Cosmetri – Software User Manual

1. Cosmetri – Software User Manual [Version 1.01 | Last updated: 12 November 2015] support@cosmetri.com | www.cosmetri.com To download the latest version of this document: http://www.cosmetri.com/docs/Cosmetri-Getting-Started-Guide.pdf [Getting Started Guide] The regulatory, formulation and workflow software for cosmetics businesses. Copyright Cosmetri © 2015. All rights reserved.

2. C osmetri - Getting Started Guide 1. Introduction Welcome to Cosmetri! We want you to get the best possible start in using the software. This guide is intended to cover the basic principles of Cosmetri, enabling you to later to build on this by using a range of further powerful features not covered in this document – features such as managing your product batches, calculating and optimising your costs and generating production reports. We highly recommend that you take a few minutes to read the following section 2. ‘Terminology’ before beginning with the step-by-step guide described in section 3. By the end of section 3 you’ll be able to: 1.Create raw materials 2.Create a product 3.Create a formula 4.Build your formula composition 5.Check compliance of your formula (EU) 6.Add data and documents 7.Generate a compliant PIF If at any point you still feel stuck or have specific questions please contact Cosmetri support. You can use the following link to schedule a free one-to-one call at a time convenient to you. If you choose the Skype option, we can share screens and walk you through the software in a live demonstration, customised to your requirements. Use the link below to schedule a call: http://www.cosmetri.com/schedule.htm Alternatively, drop us an email any time at support@cosmetri.com and let us know how we can support you. Copyright Cosmetri © 2015. All rights reserved.

3. C osmetri - Getting Started Guide Ready to get started? Please read through the following short section, before proceeding to the step-by-step guide. 2. Terminology Throughout this Getting Started Guide reference will be made to certain key terms which are defined below. Ingredient Cosmetri accounts are pre-configured with 23,000+ cosmetic ingredients. These ingredients are the building-blocks of your raw materials and hence, your formulas. You can access this ingredient data directly within the Cosmetri software, including by default all regulatory and directive annexes that detail any restrictions for each ingredient according to EU cosmetic regulations. Special directives and regulations apply to certain ingredients such as perfume allergens and colorants. Cosmetri simplifies things by letting you access these in separate lists. You can keep notes for any ingredient. Raw Material You create your raw materials before you build your formula. You create your raw materials before you build your formula. A raw material consists of one or more ingredients. Creating a single-ingredient raw material requires a single click once you have located the ingredient in the main inventory. Once you're ready to go into production, each raw material in your formula is assigned to a supplier, along with supplier batch data. You can also enter cost arrays from your raw material supplier which will enable you to calculate total raw materials costs for your trial formulas. Formula A formula is created by adding your raw materials to the formula composition at the % amounts you require and presto! - Cosmetri then calculates everything for you and displays any regulatory data. A formula is always associated with a specific product. You can easily clone a formula to enable you to create different trial versions. Copyright Cosmetri © 2015. All rights reserved.

4. C osmetri - Getting Started Guide Product You create a product before you add your first formula. A product is, well... 'ABC Hand Cream', 'XYZ Lip Moisturiser', or the like. Certain data is required to be added at product-level that will apply to all formulas associated with the product. You can organise your products in product categories - especially helpful if you have different brand lines, clients or product ranges. PI File (PIF) Companies selling products within the EU are obliged under Article 11 of the EU Cosmetics Regulation to compile a product information file or PIF. A PIF is a living document - meaning, that it must be kept updated throughout the life of your product, as you produce each batch. The regulatory authority must be able to easily access PIFs at the address indicated on the product label. PIFs have to be retained for ten years as of the point in time when the last batch of a specific cosmetic product was launched on the market. Cosmetri ensures that nothing is missing from your PIF and then generates this as a .zip file, with all the necessary supplementary files included and referenced within a main PDF report. Suppliers Once a formula is ready for production it is important that each raw material in the formula is associated with a supplier and supplier batch. Suppliers must provide you with certain raw material data and documents which will be required for completing your PIF and maintaining regulatory compliance. Cosmetri greatly simplifies the managing of supplier/raw material relationships and in keeping your supply-chain documents and data in the right places. 3. Getting Started The following seven simple steps assume that you are not using the data import tool to import your formulas and raw materials from existing spreadsheets. Even if you do use the tool it’s really useful to familiarise yourself with Cosmetri by following the steps Copyright Cosmetri © 2015. All rights reserved.

