INSIGHT: ECHA shows how the EU might identify more toxic substances

10 December 2013 16:49  [Source: ICIS news]

By Nigel Davis

LONDON (ICIS)--“It is in the authorisation process that the complexity of Reach is becoming increasingly evident across the entire supply chain,” European industries from chemicals to aerospace said earlier this year.

A wide range of manufacturers and producers were reacting to the growing complexity of the EU chemicals registration and authorisation programme, Reach, and the impact the authorisation process for certain substances was having down supply chains even as far as recycling.

In February, the European Commission had issued its ‘Roadmap on Substances of Very High Concern’ a document which laid out the EU’s objectives for identifying more substances of very high concern (SVHCs) the use of which might in future be restricted.

The substances might include largely unrecognised carcinogens and mutagens, or persistent or bioaccumulative chemicals, used in industry and commerce. The Commission showed that the regulatory net was being widened to encompass certain endocrine disruptors, respiratory and skin sensitizers.

The chemical industry particularly, but increasingly other participants in often complex supply chains, have this year begun to feel the impact of Reach with not only the second, of three, registration deadlines, but also the gearing up of the Reach evaluation and authorisation process that is the ultimate goal of the chemicals control legislation.

The overarching aim of Reach is to make the EU a safer place for its citizens and to avoid unnecessary exposure to toxic chemicals.

As the Reach process has moved from initial substance registration through evaluation of the available toxicity and other data by the European Chemicals Agency (ECHA) and EU member states, the burdens on industry, financial and otherwise, as well as the implications of authorisation have become more widely apparent.

The ECHA manages, for instance, a ‘Candidate List’ of substances that are being considered for authorisation under Reach. The inclusion of a substance on that list has, not surprisingly, caused problems in the marketplace for producers and users, whether or not the substance is eventually authorised for sale.

The EU wanted to have 136 substances on the Candidate List by the end of 2012 and Member States, the Commission and the ECHA managed to identify 138 SVHCs.

The commitment now is to the 2020 SVHCs Roadmap which lays out how a greater number of potentially harmful substances might be identified and the processes required to deal with them.

There are no numerical targets in the roadmap but it has been suggested that as many as 440 substances could fall into the SHVCs category – a number which might cause a headache for the agency.

Industry is supportive of the roadmap idea but wants a transparent and predicable system which can avoid disruption in supply chains.

The ECHA on Monday released its SVHC roadmap implementation plan which, it says, foresees the use of screening methods and Risk Management Option (RMO) analyses to identify relevant SVHCs.

The ECHA will cast its net wide when it looks for SHVCs including its Reach and chemicals labelling and packaging (CLP) legislation databases.

The RMO analysis is seen by industry as crucial to the handling of potential SVHCs. “This RMO analysis should always take place before a substance is proposed to be placed on the Candidate List,” the industries said in March.

Industry does not believe that authorisation is necessarily the best risk management option considering the “black-list effect” of the list and suggests that restriction of use might in some cases be more appropriate.

“Experience has shown that an effective RMO is only possible in consultation with industry along the entire supply chain.” If that is not the case it sees the potential for major and unpredicted consequences.

The ECHA has worked to allay some of those fears. “Communication towards stakeholders and the public in general is another element considered important in the 2020 SVHC Roadmap,” it says in its implementation plan.

“Transparency on the objectives and activities will support the acceptability of the implementation work and increase its predictability,” it adds.

“Clarity on the aim of the authorities’ work and openness on the status of the substance in the process should also help avoiding the ‘black-list’ effect for substances under scrutiny,” the ECHA says.

Industry certainly wants greater clarity in the roadmap process and while the ECHA implementation plan goes some way to providing that it can only be seen as work in progress.

By: Nigel Davis
+44 20 8652 3214

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