Bad chemistry: Chemical companies fail to comply with EU regulations

May 18, 2017 - 06:49

Chemical companies are required to document that their chemicals are safe but the majority withhold or submit incomplete information to the European authorities, allowing dangerous substances to stay on the market.

Chemical companies under report health hazards of their products with serious consequences for public health, even if companies are not deliberately concealing data, shows a new EU report. (Photo: Shutterstock)

For the past ten years, it has been the responsibility of European chemical companies to ensure that their products do not contain substances that are harmful to human health or to the environment. To a large extent the system depends on trust and now it appears that this trust has been misplaced.

Chemical companies in Europe do not adequately report the harmful effects that their products could inflict on people and the environment. This means that we may be exposed to various types of dangerous substances, such as endocrine disrupting chemicals—substances that may interfere with the hormone system with negative side-effects for people and the environment.

So says Henrik Holbech, from the European Chemicals Agency’s (ECHA) expert group on endocrine disruptors. The information that chemical companies are obligated to submit to the agency about harmful substances in their products is often missing or wrong, he says.

“Unfortunately I can’t give concrete examples since the expert group’s work is confidential. But overall a lot of statutory data are missing. There’s also examples of data sitting with the chemical companies from studies that they conducted, but haven’t shared before we force them to do so. It’s very frustrating and a big problem for regulating harmful substances,” says Holbech.

In 2016, an ECHA test revealed that 72 per cent of company reports were missing important information on substances that they produce or import. Screening by German authorities in 2015 showed that just one of 1,814 so-called “data packs” that companies had submitted met the authority’s requirements.

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“An obstacle to protecting public health”
The Director of the EU's Chemicals Agency, Geert Dancet, is deeply concerned about the lack of data and demands that companies improve. (Photo: European Chemicals Agency (ECHA))

The situation is so bad that the director of ECHA, Geert Dancet, sent an email to the chemical industry in April 2017, demanding an immediate improvement so that the authorities could do their job.

Dancet wrote that “the failure of companies to comply with the requirements of EU chemicals legislation is a fundamental obstacle to ECHA's efforts to protect public health.”

If companies do not improve, then this will have severe consequences, he warns.

“The current data is simply insufficient to make a well-founded assessment of the risk of a chemical. This has two significant consequences: We waste our time hunting harmless substances and, far worse, may not prioritise the most worrying substances.”

The extent of this lack of information on chemicals in the market place, surprises the Danish Consumer Council THINK Chemicals.

“It’s unacceptable that companies report insufficient information on any effects of these substances, as the spot check shows. This must be the foundation of the EU’s work on chemicals, and it’s the companies’ responsibility. They owe us consumers, who eventually buy their goods, to live up to that responsibility,” says project manager Stine Müller.

For endocrine disrupters, companies are obligated to conduct a single test if they produce or import more than 1,000 tons of the substance a year. Therefore it is important that companies reveal all existing scientific data on the effects of endocrine disrupters. (Photo: Lauri Rotko, Det Europæiske Kemikalieagentur)

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Scientific data omitted

European companies have been obligated to submit all available and relevant scientific data to ECHA since 2007. This applies to chemicals that they produce themselves or import from other parts of the world.

But when the experts, including Holbech, reviewed the data packs it seemed that “very often” crucial scientific data on chemicals are missing.

“In the meantime we see that such data already exists, but the companies don’t share it, and this is especially problematic if they show harmful effects,” says Holbech.

“I don’t think that chemical manufacturers are trying to put harmful substances out into the market place. It’s probably more about taking advantage of the political uncertainty that still exists around many of these potential endocrine disrupting substances,” he says.

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Danish Environment Agency: It does not look like an honest mistake


Disturbed hormones

This article is part of series on endocrine disrupting chemicals (EDCs).

These are chemicals that can have harmful impacts on the body’s endocrine, or hormone, system.

Follow us over the coming weeks where we bring you the latest knowledge in the field, cover scientific disagreements, and establish why it is so difficult to avoid EDCs.

Bookmark the theme homepage to read more articles when they are available.

The Environment Agency in Denmark are well aware of the problem, says Marie Louise Holmer, who works with endocrine substance regulation in Denmark.

Chemical companies regularly try to avoid testing their chemicals by posting earlier decisions for other substances.

Her colleague, Magnus Løfstedt, who is responsible for The Danish Environment Ministry’s adoption of REACH legislation, suggests that some of the failures may be honest mistakes, but this is still problematic.

“I don’t want to argue that the rules are clear and we certainly find companies that trade in good faith, despite not complying with all the rules. But from this study on the quality of the data packs that they must submit, many companies clearly evade the rules regarding standard information requirements,” says Løfstedt.

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Many companies do their best

Chemical manufacturers and importers in Denmark are aware that data packs are not as good as they could be. But this does not mean that people are cheating the system, says Karin Klitgaard, head of environmental policy from The Confederation of Danish Industry.



Chemical companies are responsible for testing hazardous chemicals

European chemical law is designed to make companies aware of the harmful effects and to take the cost of testing away from tax payers.

The law is called REACH, which stands for Registration, Evaluation and Authorisation of Chemicals.

Companies are required to document that all substances produced or imported in quantities greater than one ton a year are safe.

This documentation is submitted to the ECHA.

The law was implemented in three stages, starting with substances over 1,000 tons, then 100 tons, and most recently down to one ton.

All documentation should be registered by June 2018.

See the full database of substance here.

“It’s not our experience that the data packs are deliberately neglectful. Our members spend an enormous amount of energy correctly registering and reporting substances. No one wants to make mistakes and send harmful substances out into the market place,” she says.

In fact, company’s want more control over the data packs, says Klitgaard.

“Those who don’t do it right, undermine the entire system and make the rest look bad. So we want ECHA to reveal the data packs that don’t meet their requirements and enforce the rules better,” she says and adds that REACH legislation was designed to prevent substances being sold if there was not enough information regarding their effects.

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Only five per cent of data have been checked

Right now, ECHA cannot do much to encourage companies to improve their data reporting, says Holbech.

ECHA have spot checked just five per cent of company reports and so there are probably many more undetected incidences. By the time ECHA becomes aware of any potential harmful effects, the products are already on the market, he says.

Hence the Danish Consumer Council THINK Chemicals would also like to see the rules tightened, though they regret that such steps are necessary.

“The REACH requirements should certainly be met and if they’re not, then the EU should have tools to ensure that they are. But it is of course sad that our authorities need to use extra time and resources to control rather than work more pro-actively for consumer safety,” says Müller.

Read the original article in Danish on

Translated by
Catherine Jex