Ceci est une version HTML d'une pièce jointe de la demande d'accès à l'information 'Correspondance about environmental and food safety standards in relation to TTIP'.







Ref. Ares(2015)2132382 - 21/05/2015
Ref. Ares(2016)7049618 - 19/12/2016
Hundreds of disclosed documents reveal:  
 
 

How EU Commission Health service DG 
SANTE joined forces with economic DG's on 
the criteria for endocrine disruption and 
crushed not only their enemy, lead DG 
Environment, but also the entire new EU policy 
on endocrine disruption. 
 
 

= PAN Europe report, May 20, 2015 = 
 
 
EU Health service DG SANTE (former DG SANCO) has been in a constant fight with 
DG Environment who was granted the lead by EU Commission to develop the criteria 
for endocrine disruptors (EDs), a crucial element of the new EU endocrine policy. 
Following an access to documents request and based on 230 documents obtained, PAN 
Europe now can reveal the disloyal role of DG SANTe who collaborated with DG 
Enterprise and other Directorate-General's (DGs) to block the work of DG Environment 
(DG ENV). This collaboration of the DG SANTE with industry-friendly DGs behind the 
back of DG Environment put industry interests and US-EU trade talks TTIP at a 
platform. In the end the draft criteria developed by DG ENV never got published and 
the Commission missed its mandatory deadline for publishing criteria on December 
2013.  
 
While DG ENV was conducting an in-depth research to compose the criteria for EDs, 
DG SANTE in 2012 secretly started cooperating with economic DGs, such as Enterprise, 
and put the first knife in the back of DG ENV by mandating Food Authority EFSA to 
redo the work of DG ENV. DG SANTE knew very well that EFSA had published 
industry-friendly opinions on endocrines, opposing the work of DG ENV.  The hostilities 
continued and in 2013 DG SANCO joined forces with more DGs such as DG Enterprise, 
DG Trade and the Secretary-General behind the back of DG Env to further undermine 
its work. While DG Entr and Trade were collaborating with industry, the endocrine 
agenda was changed in favour of industry; now a majority of DGs prepared a ‘coup’ 
against DG Env. The full knockout of DG Env was achieved by DG SANCO when the 
Secr-Gen. stopped the work of DG Env in July 2013 and demanded an impact 
assessment, making the costs for industry the major topic in a health regulation. 
 
In summary: 
•  After 25 years of accumulated scientific knowledge on endocrine disruption (ED), the 
EU finally in 2009 adopted a new policy to protect people against the harms of ED 
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•  DG Environment was granted the lead by other DG's to develop criteria (deadline Dec 
2013) 
•  UK and industry protested against the new policy and started drafting undermining 
criteria; they managed to get Germany on their side in 2010 (discussion on potency) 
•  Food Authority EFSA was also opposing the new policy and tried to get involved but 
stayed at the sideline for some time 
•  The work of DG Env and Prof. Kortenkamp on draft criteria in 2011 was blamed by 
industry and UK and the start of a massive lobby campaign 
•  Secretly DG SANCO started cooperating with DG Enterprise behind the back of DG 
Environment; industry and DG ENTR demanded a 'peer-review' of the work of 
Kortenkamp 
•  June 2012 the first "knife in the back" of DG Env was put by DG SANCO by 
mandating EFSA not only to peer-review the work of Kortenkamp but to fully reassess 
the criteria for endocrines 
•  December 2012 EFSA managed to invite experts to their working group on the criteria 
that were no specialists on ED nor were independent scientists; even civil servants 
from Germany and UK, being in the forefront of opposing the work of DG 
Environment, were invited as an independent expert 
•  March 2013 WHO-UNEP published their landmark report on ED with top-level 
endocrinologists, saying that traditional risk assessment cannot assess the adverse 
effects of ED and that new scientific insights on low dose effects should be applied; 
•  EFSA in March 2013 publishes their opinion, completely contradicting WHO-UNEP 
and saying that there is no reason to treat ED in any other way than most chemicals; 
•  Also in March 2013, draft criteria are sent by DG Env to the other DGs to get to the 
required Commission consensus; several of the industry demands are not part of the 
draft criteria 
•  This (not-published) draft creates an unprecedented industry lobby at all Brussels 
levels with exaggerated claims of damage to industry, demanding to include potency 
and to conduct an impact assessment; 
•  SANCO-director Ms. Testori gives credits to the ECPA-claim that 20% (=100 
pesticides) will be banned because of the ED-policy; a claim based on science-fiction 
but still a reason for Testori to alarm the Secretary-General, the one that could start an 
impact assessment; DG ENV is not cc-ed in the mails 
•  Also US-companies, -chamber of commerce and -embassy join the industry-campaign 
and refer to the EU-US trade talks TTIP that could be harmed by the ED policy 
•  DG ENTr and TRADe clearly collaborate with industry behind the back of DG ENV 
and support the claims on potency and impact assessment; DG ENV is isolated 
•  Barrosso's chief scientific advisor Prof. Glover adds to the choir of critics with an 
alarming message to high-level officials, based on a letter of scientists that later all 
appear to have conflicts of interests with industry 
•  In June 2013 SANCO-director Testori sends a message to Commissioner Borg saying 
that many countries complain about the impact of the criteria and that an impact 
assessment "can be expected". 
•  In June 2013 the long-awaited 'interservice meeting' to get to a consensus between 
DGs is convened; the result is negative, a massive coalition of SANCO, ENTR, 
TRADE, AGRI  does not support the DG ENV draft criteria 
•  July 2, 2013, SG-director Catherine Day puts the second knife in the back of DG ENV 
by stopping the criteria-setting process and demanding an impact assessment 
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•  One year later the downfall of the ED-policy was manifested to a full extent in a 
'roadmap' for the impact assessment where 3 out of 4 options violated the EU rules or 
even completely destroyed the agreed EU policy on ED; DG SANCO now has 
obtained the leading role. 
 
