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Substances of Very High Concern (SVHCs) are a group of chemical substances regulated under the European Union’s REACH regulatory framework.
Their classification means that they pose a serious risk to human health or the environment, which is why the European Chemicals Agency (ECHA) subjects them to strict control and monitoring.
Classification criteria for SVHCs
For a substance to be included on the Candidate List of SVHCs, it must meet at least one of the criteria set out in Article 57 of the REACH Regulation:
- CMR (Carcinogenic, Mutagenic or Toxic to Reproduction): Categories 1A or 1B.
- PBT (Persistent, Bioaccumulative and Toxic): Substances that persist in the environment and accumulate in living organisms.
- vPvB (Very Persistent and Very Bioaccumulative): Substances with a high degree of persistence and the capacity for biological concentration.
- Equivalent level of concern: Substances which, whilst not strictly meeting the above criteria, cause an impact of similar severity (for example, endocrine disruptors).
You can consult the complete and up-to-date list of these substances in the official table published by the ECHA (European Chemicals Agency).
Authorisation process for SVHC substances
The regulatory cycle for an SVHC substance within the European Union consists of three main stages:
- Inclusion on the Candidate List: Formal identification by ECHA or the Member States.
- Prioritisation: Technical assessment to determine its inclusion on the Authorisation List (Annex XIV of REACH).
- Authorisation: Once the sunset date (limit date) has passed, the substance may not be placed on the market or used in the EU unless the company obtains a specific authorisation demonstrating safe risk management or the lack of viable alternatives on the market.
Legal obligations for companies
The handling or presence of SVHC substances entails compliance with immediate requirements within the supply chain:
| Requirement | Threshold / Condition | Legal Obligation |
|---|---|---|
| Safety Data Sheet (SDS) | Present in substance or mixture | Provide an up-to-date SDS to professional customers. |
| Supply chain notification | Conc. > 0,1% w/w in articles | Let the client know about the presence of SVHC and the measures for safe use. |
| Consumer notification | Conc. > 0,1% w/w in articles | Provide enought information within a maximun of 45 days of the request. |
| Notification to ECHA | Conc. > 0,1% w/w y > 1 metric tonne/year | Notify ECHA in accordance with Article 7(2) of the REACH Regulation. |
| SCIP database | Article placed on the market in the EU containing SVHCs > 0,1% w/w | Register the article’s details in ECHA’s SCIP database. |
Mitigation strategies and regulatory compliance
To minimise the operational, commercial and legal impact of SVHCs, it is recommended that the following management actions be implemented:
- Composition audit: Analyse the presence of SVHCs in raw materials and end products through analytical testing and supplier declarations.
- Substitution of substances: Research and develop safer chemical or technical alternatives to anticipate future restrictions.
- Regulatory monitoring: Periodically review the biannual updates that ECHA publishes on the Candidate List.
Conclusion
Proper management of SVHC substances is not only a legal obligation to avoid penalties and disruptions to marketing within the European Union, but also a key strategy for ensuring the sustainability and safety of your product range. The constantly evolving ECHA lists require active regulatory monitoring and rigorous control over the supply chain.
At Kaeltia, as a consultancy specialising in Regulatory Affairs, we help you navigate the complex framework of the REACH Regulation. Our technical team will advise you on identifying SVHC substances, updating Safety Data Sheets (SDSs), submitting notifications to the SCIP database and developing substitution plans for hazardous substances.
Do you want to ensure that your products and articles comply with current European regulations?
Get in touch with Kaeltia’s team of experts
