Companies leave gaps in chemical safety information

Chemical companies in Europe are not providing sufficient information on the hazards and risks of the substances they produce to ensure their safe use by citizens, says a report from the European Chemical Agency (ECHA), Europe’s chemical regulator.

In a report published on 27 February, the agency finds that companies are not complying with a new European Union (EU) law — REACH (registration, evaluation, authorization and restriction of chemicals) that came into force in 2006.

Nature first revealed problems with companies’ compliance with the law in July last year (see Data gaps threaten chemical safety law). At the time, Jukka Malm, director of regulatory affairs at the ECHA, told Nature: “Industry has not taken full responsibility for the quality of data.”

The ECHA says that it has identified “deficiencies” in the safety reports submitted by companies, which detail substances’ hazards, uses or potential exposures, risks and risk-management measures. Given the missing information, the “safe use of chemicals cannot be achieved”, the agency says.

In 2011, the ECHA checked 146 dossiers containing chemical-safety information submitted by companies as required by law. Of these, 134 lacked sufficient data and the ECHA had to request that companies fill these information gaps.

In particular, companies are not properly identifying the substances they produce. This “undermines the pertinence of the hazard information” supplied by companies and of information on how to use the substances safely, says the agency.

The ECHA calls on companies to “proactively” update and improve the quality of the information they have provided on the substances they produce.

Millions of animals spared from chemical safety tests

Tens of millions of animals could be saved from use in chemical-safety tests over the next eight years after Europe’s chemical regulator gave the go-ahead to a new streamlined study to assess the safety of substances.

European Union (EU) legislation requires companies to test the safety of the chemicals they produce in two generations of animals to assess the effects on their reproductive systems. Toxicologists were concerned that the testing requirement would mean up to 54 million animals would be used in chemical-safety studies to meet the requirements of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) legislation introduced in 2007 (see Chemical-safety costs uncertain).

A proposed new test would allow just one generation of animals to be used, with additional tests on a second generation required only if the first round raised concerns. The regulator, the European Chemical Agency (ECHA), based in Helsinki, had threatened to reject the test, saying that there is not yet enough evidence to rely on one-generation testing (see Streamlined chemical tests rebuffed).

But on 15 February, ECHA announced that it has now changed its mind in favour of the Extended One-Generation Reproductive Toxicity Study (EOGRTS). The agency says that the streamlined test will, “under certain conditions”, provide sufficient safety information to replace the two-generation reproductive toxicity study. It says it has already received around 230 proposals from companies to carry out the new test.  Clarifying its role, ECHA says, “Our role is neither to reject or generally approve test guidelines but to assess whether, and under which conditions, relevant new test guidelines could be applied to fill standard information requirements.”

The move comes after Nature revealed that chemical companies were not providing the safety data on reproductive and developmental toxicity REACH requires of them.  Nature also found that very few companies were proposing to carry out alternative non-animal tests, causing further concern that REACH would boost the number of animals used in toxicity testing.

Toxicologists say that allowing the streamlined test, which is quicker and cheaper to conduct, will encourage more companies to test their products.