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 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 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

Climate impact of potential shale gas production in the EU – Highlights of a report to DG Environment

Highlights proposed by  GreenFacts of the report: Climate impact of potential shale gas production in the EU delivered to the  European Commission DG CLIMA by AEA, in collaboration with CE Delft and Milieu.

1.       Objectives of this report

The objective of this study is to provide state-of-the-art information to the European Commission on the potential climate implications (via greenhouse gas (GHG) emissions) of possible future technically recoverable shale gas (gas reserves trapped within shale rock[1]) resources inEurope to produce electricity.  According to the report, these resources are of a similar scale to those technically recoverable in theU.S.

The study provides also an assessment of the adequacy of GHG emissions reporting frameworks to cover fugitive emissions of the production of shale gas and, if needed, propose measures for its improvement.

Drawing upon existing research this report provides an examination of the potential climate impacts of shale gas production in the EU. It begins with a review of existing estimates of GHG emissions from shale gas production and of the potential options for abating emissions from shale gas processes. This evidence is then used to estimate the potential emissions that might be associated with shale gas exploitation in the EU about 60-70 g CO2 /MJ, see graph in the report p 64) . The reports estimates also, through the use of appropriate models, each step of the lifecycle GHG emissions of electricity production from shale gas, taking into account the direct and indirect GHG gas emissions associated with gas extraction, transportation and use, including pre-production and production phases (excluding the exploration stage). Continue reading

Potentially endocrine disruptors chemicals: updated assessment for the E.U. of their impact on human health and the environment.

Highlights prepared by GreenFacts of the report “State of the Art Assessment of Endocrine Disrupters” which presents the results of a project commissioned by the European Commission, DG Environment

http://ec.europa.eu/environment/endocrine/documents/4_SOTA EDC Final Report V3 6 Feb 12.pdf

The report summarises advances in the state of the science since 2002 and maps out ways of dealing with endocrine disrupters in important pieces of EU chemicals regulation, such as e.g. the Plant Protection Product Regulation, PPPR (1107/2009), the new Biocide Regulation and the chemicals regulation, REACH (1907/2006).

1. The context of concerns about endocrine disruption and its relation to some chemicals  

During the last two decades evidence of increasing trends of many endocrine-related disorders in humans has strengthened.

Although the correct description of disease time trends is often complicated by a lack of uniform diagnostic criteria, unfavourable disease trends have become apparent where these difficulties could be overcome. There are negative impacts on the ability to reproduce and develop properly. There is good evidence that wildlife populations have been affected, with sometimes widespread effects. Continue reading

The risks from exposure to mixture of chemicals : adequately evaluated ?

Excerpts selected by GreenFacts of a summary of a recent state-of-the-art report and of a Preliminary Opinion approved for Public Consultation on  Toxicity and Assessment of Chemical Mixtures expressed by the non-food Scientific Committees of the EU Commission.

1. – THE REPORT details the scientific state of the art findings of a project on mixture toxicology and ecotoxicology commissioned by the  European Commission, DG Environment.

According to it, there is strong evidence that chemicals with common specific modes of action work together to produce  combination effects that are larger than the effects of each mixture component applied singly. In the case of such combinations of chemicals that interact with the same sub-system of an organism, the concept of dose addition is applicable for the prediction of their effects when the toxicities of individual mixture components are known.

The currently available scientific evidence as well as pragmatic considerations, says the report, support the idea of adopting dose addition as the preliminary default concept for the assessment and prediction of mixture effects. Indeed, deviations from predicted additivity, indicative of synergisms or antagonisms, are comparatively rare, relatively small and largely confined to mixtures with only a few compounds.

This approach, says the report is borne out by current practice in many regulatory bodies in the EU, USA and by recommendations of international bodies.

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EU criteria for risk assessment of persistance, bioaccumulation and toxicity of chemicals

GHS-pictogram-environment dangerA summary prepared by GreenFacts of the COMMISSION REGULATION (EU) No 253/2011  of 15 March 2011

This regulation is amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XIII

16.3.2011 Official Journal of the European Union L 69/7


1. The specific importance of persistance, bioaccumulative and toxic properties for managing risks

The identification of persistent, bioaccumulative and toxic properties of substances (PBT substances), and very persistent and very bioaccumulative substances (vPvB substances) is important in order to evaluate their intrinsic potential impact to affect human health and the environment and assess the real risks.

This is also the basis on which define regulatory rules regarding their use, substitution or ultimate ban, depending on each specific case (within the global EU chemicals Regulation or more specific Regulations such as the one on electric/electronic equipments (RoHS Regulation) .

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The tolerable intake of cadmium via food to avoid adverse effects to health: the opinion of the European safety agency EFSA

The current tolerable weekly intake (TWI) of 2.5 µg/kg body weight (b.w.) for cadmium adopted in its previous opinion on cadmium in food is still considered appropriate and maintained. This is the conclusion of the Panel on Contaminants in the Food Chain of the European Food Safety Authority (EFSA, CONTAM Panel).


Cadmium exerts toxic effects after long-term exposure mostly on the kidney but also on the bones. Foodstuffs are the major source of cadmium exposure for the non-smoking general population.

This opinion was given in answer to a request of the European Commission in view of the provisional tolerable monthly intake (PTMI) of 25 µg/kg b.w. established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 2010.

Both assessments used the same epidemiological dataset and considered particularly two elements : the relation between the concentration of cadmium in urine and that of a biomarker of renal toxic effects and also a model that relates urinary cadmium concentration to dietary cadmium intake.

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