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February 2012

A decade of industry influence at the

European Food Safety Authority (EFSA)

Conicts

on the menu


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A decade of industry influence at the European Food Safety Authority (EFSA) | February 2012

1

Contents

Executive summary 2

Introduction 3

1. How EFSA works 5

EFSAs relationship with EU institutions 5

What guarantees EFSAs independence? 6

How EFSA is organised 6

2. The EFSA-ILSI connection 8

ILSI not an industry lobby group? 8

3. The science behind our ood saety 10

How the authorisation process works 10

Why the authorisation process does not protect the public 10

Risky products: What were not allowed to know 15

EFSA guidance: Favouring industry? 17

Case study I. Whos (not) araid o bisphenol A? 19

Case study II. The not-so-sweet truth about aspartame 21

4. Conicts o interest and revolving doors: How independent are EFSA experts? 23

Conicts o interest exposed 23

EFSAs credibility undermined 26

EFSA rules allow serious conicts o interest 27

Declarations o interest: Transparent but ineective? 27

Reorm at European Medicines Agency not replicated by new EFSA rules? 29

Independent experts: As rare as the unicorn? 29

What sort o expertise is needed in risk assessment agencies? 30

Holiday in Parma, anyone? No pay or EFSA experts 30

Do independent experts want to work or EFSA? 31

Revolving door: EFSA as springboard to lobbying career? 31

Case study III. Gambling with antibiotic efectiveness: GM potato 33

Conclusions and recommendations 35

List o abbreviations used in the text 37

Endnotes 38


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Executive summary

2

Executive summary

In 2012 the European Food Safety Authority (EFSA) celebrates its 10th anniversary. ESFA has been strongly

under attack, and increasingly so in the past ew years. In this report Corporate Europe Observatory and

Earth Open Source take stock o what there is to celebrate. But the reality is sobering.

Criticism o the way the way EFSA deals with the saety o products like pesticides, ood additives, and

genetically modied organisms (GMOs) is widespread and comes rom many dierent sources: civil society

groups, Members o the European Parliament, other public institutions, scientists, and, increasingly, the

media.

Too oten its not independent science that underlies EFSA decisions about our ood saety, but industry

data. EFSA panels base their scientic opinions on risky products like pesticides and GMOs largely on

industry-sponsored studies. EFSA has oten been ound to ignore independent research or unscientic

reasons. The agency has issued controversial guidelines or the assessment o pesticides and GMOs that

benet industry, not the public interest. In some cases EFSA even copies wording rom industry sources.

Nor are all o the EFSA experts who make these decisions independent. Many EFSA panel members have

ties with biotech, ood, or pesticide companies. EFSAs rules allow blatant conicts o interest to persist. Food

industry lobbies are even represented on the EFSA management board. Panel members and management have

strong, systematic ties to the industry lobby group, the International Lie Sciences Institute (ILSI), which is

unded by major ood, chemical, and biotech corporations. The revolving door (where public ofcials move to

industry jobs or vice versa) is also at work in EFSA.

EFSA revised its independence policy on scientic decision-making and conicts o interest in 2011, but this

resulted largely in a summary o the policies already in place. Despite some improvements, the new policy ails

to address the undamental problems o industry science and conicts o interest.

EFSA and the European Commission claim that it is not realistic to exclude experts with industry links

since EU and national policies promote public-private partnerships or the sake o innovation-driven competi-

tiveness. But there may be other reasons or the high number o industry-linked experts, such as the act that

EFSA panel members do not get paid and work in their ree time.

Important developments will take place in 2012 that will show whether EFSA and the EU institutions

have any intention to bring about the radical changes needed. For instance, the membership o eight panels

and the scientic committee will be renewed, EFSA is undergoing an ofcial evaluation, and the European

Commission will start this year with a revision o EFSAs ounding regulation.

In anticipation o these developments, this report by Corporate Europe Observatory (CEO) and Earth

Open Source (EOS) explains how EFSA works, what science is used, how conicts o interest occur, and howindustry inuences the agencys work. With this report, Corporate Europe Observatory and Earth Open

Source aim to contribute to the debate on what changes are needed in the interest o ood saety, public health

and the environment. We also aim to engage more people and organisations in the push or radical change at

EFSA and to reverse its current pro-industry bias.


