EC 45 (4) 1272/2008 (CLP

Transcription

1 Basic application to facilitate exchange of information between Poison Centres, according to Article 45 (4) of EC Regulation No 1272/2008 (CLP Regulation) User Guide Version /11/2015

2 Table of Contents 1 Introduction Purpose of the document Browser requirements Local application Display rules Notations used in this guide Launching the application Entering submission data Administrative information Submitter information Product information Mixture information Mixture components Component concentration rules Component classification Substance component Mixture in mixture component Generic component Sorting components by their concentration Comments Saving a submission Browser save settings Filename construction rules Preparing templates Opening a submission Printing a submission Clearing a submission Leaving the application...45 A Annex Packaging types...47 Version /11/2015-2/49

3 Tables Table 3-1: Component ordering example...35 Table A-1: Packaging types...47 Figures Figure 1-1: JavaScript checker... 6 Figure 1-2: Examples of incorrect fields... 6 Figure 1-3: Incorrect field example... 7 Figure 1-4: Correct field example... 7 Figure 1-5: Error message for a mandatory field... 7 Figure 1-6: Error message for an invalid value... 7 Figure 1-7: Example of a warning sign... 7 Figure 1-8: Example of a warning message... 7 Figure 1-9: Mandatory multi-valued properties... 8 Figure 1-10: Mandatory multi-valued properties Deleting and re-ordering... 8 Figure 1-11: Optional multi-valued properties... 8 Figure 1-12: Optional multi-valued properties... 8 Figure 1-13: Optional multi-valued properties... 8 Figure 2-1: Application welcome page...10 Figure 2-2: Application page...10 Figure 3-1: Submitter information tab selection...11 Figure 3-2: Administrative information tab Initial display...11 Figure 3-3: Administrative information tab Limited submission...12 Figure 3-4: Administrative information tab Language selection...13 Figure 3-5: Multi-lingual field Trade name...13 Figure 3-6: Multi-lingual field Error when submission language is not set...13 Figure 3-7: Administrative information tab Data entered New mixture...14 Figure 3-8: Administrative information tab Data entered Update submission...14 Figure 3-9: Submitter information tab Initial layout Submitter details...15 Figure 3-10: Submitter information tab Initial layout Contact information...15 Figure 3-11: Submitter information tab Contact for rapid information...15 Figure 3-12: Submitter information tab Data entered Submitter...16 Figure 3-13: Submitter information tab Data entered Contacts...16 Figure 3-14: Product information tab Initial display...17 Figure 3-15: Product information tab Multiple trade names...17 Figure 3-16: Product information tab User identification when limited submission..18 Figure 3-17: Product information tab Other identifiers...18 Figure 3-18: Product information tab SDS selection field...19 Version /11/2015-3/49

4 Figure 3-19: Product information tab Selecting a SDS...19 Figure 3-20: Product information tab SDS selected...19 Figure 3-21: Product information tab Wrong SDS attachment type...19 Figure 3-22: Product information tab One packaging type...20 Figure 3-23: Product information tab Other packaging type...20 Figure 3-24: Product information tab Other packaging type with a value...20 Figure 3-25: Product information tab Several packaging types...20 Figure 3-26: Mixture information tab Initial display...21 Figure 3-27: Mixture information tab Adding UFI...21 Figure 3-28: Mixture information tab UFI added...21 Figure 3-29: Mixture information tab ph is not relevant...22 Figure 3-30: Mixture information tab ph as exact value...22 Figure 3-31: Mixture information tab ph as a value range...22 Figure 3-32: Mixture information tab Adding a hazard category...23 Figure 3-33: Mixture information tab Selecting a hazard category...23 Figure 3-34: Mixture information tab Hazard category added...23 Figure 3-35: Mixture information tab Several hazard category...23 Figure 3-36: Mixture information tab Acute Tox. route of exposure...24 Figure 3-37: Mixture information tab Labelling statements...24 Figure 3-38: Mixture information tab Editing signal and pictograms Step Figure 3-39: Mixture information tab Editing signal and pictograms Step Figure 3-40: Mixture information tab Editing signal and pictograms Step Figure 3-41: Mixture information tab Resetting labelling to CLP defaults...25 Figure 3-42: Labelling Adding a hazard statement...25 Figure 3-43: Labelling Selecting a hazard statement...25 Figure 3-44: Labelling Hazard statement added...25 Figure 3-45: Labelling Hazard statement with additional text...26 Figure 3-46: Labelling Statement with additional controlled text Step Figure 3-47: Labelling Statement with additional controlled text Step Figure 3-48: Labelling Statement with additional controlled text Step Figure 3-49: Labelling Statement with additional free text Step Figure 3-50: Labelling Statement with additional free text Step Figure 3-51: Labelling Statement with additional free text Step Figure 3-52: Labelling Statement with optional additional free text...27 Figure 3-53: Mixture components tab Initial display...27 Figure 3-54: Mixture components tab Inconsistant range values...27 Figure 3-55: Mixture components tab Sum of concentrations is not 95%...28 Figure 3-56: Mixture components tab Composition overflow...28 Figure 3-57: Mixture components tab Sum of generic concentrations is over 10%.29 Figure 3-58: Mixture components tab Concentration range width is over 5%...30 Version /11/2015-4/49

