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1. KBO BCE Number for Belgian enterprises VAT Number for foreign enterprises Zip code City Former Local admin First name Last name TT Registered e mail address Phone number New Local admin Ee Address to fill in only if different from Enterprise address Street Nr Box Zip code City Date Name Signature To be sent to Federal Public Service Public Health DG4 Service Food FOODSUP Eurostation II Place Victor Horta 40 box 10 1060 Brussels Belgium PAGINA 38 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU ANNEX 3 FOODSUP Delegations FOODSUP allows for Enterprises responsible for putting food supplements and fortified foods on the Belgian market to give a delegation to a consultant for the notification of the products For more information about delegations and access and reading rights please consult the FOODSUP Front Office Manual more in particular point 7 5 Enterprise Name Notification Company Number for new companies indicate new KBO BCE Number for Belgian enterprises VAT Number for foreign enterprises Zip code City Gives a delegation to consultant Consultant Name KBO BCE Number for Belgian enterprises VAT Number for foreign enterprises Zip code City Country Simple delegation YES NO And product specific delegation YES NO If p
2. Figure 41 Enterprise details tab Divisions 7 3 Tab Invoicing The tab Invoicing will contain all billing addresses New billing addresses can be added or the existing ones can be changed Enterprise Detail Divisions Invoicing Contact Persons Delegations Email Street Nr ZipCode City Country Action facturatie democompany be Victor Hortaplein 40 1060 BRUSSEL BELGIUM View Edit Create Figure 42 Enterprise details tab Invoicing 7 4 Tab Contact Persons The tab Contact Persons will contain all contact persons New contact persons can be added or the existing ones can be changed Enterprise Detail Divisions Invoicing Contact oo Delegations Firstname Lastname Email Street Nr ZipCode city Country Action Pascale De Gryse pascale degryse Victor Hortaplein 40 1060 BRUSSEL BELGIUM View Edit Create Figure 43 Enterprise details tab Contact Persons 7 5 Tab Delegations Responsible companies can appeal to a consultant for notifying food supplements and fortified foods In the tab Enterprise Details it can be indicated that one operates as consultant There are two possibilities for a responsible to give a delegation to a consultant 1 Simple delegation Once a simple delegation is given the consultant will be able to notify new products but has no access what so ever to already existing products of the company The c
3. federale overheidsdienst directoraat generaal VOLKSGEZONDHEID Dier Plant en Voeding VEILIGHEID VAN DE VOEDSELKETEN Dienst EN LEEFMILIEU Voedingsmiddelen Dierenvoeders en Andere Consumptieproducten FOODSUP Front Office DG Animals Plants and Foodstuffs Staff Service ICT last modification 07 04 2015 Index Tif SS spss ecstasy ePrice cers escent gee EE E EAA E E 1 Abbreviations used in this CO CN i sissrcirreesieinreseridrr ues sncztisesusoasinedsece tose net ea oss nacatiossssuasyucsect sna veiecontsscetontsese 2 E a E E A E A E E edatee 3 CBAC EE E o TA NEE EAE dacs NEA NEO AE A O 4 E E aE E E O E E E em O OE et teae 5 A ROW E E E sens oe oe essen A O A E eee eee 5 4 1 Rone ea a O a E E E ee 5 4 2 OG UNC CC E E E E E E E T 7 Te Forcal ACI e A 7 M E Si e E E E E E E EE E ce q 4 3 O aa E E E E ctenaacreeeeeaea contest 7 BoE TASS TAS E E E anges eseasanacte E sats 8 oe Chonpe Cindi ANd Dass Old areca eae eka an 8 5 e Bie OD Clue os 6s paler or oo a 9 E Na a rt ain rTP VE eR et Pe Cee ee Tee SPE Te 10 6 1 A I O A ON acess carsesses case sass gnc east incese mscuatan me osetia as ss ea 10 6 1 1 Nonficaton forta Dey PDrodUCt uaa neee areca earns 10 6 1 2 Notification for an existing product i e modification of an existing notification 10 6 2 IN GUE CAT OU detil ccssar innr EN TE N EOT E TEATA 11 6 2 1 Possible actions when a notification is in draft esseesssessesssesseessssreessssreesss
4. Packaging free text field Recommended daily portion free text field Product Product Name demo product 3 Division DEMO COMPANY Nr 2196 3 version 1 Product State Draft Selected notification Product Ingredients Nutrients Other Substances Nutritional Analysis Toxicity stability and analysis Describe the presentation including the amounts and the unit weight Form tablet x Presentation tablets of 678 9 mg Packaging 4 blisters with 8 tablets in a box Recommended daily portion 1 per day Figure 17 Notification details tab Product 6 2 4 Tab Ingredients In the tab Ingredients following details are encoded the way ingredients are expressed this is a mandatory field all the ingredients of the product their quantity unit function and comments can be made free text field at the bottom of the page PAGINA 12 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Product Product Name demo product 3 Division DEMO COMPANY x Nr 2196 3 version 1 ProductState Draft Selected notification Ingredients Nutrients Other Substances Nutritional Analysis Toxicity stability and analysis J Ingredients and composition will be provided by third party for reasons of confidentiality Ingredient expressed per recommended daily portion fxd Jof the product Selected ing
5. and in the tab Other Substances This is a mandatory field that can only be modified trough the tab Nutrients so even if the product does not contain nutrients this field must be filled in quantity and unit of the nutrient of recommended daily intake and comments can be made If the ingredient list contains chemical forms the nutrients linked to that chemical form will be automatically filled added the tab Nutrients However it is possible to delete those nutrients Be aware that if a nutrient is deleted the corresponding chemical form s will not be deleted in the tab Ingredients It is also possible to add other nutrients this will also not have any impact on the tab Ingredients Therefore all possible necessary modifications in the list ingredients have to be done by the user himself in the tab Ingredients Quantities will not be copied from the tab ingredients this because the quantity of the ingredient is not necessarily the same as the quantity of the nutrient for example for 6 caroteen there is a conversion factor or the ingredient list can contain more than one chemical form of the same nutrient PAGINA 16 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Product Product Name demo product 3 Division DEMO COMPANY 7 Nr 2196 3 version 1 ProductState Draft Selected notification Notification Produc
6. versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Withdrawn from the market by producer importer reseller The responsible has indicated that the product is not on the market anymore Withdrawn by the administration The administration has withdrawn the notification number In general the last notification for which a decision has been taken determines the state of the product except when the notification number was temporarily attributed or when the product has been withdraw from the market The product state will not change when a new notification is created draft or is waiting for decision except for extended temporary attribution 3 System requirements FOODSUP has been developed to be used with Internet Explorer 7 to 9 FOODSUP will most probably work with other web browsers for example Mozilla Firefox but stability cannot be guaranteed After the login FOODSUP will open in a pop up therefore it might be necessary to specify in the web browser that pop ups are allowed if the warning would appear 4 How to get access FOODSUP can be found on following link www health beleium be foodsup All users need a classic e mail based login to enter FOODSUP Every organization using FOODSUP needs a local admin account this local admin account can only be created by the FPS and that only on request The local admin is r
7. EN LEEFMILIEU Enterprise Detail Divisions Invoicing Contact Persons Delegations Enterprise name DEMO COMPANY KBO BCE Number for Belgian 0884233785 enterprises VAT number for foreign enterprises Belgian KBO BCE number not known O Foreign company Language z English Legal Address Steck Victor Hortaplein Nr 40 Box Nr 10 City BRUSSEL ZipCode 1060 oe aun y Email Website Tel Mobile phone Fax Functions as a consultant E Local admin email Save Save and Close Cancel Figure 40 Enterprise details tab Enterprise Detail 7 2 Tab Divisions The tab Divisions contains all divisions of a company If a company known in FOODSUP takes over another company also known in FOODSUP the one that has been taken over becomes a division of the first one Creating and transferring divisions will only be done by FPS The form to request a transfer of a division has be included in Annex 4 a Word version can be downloaded on the website of the FPS PAGINA 26 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Invoicing Contact Persons Delegations Enterprise Detail Diane Name Nbr Provincial Unit Action DEMO COMPANY 2196 AFSCA Si ge Central FAVV Hoofd View Edit TAKEN OVER BY DEMO 2198 AFSCA Si ge Central FAVV Hoofd View Edit
