Exposure Conditions Reasonable Foreseeable Exposure Conditions of the Nanomaterial Rinse off Leave on Rinse off Leave on Exposure route Dermal Oral Inhalation Do you want to upload a new file or make a reference to an already existing file Upload Reference In this section the Responsible Person or a Delegate acting on their behalf has to provide information on the exposure conditions by indicating whethe
14. he bottom part of each accessible tab the Delegate RP can upload a document and there is also a free text box to formulate a reply to the request The use of English is strongly encouraged Information provided by the responsible person delegate during safety assessment for Commission s evaluation 21 If the Delegate RP uploads a document this document will not replace the previously uploaded documents It will be stored in the notification with all the other documents that were already uploaded into the notification 12 EMAIL NOTIFICA TIONS The system will at certain moments in time sent e mail notifications to the Delegate and to the RP These e mail notifications will let the Delegate RP know that the status of the notification changed The e mail notifications are sent when When is e mail notification sent Who receives e mail notification 1 Delegate sends filled out notification to RP Delegate and RP 2 RP notifies to the Commission Delegate RP and Commission Delegate 4 The Commission makes a request for additional information the RP and sends the notification to the SCCS information to the RP 10 RP sends his final reply to the SCCS request Delegate RP Commission and SCCS 11 The SCCS has formulated an opinion Delegate RP Commission and SCCS 12 The deadline has expired Delegate RP Commission and SCCS Note that when an e mail notification is sent to a Delegate and to a RP the same e mail is also sent to
15. heck box the Delegate locks the following tabs Specification Tox Profile and Safety Data All the data provided in these tabs will not be visible to the RP It is important to note that a Delegate can only lock these tabs if he provides ALL the information in these tabs If some information in these tabs is missing the system will prevent the Delegate from locking these tabs and sending the notification to the RP The lock function always and only covers these three tabs Specification Tox Profile and Safety Data A Delegate can thus neither lock more nor lock less than these three tabs The above means that the tabs Identification Exp Cond and Other can never be locked and will always be visible to the RP The lock function is only available to the Delegates The RP will not see this function on his screen 1 2 IDENTIFICATION This tab contains several parts identification of the product identification of the nanomaterial and contact information of the Delegate RP and their contact person 1 2 1 Identification of the product Product category Product category Level 1 Please choose one 7 Level 2 Please choose one 7 Level 3 Please choose one 5 Mame The Responsible Person or a Delegate acting on their behalf has to first of all provide information on the category of the cosmetic product in which the nanomaterial will be used by selecting three category levels starting by the level 1 subsequently followed b
16. is done by an RP alone The second flow chart shows how a notification is done by a Delegate and an RP together The shows where there are e mail notifications 3 Fill out form reply to request for extra information RP Notify to Commission Reply Y to Commission Yes IN Check notification Commission Reply to SCCS Extra info needed Yes Notification treated is stored and can still be changed to Sent to SCCS O IN Assess dossier SCCS Extra info needed No Give opinion Fill out form reply to request for extra information Delegate Send to RP Complete form complete reply to request for extra information RP to Commission in Check notification Commission Yes Reply to SCCS Extra info needed Notification treated is stored and can still be changed to Sent to SCCS in Assess dossier SCCS Extra info needed No Give opinion 1 CREATE A NOTIFICATION OF A PRODUCT CONTAINING NANOMATERIALS Home Products gt Useful links gt Nanomaterials Contact persons My notifications Notify a nanomaterial To create a notification of a product containing a nanomaterial the Responsible Person or a Delegate acting on their behalf has to click on the Nanomaterials tab and then on Notify a nanomaterial Several sections will appear on the screen Each of them has to be completed Identification Sp
17. ndicated by clicking on the corresponding box If solubility in n octanol is not relevant in the cases of inorganic and not coated with organic coating nanomaterials this should be indicated by clicking on the corresponding box For organic and organically coated inorganic nanomaterial for which n octanol solubility has not been measured it is possible to check the same box and a justification may be provided under the tab Other in the text box reserved for Other information 13 The octanol water partition coefficient should be provided If not applicable e g inorganic and or not coated with an organic substance the corresponding box should be checked 2 6 Surface area Surface area Information on surface area should be provided The specific surface area SSA and volume specific surface area VSSA are mandatory for powders For non powder materials both parameters are optional The BET method measures particle surface area Dividing the absolute surface area by the sample mass gives the so called mass specific surface area commonly reported in the unit square metre per gram m g It is possible to give the value as volume specific surface area VSSA expressed in m 2 cm Therefore the calculation of the VSSA from the common result of a BET measurement requires the knowledge of the material density 2 7 Catalytic activity Catalytic activity in final formulation Chemically reactive surface Yes No Is
