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Rachel's Precaution Reporter #69

"Foresight and Precaution, in the News and in the World"

Wednesday, December 20, 2006.........Printer-friendly version
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Table of Contents...

REACH Chemicals Law Adopted amid Final Controversy
  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 Precautionary Approach To Protect Pregnant Women from Chemicals
  "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".
Should Precaution Be Applied To Caesarean Births?
  "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?"


From: EurActiv, Dec. 14, 2006
[Printer-friendly version]


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

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

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

"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

"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

"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

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

"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.

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.

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

Return to Table of Contents


From: Medical News Today, Nov. 11, 2006
[Printer-friendly version]


Precautionary Approach Suggested To Protect Pregnant Women
And Children Against Industrial Chemicals

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

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

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 .

Return to Table of Contents


From: NewScientist.com News Service, Dec. 15, 2006
[Printer-friendly version]


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

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.

Return to Table of Contents


  Rachel's Precaution Reporter offers news, views and practical
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