8. Language TEST_ENVIRONMENT FR NL EN Welcome pascale de gryse Change password Change mail Figure 9 Change email address After changing password or e mail the user will recetve a mail with a confirmation PAGINA 8 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 5 FOODSUP Home screen After logging in the user sees the FOODSUP home screen The home screen allows to create notifications Oo notifications for a new product see point 6 1 1 Oo notifications for existing products modify existing notification see point 6 1 2 manage the details of the company see point 7 manage the log ins of a company see point 8 this button is only visible for local admins change the password see point 4 3 2 change mail address see point 4 3 2 refresh the home screen use filters through a drop down list search products based on their full name or a part of it enter the search criteria and click enter see a list of notifications in draft for these notifications o the notification can be edited see point 6 2 O the history of the product can be consulted see point 6 5 o aPDF document containing all encoded data can be generated see point 6 2 1 see a list of notifications waiting for decision for these notifications o the PDF document containing all details can be downloaded see point 6 3 2 O the history of the product can be co
9. Product Name demo product 3 Division DEMO COMPANY Nr 2196 3 version 1 ProductState Draft Selected notification Ingredients Nutrients Other sn ja Nutritional Analysis Toxicity stability and analysis Annexes Other substances expressed per recommended daily portion of the product Add other substance Selected other Substances Qty Other Substance per recommended Unit Action daily portion Name Figure 26 Notification details tab Other Substances 6 2 8 Tab Nutritional Analysis In the tab Nutritional Analysis following details are encoded the way the nutritional analysis is encoded energy carbohydrates proteins fats and comments can be made Product Product Name demo product 3 Division DEMO COMPANY Nr 2196 3 version 1 Product State Draft Selected notification Notification Ingredients Nutrients Other Substances Nutritional Analysis Nutritional analysis expressed per joos O H after preparation following instructions of the producer ls Eneray in kcal 6 kcal Energy in kJ 27 kJ Carbohydrates 1 Proteins 1 Fats 1 Comments Figure 27 Notification details tab Nutritional Analysis PAGINA 19 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 6 2 9 Tab Toxicity stability and analysis In the tab Toxicity stability and analysi
10. Register a new user Email jet gezondheid belgie be ea Sati Figure 48 Add a new user If the user was added successfully a confirmation screen will appear and the user will receive an email PAGINA 29 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Admin Organization Y 1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management Confirm the addition of a user heyvaert els The data for this user have been added Figure 49 Confirmation after adding a user Once the user was added specific access rights have to be given Therefore click Back in the confirmation screen Specific access right are given by selecting the user and by clicking on Management of the 22 accesses Admin Organization Y 1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management User list am Name First name Ooo e O de gryse degrysepascale gmail com heyvaert ls els heyvaert gezondheid belgie be Add User Management of the accesses Figure 50 Select user in order to give specific access rights After clicking on Management of the accesses the screen Allocation of authorisations applications for a user will open there the flag FRONT_OFFICE Role management should be flagged after that click on Validate After clicking on Validate a confirmation sc
11. federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU By clicking Add ingredients can be added to the list of ingredients in the notification details By clicking View the user can see information about the ingredient for example for plants all specifications in the royal decree on plants can be consulted FoodSup Language TEST_ENVIRONMENT FR NL EN Welcome pascale de gryse Change password Change mail Plant Fr Echinac e pourpre NI Purperen rudbeckia Rode zonnehoed Comment Fr NI Latin Name Plant Type F ant r T wild F List 1 IV Asterisk Cultivated IV List 3 Echinacea purpurea L Moench Cancel Figure 20 Consulting details of an ingredient cdi ingredients are present in FOODSUP Chemical forms of nutrients All authorized chemical forms are present in FOODSUP as well as chemical forms that were used before a limitative list was foreseen in the legislation Plants All plants in the annexes of the royal decree on 29 August 1997 Additives All additives in EU regulations Other substances Other ingredients All the ones present in notification dossiers already received The presence of an ingredient in FOODSUP does not necessarily mean that the use of that ingredient is permitted in foods or food supplements Guidelines for encoding the list of ingredients All ingredients are encoded separately even in they were ad
12. 33 Id Dati SC CEI Proe CUON serier in EEEE TE EE E E TO yeceacacest 33 a Mails sent and documents created by POO DSUP ssssesesesssesrsrsrrrrrrrsrrrrrrerrrerrrrrrrerrerrrreness 33 KEE MI o5ssc3teosstithocseche acres te tecantceene ae ae ieeestaieceee 34 DO Ngadon tatoo bf eT aisaesactantacea deere e E A AO 34 9 3 2 Before submitting the first MOU MCANIO Ms ccacessasssnce asennsasacasnanostantsmaaonsasacapentsasioasianestannenaaonate 34 oa ZO de nha cl Mere nmT er TTR eRe Re reo TET TCE TOR aN ere Teer oT rete A 34 9 34 Downloading dOCUMIENTS peetenrerreterreoretcerer er rrrrcret etre rete oreoretrerer evrrrrcret crete aiai aeai ty 34 9 4 EE ai O Pee eee Te EEEE T E a ee ee 35 ANNEX 1 POODSUP Creation of local AC t wccsioseessuens rsscesioonsneeneensacadarnaerecsianinaoutdenaseiseniauess 37 ANNEX 2 FOODSUP Modification of local admin sssssssssssssssssssssssesesessssssssssesesesssesssneseseseseseseeses 38 ANNEX S T TOJD UPD OS E Creer reer ent trey ere re 39 ANNEX 42 FOODSUP Transiter diyiSiON S ssssernsisintirianne a ENEE E 40 Abbreviations used in this document Notifier the person who introduces notification dossiers FPS Federal Public Service Public Health Food Chain Safety and Environment responsible for the treatment of notification dossiers FASFC Federal Agency for the Security of the Food Chain responsible for the control of products on the Belgian market Local admin the user responsible for the management of the use
13. federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU ANNEX 1 FOODSUP Creation of local admin Every organization using FOODSUP needs a local admin account the local admin account can only be created by the FPS and that only on request by using this form This form should be sent to the FPS only after the user who has to become local admin has registered on the website For more information about the registration and the responsibilities of the local admin please consult the FOODSUP Front Office Manual more in particular point 4 Enterprise Name Notification Company Number for new companies indicate new KBO BCE Number for Belgian enterprises VAT Number for foreign enterprises pe SS es SS es Address o o Street Nr Box oo o Zipcode City oo o Country oo S E ns po Contact person Local admin First name Last name Registered e mail address Address to fill in only if different from Date Name Signature To be sent to Federal Public Service Public Health DG4 Service Food FOODSUP Eurostation II Place Victor Horta 40 box 10 1060 Brussels Belgium PAGINA 37 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU ANNEX 2 FOODSUP Modification of local admin Enterprise Name Notification Company Number for new companies indicate new