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Introduction

3

Introduction

Todays ood products contain plenty o substances the eye does not see: ood additives such as colourings

and sweeteners, genetically modied organisms (GMOs), and pesticide residues. All have possible impacts on

ood saety, public health, and the environment. The responsibility or assessing these risks at the EU level lies

with the European Food Saety Authority (EFSA). EFSA was set up to provide independent scientic advice tothe EU institutions on all matters with a direct or indirect impact on ood saety.1

Companies that want to market new ood products or substances in the EU have to seek authorisation

according to procedures laid down in EU laws. EFSAs risk assessment is key to getting your product onto

the market. Huge economic interests hang on a green light rom EFSA, with just a ew big ood companies

dominating the European market. These companies have a particular interest in how the product is tested,

who carries out the testing, and how the data are assessed.

EFSA was created by the EU as the voice o independent science, acting in the public interest. But EFSA has

increasingly come under re or being biased in avour o industry. As this report shows, this is partly due to

the way EFSA was set up by the EU and partly EFSAs own ault.

EFSA has been criticised by civ il society organisations or years. But the criticism has recently intensied,

including in mainstream media channels. Members o the European Parliament and independent scientists

have voiced concerns.2 Controversial cases include EFSAs interventions on the ood and drink sweetener

aspartame, the ood packaging plastics chemical bisphenol A (BPA), and BASFs genetically modied Amora

potato.

Criticisms have ocused on three main problem areas:

EFSA mostly uses industry science to judge whether products are sae and resists taking on board

independent scientic ndings.

Some o EFSAs guidelines or risk assessments oer industry major loopholes. Multiple conicts o interest exist among EFSA management and scientic panel members.

EU law dictates that companies that want to market a product provide a dossier containing saety studies

in support o their application. But these are the companies that stand most to prot rom a verdict o sae to

market or the product. These studies are oten unpublished and are sometimes hidden under commercial

condentiality rules, so they cannot always be examined or tested by independent scientists. Taking into

consideration the ndings o independent studies would bring some balance to the process, but EFSA oten

nds reasons to ignore or dismiss such evidence in its assessments.

EFSA also stands accused o setting guidelines or risk assessments that have originated or been promoted

by industry with the aim o reducing the cost and rigour o testing and evaluation. EFSAs guidelines on

GMOs and pesticides are examples.

EFSAs mission

EFSA provides transparent and scientic advice to underpin the policies and decisions o risk managers in the

European Commission, European Parliament and member states.

It also provides eective and timely communication on all risks associated with the ood and eed chain to a

wide audience, including the public.

The Authority is committed to the core values o scientic excellence, independence, openness, transparencyand responsiveness. EFSA Management Plan 2010


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Introduction

4

Adding to EFSAs credibility problem is the act that members o EFSAs panels on GMOs, ood additives,

and pesticides have been exposed as having conicts o interest. Panel members are requently involved with

industry lobby group ILSI, the International Lie Sciences Institute. EFSAs lax rules allow blatant conicts o

interest to persist. As a result, and at the request o the European Parliament, the EU nancia l watchdog, the

European Court o Auditors is investigating whether the conict o interest policies at EFSA and other EU

agencies are sufcient.

All this is only the tip o the iceberg. It is now widely recognised that EFSA suers rom a lack o public trust

and that radical changes are needed. There will be some opportunities this year. For instance, the member-ship o eight expert panels and the scientic committee will be renewed and the Commission will revise

EFSAs ounding regulation.

This report by Corporate Europe Observatory and Earth Open Source is intended to eed into these

processes and to inorm the public, civi l society groups, independent scientists and policy-makers. The report

explains how EFSA operates and summarises the main criticisms o the agency. It draws on publicly available

documents and interviews with EFSA sta, MEPs, civil society groups, and scientists.3 It indicates where EFSA

is responsible and where the EU institutions need to act. Finally, the report suggests changes that would help

bring EFSA into line with the interests o public health and the environment.


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1. How EFSA works

5

1. How EFSA works

The European Food Saety Authority (EFSA)

was set up in 2002 by the European Union as

an independent source o scientic advice and

communication on risks associated with the ood

chain.4 It is one o 24 specialised EU regulatory andpolicy agencies and is based in Parma, Italy. Other

such agencies include the European Medicines

Agency (EMA), the European Chemicals Agency

(ECHA), and the European Environment Agency

(EEA).

