Tech Instr ENG-28Mat2013
Contents
1. Additionally the marketing company must send a document to the INTCF certifying that the mixture has not been manipulated and therefore confirming that the product remains unaltered Finally this document must confirm the commitment of the manufacturing company to inform the marketing company about any modification in the chemical composition of the products so that the marketing company can duly notify the INTCF formula modification 12 File completed by Indicate whether the marketing company the manufacturing company technical consultant or others elaborated the file 13 Marketing company company responsible for placing the product on the market The marketing company must provide the corporate name registered office full address telephone FAX numbers Email and the name of the person to be contacted in case the INTF requires information concerning the marketing of the product The company logo should also be included The marketing company is recognized as the company displayed on the product s label Under the current regulations it is the responsibility of the marketing company to inform the INTCF about any information concerning the mixtures including modifications and withdrawals from the market Instructions INTCF 28 May 2013 Page 15 The data is introduced by clicking the tab Gesti n de Empresas of the application lt can be stored and subsequently used to fill in the information on the market2. Copy Copiar to prepare a product file that is very similar to a previously completed product file This command enables to copy from the old file and modify the differing data of the new product Edit Editar to open a file and modify data before submission to the INTCF Moreover once submitted the option enables to include the date of the receipt acknowledgement and the product reference number provided by the INTCF COMPLETING THE TOXICOLOGY FILE 1 Trade name The complete trade name must be provided in CAPITAL LETTERS as displayed on the label avoiding abbreviations in order to guarantee the unambiguous identification of the specific product and discriminate the variants of a product name Moreover if available indicate the register numbers displayed on the label Although the preferred option is to fill in one file per product an exception is allowed for variants with the same product trade name differing in colour or fragrance but only if all variants comply with the reported concentration ranges and if no changes affect the concentration of hazard classified ingredients included in the following categories according to Regulation EC 1272 2008 Acute toxicity oral dermal inhalation category 1 2 or 3 STOT single exposure category 1 and 2 STOT repeated exposure category 1 and 2 Skin corrosion category 1A 1B and 1C Severe eye damage category 1 In this case rememb
3. selected by checking the first column of the table and clicking on icon E Usar seleccionados to recover the information of the selected ingredients and include it in the file that is being generated C Instructions INTCF 28th May 2013 Page 13 Concentration Report the concentration range in percentage for each ingredient by choosing among the default ranges Porcentaje or by introducing your own concentration range or the exact percentage Propio In any case the following criteria must be regarded For all the ingredients in the mixture classified according to Directive 1999 45 EC as Tt Lod Or according to the CLP Regulation 1272 2008 as Acute toxicity oral dermal by inhalation category 1 2 or 3 STOT by single exposure category 1 and 2 STOT by repeated exposure category 1 and 2 Skin corrosion category 1A 1B and 1C Severe eye damage category 1 The concentration of the ingredients must be preferentially reported in concentration ranges within the following limits Exact concentration Differences between range limits max 25 100 5 units 10 25 3 units 2 10 1 unit 1 2 0 5 units 0 1 1 0 3 units 0 0 1 0 1 units For instance in order to notify a hazard classified ingredient under any of the categories indicated above with an exact concentration of 26 the user can choose to report 21 26 22 27 23 28 26 31 or also 25 27
4. Herbicida Herbicides Insecticida inhibidores de acetilcolinesterasa Insecticides acetyl cholinesterase inhibitors Insecticida Organoclorados Insecticides organochlorine Insecticida Piretroides Insecticides pyretroids Insecticida otros Insecticides others Larvicida Larvicides Molusquicida Molluscicides Nematicida Nematicides Repelente Repellents Rodenticida Rodenticides Topicida Mole pesticides Otros Fitosanitarios uso agricola Other Phytosanitary products for agricultural use 00 0 6 oO O 0 0 0 0 oOo OO O CO 0 0 Oo 0 0 Medicamentos Drugs for Instructions INTCF 28 May 2013 Page 6 o A Medicamentos Aparato digestivo y metabolismo Alimentary tract and metabolism B Sangre y rganos hematopoy ticos Blood and haematopoietic organs C Aparato Cardiovascular Cardiovascular system D Terapia Dermatol gica Dermatologicals G Terapia Genitourinaria Incl Hormonas sexuales Genitourinary system including sex hormones H Terapia hormonal Hormone therapy J Terapia antiinfecciosa sist mica Anti infective systemic therapy L Terapia antineopl sica y agentes inmunomodulares Antineoplastic and immunomodulatory agents M Aparato locomotor Musculoskeletal system N Sistema nervioso Nervous system P Antiparasitarios Antiparasitic drugs R Aparato respiratorio Respiratory system S Organos de los sentidos Sensory organs V Varios Various Medicamentos de uso veterin
