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Dr Reach: How REACH is raising the bar for risk management

REACH underpins the need for well-organised product portfolios, which appropriately reference chemical risk information. In combination with other legislation, REACH has driven the development of chemical communication systems and networks across international supply chains.

The run-up to pre-registration also caused many companies to re-evaluate safety data sheets (SDSs). Undoubtedly, REACH has already spurred improvements and more will follow as classifications are reviewed and SDSs reissued.

Across sectors, REACH and other initiatives are pressing companies to review potential hazardous components and constituents in products. This is leading to improvements in classifications and SDSs, as well as being important for product safety in other areas.

The examples given above show that industry is ‘raising the bar’ concerning basic principles and standard practices. Indeed, well-prepared companies can find themselves at an advantage, particularly in terms of administrative relief.

At the same time, REACH cannot replace fundamental aspects of risk communication and management, such as the need to change air cleaner filters in workplaces, professionals wearing protective clothing or consumers following product-use instructions.

To this extent, it is critical that REACH does not usurp resources from other chemical safety activities and initiatives. Instead, it should supplement and reinforce these.

Sledgehammer?

REACH can at times appear to be a sledgehammer to break a nut. But without the political intensity and media coverage surrounding adoption of the Regulation, it may not have been possible to achieve such a high level of attention across non-chemical industry sectors and international supply chains nor such extensive reform.

But the force behind REACH should be handled with care, not only in terms of legal compliance and civil liabilities... Recent experiences have demonstrated just how powerful market responses to REACH can be.

Take for instance, companies pre-registering hundreds, even thousands, of substances in case they may be present in a formulation, part of a polymer product or a future good, or recycled. The high number of pre-registrations slowed the European Chemicals Agency’s REACH-IT system,which had an impact on companies across the EU.

Another example is the multitude of declarations on substances of very high concern (SVHCs) being requested through supply chains following publication of the first REACH Candidate List. It seems consideration is rarely given beforehand to whether information is already available in SDSs or whether a SVHC can even possibly be present in a material.

Communicating uses

As the next phase of REACH implementation proceeds, it is especially critical that companies and regulators retain a firm hold on objectives. Specifically, I am referring to methods and mechanisms to communicate ‘uses’ for the purpose of registrations in 2010.

Only a fraction of all substances subject to registration will be registered in 2010. For many of these substances, a hierarchical method of describing use will frequently apply, which may not be so relevant for many 2013 and 2018 registrations.

Tools and methods for use descriptions are still being developed and will certainly continue to be refined over coming years. Ways to link these to exposure scenarios are also still being determined.

Certain aspects of use communication also require forethought on the practical implications, for instance for downstream users that decide to cover uses after registration or that must verify uses within an exposure scenario, as well as the legal obligation of providing exposure data during use communications at least 12 months prior to each registration deadline.

Use data relevant for the 2010 registration deadline can often be found in technical product sheets, existing SDSs or ‘fit-for-purpose’ descriptions and product specifications.

Companies and regulators need to acknowledge in guidance differences in methods to describe and confirm use in various sectors, in particular regarding the technical terms employed and the parameters determining exposure.

Guidance must follow from case-studies, where the relevance of use is presented and related to a chemical safety assessment and exposure scenario. Only then can the delineations, limitations and implications of any given ‘use’ be understood. Cases exist where the adopted use descriptor system for chemical safety assessments does not clearly align with sector-specific terminology or categories adopted in generic exposure scenarios.

Havoc or restraint?

Hopefully, downstream users (and consultants) will adopt proportionate, thought-out and meaningful approaches to 2010 registrations, thereby avoiding mass emails requesting use data for all materials in all supply chains. Otherwise, the end of this year will present another ‘unforeseen’ administrative hurdle to companies, especially as documentation must be kept for ten years after last supply or use.

Of equal importance, exposure and safety assessments must not be reduced to ‘tick-box’ approaches. This would undermine the basic premise of improving risk communication and management practices.