18. ng placed on the market Home Products tanomaterials gt Contact persons wv Useful links The module called Nanomaterials in CPNP allows for this kind of notifications Article 16 of Regulation EC No 1223 2009 also establishes that the Responsible Person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof The system therefore foresees two different roles the Delegate and the Responsible Person RP When an RP mandates a Delegate the Commission is informed through the system once each individual notification is submitted The role of the Delegate allows entering certain data in the notification if the RP made such a request In the system this means that a Delegate will initiate a notification and once he has finished entering all the information he wants needs to enter he will have to pass the notification on to the RP It is then the RP who will complete the notification and notify it to the Commission It is important to note that a Delegate can never fill out a full notification and submit it to the Commission Certain data like the estimated quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year always needs to be entered by the RP and only the RP can click on the button Notify The access rights of a Delegate are thus different from those of an RP The first difference is that a
19. on The aspect ratio of elongated particles should be calculated and provided 2 4 Surface characteristics Surface characteristics Surface charge zeta potential Po mY Mot measurable surface modifications or functionalization Yes No Coating Please choose one The Responsible Person or a Delegate acting on their behalf has to provide detailed information on nanomaterial surface characteristics This includes information on zeta potential measured in water or buffer which is an indication of the strength of surface charge expressed in millivolt mV when it is measurable and information on whether the nanomaterial is coated or uncoated l the zeta potential is not measurable the corresponding box should be checked Any chemical biochemical surface modifications that could change the surface reactivity or add a new functionality shall be indicated by selecting Yes or No 2 5 Solubility Solubility Solubility dissolution in relevant solvents t Aqueous media OoOo mg l Below 0 01 W octanol fe mg l Not relevant Octanol water partition coefficient Po Not Applicable The Responsible Person or a Delegate acting on their behalf has to provide information on the solubility of the nanomaterial in relevant solvents such as aqueous media and n octanol The solubility is expressed in milligrams per litre mg l In case the solubility of the nanomaterial in aqueous media is lower than 0 01 mg l it must be i
20. on and then sent the notification to the RP so that the RP can also give his reply to the request for additional information It is important to note that if a request for additional information only concerns the Quantity tab the request will only go the RP the Delegate does not have access to this tab 2 There is no Delegate The request is only sent to the RP The RP needs to give his reply and send this reply to the Commission or the SCCS 20 Both the Commission and the SCCS need to clearly formulate their request They also need to indicate the tab or tabs in which some information needs to be added by checking the relevant box es It is important to note that only the tabs that were indicated will be accessible to the Delegate and the RP Identification Specification Quantity Tox Profile Safety Data Exp Cond Other Need Info Commission s evaluation Complete Mot complete Request for information Specification Quantity Toxicological Safety data Exp Cond When the Delegate and the RP will receive the request for additional information they will find the following information in the tab Need info e who formulated the request e which tabs were selected and e the request How to reply to a request for additional information The Delegate RP will have access to the tabs that were selected by either the Commission or the SCCS In these tabs the Delegate RP can edit any information All the fields are editable Also at t
21. phology Physical form Please choose one Please choose one solid Powder solution suspension Dispersion Other Crystalline shape Information on the physical form of the nanomaterial has to be provided It is possible to select one among several physical forms as it is indicated by the drop down menu Crystalline shape Spherical Hexagonal Pyramidal Rod Plate Wire Whisker Star like Needle like Fiber Tube Isometric Crystalline Irregular Amorphous Other Agglomeration aggregation state Dispersed free particles Agglomerate Aggregate Other In addition information on the crystalline shape has to be provided It is possible to select several crystalline shapes by ticking the corresponding boxes NOTE Whiskers are a type of nanofibres Nanofiber is defined as nanoparticle with two dimensions at the nanoscale and an aspect ratio of greater than 3 1 Types of nanofibre include nanowhiskers nanorods and nanowire ISO Publically available Specifications PAS 71 2005 Isometric refers to a form of crystal where the unit cell is equal in all dimensions Both under Physical Form and Crystalline Shape when the answer is Other a free text box will appear to specify what Other means It is strongly recommended to fill the box in English 12 The Responsible Person or a Delegate acting on their behalf also has to indicate the agglomeration aggregation state lt is possible to select more than one opti