5. It is also important to avoid changing the file names once they are attached to the Product File Instructions INTCF 28 May 2013 Page 16 SAVING THE COMPLETED FILE Once completed the Product File can be saved in pdf format and stored in a folder Open the file click icon Imprimir then icon m Export to select pdf format and finally save it into a folder of your choice To finish a Toxicology Information file click on icon fh Aceptar You must name the file for identification There are fields that must be completed in the file product trade name unique product identifier UPI composition product type presentation pH and marketing company If any of these fields is not completed the user will be reminded by an error message and requested to amend the mistake in order to proceed MODIFICATIONS The marketing company must update the information on the mixtures placed on the market provided to the INTCF therefore any modification of the mixture and the withdrawals from the market must be notified following the procedure described below Formula modifications The company must notify the SIT of a modification when albeit retaining the previously notified trade name of the product the composition of the mixture has been modified under any of the following circumstances e When an ingredient is added to or excluded from the mixture that was previously notified e When the ingredient concen
6. 2013 Page 23 When notifying a modification or withdrawal of a toxicology file that was generated before the implementation of the reference number the marketing company must identify the product by providing the trade name and date that was reported by the Institute Instructions INTCF 28 May 2013 Page 24
7. Soaps bath gels shampoos Lociones colonias perfumes Lotions cologne water perfumes Otros P cosm ticos Other cosmetic products o Desinfectantes y biocidas generales Disinfectants and general biocides B1 Biocidas para la higiene humana Biocides for human hygiene B2 Otros biocidas generales desinfecci n del aire piscinas acuarios aire acondicionado centros sanitarios residuos y aguas residuales etc Other general biocides disinfection of air swimming pools aquariums air conditioning systems sanitary establishments residues and residual waters etc B3 Biocidas para higiene veterinaria Biocides for veterinary hygiene B4 Desinfectantes para superficies en contacto con alimentos y piensos Disinfectants for surfaces in contact with food and feed B5 Desinfectantes para agua potable Disinfectants for drinking potable water o Conservantes Preservatives B6 Conservantes para productos envasados Preservatives for packaged products B7 Conservantes para pel culas Preservatives for films B8 Protectores para maderas Wood conserving agents B9 Protectores de fibras cuero caucho y materiales polimerizados Conserving agents for fibres leather rubber and polymeric materials B10 Protectores de mamposter a Conserving agents for masonry B11 Protectores para l quidos utilizados en sistemas de refrigeracion y en procesos industriales Conserving agents for liquids in cooling systems and industrial p
8. and composition previously notified to the INTCF remain unaltered b Trade name of the product c SIT reference number awarded to the product when originally notified to the INTCF d Detailed and precise description of the changes introduced e Date on which the modified product is placed on the market The modification of non critical aspects is exempt of fees Instructions INTCF 28 May 2013 Page 18 Modifications of the product trade name Any change in the trade name of the product implies notifying the withdrawal of the previously notified product and the entry of the product with the new trade name Updating of attached documents In order to update the attached documents safety data sheet labels technical files etc and always considering that the composition of the product has not been modified the following procedure applies 1 Include a list of the trade name and the reference number attributed to each product by the INTCF when they were notified the reference numbers are supplied to the notifying company in the Receipt of Acknowledgement 2 Submit a document certifying that the product composition previously notified to the INTCF remains unchanged Clearly indicate the modifications to be introduced e g changes in label design CLP classification SDS contents etc that will therefore modify the attached documents that were previously submitted The marketing company of the product must sign this lett
