What Makes a Substance of Very High Concern? Characteristics and the Importance of Identification

The REACH Candidate List, a list of substances of very high concern (SVHC) as determined by the European Chemicals Agency (ECHA), has been updated over twenty-five times. In forming this list, substances are proposed by EU member states or by ECHA itself, at the request of the European Commission. Upon detailed review and unanimous consent, the substance may become a substance of very high concern.

Because the goal of including a substance on the Candidate list is to promote replacement by less dangerous substances or technologies where technically and economically feasible alternatives are available, businesses should ensure that they have the tools and process in place to identify them quickly.

Additionally, ensuring that the inherent risks of SVHC are controlled through a product’s lifecycle is key to not only compliance, but also to reassure customers and partners alike.

Understanding the basics of SVHC can provide context on how and why they are becoming more important than ever for businesses to monitor. 

EU’s History of Monitoring Dangerous Substances

In 1967, The European Economic Community, a forerunner to the EU and European Commission enacted Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances. This Directive, also known as the “Dangerous Substances Directive,” sets requirements for communication of the dangers of substances based upon their classification (e.g. explosive, flammable, toxic, etc.) via material safety data sheets, MSDS. It issues safety recommendations for the substances, as well as establishes requirements for labeling and packaging. Furthermore, certain substances were deemed to be carcinogenic, mutagenic, or toxic for reproduction. This set the basis for REACH and the evaluation of a substance for the Candidate List. The Dangerous Substances Directive was repealed and replaced by Regulation (EC) 1272/2008, classification, labeling and packaging of substances and mixtures (CLP) in 2015.

Defining Characteristics of an SVHC

Article 57 of the REACH Regulation (EC 1907/2006) identifies the criteria for SVHC. The criteria are based upon classification as either,

(a) carcinogenic: cancer causing,

(b) mutagenic: gene/DNA damaging, or

(c) toxic to reproductive health: having an adverse effect on fertility or causing developmental damage to an unborn child

as determined by the Dangerous Substances Directive and its successor, CLP. In the criteria, CLP assigns the substance to either category 1 or category 2, depending on the available evidence of the substance’s toxicity.

Specifically, substances demonstrating a causal relationship to cancer based upon epidemiological and/or animal studies would be considered category 1 carcinogens. Substances that show a causal relationship, but with incomplete or less conclusive evidence and fewer studies completed are considered category 2 carcinogens.

Specific criteria in the REACH Directive provide the basis for inclusion and are cited in Article 57 of the directive. The criteria for inclusion are indicated on the Candidate List and must demonstrate that the substance is either:

(a) persistent, bioaccumulative, and toxic (PBT)

(b) very persistent and very bioaccumulative (vPvB)

In order to be considered persistent, Annex XIII of the REACH Regulation states that

the substance must exhibit a half-life in specific matrices (marine water, fresh or estuarine water, marine sediment, fresh or estuarine sediment, and soil) of longer than a set duration.

To be considered bioaccumulative, the substance must exhibit a bioconcentration factor higher than 2000 in freshwater and marine species. A bioconcentration factor of 2000 means that there is 2000 times as much of the substance in the organism as there is in the organism’s environment.

The bioconcentration factor is a measurement of a substance’s ability to concentrate in an organism when the substance is present in that organism’s environment. Essentially, if the measurement of the substance in the tissue of the organism is higher than the measurement of the substance in the environment, the conclusion is that the substance concentrates in the organism due to exposure in the organism’s environment. Further, the organism cannot eliminate the substance at the rate to which it is exposed. Thus, the substance becomes elevated in the organism to a concentration higher than the environment.

To be considered toxic, the substance must be considered carcinogenic, mutagenic, or toxic for reproduction by the Dangerous Substances Directive, demonstrate other chronic toxicity, or demonstrate “no observable effect” at a concentration of less than 0.01 mg per liter (1 part per million).

To be considered very persistent and very bioaccumulative, the substance must exhibit a longer half-life in its matrices and have a bioconcentration factor of 5000, or show 5000 times as much substance in an organism than in the organism’s environment.

There are substances of concern that are not covered by the above criteria. These substances, such as endocrine disruptors (substances that mimic hormones and can activate or interrupt normal endocrine function), may be included in the Candidate List. The inclusion is due to concern of probable serious effects to human health or the environment based upon the presence of scientific evidence.

REACH, Emerging Regulations, and Effective SVHC Identification

The Candidate List will grow, change, and evolve over time. One of the major impacts to it may be through new substances and technologies that drive a more sustainable solution to the marketplace. Knowledge of the REACH Candidate list and understanding SVHC is only the first step to effective change. Ultimately, instant identification paves the way for replacement of an SVHC with a less dangerous substance and encourages compliance until a replacement can be identified.

Maintaining an effective solution that allows a business to understand the content of its products will allow for quick identification of SVHC and an ability to alert customers and maintain compliance to the REACH Regulation. Decisive implementation of new technologies and substances that will demonstrate your company’s commitment to human health, the environment, and sustainability are hallmarks of corporate social responsibility and essential to the success of a modern business impacted by SVHC and REACH.


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