News 17 juni 2009
Depression Medications May Reduce
Male Fertility
As many as half of all men taking the antidepressant medication paroxetine (trade names
Seroxat, Paxil) may have increased sperm DNA fragmentation -- a predictor of compromised
fertility. Research led by NewYork-Presbyterian Hospital/Weill Cornell Medical Center also
found that the changes are reversible with normal levels of sperm returning after
discontinuation of the drug. The study is currently published in the online edition of the
journal Fertility & Sterility, and represents one of the first scientific
investigations into the effect of antidepressants on sperm quality. "It's fairly well
known that SSRI antidepressants negatively impact erectile function and ejaculation. This
study goes one step further, demonstrating that they can cause a major increase in genetic
damage to sperm," says Dr. Peter Schlegel, the study's senior author. "Although
this study doesn't look directly at fertility, we can infer that as many as half of men
taking SSRIs have a reduced ability to conceive. These men should talk with their
physician about their treatment options, including non-SSRI depression medications."
Dr. Schlegel is chairman of the Department of Urology and professor of reproductive
medicine at Weill Cornell Medical College, and urologist-in-chief at NewYork-Presbyterian
Hospital/Weill Cornell Medical College. The study followed 35 healthy male volunteers who
were given paroxetine, a selective serotonin reuptake inhibitor (SSRI), for five weeks.
The drug was used because of its relatively short half-life and because it has previously
shown to exert the strongest effect in delaying ejaculation. DNA fragmentation, defined as
missing pieces of genetic code in the sperm DNA, was measured using an assay called
terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL). Results showed that
the percent of participants with abnormal DNA fragmentation rose from less than 10 percent
to 50 percent while taking the drug. DNA fragmentation, the authors note, is known to
correlate with poorer fertility and pregnancy outcomes, even when techniques such as in
vitro fertilization and intracytoplasmic sperm injection are applied. It has also been
linked with an increased risk for birth defects.
Researchers Identify DNA Mutation
That Occurs At Beginning Point of T Cell Lymphoma
Researchers at the Keck School of Medicine of the University of Southern California (USC)
have identified a key mechanism that causes chromosomes within blood cells to
break—an occurrence that marks the first step in the development of human lymphoma.
The study provides researchers with the clearest insight yet into why these
breakages—called chromosomal translocations—occur at a specific points in the
chromosome, says principal investigator Michael R. Lieber, M.D., Ph.D., Rita and Edward
Polusky Professor in Basic Cancer Research at the Keck School of Medicine.The study
appears as the featured cover article in the June 12 issue of the journal Molecular Cell.
The study is the second led by Lieber to appear on the cover of a Cell journal in the past
six months. “The new findings go to the heart of why cancers begin. This is an
opportunity to see the very beginning step of human lymphoma,” Lieber says.
“With this information, we can now begin to look at ways to interfere with this
process in order to stop the lymphoma and to develop more targeted therapies for
treatment.” There are two types of lymphoma: B cell lymphomas and T cell lymphomas.
Both B cells and T cells perform vital functions in the immune system by creating
antibodies and destroying virus-infected cells. However, the beginning point, or
inception, of most human lymphomas occurs when two chromosomes break and the resulting
fragments are reassembled in an exchange. Researchers specifically looked at T cell acute
lymphoblastic lymphomas (ALL). ALL accounts for half of all childhood cancers under the
age of five, and T cell ALL represents about 10 percent of ALL. The USC scientists
identified a specific enzyme known as the RAG complex that occasionally cuts the
chromosome at an off-target site, causing lymphocyte (blood) cells to proliferate
uncontrollably. They showed that the RAG complex selects the wrong target largely because
the proteins in which the wrong chromosome is wrapped (called chromatin) lures the RAG
complex to the wrong site.