 
 
Reconstruction of the timeline of events. 
 
 
 

December 2008:  
Compromise agreed on the hazard approach for endocrines 
 
1. In December 2008 EU Council, Commission and Parliament agreed on a compromise 
in the "trialogue" for the final text of the pesticide Regulation, declaring that "pesticides 
with endocrine disrupting (ED) properties that may cause adverse effects" cannot be 
approved; no exposure to humans is allowed (a "hazard" approach), comparable to 
pesticides with genotoxic effects and a policy in clear contrast to traditional risk 
assessment; 
 
2. However, it was also agreed that Commission had to present "measures concerning 
specific scientific criteria for the determination of endocrine disrupting properties"; 
Commission agreed that DG Environment has the lead in developing such measures and 
criteria; 
 

2010: While DG Environment has the lead,  
industry, UK, Germany and EFSA already start their undermining activities 
 
3. After the adoption of the pesticide Regulation, industrial lobby groups like ECETOC, 
ECPA and CEFIC have immediately started lobbying to reverse the new policy on 
endocrine disrupting pesticides (ED-policy) EDs policy and criteria, and to maintain the 
standard risk assessment with 'safe levels' of exposure. Furthermore, they promoted 
numerous ways to disqualify observed adverse effects in animal studies, for example 
assuming that effects in rats are not relevant for humans; 
 
4. UK and Germany tries to take the lead on criteria by putting their ideas forward and 
especially introducing the criterion "potency", meaning that adverse effects seen in test 
animals at high dose do not count, knowing very well that generally only high doses are 
tested in animal studies;  
 
5. July 2010, EFSA asked to get a role on defining criteria for endocrines; Health DG 
SANCO keeps EFSA in check at that time still by saying not to overlap the work of DG 
ENV. SANCO promised EFSA that it will be consulted on the work of DG Env. during 
the development of criteria 
 
6. EFSA in July 2011 adopts the typical industry view in an opinion on Threshold of 
Toxicological Concern (TTC) that endocrine effects are reversible and have safe levels. 
 

Spring 2012: the pressure is rising;  
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DG Enterprise demands a peer-review 
 
7. Pressure increased at the time that Prof. Kortenkamp was hired by DG Environment 
to develop a 'state-of-the-art' document on endocrine disruptors. Kortenkamp developes 
draft criteria in February 2012; at the same time industry lobby group ECPA launches a 
personal attack on Kortenkamp; 
 
8. April 2012, DG ENTR, DG EMPL and DG SANCO are joining forces to have a peer-
review of the work of Kortenkamp (they call him "the guy"); May 2012, DG ENTR 
internally reports that DG ENV gets nowhere with their criteria-drafting ("no 
agreement on anything" between member states and industry, NGO's) and qualify them 
as arrogant; behind the back of DG ENV, they prepare a peer review 
 
9.  A scientific meeting organised by DG ENV on the state of the science on endocrine 
disruptors in June 2012 in Brussels with international top-level scientists was fiercely 
opposed by ECPA and industry; they lobbied at all levels to stop the meeting and also 
asked science advisor Glover to help including "regulatory scientists" in the meeting; 
 
10. EFSA tries more and more to take a role; in June 2012 it organises a colloquium 
with numerous industry representatives casting doubt on new scientific insights such as 
low dose and non-monotonous effects that are observed in independent research on 
endocrine disruptors; 
 

June 29, 2012,  
Health DG SANCO puts the first knife in the back of DG Environment. 
 