5 Figure 3-59: Mixture components tab Concentration range width is over 20%...30 Figure 3-60: Mixture components tab Component classification Step Figure 3-61: Mixture components tab Component classification Step Figure 3-62: Mixture components tab Generic component classification...31 Figure 3-63: Mixture components tab Substance Initial display...32 Figure 3-64: Mixture components tab Concentration as exact value...32 Figure 3-65: Mixture components tab Concentration as range...32 Figure 3-66: Mixture components tab Substance Completed...33 Figure 3-67: Mixture components tab Mixture in mixture Initial display...33 Figure 3-68: Mixture components tab Mixture in mixture Completed...34 Figure 3-69: Mixture components tab Generic component Initial display...34 Figure 3-70: Mixture components tab Generic component Completed...34 Figure 3-71: Comments tab Initial display...35 Figure 3-72: Comments tab Data entered...36 Figure 4-1: Saving a submission Warning when incomplete...37 Figure 4-2: Example of save dialogue in Chrome (with folders hidden)...37 Figure 4-3: Example of save dialogue in Firefox Step Figure 4-4: Example of save dialogue in Firefox Step Figure 4-5: Example of save dialogue in Internet Explorer (Step 1)...38 Figure 4-6: Example of save dialogue in Internet Explorer (Step 1)...38 Figure 5-1: File upload warning...41 Figure 5-2: Selecting a submission...41 Figure 5-3: Selecting a submission among many...42 Figure 6-1: Print window...43 Figure 6-2: Print dialogue...43 Figure 7-1: Warning when clearing a submission...44 Figure 8-1: Close warning in Chrome...45 Figure 8-2: Close warning in Firefox...45 Figure 8-3: Close warning in Internet Explorer...45 Figure 8-4: Reload warning in Chrome...46 Version /11/2015-5/49

6 1 Introduction 1.1 Purpose of the document This document is the user s guide for the PC Editor application developed in the context of the Feasibility study on interlinked databases, format and basic application to facilitate exchange of information between Poison Centres. The PC Editor allows encoding and saving a mixture submission in the harmonised format for submission to Poison Centre. It also allows viewing a submission that has been saved as a file and printing its content in a one-page print-friendly format. This guide is destined to all application users at Industry and in Poison Centres. 1.2 Browser requirements Running the application only requires a recent browser with JavaScript enabled. The minimum browser requirements are: Internet Explorer 10 and higher. Mozilla Firefox 29. Google Chrome 35. If you are unsure that JavaScript is enabled in your browser, you can go on This page will check your browser settings and tell you if JavaScript is activated or not. Figure 1-1: JavaScript checker If JavaScript is disabled, the method to enable it is provided. It is generally possible to selectively allow JavaScript for some sites only. It is this possible to enable JavaScript for this application only while keeping it otherwise disabled as a matter of policy in an organisation. 1.3 Local application This editor is a local application: it runs in your browser and does not save your submissions on a web server. This means that you must save your data yourself using the Save functionality as will be explained in section Display rules Some display rules are consistently used by the application: Incorrect fields are marked by a red border and the error sign. Figure 1-2: Examples of incorrect fields Version /11/2015-6/49

7 This is the case for empty mandatory fields and incorrect entries. Figure 1-3 shows an incorrect UFI field and Figure 1-4 shows the correct entry. Figure 1-3: Incorrect field example Figure 1-4: Correct field example Hovering over the error sign displays the relevant error message. Figure 1-5 and Figure 1-6 illustrate how error messages can be viewed. Figure 1-5: Error message for a mandatory field Figure 1-6: Error message for an invalid value Warnings are marked by an orange border and the warning sign, as illustrated by Figure 1-7. Figure 1-7: Example of a warning sign Hovering over the warning sign displays the relevant message, as illustrated in Figure 1-8. Figure 1-8: Example of a warning message Mandatory multi-valued properties always have a first field and an Add action. This is for instance the case for Trade name and is illustrated by Figure 1-9. Version /11/2015-7/49

8 Figure 1-9: Mandatory multi-valued properties When other values are added, they can be removed by clicking the Delete button. They can also be reordered by clicking the Up and Down arrows. This is shown in Figure Figure 1-10: Mandatory multi-valued properties Deleting and re-ordering In the case where the field is mandatory, it is never possible to delete the last entry. Optional multi-valued properties never have an initial field and only have the Add action. This is for instance the case for the Other identifier field and is illustrated by Figure Figure 1-11: Optional multi-valued properties In this case where the field is optional, it is always possible to delete the last entry as shown in Figure Figure 1-12: Optional multi-valued properties Tooltips are available hovering over the sign. This is illustrated by Figure Figure 1-13: Optional multi-valued properties 1.5 Notations used in this guide The following conventions are used in the guide: Name label of fields are underlined, for instance Trade name. Values in fields are emphasised, for instance Mixturiol. Actions such as buttons or links are noted in blue, for instance OK. Version /11/2015-8/49

9 Tips will be bordered as shown below. Tip: This is a tip to do something. Warnings will be bordered as shown below. Warning: This is a warning. Version /11/2015-9/49

10 2 Launching the application The application is available from the link Warning: This link leads to a test application. It is not the one of the final application. Please consult DG GROW website for further information on the official link for the final application The application welcome page is displayed; see Figure 2-1. Click Start using the PC Editor! The application main page is displayed; see Figure 2-2. From now on you will remain in the same page and will navigate the different application tabs to encode your data. Figure 2-1: Application welcome page Figure 2-2: Application page Version /11/ /49

