Highlights of the Scientific Opinion of EFSA on the testing methods for assessing of the effects of endocrine disruptors on human health and the environment

EndocrineHighlights prepared by Greenfacts of the report: The scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment. A report adopted on 28 February 2013 and prepared on request from the European Commission.   


The Highlights of the report in 8 questions and 8 answers

 1. What were the questions asked to the Scientific committee? Three specific questions were posed by the Commission in the terms of reference, namely:

  1. What scientific criteria should be used to identify EDs?
  2. What is an adverse effect and how can it be distinguished from physiological modulation?
  3. Are existing toxicity testing methods appropriately covering the effects of endocrine active substances?

The opinion expressed is based on an evaluation of existing information, current insights and scientific activities on „endocrine disruptors‟, from European and other international parties which had to include the final report „State of the Art Assessment of Endocrine Disrupters‟(Kortenkamp et al., 2011)[1].  To this end, EFSA followed its specific Standard Operating Procedure detailing the steps necessary for establishing, updating or closing a scientific working group.

The declarations of interests of all short-listed experts were checked for absence of conflicts of interest before they could be invited to participate in the working group to contribute in their personal capacity, as an observer or as a hearing expert.

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Highlights of “Turn down the heat” : an assessment prepared for the World Bank of the health, social and environmantal impact of climate change induced by a global warming of 4°C

Highlights by GreenFacts of the executive summary of the Report “Turn down the heat ~ 4°C “

A Report for the World Bank by the Potsdam Institute for Climate Impact Research and Climate Analytics  http://climatechange.worldbank.org/content/climate-change-report-warns-dramatically-warmer-world-century

Turn down the heat

The conclusions of the report in a glance

This report spells out what the world would be like if it warmed by 4 degrees Celsius, which is what scientists are nearly unanimously predicting by the end of the century, without serious policy changes.

It is a stark reminder that climate change affects everything. The solutions don’t lie only in climate finance or climate projects. The solutions lie in effective risk management and ensuring all our work, all our thinking, is designed with the threat of a 4°C degree world in mind.

 The President of the World Bank Group, Dr. Jim Yong Kim, is very clear in its foreword of the report :  The lack of action on climate change not only risks putting prosperity out of reach of millions of people in the developing world, it threatens to roll back decades of sustainable development.  The scenarios evaluating the consequences of an increase of the global earth temperature of 4°C are indeed devastating:

  • the inundation of coastal cities;
  • increasing risks for food production potentially leading to higher malnutrition rates; many dry regions becoming dryer, wet regions wetter;
  • unprecedented heat waves in many regions, especially in the tropics;
  • substantially exacerbated water scarcity in many regions;
  • increased frequency of high-intensity tropical cyclones;
  • irreversible loss of biodiversity, including coral reef systems.

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Highlights of the FAO draft report on Nanotechnologies used in food and agriculture and their risk assessment

Some Highlights by GreenFacts of the draft report :  State of the art on the  initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors, FAO-WHO, 2012


arbre en Toscane

This draft report was submitted to public review which ended in November 2012. These  Highlights will be adapted when the final report will be issued.

Food can be cultivated, produced, processed or packaged with nano-technology, or engineered nanomaterials can be added to food. Recent scientific reviews on risk assessment of nanotechnologies in the food and agriculture sectors, says the draft report, confirm that information on this topic is limited .

A section of this draft FAO/WHO report briefly summarizes national and regional initiatives and activities related to the risk assessment and risk management of nanomaterials, such as research projects, development of  guidance documents and drafting of regulations, that have been carried out. Emphasis is placed on issues that contribute to the definition of the term  “nanomaterials” (to be subjected to specific risk assessments) and case-studies where a riskassessment has been undertaken for a defined material. Continue reading

Highlights of the US-EPA draft report on the health and environmental impact of the production of the transgenic salmon AquAdvantage

A short summary followed by the Highlights of the report in nine questions.

