Rachel's Precaution Reporter #69
Wednesday, December 20, 2006

From: EurActiv ...........................................[This story printer-friendly]
December 14, 2006


European Parliament shifts the burden of proof: businesses will now need to demonstrate the safety of thousands of chemicals.

[Rachel's introduction: Here's a good overview of the new European chemicals policy, called REACH, and the positions on REACH taken by various groups. Good summaries of the new law are available from the European Commission and from Greenpeace (here and here).]

A compromise deal on the proposed REACH regulation was adopted by [the European] Parliament on 13 December with 529 votes in favour, 98 against and 24 abstentions.

The package will now be forwarded to the EU [European Union] Council of Ministers for final approval on 18 December 2006 in what will be a formal rubber-stamping exercise.

The new rules, which will come into effect starting in June 2007, will require importers and manufacturers of chemicals to provide health and safety data for some 30,000 substances currently used in everyday products. These range from plastics used in computers and mobile phones to substances used in textiles, paints, furniture, toys and cleaning products.

All must be registered over an 11-year period within a new chemicals agency to be set up in Helsinki. The registration process will begin with the most toxic chemicals as well as those marketed in higher volumes.

Details of the compromise were unveiled on 1 December by Guido Sacconi, the Parliament's chief negotiator on REACH. Central to the agreement is the replacement of the most toxic substances with safer alternatives (EurActiv 4/12/06). If one exists at reasonable cost, dangerous substances will have to be replaced. If not, companies will need to produce either a substitution plan or an R&D plan to replace them at a later stage.

Despite warnings by environmental groups that the bill has been severely watered down after industry lobbying, MEPs [members of the European Parliament] managed to keep the fundamental part of the text intact -- the reversal of the burden of proof from authorities to businesses.

"Instead of national authorities having to justify concern about particular chemicals, the responsibility for proving that their products are safe will now rest with the manufacturers," said Chris Davies, environment spokesperson for the liberal democrats (ALDE).


The European Chemicals Industry Council (CEFIC) acknowledged the efforts made by EU institutions to arrive at a compromise acceptable to all stakeholders -- industry, downstream chemical users and environmentalists.

"The challenge during the legislative period has been to ensure the workability of the legislation, so that it can deliver real improvements," said CEFIC Director-General Alain Perroy. However, he regretted the "unnecessary requirements added to the authorisation element of REACH" relating to the substitution of dangerous substances.

"It will clearly add to costs," said Perroy who denounced the "illusion" that substitution could be governed by a "command and control approach". The end result will be "legal uncertainty" for business and, consequently, reduced investments and innovation, Perroy warned.

CEFIC said that efforts should now focus on implementing the new rules. Perroy called on EU institutions "to continue developing the technical guidance and instruments needed to secure the successful implementation of REACH. In this context, it will be of paramount importance to establish an efficient and cost-effective agency".

Small-business organisations said that they appreciated efforts made to ease the bureaucratic burden for SMEs by cutting down on safety assessments for substances produced in smaller quantities. But overall, small business organisation UEAPME said the result is "quite disappointing."

"The issues of data sharing and data liberalisation have been sidelined during the debate, and legal certainty on cost sharing is left to future guidelines. More could have been done," said Guido Lena, environmental policy director at UEAPME.

The European trade union confederation (ETUC) said that it welcomed progress made on the management of chemical risks, but condemned "the chemical industry's seven-year lobbying campaign to get the European institutions to scale down the reform".

In particular, ETUC said that information vital to protecting workers' health in chemical safety reports "will now only be required for a third of the chemicals originally planned."

ETUC however welcomed that the burden of proof is now firmly placed on producers to prove that their products are safe. "That marks clear progress, because industry will now have to provide information on the safety of their chemicals before they can put them on the market," said Joel Decaillon of ETUC.

Environmental organisations were doubtful about the compromise. On the positive side, Greenpeace and the WWF welcomed:

The fact that companies will now be responsible to prove the safety of chemicals produced or imported in large volumes (above 10 tonnes a year); that there is a mechanism to replace persistent and bioaccumulative chemicals if safer alternatives exist, and; that the public is allowed to request information about the presence of chemicals in products. But on the negative side, they pointed to "major loopholes". These include:

Less stringent safety requirements for carcinogens and chemicals which can cause birth defects and reproductive illnesses; substances imported in low volumes (below ten tonnes per year) for which "no meaningful safety data" will be required, and; provisions relative to 'high-concern' chemicals that will still be allowed onto the market if producers can prove that they can be "adequately controlled" when a "safe threshold" can be defined where their detection is considered as posing no threat to human health. "The approach of adequate control -- and safe thresholds -- is premised on a risky gamble, given the unknown effects of chemicals in combination, on vulnerable hormone functions, and on the development of children from the earliest stages of life," the organisations said.

