TRANSCRIPT OF THE VIDEO - REACH - SCIP NOTIFICATION - HOW TO REGISTER COMPLEX PRODUCTS

Let’s say you have a product under REACH and you discover it contains one or more SVHCs. What do you need to do for a complex product? You may need to submit a SCIP notification for those SVHCs.

What is the REACH SCIP Database?

SCIP stands for Substances of Concern In Products. The official long name is Substances of Concern In articles, as such, or in complex objects (products).

The SCIP database declaration:

enables greater transparency on the presence of SVHCs above the 0.1% w/w threshold in products;
influences purchasing choices; and
enhances waste reduction, treatment, and recycling throughout the product life cycle—supporting the circular economy.

These objectives align with the EU Waste Framework Directive (WFD) and the EU action plan for a circular economy.

When you May Need to Declare and What it Covers?

In practice, when SVHCs are present above the declarable threshold, you must inform your customers—and for articles or complex objects, you may also need to submit a declaration through the SCIP database, managed by the European Chemicals Agency (ECHA). SCIP can apply to most complex products, whether consumer or professional/B2B.

For example, the following types of products can fall under SCIP:

a PCB assembly,
an aircraft,
a car,
a satellite.

Even if you are placing a component or a “simple” item on the EU market (not only a finished product), you may still have SCIP obligations depending on your role in the supply chain and whether SVHCs are present above the threshold.

If you do not submit anything to SCIP, you are effectively stating that your products do not contain SVHCs above the declarable limit—which can be true. However, if SVHCs above the threshold are later identified, the product may be subject to enforcement actions (for example, corrective measures or market withdrawal) until the compliance situation is resolved.

Why does the REACH SCIP Notification Matters?

Depending on your supply chain, the SCIP declarations apply to importers, assemblers, distributors, or manufacturers of articles. If you are a manufacturer offering your products to the European market, chances are that you are directly impacted by the SCIP reporting.

In essence, if after January 5th, 2021:

You don’t declare anything on the SCIP database, then you are stating that your products don’t contain any SVHCs above the threshold.

You find out SVHCs listed in the Candidate list in your products above the 0.1% threshold, then you must declare these SVHCs on the SCIP database accordingly.

The SCIP Notification 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 EU 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 Notification Database

Close that window, then click “Articles.” This module is for articles/products (including complex products), not substances or mixtures.

On the Articles page:

If it’s your first time, click the + to add a new article.
If you already created articles before, they’ll be listed here.
You can also click “New article” at the top (same result).

To create the article:

Enter the product name (example: FMD-100).
Choose the identifier type (European options and other types are available).
Fill in all mandatory fields and make sure the identifier is unique.
Click Create. You’ll see a message confirming it was created successfully.

Then:

Click “Open.”
You’ll reach the product page where you can make your declarations.
You should now see your product name (e.g., FMD-100), confirming it’s registered.

Next Steps to Complete SCIP Notification Database

Now click “Please search” to choose the article category. You’ll see many options.

To find the right code:

Type the product code (if you have it), or
Type a short product description, then select the best match.

In this example, you search for a magnetic resonance imaging device, find the correct description, and select it.

After you choose the best category for your product:

Click “Production” in the European Union.
Answer whether you import the product into the EU or produce it in the EU.

Here, the product is manufactured overseas and imported into the European Union.

Create a Part of your Complex Article

Click “New item” when you want to declare an SVHC found in a part/component within your product.

You start with the full product (the full medical device in this example). You do not declare every component in your parts list—only the components that contain at least one SVHC.

To add an SVHC-containing component:

Click “New item.”
Click “Article.”
Select the article you want to include (the component inside your product).

If the system shows “Not found,” you haven’t created any component articles yet. In that case, create a new article/component for the part you want to declare.

The system then displays a list of fields for that component—some mandatory, others optional.

Click the mandatory Article name field.
Enter the component name.
Add the identifier (as you did for the main 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 Notification 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 the 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 SVHC in a complex product.

TOP TIPS for a successful SCIP Notification of Complex Articles

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 notification 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 notification 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 notification. 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.

Useful SCIP Compliance Tools

A SCIP database is available online. You need to create an account to access ECHA Cloud Services, including the SCIP database.

ECHA also offers insightful REACH support and workshops on SCIP, including guidance on how to prepare and submit a SCIP notification dossier.

You can use the free Enviropass Product Environmental Compliance (EPEC) form, REACH tab, to gather the necessary REACH information per component.

The IPC Association Connecting Electronics Industries has also created the standard IPC-1752B to enhance REACH reporting.

SCIP Notification FAQ

Where do I start to create a SCIP notification (what platform do I use)?

You start on the SCIP page on ECHA’s website, then go to ECHA Cloud Services and use IUCLID to prepare and submit your SCIP dossier. You’ll need to register/log in and subscribe to the relevant cloud service before you can work in IUCLID.

In IUCLID, why do I click “Articles” instead of “Substances” or “Mixtures”?

Because SCIP is about articles/complex objects, not manufacturing or registering substances/mixtures. Your product (and any SVHC-containing parts) must be created and managed under Articles.

Do I need to declare every component of my BOM for a complex product?

No. The tutorial explains you typically create “items” (parts/articles inside the complex object) only for components that contain at least one SVHC above the threshold—rather than declaring every single component in the parts list.

How do I add an SVHC to a specific part, and what concentration range should I report if I don’t know the exact %?

In the SVHC-containing item, you add the substance under “Concern elements” by entering the SVHC name or CAS number and a concentration range. If you only know it is above the threshold, the tutorial indicates reporting a default range of 0.1–100%.