9. options provided aerosol gas gel granules light liquid viscous liquid volatile liquid paste powder solid others 8 Colour Provide a precise description of the product colour not the colour of the packaging When the product has different colours with the same trade name and formula all colours must be reported 9 Package format Indicate the type and size of the packaging by choosing among the following options when possible Bottle flask carafe carboy barrel can container cistern tank m Box packet case casket m Bag envelope sachet m Skin pack blister film wrap m Aerosol a Tin m Jar can m Tube m Carton for liquids m Bag in box E Holder carcass Instructions INTCF 28 May 2013 Page 12 For products with the same formula that are sold in more than one type of packaging indicate all the packaging types For products sold with external and internal packaging both must be described All product sizes must be indicated usually in grams Kilograms or litres In certain packages containing units further description is required e g blocks tablets wet wipes etc All product sizes commercialised on the same date can be reported in the same file 10 pH For liquids indicate the pH as undiluted or in solution in the latter case the percentage of dilution for pH measurement must be specified in the corresponding box For solids indicate the pH in solution and indicate t
10. TECHNICAL INSTRUCTIONS NOTIFICATION PROCEDURE OF SUBSTANCES AND MIXTURES TO THE INSTITUTO NACIONAL DE TOXICOLOG A Y CIENCIAS FORENSES As a result of Law 8 2010 of 31 March which establishes the sanctions regime of the EC Regulation concerning the Registration Evaluation Authorisation and Restriction of Chemical substances REACH and the guidelines on the Classification Labelling and Packaging of substances and mixtures CLP which modifies the former Regulation as well as the recently published Law 10 2012 of 20 November regulating certain fees of the Administration de Justicia and the Instituto Nacional de Toxicolog a y Ciencias Forenses INTCF The Order of 7 may regulates both the notification procedure of new entries modifications and withdrawals of toxicology files to the Registry of chemical products at the Servicio de Informaci n Toxicol gica of the Instituto Nacional de Toxicolog a y Ciencias Forenses as well as fee payment procedure established by Law 10 2012 of 20 November which applies to certain fees of the Administraci n de Justicia and the Instituto Nacional de Toxicolog a y Ciencias Forenses Subsequent to the introduction of this policy and the development of the informatics application for the notification procedure the Enterprise has encountered practical concerns which have been occasionally reported to the INTCF Thus and in order to offer further support the INTCF has provided a series of recommendat
11. ario Veterinary drugs Fitoterapia Phytotherapy Medicamentos homeop ticos Homeopathic drugs O O OO oO 0 0600000395 Productos de Limpieza Cleaning products It is relevant to specify the main downstream users of a product end users Consumer private household or professional institutional when products are used by institutional cleaning workers or industrial when used as cleaning products for industrial machinery o Productos de Limpieza DOMESTICOS Cleaning Products HOUSEHOLD LD Activadores de lavado de ropa liberadores de ox geno Washing activators for laundry active oxygen release LD Amoniaco Ammonia LD Anticalc reo desincrustante Scale remover LD Desatascador Drain cleaner LD Desengrasante Degreaser LD Desinfectantes Disinfectant LD Detergente de ropa Laundry detergents LD Lavavajillas a mano Dishwashing detergents manual LD Lavavajillas a m quina aditivos abrillantadores sal Dishwashing machine additives salt rinse and shine aids etc LD Lavavajillas a m quina detergentes Dishwashing machine detergents LD Lej a y otros liberadores de cloro Bleaches and other chlorine based cleaners LD Limpiacristales Glass cleaners LD Limpiahogar General purpose cleaners LD Limpiahornos Oven cleaners Instructions INTCF 28 May 2013 Page 7 LD Limpiametales Metal cleaners polishes LD Limpiamuebles Furniture cleaners and wood ca
12. d in the aforementioned manual Similarly the companies can replace the INTCF Toxicology Information File generated by the program by their own file containing the information of the mixtures as long as it complies with the previously indicated syntax NOTIFICATIONS ENTRIES MODIFICATIONS AND WITHDRAWALS This application has been designed to notify the entries of new products as well as the modifications and withdrawals of products that were previously registered in the INTCF databank The tab Management of toxicological files Gesti n de fichas toxicol gicas provides the following options Add A adir to notify the entry of a new product Modify Modificar to notify changes or modifications of a previously registered product Withdrawal Dar de baja to notify the withdrawal of a product from the market Indicate date for withdrawal considering the date when the product is out of stock for the marketing company Instructions INTCF 28 May 2013 Page 4 However the product file will be stored in the INTCF databank for 10 years because products remain available for potential poisoning long after marketing withdrawal In order to help with file submission the application provides three extra functions Modify F Paper Modificar F Papel to modify a product file that was reported to the INTCF before the implementation of this program