SHORT SUMMARY The salmon evaluated by the FDA is a genetically modified (“engineered” or also “transgenic”) Atlantic salmon to be produced and grown under specified conditions. This fish, named AquAdvantage Salmon, is a triploid (effectively sterile) female fish containing a rDNA construct designed to exhibit a rapid-growth phenotype that allows it to reach smolt  size (or approximately 100 g) faster than non-genetically modified farmed salmon. The objective of the project is to meet increasing demand for fish protein in light of declining stocks and diminishing capture of wild fish.

FDA has made the preliminary determination, based on the evidence collected and evaluated,  that it is reasonable to believe that approval of the AquAdvantage Salmon NADA will not have any significant impacts on the quality of the human environment of the United States, and on the populations of endangered Atlantic salmon when produced and grown under the conditions of use for the proposed action. 

The US-FDA regulates animals containing rDNA constructs under the new animal drug provisions of the FD&C Act, must meet environmental review requirements under the National Environmental Policy Act (NEPA) and FDA’s regulations.

The FDA’s Center for Veterinary Medicine (CVM) has evaluated both the direct and indirect food safety impacts of AquAdvantage Salmon and any potential impacts of the rDNA insertion on target animal safety. CVM has also thoroughly evaluated the potential environmental impacts of approving an NADA for AquAdvantage Salmon.

The potential hazards and harms to the environment include the hypothesis that the transgenic salmon would escape the conditions of confinement but, as the transgenic salmon would be produced and grown-out in secure facilities that have been verified and validated by FDA, the possibility that transgenic fish could escape from containment, survive and reproduce is extremely remote. In addition, because populations produced will be triploid (effectively sterile), all-female animals, the possibility of their reproducing in the wild is likewise extremely remote. FDA, has also considered that approval of the AquAdvantage Salmon will not jeopardize the continued existence of United States populations of threatened or endangered Atlantic salmon.

The potential effects on the local environments of Canada and Panama have not been considered and evaluated in this draft assessement because the US NEPA does not require an analysis of environmental effects in foreign sovereign countries, except if  there would be significant effects on the environment of the United States.

With respect to food safety, FDA has concluded that food from AquAdvantage Salmon is as safe as food from conventional Atlantic salmon, and that there is a reasonable certainty of no harm from consumption of food from triploid AquAdvantage Salmon.


1. What is the genetically modified (“engineered” or also transgenic) salmon which is evaluated by the FDA?

The development of a genetically modified salmon is the end result of advances in genetic engineering within the past 30+ years. Recombinant DNA technology was first used to produce genetically modified (engineered or transgenic) animals in 1973.  Although initial interest centered primarily on mammals, by the late-1990s, genetically modified (or engineered – GE) carp, trout, loach, tilapia, catfish, and salmon had been produced.

AquaBounty Technologies, Inc. (ABT or the sponsor) has provided data and information in support of a New Animal Drug Application (NADA) for a genetically modified Atlantic salmon1 to be produced and grown under specified conditions. This fish, named AquAdvantage Salmon, is designed to exhibit a rapid-growth phenotype that allows it to reach smolt  size (or approximately 100 g) faster than non-genetically modified farmed salmon.

The AquAdvantage Salmon founder animal was generated in 1989 by micro-injecting a recombinant deoxyribonucleic acid (rDNA) construct, composed of a element from an ocean pout antifreeze protein gene and a protein-coding sequence from a chinook salmon growth hormone gene into the fertilized eggs of wild Atlantic salmon. Continue reading

Highlights of recent reports on the consequences of the Chernobyl accident on thyroid cancer, leukaemia, effects on children health and birth defects (updated version)

Higlights selected by GreenFacts of two recent publications:

1.     the summary of  the UNSCEAR’s assessments of the radiation effects;


2     The summary report on Recent scientific findings and publications on the health effects of ChernobylWorking Party on Research Implications on Health. RADIATION PROTECTION NO 170 Directorate-General for Energy Directorate D — Nuclear Energy Unit D.4 — Radiation Protection 2011


Short summary . The global conclusions of the UNSCEAR report are that besides the most highly exposed individuals, the great majority of the population, according to the UNSCEAR report, is not likely to experience serious health consequences as a result of radiation from the Chernobyl accident. Many other health problems have been noted in the populations that are not related to radiation exposure.