11 3 Entering submission data The application main page is divided into six tabs: Administrative information Submitter information Product information Mixture information Mixture components Comments You can navigate freely between the tabs by clicking on a tab header. For instance, if you click on Submitter information, you enter into that form; see Figure 3-1. Figure 3-1: Submitter information tab selection 3.1 Administrative information The initial layout of the Administrative information tab is depicted in Figure 3-2. Figure 3-2: Administrative information tab Initial display The fields in this form are: Country of placing on the market: Selection of the Member State where the submission is to be sent. Only one Member State can be selected in to accordance the regulatory provision that submissions to Poison Centres/Appointed Bodies are made per Member State. Submission type: This selection allows indicating that the submission concerns a non-hazardous mixture. The default submission type is Hazardous mixture 1. 1 Hazardous in this context meaning A mixture classified as hazardous for its physical and health effects under Art. 45(1) of the CLP Regulation, thereby considering only physical and health hazards and excluding environmental hazards. Version /11/ /49

12 If Submission type is Hazardous mixture, the mixture must have a UFI and a classification in the Mixture information tab. Submission reason: If Update is selected, then one or several of the update reasons must be selected. The update reasons are: o o o o o Change to the mixture classification. Change in the mixture component(s) or their concentration. Change to the mixture product identifier. Change of toxicological information. Other change. Figure 3-8 below shows an example of update submission. Limited submission (industrial use only): This option allows indicating that the submission is limited and concerns a mixture for industrial use only. If this option is selected, then: o o The contact for rapid information must be provided in the Submitter information tab. The user identification in the Product information tab must be Industrial and cannot be changed. Click the help icon beside the field to see an help text on the concept of limited submission. Figure 3-3: Administrative information tab Limited submission Submission languages: The language(s) into which this submission is prepared. The multi-lingual fields may be entered in the languages selected. If, for instance, English and French are specified as the submission languages, all multi-lingual fields will be requested in these languages only, imposing coherence and avoiding having to specify the encoding languages for every such field. A modal dialogue 2 to specify the submission languages appears when clicking the Select language button. 2 A modal dialogue must be acknowledged or completed before being allowed to return to the main application screen. Version /11/ /49

13 Figure 3-4: Administrative information tab Language selection Click OK to record and display the selected language as shown in Figure 3-7 below. The multi-lingual fields in the application are: o Trade name in the Product information tab. Figure 3-5 gives an example of the display when English and French are specified as submission languages. o o o o o o o Figure 3-5: Multi-lingual field Trade name Product use remark in the Product information tab. Colour in the Mixture information tab. Toxicological information in the Mixture information tab. SDS in the Mixture information tab. Hazard or precautionary statements in the Mixture information tab when the statement has placeholders for values. Chemical name and Mixture name in the Mixture components tab. Comments on the submission in the Comments tab. To be able to enter values in any of the multi-lingual field, at least one submission language has to be selected. Should it not be the case, an error sign is displayed informing you as illustrated in Figure 3-6 for the trade name field. Figure 3-6: Multi-lingual field Error when submission language is not set Figure 3-7 and Figure 3-8 show different examples of a completed Administrative information section. Note that since all mandatory fields in this tab are correctly entered no error sign is shown in the tab header. Version /11/ /49

14 Figure 3-7: Administrative information tab Data entered New mixture Figure 3-8: Administrative information tab Data entered Update submission 3.2 Submitter information The initial layout of the Submitter information tab is depicted in Figure 3-9 and Figure As reminded by the message at the top of the form, the submitter is the importer or downstream user placing the mixture on the market (according to Article 45(1) of CLP Regulation). Version /11/ /49

15 Figure 3-9: Submitter information tab Initial layout Submitter details Figure 3-10: Submitter information tab Initial layout Contact information If Limited submission (industrial use only) is selected in the Administrative information tab, the Contact information for rapid access becomes mandatory as shown in Figure Figure 3-11: Submitter information tab Contact for rapid information Figure 3-12 and Figure 3-13 show an example of a completed Submitter information section. Version /11/ /49

16 Figure 3-12: Submitter information tab Data entered Submitter Figure 3-13: Submitter information tab Data entered Contacts 3.3 Product information The initial layout of the Product information tab for two submission languages is depicted in Figure Version /11/ /49

17 Figure 3-14: Product information tab Initial display The fields in this form are: Trade name: The product trade names. Tip: Trade name is a multi-lingual field. The submission language(s) must be selected in the Administrative information section to encode this field. More than one trade name can be submitted in each of the submission language. Click Add to add a trade name to the product for each of the submission languages. Figure 3-15 shows the result of adding a trade name when the submission languages are French and English. Figure 3-15: Product information tab Multiple trade names User identification: One or several user identifications selected from the values Consumer, Professional and Industrial. Version /11/ /49