The original motivation or setting up EFSA was a

series o ood saety crises in the 1990s, notably the

BSE (mad cow disease) and dioxin scares.5 A second

key motive behind EFSAs creation was to separate

the responsibility or the scientic risk assessments

rom risk management. Beore EFSA was created,

risk assessments were done by expert committees

that were part o the European Commission. At EU

level, risk assessment is now EFSAs job, while the EU

institutions are responsible or risk management.6

EFSA was supposed to provide independent

scientic advice on ood saety issues to the EU

institutions without getting mixed up in politics.

With new environmental and health concerns

emerging rom ood and animal eed products

involving technologies like genetic engineering and

nanotechnology, the establishment o EFSA came at

a critical moment.

EFSAs relationship with EU institutions

EFSA is known as an independent EU agency. But

it was set up by the EU institutions and they have

an important role in deciding how EFSA works.

The EU institutions established EFSAs ounding

regulation,7 which describes EFSAs mission and role,

how it is organised, how responsibilities are div ided,

and how members o the expert panels are chosen.Importantly, too, the EU institutions decide who is

on EFSAs management board.

But while the ounding regulation lays down gen-

eral principles, it mandates EFSA to design its own

internal rules. So EFSA decides how the management

board and the Advisory Forum and expert panels

unction. It also decides how its scientic opinions

are shaped and how principles on transparency and

condentiality will work in practice.

Key to the theme o this report is that EFSA has

shaped its own rules on how scientic decisions are

made in the panels and how conicts o interest are

dealt with.

The EU institutions, or their part, establish the

rules governing the approval and use o the sub-

stances that all within EFSAs remit. EFSA receives

its mandates (tasks) and unding mostly rom theEU institutions predominantly the European

Commission, but also the European Parliament and

member states. The conditions and payment or each

task are negotiated by the EU institution and EFSA.

Here too the EU institution has inuence over which

questions are asked.

The European Parliament has some power over

EFSA, though it is limited. The Parliaments most

concrete leverage over EFSA lies in its power to

approve the way EFSA spends the money it gets

rom the EU (the discharge). Corinne Lepage MEP

invoked this power in July 2011 when she proposed to

Risk assessment and risk management

Risk assessment is the process o identiying

risks posed by potentially hazardous products and

assessing the likelihood o unacceptable exposures.

It is considered to be a purely scientic procedure.

EFSA experts do not do any testing themselves. They

mainly review studies done by the company that

requests authorisation or a product and opinions rom

government bodies.

Risk management is a political decision-making

process to select steps to reduce risk to levels deemed

acceptable.


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1. How EFSA works

6

block 5% o EFSAs 2012 budget because o recurring

conicts o interest.8 While there was no majority

in avour o this proposal, in December 2011 the

discussion ared up again, with several Members o

the European Parliament demanding that EFSA take

action against conicts o interest.9

What guarantees EFSAs independence?

Dierent types o interests scientic, political,

or economic can lead to bias. However, in thisreport we ocus solely on the most obvious conict

o interest: economic interests. When we talk

o independent science or scientists, we mean

independent o industry.

EFSAs ounding regulation lays the basis or

how EFSA is supposed to achieve scientic excel-

lence, independence and transparency. Regarding

independence, it says that everyone involved in EFSA

shall declare at each meeting any interests which

might be considered prejudicial to their independ-ence in relation to the items on the agenda.10 These

declarations o interest orm the heart o EFSAs

approach to dealing with conicts o interest.

Over the years, EFSA has translated the ounding

regulations principles into more detailed poli-

cies, including its 2007 Policy on Declarations o

Interest.11 In addition, EFSA has established a set o

implementing rules on issues such as how experts are

selected, how panels operate, and the responsibilities

o sta members.12

But aced with a deluge o criticism on its use o

science and conicts o interest in its ranks, in early

2011 EFSA launched a review o its independence

policy, including a public consultation. Executive

director Catherine Geslain-Lanelle acknowledged,

EFSAs independence is occasionally challenged,

and public perception o our independence can bestrengthened.13

In December 2011 EFSA published its new

independence policy.14 However, it is little more than

a summary o previous policies. It contains some

useul changes, but the bottom-line problems remain

(see section 4, EFSA rules allow serious conicts

o interest). No strong rules against conicts o

interest have been introduced, so there is a serious

risk that these will continue. Also, the new policy

does not remind the expert panels o their obligationunder certain EU laws to take independent science

properly into account in assessments, rather than rely

overwhelmingly on industry studies.

