Substances of Very High Concern (SVHC) under REACH

Substances of Very High Concern (SVHC) are chemical substances identified under the European Union's REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) regulation. These substances are recognized for their potential serious impacts on human health and the environment. The identification, classification, and management of SVHCs aim to enhance chemical safety and minimize harmful effects.

Characteristics of SVHCs

A substance can be identified as an SVHC and included in the Candidate List if it meets one or more of the following criteria outlined in Article 57 of REACH:

1. Carcinogenic: Classified as Category 1A or 1B.
2. Mutagenic: Classified as Germ cell mutagenicity Category 1A or 1B.
3. Toxic for Reproduction: Classified as Category 1A or 1B.
4. Persistent, Bioaccumulative, and Toxic (PBT): Meets the criteria defined in Annex XIII of REACH.
5. Very Persistent and Very Bioaccumulative (vPvB): Meets the criteria defined in Annex XIII of REACH.
6. Equivalent Level of Concern: Substances for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern (e.g., endocrine disruptors, respiratory sensitizers).

Management of SVHCs: The Authorisation Process

1. Identification & Candidate List: Member States or ECHA can propose a substance as an SVHC. Following a consultation process, if identified, the substance is added to the Candidate List.
2. Communication Obligations: Once a substance is on the Candidate List, specific legal obligations apply to suppliers of articles containing it above a concentration of 0.1% w/w (e.g., duty to communicate information down the supply chain and to consumers upon request, notification to ECHA's SCIP database).
3. Prioritisation & Authorisation List (Annex XIV): Substances from the Candidate List may be prioritized for inclusion in the Authorisation List (Annex XIV of REACH).
4. Authorisation Requirement: Once a substance is on the Authorisation List, its use and placement on the market after a specific "sunset date" are prohibited unless an authorisation is granted for specific uses. This process aims to progressively replace SVHCs with safer alternatives where technically and economically feasible.

Impact of SVHCs

• For Companies: Producers and importers of articles containing SVHCs above 0.1% w/w have legal obligations to communicate this information. Companies wishing to continue using substances listed on the Authorisation List after the sunset date must apply for authorisation.
• For Consumers: Consumers have the right to ask suppliers if products contain SVHCs above 0.1% w/w and must receive this information within 45 days, free of charge. This empowers informed purchasing decisions.
• For the Environment: Identifying and controlling SVHCs helps reduce their release into the environment, protecting ecosystems and promoting sustainability.

Examples of SVHCs

The Candidate List contains numerous substances. Some well-known examples include:

• Bisphenol A (BPA): Identified primarily for its endocrine-disrupting properties and reproductive toxicity.
• Certain Phthalates (e.g., DEHP, DBP): Identified mainly for their reproductive toxicity.
• Lead and its Compounds: Identified for reproductive toxicity and other hazards.
• Certain Per- and Polyfluoroalkyl Substances (PFAS): Identified for PBT/vPvB properties or equivalent concern.
• Chromium VI Compounds: Identified primarily for their carcinogenicity.

SVHCs and the associated regulatory processes play a critical role in advancing chemical safety and environmental sustainability within the EU. For the official and most up-to-date information, including the full Candidate List and Authorisation List, visit the **European Chemicals Agency ECHA official website.