14. for that product it will be possible to create a new notification for a product Obviously it is possible to have multiple drafts or notifications concern different products 4 waiting for decision if they A product can have 9 states 1st notification waiting for decision A notification for a new product has been introduced but not yet treated by the administration Attributed Based on the last notification a notification number has been granted Not attributed Based on the last notification a notification number has not been granted Not applicable Based on the last notification the product should not have been notified Temporarily attributed Based on the last notification a notification number was attributed but only valid for three months Extended temporary attribution If a new notification has been submitted within less than three months after a notification number was temporarily attributed that temporary notification number stays valid until the administration has treated the new notification Expired after a temporary attribution If a new notification has not been submitted within the three months after a notification number was temporarily attributed the notification number becomes invalid If a notification is submitted after more than three months after a notification number was temporarily attributed the product state will still be Expired after a temporary attribution PAGINA 4
15. given by clicking next to the products for which a delegation needs to be given In that case a consultant gets access to the whole history of the product that means that he can see all notifications for that product even the ones dating from before he was consultant Delegation x This is the list of consultants known in FOODSUP The presence of a consultant in this list does not restrain any responsibility of the FPS Public Health nor is it a recognition of expertise or experience Name Nr Division Product name Contact person Language Conclusion DEMO COMPANY 2196 demo product 1 Pascale De Gryse nl M DEMO COMPANY 2196 demo product 2 Pascale De Gryse nl attributed MV DEMO COMPANY 2196 demo product 3 Pascale De Gryse fr Save Save and Close Cancel Figure 45 Enterprise management product specific delegation Both simple and product specific delegations can be stopped at any time If one clicks stop in the list of delegations both simple and product specific delegations will be stopped Stopping one or several product specific delegations can be done by clicking view and unflagging next to the concerned product do not forget to save Enterprise Detail Divisions Invoicing Contact Persons Delegations Delegations to consultant companies Add Consultant Company Name Started on Nbr of products Action CONSULTANT View Edit _ Figure 46 Enterprise management stopping delegati
16. it submitted and inform the user about elements that are missing There are two types of messages Blocking errors With this kind of messages it will not be possible to submit the dossier Gentile warnings amp The user will be warned but can ignore the message and submit the notification anyway Product Product Name demo product 3 Division DEMO COMPANY x Nr 2196 3 version 1 ProductState Draft Selected notification Ingredients Nutrients Other Substances Nutritional Analysis Toxicity stability and analysis x Errors Error Messages for this page are listed below Plant Checkbox I confirm that all active substances of all plants have been specified must be checked A Ingredients One or more quantities or unities have not been filled in or equals 0 Figure 31 Messages at submit PAGINA 21 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU The first part of the message indicates the tab where the information is missing the second part gives more specific information Blocking errors happen when following fields have not been filled in contact person or when his email address is not known in FOODSUP invoice address for the first notification of a food supplement or when its email address is not known in FOODSUP the way ingredients are expressed in the tab Ingredients the way data are expressed in
17. INA 9 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 6 Notification 6 1 Create a new notification Notifications can be created for new products and for already existing products 6 1 1 Notification for a new product A notification for a new product can be created by clicking on the button create notification for new product on the home screen After that the following screen will appear Product name Enterprise DEMO COMPANY Division DEMO COMPANY Create product Close Figure 11 Create a new notification for a new product Companies with more than one division in FOODSUP and consultants can by means of the drop downs enterprise and division indicate to whom the product belongs to for more information about multiple divisions and delegations to consultants see points 7 2 and 7 5 Once the product name is encoded and one clicks create product the new product is created and the notification details can be encoded 6 1 2 Notification for an existing product i e modification of an existing notification To create a notification for an existing product one should click view on the home screen to go into the details of the notification After that a new notification can be created by clicking on modify the notification Products with decisions Division Da nbr Product name Prod
18. O user can notify products for which the complete quantitative list of ingredients is send to the FPS by another operator For these cases where the quantitative data are confidential the field ingredients and composition will be provided by a third party for reasons of confidentiality has to be flagged In those cases the FPS will encode the quantitative list of ingredients in FOODSUP and afterwards these data will not be visible for any of the FO users and therefore stay confidential 9 2 Mails sent and documents created by FOODSUP When access rights are given FOODSUP will send mails to Local admin When the local admin is created the one who owns the local admin account will recetve a mail Once the mail is sent the local admin can log in Other users when the local admin gives access to other users three mails will be sent Once all three mails have been sent the other user can log in FOODSUP will also send mails when the user changes his her e mail address or password a notification is submitted see also point 6 3 2 O an e mail containing the IN will be sent to the contact person and the local admin of the responsible company The IN is a PDF document containing all details of the notification that was submitted The IN does not contain a list of the uploaded documents O an e mail containing the invoice will be sent to the email address linked to the invoice address and a copy will be sent to the
19. ail to the contact person and to the local admin of the responsible At the same time a PDF NAE will be created containing all notification details after treatment by the FPS The electronic letter of receipt will not contain a signature the signed letter of receipt will be sent on paper by the post Once the letter of receipt has been sent the product will be visible in the list of products with decision After clicking on Edit all product details will be visible as well as in the annexes the PDF NAE and the letter of receipt Selected notification Ingredients Other Substances Nutritional Analysis Toxicity stability and analysis Annexes Upload File type File name Short description Action notification after evaluation Report 141517 NAE Download letter of receipt Report 141517 RECEIPT Download invoice Report 287 INVOICE Download introduced notification Report 141517 IN Download other analysis report Download labeling label Download Figure 35 Annexes after treatment by the FPS PAGINA 23 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 6 5 View history Over time there can be several notifications for one product for example when the composition ot labeling of a notified product changes All versions of a notification dossier are saved in FOODSUP The history of a product can be consul
20. aracters long and contain at least one number one upper case letter and one lower case letter LaseName i stsS FirstName Email Language French Password Confirm password Submit Figure 4 The registration screen PAGINA 6 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Once all data have been encoded and the user clicks on Submit a confirmation screen will appear After that the user will receive an e mail with a confirmation of the registration 4 2 Getting access 4 2 1 Local admin Each organization needs a local admin account in order to be able to use FOODSUP The local admin is responsible for the management of the users of his her organization and can therefore add or remove users The one who has to be local admin for an organization should after registration as described in point 4 1 send the form in Annex I completely filled in and signed to the FPS Federal Public Service Public Health DG4 Service Food FOODSUP Eurostation II Place Victor Horta 40 box 10 1060 Brussels Belgium A Word version of this document can be downloaded on the website of the FPS Once the local admin rights have been accorded the local admin will receive a mail and he she will be able to log in see point 9 2 4 2 2 Other users Other user should after registration as described in point 4 1 contact thei