In March 2012 eight panels and the scientic

committee will be renewed. This will be an impor-

tant moment to see whether EFSA has changed its

attitude to conicts o interest in spite o its lack o

robust rules. The Commission has a lso requested an

evaluation o EFSA. Following that, EFSAs ounding

regulation will be revised, creating an opportunity

to correct aws such as the composition o the

management board. There will also be a chance to

orce EFSA to implement strict rules on conicts o

interest and to take a more robust stance on using

independent science.15

How EFSA is organised

EFSA is governed by a management board that

oversees its work and appoints the executivedirector currently Catherine Geslain-Lanelle, a

ormer high-ranking ofcial in the French ministry

o agriculture who is responsible or day-to-day

operations.

The core o EFSAs work is done by its expert panels

and units. The agency also a llocates work to external

experts registered on its special database. EFSAs

work is supported by around 450 permanent sta

members.16 It has an advisory orum that connects it

with the national ood saety agencies and advises on

scientic matters and emerging risk issues.

EFSA management board

EFSAs management board has considerable inu-

ence, as it sets EFSAs budget, approves its annual

work programme, and appoints the experts on its

scientic panels.

As laid out in the ounding regulation, its members

are appointed by the EU member states (the Council)

in consultation with the European Parliament.

Members are chosen rom a shortlist o candidates

drawn up by the European Commission, ollowing a

public call or expression o interest. A representative

rom the European Commission sits on the manage-

ment board.17 Management board members are


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1. How EFSA works

7

appointed or our years, a term that can be renewed

once.

While the ounding regulation says that our o

the 14 board members shall have a background in

organisations representing consumers and other

interests in the ood chain,18 it also states that they

are appointed in a personal capacity and are sup-

posed to act independently in the public interest.19Nevertheless, Corporate Europe Observatory ound

that at least ve board members have industry

afliations.20 One is chair Diana Bnti, who was

on the board o directors o the industry body, the

International Lie Sciences Institute (ILSI) (see

section 2). She stepped down rom her ILSI role ater

a controversy broke out about her conicts o interest

(see section 4, Conicts o interest exposed).

Expert panels and scientic committee

The core work in EFSA (risk assessments, scientic

opinions, and guidance documents) is done by the

experts who sit on 10 scientic panels, such as the

GMO panel, the pesticides (PPR) panel, and the ood

additives (ANS) panel.

Each panel has around 20 members. These panels

are renewed every three years, when, on average,

one-third o the members are replaced. EFSA has

imposed a limit o three terms in a row or any one

expert to remain on the same panel.21 The experts

are not paid they are volunteers who only get their

costs reimbursed.

Panel members are selected ollowing a call or ex-

pressions o interest. A team o EFSA sta evaluates

eligible candidates. EFSAs executive director nally

presents a shortlist o candidates to the management

board, which takes the nal decision.

EFSAs selection criteria do not include independ-

ence rom industry.22 The candidates have to declare

any interests when they apply, but EFSAs policieshave not made clear what level o industry interest

is tolerable (see section 4, Conicts o interest

exposed).

EFSAs scientic committee consists o the chairs

o all panels, plus six experts who do not belong to

any panel. It has an important role, writing opinions

on cross-cutting scientic matters, such as methods

o risk assessment, and advising EFSAs executive

director. So conicts o interest or members o this

committee are especially serious.

In some cases, an EFSA panel or its scientic com-

mittee can establish a working group on a particular

issue, consisting o some o its members and some

external experts.


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2. The EFSA-ILSI connection

8


Many people have heard o Monsanto, BASF,

Bayer, and Syngenta. But ew know about ILSI, the

International Lie Sciences Institute. For many EFSA

sta and experts, however, ILSI is a amiliar ally.

ILSI is a Washington DC-based industry lobby

group, with ofces throughout the world, including

in Brussels. It is primarily unded by its member

corporations rom the ood, chemical, and biotech

industry, such as Ajinomoto (the worlds leading

producer o aspartame), BASF, Coca-Cola, Danone,

Krat, McDonalds, Monsanto, Nestl, Syngenta, and

Unilever.