18 The user identification will be forced to Industrial and disabled if Limited information has been selected in the Administrative information tab. This is illustrated by Figure Figure 3-16: Product information tab User identification when limited submission If you create a limited submission for a mixture for industrial use, all products in the submission will have the Industrial user identification. Product category: The product category in the Product Categorisation System (PCS). Warning: A Product Categorisation System is not defined yet. The application reserves a place for this value and indicates it will be added in a future version when the PCS is defined. The PCS is expected to become available by end Please consult DG GROW website for further information Product use remark: Optionally, a remark on the product use can be provided in each of the submission languages. Tip: Product use remark is a multi-lingual field. The submission language(s) must be selected in the Administrative information section to encode this field. Other identifier: Any other identifier useful to identify the mixture. This field is a general placeholder to provide any information deemed interesting to identify the product. For instance: o o o Authorisation number (pesticide or biocide) Other names or synonyms Company specific codes (e.g. EAN) Other identifiers are optional. Click Add to insert an entry to this field. Figure 3-17 illustrates the addition of several such identifiers. Figure 3-17: Product information tab Other identifiers The identifiers can be removed by clicking the Delete button. SDS: Optionally, the product SDS (Safety Data Sheet) can be attached to the submission in any of the submission languages. The type of the attached SDS file is restricted to PDF and MS Word. Version /11/ /49

19 Tip: SDS is a multi-lingual field. The submission language(s) must be selected in the Administrative information section to encode this field. Figure 3-18: Product information tab SDS selection field To attach the product SDS, click on the icon. The browser opens a dialogue to select a file in the filesystem. Figure 3-19 shows an example of the Open dialogue in Chrome. The application instructs the browser to filter only PDF documents. Figure 3-19: Product information tab Selecting a SDS Select the SDS file and click Open in the dialogue. The display now shows the SDS filename as illustrated in Figure Figure 3-20: Product information tab SDS selected The attached file can be removed by clicking the Delete button. The SDS can be opened by clicking the file is actually attached to the submission. icon which is displayed only when a If the attached file type is not PDF or MS Word (either.doc or.docx format), an error message is displayed and the document is not attached. Figure 3-21: Product information tab Wrong SDS attachment type Version /11/ /49

20 Product packaging: One or several packaging information for this product, giving the packaging Type and Size. The latter is given as a free text to easily support multiple sizes for a single type; for instance 1 litre or 1 L, 2 L. Figure 3-22 illustrates a product with one packaging type. Figure 3-22: Product information tab One packaging type The available types of packaging are described in Annex A. If the proposed packaging Type does not match the mixture packaging, it is possible to select the value Other and enter a value in a free text field. This is illustrated in Figure 3-23 and Figure Figure 3-23: Product information tab Other packaging type Figure 3-24: Product information tab Other packaging type with a value To add another packaging type for this product, click Add packaging type. The application opens a new packaging block where packaging Type and Size can be encoded. Figure 3-25 illustrates a product with several packaging types. Figure 3-25: Product information tab Several packaging types The packaging types can be removed by clicking the Delete button. They can also be reordered by clicking the Up and Down arrows. It is possible to add another product for the mixture by clicking the Add product button. The application opens an empty product block that can be completed. The Version /11/ /49

21 product blocks can be removed by clicking the by clicking the Up and Down arrows. Delete button and can be reordered 3.4 Mixture information The initial layout of the Mixture information tab is depicted in Figure 3-2. Figure 3-26: Mixture information tab Initial display The fields in this form are: UFI: The Unique Formula Identifier for the mixture. Warning: The study on analysis, development and testing of the Unique Formula Identifier has not been finalised yet. It will be possible to generate the UFI on the poison centres website at later in A UFI is mandatory for hazardous mixtures; i.e. when Submission type is Hazardous mixture in the Administrative information tab. A mixture can be given multiple UFIs. To add other UFIs, click the Add UFI button. The application will add a UFI entry as shown in Figure Figure 3-27: Mixture information tab Adding UFI Figure 3-28: Mixture information tab UFI added Version /11/ /49

22 UFIs can be removed by clicking the Delete button and can be reordered by clicking the Up and Down arrows. Physical state: The mixture physical state. Colour: A free text in the submission languages. Tip: Colour is a multi-lingual field. The submission language(s) must be selected in the Administrative information section to encode this field. ph: The mixture ph when relevant. If the ph is not relevant, select the Is not relevant checkbox. The related fields will then be disabled, as illustrated by Figure Figure 3-29: Mixture information tab ph is not relevant The ph value may be given as an exact value or a range. The latter requires that two different values are given. This is illustrated by Figure 3-30 and Figure A value may not be entered in the upper value until one has been in the lower. Figure 3-30: Mixture information tab ph as exact value Figure 3-31: Mixture information tab ph as a value range Warning: The ph decimal separator is the dot. not the comma. Toxicological information: Free text to provide information on the hazardous properties of the mixture contained in Section 11 of the Safety Data Sheet of the mixture. This information can be entered in all the languages of the submission. Tip: Toxicological information is a multi-lingual field. The submission language(s) must be selected in the Administrative information section to encode this field. Note that this field is mandatory and that attaching an SDS to the product is not considered a valid way of providing this information. The Classification of the mixture. A classification is mandatory for hazardous mixtures; i.e. when Submission type is Hazardous mixture in the Administrative information tab. To add a Hazard category, click the Add category button. The application adds a new empty category as shown in Figure Version /11/ /49

23 Figure 3-32: Mixture information tab Adding a hazard category Select the category in the dropdown list, for instance Expl. 1.1 as shown in Figure Figure 3-33: Mixture information tab Selecting a hazard category The application will display the selected category as well as the related hazard and precautionary statement codes as illustrated in Figure Tip: The hazard and precautionary statement codes are initialised from the CLP Regulation. They are provided as an encoding hint and they will not be part of the mixture labelling. Figure 3-34: Mixture information tab Hazard category added Click the Add category button and repeat the selection for all hazard categories that are relevant to the mixture classification. Figure 3-35 illustrates a situation where there are three hazard categories. The hazard categories can be removed by clicking the clicking the Up and Down arrows. Delete button. They can also be reordered by Figure 3-35: Mixture information tab Several hazard category When selecting the Acute Tox. Categories, the route of exposure must be added. This is illustrated in Figure Version /11/ /49