21. contact person The invoice contains the reference that should be used for the payment of the notification the FPS has finished the treatment of the notification see also point 6 4 PAGINA 33 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU The letter of receipt and the PDF NAE will be sent to the contact person and the local admin of the responsible company The NAE is a PDF document containing all details of a notification after treatment by the FPS The electronic letter of receipt will not contain a signature the signed letter of receipt will be sent on paper by the post For notifications that are not submitted through the FOODSUP Front Office but on paper FOODSUP will not send any email 9 3 Tips and tricks READ ME 9 3 1 Navigation through FOODSUP By clicking Cancel on the bottom of each page the user can go back to the home screen By clicking on Cancel modifications are not saved Modifications will only be saved by clicking on Save So first click save then cancel Some pages however have a Save and Close button https tapplb health belgium be foodsup faces privat In order to leave FOODSUP the user should close the browser Language TEST_ENVIRONMENT FR NL EN Welcome pascale de gryse Change password Change mai Create notification for new product Enterprise managem
22. ct packaging that consists of more than one product for example capsules for the morning and capsules for the evening As every list of ingredients has to be encoded separately those products have to be encoded as two separate products and a difference needs to made in the name of the product for example XXX pack 1 2 and XXX pack 2 2 Both products will therefore have a different notification number which was not the PAGINA 35 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU case before If the products are never going to be sold separately only one invoice should be paid Why can t I download or open a document after uploading a document The following error message can appear if immediately after uploading the user tries to download that document Error An error was encountered while downloading Please retry later Figure 57 Error downloading documents Usually this happens because FOODSUP and the document management system behind have not finished archiving the document Waiting for a few minutes should solve the issue I have created a shortcut and now I have troubles to log in The module to log in uses a few redirects check if the right url www health belgium be foodsup was saved click right gt properties All comments about this User Manual can be sent to foodsup health belgium be PAGINA 36 versie van 26 02 2013
23. d provoke a time out error therefore users are recommended to limit the size of the annexes a much as possible Upload File name Annex Type Short description File analysis report Bladeren proof of payment mn scientifc dossier info Novel Food Upload Cancel info stability info toxicib Figure 29 Notification details uploading annexes possible types of annexes PAGINA 20 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Upload File name label Annex Type labeling aa short description sbelling of the product Bladeren Upload _ Cancel Figure 30 Notification details uploading annexes File C Documents and Settings pge De If the notification dossier does not contain an annex of type labeling the user will receive a warning while submitting the dossier 6 3 Submitting the notification Once the notification is finalized it should be submitted Be aware that once a notification has been submitted the state of the notification changes from draft into waiting for decision itis no longer possible to make modifications to that notification what so ever itis also not possible to create another notification for that product as long as the FPS has not sent the letter of receipt 6 3 1 Validations FOODSUP will perform some validations on the notification when
24. dSup Bill amp Pay TEA f ee Ee Enterprise I Document gt E a management Te a salad Figure 1 FOODSUP structure PAGINA 3 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 2 General concepts Over time there can be several notifications for one product for example when the composition ot labeling of a notified product changes All versions of a notification dossier are saved in FOODSUP Therefore there will be a difference between the state of a notification and the state of a product A notification can have 3 states draft notifier is encoding all details but has not yet submitted the dossier The notifier can make modifications save the dossier and submit the dossier Drafts are not visible for FPS ot FASFC waiting for decision the dossier has been submitted and has to be treated by the FPS The dossier is frozen and the notifier can not make modifications anymore decided the FPS has sent the letter of receipt At a given moment and for one and the same product only one notification in the flow is allowed Therefore it will for example not be possible to have 2 draft notifications for 1 product nor will it be possible to create a new draft notification for a product when at the same time and for that same product there is a notification waiting for decision Only once the FPS has sent the letter of receipt
25. ded through a mixture of ingredients Ingredients are encoded by their specific name name in the legislation and not with their commercial name brand name PAGINA 14 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU fa mixture was added details of the mixture should be encoded in the field comments on the bottom of the page for example mixture containing x of ingredient XX y of ingredient YY and z of ingredient ZZ Some ingredients are present in FOODSUP more than once for example magnesium chloride is present as additive and as chemical form it is important to check the function of the ingredient indicated in FOODSUP before adding the ingredient For plants specifications about the extract should be encoded in the column used preparation for example extract water 70 ethanol 30 Plants can be added more than once in the list of ingredients when different parts or preparations are used Guidelines for searching ingredients For plants it is recommended to search on the Latin name For additives it is recommended to search on the E number If an ingredient is not found it might be usefull to modify slightly the search criterion and try again If a user does not find an ingredient in FOODSUP he can create one himself through the buttons under the search criteria Ingredients created by one of the FO users will afterwards be pr
26. ent Admin Org Management Refresh Figure 56 Leaving FOODSUP The usual buttons for navigations have been blocked By using these buttons and going to the previous page users would accidently leave FOODSUP 9 3 2 Before submitting the first notification It is advised to check all data address phone number email addresses about the company and to add the e mail address of the contact persons invoice address and local admin 9 3 3 Downtime In order to upgrade FOODSUP or for maintenance it might be necessary to put it down Downtime will be announced on the website near the url to FOODSUP and all other documents concerning FOODSUP 9 3 4 Downloading documents Depending on the settings of the web browser downloading documents may be blocked If the Information Bar does not appear you can change the setting that controls automatic download blocking 1 In Internet Explorer click Tools and then Internet Options PAGINA 34 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 2 In the Internet Options dialog box from the Security tab select the Internet zone and then click Custom level 3 Scroll down to Downloads Under Automatic prompting for file downloads select Enable 9 4 FAQ Which products are visible in the WWW module The WWW module only shows products for which a notification nu
27. esponsible for the management of the users of his her organization Once the local admin account has been created the responsible for the local admin account can add or remove other users In order to get access three steps have to be followed 1 The users have to create an account by registering 2 Specific rights have to be accorded 3 Login with email and password FO users cannot login with a token or electronic identity card 4 1 Register create account Users have to register on the website of the FPS before access can be given Registration can be done on following url www health belgium be foodsup and after choosing Identification by e mail and password PAGINA 5 versie van 26 02 2013 D federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 4 L fate ee am Fr Identification by electronic identity card Either by using your e mail and password registered on our site ee 7 e mail and password Figure 2 Click on Identification by e mail and password Mail Password Login i Lost Password Figure 3 Register After clicking on Register the user can encode his e mail address and a chosen password Welcome on the registration screen of the FPS in order to register you must provide an email address that email address must be valid in order to receive your applications accesses The password must be at least T ch