13. er 3 Enclose a clearly identified CD containing the following items o A folder with all the documents to be included in the INTCF Database safety data sheet labels etc Preferentially send these documents in pdf format o A text file txt with the same number of lines as the number of documents to be included in the INTCF databank Each line must comply with the following structure Product reference number trade name PATH of the document to be included See the following example The folder included in the CD is named labels or SDS The different documents labels or SDS are named abel1 paf label2 pdf SDS1 paf SDS2 pdf etc The previously notified products to which we want to attach the new labels or SDSs have the following INTCF reference number product 1 SITX 1234 12 and product 2 DRP12 0000038 The PATH of the document to be included should be labels label1 pdf labels label2 pdf SDS SDS1 pdf Instructions INTCF 28 May 2013 Page 19 The structure of the text file txt will be the following SITX 1234 12 name_productl labels label1 pdf SITX 1234 12 name_product1 SDS SDS1 paf DRP12 0000038 name_product2 labels label2 pdf GENERATION OF THE EXPORT FILE TO NOTIFY THE INTCF Once the files are completed and saved and in order to submit the data to the INTCF click icon Imprimir and then select the files you wish to notify by clic
14. er to attach one label for each variant You must complete a file for each product trade name even when products with the same composition are commercialized with different product trade names When the product is commercialized in Spain with different names translated into Instructions INTCF 28 May 2013 Page 5 other national languages such as Basque Catalan etc all product names must be provided in the same Toxicology Information File 2 Unique Product Identifier UPI product ID The unique product identifier is the company reference code provided by the enterprise which identifies the composition of the mixture Thus it must vary for a product that albeit preserving the trade name actually modifies its composition over time 3 Person completing the file and date Report the full name of the person completing the file and the date on which the file was generated The date is provided by default however the user can modify it by directly typing or using the supplied calendar 4 Type of product Report the type of product according to the classification supplied by the application by selecting the main use of the product Fitosanitarios uso Agr cola Phytosanitary products for agricultural use Acaricida Acaricides Alguicida Algaecides Atrayente Attractants Bactericida Bactericides Desinfectante Disinfectants Fitorregulador Phytoregulators Fumigante Fumigants Fungicida Fungicides
15. he percentage of dilution for pH measurement in the corresponding box When pH is not determined indicate ND 11 Quantitative composition For the moment and until the process of European harmonisation for the notification of information to the Poison Control Centres is accomplished the following criteria must be fulfilled All ingredients of the mixture notwithstanding their toxicity must be reported in order of decreasing concentration It is optional to notify the non classified ingredients according to the CLP Regulation when their concentration in the mixture is less than 1 Identifying the ingredients All the ingredients of the mixture must be identified by using the chemical names found in Annex VI Part of 3 of the CLP Regulation IUPAC and INCI names or other internationally accepted chemical names together with the CAS numbers or the EC numbers EINECS ELINCS When possible the company should indicate the toxicological family of the ingredients in the mixture The toxicological family is defined as the group of ingredients that have similar chemical structure and exhibit equivalent toxicity The ingredients can be selected by clicking on the icon el Actualizar lista which enables to access the Management of Ingredients Gesti n de ingredientes file The ingredients currently used by the enterprise can be stored m Guardar and subsequently selected for future notifications Thus the ingredients of a mixture are
16. ing company or the company generating the files 14 Information provided by Identify the company by providing the corporate name registered office full address telephone FAX numbers Email and the name of the person to be contacted in case the INTF requires information concerning the mixture The company logo should also be included Completing this section does not exempt the companies from providing the information about the marketing company which is always mandatory 15 Attached documents Enclose the following items by selecting Tipo de Adjunto in first left column e 1 Label Attach the label as is displayed on the product for the Spanish market preferentially in pdf format Select icon A Seleccionar adjunto to locate the corresponding file in the computer If the product is available in different volumes only one label is attached as long as the label design does not vary 2 Safety Data Sheet SDS Select icon Seleccionar adjunto to locate the corresponding file in the computer e 3 Optional Others optionally the user can attach other documents technical files certificates etc Select icon A Seleccionar adjunto to locate the corresponding file in the computer IMPORTANT The name of the attached files must have the following characteristics It must contain a maximum of 30 characters including letters numbers and dots The name cannot contain special characters e g _ etc