22. r the product is a rinse off or a leave on product the exposure route dermal oral and or inhalation in the case of spray applications the concentration of the nanomaterial in the product expressed in w w The Responsible Person has to provide all the information related to the reasonable foreseeable exposure conditions which can be included in the safety data In addition the Responsible Person or a Delegate acting on their behalf can provide further information via the following two possibilities The first possibility is to upload a new file containing the information related to the reasonable foreseeable exposure conditions by clicking on upload In the case of deodorants it is recommended to upload a file indicating the type of product of the listed in Table 3 of the SCCS s Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation SCCS 1416 12 deodorant non spray aerosol spray ethanol based or spray not ethanol based Where there is no file uploaded the SCCS may apply the most conservative values for exposure Alternatively the Responsible Person or a Delegate acting on their behalf can make a reference to an already uploaded file by clicking on Reference A pop up window will show all the files on Exposure Conditions uploaded by the same Responsible Person or Delegate acting on their behalf The Responsible Person or Delegate can then select the relevant file 17 7 Other
23. t is already placed on the market by clicking on Yes or No 4 Toxicological profile The user guide for this section should be read in conjunction with the SCCS s Guidance on the Safety Assessment of Nanomaterials in Cosmetics SCCS 1484 12 available on http ec europa eu health scientific committees consumer_safety docs sccs s 005 pdf Toxicological Profile of the Nanomaterial Do you want to upload a new file or make a reference to an already existing file w Upload Reference 15 The toxicological profile of the nanomaterial must be provided The Responsible Person or a Delegate acting on their behalf has two possibilities The first possibility is to upload a new file containing the toxicological profile of the nanomaterial by clicking on the button Upload Alternatively the Responsible Person or a Delegate acting on their behalf can make a reference to an already uploaded file by checking the box Reference A pop up window will show all the files on Toxicological Profile uploaded by the same Responsible Person or Delegate acting on their behalf The Responsible Person or Delegate can then select the relevant file When the Responsible Person or a Delegate acting on their behalf makes reference to a file he has already uploaded he must indicate whether the specifications are the same In case the specifications are not the same the Responsible Person or a Delegate acting on their behalf has to justify
24. the contact persons of both the Delegate and the RP whose the contact details were included in the notification 22
25. there photocatalytic activity Yes No Your material has photocatalitic activity Please consider carefully whether photo induced toxicity test should be provided in the toxicological profile based on the exposure and condition of use of your product Core material doped Yes No The chemical reactivity of the surface of the nanomaterial should be indicated by selecting the Yes or No box The Responsible Person or a Delegate acting on their behalf has to indicate whether the nanomaterial has photocatalytic activity by selecting Yes or No If it is Yes they will need to indicate the level of photocatalytic activity in terms of to reference The reference refers to the same but uncoated form of the nanomaterial Any values above 0 should be reported It should also be indicated if the core material is doped by checking the Yes or No boxes 14 NOTE Doped nanomaterials are those that contain other intentionally introduced materials usually for the purpose of modulating certain chemical biochemical or catalytic reactivity 3 Quantity Quantity of the Nanomaterial contained in the Cosmetic Product Is the product on the market cl Yes gt No An estimate of the quantity of nanomaterial contained in cosmetic product intended to be placed on the market per year must be provided by the RP It shall be expressed in kilograms kg Until 10 July 2013 the Responsible Person should indicate whether the produc
26. y level 2 and 3 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 All existing categories are available for consultation in Annex to this User Manual The Responsible Person or a Delegate acting on their behalf has to provide the Foreseen Cosmetic Product name of the cosmetic product that will contain the nanomaterial notified It is important to note that if the cosmetic product is already on the market the Responsible Person or a Delegate acting on their behalf has to indicate the actual name of the product identical to the one mentioned in the notification pursuant Article 13 of Regulation EC No 1223 2009 It is important to note that the fields preceded by are mandatory in order to create the notification as draft while the fields indicated by are mandatory in order to submit the notification 1 2 2 Identification of the nanomaterial Descriptors nanomaterials TUPAC INCI CAS EC Number INN XAN Class of compound The Responsible Person or a Delegate acting on their behalf has to provide information on the identification of the nanomaterial The IUPAC name is mandatory and other descriptors i e INCI CAS number EINECS and or ELINCS EC number INN number XAN number which is the name approved by specific country X e g USAN which corresponds to the United States approved name shall be
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