Ultimately, they say a lot will depend on the new chemicals agency to be set up in Helsinki, Finland. "The new EU Chemicals Agency in Helsinki will have to be closely monitored to ensure that REACH can deliver," WWF said. "Without the necessary support, hazardous chemicals will continue to contaminate wildlife, our homes and our bodies, and REACH will prove a failure."

Latest & next steps:

18 December 2006: Council to formally rubber-stamp the agreement ('A' point to be adopted without debate).

June 2007: REACH regulation comes into force.

June 2008: European Chemicals Agency becomes operational, pre- registration phase starts.

June 2018: Registration phase closes with substances produced in smaller quantities (1-10 tonnes).


EU official documents

Parliament (Press release): Parliament adopts REACH -- new EU chemicals legislation and new chemicals agency (13 Dec. 2006)

Commission (Press release): REACH: Commission welcomes European Parliament vote on new EU chemicals legislation (13 Dec. 2006)

Commission: Q&A on the new Chemicals policy, REACH (13 Dec. 2006)

Political Groups

EPP-ED: REACH adoption welcomed: EPP-ED success on core issues (13 Dec. 2006)

PSE: Euro MPs adopt world's toughest curbs on dangerous chemicals (13 Dec. 2006)

ALDE: Making chemicals safer -- MEPs vote tomorrow for record breaking EU law (12 Dec. 2006)

Greens/EFA: REACH: EP rubberstamps weak deal with no guarantee of greater protection from hazardous chemicals (13 Dec. 2006)

GUE/NGL: REACH -- a new regulatory framework for chemicals (13 Dec. 2006)

EU Actors positions

CEFIC: European Chemical Industry committed to making REACH work (13 Dec. 2006)

European Association of Chemical Distributors (FECC): Press Release: "on Council political agreement on REACH" (13 Dec. 2006)

UEAPME: REACH: last-minute deal a step forward for simplification, a step back for SME formulators (13 Dec. 2006)

SME Union: REACH compromise less toxic for SMEs (12 Dec. 2006)

UNICE / CEFIC / Eurometaux / Orgalime: Implementation of REACH: a demanding challenge for EU industry (6 Dec. 2006)

European Trade Union Confederation (ETUC): European Parliament adopts watered-down REACH: a result for chemical industry lobbying (13 Dec. 2006)

WWF/ Greenpeace: REACH: Alive but not kicking (13 Dec. 2006)

Greenpeace: REACH in brief

Greenpeace: Flowchart on decision-making process

BEUC: REACH is not the end of the story (13 Dec. 2006)

European Small Business Alliance (ESBA): REACH vote in plenary - mixed result for SMEs (13 Dec. 2006)

Eurometaux: Further work is needed to make REACH workable for metals (Dec. 2006)

Unilever: Call for industry partners to join forces in order to make REACH a real success (13 Dec. 2006)

People for the ethical treatment of animals (PETA): Replace animal tests in massive, deadly programme (13 Dec. 2006)

Copyright EurActiv.com PLC


From: Medical News Today ..................................[This story printer-friendly]
November 11, 2006


[Rachel's introduction: "A precautionary approach, which is now beginning to be used in the EU, would mean that early indications of a potential for a serious toxic effect, such as developmental neurotoxicity, should lead to strict regulation, which could be relaxed, should subsequent documentation show less harm than anticipated".]

Exposure limits for chemicals should be set at values that recognise the unique sensitivity of pregnant women and young children, and they should aim to protect brain development, according to a Review this week.

Neurodevelopmental disorders such as autism, attention deficit disorder, and cerebral palsy are common, costly and can cause lifelong disability. One in every six children has a developmental disability and in most cases these disabilities affect the nervous system. The two main obstacles to preventing neurodevelopmental disabilities caused by chemicals are the great gaps in testing chemicals for developmental neurotoxicity and the high level of proof required for regulation.

A few industrial chemicals such as lead are recognised causes of neurodevelopmental disorders. Exposure to these chemicals during early fetal development can cause brain injury at doses much lower than those affecting adults. Recognition of these risks has given rise to evidence-based programmes of prevention, such as elimination of lead additives in petrol. Although, these campaigns are highly successful, most were initiated only after substantial delays, state Dr Philippe Grandjean (Department of Environmental Medicine, University of Southern Denmark, Odense, Denmark) and Dr. Philip Landrigan (Department of Community Medicine, Mount Sinai School of Medicine, New York, NY, USA).

In the EU, 100 000 chemicals were registered for commercial use in 1981 and in the USA 80 000 are registered. Of the chemicals most commonly used in commerce, fewer than half have been subjected to even token laboratory testing. The few substances proven to be toxic to human neurodevelopment should therefore be viewed as the tip of a very large iceberg.

Dr Grandjean concludes: "The vulnerability of the human nervous system and its special susceptibility during early development suggest that protection of the developing brain should be a paramount goal of public health protection.

