Petition for the Protection of Human and Animal Health from Toxic Substances and Pesticides

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(Englisch-Übersetzung: Dr. Andre Menache, Antidote Europe)


1. We ask the European Union (EU) to ensure compliance by the EU member states of their duty to protect the health of humans and animals.
We believe that this has not been the case so far. Laws and regulations are not being enforced and industrial interests are systematically favored, as we will show below.

2. We demand that the European Commission prohibit without exception chemicals recognized as being of high concern for health.

3. We ask the European Commission (EC) to ensure compliance by the EU member states of their duty to protect the health of humans and animals.

4. We call on the EC to ensure, when drafting and enacting of laws, EU Directives and Regulations concerning the health of all EU citizens, animals and the environment, that the participation of institutions or industry lobbyists or commerce be prohibited whatever the supposed relevance of their advice, policy positions and their expertise.

5. We demand that the assessment of human toxicity of chemicals make use without delay of modern science and intelligent scientific test strategies, and immediately abandon animal testing "models" as useless and dangerous.

Motivation.

Transparency and independence are the foundation of a risk assessment and are essential for a reliable and credible communication on these risks. This would normally be the case, but it is not the case!

In France, chemical risk assessment is carried out by the INERIS, the AFFSET, ANSES ... whose expert committees are enveloped by a thick fog. This is not the case in Germany, where even the Federal Institute ZEBET (Centre for Documentation and Evaluation of Alternative Methods to Animal Testing) openly states that among its members are those who
represent the chemical or pharmaceutical industry: Evonik, Henkel AG & Co KGaA, Clariant, Beiersdorf, Bayer Pharma AG. The independence of ZEBET is not guaranteed. For example, the evaluation of risks to humans and animals of pesticides and biocides, conducted by ZEBET in
accordance with Directive (EC) 2009/128, is made by the very people who manufacture them!

Once recruited, interested experts are obliged, once they become members of the Commissions, to act for the public good independently. Possible conflicts of interest that might arise during some sessions, must necessarily be subject to written statements to be published on the internet.
In addition, before the registration, the experts are asked about a possible conflict of interest on the subject at the agenda. The Minutes of the meeting must mention the experts' answers.

The Minutes of the meeting, citing the opinions and scientific arguments and the conclusions of the debate, is made available to the Public on the site of ZEBET. The conclusions of the session are opinions that are ultimately included in the ZEBET's stance.

The assessment, made in particular by the representatives of manufacturing industries is in the form of scientific positions taken, reports or comments, and published in the Narrative. The evaluation of health hazards of substances or preparations or formulations must be in accordance with regulations and risk management provisions, according to
national, European or global provisions on evaluation, acceptance and authorization:

the Regulations (EC) Nr. 1107/2009 on the authorization of plant health products (PSM-VO)
the Regulations (EC) Nr. 528/2012 on the sale and use of biocidal products (Biozid-VO)
the Regulations (EC) 396/2005 on the maximum dose of pesticide residues (RHG-VO) and
Directive (EC) 1272/2008 concerning the characteristics, labeling and packaging of substances and mixtures (CLP-VO).

The work of the Commission should focus first and foremost on product acceptance of pesticides and biocides, with particular expertise involving representatives of industry and government, in accordance with national and European regulations for these substances. 

Three pesticides -the herbicide Glyphosate, the insecticide Malathion and Diazinon- were declared by the IARC (International Agency for Research on Cancer) as "probable carcinogens" Group 2A, which are carcinogenic in animals, and which could also be carcinogenic in humans, but not confirmed by epidemiological data. This classification depends on the states, and Tetrachlorvinphos eg parathion insecticides are allowed in the US but not in Europe.

The Federal Risk Assessment Office sees things differently, for example by considering letters sent by colleagues as equivalent to evaluation studies.

The European Parliament has set out an ambitious Regulations on chemicals with endocrine disrupting activity, which includes many pesticides used in agriculture.

Industrial lobbies are opposed to this regulation, predicting catastrophic harvests if These pesticides would be prohibited. The Federal Office of Risk Assessment has adopted a similar rhetoric and reported in a 2011 statement of "great concern" and "serious economic consequences" with regard to this Regulation.

Meanwhile, the European Commission has appointed EFSA (the agency responsible for Food security) to comment on these regulations, even though the Federal Office of Risk Assessment EFSA is equally responsible.

