Candidate List of substances of very high concern

Candidate List of substances of very high concern
Name	Candidate List of substances of very high concern
Jurisdiction	European Union
Legislation	REACH
Administered by	European Chemicals Agency
Established	2008

Candidate List of substances of very high concern is a regulatory inventory maintained under REACH by the European Chemicals Agency that compiles chemical substances considered for eventual restriction or authorisation across the European Union. It functions as an interim policy instrument connecting scientific assessment by bodies such as the European Food Safety Authority and enforcement by national authorities including France and Germany, while informing industry stakeholders such as BASF, Bayer AG, and Dow Chemical Company. The List interacts with international frameworks like the Stockholm Convention, the Rotterdam Convention, and institutions such as the Organisation for Economic Co-operation and Development.

Overview

The List originates from provisions in Regulation (EC) No 1907/2006 and is operated by the European Chemicals Agency in dialogue with the European Commission, European Parliament, and member states like Sweden and Italy. It serves as a precursor to entries on the REACH Authorisation List and the REACH Restriction List, aligning with global instruments such as the United Nations Environment Programme initiatives and the World Health Organization chemical safety guidance. Major stakeholders include corporate actors such as Ineos, Solvay, and AkzoNobel, trade associations like CEFIC, and advocacy organisations including Greenpeace and Friends of the Earth.

Criteria and Identification Process

Identification follows hazard-based criteria defined in Annex XIII of REACH and considers classifications under the CLP Regulation with endpoints such as carcinogenicity, mutagenicity, reproductive toxicity (CMR), and persistent, bioaccumulative and toxic (PBT) properties. Scientific dossiers are prepared by member states like Denmark or third parties such as ChemicalWatch contributors and evaluated by committees such as the Committee for Risk Assessment and the Committee for Socio-economic Analysis. The process integrates data from registrants such as DuPont and laboratories certified by organisations like OECD and may use monitoring data from agencies including ECHA and European Environment Agency.

Regulatory Implications and Obligations

Inclusion triggers information and notification duties under REACH for suppliers, downstream users, and importers such as Samsung Electronics, Apple Inc., and small and medium enterprises operating in Poland and Spain. Suppliers must provide Safety Data Sheets and communicate uses to the European Chemicals Agency, while import/export considerations invoke interfaces with the World Trade Organization rules and customs authorities of states like Netherlands and Belgium. The List informs permitting by national regulators such as Environment Agency (England) and enforcement actions coordinated with bodies like Europol in cases of illicit trade.

Impact on Industry and Trade

Placement on the List influences substitution programs at firms including Siemens, Thales Group, and Rolls-Royce Holdings and shapes supply chain management for retailers such as IKEA and H&M. Market effects ripple through sectors—automotive manufacturers like Volkswagen and Toyota adjust formulations, while chemical producers in regions such as Nordrhein-Westfalen and Rhône-Alpes reassess production. Trade patterns with partners such as China and United States are affected via import controls and voluntary industry commitments from consortiums like Zero Discharge of Hazardous Chemicals and corporate responsibility initiatives linked to ISO standards and the United Nations Global Compact.

List Composition and Notable Substances

The List comprises a broad range of organic and inorganic substances identified by registrants including multinational corporations and small producers; notable examples (without linking the List title) include chemicals historically discussed in regulatory contexts such as phthalates cited in RoHS debates, per- and polyfluoroalkyl substances considered in investigations by European Parliament committees, and legacy substances addressed by the Stockholm Convention. Substances often invoked in case studies involve actors like 3M, Monsanto, and research cited by institutions such as European Chemicals Agency scientific committees and national research institutes including German Environment Agency.

Updates, Review and Deregistration Procedures

The European Chemicals Agency periodically updates the List following submissions from member states like Finland and review by committees including the Scientific Committee on Health, Environmental and Emerging Risks. Stakeholders such as industry consortia and NGOs may request reconsideration; dossier holders can submit new evidence following procedures under REACH and engage with the European Commission appeals mechanisms and administrative review processes analogous to those used by agencies like European Medicines Agency. Delisting or deregistration may occur when scientific evidence—originating from laboratories accredited by bodies such as ISO/IEC or peer-reviewed studies in journals associated with European Research Council grants—demonstrates that criteria no longer apply.

Category:European Union chemical regulation Category:European Chemicals Agency