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Dr Reach: Harmonisation on substance restrictions under REACH?

While industry is ramping up for REACH registration in 2010, Member State competent authorities will be grappling with new decision-making processes on evaluation and restriction.

These processes have got off to a slow start due to the transitional periods in the Regulation. The European Commission has been handing over its work from previous chemicals legislation to the European Chemicals Agency (ECHA), which must be finalised by June 2010.

So far, although evaluation formally started in June 2008 and restriction began in June 2009, Member States’ involvement has been minimal. Work has mainly followed through from the EU existing substances Regulation and the EU Directive on marketing and use restrictions.

Administration

Regulators including ECHA and the European Commission, have therefore not yet needed to be particular active in the area of inter-Member State decisions on evaluation and restriction, as the discussion has generally concerned administrative issues.

This is likely to change rapidly as decision making becomes substance-specific. I then expect differences in approaches to chemical risk management between Member States to become more evident.

No verdict yet on assessing and reducing risk

There will always be more than one way to assess and reduce a risk, none more correct than another. For instance, comparisons have been made between the Swedish model of requiring case-by-case authorisations for trichloroethylene with strict German technical standards. Which is better at controlling risk and fostering substitution? I think the jury is still out on that.

ECHA guidance documents for Member State competent authorities on evaluation and restriction read more like ‘textbooks’ than practical guides or rules on decision-making. However, even with standardised procedures and guidance, harmonised decision-making is not a given.

What is viable in achieving risk reduction in one Member State may differ significantly in another for a multitude of reasons, such as industry sector activity, operator training and enforcement infrastructure. What is deemed as an ‘acceptable’ or ‘tolerable’ level of risk can also vary, for instance due to socio-economic factors.

Secrecy

Moreover, Member States have their own national chemicals policies, environmental objectives and regulatory infrastructures that will continue to result in variations across the EU.

The minutes from ECHA meetings do not publicly report which Member States raise, comment or engage on issues, which means differences may not be so apparent. As an outsider, it becomes difficult to track and observe patterns of decision-making behaviours. And ironically, as a result of increased transparency, more discussions may be held as “closed sessions”.

Nevertheless, we know already of several areas of contrasting approach concerning, for example:

• national enforcement legislation (CW Briefing December 2009)
• interpretation of the 0.1% w/w concentration threshold for substances of very high concern (SVHCs) in articles (CW 22 January 2010)
• activity on SVHC nominations (CW 29 September 2009)

A comparison of chemical risk management approaches of four Member States prominent in EU decision making is shown in the table below which illustrates the variables involved.

Secrecy

Whether REACH actually introduces any significant changes to previous decision-making remains to be seen. Despite new meeting rooms, risk assessment tools and IT systems, cultural differences may prevail.

Member States should carry over experience from the Commission’s limitations working group, which handled restrictions under previous EU legislation, through the appropriate appointment of experts and good co-ordination activities with previous representatives. Otherwise, those responsible for decision-making may find themselves facing many of the same challenges in reaching agreement on risk assessment and management as their predecessors.

But differences between Member States should be recognised and respected. Decision making will need to account for this, which may lead to a new concept of ‘harmonisation’.

Ensuring a fair distribution of the workload

REACH does bring some innovations, such as the remuneration of authorities by ECHA for their work which will be a factor in their choice of workloads. I welcome comments from readers on how they see this operating in practice.

From my reading of the rules, ECHA will need to ensure that work is fairly distributed amongst Member States and that there are no ‘incentives’ for a Member State rapporteur to reach certain types of conclusion, for example, that further data are required, restriction followed by evaluation and so on.

Another significant change is the creation of ECHA’s Enforcement Forum. This group may become an important influence on the restrictions process, for instance in deciding suitable analytical techniques to implement standards and managing the interaction with other legislation such as that on toys, construction products and integrated pollution prevention and control.

Greater formality and openness

Another change is that under REACH, the procedures for consultation on proposals for restriction are both more formal and more open compared to the previous regime when consultation was often often limited between the Member State rapporteur and identified companies or industry groups.

So REACH will bring some some important changes compared with previous EU decision-making processes. But it will be for all stakeholders to make the most of the new system.