Tag Archives: Chemical saftey

Europe’s chemical safety law reviewed

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The world’s most extensive chemical safety regulation, implemented five years ago in Europe, is working well, according to a review published today by the European Commission.

The law, known as REACH (registration, evaluation, authorization and restriction of chemicals), requires companies that produce or sell chemicals in the European Union (EU) to register toxicity data on the compounds and to outline any new tests needed to clarify their biological effects.

According to the review, the law has improved the available information about chemical substances on the market and upgraded risk management measures implemented by companies, thereby reducing the risks these substances pose to the EU population, the review says.

REACH is also making EU citizens feel safer — 61% of people interviewed in a survey of more than 25,000 said that chemicals are safer now than they were ten years ago.

Janez Potočnik, EU commissioner for the environment, said: “This report shows that REACH works. Companies are facing their responsibilities and as a result we have better data about the chemicals they produce and place on the market.”

But the report concedes that it is still too early to quantify the benefits of the regulation. The commission’s conclusions are based mainly on examination of initial trends and qualitative information.

Improvements to the law’s implementation are also needed, it says. These include reducing the registration and processing fees for small business to more evenly spread the financial burden of the regulation. The review also found that member states need to make more effort to ensure that companies comply with the law.

Nature has previously reported on a host of problems that have plagued REACH. Among those issues was that European companies were not providing robust information on the safety of chemicals, and that they were avoiding proposing expensive animal tests.

Animal-welfare groups criticized the review, adding that the law has failed in its goal of promoting alternatives to animal experiments. In a statement, the London-based European Coalition to End Animal Experiments said, “We are seeing routine additional requests for animal tests in some areas, and a lack of leadership… on the promotion of alternative methods that already exist.”

Millions of animals spared from chemical safety tests

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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.