INSIGHT: SMEs need more help with EU demands for Reach safety data

31 May 2013 16:03  [Source: ICIS news]

By Nigel Davis

LONDON (ICIS)--Two down and one to go, but it doesn’t get any easier. The second registration deadline for the EU’s gargantuan chemicals control legislation, Reach (Registration, Evaluation and Authorisation of Chemicals), is on Sunday (31 May). This phase of the process to register, evaluate and eventually authorise for sale chemicals in the EU has swept up substances in the 100 tonnes to 1,000 tonnes of annual production band, a great number of specialty and smaller volume fine chemicals.

The burden of collecting and collating health and safety data has fallen largely on Europe’s army of small to medium sized chemical producers (SMEs). The fewer the number of producers or importers of a particular substance the greater the cost burden has been.

Indeed, the cost of registration has risen to surprisingly high levels with many complaints about the cost of letter of access to substance information held by closed groups of producing/selling companies in Substance Information Exchange Forums, or SIEFs.

The large industry trade associations and the executive arm of the EU, the European Commission, have become concerned about registration costs and are looking at ways of reducing the burden.

And Germany’s chemicals trade association, the VCI, highlighted the fact this week that there has been no break for companies in Reach (implementation.

“During the second registration period under Reach, the workload and time pressure were immense for the companies – especially for small and medium-sized enterprises,” said the VCI’s director of science, technical and environmental affairs, Gerd Romanowski, this week.

More than 32,000 registration dossiers covering nearly 6,500 different substances have been submitted to the European Chemicals Agency (ECHA) under the Reach rules to date, the VCI says.

More than 8,000 of those registrations, for over 3,500 substances, have originated in Germany.

Germany’s is a €186bn ($242bn) turnover chemical industry and the VCI represents 1,650 companies of German and foreign origin.

The ECHA will announce the results of the second Reach deadline on Monday (3 June) but the statistics up to 25 May showed that the agency was expecting the registration of 3,102 new substances.

This was the number of substances indicated in a survey of potential registrants, although the registrants of more than 500 companies could not be identified. The VCI data include these ECHA statistics.

The agency has given potential registrants a great deal of help but the complexity of the task, and the time it takes to prepare a registration dossier, have been criticised.

The VCI and other trade associations in Europe are most concerned about the impact on smaller chemical operations, in other words on the vibrancy and diversity of the European chemical sector.

The ECHA says a medium-sized chemical company is one with fewer than 250 employees and a turnover of less than €50m. A small company has fewer than 50 employees and an annual turnover of less than €10m. Micro concerns are defined as having fewer than 10 employees and an annual turnover of less than $2m. Clearly, they are dwarfed by the industry giants.

These smaller enterprises need to get working on the next step of Reach, or rather working towards the next registration deadline of 31 May 2018, which is for substances sold in the EU in the 1-100 tonnes/year band.

“This phase of Reach implementation, too, is going to make heavy demands on SMEs,” Romanowski said.

“The registration costs for low volume chemicals are relatively high, as compared with sales.”

By far the majority of chemical firms in Germany (93% of the 2,000 plus concerns) are identified as SMEs.

At least these companies’ worries have not been ignored with calls for more consideration of the challenges SMEs face from Germany’s regulatory control council, Normenkontrollrat (NKR), and other groups.

“SMEs in the chemical industry need direct contact persons at ECHA,” according to Romanowski.

“Moreover, possibilities for dossier submission and information requirements should be simplified and tailored to the lower volume band. Here, online registrations could be one example.”

Companies have found communication along supply chains difficult, particularly with extended data sheets for the substance concerned.

European Commission-sponsored studies have shown that these safety data sheets are seen as “overly comprehensive and rather unintelligible, both by those compiling them and by users,” the VCI says.

“Industry and competent authorities should jointly agree the further course of action, said Romanowski.

“Primarily, this is about simplifying and harmonising the approach for safety data sheets – in order to make them more manageable also for SMEs.”

($1 = €0.77)

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By: Nigel Davis
+44 20 8652 3214



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