17. ions which will undoubtedly facilitate the knowledge and implementation of these rather mutable and complex regulations by swiftly adapting to any potential changes Additionally they are meant to assist in the use of the informatics application that has been developed which is expected to achieve a more efficient management by improving the procedure In addition to these instructions the companies are provided with the informatics application manual which describes the process of downloading installing and use as well as the enterprise user manual supplying the information required for data transfer via a Secure File Transfer Platform SFTP All these documents are available from the internet Justice Administration Portal Instructions INTCF 28th May 2013 Page 2 INDEX The informatics application how to download the application Notifications entries modifications and withdrawals Completing the toxicology file Trade name commercial name UPI Unique Product Identifier product ID Person completing the file and date Type of product Uses Hazard classification Presentation Colour Package format 10 pH 11 Quantitative composition 12 File completed by 13 Marketing company company responsible of placing the product on the market 14 Information provided by 15 Attached documents dd o Saving the completed file Modifications 1 Formula modification 2 Modification of non c
18. king the tab Estado and proceed as follows Entries If the user wants to notify new files or Entries that have not been previously notified select the files in Pendientes de Remitir Altas and then click icon eu Buscar to look for the stored files The screen will display all the new files that have not yet been notified to the INTCF Select the files you want to notify in the first left column Modifications If the user wants to submit information about a modification considering a modification as the notification of a previously reported product for which the composition has changed see section formula modifications click tab Estado and then select Modificaciones and click icon A Buscar Product withdrawal To notify the withdrawal of products previously registered at the INTCF because their marketing has been interrupted select Estado then Baja and finally click icon Buscar The user can process a maximum of 50 product toxicology files per export file It is not allowed to process in the same file the entries modifications or withdrawals of mixtures that are commercialized by different marketing companies In any case select the Toxicology Information files you want to process and click icon A Exportar Data is then exported generating an export file which is saved in directory Program files GesFicCom Export or in any other directory that is chosen by the user as
19. mestic pets except veterinary drugs PC1 Pegamentos colas adhesivos y sellantes Adhesives sealants PC2 Adsorbentes o Desecantes Adsorbents or Desiccants PC9a Disolventes uso dom stico Solvents household use PC9a Pinturas y barnices uso dom stico Coatings and paints household use PC9b Rellenos masillas yeso arcilla de modelado Fillers putties plasters modelling clay o PC9Qc Pinturas de dedo Finger paints PC12 Fertilizantes Fertilizers o PC20 Prod para mantenimiento de piscinas floculantes precipitantes neutralizantes antialgas control pH Products for swimming pool maintenance ph regulators flocculants precipitants neutralization agents o PC24 Lubricantes grasas y desmoldeantes Lubricants greases release products o Otros productos del hogar Other household products O 00010 Oo 6000 O Productos industriales Industrial products Instructions INTCF 28 May 2013 Page 10 Aromas alimentarios Food flavouring Betunes asfaltos ceras y parafinas Bitumen asphalts waxes and paraffin Materias primas Raw materials PC1 Adhesivos y sellantes Adhesives sealants PC2 Adsorbentes o desecantes Adsorbents or desiccants PC4 Anticongelantes y descongelantes Anti Freeze and de icing products PC7 Metales y aleaciones Base metals and alloys PC9a Decapantes Paint and varnish removers PC9a Disolventes clorados Thinners chlorine based PC9a Disolventes excepto clo
20. n of substances and mixtures to the INTCF and if willing to enjoy from the fee reductions established for the PYMES the marketing company must certify its PYME status by submitting together with the previous documents the form PYME Modelo de declaraci n responsable found in the Justice Administration Portal duly completed and signed The marketing company must submit the previous document only the first time they notify their products to the INTCF Subsequent notifications do not require this procedure unless the company situation changes in this case the company must send the documents stating the new situation RESPONSIBILITY OF THE COMPANIES The companies are responsible for the reliability of the information submitted and that guarantee that it complies with the criteria established by this Institute thus any default in their observance deriving in the inability to provide an appropriate medical response will be attributable to these companies If during the analysis of the documents the Institute deems necessary to obtain further information about a mixture or to amend any deficiency it will be duly requested from the companies RECEIPT ACKNOWLEDGEMENT The receipt acknowledgement issued by this Institute upon the arrival of the documents will assign a reference number to each product Any subsequent notification regarding the product must refer to this reference number Instructions INTCF 28 May