Laptops Linked to Male Infertility
While fatherhood might be far from the minds of most young men, behavior patterns they
establish early on may impact their ability to become a dad later in life. Excessive
laptop use tops this list of liabilities, according to one reproductive specialist at
Loyola University Health System (LUHS). "Laptops are becoming increasingly common
among young men wired into to the latest technology," said Suzanne Kavic, MD,
director of the division of reproductive endocrinology at LUHS and associate professor in
the department of obstetrics and gynecology and department of medicine at Loyola
University Chicago Stritch School of Medicine. "However, the heat generated from
laptops can impact sperm production and development making it difficult to conceive down
the road." Kavic recommends placing laptops on desktops to prevent damaging sperm and
decreasing counts and motility.
Chemical in Blood May Explain
Susceptibility to Bladder Pain
Marker in the blood of both cats and humans that was identified in a recent study might
signal both species' susceptibility for a painful bladder disorder called interstitial
cystitis, a condition that is often difficult to diagnose. Follow-up studies of the
chemicals that appeared in blood samples suggest that the way tryptophan, an essential
amino acid, is processed in cats and humans with interstitial cystitis ultimately could
affect the way signals are transmitted in the brain. The results, while preliminary,
suggest that the disease is not just a malfunction of the bladder, but might instead have
origins in the central nervous system, researchers say. Symptoms of interstitial cystitis,
known as IC, include recurring discomfort or pain in the bladder and pelvis, and often
both an urgent and frequent need to urinate. A diagnosis typically follows tests to rule
out other diseases, such as infections or cancer. No diagnostic test currently exists for
IC, and the cause is unknown. Treatments range from oral medications to exercise for
humans, and maintaining a safe environment for cats."What we know now is that this
testing method is very sensitive and specific for the disorder in both humans and domestic
cats. So far it hasn't missed one diagnosis," said Tony Buffington, senior author of
the study and professor of veterinary clinical sciences at Ohio State University.
Chronic Infection Now Clearly Tied
to Immune-System Protein
The reason deadly infections like human immunodeficiency virus (HIV) and hepatitis C never
go away is because these viruses disarm the body’s defense system. Researchers at the
University of Alabama at Birmingham (UAB) have discovered that a key immunity protein must
be present for this defense system to have a chance against chronic infection. Research up
to now has tried but failed to decipher the cross-talk between ‘killer T-cells’
and ‘helper T-cells’ in the fight against viruses. The new UAB study finds this
cross-talk can only happen in the presence of interleukin-21, a powerful immune system
protein. If interleukin-21 is missing for whatever reason, then the immune system’s
anti-viral efforts fail, said Allan Zajac, Ph.D., an associate professor in UAB's
Department of Microbiology and lead author on the study. The findings are published in the
journal Science. “Adding interleukin-21 back in stimulates the immune response and
controls the infection,” Zajac said. “We demonstrate that the loss of this
protein prevents the control of the infection and diminishes the function of the killer
T-cells, specifically CD8 T-cells.” The study mice were treated for lymphocytic
choriomeningitis, a viral infection of the membranes surrounding the brain and spinal
cord. Measurements were taken for two types of T-cells, CD4 and CD8 T-cells, before and
after the mice were treated with interleuikin-21.
Predicting Fatal Fungal Infections
In a study published in The Journal of Infectious Diseases, researchers from Albert
Einstein College of Medicine of Yeshiva University have identified cells in blood that
predict which HIV-positive individuals are most likely to develop deadly fungal
meningitis, a major cause of HIV-related death. This form of meningitis affects more than
900,000 HIV-infected people globally—most of them in sub-Saharan Africa and other
areas of the world where antiretroviral therapy for HIV is not available. A major cause of
fungal meningitis is Cryptococcus neoformans, a yeast-like fungus commonly found in soil
and in bird droppings. Virtually everyone has been infected with Cryptococcus neoformans,
but a healthy immune system keeps the infection from ever causing disease.