24 Figure 3-36: Mixture information tab Acute Tox. route of exposure The hazard and precautionary statement codes displayed below each category can be selected and will automatically fill the relevant parts in the Labelling block. For instance, if H310 and P262 are selected, the statements are added to the mixture labelling as illustrated in Figure Figure 3-37: Mixture information tab Labelling statements The mixture Labelling. Most of the Labelling is automatically filled in from the Classification block. The Signal word and Pictograms are automatically added depending on the selected hazard categories. Note that for pictograms, their union is displayed and precedence rules set out in Article 26 of the CLP Regulation 3 are not applied. It is also possible to manually edit the Signal word and the Pictograms. Click Edit signal word or Edit pictogram to set the respective field in edit mode. Figure 3-38 shows how the situation in Figure 3-37 would appear after selecting both buttons. Figure 3-38: Mixture information tab Editing signal and pictograms Step 1 Change the values and save them clicking Ok, or return to the initial situation clicking Cancel. Figure 3-39 and Figure 3-40 show how the signal word can be changed to Warning and the pictograms completed with GHS02 and GHS08. Figure 3-39: Mixture information tab Editing signal and pictograms Step 2 3 The current version of the CLP Regulation (Regulation N 1272/2008) is available at Version /11/ /49

25 Figure 3-40: Mixture information tab Editing signal and pictograms Step 3 After changing signal word or pictograms, it is always possible to come back to the situation that prevailed after mere selection of the hazard categories; i.e. the CLP defaults. Click Reset Labelling in the Classification block: the application asks for confirmation and resets signal word and pictograms. Figure 3-41: Mixture information tab Resetting labelling to CLP defaults As indicated above, the Hazard and Precautionary statements can be added by selecting the codes under the hazard categories. It remains possible to explicitly add Hazard or Precautionary statements. Click Add hazard statement or Add precautionary statement. The application adds an entry in the respective section where you can select the statement code. The steps to follow are illustrated in Figure 3-42, Figure 3-43 and Figure Figure 3-42: Labelling Adding a hazard statement Figure 3-43: Labelling Selecting a hazard statement Figure 3-44: Labelling Hazard statement added Version /11/ /49

26 Some hazard or precautionary statements have additional text that has to be encoded in the different submission languages. This is done as follows. When selecting a statement such as EUH018, the application displays the sentence in the submission languages with an indication that placeholders must be completed. This is illustrated in Figure Figure 3-45: Labelling Hazard statement with additional text Filling the additional text happens as follows: 1. Select the placeholder ellipsis: the placeholder is replaced by an entry box as shown in Figure Enter the additional text. This can be either a free text or a selection between predefined values as shown in Figure When leaving the field or clicking the save icon, the value is saved. This is shown in Figure The additional text is eventually displayed with a background colour and the whole field is valid. Figure 3-46: Labelling Statement with additional controlled text Step 1 Figure 3-47: Labelling Statement with additional controlled text Step 2 Figure 3-48: Labelling Statement with additional controlled text Step 3 EUH208 is an example where the additional text is free. Entering data in that case is shown in Figure 3-49, Figure 3-50 and Figure Figure 3-49: Labelling Statement with additional free text Step 1 Figure 3-50: Labelling Statement with additional free text Step 2 Version /11/ /49

27 Figure 3-51: Labelling Statement with additional free text Step 3 H340 has optional additional info. In this case, the placeholders are not marked in red and may not be filled. This is shown in Figure Figure 3-52: Labelling Statement with optional additional free text 3.5 Mixture components The initial layout of the Mixture components tab is depicted in Figure Figure 3-53: Mixture components tab Initial display It is possible to encode the three types of components from this tab: Substance component by clicking the Add substance button. Mixture in mixture component (also referred to as MIM in this guide) by clicking the Add mixture in mixture button. Generic component by clicking the Add generic component button. Clicking any of the Add buttons inserts the relevant component block at the top of the page. A component can be removed by clicking the Delete button. They can also be manually reordered by clicking the Up and Down arrows. It is possible to sort the components in decreasing order of their composition by clicking the Sort components button. This feature is detailed in section Sorting components Component concentration rules As many components as needed can be entered to provide the composition of the mixture. The application enforces concentration business rules. Consistent range values: The minimum value in a concentration range must be lower than the maximum value. This is illustrated by Figure Figure 3-54: Mixture components tab Inconsistant range values Version /11/ /49