21. n the same CD but in this case they must enclose the corresponding product list of each export file printed and signed as well as the fee payment receipt s for all the products The address for data submission is the following 2 Submission via the Secure File Transfer Platform SFTP In order to use the Secure File Transfer Platform the company providing the information must previously complete a Form to identify the platform user Formulario de Registro de Empresas Enterprise Record Form The completed Enterprise Record Form must be submitted to the Email address documentacion empresas intcf justicia es Subsequently the user will receive the authorisation to transfer the files by Email as described in the Manual usuario Empresas Plataforma intercambio seguro de fichas User Manual Enterprise Secure File Transfer Platform Instructions INTCF 28th May 2013 Page 22 When notifying with this procedure the user must compress encrypt and sign the export file generated by the application and finally perform the transfer to the Ministry server as described in the mentioned manual above The product list generated by the application printed and signed by the marketing company and the company preparing the information must be sent to the INTCF address by post or courier together with the fee payment receipt Modelo 790 of the notified products In all cases the first time that the company pays the fees for the notificatio
22. ners LI Limpiacristales Glass window cleaners LI Limpiador general General purpose cleaners LI Limpiahornos Oven cleaners LI Limpiametales Metal cleaners polishes LI Limpiamuebles Furniture cleaners and wood care cleaners LI Limpiasuelos Floor hard surface cleaners LI Limpiavitroceramica Vitro ceramic cleaners LI Limpiazapatos Shoe cleaners Ll Limpieza de WC con liberador de cloro WC cleaners chlorine based Ll Limpieza de WC sin liberador de cloro WC cleaners without chlorine LI Quitamanchas Stain removers LI Suavizantes de ropa Fabric conditioners LI Otros Prod de limpieza institucional Other institutional cleaners o Productos de limpieza INDUSTRIAL maquinaria industrial Cleaning Products INDUSTRIAL industrial machinery Instructions INTCF 28t May 2013 Page 8 Prod Limpieza ca sticos cidos Caustic acid cleaning products Prod Limpieza c usticos alcalinos Caustic alkaline cleaning products Prod Limpieza neutros Neutral cleaning products Otros Prod Limpieza industrial Other industrial cleaning products Cosm ticos Cosmetics ooo Oo 0 0 0 6 6G Biocidas Biocides Cosm ticos cuidado de la piel Cosmetics for skin care Cosm ticos cuidado de las u as Cosmetics for nail care Cosm ticos cuidado del cabello Cosmetics for hair care Depilatorio Depilatory cosmetics Desodorante Deodorants Higiene bucal Oral hygiene Jab n geles ba o champ
23. or even 26 depending on the enterprise concerns confidentiality to minimize re notifications due to minor concentration changes etc For the remaining ingredients such as substances classified under categories other than those mentioned above or for non classified substances above 1 they can be notified in concentration ranges without exceeding the following range limits or alternatively using the standard concentration ranges found in the last column Porcentaje Instructions INTCF 28 May 2013 Page 14 Exact concentration Differences between range limits max 40 100 20 units 10 40 10 units 1 10 3 units 0 1 1 0 5 units 0 0 1 0 1 units All ingredients of the mixture must be reported in order of decreasing concentration Terms such as perfume fragrances dyes essential oils of and extracts of can be used only if the CLP Regulation does not classify them as dangerous or when their concentration is less than 5 If these ingredients have a concentration higher than 5 further detailed information about solvents and other substances must be supplied If a marketing company commercializes with its trade name a product purchased from another manufacturing company the name and address of the marketing company displayed on the product label it can include the INTC product reference number which was provided to the manufacturer in box composition cuantitativa