Good news for some hard-to-treat
hepatitis C patients
In a multi-center trial led by a Saint Louis University researcher, investigators found
that a new combination therapy of daily consensus interferon and ribavirin helps some
hepatitis C patients who have not responded to previous treatment. The findings, published
in the June issue of Hepatology, offer a new option for hepatitis C patients, and may be
effective even for those patients with factors that make their condition difficult to
treat. "This represents an important advance for difficult to treat hepatitis C
patients who have failed to respond to traditional therapy," said Bruce Bacon, M.D.,
director of the division of gastroenterology and hepatology at Saint Louis University
School of Medicine and co-director of the Saint Louis University Liver Center . About 4
million people in the U.S. have been infected with hepatitis C; an estimated 10,000 to
12,000 people die from complications each year in this country. Hepatitis C is caused by a
virus, transmitted by contact with blood, and may initially be asymptomatic. For patients
who develop chronic hepatitis C infection, inflammation of the liver may develop, leading
to fibrosis and cirrhosis (scarring of the liver), as well as other complications
including liver cancer and death. For patients with chronic hepatitis C, the prognosis
varies. About half fully recover after an initial course of pegylated interferon and
ribavirin anti-viral therapy that may last from six months to a year.
Test detects molecular marker of
aging in humans
In 2004, researchers at the University of North Carolina at Chapel Hill Lineberger
Comprehensive Cancer Center announced a crucial discovery in the understanding of cellular
aging. They found that as cells and tissues age, the expression of a key protein, called
p16INK4a, dramatically increases in most mammalian organs. Because p16INK4a is a tumor
suppressor protein, cancer researchers are interested in its role in cellular aging and
cancer prevention. Now the team has proven that the same biomarker is present in human
blood and is strongly correlated both with chronological age and with certain behaviors
such as tobacco use and physical inactivity, which are known to accelerate the aging
process. In a paper published online ahead of print in the journal Aging Cell, the
researchers reported that they have solved technical hurdles to develop a simple blood
test to detect p16INK4a expression, which is present in cells called T-lymphocytes, also
known as T-cells. "This is a major step toward a practical tool to clinically
determine a person's actual molecular, as opposed to just their chronological age,"
said UNC Lineberger member Norman Sharpless, M.D., the senior author of the study and
associate professor of medicine and genetics at UNC's School of Medicine. They validated
the test by obtaining blood from two groups of healthy human volunteers, totaling 170
subjects, who also filled out a questionnaire about current and past health status and
health behaviors. They found that expression of the biomarker was strongly correlated with
the donor's chronological age and, in fact, increased exponentially with age. In addition,
increased levels were independently associated with tobacco use and physical inactivity as
well as with biomarkers of human frailty.
RNA snippet suppresses spread of
aggressive breast cancer
A low cellular level of a tiny fragment of RNA appears to increase the spread of breast
cancer in mouse models of the disease, according to researchers at Whitehead Institute for
Biomedical Research. Measuring levels of this so-called microRNA, which is also associated
with metastatic breast cancer in humans, may more accurately predict the likelihood of
metastasis (which accounts for 90% of cancer-related deaths) and ultimately help determine
patient prognoses. In the study, whose results are reported in the June 12 issue of Cell,
Scott Valastyan, a graduate student in Whitehead Member Robert Weinberg's laboratory,
screened patient breast cancer samples for microRNAs with potential roles in metastasis.
MicroRNAs are single strands of RNA about 21-23 nucleotides long. Within a cell, a single
microRNA can fine-tune the expression of dozens of genes simultaneously. This capability
could be particularly important in metastasis, a multi-step process that could be
influenced by a single microRNA at several points. The screened samples were classified as
either metastatic cancer or non-metastatic cancer. After analysis, the microRNA miR-31
stood out because of its inverse correlation with metastasis. In samples where a patient's
original tumor had not metastasized, the cancer cells retained high levels of the
microRNA. But where the tumor had metastasized, the cancer cells came to possess lower
levels of miR-31. The functional role of miR-31 in metastasis regulation was then
confirmed in mice. When Valastyan removed miR-31 from normally non-aggressive breast
cancer cells and implanted those cells into mice, the cells formed highly aggressive
tumors. Mice injected with the cancer cells lacking miR-31 had 6 to 10 times more cancer
cells that metastasized to their lungs than did their counterparts implanted with
unmodified cancer cells.To see how increasing miR-31 levels could affect metastasis,
Valastyan introduced miR-31 into breast cancer cells that readily metastasize. After
injecting these altered cells into mice, the mice had four to 40 times fewer metastases
than mice injected with the unaltered cells. Valastyan says that quantifying miR-31 levels
in a patient's cancer cells could one day support a more accurate prognosis. Currently,
breast cancers are divided into three major categories, two of which are typically
associated with poor prognoses. "This microRNA seems to be quite unique, in that it
seems to provide some prognostic utility across these existing subclassifications [of
cancers]," says Valastyan. A better-defined prognosis could help patients determine
whether they might benefit from poorly tolerated cancer therapies.
