Dr Reach: Traceability and transparency key to good REACH decisions

It is difficult to imagine that an audience could be made to roll with laughter at a presentation on the many ongoing implementation difficulties with the REACH Regulation. But Roger van der Linden from Borealis managed this at a recent European Chemical Industry Council (CEFIC) workshop by likening the challenges with driving a train across a bridge that is collapsing behind and still being built ahead.

Some light relief is welcome as we approach what many regard as a crisis year for REACH implementation.

Some issues have been debated for months but without solution, for example, on registration numbers, some nanomaterials and ‘naturally occurring substances’.

There are well known ongoing SIEF concerns such as handling bogus members, communication problems and deciding whose joint submission is valid. In addition, there is potential for divergence on technical and scientific topics, such as the determination of derived no-effect levels (DNELs) and testing under the EU classification, labelling and packaging Regulation.

These issues have been discussed frequently in various fora, such as the EU Council of Ministers, the European Parliament, the European Commission and in REACH Implementation Projects (RIPs).

So many actors are involved in such decisions it can be difficult to establish common understandings and positions without help to understand how and when decisions have evolved.

The Commission’s initial legal text on reaction mixtures, for instance, was changed to enable the registration of substances in mixtures as manufactured, the RIP guidance granted flexible rules for managing separate constituents in substances and then the Commission working group changed the term to ‘reaction masses’ to facilitate distinctions.

Traceability

Thankfully, the Commission is stepping up to the job with a tracking document on interpretation issues on REACH.

It seems the appropriate actor to do this as it provides a crucial link between the European Chemicals Agency (ECHA), competent authorities, legislative processes and wider stakeholders.

This effort is not just recording current decisions; it helps to track previous Commission Working Group meetings that took place prior to establishment of the current forum for REACH and CLP competent authorities (CARACAL). Moreover, the document should link to other sources, such as justifications made during legislative decision-making and the original drafting of guidance in the RIPs.

ECHA’s role in all this should be clarified. Although it apparently cannot interpret legal requirements and thereby seems to sometimes distance itself from decision-making, it is critical that it provides analyses of the practical implications that decisions may have on regulators and industry.

Industry must be given sufficient opportunity to input and that doesn’t just mean contributing to impact assessments. Official recognition of documents already available from industry associations would be useful.

Before a decision is made that may significantly impact industry, it is appropriate to account for previous positions and interpretations.

If industry has already adopted a position on a topic that its members have been handling for several years this should be considered in decision-making. Similarly, if companies have been following advice from an official REACH helpdesk, this should be accounted for – at least during enforcement.

In my experience, many companies are reluctant to raise issues, because it results in uncertainty. Commission and CARACAL decision-making rules appear rather unclear and unpredictable. And it may be months (or even years) before resolution.

Yet, hope exists. Practical solutions have been found, for instance, agreement on a transition period for the new format of safety data sheets. Here, a common approach was adopted by regulators to give industry time to implement the change.

A similar discussion is ongoing concerning the deadline of 1 December 2010 for classification and labelling notifications and whether those submitted by 1 January 2011 will be accepted. A bit of scope for interpretation and creativity could easily reduce the numbers of notifications by an order of magnitude or more.

Parallel joint submissions

Another example concerns the inability to submit joint submissions for intermediates and non-intermediate substances in parallel. Here the aims of ‘one substance, one registration’ need to be remembered, in particular the political aims and business impact assessments that resulted in its adoption.

To ask a 2010 lead registrant that only ever plans to supply a substance as an intermediate to then be responsible for other companies’ non-intermediate registrations in 2013 (or 2018) will present extra challenges and costs and is likely to increase the number of opt-outs sought from joint registration. Separate joint submissions for the same substances should be allowed in these circumstances.

There is much potential for improving the efficiency and effectiveness of REACH implementation. Good communication on the issues and transparency on the path to reaching solutions are essential to prevent unintended consequences.

With the tight deadline of 2010, cutting repetition of effort and applying reason may prove critical to REACH implementation success.