28. ice will be sent to the mail address that is linked to the invoice address and a copy will be send to the contact person The invoice can also be consulted through the list of notifications waiting for decision in the home screen The invoice will contain the reference that should be used for the payment of the notification 6 3 3 Possible actions when a notification has been submitted When the notification has been submitted and is waiting for treatment by the FPS following actions are possible a PDF document containing all details can be downloaded the history of the product can be consulted see point 6 5 for food supplements notified for the first time the invoice can be downloaded It will not be possible to make modifications to that notification nor will it be possible to create another notification for that product as long as the FPS has not sent the letter of receipt Products waiting for decision Product name Product State Contact person Lanqu Date Submitted Actions submitted jviaFO 2196 demo product 1 ist notification waiting for decision Pascale De Gryse nl 03 01 2013 IN Invoice History 2196 demo product 2 ist notification waiting for decision Pascale De Gryse nl 03 01 2013 IN History Figure 34 Home screen once notification has been submitted 6 4 Letter of receipt Once the FPS has finished treating the dossier the letter of receipt will be sent The letter of receipt will be sent by e m
29. ining plants for which in the ingredient list their function is active ingredient Without confirming it will not be possible to submit the notification 6 2 7 Tab Other Substances In the tab Other Substances following details are encoded the way the information is expressed which is the same as in the tab Nutrients This is a mandatory field that can only be encoded in the tab Nutrients quantity and unit of the other substance and comments can be made this field can also be used to indicate the origin of the other substances If the ingredient list contains other substances they will be automatically added in the tab Other Substances However it is possible to delete those other substances to add other ones or to create new ones Be aware that when other substances are deleted or added this will not provoke PAGINA 18 versie van 26 02 2013 D federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU any automatic changes in the list of ingredients Therefore possible necessary modifications in the list ingredients have to be done by the user himself in the tab Ingredients Quantities will not be copied from the tab Ingredients this because the quantity of the ingredient is not necessarily the same as the quantity of the other substance for example the ingredient list can contain more than source of the same other substance Product
30. ion concerns an already existing product the product and the previous notifications encoded in FOODSUP will not be deleted from FOODSUP View history see point 6 5 Cancel go back to home screen if one clicks cancel without saving all modifications are lost Save Submit Delete notification History Cancel Consult the user quide on the website of the FPS Public Health for more information Figure 14 Actions in draft While a notification is in draft it is possible to generate a PDF document containing all encoded data Therefore the notification should be saved and the user should go back to the home screen The PDF document can be generated by clicking on draft next to the name of the product Products in Draft Division nbr 2196 demo product 3 Draft fr Edit History Draft Product name Product State Contact person Langu Actions Figure 15 generating a PDF document containing the details of a notification 6 2 2 Tab Notification In tab Notification following details are encoded whether the product is a food supplement or a fortified food the language of the notification this is a mandatory field this is the language in which ingredients will be shown in the following tabs the contact person for the notification this is a mandatory field the invoice address If the notification concerns a food supplement notified for the first time indicating the in
31. mber has been granted however products for which it has been indicated that they are withdrawn from the market are not visible The WWW module only shows the name of the product the name of the responsible and the notification number The WWW module is update in real time Why are there no warnings for ingredients nutrients active substances that are overdosed but only technical validations when a notification is submitted This is a very deliberate decision made during the analysis before FOODSUP was developed The main elements that have led to this decision the way limits are expressed in the legislation some limits are expressed per daily portion others by kg l of the product some limits are applicable on the product as such other on the product after preparation following the instructions of the responsible the way data are encoded in order to implement a check on the composition of a product FOODSUP would need much more structured and mandatory fields than it is the case now My account has been blocked When the user encodes three times the wrong password the account will be blocked After half an hour the account will be unblocked and a new password can be asked through the lost password module see point 4 3 1 I do not succeed to submit my notification because of error messages See point 6 3 1 Can I put or for searches No How to do with packs With Pack we understand one produ
32. nsulted see point 6 5 O the invoice can be downloaded see point 6 3 2 see a list of notifications that have been treated by the administration for these notifications O the details can be consulted by clicking on view O the history of the product can be consulted see point 6 5 Oo it can be indicated that the product is no longer on the market see point 6 6 FoodSup Langue TEST_ENVIRONMENT FR NL EN Bienvenue pascale de gryse Changement de mot de passe Changement de mail Cr er une notification pour un nouveau produit Gestion de l entreprise Gestion des utilisateurs Actualiser Entreprise Tous z Division Tous z Nom du produit Personne de contact Tous v Dossiers en pr paration N de division 2196 demo product 3 Ebauche Pascale De Gryse fr Editer Historique Ebauche Nom du produit Statut du produit Personne de contact Langue Actions Produits en attente de conclusion N de Date Introduit aon Nom du produit Statut du produit Personne de contact Langue Wendie heh Actions 2196 demo product 1 i re notification en attente de d cision Pascale De Gryse nl 03 01 2013 IN Facture Historique Produits avec conclusion N de Nom du produit Statut du produit Personne de contact Langue Date de Conclusion Introduit Actions division conclusion via FO 2196 demo product 2 Attribue Pascale De Gryse nl 30 01 2013 attribu Voir Historique Retirer du march Figure 10 Front office Home screen PAG
33. o withdraw except by submitting a new notification Products with state withdrawn will not be visible in the WWW module as from the date that was indicated PAGINA 24 versie van 26 02 2013 B federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Are you sure you want to withdraw this product from the market a In order to bring the product back on the market you will need to create a new notification Date from p 4 January 2013 p SUN MON TUE WED THU FRI SAT 30 31 1 3 m 5 T a 10 12 13 14 15 17 19 20 21 22 24 26 27 28 29 Es 314 i 2 Figure 39 Withdraw from market 7 Management of Enterprise details The details of a company are divided in multiple tabs 7 1 Tab Enterprise Detail The tab Enterprise detail contains all information about the company amongst others the name KBO BCE number address The user will be able to change the information but new companies can only be created by the FPS For companies that work as consultant a special flag is foreseen In order to fill in the field KBO BCE Number only digits are accepted the BE shouldn t be encoded nor the The field local admin email will only be visible for people who are local admin other users will not be able to see this field PAGINA 25 versie van 26 02 2013 D federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN
34. ocessed by the FPS The FPS can approve the ingredient and then all other FO users will also be able to select that ingredient The FPS can reject the ingredient for example if it already existed within FOODSUP or if it has been created within the wrong type and then the FPS will replace it the existing one Creating new ingredients can be done by clicking on one of the buttons create FO users can create plants other substances and other ingredients themselves Chemical forms of nutrients and additives cannot be created by FO users because for those types of ingredients the legislation foresees limitative lists For creating other substances and other ingredients at the name of the ingredient in at least one language is mandatory For plants the Latin name and type sort plant or fungus are mandatory For the moment there is no button to edit a newly created ingredient Therefore if a mistake happened typing error the ingredient should be deleted and a new one can be created Other ingredient new other ingredient r Comment Figure 21 Creating new compositional elements PAGINA 15 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Once all ingredients of a product have been added quantity unit function can be completed and for plants the used plant part and the used preparation Product Product Name demo prod
35. olen Add View Figure 24 Notification details adding active substances Product Product Name demo product 3 Division DEMO COMPANY yi Nr 2196 3 version 1 Product State Draft Selected notification Notification Ingredients Nutrients Plant Other Substances Nutritional Analysis Toxicity stability and analysis All plants with function Active Ingredient in the list of ingredients are listed here If a plant is missing please correct under the tab Ingredients Substances expressed per recommended daily portion of the product IV I confirm that all active substances of all plants have been specified Selected Plants from tab ingredients Qu dry plant per Latin name French name Dutch name Used plant part Used preparation recommended daily Unit dry plant Action portion Echinacea angustifolia DC Echinac e feuilles troites Kogelbloem Rode zonnebloem root dried plant 117 5 pee a Add active substance Active substances can only be added once a plant is selected Selected active substances Qty Active Substance per recommended Action daily portion Echinacea angustifolia DC root polyphenols h a Delete Latin name Used plant part Name Unit Comments Figure 25 Notification details tab Plants Important the flag I confirm that all active substances of all plants have been specified is a mandatory field for products conta
36. ons When a consultant uses FOODSUP but the company he is working for doesn t delegations can be encoded in FOODSUP by the FPS The form in annex 3 should be filled in and signed by the responsible company and then be sent to the FPS Federal Public Service Public Health DG4 Service Food FOODSUP Eurostation I Place Victor Horta 40 box 10 1060 Brussels Belgium A Word version of this document can be downloaded on the website of the FPS PAGINA 28 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 8 Management of log ins Users can be added after clicking on Admin Org Management on the home screen on FOODSUP Only the local admin has the rights to add users therefore this button is only available for the local admin In order to add a new user click Add User Admin Organization Y 1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management User list de gryse ascale degrysepascale gmail com Add User NS Management of the accesses Figure 47 Home screen user management In order to add the new user the email address of the user has to be filled in after that click add user Important remark Before the local admin can add a user this user has to registered following the description in point 4 1 Admin Organization Y 1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management
37. onsultant can create new products and will have access to the products he created and can create new notifications for those products However he has access only as long as the responsible has not stopped the delegation To create a simple delegation click add in the tab Delegations after that a consultant can be chosen in the list of all companies known in FOODSUP functioning as consultant PAGINA 27 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU The list in the dropdown box only contains the consultants known in FOODSUP The presence of a consultant in this list does not restrain any responsibility of the FPS Public Health nor is it a recognition of expertise or experience Delegation to CONSULTANT This is the list of consultants known in FOODSUP The presence of a consultant in this list does not restrain any responsibility of the FPS Public Health nor is it a recognition of expertise or experience Name Nr Division Product name Contact person Language Conclusion DEMO COMPANY 2196 demo product 1 Pascale De Gryse nl DEMO COMPANY 2196 demo product 2 Pascale De Gryse nl attributed DEMO COMPANY 2196 demo product 3 Pascale De Gryse nl Save emie Cancel Figure 44 Enterprise details simple delegation 2 Product specific delegation Once a simple delegation has been given a product specific delegation can be
38. plante Add View Baies roses Poivre rose Schinus terebinthifolius Raddi plante Add View thyl ester malate de cr atine autre substance Add View Plantain pucier Plantain des Indes Plantago ovata Phil plante Add View phosphates de magn sium E343 additif Add View Caulophyllum thalictroides L Michx Caulophyllum thalictroides L Michx plante Add View Fleur des elfes grands fleurs Epimedium macranthum Morr et Decne plante Add View jus de nectarine autre ingredient Add View Ip ca du Br sil Cephaelis ipecacuanha Brot Tussac plante Add View Pleurote corne Rolland d abondance Pleurotus cornucopiae Paulet ex Pers plante Add View Trolle d Europe Trollius europaeus L plante Add View Alch mille des Alpes Alchemilla alpina L plante Add View Am lanchier fruits noirs Aronie frui Aronia melanocarpa Michx Elliott plante Add View Tricholome des peupliers Tricholoma populinum Lange plante Add View Gymnema sylvestre Retz R Br Ex 5 Gymnema sylvestre Retz R Br Ex Schultes plante Add View Tr fle des pr s Tr fie rouge Triolet Trifolium pratense L plante Add View Pivoine blanche Pivoine commune Paeonia lactiflora Pall plante Add View Saccharomyces cerevisiae autre substance Add View sulfate de zinc mono L m thionine forme chimique du Add View lactoalvc rides E472b additif Add View hd Figure 19 Notification details adding ingredients PAGINA 13 versie van 26 02 2013
39. r local admin who can grant access When the local admin gives access the user will recetve some mails 4 3 Login Once access has been granted the user can login with e mail and password Therefore on the url www health beleium be foodsup one has to choose again for Identification by e mail and password Log in can be done after encoding email and password demo health belgium Password OT Register Lost P amp ssword Figure 5 Log in into FOODSUP Important remark FO users cannot login with a token or electronic identity card PAGINA 7 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 4 3 1 Lost password Users who lost their password can ask for a new one After clicking on Identification by e mail and password and Lost Password a new password can be requested Mail O Password Register Lost ea P Figure 6 Lost password Enter your email address below we will send you a new password Email demo health belgium he Figure 7 Request a new password The new passwotd will be sent by mail to the indicated email address 4 3 2 Change e mail and password After log in into FOODSUP the user can change his her email address or password FoodSup Language TEST_ENVIRONMENT FR NL EN Welcome pascale de gryse Change password Change mail Figure 8 Change password FoodSup
40. redients lQu per Used preparation recommended daily portion Name Latin name E Number Used plant part Unit Function Action Figure 18 Notification details tab Ingredients The flag ingredients and composition will be provided by a third party for reasons of confidentiality can be used by FO users that submit notifications and for which another operator will send the complete quantitative list of ingredients to the FPS In those cases FPS will encode the quantitative list of ingredients in FOODSUP and afterwards these data will not be visible for all FO users and therefore stay confidential In FOODSUP ingredients are divided into 5 types chemical forms of nutrients plants other substances additives other ingredients Adding ingredients can be done by clicking the button Add ingredient In that case a pop up screen will appear and one can search ingredients based on name or parts of a name Latin name only for plants or parts of a Latin name E number only for additives Once one of the search fields has been filled in clicking on search will give all the ingredients known in FOODSUP fulfilling the search criterion Search ahs es Latin name E Number Search Reset Create Other Ingredient Create Plant Create Other Substance Name lLatin name E Number Type Action phosphates de potassium E340 additif Add View 4 Polygala Polygala spp