The anti-consumption movement -
Researchers examine resistance to global brands
What motivates people to rebel against global brands—or consumption in general? A new
study in the Journal of Consumer Research examines the connection between nationalism and
the anti-consumption movement in India. Authors Rohit Varman (Indian Institute of
Management, Calcutta) and Russell W. Belk (York University, Toronto) examined a movement
against Coca-Cola based in the village of Mehdiganj in the Indian state of Uttar Pradesh.
They found that the movement employs a version of the nationalist ideology of swadeshi, an
ideology that has been associated with Ghandhi and the overthrow of British colonialism.
"According to swadeshi, indigenous goods should be preferred by consumers even if
they are more expensive and inferior in quality," write the authors. "The
contemporary processes of globalization have again unleashed a resurgence of opposition,
this time involving neo-nationalism. As a result, the ideology of swadeshi continues to
shape the ongoing debate about the concept of nationhood in India." The researchers
examined the practices of organizations involved in the struggle against Coca Cola. They
conducted interviews with activists, villagers, and Coca Cola workers and managers. They
observed protest activities and analyzed written material on the movement.
The freebie dilemma - Consumers are
skeptical about 'free' products
It's common for retailers to bundle two different products (like razors and blades)
together and describe one as free. A new study in the Journal of Consumer Research shows
that this strategy leads consumers to devalue the items when they're sold individually.
Authors Michael A. Kamins (Stony Brook University-SUNY), Valerie S. Folkes (University of
Southern California), and Alexander Fedorikhin (Indiana University) found that describing
a bundled item as free decreases the amount consumers are willing to pay for each product
when sold individually. They call this the "freebie devaluation" effect.
"Why does a freebie decrease the price consumers are willing to pay for each
individual product? Our research shows that consumers tend to make inferences about why
they are getting such a great deal that detract from perceptions of product quality,"
the authors explain. "For example, consumers figure the companies can't sell the
product without this marketing gimmick." The authors also found exceptions to the
"freebie devaluation" rule. For example, when the researchers explained that the
products were paired so consumers would become familiar with the freebies, they were
willing to pay more.
'Shortcuts' of the mind lead to
miscalculations of weight and caloric intake, says Penn study
Psychologists at the University of Pennsylvania have identified a cognitive shortcut, or
heuristic, they call "Unit Bias," which causes people to ignore vital, obvious
information in their decision-making process, points to a fundamental flaw in the modern,
evolved mind and may also play a role in the American population's 30 years of weight
gain. Researchers who focus on the cognitive aspects that contribute to obesity conducted
several studies with college-age participants in which the subjects were asked to estimate
the weight of adult women from either photographs or a live presentation by models. Other
student participants were asked to estimate the calories in one of two actual meals. Both
meals contained the same foods, but one had larger portion sizes than the other. The
results demonstrated that when estimating the body weight of women, participants
apparently disregard or ignore the provided height information and focus solely on the
width of the model. In certain instances, researchers would inflate the provided height
information of the models as much as 10 inches, though that did not alter participants'
estimates of the models' weights. When estimating calories, study participants assumed
portion sizes were culturally typical and guessed no caloric differences between small and
large portions. The findings are akin to asking a room full of people to calculate the
volume of a box when given only the height and width and no one asks for the length. Or,
more accurately, the length is provided and no one pays attention to that one, crucial
dimension, thereby making it impossible to arrive at the correct answer. The study
suggests that there are situations where critical dimensions to understanding are devalued
or ignored. The paper examines different circumstances discovered by researchers where
single dimensions dominate multidimensional judgments. In these studies specifically,
participants estimated body weight based on the model's shape even though height
information was provided in the photographs or directly available with live models.
Meanwhile, participants devalued or completely ignored other parameters critical to an
accurate judgment.