EFSA has convened a committee of 18 experts, including 8 with links to industry, three of whom have come out in favor of industry and only four of whom have conducted any scientific research in the field of endocrine disruptors. EFSA Conclusion: these substances can be evaluated like any other chemical.

The EFSA opinion and that of the Federal Office of Risk Assessment will be considered by the US and the European Union when, in a few months, the authorization to place Glyphosate on the market will be renewed. What will these Agencies and Offices know of the hazards to human health posed by Glyphosate, when they will have to decide?

The fact that several employees of BASF and Bayer serve in the Office of the Committee on Pesticides of Federal Risk Assessment, is problematic. Academic independence and absence of conflicts of interest of those who benefit from the authorization of Glyphosate raise big questions.

It's the same for EFSA, where 59% of their employees have links with the agro-food industry, according to the Observatory of European Corporations (CEO). In the past, the individuals in charge of key positions- in EFSA's expert committees and the Federal Office of Risk Assessment was severely criticized.

It is shocking that the toxicity assessment is always based on animal 'models', while there are many alternative methods that do not involve animals. For example, toxicogenomics using human cell cultures, "in vitro" tests, and intelligent combinations of assessment strategies could
completely replace animals.

1. EC regulation 1907/2006 of the European Parliament and the Council
dated 18 December 2006 for Registration, Evaluation, Authorisation and restriction of Chemical substances (REACH), explicitly mentions in Article 40 Toxicogenomics as an alternative method of toxicity assessment:

(40) The Commission, Member States, industry and other stakeholders should continue to contribute to the promotion of alternative test methods at the international and national, including computer-assisted methods, in vitro methods, example, where appropriate, those based on toxicogenomics and other methods relevant. The Community's strategy to promote testing methods replacement is a priority and the Commission should ensure, in the context of its future Research Framework Programmes and initiatives such as that of the plane Community action on the protection and welfare of animals 2006-2010 at that this status is maintained. Stakeholder involvement as well as making initiatives call for all interested parties should be sought.

All interested parties were invited to comment. Antidote Europe has implemented successfully toxicogenomics in 2004-5. 30 chemicals were evaluated on human cells in culture. Each test was duplicated to ensure reproducibility of results. Deregulation of the genes of cells exposed to the
test substance, compared with those of the genes of cells not exposed, allowed scientists to identify relevant dysregulation leading to diseases such as cancer, diabetes or neurodegenerative or neurodevelopmental diseases, such as Alzheimer's or autism.

In the USA, this method allows robotic devices to test the toxicity of 100 substances per day. But the European Commission rejected the implementation of this method in REACH, on the pretext that the technique had not be "validated". Have the animal tests ever been validated?


Never, for the simple reason that it is simply impossible to do so, since it can be easily proven that no species is a biological model for another, even very close in terms of evolution.


Although this method gives valid results for humans and it is 100 to 1000 times faster and cheaper than testing on rodents, the refusal to include it in REACH is incomprehensible – unless of course there are vested interests involved ?

Using animals as human models is obviously a huge benefit to the industry, as it allows industry to choose the species of animal to "prove" that a substance is not carcinogenic or not an endocrine disruptor. For example, one could select mice of the C57Bl strain (which is resistant to carcinogens) or CD-1 strain (insensitive to estrogen), while the test on the C3H line (100
times more sensitive to carcinogens) or C57BL / 6J (15 times more sensitive to estrogen) "prove" that this substance is a severe carcinogen or powerful endocrine disruptor.

The toxicologist can choose from thousands of such strains of mice or rats which can be used to indicate the innocuity of a substance and accordingly obtain authorization to be placed on the market, while a different choice would show that the same substance is highly carcinogenic or mimics the effect of female hormones. Such tests can prove anything or its opposite. This is scientific fraud for which toxicologists should be held to account because of all the human disease it leads to.

Such abuses are not possible with toxicogenomics, because the genes of cells can neither lie, nor cheat, which is obviously why industry continues to avoid using it.

Tests on animals are not only unnecessary and cruel, but also an enormous deception to the detriment of millions of consumers who will wonder later what is the origin of their tumor, what is the cause of their diabetes or Alzheimer's.

Of course, the industry is not responsible since the toxicity assessment was made in accordance with the REACH regulation.

