REACH Data Quality Comes Under Renewed Fire

Having a complete picture of which substances must be risk managed, and which measures are most appropriate, will only be achieved once REACH registration dossier have high quality, complete data on hazards and risks and up to date information on a substance’s uses, experts say.

In her article in this month’s Global Business Briefing entitled: REACH revolution at a crossroads, Chemical Watch CEO Mamta Patel says the "inescapable conclusion" is that many companies have done a poor job in providing adequate safety data.

The article quotes Echa head Geert Dancet’s recent comments at Echa’s tenth anniversary celebrations that "the detailed work of member states and Echa can only really begin when we have all the data. Only then can regulators judge whether a substance is of concern or not...At the moment this is not easy to do."

Echa says it lacks the information to decide what risks are posed by 3,000 of the 4,500 substances manufactured or imported by companies in volumes above 100 tonnes per year or notified under the previous EU new chemicals regime. And for 2,000 of these, their registration dossiers suggest some exposure is likely but the hazard properties are unclear.

REACH principles not applied

At the same event, head of the European Environmental Bureau Jeremy Wates warned that "there are very real problems with the slow pace of roll-out of REACH." When companies are awarded a registration number - whether or not they have complied with the data requirements - key principles of REACH, such as ‘no data, no market’ and ‘reversing the burden of proof’, are not, he said, being applied.

This situation, in turn, causes delays in other processes, such as substance evaluation, says ClientEarth’s Vito Buonsante,. When member state authorities select substances to examine, they see the holes in the data and instead send the dossiers to Echa for compliance checking.

The way REACH is implemented "gives perverse incentives to companies to drag their feet...companies are rewarded for having submitted poor data by winning more time to comply,"

Registrants faced big challenges

Cefic’s Erwin Annys agrees there is a data quality gap but says companies faced significant challenges in meeting the 2010 registration deadline. Many companies, says the chemical industry, lack the resources, motivation or in-house expertise of some multinationals.

Consequently, most dossiers have never been updated, as required by the Regulation. This will only happen, says Rainer Otter, head of regulatory affairs for BASF’s industrial petrochemicals business, when a legal obligation to do so is inserted into the REACH legal text.

Bjorn Hansen, head of DG Environment’s chemicals unit, says Echa should view dossiers with inadequate data as non-compliant rather than poor quality, and use its legal powers to bring them into compliance. He has suggested to Echa that it could speed things by conducting compliance checks at the same time as substance evaluations.