Stress puts double whammy on
reproductive system, fertility
University of California, Berkeley, researchers have found what they think is a critical
and, until now, missing piece of the puzzle about how stress causes sexual dysfunction and
infertility. Scientists know that stress boosts levels of stress hormones -
glucocorticoids such as cortisol - that inhibit the body's main sex hormone, gonadotropin
releasing hormone (GnRH), and subsequently suppresses sperm count, ovulation and sexual
activity. The new research shows that stress also increases brain levels of a reproductive
hormone named gonadotropin-inhibitory hormone, or GnIH, discovered nine years ago in birds
and known to be present in humans and other mammals. This small protein hormone, a
so-called RFamide-related peptide (RFRP), puts the brakes on reproduction by directly
inhibiting GnRH. The common thread appears to be the glucocorticoid stress hormones, which
not only suppress GnRH but boost the suppressor GnIH - a double whammy for the
reproductive system. "We know stress affects the top-tier reproductive hormone, GnRH,
but we show, in fact, that stress also affects another high-level hormone, GnIH, to cause
reproductive dysfunction," said lead author Elizabeth Kirby, a graduate student at UC
Berkeley's Helen Wills Neuroscience Institute. "This work provides a new target for
researchers, a new way to think about infertility and dysfunction. The more we know, the
more we can look for ways to treat it." The results will be published the week of
June 15 in the Online Early Edition of the journal Proceedings of the National Academy of
Sciences (PNAS)
New method separates cancer cells
from normal cells
The vast majority of cancer deaths are due to metastasis, the spread of cancer cells from
its primary site to other parts of the body. These metastatic cells tend to move more than
their non-metastatic variants but this movement is poorly understood. Scientists are
studying cancer cells intently with the hope they can learn to control the movements of
the dangerous cells. Northwestern University researchers now have demonstrated a novel and
simple method that can direct and separate cancer cells from normal cells. Based on this
method, they have proposed that cancer cells possibly could be sequestered permanently in
a sort of "cancer trap" made of implantable and biodegradable materials. The
demonstrated device, which takes advantage of a physical principle called ratcheting, is a
very tiny system of channels for cell locomotion. Each channel is less than a tenth of a
millimeter wide. The asymmetric obstacles inside these channels direct cell movement along
a preferred direction.Details are published online by the journal Nature Physics. "We
have demonstrated a principle that offers an unconventional way to fight metastasis, a
very different approach from other methods, such as chemotherapy," said Bartosz
Grzybowski, the paper's senior author. "These are fundamental studies so the method
needs to be optimized, but the idea has promise for a new approach to cancer
therapy." Grzybowski is associate professor of chemical and biological engineering in
the McCormick School of Engineering and Applied Science and associate professor of
chemistry in the Weinberg College of Arts and Sciences. The researchers first discovered
they could design channels of different geometries -- some a series of connected triangles
-- through which cells can move in a single direction. (Live mammalian melanoma, breast
cancer and normal cells were studied.) To create the channels, the researchers patterned
cell-adhesive and cell-repellant chemical compounds onto a substrate. The cells stayed out
of the repellant areas and localized onto the "ratchet" channels, which then
directed the cells' movements.
Newborn weights affected by
environmental contaminants
Recent epidemiological studies have revealed an increase in the frequency of genital
malformations in male newborns (e.g., un-descended testes) and a decrease in male
fertility. The role played by the growing presence in our environment of contaminants that
reduce male hormone action could explain this phenomenon. It is known that the birth
weight of males is higher than that of females due to the action of male hormones on the
male fetus.If the exposure of pregnant women to environmental contaminants that diminish
the action of male hormones has increased over the years, one would expect to see a
decrease in the sex difference in birth weight. This is exactly what a new study published
in the July 2009 issue of Epidemiology shows. Investigators analyzed the Public Health
Agency of Canada's database on the birth weights of more than five million children born
in Canada between 1981 and 2003. Using statistical methods that control for changes over
time of mother's age and parity, the investigators effectively show a sustained decrease
in birth weight differences between boys and girls, which supports the hypothesis of
growing endocrine disruption related to environmental contaminants. Contaminants found in
plastic materials represent lausible candidates, since they are known to diminish the
action of male hormones. "Our study underlines the importance of probing the impact
of environmental contaminants on the health of mothers and fetuses and on the reproductive
potential of future generations," says lead researcher Dr. Guy Van Vliet, a pediatric
endocrinologist and investigator at the Sainte-Justine University Hospital Research Center
and a professor at the Department of Pediatrics of the Université de Montréal.