1.  Consequences for the persons directly exposed Among the 106 patients surviving radiation sickness, complete normalization of health took several years. Many of those patients developed clinically significant radiation-induced cataracts in the first few years after the accident. Over the period 1987-2006, 19 survivors died for various reasons; however, some of these deaths were due to causes not associated with radiation exposure.

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Highlights of a report on the European aquatic environment: hazardous substances in fresh and marine waters


“Highlights” by GreenFacts of this technical report of the European Environmental Agency (EEA)

 In summary :

The main aims of this report are:

  1.  to document the sources, pathways, emissions and discharges of selected hazardous substances to Europe’s fresh and marine waters and provide an overview of the current status of, and recent trends in, chemical pollution ofEurope’s in these waters;
  2. to describe some of the impacts that hazardous substances can have upon aquatic biota and outline the potential for human exposure to these substances via water;
  3. to outline key European policy and legislation that addresses the use of hazardous substances and their release to water and highlight selected measures to reduce these emissions;
  4. to present tools and innovative approaches to assess the sources, levels and effects of hazardous  substances, including chemical mixtures.

Note :  The term ‘hazardous substances’ is used throught this report in a broad sense, encompassing a.e. substances of very high concern as defined by the European regulation REACH on chemicals, the hazardous substances as defined by the OSPAR marine Convention (covering the North Atlantic Ocean and the North Sea) or the potentially wide-ranging list of substances for which EU Member States are to establish their own surface and groundwater standards. Continue reading

Highlights of a report on the potential health impact of pharmaceuticals products released in the environment

The results of a European Environmental Agency workshop

EEA Technical report  No 1/2010, 34 http://www.eea.europa.eu/publications/pharmaceuticals-in-the-environment-result-of-an-eea-workshop

The highlights prepared by GreenFacts are those from the executive summary and from the conclusions chapter of the report [1] Pharmaceuticals in the environment.

The five key facts of the report :

1. All over Europe wastewater and rivers contain a broad variety of  pharmaceutical substances and their metabolites. Not all of them are known.:

2. Research results have confirmed that both human and veterinary medicines pose environmental risks, and some eco-toxicity data indicate that the concentrations found in the environment have detrimental effects.

3. To date, two cases have been identified of pharmaceuticals affecting wildlife.

4. A project financed by the European Commission’s Research Directorate-General reveal however no evidence that current concentrations of pharmaceutical products in the environment will result in significant environmental impact or human harm .

5. There is considerable need for greener pharmacy innovations that are ‘benign by design’ and extending the patent duration for such pharmaceuticals that are ‘benign by design’ could boost incentives to develop substances with less environmental impact. Continue reading

Highlights of a report on the toxicity, dangers and risks from exposure to chemical mixtures (“cocktails”)

Highlights by GreenFacts of an opinion of the non Food  EU Scientific Committees

SCHER, SCCS, SCENIHR, Opinion on the Toxicity and Assessment of Chemical Mixtures, 2012, 50 p.

The non-Food scientific committees are[1]

– The Scientific Committee on Health and Environmental Risks -SCHER

– The Scientific Committee on Emerging and Newly Identified Health Risks SCENIHR

– The Scientific Committee on Consumer Safety – SCCS

Since humans and their environments are exposed to a wide variety of substances, there is increasing concern in the general public about the potential adverse effects of the interactions between those substances when present simultaneously in a mixture (in the media often referred to as “cocktail-effects”). Continue reading