5. C osmetri - Getting Started Guide described below so that you can work effectively with the software and know how to create, edit and manage your products, formulas, raw materials and ingredients. In the following seven steps you will learn how to: 1.Create raw materials 2.Create a product 3.Create a formula 4.Build your formula composition 5.Check compliance of your formula (EU) 6.Add data and documents 7.Generate a compliant PIF TIP TIP If you have a large number of products and your formula data can be made available in spreadsheet format, please check the ‘Import data’ menu item in the Cosmetri application. Contact support (support@cosmetri.com) to discuss your data import needs and we will advise you of the options available to you. Step 1. Create raw materials Your Cosmetri account provides access to over 23,000 pre-loaded cosmetic ingredients. To use these in your formula composition you need first to create your raw materials using these ingredients before you can create your formula. using these ingredients before you can create your formula. To use these in your formula composition you need first to create your raw materials There are two ways to create a raw material depending on whether it is single or multiple-ingredient. 1.Single ingredient raw material Single ingredient raw material - go to ‘Main Inventory' in the ingredients menu and search for an ingredient, either by INCI name or CAS number. If searching by CAS you do not need to enter the hyphens correctly, since Cosmetri ignores these. For INCI searches you only need to enter a part of the INCI name to instantly see any matches. Narrow your search by typing an additional character in the string until you find the ingredient you require. Copyright Cosmetri © 2015. All rights reserved.

6. C osmetri - Getting Started Guide In the 'Actions' column, click on the icon pictured left to instantly convert the ingredient into a raw material which is then saved in your raw materials list. Click OK to open the new raw material or cancel to convert further ingredients. Certain ingredients such as perfume allergens and UV filters can be found in the separate lists and must be added from there. Some ingredients appear in more than one list, as well as in the main ingredients inventory – an example being Benzyl Alcohol (CAS 100-51-6). If you locate one of these ingredients in the main inventory, check the ‘Function’ column to see the different lists that the ingredient belongs to. It is important that you click on any available link if you know that you want to use the ingredient e.g. as a preservative and convert the ingredient to a raw material from the ‘Preservatives’ list and not from the main inventory. Copyright Cosmetri © 2015. All rights reserved.

7. C osmetri - Getting Started Guide 2. Multiple ingredient raw material Multiple ingredient raw material - go to 'Raw Materials / New'. In the 'Information' tab enter a 'Trade Name'. Click on 'Save' and then click on the 'Composition' tab. Certain ingredients can only be found under one of the following ingredients lists and must be added from there: For all other ingredients, add each ingredient by entering the INCI name or CAS number: Now enter the min. %w/w and max. %w/w values for the ingredient in your raw material. If you know the exact percentage enter the same value in both fields enter the same value in both fields. Copyright Cosmetri © 2015. All rights reserved.

8. C osmetri - Getting Started Guide Once you have entered the ingredient details click on ‘Add New’ to add a further ingredient. If you have more than one ingredient in your multi-ingredient raw material you’ll notice that the ‘Functions’ checkboxes appear, allowing you to specify any functions each of the ingredients perform in the raw material’s composition. Check the CoA or specification file for this data, or ask your supplier. Leave the checkboxes unchecked for now, if you cannot find this data. TIP TIPSome suppliers publish the % range of concentration for each ingredient in the raw material composition. It's always best to obtain exact percentages, but many suppliers are reluctant to provide this data. They do however Copyright Cosmetri © 2015. All rights reserved.

9. C osmetri - Getting Started Guide have a statutory obligation to provide a complete list of all ingredients and a min. % w/w and max %w/w for each. Always click 'Save' to complete this step and to save your raw material composition! Always click 'Save' to complete this step and to save your raw material composition! Step 2. Create a product Go to 'Products / New'. To begin with you only need to enter the following three items in the first tab: a. Title b. Product type c. Type of exposure To create a compliant PIF you'll eventually need to complete all fields in all tabs. Think of your product as a 'container' that holds certain data that apply to ALL of its formulas. Once you go into production status you should not change information at the product-level, so be sure that it is correct! TIP TIPIf you intend to add several products to Cosmetri, it can be helpful to create different product categories to help you organise these, for example according to clients, product type or brand lines. Click on 'edit categories' and create as many categories as you like. Then assign each product to the appropriate category. Click 'Save' to create your product. Click 'Save' to create your product. Copyright Cosmetri © 2015. All rights reserved.

10. C osmetri - Getting Started Guide Step 3. Create a formula You can create your first formula by clicking on the 'Add Formula' button, as shown in the view (see left). Or go to 'Products/List' and you will see your new product with the same 'Add Formula' button available. Formula version numbers are automatically assigned by Cosmetri in the sequence 1.01, 1.02, 1.03 etc. Think of formula versions as your different trials. It's good practice to keep your different versions and clone the current one before making further changes until you create a 'locked' production formula which will be used for generating your product's PIF. TIP TIPFrom within a formula (or if you are in the product view), you can switch easily between formula versions as follows: Click 'Save' to create your formula! Click 'Save' to create your formula! Copyright Cosmetri © 2015. All rights reserved.

