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Transcript of the Video - REACH - How to Register Complex Products
Let's say you have a REACH substance. You find out that there are some SVHCs or at least one in your product. What do you have to do for a complex product?
Well, you have to inform your customers that you do have this substance in their products. So, other substances in articles or complex objects must be declared via a database, which is a SCIP database. it's called the SCIP database. It's managed by the European Chemicals Agency and it covers most of the complex products. You see here some examples:
- a PCB assembly would be on the SCIP database.
- a plane.
- a car.
- A satellite, so it doesn't matter if it's a consumer or a professional B2B type of product you will need to report it.
If it's just a part of a simple item that is not finished, you will still need to report it on the SCIP database. If you don't declare anything on the SCIP database, you are saying that you don't have any SVHCs above the declarable limit, which is possible. But if it's not the case and the European Union finds out that it's not the case, well in that case your product could be withdrawn from the market. You may have to fix the situation before being able to reintroduce it into the European market.
The SCIP Database
Here is a tutorial, step by step, on how to prepare a product dossier on the SCIP database. We will do it from scratch, step by step.
If you google SCIP or REACH SCIP, you will eventually find this website: the www.echa.europa.eu/scip. Then you will see the first page where you could access the cloud services. That's where you need to click to declare your product and the SVHCs in your product.
Click on Access Cloud Services. Then, you will need to register. They will ask you for details about your company, credentials about your company, pretty much.
The IUCLID Registration of your Organization
If you have already registered with the ECHA cloud services or other tools then you would just need to log in then when you log in you will access this page and here you would click on ECHA cloud services that's where you will be able to do your SCIP notifications, then you will access this page and then you would click on ‘Subscribe’ on the first option you would access this page and you would close that if we tell you that you are welcome and what they call the IUCLID which is the cloud services managed by the ECHA.
Enter a Complex Article into the SCIP Database
Once you close it, then you would click on ‘articles’. You don't manufacture substances or mixtures. It applies to articles, including complex articles. Here you see a very simple screw but if your products are more complex, that’s in the same place that you need to click. Then you would be on this page so you would add a new article. If you have already added articles, they will be listed here. But if it is the first time that you are doing it, then you would just need to click on the plus. On the top, it says 'new article'. You can click there, as well. Same thing. Then you would access this and here you would create a new article. You would enter its name. So here, we entered a fictitious medical device FMD 100. You would enter the device name and then you would enter its identifier type. There, you have different options: European ones and other types of options to identify your article. All of these fields are mandatory. You need to give a unique identification of your product. Here and then, you would create your article, then it will tell you that the article has been created successfully. Then you would click on ‘open”. You'll access this page and you will be able to make your declarations on your product. So you see here, it says ‘fictitious medical device FMD-100’ so your product is registered. You can see the name of the product.
Now, what you need to do is click on ‘please search’ and select to select the article category, so you will have many options. You would need to type either ‘you already have the product code’ or you would type a description of the product and find the right code. In that case, it's a magnetic resonance imaging device. We found it and we get this description. You would select it. Once you find the best fit for your product, the best description, then you would click on ‘production’ in the European Union and it will ask you whether it's imported in the European Union or produced here in the European Union. In that case, this product is produced overseas but imported in the European Union.
Create a Part of your Complex Article
Then you would need to click on ‘new item’ if you want to declare an SVHC that is found in a part within your product. You have the whole product, the whole medical device in this example. You won't declare all the components in your product. All the components in your parts list. No. Only the components that do contain at least one substance of very high concern, i.e. one SVHC. In that case, you would need to click on ‘new item’. Then you would click on ‘article’, and you would select the article so you will create, i.e. an article within your product. Here it says not found, because you don't have any other articles already created for your product. You need to create a new article or new component, if you will, in your product.
And you have a list of questions about this article. Some are mandatory, others are optional. So, you need to click on the article name field, which is mandatory. Then you would enter the name and you could enter the name of the product, its identifier just as you did with your medical device.
Then you would enter whether it's imported or produced in the European Union. Since the whole assembly is imported in the European Union, everything that is inside is also imported in the European Union.
Register SVHCs into the SCIP Database
Then you would enter the SVHC that is in this article you would enter it in the category called ‘concern
Elements’. You would add new and enter the CAS number or the name of the SVHC, then the concentration rate range. If you don't know the concentration, you just know it's above the threshold, then you would report between 0.1 to 100 %. That's by default what you would declare. So here, this substance is the Tetra-EGDME which is used in the lithium-ion battery inside of my medical device. Then you would click on ‘save’ and you have created your component with the SVHC. So, you would click on ‘save’ again. You can see you have your product listed with a lithium-ion battery and inside of the lithium-ion battery, the SVHC. You could also declare multiple SVHC.
There may be several SVHCs in one same component. Then you would click on ‘save’ when it's done.
Validate the Data in IUCLID
Now you need to validate the data, before submitting it officially on the IUCLID. So, you need to click on ‘new working context’. Then in your working context, you will see this little window that would pop up. You would select that it's about SCIP notification and click on ‘apply’. Then you will see this page and you will click on ‘validate’. It's going to validate your data. If there is no issue, that's what you will see: ‘no business rule failures’ etc. If there is an issue, it will be declared here as well.
Create a REACH Article Dossier and Submit it
You have validated your dossier and then you need to create it before submitting it. So, you would click on ‘create dossier’, then your dossier is created. When you submit a dossier then a submission number will be given to you. You will receive a submission report with a SCIP alphanumerical number, that you can share with your customers or third parties.
Then you can proceed to the submission of your dossier. You can also view your dossiers by clicking here.
That's the idea of how to declare as SVHC in a complex product.
TOP TIPS for a successful SCIP Notification of Complex Articles
The ECHA has published different tips in a document called ‘Key tips for successful SCIP notifications’, and I found a couple of tips particularly helpful to improve your data submission.
TIP# 1: Grouping
The first one that we found very helpful is grouping. You group identical or quasi-identical articles. So, let's say you have different models for the same type of product. You don't have to make multiple declarations, especially if they have the same SVHCs, same substances, pretty much the same declaration, just different types, different features in your products. You can group or even if you are talking about the same type of components that have the same SVHCs, same supplier, it's just a component family. Then you could also group. So that's very convenient, very useful and it will save you a lot of energy and time, by grouping as much as possible.
TIP# 2: Referencing with SCIP numbers
Another tip that we found particularly interesting is to reference. You use referencing in complex dossiers. What does it mean? It means that you need to request SCIP numbers from your suppliers. So, let's say you ask your suppliers whether or not a specific product contains substances of very high concern, you would also ask them if they are if they have already registered via the SCIP database and if they have their SCIP numbers so that you could enter the number when you do your declaration. You would benefit from the applicable information your suppliers have already entered in the SCIP database so that you save a lot of time, avoid mistakes, etc. It's very convenient and very useful if your suppliers have done the notifications.
TIP# 3: Lowest Number of Layers of Components
Tip 3 is only the lowest number of layers of components applied. So, let's say you have subassemblies between the finished product and the component that contains the SVHC. You don't have to declare all the different subassemblies. We don't want to know that. That's not the intent of the SCIP notifications. The SCIP database wants to know whether there is an SVHC and where it is in your design, not necessarily knowing what the different layers of sub-assemblies in your product are. So, you don't have to do that. You can jump directly from the last level of your assembly if you will. You typically have your product name and the last level with the SVHC.