24. rados Thinners except chlorine based PC9a Pinturas y barnices uso profesional Coatings and paints professional use PC9b Rellenos masillas yeso arcilla de modelado Fillers putties plasters modelling clay PC9c Pinturas de dedo Finger paints PC11 Explosivos Explosives PC12 Fertilizantes Fertilizers PC13 Combustibles Fuels PC14 P para el Tratamiento de superficies met licas galvanizado y electrolisis Metal surface treatment products including galvanic and electroplating products PC15 P para el tratamiento de superficies no met licas Non metal surface treatment products PC16 Fluidos portadores de calor Heat transfer fluids PC17 Fluidos hidr ulicos Hydraulic fluids PC18 Tintas y toners Ink and toners PC19 Sustancias intermedias Intermediate substances PC20 Prod aditivos de procesados qu micos floculantes precipitantes neutralizantes control pH Additives in chemical processing pH regulators flocculants precipitants neutralization agents PC21 Productos qu micos de laboratorio Laboratory chemicals o PC23 Tratamiento de cuero curtido te ido acabado impregnaci n y cuidado Leather tanning dye finishing impregnation and care products o PC24 Lubricantes grasas y desmoldeantes Lubricants greases release products o PC25 L quidos para metalurgia Metal working fluids o PC26 Tintas y p procesado de papel y cart n Paper and board dye and other processing produc
25. re cleaners LD Limpiasuelos Floor hard surface cleaners LD Limpiavitrocer mica Vitro ceramic cleaners LD Limpiazapatos Shoe cleaners LD Limpieza de WC con liberador de cloro WC cleaners chlorine based LD Limpieza de WC sin liberador de cloro WC cleaners without chlorine LD Quitamanchas Stain removers LD Suavizantes de ropa Fabric conditioners LD Otros Prod de limpieza dom sticos Other household cleaners o Productos de Limpieza INSTITUCIONAL grandes superficies Cleaning Products INSTITUTIONAL large areas LI Abrillantadores de suelos Floor polishes LI Activadores de lavado de ropa liberadores de ox geno Washing activators for laundry active oxygen release LI Amoniaco Ammonia LI Anticalc reo desincrustante Scale remover LI Cristalizadores de suelos Floor crystallizers LI Desatascador Drain cleaner LI Desengrasante Degreaser LI Desinfectantes biocidas uso Industria Alimentaria Disinfectants biocides used in food industry LI Detergente de ropa Laundry detergents Ll Lavavajillas a mano Dishwashing detergents manual Ll Lavavajillas a m quina aditivos abrillantadores sal Dishwashing machine additives salt rinse and shine aids etc Ll Lavavajillas a m quina detergentes Dishwashing machine detergents LI Lavavajillas l quidos alcalino Dishwashing liquid alkaline detergents Ll Lej a y otros liberadores de cloro Bleaches and other chlorine based clea
26. ritical aspects 3 Modification of the product trade name 4 Updating of attached documents Generation of the export file to notify the INTCF Compression encryption and signature of the export file Data submission to the INTCF By post mail regular or express Via the Secure File Transfer Platform SFTP Responsibility of the Companies Receipt acknowledgement Instructions INTCF 28 May 2013 Page 3 THE INFORMATICS APPLICATION HOW TO DOWNLOAD THE APPLICATION The application designed for the notification procedure to the INTCF cliente generador de fichas will be available for the Enterprise at the Justice Administration Portal This application is totally free both for companies for which product notification is mandatory as well as for those willing to provide the information to the INTCF Alternatively the company will be able to generate directly the xml files employed by the application following the syntax indicated in the Manual that describes how to install and use the application Productos INT Manual de Administrador Usuario so that it is compatible with the program managed by the Institute For instance the companies can replace the file INGREDIENTES xml located in directory C Program files GesFicCom ListView by another file generated by them containing the substances currently used by the company or by the specific industrial sector as long as it complies with the syntax indicate
27. rocesses B12 Productos antimoho Anti mould products B13 Protectores de l quidos de metalister a Conserving agents for metalwork o Plaguicidas Plaguicides B14 Rodenticidas Rodenticides Instructions INTCF 28 May 2013 Page 9 B15 Avicidas Avicides B16 Molusquicidas Molluscicides B17 Piscicidas Piscicides B18 Insecticidas acaricidas y otros artr podos Insecticides acaricides and other arthropods B19 Repelentes y atrayentes Repellents and attractants o Otros Biocidas Other Biocides B20 Conservantes para alimentos o piensos Preservatives for food and feed B21 Productos antiincrustantes Antifouling products B22 L quidos para embalsamamiento y taxidermia Liquids for embalmment and taxidermy B23 Control de otros vertebrados par sitos Control of other vertebrates parasites Productos del hogar Household products o Ambientadores dom sticos e institucionales Room deodorizers household and institutional Cerillas Matches Correctores de m quina Typewriter correctors Prod encendido de barbacoa Barbecue tablets L pices rotuladores tinta Pencils markers ink Mantenimiento y limpieza del autom vil dom stico Car maintenance and cleaning products household o P de Bricolage no especificados en otros apartados Bricolage products not specified in other sections o P para mascotas dom sticas excepto med uso veterinario Products for do