11. Behind the back of DG Environment , but supported by DG Enterprise and others, 
DG SANCO decides to make a mandate for a peer-review, first for the three SANCO 
advisory committees, but later for EFSA, now not only on the report of Kortenkamp but 
on criteria for endocrines in general; DG Environment is not informed till the mandate 
is send off;  
 
12. The first drafts of the mandate in July 2012 talk about risk assessment instead of the 
hazard in the Regulation and the work of DG Environment is completely ignored, 
allowing EFSA to start from scratch; in the final mandate of July 26, risk assessment is 
deleted but still regulatory irrelevant exposure-topics for EDs are mentioned such as 
safe thresholds;  
 
13. November 2012, DG ENTR suggests to involve science advisor Glover on endocrines 
"to control DG Environment"; 
 
14. November 2012, EFSA starts the endocrine Working Group (wg); the first selection 
had no mammalian endocrinologist on board at all, 5 out of 9 had no endocrinology 
experience whatsoever, 4 out of 9 were civil servants from UK/IRL, countries known to 
oppose hazard criteria, and only 2 out of 9 were scientists; 
 
15. December 2012, as a response to the protests, EFSA includes 3 endocrinologists (out 
of 18), while still 11 out of 18 have no experience whatsoever on endocrinology; the 
German and UK representatives are civil servants with double hats, having fiercely 
opposed the criteria proposed by DG ENV in the expert groups organised by DG ENV; 

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16. February 2013, DG Environment proposes draft criteria to the other DGs, but 
refuses to include the industry- and the UK-proposed risk assessment elements: potency, 
lead toxicity, reversibility and severity; 
 
17. February 20, 2013, a discussion starts in the EFSA wg. Now it appears that the draft 
EFSA opinion on virtually all points contradicts the just released 2012 WHO-UNEP-
report on endocrine disruptors; WHO-UNEP concludes that traditional risk assessment 
is not fit for the purpose to assess endocrines, whereas EFSA concludes that risk 
assessment is the best method. A big majority, with UK and German-representatives in 
the forefront in the wg. decides to ignore the WHO-UNEP-report;  
 
18. February 21, 2013, EFSA’s staff propose to delete the words "endocrine disrupting 
chemicals could be considered like most other chemicals" to avoid contradicting openly 
UNEP/WHO but at the end the working group didn't change anything to the EFSA-
report; 
 
19. February, 26, 2013, industry group CEFIC, DG ENTR and DG TRADE, behind 
closed doors, agree to prioritise endocrine disrupting chemicals for the trade talks with 
US; DG TRADE proposes "advanced talks" on this particular topic, before the official 
launch of the process; 
 

March 2013, industry in highest lobby gear to ask for an impact assessment  
and for inclusion of "potency" in the criteria. 
 
20. March 2013, industry starts a new lobby campaign to promote an impact assessment 
including the impact on international trade, alarmed by the  draft criteria of DG ENV; 
ECPA, DOW, CEFIC, Croplife America, all focus their lobby on the Secr. Gen. (Duncan 
Johnston) in different meetings; CEFIC states that without "potency" the forthcoming 
EU-US trade talks could be impaired; 
 
21. March 1, 2013, SANCO Director Testori gets impressed by the ECPA story that 20% 
of all pesticides (this is 100 of the current total of 500) could be banned by current 
criteria and 80% of the fungicides (azoles, dithiocarbamates) for cereals, and 
communicates this with SG (Michel Servoz), in a kind of panic mail; 
 
22. March 12, 2013, next SG (William Sleath) wonders if intervention by SG in the 
interservice consultations is needed at this stage; SANCO (Eric Thevenard) thinks it is 
not needed at this stage; DG ENV seems unaware of all this communication; 
 
23. March 2013, BASF states internally to DG ENTR that criteria could be acceptable 
by including "potency"; the company will contact DG TRADE to talk about the major 
market impact that the criteria will have; ENTR and TRADE actively lobby for 
inclusion of potency; 
 
24. March 20, 2013, EFSA publishes an opinion fully supporting industry views such as 
including "lead effect", "reversibility" and "potency" and favouring traditional risk 
assessment over a hazard approach that is agreed in the Regulation;  
 

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25. April 2013, DG ENTR, on a BASF-meeting, reassures BASF-employees that they 
support a risk-based assessment of chemicals and invite industry to put forward 
proposals to include elements of risk assessment (e.g. potency)  in the criteria, which 
then could be discussed with DG ENV, may-be not for the horizontal (criteria counting 
for all chemicals) but at least for the vertical legislations (criteria for specific chemicals 
such as pesticides);  
 
26.  May 2013, new wave of industry lobby (Amcham, DuPont, US industry) to DG 
ENTR (and AGRI) emerges asking for inclusion potency and for accepting safe 
thresholds;  
 
27. June 2013, industrial lobby at maximum gear, Bayer to SG, ECPA and CEFIC to 
ENTR, ECPA to AGRI, COPA to AGRI, and even communication company Burston 
Marsteller lobbies DG ENTR; ECPA claims less R&D in Europe because of regulatory 
hurdles.  
 