41. reen will open PAGINA 30 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Admin Organization Y 1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management Allocation of authorisations applications for a user Selected user heyvaert els J FRONT_OFFICE Role management Figure 51 Give access Admin Organization W1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management Confirmation of the changes of the authorisations applications user J heyvaert els The authorisations for this user have been modified Figure 52 Confirmation screen After clicking on Back the role itself has to be accorded This is done by clicking on Role management In the screen that opens the flag FO user should be flagged and after that one schould click on Validate PAGINA 31 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Admin Organization V1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management Allocation of authorisations applications for a user Selected user heyvaert els V FRONT_OFFICE Role manageme Figure 53 Management of roles Admin Organization Y 1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management Allocation of the authorisa
42. roduct specific delegations are given indicate the notification number and the name of the product Notification number or not attributed or Name of the product busy Date Name Signature To be sent to Federal Public Service Public Health DG4 Service Food FOODSUP Eurostation II Place Victor Horta 40 box 10 1060 Brussels Belgium PAGINA 39 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU ANNEX 4 FOODSUP Transfer divisions If a company known in FOODSUP takes over another company also known in FOODSUP the one that has been taken over becomes a division of the first one For more information about divisions consult the FOODSUP Front Office Manual more in particular point 7 2 Enterprise Name Notification Company Number for new companies indicate new KBO BCE Number for Belgian enterprises VAT Number for foreign enterprises Zip code City Country Enterprise Name that has been taken over Notification Company Number KBO BCE Number for Belgian enterprises VAT Number for foreign enterprises Zip code City Country Date Name Signature To be sent to Federal Public Service Public Health DG4 Service Food FOODSUP Eurostation II Place Victor Horta 40 box 10 1060 Brussels Belgium PAGINA 40 versie van 26 02 2013
43. rs of his her organization and can therefore add or remove users PAGINA 2 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 1 What and why FOODSUP is an application that allows on line notification of food supplements and fortified foods Comparing to the paper notification FOODSUP only changes the way of communication between the industry and the authorities and in between the different authorities FOODSUP doesn t change the notification procedure itself nor does it change the legislation for food supplements or fortified foods Information about the legislation and the notification procedure can be found on the website www health belotum be gt Food safety gt Foodstuffs gt Food supplements Advantages of FOODSUP Less paper All data are directly saved in the FOODSUP database All documents are available electronically Processing of dossiers is more transparent easier more efficient and faster Smoother communication FOODSUP has 4 interfaces see structure in Figure 1 Front Office can be used by notifiers to submit notification dossiers Back Office will be used by the FPS to treat notifications Extranet gives FASFC read only access to all details of all products Public Web Site will replace the current list of notified products on the website of the FPS Public Web Site FoodSup E Front Office FAVVJAFSCA Sa Foo
44. s the necessary guarantees about toxicity stability and analysis should be made Guaranties from the notifier are enough it is not necessary to add a copy of all literature studies Product Product Name demo product 3 Division DEMO COMPANY Nr 2196 3 version 1 Product State Draft Selected notification Ingredients Nutrients Other Substances Nutritional Analysis Toxicity stability and analysis Annexes Toxicity data The non toxicity of the product is guaranteed based on N tests on the final product other to specify in the field comments Comments bibliographic data see list in the annexes Stability Data The stability of the product is guaranteed based on tests on the final product other to specify in the field comments Comments IV We undertake to carry out frequent random analyses and to keep the results available for the Federal Agency for the Safety of the Food Chain Figure 28 Notification details tab Toxicity stability and analysis Important without choosing an option for toxicity and stability or confirming that analysis will be done at regular and variable moments it will not be possible to submit the notification 6 2 10 Tab Annexes In the tab Annexes the labeling and other important documents can be uploaded by clicking upload There is no limit for the size of the uploaded annexes However uploading very big annexes can take a very long time an
45. sreesssssreessssns 11 cy E mae Gj a6 or 0 a 0 gee AEE S EEE A E S E A E 11 Ca Ta cal Cx b e a EAA E EE EAEE E EAEE ee re 12 oad Tar GO rna a A AO AEO N AOO ENEON ONOONO 12 a 211 tl os 2 A E E E E 16 G T T a A AAE EEE AEA AEAEE 17 Cag TT e a 1c 02 0 Le cr a AAE eee 18 O28 Tab SING OR Al Analysis spires dees Eea Ae aE ase Ea E E 19 029 Tab Toxicity stability and analysis opeisen riren eE eVi E EEEE AETR 20 6 2 10 TE a E A EE E EEEE EE 20 6 3 Submitting the Noica ON ereere E e E E 21 o yO E E E A l Gs A TO E O E A A 22 6 3 3 Possible actions when a notification has been submitted ssesssessssssssssresessssssrreessssse 23 6 4 E O gale R E E PT eRnOr Serre ene Sarr Tr re Te 23 6 5 VIE abl O aerrer net etre Serre crr ere ner cere eee re eter tree ee E ee 24 6 6 RY GT ava a2 sora 80169 EET TE oy ete meee EEP SA re erp nme ee an eee eee ee 24 Victor Hortaplein 40 bus 10 e 1060 Brussel e www health fgov be federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU T Manacemcntol Enempise dotdiliesssssressirie na a A O E O 25 7 1 SENOS EAP DE e r cote EE E E A A SO ES 2D Tl Po DE O er a E E E E A E E 26 1 3 Ta L O a E EE E E E EEN EE E EEE a 7 4 Tab Contat PEOS aireari E taconite eres EA E EAE oun EA EOE E SE 2 ies Gb oes Dc oer O a E eee Crete rere eer reer ect n cre etter eee or 21 Management oflo NS eremie ienaa ie EE EENAA EEE EE RE EEE AEE EEr 29 TDD E A A E acess E E E euseeeea tose
46. t of dry plant and for some plants the royal decree on plants foresees limits expressed as equivalent of dry plant For those plants the fields Quantity dry plant and Unit dry plant must be filled in In order to specify active substance the plant has to be selected click on it and then active substances can be added after clicking on the button add The way of searching and selecting active substance is similar to adding ingredients Active substances will never be added automatically by the system Searches should be done based on the name of the substances and not on the name of the plant As long as the pop up for adding active substances has not been closed the substances that are added will be linked to the plant that was selected before the pop up was opened If active substances have to be linked to another plant the pop up should be closed the other plant should be selected and the use should click on the button add again If active substances are not found the user can create active substances which is also similar to creating new ingredient Once an active substance is added the quantity and unit can be specified PAGINA 17 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Existing active substances Name polyph sont Reset Create Active Susbtance French name Dutch name Action polyphenols polyfen
