SVHC 247 Substances of Very High Concern

SVHC Candidate List, European Chemicals Agency (ECHA) This is a list of chemicals considered by the European Union to be carcinogenic, mutagenic, toxic for reproduction, persistent, bioaccumulative or of equivalent concern (e.g. endocrine disruptors). SVHC 247 refers to the candidate list of substances of very high concern (SVHC) under the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation EC No 1907/2006, a regulation that establishes the European Union's new chemicals policy and brings together many existing chemical regulations in the European Union. This list currently contains 247 substances, including individual chemicals and related groups of compounds. The inclusion of new substances on the candidate list is the result of a consultation process.

In January 2025, ECHA officially added five new substances, bringing the total to 247. Substances on the candidate list must be reported by suppliers if they are present in products at more than 0,1 weight percent. Importers or manufacturers must report substances to the European Chemicals Agency (ECHA) if they contain at least 1 tonne per year and at least 0,1 percent SVHCs. Listing may ultimately trigger authorization or restrictions, meaning their use may be banned unless specifically authorized.

SVHC 247, in short, is the candidate list under REACH and currently contains 247 substances of high concern. These substances are closely monitored by industry because they impact supply chain compliance, regulatory reporting, and could lead to future use bans or restrictions.

SVHCs (substances of very high concern) are chemicals that may have serious effects on human health or the environment. They are defined by the following criteria:

• carcinogenicity
• Mutagenicity
• Reproductive toxicity (CMR)
• Persistence, bioaccumulation and toxicity (PBT)
• Very persistent and very bioaccumulative (vPvB)
• Substances of equivalent concern (e.g., endocrine disruptors)

SVHC 247 represents the total number of entries (not necessarily unique substances) on the candidate list as of the last update. New substances are added because of their hazardous properties and widespread use.

The regulatory effects are as follows:

• For manufacturers and importers: If SVHCs are present in products at levels of 0,1% by weight or more, this must be reported to downstream users and consumers. If present in quantities exceeding 1 tonne per year, companies must notify ECHA.
• For product compliance: Inclusion on the candidate list may trigger product recalls, supply chain reassessments, and consumer concerns. These substances may be moved to the authorization list, and companies may be required to obtain authorization to continue using them.

The SVHS 247 candidate list plays a critical role in promoting and is therefore considered important:

• Safe substitution of hazardous materials
• Greater transparency in material content
• Improved consumer safety
• Environmental protection

SVHC listing also encourages innovation, pushing industries to develop safer alternatives.

Ultimately, the expansion of the SVHC 247 list highlights the European Union's rigorous regulatory approach to chemical safety. Companies handling chemicals or finished products within the European Union should closely monitor candidate list updates to remain compliant and proactively manage risks. As chemical regulations evolve, understanding and responding to SVHC definitions is more important than ever.

Essentially, the SVHC 247 compliance checklist includes:

• Identification and tracking:
  • Stay up to date with the latest ECHA candidate list (currently SVHC 247).
  • All raw materials, ingredients and finished products must be cross-checked against the SVHC list.
  • All new additions should be followed.
• Threshold and usage assessment: Assess whether any of the following SVHCs are present at or above 0,1 percent w/w:
  • Articles.
  • Mixtures.
  • Items (complex objects).

If there is an excess, it must be determined whether the annual volume per item per producer / importer is at least 100 tons or more.

For each available SVHC, the following should be considered:

• Intended use.
• Exposure potential.
• Safer alternatives available.

• Customers and downstream users must be notified when an SVHC is at least 0,1 percent.
• Where appropriate, safety data sheets (SDS) and safe usage information should be provided.
• Consumer inquiries regarding SVHCs in products must be responded to within 45 days.

• ECHA must be notified via the substances of concern (SCIP) database in products in the following cases:
  • SVHC in the substance at least 0,1 percent w/w.
  • At least 1 tonne/year produced or imported into the European Union.
• Ensure that the substances of concern (SCIP) file in products is updated with each SVHC list update.

• The potential for substitution of SVHCs with safer alternatives should be evaluated.
• Action plans should be prepared if listed SVHCs are to be considered for authorization.
• Internal audits of important declarations from suppliers should be carried out.

• Up-to-date SVHC inventories and compliance reports must be maintained.
• Supplier declarations, test reports and communications should be archived.
• Technical documentation should be kept available for audits or inspections.

• SVHC potentially moved to the authorization list (Annex XIV) and restrictions list (Annex XVII) should be monitored.
• Early interaction with suppliers regarding material substitution should be established.

In summary, SVHC 247 is important in the following respects:

• Health and environment: Reduces exposure to hazardous chemicals.
• Legal compliance: Triggers strict REACH obligations.
• Stimulating innovation: Encouraging safer chemical substitution.
• Global trade compliance: Affects product access to the European Union market.
• Future regulatory forecast: Indicates the potential for bans or authorization requirements.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services to businesses within the scope of the "SVHC 247 Substances of Very High Concern" list.