28. June 20, 2013, Barrosso's science advisor Glover adds to the choir of lobbyist 
complaining about endocrine criteria with an alarming message to Catherine Day, the 
Commission's Secretary-General, and to Johannes Laitenberger, Barroso's head of 
cabinet, based on a letter of a group of toxicology and pharmacology experts, later all 
shown to have conflicts of interest with industry. 
 
29. June 24, 2013, SANCO director Testori to Commissioner Borg in internal note states 
that an impact assessment could reasonably be expected for the decision on criteria; 
"US, Brazil and Canada voiced concerns, which might lead to important repercussions 
in trade"; 
 
30. June 26, 2013 Amcham again meeting ENTR and TRADE emphasizes need for 
impact assessment; TRADE says that while they want trade talks to be successful, "they  
would not like to be seen as lowering EU standards;  
 

July 2013, industry and UK get their way;  
ENTR, TRADE and SANCO put the second knife in the back of DG ENV 
 
31. June 2013, Interservice meeting. DG ENTR, AGRI, TRADE demand inclusion of 
"potency" in the criteria; DG ENV refuses to do so;  at the very first Interservice 
meeting the criteria were already blocked by ENTR and SANCO at desk level;  
 
32. July 2, 2013, SG-director Catherine Day intervenes and puts the Interservice talks to 
a halt and imposes an impact assessment on regulation of pesticides and biocides by the 
various options for criteria; the result of the exercise should be two legal proposals for 
implementation with the same content; 
 
33. July 12, 2013, SANCO director Testori to Comm. Borg and Dir. Falkenburg of DG 
ENV: since both proposals need to be identical, the implementing act 
(SANCO/pesticides) should precede the delegated act (ENV/biocides), meaning that the 
Standing Committee on pesticides with the 28 ministries of agriculture decides on both 
pesticides and biocides, effectively SANCO taking the lead from DG ENV;   
 

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34. July 16, 2013, DG SANCO drafts a roadmap for the impact assessment on the 
criteria; however the roadmap is delayed for months; SG (Duncan Johnston) in 
different messages throughout Nov and Dec pushes DG ENV to move on and not publish 
"only DG ENV views";  
 
35. August 13, 2013, EFSA states to Ms. Glover that it is cooperating with DG SANCO 
to open a route so that endocrine disrupting pesticides can remain on the market; 
SANCO develops a general derogation option by widening the text on "negligible 
exposure"; 
 
36. August 16, 2013, Assistant Jan Mueller of Ms. Glover suggests to organise a 
consensus meeting between two groups of scientists fighting over thresholds, low-dose 
effects and non-monotonic effects; in the meeting on November 24 a consensus is 
achieved on thresholds ("it is uncertain that there are thresholds at all"), on non-
monotonic dose-response curves "(they exist but have been observed only 
occasionally"), effects on foetuses ("windows of vulnerability exist", but rarely tested 
pointing at the only recent discovered effects of Paracetamol on foetuses), while 
disagreement remained on the use of "potency" and "safe levels of exposure" in the EU 
regulations. 
 
37. October 13, 2013, Group of MEP's write to the EU President, asking to base the 
endocrine criteria on science and according to the rules and not on economic impacts as 
will be done in the impact assessment; 
 
38. January 2014, industry lobby continues, Amcham meets SG again, US farmers 
complain about too strict food standards, ECPA provides for input on the impact 
assessment; 
 

The end of endocrine criteria,  
the economic impact assessment and the EU-US trade talks TTIP will give the endocrine 
policy the final blow. 
 
39.  June 2014, DG SANCO and ENV present the roadmap for the “socio-economic” 
impact assessment; derogations for a ban of endocrines are already included as a 
reality; three of the options suggested are a complete violation of the Regulation: not 
present criteria at all, change the law from hazard to risk assessment, and  allow 
derogations for socio-economic reasons; 
 
40. August 2014, in the EU-US trade talks start a "pilot" on the EU-US “harmonisation” 
of endocrine criteria. 
 
41. The topic "biocides" is moved from DG ENV to DG SANCO by new EU President 
Juncker, sidelining DG  ENV even further. DG SANCO (now SANTE) on the steering 
wheel. 
 
 

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