New SVHC Added to the ECHA’s Candidate List – what this means for you

A new SVHC (Substance of Very High Concern) has been added to the ECHA Candidate List of substances of very high concern for Authorisation:

If you are a ChemiusPro subscriber of our software Chemius (Pro Flex, Pro Bundle), this change has already been implemented in our database. When you publish a new version of the SDS containing this substance, the SVHC note will be added:

3.2 Mixtures

Subscribers to our Chemius Expert service already have this change implemented in their Safety Data Sheets.

This change however triggers immediate legal obligations under EU chemical legislation, which may affect your product portfolio, supply-chain and documentation.

Let me give a breakdown of the key requirements:

1. REACH requirements (substances, mixtures & articles)

When a substance is added to the Candidate List, the following apply for:

a) Substances on their own and in mixtures

• Suppliers of a substance on its own or in a mixture must provide a Safety Data Sheet (SDS) where required. In particular, when the substance is listed as an SVHC, Section 15 of the SDS should be updated to reflect that the substance is now on the Candidate List.
• If the substance is present in a mixture, even if the mixture is not classified as hazardous, the supplier must provide an SDS on request if the individual concentration of the substance in the mixture is ≥ 0.1 % w/w (for non-gaseous mixtures and ≥ 0.2% by volume for gaseous mixtures where that substance poses human health or environmental hazards.
  b) Articles (objects, components) containing the SVHC

• Suppliers of articles placed on the EU/EEA market must inform their customers when an article contains a Candidate List substance above 0.1 % w/w. They must provide sufficient information (e.g., substance name, safe-use instructions) to allow safe use of the article.
• Upon request by a consumer, suppliers must provide the same information within 45 days.
• Notification to ECHA: Producers or importers of articles containing the Candidate List substance above the 0.1 % w/w threshold and in quantities above 1 tonne per year must notify ECHA. This must be done within six months of the substance’s inclusion on the Candidate List.
  
  c) Risk management and safe-use

• For substances meeting PBT / vPvB / equivalent concern criteria, manufacturers and importers must use the information from the Chemical Safety Report (CSR) and apply risk-management measures. Downstream users must identify and apply appropriate measures to control risks.

2. SCIP database requirements

In addition to REACH obligations, the correct submission to the SCIP database is required when articles contain a Candidate List substance above the threshold. Here are the main points:

• The SCIP database (Substances of Concern In articles as such or in complex objects (Products)) is maintained by ECHA under the Waste Framework Directive.
• Suppliers of articles which contain a Candidate List substance at > 0.1 % w/w and are placing those articles on the EU market must submit a notification to the SCIP database.

What we recommend you do now

1. Inventory review: Identify all substances, mixtures and articles in your portfolio. Check whether the new SVHC is present (on its own, in a mixture, or in an article) and at what concentration.
2. Engage your suppliers: Ask upstream suppliers for composition declarations (e.g., SDS, material declarations) to verify whether the SVHC appears and at what level.
3. Update SDSs & documentation: If the substance is present in a substance or mixture you supply, update the SDS, especially Section 15, and ensure compliance with Annex II of REACH.
4. Article obligations: For any articles you supply or place on the market, check whether the SVHC is present > 0.1 % w/w. If yes:
   • Provide information to your customers/recipients about the safe use and disposal.
   • Determine whether you must notify ECHA (and/or via SCIP) and prepare the submission.
5. Consider substitution / risk minimisation: Because SVHC listing signals future regulatory action (e.g., possible inclusion in Annex XIV for authorisation), consider alternatives or reduce the use of the substance.
6. Monitor deadlines: Check the date the substance was added to the Candidate List and ensure you meet notification deadlines (e.g., six months for article notifications under REACH, immediate obligations for communication).

I hope this was helpful to you. If you need further assistance you can write to us at info@bens-consulting.eu.