REACH (Registration, Evaluation, Authorization and Restriction of Chemicals, EC 1907/2006) is the European Union’s chemical regulation that requires that chemical substances on their own, in preparations and all intentionally released substances from articles must be registered with the European Chemicals Agency (ECHA).
The regulation applies to substances manufactured in, or imported to the EU in annual quantities of 1 ton or more. According to the REACH requirements on Substances of Very High Concern (SVHC) a supplier of manufactured and imported articles shall provide customers with information on SVHC if they are present above a concentration limit of 0.1 % on an article level. SVHC will be defined through the list of candidate substances for authorization that is produced by the European Chemicals Agency.
Making an EU REACH SVHC Declaration in the Supplier Portal
Once you receive the relevant campaign email, you can make the declaration:
- Before you begin, prepare the information you will need to complete your declaration:
From this window, you can download your Product List and Substance List for reference. These files download in Excel format.
- On the main page, review the regulation details and the available regulation Resources:
- Select the desired REACH Query List from the Version drop-down menu:
The most recent RQL is available by default.
- Use the checkboxes to select your products and click Declare:
You can declare for individual products or select in bulk. To display more products, open the drop-down menu on the bottom right of the table and select the desired number of products to display (20, 40, 50, or 500):
To declare for all products, do not use the checkboxes, and click Declare for ALL (x).
- On the next page, review the Product Details section:
- If you have an IPC-1752A XML file to speed up the declaration process, click Upload File:
Uploading a valid IPC-1752A XML will populate the corresponding sections below with the data contained in the XML. To continue declaring manually, skip to step 10.
- Using the File Explorer, browse your organization's resources, attach the XML file, and click Open.
- To continue declaring manually, click Next to expand the Product Statements section.
- Select a declaration statement for your products and click Next:
- In the Supporting Documents section, click Upload:
- Using the File Explorer, browse your organization's resources, attach the desired file, and click Open.
- Select a file type for the uploaded file from the drop-down list:
To remove a document, click the “x”. You can upload multiple pieces of supporting documentation:
- When you have uploaded your supporting documentation, click Next.
- In the Substances section, click Add Substance:
- Enter the substance’s CAS or EC number to populate the desired search result:
- Check the box if the substance is Contained in product:
In Product: This substance is contained in the composition of the product in its final state (i.e. completed all manufacturing stages and ready for delivery/sale)
- Enter the Nominal Concentration of the substance.
Nominal Concentration is the value of mass when a single estimate value is provided.
- Select the Substance Status from the drop-down list:
- Enter where in the product the substance is found:
Describe the Sub-Product or Material in the Product where the Substance is found.
- Enter the total weight of the substance in the product.
The total weight of a substance in a product is the sum total of every instance of a substance occurring within a Product. The sum total must account for sub-product occurrences within a Product and must assume the maximum concentration reported for a substance when a min/max range has been identified.
- Select the Unit of Measure from the drop-down list:
Grams, Kilograms, Milligrams, Parts per Million (PPM), or Mass Percentage (%).
- To finish adding the substance, click Save.
- Repeat this process for every substance you need to manually declare and click Next:
- In the Review section, the system will notify you if you are ready to submit your declaration:
If your customer has requested it, you may need to provide a Comment in this section.
- Click Submit to finish and return to the main page.
- If necessary, repeat the declaration process for any remaining parts and click Done to submit your declaration(s).
- On the Declaration Summary page, you can review the details and click Continue to finish:
Making a Legacy REACH SVHC Declaration in the Supplier Portal
REACH (Registration, Evaluation, Authorization and Restriction of Chemicals, EC 1907/2007) is a European Union chemical regulation that applies both to individual chemical substances and substances contained within objects (termed “articles” under the Regulation). The Regulation affects the use and sale of a vast array of goods, including industrial goods, cleaning products, clothing, furniture, and appliances.
All companies manufacturing or importing chemical substances into the European Economic Area (EEA) in quantities greater than one ton per year are required to register these chemicals with the European Chemicals Agency (ECHA) in Helsinki, Finland. In doing so, they must be able to prove to the ECHA the chemical can be used safely.
The REACH Regulation requires any supplier of articles containing Substances of Very High Concern (SVHCs) to provide the recipient of the article with the necessary safety information about that article when (1) the substance is included on the Candidate List and (2) when the substance is present in articles produced and/or imported above the threshold concentration of 0.1 percent weight by weight. This information should be given to the recipient of the article when it is supplied for the first time after being added to the Candidate List.
The REACH candidate list can be found here.
Once you receive the relevant campaign email, you can make the declaration:
- Review the REACH SVHC update ruling and click Ok:
- You will see the REACH SVHC regulation details:
Under the Resources sidebar, click:
Create IPC-1752A XMLto open the FMDComplete tool in a new browser window, allowing you to build a Class A, Class C, or Class D IPC-1752A declaration, which generates in XML format
View Substance List to initiate the download of an Excel file containing REACH SVHC list
Acceptance Criteria to download a PDF with guidance on creating an acceptable REACH SVHC declaration
- If necessary, select the REACH Query List related to your declaration from the drop-down menu:
- From the part list displayed, either:
Use the check-boxes to select individual Parts and click Declare # Selected Parts:
Click the Declare for # Parts button to declare for all visible Parts:
- On the Select Declaration window, choose whether the part(s) Does Not Contain SVHC(s) Over 0.1% w/w or Contains SVHCs Over 0.1% w/w:
For parts that Contains SVHCs Over 0.1% w/w, the Edit Substances window will open to allow users to enter one or more substances that are included in the part:
To enter a substance:
a) Click the Substance field and begin typing a Substance Name or CAS Number to search
b) Click the Substance in the drop-down list to select it
c) Enter a Concentration (%) for the selected substance
d) Enter where in the Product the Substance is located using the Contained In field
e) Click the [+] button to add the substance to the part
If you click Does Not Contain SVHC(s) Over 0.1% w/w, you skip over the Edit Substances window straight to the Upload Supporting Documentation window.
Once you have added all your substances, click Next to proceed to the Upload Supporting Documentation window.
- Choose the type of supporting documentation you are uploading:
- Use the calendar to choose the date this supporting documentation was created.
- Click Attach File to open the File Explorer and click Open to upload the document.
You can upload multiple files using this window.
When you have finished uploading your supporting documentation, click OK.
- Upon returning to the part list, complete the declaration process for any remaining parts:
- Click Continue to proceed to the next module(s).
- Once all declarations are complete, click Continue to proceed to the Feedback page.
For additional information on REACH SVHCs, download a copy of Assent's REACH in 2020 & Beyond Guide.