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The registration of an isolated or an isolated and transported intermediate under strictly controlled conditions (SCC) as foreseen in regulation (EC) 1907/2006 (REACH) requires only a reduced dataset compared to a "standard" registration. In order to comply with the requirements of such a simplified registration, strict conditions for the handling and use of such substances are specified under REACH. The registrant is required to confirm that the substance is used under SCC and that it should be rigorously contained during its whole life cycle according to Article 17(3) or 18(4).
It is noted that strictly controlled conditions (SCC) and rigorous containment (RiCo) are not independent concepts: RiCo is an integral part of SCC and therefore has to be seen in this context merely as one of several aspects of a SCC compliance check. This tool is intended to provide guidance to registrants of isolated intermediates on how RiCo of their intermediates could be assessed and documented according to the stipulations of REACh. As for any tool associated with human health and environmental welfare aspects, the tool is intentionally designed in a precautionary way. Any conclusions drawn by the tool should therefore be interpreted with this built-in conservatism in mind, and negative results should not be seen as conclusive but instead should serve as an entry point for further (higher tier) assessments of RiCo.
Thus, in an integrated assessment of SCC for an entire process, RiCoG can be used to prioritise process steps requiring such higher tier assessments, and provides an easy and structured way to assess and to document RiCo for the remaining process steps. RiCoG is provided free of charge, and its use is of course not mandatory. It is intended to support registrants and has been developed to address specific needs of an assessment of RiCo for metal intermediates. In the development of RiCoG, experts from various metals' industries have facilitated adopting the original approach as published by Hirst et al. (2002). Consequently, it is explicitly noted that this tool is designed for use only in compliance checks of RiCo for inorganic substances.
It is noted that SCC and RiCo are only generically addressed in REACH and the associated technical guidance, so that they are consequently subject to interpretation. Any results obtained by the use of this tool can therefore not be - and are not intended to be - legally binding. The disclaimer included in this tool should also be considered in this respect.
By using RiCoG, it is assessed whether the substance is rigorously contained at a process level. If rigorous containment is achieved, relevant exposure of workers and the environment is excluded at that level. It is noted that at a higher level (i.e. at the site level), "...releases and any resulting exposure occurring despite rigorous containment by technical means of the process (i.e. at the process level) are to be minimised by procedural and control technologies (i.e. at the site level)" (Guidance on intermediates, ECHA, December 2010, text in brackets represent an interpretation by the author). Where they exist, the control (minimisation) of these emissions to the environment shall therefore be addressed in an additional assessment outside the scope of RiCoG (i.e. as part of an assessment of further criteria for satisfying SCC).
As already noted, RiCo is merely one aspect of SCC. The other SCC components also need to be fulfilled to make use of the reduced information requirements under REACh for isolated intermediates. In addition, it is required that the registrant (and any downstream user) documents SCC and archives such documentation in-house. It is therefore recommended retaining copies of any RiCo assessment for future reference.
BAUA (2005a): Einfaches Maßnahmenkonzept Gefahrstoffe: Empirische Zusammenhänge von Einstufung und Arbeitsplatzgrenzwert, Stand. 10. Januar 2010, Bundesanstalt für Arbeitsschutz und Arbeitsmedizin.
BAUA (2005b): Einfaches Maßnahmenkonzept Gefahrstoffe - Fachliche Konzeption, Stand. 10. Januar 2010, Bundesanstalt für Arbeitsschutz und Arbeitsmedizin.
ECHA (2010): Guidance on intermediates, Version 2, European Chemicals Agency, http://echa.europa.eu/, December 2010.
HSE (2002): Control of lead at work (Third edition), Control of Lead ar Work Regulations 2002, Approved Code of Practice and guidance, ISBN 978 0 7176 2565 6, 2002.
HSE (2009): "The technical basis for COSHH essentials: Easy steps to control chemicals, Health and safety Executive, 2009.
Hirst, N., Brocklebank, M., Ryder, M. (2002): Containment Systems, A Design Guide, Institution of Chemical Engineers (IChemE), ISBN 0 7506 7612 4, 2002.
United Nations (2009): Globally Harmonized System of Classification and Labelling of Chemicals (GHS), third revised edition, ISBN-13: 978-92-1-117006-1, New York and Geneva, 2009.
Eurometaux, the EU association of the non-ferrous metals industry:
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