28 Minimum composition: If the mixture is hazardous, the submission is not limited and the sum of the concentration maximums is not 95 percent, warning messages will be displayed for every relevant concentration value as shown in Figure The intention behind this warning is to hint at the encoding of complete compositions without invalidating the submission. The values taken in consideration for this s are the exact concentrations and the maximum values in the concentration ranges. Figure 3-55: Mixture components tab Sum of concentrations is not 95% This warning will not be displayed if any of the following condition exists: o o The mixture is non-hazardous. The submission is limited for industrial use only. Composition overflow: If the sum of the concentration minimums is above 100 percent, an error message is displayed for every relevant concentration value as shown in Figure The values taken in consideration for this validation are the exact concentrations and the minimum values in the concentration ranges. For instance, considering the composition displayed in Figure 3-56, the application sees that is over 100 and displays the error message. The message is attached with an error sign in all values concerned in all components. Figure 3-56: Mixture components tab Composition overflow Generic component ceiling: If the sum of the concentrations of the generic components is above 10 percent, an error message is displayed as shown in Figure The values taken in consideration for this validation are the exact concentrations and the minimum values in the concentration ranges for all generic components in the composition. For instance, considering the composition displayed in Figure 3-57, the application sees that is over 10 and displays the error message. The message is attached with an error sign in all values concerned in all generic components. Version /11/ /49

29 Figure 3-57: Mixture components tab Sum of generic concentrations is over 10% Range width: The concentration range width, i.e. the difference between the maximum and the minimum values, of a substance or mixture in mixture component may not exceed 5% when the component is classified for a health hazard of major concern: o Acute toxicity, Category 1, 2 or 3; o Specific target organ toxicity Single exposure, Category 1 or 2; o Specific target organ toxicity Repeated exposure, Category 1 or 2; o Skin corrosion, category 1, 1A, 1B or 1C; o Serious eye damage, Category 1. Otherwise, their concentration range width may not exceed 20%. This check does not apply to generic components whose concentrations are already controlled via the generic component ceiling check. The values taken in consideration for this validation are the concentration range values in each component separately. Figure 3-58 shows an example where the range width should not be over 5% (16 10 = 6) because the substance is classified STOT SE 1. Figure 3-59 shows an example where the range width should not be over 20% (31 10 = 21). Version /11/ /49

30 Figure 3-58: Mixture components tab Concentration range width is over 5% Figure 3-59: Mixture components tab Concentration range width is over 20% Component classification It is possible to add a classification to any component by clicking Add classification. Figure 3-60 shows how the application opens a classification block and Figure 3-61 illustrates the result of having added two hazard categories to the component. Note that the application will not display the related hazard and precautionary statements as it did fpr the mixture classification (see Figure 3-34). Version /11/ /49

31 Figure 3-60: Mixture components tab Component classification Step 1 Figure 3-61: Mixture components tab Component classification Step 2 The following rules are enforced when displaying hazard categories for a component classification. For substances and mixtures in mixture, all hazard categories are available for selection, irrelevant of the nature of the mixture (hazardous or not) or the submission (limited or not). For generic components, the hazard categories do not include health hazards of major concern. This is illustrated by Figure 3-62 where you see that Acute toxicity category 1, 2 and 3 are not present. Figure 3-62: Mixture components tab Generic component classification Substance component The initial layout in the Mixture components tab for a Substance component is depicted in Figure 3-63 when English is the submission language. Version /11/ /49

32 Figure 3-63: Mixture components tab Substance Initial display The fields in this form are: Concentration: The concentration of a component may be given as an exact value or a range. The latter requires that two different values are given. This is illustrated by Figure 3-64 and Figure A value may not be entered in the upper value until one has been in the lower. Warning: The concentration decimal separator is a dot. not a comma. Tip: Up to 4 fractional digits can be entered in a concentration value. Figure 3-64: Mixture components tab Concentration as exact value Figure 3-65: Mixture components tab Concentration as range CAS number: The CAS number of the chemical substance. For the exceptional cases where this is required, several CAS numbers can be entered by clicking the Add button as many times as necessary. Index number: If any, the index number of the chemical substance in Annex VI of the CLP. EC number: The EC number of the chemical substance. For the exceptional cases where this is required, several EC numbers can be entered by clicking the Add button as many times as necessary. Chemical name: The chemical name of the chemical substance in the submission languages. Tip: Chemical name is a multi-lingual field. The submission language(s) must be selected in the Administrative information section to encode this field. Version /11/ /49

33 Warning: There is no correlation between the values of chemical name, CAS, index and EC number. It is the responsibility of the user to ensure coherence between these values. Figure 3-66 shows an example of a completed Substance block. This example is for a substance listed in CLP Annex VI. Figure 3-66: Mixture components tab Substance Completed Mixture in mixture component The initial layout in the Mixture components tab for a Mixture in mixture component is depicted in Figure 3-67 when English is the submission language. Figure 3-67: Mixture components tab Mixture in mixture Initial display The fields in this form are: Concentration: The concentration of the component. Mixture UFI: The UFI of the mixture component if it exists. Version /11/ /49

34 Mixture name: The name of the mixture in the submission languages. User Guide Contact information: Contact information of the mixture in mixture (MIM) supplier. Figure 3-68 shows an example of a completed Mixture in mixture block. Figure 3-68: Mixture components tab Mixture in mixture Completed Generic component The initial layout in the Mixture components tab for a Generic component is depicted in Figure Figure 3-69: Mixture components tab Generic component Initial display The fields in this form are: Concentration: The concentration of the component. Type: The type of the generic component, one of Perfume/Fragrance or Colouring agent. Figure 3-70 shows an example of a completed Generic component block. Figure 3-70: Mixture components tab Generic component Completed Version /11/ /49

