Substances of very high concern (SVHC)
Substances that may have serious effects on human health and the environment can be identified as substances of very high concern (SVHCs). These are primarily substances which are carcinogenic, mutagenic or toxic to reproduction as well as substances with persistent and bio-accumulative characteristics. Other substances of equivalent concern include, for example, endocrine disrupting chemicals.
After a substance has been officially identified in the EU as being of very high concern, it will be added to the Candidate List. This list indicates to consumers and industry which chemicals are identified as SVHCs.
Companies manufacturing or importing articles containing these substances in a concentration above 0,1% weight of the article, have legal obligations. They are required to inform recipients of the articles about the presence of the substance and therefore how to use it safely. They also need to inform consumers requesting this information.
Substances placed on the Candidate List can move to the Authorisation List. This means that, after a given date, companies will not be allowed to place the hazardous substance on the market or to use it, unless they have been authorised to do so. One of the main aims of authorisation is to phase out SVHCs where possible.
ECHA publishes information on SVHCs in consumer articles, combining information from registration dossiers and notifications it receives from the importers and producers of the articles.
These chemicals are very hazardous for human health. They can interfere with the DNA – our genetic blueprint - change it, and cause uncontrolled growth of cells (cancer) or disturb sexual development. CMRs have different levels of hazard and the most hazardous of them, based on evidence from humans and from animal tests, may be identified as SVHCs.
- Phthalates as a group of substances are the most commonly used plasticisers in the world. Certain phthalates have been classified as having a damaging effect on reproduction and several of them – including DEHP, DBP, BBP and DIBP – have been placed on the Candidate List of SVHCs. These phthalates can be found in a range of indoor and outdoor products, including flooring, roofing, wires, cables, hoses, and coated fabrics, such as artificial leather for bags and book covers.
Substances that are difficult to break down (persistent), accumulate in living organisms (bio-accumulative) and are toxic, are known as PBTs. Some substances may also be identified as being very persistent and very bio-accumulative (vPvB). The long-term effects of PBT and vPvB substances are difficult to predict. Once they are dispersed in the environment, exposure to these substances is very difficult to reverse. They may accumulate in plants, animals and ultimately in human beings. They may also pollute remote areas.
- The brominated flame retardant HBCDD (hexabromocyclododecane) is used in polystyrene products - mainly in thermal insulation boards/panels of buildings, in packaging material and in the plastic housing of electronic or electric devices. It is also applied in textile coatings, mainly for upholstered furniture and seating in transportation, draperies, including curtains and blinds, bed mattress ticking, interior and automobile textiles. It is now going to be banned globally as it is persistent, bio-accumulative and toxic and it can travel long distances in the environment. For example, it has even been found in animals in the Arctic. Its hazardous properties are likely to lead to significant adverse human health and environmental effects worldwide.
These are chemicals for which there is evidence of probable serious effects to human health or the environment, giving rise to a similar level of concern as CMRs and PBTs. These include certain endocrine disruptors and respiratory sensitisers, assessed case by case.
- 4-tert-octylphenol ethoxylates are one of a number of endocrine disruptors which have been identified as SVHCs due to environmental concerns. In the environment, they degrade to 4-tert-octylphenol which has been shown, for example, to cause endocrine disruption in fish. These substances have a variety of uses including use in paints and medical products or devices. It is considered that the impacts caused by 4-tert-octylphenol ethoxylates on the environment are comparable to those of PBT substances and therefore they give rise to an equivalent level of concern.
A growing list
The Candidate List is published by ECHA and updated every six months. This official list of SVHCs at EU level is based on proposals made by national authorities or ECHA, wide public consultation and scientific rigour in the decision-making. The "Roadmap on Substances of Very High Concern" aims to have all relevant currently known SVHCs included in the Candidate List by 2020.
In addition, trade unions, non-governmental organisations and some national governments have established their own lists of substances that they consider to be of concern because of their negative effects on human health or the environment.