A precautionary approach, which is now beginning to be used in the EU, would mean that early indications of a potential for a serious toxic effect, such as developmental neurotoxicity, should lead to strict regulation, which could be relaxed, should subsequent documentation show less harm than anticipated".


Contact: Dr Philippe Grandjean, Department of Environmental Medicine, University of Southern Denmark, Winslowparken 17, 5000 Odense C, Denmark .


From: NewScientist.com News Service ......................[This story printer-friendly]
December 15, 2006


[Rachel's introduction: "We have grave concerns about the trend for caesareans," says Sakala. "Instead of going full-steam ahead, shouldn't we be calling on the precautionary principle?"]

By Roxanne Khamsi

The massive surge in the maternal hormone oxytocin that occurs during delivery might help protect newborns against brain damage, a new study in rats suggests.

Researchers say the findings should encourage scientists to investigate whether elective caesarean sections, which lack this oxytocin surge, disrupt normal brain development.

Yehezkel Ben-Ari, a neuroscientist at the Mediterranean Institute of Neurobiology in Marseille, France, and colleagues compared brain tissue samples from rat pups born naturally or by caesarean section. Brain cells from the naturally born pups did not fire in response to the nerve signalling chemical GABA, the researchers found.

By comparison, at least 50% of the sampled cells from rats delivered by caesareans responded to the GABA signals.

When the team gave pregnant rats atosiban -- a drug that specifically blocks oxytocin's effects -- the brain cells from these rats were easily excited by GABA. This revealed that oxytocin was the hormone that made neurons from naturally delivered pups less receptive to GABA.

Natural safety net

Oxytocin levels surge dramatically during labour -- partly due to the pressure exerted by the baby's head on the cervix -- along with other hormones such as prostaglandins.

Ben-Ari believes that by "quieting" cells, oxytocin may prevent brain damage due to oxygen deprivation that can occur during labour. In fact, they found that the brain cells of rat pups delivered naturally lived for an hour when placed in a solution that lacked oxygen. Brain cells from pups with a mother whose oxytocin was blocked by atosiban lived only 40 minutes.

By making cells less responsive, oxytocin reduces the oxygen they require for energy production, the team says. The hormone could provide a natural, temporary safety net to avoid damage from lengthy or difficult deliveries, says Ben-Ari.

"It's like putting a television in standby mode to reduce energy consumption," explains team member Rustem Khazipov.

Missing out?

Intense exposure to oxytocin during natural delivery might also encourage brain cell maturation, says Ben-Ari. He wonders if babies born by elective caesarean section miss out. "I think the oxytocin and other hormones the mother is providing are important -- we should not ignore them," he says.

In many places the rate of caesarean deliveries is going up. According to the US National Institutes of Health, the rate has increased 40% over the last decade and now accounts for three deliveries in every 10. This is partly due to a rise in the number of women having elective caesareans, rather than for emergency delivery purposes.

"This is exactly the kind of study that gives me pause," says Carol Sakala, director of programs at the New York-based Childbirth Connection, a maternity care advocacy group. "We have grave concerns about the trend for caesareans," says Sakala. "Instead of going full- steam ahead, shouldn't we be calling on the precautionary principle?"

But others say it is too soon to view these findings as reason to avoid c-sections wherever possible. "It is premature to translate these findings into clinical practice for women," says Cynthia Chazotte at the Albert Einstein College of Medicine in New York.

"While the fetuses delivered by elective caesarean will not have the protective effect of oxytocin, they presumably will not be at the same risk for [oxygen deprivation] as fetuses exposed to the stresses of labour," says Ashley Roman at the New York University School of Medicine. "I don't think that these results can be used to counsel patients against elective caesarean delivery," she adds.


Rachel's Precaution Reporter offers news, views and practical examples of the Precautionary Principle, or Foresight Principle, in action. The Precautionary Principle is a modern way of making decisions, to minimize harm. Rachel's Precaution Reporter tries to answer such questions as, Why do we need the precautionary principle? Who is using precaution? Who is opposing precaution?

We often include attacks on the precautionary principle because we believe it is essential for advocates of precaution to know what their adversaries are saying, just as abolitionists in 1830 needed to know the arguments used by slaveholders.

Rachel's Precaution Reporter is published as often as necessary to provide readers with up-to-date coverage of the subject.

As you come across stories that illustrate the precautionary principle -- or the need for the precautionary principle -- please Email them to us at rpr@rachel.org.

Peter Montague - peter@rachel.org
Tim Montague - tim@rachel.org


To start your own free Email subscription to Rachel's Precaution Reporter send a blank Email to one of these addresses:

Full HTML edition: join-rpr-html@gselist.org
Table of Contents edition: join-rpr-toc@gselist.org


Environmental Research Foundation
P.O. Box 160
New Brunswick, N.J. 08901