35 3.5.6 Sorting components by their concentration User Guide Components can be sorted in decreasing order of their composition by clicking the Sort components button at the top of the Mixture components tab. The components will be displayed in decreasing order of the minimum values and, when minimums are equal, by decreasing order of the maximum values. The table below shows an example of the result of sorting components by their concentration. Table 3-1: Component ordering example Initial order Order after sort Comments The initial layout of the Comments tab is depicted in Figure Free comments regarding the submission can be entered here. Tip: Comment is a multi-lingual field. The submission language(s) must be selected in the Administrative information section to encode this field. Figure 3-71: Comments tab Initial display An example of a completed form is shown in Figure Version /11/ /49

36 Figure 3-72: Comments tab Data entered Version /11/ /49

37 4 Saving a submission The data entered in the forms can be saved locally as an XML document at any time. 1. Click the Save button. 2. It is allowed to save incomplete or incorrect submissions. In such case, the application will display the warning shown in Figure 4-1. Figure 4-1: Saving a submission Warning when incomplete 3. Click Ok to confirm your intention to save or Cancel if you prefer to complete your submission before saving. 4. The browser displays its save dialogue, illustrated for each main browser family in a screen shot below. Browser save settings are also discussed in section 4.1 below. Tip: Your browser may not behave exactly like described below and may save your file in a default location without letting you selecting the save location and file name. See how you can change this behaviour or find out where the default save location is in section 4.1 below. Chrome Chrome asks for file location and name as illustrated in Figure 4-2. Figure 4-2: Example of save dialogue in Chrome (with folders hidden) Firefox Firefox generally asks first for a confirmation (Figure 4-3) then, after clicking Save file followed by OK, proposes to select file location and name (Figure 4-4). Version /11/ /49

38 Figure 4-3: Example of save dialogue in Firefox Step 1 Figure 4-4: Example of save dialogue in Firefox Step 2 Internet Explorer Internet Explorer displays a confirmation/selection dialogue (Figure 4-5) then, after clicking Save > followed by Save as, proposes to select file location and name (Figure 4-6). Clicking Save directly will save the file in the browser s default save location (see section 4.1 below). Figure 4-5: Example of save dialogue in Internet Explorer (Step 1) Figure 4-6: Example of save dialogue in Internet Explorer (Step 1) 5. Confirm the proposed file name or change it; select the location where you want the file to be saved; and click Save. The construction rules for the proposed file name are presented in section in 4.2 below. The sections below provide additional information on the following topics: Save settings for browsers. Rules for the construction of a proposed file name. Techniques to save re-usable template files. Version /11/ /49

39 4.1 Browser save settings User Guide Since the application makes use of the browser to save the file, the behaviour will depend on the browser configuration. By default and in the absence of particular settings, browsers save files in the user s Download directory which on Windows PC is located under the user s root directory: C:\Users\jdoe\Downloads for user jdoe. This means that the default behaviour does not allow Saving as : all saved files are created in that location with the name given to them by the application. It is possible to override this behaviour. The technique to configure your browser s save location is slightly different in each case. We provide here a pointer for the three main browsers: Internet Explorer (IE9, IE10, and IE11): Firefox: For Firefox, it is also possible to request the browser to ask for a save location each time. Chrome: In Chrome, it is also possible to request the browser to ask for a save location each time. 4.2 Filename construction rules The application will compose a name for the file by concatenating meaningful elements from the submission following the rules listed below: 1. The first trade name + date and time + indication of completeness. Date and time are formatted as YYYYMMDD_HHMMSS. Indication of completeness is either _COMPLETE or _NOT_COMPLETE. The completeness is granted only when all mandatory fields are correctly encoded. Example: Mixturiol_ _143523_COMPLETE.xml. If the trade name is too long, its first 50 characters are used to avoid issue with filesystems limits. 2. If no trade name is found, the proposed file name is made of the mixture s first UFI + date and time + indication of completeness. Example: A23Y-TY67-UK4R-677V_ _143523_NOT_COMPLETE.xml. 3. If no trade name and no UFI is available (for instance because you save an incomplete submission), the term mixture is used. Example: mixture_ _143523_not_complete.xml. You can always change the proposed name if your browser configuration permits, that is if you do not save files in the browser s default location as explained in section Preparing templates Since incomplete submissions can be saved, it is possible to save templates ready for reuse. Two common situations come to mind: Submitter template to avoid re-encoding the submitter information for each mixture. Follow these steps: Version /11/ /49

40 1. Click New. 2. Enter the submitter data in the Submitter information tab. If meaningful, the country of placing on the market and the submission languages can also be encoded in the Administrative information tab. 3. Click Save, ignore the incompleteness warning and give the file a meaningful name, including for instance your company s name. Keep for reuse. Whenever a submission needs to be prepared: 4. Click Open. 5. Open your company template to load the submitter data. 6. Complete the submission, adding product and mixture information. 7. When ready, click Save and either keep the proposed name or give the submission another name These steps can be repeated for every new submission. Mixture template to avoid re-encoding the mixture information for submitting to other Member States. Follow these steps: 1. Click New. 2. Enter pertinent information about the mixture in the Administrative information tab, for instance the submission type (hazardous mixture or not), the submission reason (new or update) and, should it be, the fact the submission is limited. 3. Enter the mixture data in the Mixture information and Mixture the Administrative information tab components tabs. 4. Click Save, ignore the incompleteness warning and give the file a meaningful name, including for instance the mixture s name. Keep for reuse. For every Member State where the mixture is placed on the market: 5. Click Open. 6. Open your mixture template to load the initial administrative information and the mixture data. 7. Complete the submission with Member State specific information, adding where pertinent: a. Country of placing on the market and submission languages in the Administrative information tab b. Submitter information in the Submitter information tab. c. Product information in the Product information tab. If product information (for instance, packaging) is common to all Member States, it can already be saved into the template. d. Mixture UFI in the Mixture information tab. e. Comments if necessary. 8. When ready, click Save and either keep the proposed name or give the submission another name. These steps can be repeated for every new submission of the mixture to another Member State. Version /11/ /49

