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Environmental assessment of ‘upstream’ sites – an opportunity to co-ordinate

September 5th, 2016

REACH takes a generic approach to exposure assessment, working on a substance-by-substance basis. A precautionary approach is intrinsic to the methodology, meaning that refinement or control are often necessary.

Industry associations for different chemicals sectors have been active in preparing SPERCs. These are still intended to be generic and apply to any substance, but have direct relevance to sites operating within specific industrial sectors. The degree of conservatism varies from sector to sector.

For ‘upstream’ sites (especially manufacturers, formulators), where chemical volumes are large, generic and conservative assumptions can suggest unacceptable risks. In this situation a fully site-specific approach can be useful to refine risks. However, moving away from generic approaches necessitates registrants to be committed to a high degree of care with ongoing post-registration maintenance.

Meanwhile, the same chemical installations must remain in compliance with statutory industrial pollution control legislation (particularly the Industrial Emissions Directive) and national or local statutes. This type of legislation uses a site-specific permit based approach to assessing and controlling risks from chemicals in combination (together with other nuisance issues such as noise and odour). Pollution control legislation applies the helpful concept of the ‘best available techniques’, for controlling chemical emissions in a specific operational sector. In this context, companies should already be aware of what measures and controls are available at their site, and the effectiveness of engineering controls.

Joint Registrants may find it useful to co-operate to produce refined scenarios appropriate to their registered substance. For example, co-registrants might agree which management measures are typically used by their sites (or their customers’ sites) to control emissions to waste water or to air from the plants undertaking a specific process. Collection of information by an impartial third party can be useful in this respect. Information about waste water volumes and on-site water treatment practices are also often very useful. Chemical analysis of waste water, in line with the standards set by both types of legislation, could be considered a gold standard for both purposes.

In REACH substance evaluation, it has been observed that the authorities’ review efforts have until now largely focused on resolving issues with substance identity, properties and hazards aspects of substance registrations. It is already clear that reviewers’ attention is beginning to turn more to exposure, and registrants are already receiving requests for additional evidence from ECHA and Evaluating Member State reviewers. This will certainly increase in future. Any parameters used in the exposure assessment, that are not the conservative, generic ‘defaults’, may need extra explanation, to demonstrate that they are appropriate and applicable, and registrants should be preparing for this. While industry sector SPERCs are to some extent a special case, ECHA may still require registrants to assemble evidence to show that the selected SPERCs are relevant for a specific case.

A co-ordinated approach, making good use of site-specific information gathered for pollution control purposes, could be beneficial within REACH, for the process of acting on ECHA letters concerning exposure queries especially for upstream life cycle stages. Registrants may find it useful to investigate what information is available, as this is likely to be useful in REACH, and compatible with other legislation.