What Are REACH’s Substances of Very High Concern?

The Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) is a European Union regulation that was entered into force on June 1, 2007. The European Chemicals Agency (ECHA) oversees and administers the regulation, which aims to protect human health and the environment from threats posed by chemicals. In this way, REACH’s overarching purpose—if not its scope—is very similar to the EU’s Restriction of Hazardous Substances (RoHS) directive. (Our 2023 article took a comprehensive look at the similarities and differences between these two laws.)

In addition to mitigating the potential harms posed by chemicals in EU member states, REACH has two complementary objectives. The legislation seeks to advance competition within the chemical industry, and it explores and advocates for alternative methods of carrying out hazard assessments of substances that do not incorporate animal testing. It’s worth pointing out that while REACH may have the most significant impact on companies that develop and produce chemical compounds and their derivatives, it does not exclusively regulate the chemical industry. Because of the high prevalence of these substances and the way they’ve become integral parts of a vast array of products and their respective manufacturing processes, REACH touches nearly every industry working in the EU. As the ECHA concisely puts it, “REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives.” 

REACH SVHC and the REACH SVHC List 

A major part of REACH’s regulatory process is identifying what it terms “substances of very high concern,” or SVHC. According to the ECHA’s definition, SVHC are “Substances that may have serious and often irreversible effects on human health and the environment.” Article 57 of the EU REACH regulation defines SVHC with a higher degree of specificity, permitting the ECHA to designate substances as REACH SVHC if they fit into one of the following categories:

• Carcinogenic, mutagenic, or toxic to reproduction (this group is often abbreviated as “CMR,” or carcinogenic, mutagenic, or reprotoxic).
• Persistent, bioaccumulative, and toxic (PBT).
• Very persistent and very bioaccumulative (vPvB).
• Possessing harmful properties that justify an equivalent level of concern (ELoC), such as endocrine disruptors. 

As of January 2024, the ECHA has placed a total of 240 chemicals on the REACH SVHC list. (The agency also refers to this as the “Candidate List.”) Once a chemical has been added to the Candidate List, the ECHA may eventually make a recommendation that it be added to the Authorisation List (sometimes referred to as Annex XIV of REACH). When the agency transfers a substance from the Candidate List to REACH’s Authorisation List, that compound is given a sunset date, after which use of the substance and its inclusion in products placed in the EU market are prohibited. Exemptions to this prohibition may only be made through explicit authorizations granted by REACH. There are currently 59 substances on the ECHA’s Authorisation List. 

Compliance Requirements for REACH SVHC List 

Once the ECHA has added a substance to the Candidate List, all companies manufacturing, importing, or otherwise incorporating that substance into their products in the EU are immediately subject to a host of legal obligations. As outlined by the ECHA, these requirements include:

• Notifying the ECHA when a REACH SVHC is present in their products or articles at levels over a concentration of .1%, or exceeding a total quantity of one metric ton annually. Companies must submit notification documentation to the ECHA no later than six months after the substance has been added to the REACH SVHC list. 

• Communicating safe use of the article to professional users and distributors.

• Responding to consumer requests for safe use information within 45 days. 

• Including a safety data sheet or other means of conveying safety information to users.

REACH SVHC Update 2023 

The ECHA adds chemicals to the REACH SVHC list every six months. As such, the agency included a number of new substances on the list in 2023. Between January and June of last year—the months the ECHA announced new inclusions—the agency added a total of 11 new hazardous chemicals to the Candidate List. These entries included the following substances:

• 1,1'-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]. This chemical was included because it has been found to be very persistent and very bioaccumulative (vPvB).
• 2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol. This substance, which is frequently used as a flame retardant, is carcinogenic. 
• 4,4'-sulphonyldiphenol. Often used in the manufacturing of paper products, 4,4'-sulphonyldiphenol is reprotoxic and possesses endocrine-disrupting properties. 
• Barium diboron tetraoxide. A flame retardant and antifungicide for paints and other products, the chemical is reprotoxic. 
• Bis(2-ethylhexyl) tetrabromophthalate. A plasticizer with a variety of applications, the substance is vPvB. 
• Isobutyl 4-hydroxybenzoate. The antimicrobial agent is a known endocrine disruptor.
• Melamine. Often used as a resin coating, melamine poses serious adverse health effects that represent an equivalent level of concern (ELoC).
• Perfluoroheptanoic acid and its salts. This PFAS chemical is both reprotoxic and vPvB. 
• Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4- (1,1,1,2,3,3,3-heptafluoropropan-2-yl) morpholine and 2,2,3,3,5,5,6,6-octafluoro-4- (heptafluoropropyl)morpholine. Used in formulation and repacking, this substance is vPvB. 
• Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide. Used in inks and toners and cosmetics, the chemical compound is reprotoxic. 
• Bis(4-chlorophenyl) sulphone. Found in the production of polymers and rubber products, the substance is vPvB.

REACH SVHC Update 2024 

On January 23 of this year, the ECHA added an additional five substances to the REACH SVHC list:

• 2,4,6-tri-tert-butylphenol. Used in jet, automotive, and marine fuel, this chemical is both reprotoxic and persistent, bioaccumulative, and toxic (PBT). 
• 2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol. Used in coating products and sealants, among other applications, the substance is vPvB. 
• 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one. Found in inks and toners, this chemical is reprotoxic. 
• Bumetrizole. Utilized for cleaning products, bumetrizole is vPvB. 
• Oligomerisation and alkylation reaction products of 2-phenylpropene and phenol. Incorporated into adhesives and sealants, these products are vPvB. 

Understanding REACH and its Candidate List is critical for businesses operating in the EU and their environmental compliance teams. Now encompassing 240 chemicals, the REACH SVHC list affects just about every sector within the European Union. Whether it’s an SMB or a large multinational employing thousands, companies doing business in any of the EU’s 27 member states need to be aware of this list and the compliance obligations it imposes. Entities in violation of REACH face penalties in the neighborhood of tens of thousands of euros, depending on the member state, and the potential to lose millions in revenue via large-scale product recalls.