Pregnant women at high risk of
complications from H1N1 influenza
With the H1N1 flu outbreak now elevated to pandemic level, a new article
http://www.cmaj.ca/cgi/rapidpdf/cmaj.090866 in CMAJ (Canadian Medical Association Journal)
reports that oseltamivir (Tamiflu®) and zanamivir (Relenza®) are relatively safe drugs
for use in pregnant and breast-feeding women. Pregnant women, especially those in the
third trimester, are at high risk of serious complications from the H1N1 A influenza
virus. The study was conducted by researchers from the Motherisk Program at The Hospital
for Sick Children (SickKids) in Toronto and the Japan Drug Information Institute in
Pregnancy in Tokyo, Japan. For treatment or prevention during the current pandemic,
"oseltamivir appears to be the drug of choice because there are more data on its
safety in pregnancy," writes Dr. Shinya Ito, Head of the Division of Clinical
Pharmacology and Toxicology at SickKids. Zanamivir can be used, although there is less
data available about its safety in pregnant women. Neither drug appears to affect the
growth and development of the fetus, although ongoing data collection is important. The
groups at high risk of flu-related complications from the novel H1N1 influenza are the
same as those for seasonal flu – pregnant women, children under 5 years, the elderly
and others such as those with chronic lung conditions. Only small amounts of oseltamivir
and zanamivir are excreted into human milk. If an infant is breastfed by the mother on
these drugs and needs treatment, the recommended dose of oseltamivir or zanamivir should
be given to the infant.
Questions and answers on the new
biocides regulation
The new regulation on the use and placing
on the market of biocidal products will repeal and replace the current directive on
biocides (98/8/EC). It will enter into force on 1 January 2013.
What are biocidal products?
Biocidal products contain or generate
active substances and are used against harmful organisms such as pests and bacteria. They
are used both to protect human and animal health. They include household products such as
disinfectants, rodenticides, repellents, and insecticides. Others are used in more
industrial applications as wood and material preservatives, anti-fouling paints, and
embalming products to avoid damage to natural or manufactured products.
Due to their intrinsic properties and uses,
biocidal products may themselves pose health risks and be harmful to the environment. It
is vital therefore to ensure that only biocidal products safe for use are placed on the
market.
What are the main differences between the
current directive and the new regulation?
The new regulation increases the protection
of health and environment, while being more efficient at the same time, notably through
the active involvement of ECHA. It will retain the two-step authorisation process brought
in by the current directive, whereby active substances are first tested and approved and
included in a Community list (known as the Annex I), with subsequent authorisation of a
product containing the active substance.
Scope
The scope has been extended to cover
articles and materials treated with biocidal products, including furniture and textiles.
The regulation will also apply to active substances generated in situ, and to biocidal
products used in materials that come into contact with food. But other products that are
sufficiently covered by existing legislation (including food and feed, food and feed
additives and processing aids) are excluded from the scope of the new regulation. Biocidal
products approved under the International Convention for the Control and Management of
Ships' Ballast Water and Sediments are considered as authorised.
Product authorisation and mutual
recognition
Under the current Directive, all biocidal
products are authorised at Member State level. This will change for two types of biocidal
products – biocidal products based on new active substances and low-risk biocidal
products – which will have access to a Community authorisation allowing them to be
placed on the market throughout the Community. All other biocidal products will still be
subject to national authorisations issued by Member States.
There will also be further changes to the
rules on mutual recognition, the process whereby an authorisation in one Member State may
be recognised by another Member State. Under the regulation, it will be possible to apply
either for a mutual recognition of an existing authorisation, or for a mutual recognition
which runs in parallel to the first authorisation process. The new regulation will also
clarify the conditions for obtaining a parallel trade permit.