28. tration changes so that it shifts to a different concentration range e When the concentration of an ingredient notified with exact concentration changes according to the following criteria Instructions INTCF 28 May 2013 Page 17 Initial ingredient concentration Notify the modification if the new included within the range concentration varies in more than O 0 2 5 O 30 O 2 5 10 O 20 O 10 25 O 10 O 25 100 O 5 You must follow the same procedure as for a new entry except that in tab Gesti n de Fichas Toxicol gicas you must choose the option Modificar and in box n Ref you must introduce the Reference number assigned by the INTCF to the product that you need to modify IMPORTANT The Unique Product Identifier UPI must be systematically updated considering that it is formula specific Modification of non critical aspects The modification of a non critical aspect of the product is considered as the modification of a product that preserving the previously notified trade name and chemical composition implies substantial changes in the appearance or design of that product e g different type of packaging or product colour obvious changes in label design or packaging size etc In this case the notification procedure for the modification of non critical aspects is to send a letter to the INTCF including the following data a Certify that both the product trade name
29. ts o PC28 Perfumes y Fragancias Perfumes and fragrances o PC30 Sustancias fotoqu micas Photo chemicals o PC32 Preparados y componentes polim ricos Polymer preparations and compounds o PC33 Semiconductores Semiconductors o PC34 Tintes y p para procesado de tejidos Textile dyes and other processing products o PC36 Descalcificadores de agua Water softeners o PC37 Productos qu micos para el tratamiento del agua Water treatment chemicals o PC38 Productos de soldadura y productos fundentes Welding and soldering products o PC40 Productos disolventes de extracci n Extraction agents o Otros productos industriales Other industrial products Oo O O O O O OS 0 O O O on Oo Oo Oo Oo Oo O oO O Instructions INTCF 28 May 2013 Page 11 Otros Others o Gases lacrim genos Spray de defensa personal Tear gases Self defence sprays o Productos del autom vil uso profesional Car maintenance products professional use o Productos reveladores de fotograf a Photographic developer When required choose more than one option by selecting the appropriate boxes 5 Uses Briefly report the use of the product and indicate whether the product is intended for consumer and or professional end use 6 Hazard Classification Report the hazard classification of the mixture according to DIRECTIVE EC 1999 45 and or REGULATION EC 1272 2008 7 Presentation Select the type of product presentation among the
30. ure File Transfer Platform 1 If the notification is sent in a CD and is delivered to the INTCF by post mail or courier it must include Instructions INTCF 28th May 2013 Page 21 a A CD containing the export file generated by the application This file will be saved inside the directory Program files GesFicCom Export in your computer or in the special working PATH designed by the user The correct syntax of the export file name must be yyymmdd_hhmmss If the export file has not been manipulated it should contain e The files for each of the notified products in xml format e A folder named Adjuntos generated by the application and containing the documents that have been attached to the file labels safety data sheets ingredients sheet etc e A copy of the product list in pdf format and generated by the application containing the products processed in the export file IMPORTANT the user cannot modify the export file it must be sent to the INTCF such as the program generates it The only processes allowed are compression encryption and signature as described in the User Manual Enterprise Secure File Transfer Platform Manual usuario Empresas Plataforma intercambio seguro de fichas b The product list provided by the program printed and duly signed by the marketing company and by the company in charge of generating the files c The fee payment receipt Modelo 790 The companies may record several export files i
31. working PATH in the latter case the name syntax must include date and time of export file generation with the following structure yyyymmdd_hhmmss Instructions INTCF 28th May 2013 Page 20 Simultaneously the screen displays a list of products in pdf format which must be printed Imprimir The user must enter the fee payment receipt number for the notified products in this document Receipt number in form 790 Modelo 790 confirming the payment of fees n 790020 Subsequently the marketing company and the company that generated the data file must sign the document manually or electronically A copy of this document is automatically saved in the export directory EXPORT FILE COMPRESSION ENCRYPTION AND SIGNATURE Compression encryption and signature of the export file generated by the application are processes that provide maximal security to transfer the data to the INTCF independently of the submission system as is further explained in the next section These procedures are described in the user enterprise secure file transfer platform Manual that can be found at the Justice Administration Portal IMPORTANT The file name yyymmdd_hhmmss cannot be modified during these procedures the only change allowed refers to the file extension DATA SUBMISSION TO THE INTCF Submission of documents to the INTCF may be performed in two different ways 1 By regular post mail or courier delivery 2 By the Sec
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