41 5 Opening a submission A submission previously saved as a file can be opened and viewed in the application. 1. Click the Open button. 2. The application displays the File Upload dialogue. 3. Navigate the file system, selects a file and clicks Open. 4. A warning message is displayed in Figure 5-1. Figure 5-1: File upload warning This ensures that you will not lose unsaved data without explicit consent. 5. Click Ok. 6. The system reads and validates the file. If the file is not valid, the data is loaded with all appropriate indications of error (see data field warning and incomplete or incorrect submission.) The XML format allows having several submissions in a single document 4. In this case, you must select the submission you want to view in the application. To achieve this, the application opens a Select Submission dialogue to show the mixtures trade names read in the submission file. This is illustrated by Figure 5-2. Figure 5-2: Selecting a submission Clicking one of the entries will immediately open the relevant submission. If no trade name exists for a submission, the mixture s UFI is displayed instead. If no trade name and no UFI are found for a submission, the term Mixture is used. Figure 5-3 shows the Select Submission when the file includes many submission. 4 Such a document is for instance prepared by software generating submissions from information read in the submitter s mixture database. Version /11/ /49

42 Figure 5-3: Selecting a submission among many Version /11/ /49

43 6 Printing a submission The content of submission, complete or not, can be displayed as a one-page printfriendly format using the print functionality. 1. Click the Print button. 2. The application opens a pop-up displaying the submission data as a continuous one-page flow. Figure 6-1: Print window 3. To print the submission, click CTRL-P to open the browser printing dialogue. Figure 6-2: Print dialogue 4. Select your printer and your printing options. The application inserts page breaks before each main section. 5. Close the pop-up window. Version /11/ /49

44 7 Clearing a submission At any point in time it is possible to clear the forms and restart from a blank page by using the New button. The application will display the warning message shown in Figure 7-1 Figure 7-1: Warning when clearing a submission It ensures you will not lose unsaved data without explicit consent. Warning: This message is displayed even when no changes have been made. Version /11/ /49

45 8 Leaving the application The application being executed in a browser, closing the browser will stop the application. To prevent this from happening without giving you a change to save your work, a warning message is displayed and you must explicitly confirm leaving the browser. The warning is displayed whenever the browser tab into which the application had been loaded is closed, the browser window is closed or another URL is entered in the browser URL bar. Warning: In Chrome, because the URL bar is also the search zone, typing anything but a URL in the URL bar will close the application without warning and display the results of the search. As illustrated in the following figures, the message is displayed in a slightly different way by each of the mainstream browsers. Chrome Figure 8-1: Close warning in Chrome Firefox Figure 8-2: Close warning in Firefox Internet Explorer Figure 8-3: Close warning in Internet Explorer Version /11/ /49

46 Warning: The default action is Leave : merely hitting the return key will close the application. A warning message will also be displayed if you attempt to reload the application via the CTRL-R or F5 key. The message is slightly different in Chrome (see Figure 8-4). Figure 8-4: Reload warning in Chrome Version /11/ /49

47 A Annex Packaging types The table below lists and documents the packaging types supported by the application. Table A-1: Packaging types Display value Definition Example Aerosol A gas-tight, pressure-resistant contained with a valve and propellant. Atomizer A device for reducing a liquid to a fine spray. Does not use a propellant. Bag Bag in box A preformed, flexible container where one side is left open for filling A bag integrated in a box. Barrel A cylindrical container whose bottom end is permanently fixed to the body and the top end (head) is either removable or non-removable. Blister Generally a plastic casing with a cardboard or plastic back. Bottle A container having a round neck of relatively smaller diameter than the body and an opening capable of holding a closure for retention of the contents. Version /11/ /49

48 Display value Definition Example Box A generally square-shaped container made out of any material, with closed faces that completely enclose its contents. Brick A rectangular-shaped, stackable package designed primarily for liquids. Bucket A container, usually cylindrical, can be equipped with a lid and a handle. Can Generally a cylindrical metallic container. Carboy Carboy. Case Re-closable container, often intended to store and preserve its contents during the product's entire lifetime. Dispenser A container with a manual mechanism to supply its contents. Envelope A flat container of flexible material. Intermediate Bulk Container A reusable industrial container designed for the transport and storage of bulk liquid and granulated substances Jar A rigid container made of glass, plastic or other appropriate material with a large opening that can be opened and resealed. Version /11/ /49

49 Display value Definition Example Jerry can A large flat-sided container for storing or transporting liquids, typically petrol or water. Jug A container with a handle and/or a lid or spout. Phial A small glass bottle Soluble packaging Packaging that dissolves in water Stick A container which is open at the top; example: a glue stick, a stick of deodorant Syringe Syringe Tank A specially constructed container for transporting liquids and gases in bulk Tube A cylindrical container sealed on one end and a cap or dispenser on the other end. Other: A value indicating that another value is given. Version /11/ /49