Data requirements
Under the current directive, the same set
of data must be submitted for all biocidal products, not all of which is always necessary.
Under the proposed regulation, data
requirements will be more aligned with the actual needs of the evaluating authorities. It
will become possible to waive requirements if data is not scientifically necessary, if it
is technically impossible to supply, or if it is not relevant (there is no need for marine
toxicity studies, for example, if a product is reserved for use on dry land). It will no
longer be possible to repeat tests that have already been carried out on vertebrate
animals, and information gained from such tests must be shared, in exchange for fair
compensation.
What active substances will be phased out?
The proposed regulation sets out 'exclusion
criteria' to prevent authorisation of active substances with very poor hazard profiles,
including substances that can cause cancer, mutations, reproductive problems and hormonal
imbalances.
In future, such substances will only be
allowed for use provided that:
human exposure to the active substance in
the biocidal product is negligible
the active substance is necessary to
control a serious danger to public health such as an epidemic of particular insects
the negative effects of banning the active
substance would be disproportionate to the impacts on human health or the environment, and
no alternatives are available.
Biocidal products with problematic active
substances will also be compared to ensure that only the products with the lower risk
remain on the market.
How will the rules on the inclusion of
active substances change?
There is a need to ensure equality of
treatment for active substances evaluated before and after the entry into force the new
regulation. It is therefore proposed that substances still being evaluated under the old
rules on 1 January 2013 should continue to be evaluated under the same rules.
The changes introduced by the new
regulation, including the data requirements, data waiving, obligatory sharing of
vertebrate animal data and so forth will only apply to active substances whose evaluation
starts after 1 January 2013.
The new proposal will not affect the rules
on the examination of existing active substance (those on the market on 14 May 2000) laid
down under Regulation (EC) No 1451/2007.
How will the rules on Community-wide
authorisation work?
Community authorisation will be available
for two types of biocidal products: those based on new active substances, and low-risk
biocidal products. Such authorisations will be granted by the European Commission, and
will allow products to be placed on the market across the EU without any need to apply for
separate national authorisations or the mutual recognition process.
Applications for a Community authorisation
will be submitted to the European Chemicals Agency (ECHA) and to a competent authority of
the applicant's choice. The competent authority will evaluate the application and send its
conclusions to ECHA for an opinion. The Commission will then decide whether a Community
authorisation can be granted, and if so under which conditions.
Community-wide authorisations should
stimulate innovation and the development of new and improved products.
What will be the impacts on animal?
The proposal strives to minimise animal
testing as far as possible Vertebrate tests may not be repeated, and a new obligation to
share data involving vertebrate animal tests will come into force. This means that data
owners will be obliged to share their data, in exchange for fair compensation.
The regulation will also encourage the
sharing of data from other types of animal tests, with a view to reducing the overall
costs and avoiding the duplication of tests..
What will be the tasks of ECHA under the
new Regulation?
The European Chemicals Agency (ECHA) will
coordinate the active substance evaluation for new and existing active substances, the
re-assessments of the already approved active substances in light of available new
information, and some related evaluation work.
The agency will also play a key role in the
centralised authorisation of products. ECHA will be in charge of coordinating the
technical and scientific work of this new centralised authorisation process. In the event
of any disputes between over mutual recognition between the Member States or the Member
States and applicants, ECHA will provide the Commission with technical and scientific
support.
ECHA will intervene in cases of
disagreements about data sharing from vertebrate animal tests. ECHA will also be
responsible for maintaining the relevant databases and other administrative and scientific
tasks, such as coordinating the meeting of experts reviewing the draft risk assessments
reports prepared by the Member States in the context of the review programme of the
biocidal active substances.
What are the costs and benefits of this
proposal?
Compared with the existing rules, the only
change involving additional costs to the industry concerns the extension of the scope to
treated articles and materials. These costs will mainly result from the inclusion of
further active substances in Annex I and the compliance with the labelling obligations.
But it should be noted that according to the impact assessment carried out to evaluate the
proposal, the environmental and human health benefits of extending the scope to treated
articles and materials will easily outweigh the costs.