47. t Ingredients Nutrients Other Substances Nutritional Analysis Nutrients expressed per recommended daily portion of the product Add nutrient Selected nutrients Name Scientific name Quantity nutrient per recommended Unit RDA Action daily portion vitamine C acide L ascorbique 80 miligram 100 View Delete Figure 23 Notification details tab Nutrients 6 2 6 Tab Plants In the tab Plants following details are encoded the way the information is expressed which is the same as in the tab Nutrients This is a mandatory field that can only be encoded in the tab Nutrients quantity and unit dry plant active substances a confirmation that all active substances have been specified and comments can be made If the list of ingredients contains plants for which their function is active ingredient they will be automatically filled in in the list of plants Adding or deleting plants in this tab can only be done by changing the details in the list of ingredients Plants with function ingredient or any other function will not be added to the list of plants in the tab Plants Together with the name of the plant the used plant part and the used preparation are copied from the list of ingredients The fields Quantity dry plant and Unit dry plant are not copied This because the quantity of the preparation used in the product is not necessary equal to its equivalen
48. ted by clicking on history next to the product in the list on the home screen or when the details of a product are opened Products with decisions ivision Division product name nbr Product State Contact person oon we Date conclusion 2196 demo product 2 Attributed Pascale De Gryse nl 28 01 2013 attributed View His Withdraw from market Conclusion lactions li Figure 36 Consult the history of the product through the home screen Create new notification Cancel onsult the user guide on the website of the FPS yblic Health for more information Figure 37 Consult the history of the product through the details History Enterprise nbr 2196 Product name demo product 2 Division DEMO COMPANY Product nbr 2 Version 2 Version Submit date Send Date Condusion Actions 1 03 01 2013 28 01 2013 attributed View 2 30 01 2013 In progress Figure 38 History of the product The details of a notification can only be opened when the history of the product is called from the home screen When the history is called from the details of a product the previous notification cannot be opened because a notification is already open 6 6 Withdrawn from market The user can indicate that a product isn t brought on the market anymore and can also indicate from what date that will be the case When no date is encoded FOODSUP will use the current date Be aware that there is no way to und
49. the tab Nutrients the guarantee that all active substance from plants have been specified if the list of ingredients contains plants with function active ingredient one of the toxicity options one of the stability options the declaration about analyzing the product Warning errors happen when no ingredients have been selected quantities units have not been filled in the labeling has not been uploaded 6 3 2 Confirmations The user will always be asked to confirm the submission Confirm submit Cancel Figure 32 Confirm submission i Information Notification has been submitted succesfully Figure 33 Confirmation that the notification has been submitted When a notification has successfully been submitted a pop up appears on the screen and the contact person and the local admin of the responsible will receive an e mail confirming the submission of the notification FOODSUP will create a PDF document containing all the details except the list of uploaded documents of the notification that was submitted This PDF which is PAGINA 22 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU called IN will be sent by mail and will be consultable through the list of notifications waiting for decision in the home screen If the notification concerns a food supplement that is notified for the first time the invo
50. tions roles for a user Selected user heyvaert els Validate Back Figure 54 Specify role After clicking on Validate again a confirmation screen will open Admin Organization W1 5 20120911 TEST_ENVIRONMENT_FOODSUP DEMO COMPANY User management Confirmation of the modification of the authorisations roles user heyvaert els The authorisations for this user has been modified Figure 55 Confirmation screen PAGINA 32 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU Once this confirmation screen opens the application for user management can be closed or one can go back to the home screen of user management by clicking on the back buttons Be aware that if not all flags are flagged the user will not have full access to the home screen of FOODSUP During the procedure of adding a new user and giving all right the user will receive three mails in total 9 AOB 9 1 Data security protection Have access to the data encoded in FOODSUP FPS has access to all data in FOODSUP FASFC has access to all data read only in FOODSUP All login accounts of responsible every user log in linked to an organization can see all the notifications of that company as well as the details of the company All login accounts of consultant For more information about delegations to consultants see point 7 5 An F
51. uct 3 Division DEMO COMPANY x Nr 2196 3 version 1 ProductState Draft Selected notification Notification Product Ingredients J Ingredients and composition will be provided by third party for reasons of confidentiality Nutrients Other Substances Nutritional Analysis Toxicity stability and analysis Ingredient expressed per caps tabligel ss of the product Add Ingredient Selected ingredients l Name A Latin name e Number Used plant part lUsed preparation cape tabl oe Unit Function faction acide L ascorbique 82 4 milligram hd actif ingredient View Delete amidon 10 milligram Me ingredient View Delete cellulose E460 165 milligram ne bulking agent View Delete dioxyde de silicium E551 4 milligram v anti caking ager View Delete Echinac e pourpre Echinacea purpurea L Moench herb dried plant 250 milligram e Jactif ingredient v Mew Delete propolis 50 jmilligram actif ingredient View Delete Echinac e a feuilles troites Echinacea angustifolia DC root dried plant 117 5 milligram hi actif ingredient View Delete Comments Echinacea purpurea and Echinacea angustifolia are part of an Echinacea mixture Figure 22 Notification details tab Ingredients after filling in 6 2 5 Tab Nutrients In the tab Nutrients following details are encoded the way the information is expressed this value will also be used in the tab Plants
52. uct State Contact person Langu Conclusion a Actions te conclusion via 2196 demo product 2 Attributed Pascale De Gryse nl 28 01 2013 attributed ye History Withdraw from market Figure 12 open details of a notification ta tne ection n History Cancel onsult the user guide on the site of the FPS Public Health for more information Figure 13 Create a new notification for an existing product When a notification for an existing product is created all details name list of ingredients details on nutrients plants other substances comments are copied into the new notification except for the declarations of toxicity stability analysis and the annexes PAGINA 10 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU 6 2 Notification details The details of a notification are divided into multiple tabs and in each of these tabs the same actions are possible 6 2 1 Possible actions when a notification is in draft While the user is encoding the details of a notification following actions are possible Save recommendation save regularly The user can save the notification leave FOODSUP and work again on the draft later on Submit see point 6 3 Delete notification the notification will be deleted from the system If the notification concerns a new product the product itself will be deleted from FOODSUP If the notificat
53. voice address is mandatory The dropdown list shows all known invoice addresses Additional invoice addresses can be created trough Enterprise Management see point Ted Consultants will be able to indicate whether the invoice should be send to the consultant or if it should be send to the company itself PAGINA 11 versie van 26 02 2013 federale overheidsdienst VOLKSGEZONDHEID VEILIGHEID VAN DE VOEDSELKETEN EN LEEFMILIEU and comments can be made Once a notification has been submitted FOODSUP will send a confirmation by e mail therefore the email addresses of the contact person and the invoice address must be known Adding email address can be done through Enterprise Management see points 7 3 and 7 4 Product Product Name demo product 3 Division DEMO COMPANY Nr 2196 3 version 1 Product State Draft Selected notification Notification Ingredients Nutrients Other Substances Nutritional Analysis Toxicity stability and analysis Food Supplement Fortified Food Created on 29 01 2013 Submitted on Not applicable Language o French z Contact person Pascale De Gryse x p Comments Invoice address OOOO Status Draft Victor Hortaplein 40 1060 BRUSSEL BELGIUM Figure 16 Notification details tab Notification 6 2 3 Tab Product In the tab Product following details are encoded Form dropdown with predefined values Presentation free text field
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