11. C osmetri - Getting Started Guide Step 4. Build formula composition In step 1 you added all the single and any multi-ingredient raw materials you require in your formula and you have a first formula version which is associated with a product. Now the fun part! We're ready to create your formula composition. Go to the 'Formula/Composition' tab and you'll see two sub-tabs. Click on 'Raw materials': Click within the 'Trade Name' field to view an alphabetical list of all your raw materials, or type any string in the field to filter the list. Click on the raw material that you want to add to your composition. Select a 'Function' from the list. If the raw material is multi-ingredient, any functions for each ingredient that were set within the raw material composition will be pre-selected. Copyright Cosmetri © 2015. All rights reserved.

12. C osmetri - Getting Started Guide Next, add the %w/w amount for the raw material and click 'Add' to add the raw material. Repeat the above steps for each raw material and make sure that the total comes to exactly 100%. exactly 100%. make sure that the total comes to Don't forget to click on 'Save' to save your raw formula! Don't forget to click on 'Save' to save your raw formula! Step 5. Check for compliance (EU) Click on the 'Ingredients List’ tab. You'll see a complete list of ingredients used in your composition. If an ingredient is used in more than one raw material the total min. and max. %w/w for each ingredient in your formula is calculated. Copyright Cosmetri © 2015. All rights reserved.

13. C osmetri - Getting Started Guide Check in the 'Regulation' column for any warning symbols. In the following example the ingredient Diazolidinyl Urea which is currently at a concentration of 0.59% is regulated. Click on the warning triangle to view the regulations: In the 'Regulations' pop-up window we see that this ingredient is only allowed to a maximum concentration of 0.5%: To make the composition compliant, return to the 'Raw Materials List' view in the formula’s composition tab and adjust the %w/w concentration of any raw material that uses Diazolidinyl Urea. Adjust the formula composition so that it still totals 100%. Save your changes, then switch back to the 'Ingredients List' view to see if the concentration is now below 0.5%. Copyright Cosmetri © 2015. All rights reserved.

14. C osmetri - Getting Started Guide Repeat the above checks for any regulated ingredients until your composition is compliant. Step 6. Add data and documents Now that we've set up your formula and have a compliant composition we need to add in all those bits and pieces of missing information and documents - at raw material, formula and product levels. Cosmetri will guide you every step of the way! In the 'Formula' view go to the 'Open Tasks' tab and check this box: You'll then see a complete list of actions you need to take before your PIF will be complete. Don't panic if the list is long - you'll be able to complete most of the tasks in no time! In the 'Actions' column, click on the 'Edit' icon and you'll be taken to the page and tab where you need to perform the action: In many cases you'll find additional advice by clicking on a '?' for any field. In some cases you will need to ask your safety assessor or supplier for the information you need. Copyright Cosmetri © 2015. All rights reserved.

15. C osmetri - Getting Started Guide Click on the back button to return to the formula view and in the open tasks you'll see each time that the task list is updated as you work through the list. Step 7. Generate compliant PIF In the formula view, click on 'Set to Production Status' once you have a formula that you will use for manufacturing and which will be submitted to the CPNP. TIP TIPOnce set to production status you cannot reset the formula to draft status. If you are unsure, use the ‘Clone’ function to clone your formula before setting it to production status, thus ensuring that you have a copy of the formula still in ‘draft’ status. In the Formula view you’ll see a status bar which displays the % readiness for creating your PIF file. If there are still any tasks to complete, click on the bar or go to the 'Open Tasks' tab to view and edit them. Click on the 'PIF Export' button to generate the PIF. The Flight Checker dialogue box will warn you of any missing data. Copyright Cosmetri © 2015. All rights reserved.

16. C osmetri - Getting Started Guide Your PIF will be exported in .zip format. Save this to a destination on your hard-drive and then double-click this. Most operating systems can open a .zip file but in some cases you may need to download and install a free utility for this. Inside the .zip folder you will find a folder named after your product and formula version. You must copy/paste or drag and drop this to a destination of your choice before opening it. You'll also require a free PDF reader, such as Adobe Acrobat or Foxit to view the PDF files in your PIF. Inside the folder you will find the main PIF info file (with _INFO in the filename). The file with _COMP is a file detailing your formula's composition. If you decide to submit an exact percentage concentration formula to the CPNP you'll need this file. Example view of the PIF folder: Open the main _INFO.pdf file and you'll see a complete, detailed document describing all regulatory aspects of your cosmetic product. Where further data is referenced a link to the document is inserted. Clicking on any link will open the document. Just make sure that you don't move or rename any of the documents in the PIF folder! Once you've got the hand of creating products, building your formulas and creating a compliant PIF from your production formula, you'll be ready to use a range of powerful Copyright Cosmetri © 2015. All rights reserved.

17. C osmetri - Getting Started Guide features within the Cosmetri application to help you maintain compliance of your products over time and improve the workflow, creativity and profitability of your cosmetics business. Copyright Cosmetri © 2015. All rights reserved.