The other measures introduced by the
proposal, such as improved authorisation procedures, including the Community
authorisation, obligatory data sharing for vertebrate animal data and streamlining the
data requirements, will result in significant cost savings. The reduction of financial and
administrative burden was also one of the main objectives of this proposal. However, this
proposal shows that these savings can be achieved without compromising the high level of
environmental and human health protection.
Further information:
European Commission:
http://ec.europa.eu/environment/biocides/revision.htm
ECHA:
http://echa.europa.eu/
Antitrust: Commission statement on
Microsoft Internet Explorer announcement
The European Commission notes with interest
Microsoft's announcement of its plans for Windows 7, and in particular of the apparent
separation of Internet Explorer (IE) from Windows in the EEA. The Commission will shortly
decide in the pending browser tying antitrust case whether or not Microsoft’s conduct
from 1996 to date has been abusive and, if so, what remedy would be necessary to create
genuine consumer choice and address the anticompetitive effects of Microsoft’s
long-standing conduct. In terms of potential remedies if the Commission were to find that
Microsoft had committed an abuse, the Commission has suggested that consumers should be
offered a choice of browser, not that Windows should be supplied without a browser at all.
At the level of both computer manufacturers
and retail sales, the Commission's Statement of Objections (SO) suggested that consumers
should be provided with a genuine choice of browsers. Given that over 95% of consumers
acquire Windows pre-installed on a PC, it is particularly important to ensure consumer
choice through the computer manufacturer channel.
As for retail sales, which amount to less
than 5% of total sales, the Commission had suggested to Microsoft that consumers be
provided with a choice of web browsers. Instead Microsoft has apparently decided to supply
retail consumers with a version of Windows without a web browser at all. Rather than more
choice, Microsoft seems to have chosen to provide less.
As for sales to computer manufacturers,
Microsoft's proposal may potentially be more positive. It is noted that computer
manufacturers would appear to be able to choose to install Internet Explorer – which
Microsoft will supply free of charge - another browser or multiple browsers. Were the
Commission to conclude that Microsoft’s behaviour has been abusive, it would have to
consider whether this proposal would in itself be sufficient to create genuine consumer
choice on the web browser market. The Commission would inter alia take into account the
long standing nature of Microsoft's conduct. It would also have to consider whether this
initial step of technical separation of IE from Windows could be negated by other actions
by Microsoft.
Consumer Choice and Innovation
The development of new online services
makes web browsers an increasingly important tool for businesses and consumers, and a lack
of real consumer choice on this market would undermine innovation.
The Commission’s preliminary concerns
are set out in detail in a Statement of Objections sent to Microsoft in January. The
specific circumstances of Microsoft’s tying of IE to Windows in this case would
appear to lead to significant consumer harm.
The SO sets out the preliminary view that,
should the Commission conclude that Microsoft’s conduct was abusive, any remedy would
need to restore a level-playing field and enable genuine consumer choice between Internet
Explorer and third-party web browsers, in order to bring the infringement effectively to
an end. A potential remedy to these concerns, which the Commission considered in the SO
and which would not require Microsoft to provide Windows to end-users without a browser,
would be to allow consumers to choose from different web browsers presented to them
through a 'ballot screen' in Windows.
Background
The Commission sent a Statement of
Objections (SO) to Microsoft on 15 January 2009 (see MEMO/09/15 ).
A Statement of Objections is a formal step
in Commission antitrust investigations in which the Commission informs the parties
concerned in writing of the objections raised against them. The addressee of a Statement
of Objections can reply in writing to the Statement of Objections, setting out all facts
known to it which are relevant to its defence against the objections raised by the
Commission.
Microsoft replied to the SO on 28 April
2009. The Commission is currently considering Microsoft’s reply, and additional
evidence in the case, and has not yet reached any conclusion.
The Commission's assessment would be guided
in particular by the principles laid down by the Court of First Instance in its judgment
of September 2007 in the Microsoft case regarding the tying of Windows Media Player (see
MEMO/07/359 ) and the Commission's experience with the remedy in that case, while taking
account of the specific circumstances of the present case.