In October 2013, we personally filed in Brussels our 1833/2013 petition concerning animal testing and the REACH regulation. The petition was processed and deemed admissible by the Petitions Committee on 1 April
2014. After a new hearing April 15, 2014, the Commission closed the petition by a "Communication from the Commission to Member" dated April 30, 2014.

The new hearing was an opportunity for us to present other arguments and questions about REACH, of great public interest but we have still had no response.

The "Communication from the Commission to its Members" fails to comment on the following:

In principle, the REACH regulation is intended to protect human health and the environment.
Our question was: The so-called citizens' health security, is it not an illusion?
Because in reality, toxic, carcinogenic, and reprotoxic substances are still on the market, although they are carefully labeled with an "expiration date" and "doses without toxic effects".

Even the substances of“very high concern”are authorised for marketing:

... If the manufacturer proves that it can control the hazard
... If there is no less toxic alternative
... If the socio-economic interest outweighs the risk
... With an exceptional authorization

If REACH should be the guarantee of protection of human health, how is it that the REACH regulation allows substances of “very high concern on to the market simply with "special permits" for example, based on "interest socioeconomic "?

The criteria for "substances of very high concern" (SVHC) are substances which are:

Carcinogens, mutagens, reproductive toxins, teratogenic, persistent, bioaccumulative and toxic.

Could it be that we are playing around with the life and health of EU citizens under the pretext  of "socio-economic interests"?

The German organization "BUND" randomly examined nine children's toys to test for chemicals. Result: all contain toxic products. In addition to reprotoxic plasticizers, these toys also harbored neurotoxic (toluene)
carcinogenic, polycyclic aromatic compounds and nonylphenol, a potent endocrine disruptor.

In the French daily "Le Monde" on 6 July, an article entitled "Why the German debt surpasses the Greek debt" evokes health spending in Europe due to diseases of the male reproductive system, cancer, obesity, diabetes and neurodegenerative diseases as consequences of exposure to chemicals. They cost 157 billion euros per year.

The 'Endocrine Society "(USA) published on the website" Science Daily "a statement citing the effects of endocrine disruptors that affect health and cause a long list of diseases, which cost is estimated in Europe between 150 and 260 billion Euros per year, confirming the article "World" (source: JCI Monaco).

Major producers of these substances: the chemical industry, which has close ties with the pharmaceutical industry and installs its "experts" in EFSA's commissions and the Federal Office of Risk Assessment.


Ironically the pharmaceutical industry provides the drugs to treat diseases caused by the chemical industry. A very profitable arrangement.

Yours sincerely,

Gisela Urban, Tierfreunde ohne Grenzen e.V.
Gabriele Menzel, Tierfreunde ohne Grenzen e.V.
Prof. Dr. Claude Reiss, Antidote Europe
Andre Menache, Antidote Europe
Rainer Gaertner, Tierversuchsgegner BRD e.V.
Bettina Jung, Bundesvorsitzende der Partei Mensch, Umwelt, Tierschutz - MUT
Karl-Heinz Greve, Partei, Mensch, Umwelt, Tierschutz - MUT

References :

1. Article de Zeit Online du 29.7.15
De nombreux arguments en défaveur du glyphosat
http://www.zeit.de/wissen/umwelt/2015-07/glyphosat-krebs-herbizid-landwirtschaft
2. Glyphosat tue des bactéries vitales pour l‘homme (arte)

Maladies mystérieuses des bovins et déformations sévères chez les porcelé. Recherches de l’Université de Leipzig
https://www.youtube.com/watch?v=rpZmev9z-Gk

3. http://www.sueddeutsche.de/wirtschaft/kampf-um-glyphosat-wenn-leserbriefe-von-monsantoals-studien-gelten-1.2570374

4. https://www.lobbycontrol.de/2015/06/efsa-bfr-gefaehrden-unsere-gesundheit-zugunsten-derindustrie/

5. New robot system to test 10,000 chemicals for toxicity
http://www.nih.gov/news/health/mar2011/niehs-10.htm

6. BUND-jouets montre: trop de poisons dans les jouets
https://www.bund.net/index.php?id=22526

7. The article " Pourquoi la dette allemande surpasse la dette grecque" ( Le Monde from 07.06.15)

8.. Exposure to endocrine-disrupting chemicals costs EU billions annually
Exposure to endocrine-disrupting chemicals costs EU billions annually



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