Originally enacted in December 2006, the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) is a safety regulation that was implemented by the European Union (EU) to manage the use of chemical substances in products manufactured, sold, and imported within the European Union (EU). The environmental framework entered into force on June 1, 2007. In the years since, REACH has undergone various updates, amendments, and other changes, including annual expansions to its Substances of Very High Concern (SVHC) List.
What Is REACH?
As the directive’s name suggests, REACH uses a multifaceted regulatory framework consisting of four primary elements: registration, evaluation, restriction, and authorization. First, REACH requires EU manufacturers and importers to register chemical substances with the European Chemicals Agency (ECHA), the EU agency responsible for managing and administering REACH. Second, the regulation mandates that the ECHA carry out regular evaluations of all registered chemical dossiers, otherwise known as compliance checks.
Finally, REACH restricts the use of substances that are found to be dangerous to human health, bioaccumulative, or persistent in the environment. Chemicals restricted through REACH in this way can only be used through special authorizations granted by the ECHA.
Learn More About REACH
How the REACH Registration Process Works
While REACH manages chemical use in the EU in several different ways, the law’s most prominent regulatory mechanism is the registration process. Companies manufacturing, selling, or importing chemical substances in the EU in quantities exceeding one metric ton annually are required to register those substances through REACH. To register a substance, organizations must assemble and submit a dossier that contains a range of relevant information on the compound, including chemical properties and uses; toxicological data and other hazardous characteristics; risks the substances may pose; and mitigation measures for those risks.
The ECHA requires companies to follow a “one substance, one registration” principle. This means that manufacturers and importers legally obligated to submit dossiers on the same substance must do so jointly (thus avoiding multiple dossiers for the same chemicals in the ECHA database). All registrations and accompanying dossiers are submitted through the EHCA website.
Since REACH entered into force in 2007, thousands of businesses have registered more than 20,000 substances with the ECHA.
Learn More About REACH Regulation
The REACH SVHC List
In addition to imposing reporting requirements on businesses manufacturing or importing chemicals within the EU, REACH also has a systematic process for identifying hazardous substances and restricting their use in the EU’s 27 member countries. The legal framework of REACH allows both the ECHA and member states to recommend that specific compounds be added to the Substances of Very High Concern (SVHC) list—also referred to as the Candidate List—if they fulfill certain criteria outlined in the original REACH legislation. Chemicals may be designated SVHC if they are carcinogenic, mutagenic, or toxic to reproduction (CMR); persistent, bioaccumulative, and toxic (PBT); very persistent and very bioaccumulative (vPvB); or have properties of equivalent concern.
As of November 2024, there are 242 substances on the REACH Candidate List.
Learn More About the SVHC List
How Substances Are Added to the SVHC List
Expansions to the Candidate List start with either an EU member country or the European Chemicals Agency itself submitting a proposal for a new substance to be legally recognized as an SVHC. Once the proposal is submitted and published in an ECHA registry—known as the “Registry of SVHC intentions until outcome”—individuals, parties, and other interested stakeholders have 45 days to submit comments related to the substance, its uses, and the proposed restriction. These public comments are reviewed by the ECHA’s Member State Committee (MSC), the group responsible for making a final decision on the chemical’s inclusion on the Candidate List.
Once a substance is officially recognized as an SVHC, it’s added to the ECHA Candidate List. Following the inclusion, suppliers who choose to continue using the chemical are legally required to fulfill several obligations, including providing detailed safety information, responding to consumer requests within 45 days, and notifying the ECHA if the SVHC exceeds certain thresholds in their product formulations.
Learn More About the SVHC Process
Understanding the Difference Between REACH and RoHS
While REACH and the Restriction of Hazardous Substances (RoHS) are both environmental regulations administered by the EU, their similarities largely stop there. REACH is a complex, multipronged directive that imposes reporting requirements on businesses, maintains a comprehensive list of hazardous substances, and restricts the use of specific chemicals through its Authorisation List. Conversely, RoHS is a far more straightforward, streamlined regulation. The initial law, which took effect in 2006, limits the use of six substances in electrical and electronic equipment (EEE) across all EU member states.
Five years later, in 2011, the EU introduced Directive 2011/65/EU, which is commonly referred to today as “RoHS 2.” This new directive expanded on the scope of the original RoHS by restricting the use of four additional substances in all EEE.
Learn About RoHS and REACH
Substances Added to the SVHC List in 2024
The ECHA typically updates its Candidate List twice annually, often adding several new substances over the course of a full calendar year. In 2024, the agency voted to designate seven new chemicals as SVHCs. These substances are used in everything from coatings and adhesives to electronic components and plasticizers. Manufacturers, importers, and other suppliers distributing any of these chemicals in the EU must now adhere to the ECHA’s requirements for using Substances of Very High Concern.
- 2,4,6-tri-tert-butylphenol
- 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol
- 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
- Bumetrizole
- Oligomerization and alkylation reaction products of 2-phenylpropene and phenol
- Bis(α,α-dimethylbenzyl) peroxide
- Triphenyl Phosphate (TPhP)
Learn About New SVHCs
What Is Turkey’s REACH Regulation?
Turkey’s landmark environmental regulation—officially called the KKDIK but frequently referred to as “Turkey REACH”—was established to manage chemicals in the country and requires manufacturers and importers operating in Turkey to register their use. The KKDIK was originally enacted back in 2017 by the country’s Ministry of Environment, Urbanisation and Climate Change. Though the registration window was originally scheduled to close on December 31, 2023, the government extended the deadline by several years. As of late 2024, the KKDIK is set to be rolled out gradually over the next half-decade, with deadlines for in-scope businesses in 2026, 2028, and 2030.
While the EU’s REACH directive and the KKDIK share a number of similarities, there’s one major distinction businesses should be aware of: unlike the former regulation, Turkey’s law requires covered companies to have their chemical registrations approved by a qualified expert.
Learn More About KKDIK