Substances of very high concern

The ongoing analysis of registration dossiers should be considered and performed with sensitivity to the waste stage. This should also be done for the selection of substances of very high concern (SVHC, candidate list). For this purpose this task should be designated to the ECHA. 

The 18 substances are shown in Table 1. Five of these substances are now (June 2012) included in Annex XIV (Authorisation list) [29]. These substances are the lead-chromate pigments, pigment yellow 34 and pigment red 104, and the phthalates DEHP, DBP and BBP, which all are used as components/additives in some printing inks. As evident from Table 1, cobalt(II) salts and trichloroethylene appear on the Annex XIV candidate list [28], and they are also used as additives in some printing inks. ECHA has recommended in its third recommendation [30] to put these two substances on the Authorisation list [29]. Besides these seven substances of very high concern (SVHC substances) appearing on either the Authorisation list or its candidate list, 11 other substances that meet one or more of the criteria for the candidate list are shown in Table 1. These substances are also... 

Substances of very high concern will have to be authorised for use for specific purposes that have been demonstrated either to present a negligible risk or are essential for socio-economic reasons. It is estimated that ca 1,400 substances will be subject to authorisation. 

As long as chemical regulation is based on this risk-based philosophy, human and environmental exposure to dangerous chemicals - substances of very high concern - will continue. The disperse and dilute model does not work for persistent bioaccumulative chemicals because Nature quite simply collects and concentrates these materials overtime. 

A safer alternative is one that does not meet the requirements for a substance of very high concern as defined in the authorisation procedure of the REACH proposed regulation. Obviously, every effort must be made to select the least hazardous alternative within this universe of "safer" chemicals. 

Are there registered alternatives not classed as substances of very high concern ... 

The availability of alternatives should not merely be seen as one consideration in the authorisation process. It should be the decisive factor in deciding the future of a substance of very high concern. Producers and users of chemicals of very high concern should be required to assess alternatives to... 

The Swedish government has also reiterated the need to substitute substances of very high concern. These substances are estimated to be relatively few and would not overload the authorisation system. Sweden states that authorisation of such chemicals may be granted only if industry can demonstrate that no feasible alternatives are available the socio-economic arguments clearly outweigh the potential risks and emissions are foreseen to be negligible during manufacture, use and disposal. ... 

Such planning for substances of very high concern would vastly improve the information flow and development of safer substitutes. It would also move Europe to become a more competitive, innovative and sustainable producer of chemicals, goods and services. More importantly, it would begin to reverse the body burdens of hazardous chemicals that we all now carry. 

The following case studies focus on chemicals likely to be defined as "substances of very high concern" i.e. that would reguire authorisation underthe REACH system. 

Common position with regard to the authorisation of substances of very high concern within REACH... 

The Confederation of British Industry, the Chemical Industries Association and Greenpeace share the common position that substances requiring an authorisation within REACH according to Title VII, Article 54 of the Commission s proposal i.e. substances of very high concern) should be replaced with less hazardous alternatives... 

Substances of very high concern must be identified as such through the application of a robust, science-based and transparent process, co-ordinated at a European level and subject to European agreement. 

Authorisations granted for uses of substances of very high concern should be time-limited appropriately such that the benefits of emerging alternatives can be realised... 

Weshare the view that a requirement within the authorisation procedure to substitute substances of very high concern if an acceptable alternative that does not fall into the very high concern category is available has the potential to drive innovation to the benefit of business, human health and the environment. However, to be effective, substitution will require commitment from the total supply chain, not just from producers. 

We therefore urge the Minister to press for substitution to be incorporated into REACH in such a way that the authorisation procedure is effective, but flexible, in progressively phasing-out substances of very high concern. 

ECHA (2008a) Member State Committee-Support document for identification of benzyl butyl phthalate (BBP) as a substance of very high concern. European Chemicals Agency, 1... 

The term substance of very hi h concern, abbreviated SVHC, is associated with a new process that was introduced to the European chemicals policy through the implementation of REACH the authorization process. This procedure aims (1) to encourage the substitution of substances of very high concern with less harmful substances or alternative technologies and (2) assure the proper control of risks arising from SVHC s. A substance being subject to authorization must principally not be used or placed on the market for any use within the European Union. However, specific uses of an authorized substance may be excluded from this general prohibition if, for example, they are a priori exempted from authorization or if the manufacturer, importer, or downstream user successfully applied for their authorization. The authorization process is laid down in REACH Articles 55-66 and may be initiated by the ECHA on behalf of the European Commission or by EU member state competent authorities. Substances which are subject... 

The first step begins with the preparation of a dossier (34) in which a substance is proposed for identification as substance of very high concern (SVHC) and it ends with the inclusion of the substance in the so-called candidate list (35). Substances which are included in the candidate list are not yet subject to authorization but specific duties are assigned to suppliers of such substances (see below). 

As mentioned previously, the authorization process starts with the identification of a substance as substance of very high concern (SVHC). For this purpose, the ECHA on behalf of the European Commission or a member state competent authority prepares a dossier. It generally includes a proposal for the identification of a substance as SVHC, a justification for this proposal and information on the substance s use, exposure, and risks as well as on alternatives. The extent of the justification may differ considerably between substances and may range from a sophisticated assessment of the harmful effects caused by the substance to a simple reference to Annex VI Part 3 of the CLP Regulation if a harmonized classification... 

ECHA (2007) Guidance for the preparation of an Annex XV dossier on the identification of substances of very high concern. http //echa. eiuopa.eu/ documents/10162/17230/svhc en.pdf. Accessed 29 Jan 2012... 

This principle is fundamental to numerous multilateral agreements and treaties. As mentioned in the conclusions quoted above, in order to make Precaution operational, pre-marketing measures ensuring the availability of an adequate set of information on the properties of chemicals are essential. Thus in order to be "safe instead of sorry" REACH establishes not only the "no data no market" approach but also an authorisation regime for substances of very high concern as they are representing serious hazards to human health and the environment. Particular inherent properties are directly linked to risk reduction measures - an unprecedented application of the Precautionary Principle. 

The one area in which REACH does give consumers the right to know about chemicals in products is with respect to the presence of substances of very high concern. However, products do not have to be labelled to indicate that they... 

ECHA (2008b) Press Release /PR/08/34, ECHA member state committee agrees on the identification of 14 substances of very high concern, European Chemicals Agency, Helsinki, Finland. 

REACH is based on the idea that the industry itself is best placed to ensure that the chemicals it manufactures and puts on the market in the EU do not adversely affect human health or the environment. This requires that industry has certain knowledge of the properties of its substances and that it manages potential risks safely. Authorities should focus their resources on ensuring that industry is meeting its obligations and on taking action on substances of very high concern or where there is a need for official action. 

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