Ensuring safe use and business continuity for chemical substances subject to authorisation, Royal HaskoningDHV has been engaged by Dominion Colour Corporation to prepare an application for authorisation under the REACH regulation. This project was done in close collaboration with our partner EPPA from Brussels, which is a specialist management consultancy that assists companies in managing alignment between business, European Union institutions and governments. Dominion Colour Corporation is a leading manufacturer of high-quality pigments and preparations for the coatings, plastics and ink industries worldwide.

The authorisation dossier covered a broad set of specialist uses of the substances throughout the paints and coatings and plastics supply chain – covering formulation of products and industrial and professional use, but excluding consumer use. To make an inventory of the activities on the various use sites and translate these to exposure scenarios, we performed site visits to a selection of downstream user sites throughout Europe. To be able to perform a solid risk assessment the conditions of use were determined as exact as possible.

The information gathered was used to extensively describe the uses applied for and to refine the risk assessment and demonstrate safe use using higher-tier exposure modelling (exposure assessment). The application for authorisation was supported by an analysis of alternatives showing no 1:1 suitable alternative candidates. Other project activities included updating the existing lead registration dossier and official meetings with ECHA and Member State officials. After nearly 4 years of work, these efforts combined, led to an approved authorisation by the European Commission for a maximum of 7 years.

The outcome of the project ensured our clients’ business for these pigments in the EU. Also, we were able to show that the pigments can be used safely throughout Europe under the prescribed operational conditions and measures, and therefore the risk of unsafe handling is minimized. Based on the socio-economic analysis it was demonstrated that the benefits of continued use of the substances for the uses applied for outweigh the risks to human health and environment. The dossier will be under review again in the future.

REACH is the European legislation for chemical substances. All chemical companies based in or tied to the European Union, have to comply with this legislation. An application for authorisation under the REACH Regulation is required for chemical substances listed on Annex XIV of the Regulation. These substances are candidate to be phased out for use in the European Union based on their hazard profile unless it can be demonstrated that the risk of their use can be adequately controlled. The authorisation dossier that needs to be compiled should demonstrate this, by taking into account alternative substances (substitution), the socio-economic impact of (dis)continued use and exposure to workers and the general population.

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Christiaan van Daalen

Senior Consultant Chemicals Management

Nijmegen, NL

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