ILSI says its mission is to build science into

regulations by bringing scientists rom academia,

government and industry together in what it calls

neutral ora, typically workshops and conerences.23

It strongly denies that it is a lobby group. 2425

Many members o EFSAs scientic panels and

its scientic committee actively collaborate with

ILSI, joining ILSI task orces and working groups,

authoring inuential ILSI reports on r isk assessment,

or chairing sessions at ILSI conerences. In this way,

ood and chemical corporations can inuence EFSA

panels, in addition to their own lobbying o the EU

institutions.

ILSI not an industry lobby group?

An Earth Open Source report concluded that ILSIs

neutral ora in act promote industry-riendly ways

o evaluating the saety o a product to government

experts. The report ound that ILSIs proposals on

risk assessment ollow a trend o making saety

testing procedures less rigorous and cheaper or

industry at the expense o public health and the

environment.26

ILSI is accused by its various critics o:

Inuencing EFSAs recommendations or the

risk assessment o pesticides, including watering

down the data requirements (tests industry has to

do in support o its applications or approval). 27

Weakening EFSAs guidelines or the risk assess-

ment o GM crops.28

Weakening the risk assessment o potentially

hazardous chemical compounds such as

bisphenol A.29

Slide from

presentation by

Nico van Belzen

(ILSI Europe) at

ESFA independ-

ence workshop,

Brussels,

October 2011


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9

ILSIs denial that it is a lobby group30 is contra-

dicted by its own claims o having inuenced EFSAs

guidelines on GMOs. The German organisation

Testbiotech reported that Monsanto employee and

chair o an ILSI task orce Kevin Glenn boasted at a

workshop in 2006 that ILSIs input had a huge impact

on EFSAs guidelines. ILSI repeated this claim in one

o its reports.31

EFSA has granted ILSI credibility as a scientic

organisation by organising joint events, paying

experts to attend ILSI events, and by being ofcially

represented on ILSI working groups.

In 2005, or example, EFSA and the World Health

Organisation (WHO) organised a conerence with

the support o the International Lie Sciences

Institute on the risk assessment o substances that

both damage DNA and cause cancer.32

EFSA ood packaging panel expert Mona-Lise

Binderups declaration o interest stated that she

was paid by EFSA to participate in an ILSI event

as a representative o EFSAs working group on

nanotechnology.33

In another example, Pesticide Action Network

ound that two EFSA sta members acted on behal

o EFSA on an ILSI task orce on the toxicological

threshold o concern (TTC), a concept that enables

industry to avoid expensive toxicological testing o

chemicals.34

But in 2010 EFSAs management board acknowl-

edged that involvement with ILSI could lead to

conicts o interest. Commenting on Diana Bnti

stepping down rom her role at ILSI, the board said

that she had resigned rom positions which may

create a potential conict o interests with EFSA

activities. (See section 4, Industry on EFSA manage-

ment) EFSA added that the chair o the management

board should not have a role in an organisation

representing interests o the ood chain, other thanpublic interests.35

However, EFSA apparently nds it acceptable or

other management board members to hold leading

positions in ILSI. When Milan Kov declared his

new interest as a member o ILSIs board o directors

in March 2011,36 no queries were mentioned in the

minutes about the conict o interest this would

represent. Following media scrutiny, he let this

position in July 2011.

It is unacceptable or an agency that is supposed

to represent independent science and to operate

in the public interest to tolerate inltration by this

industry-unded group.

ILSI restricted rom

WHO activities because

o unding sources

US groups have been aware o the nature o

ILSIs activities or several years. In 2005 the Natural

Resources Deense Council, Physicians or Social

Responsibility, the Breast Cancer Fund, InternationalFederation o Journalists, Environmental Working

Group, United Steelworkers o America, and other

groups wrote a letter to the WHO, objecting to

ILSIs role in setting standards.

The letter said that ILSI has a demonstrated

history o putting the interests o its exclusively

corporate membership ahead o science and health

concerns ILSIs special status with the WHO

provides a back door to inuence WHO activities.37

In 2006 the WHO decided that ILSI could no

longer take part in WHO activities setting saetystandards or ood and water, because o its unding

sources.3839


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3. The science behind our ood saety

10


What science underpins the way products like

pesticides, GMOs and ood additives are approved

or the EU market? In part, EU regulations and

directives decide what science is used. But EFSA has

considerable inuence on the approvals process. It

writes guidance documents on how the laws should

be interpreted, which tests industry has to carry

out on its products, and how the products should be

assessed or risk.

How the authorisation process works

When a company applies or a particular product or

substance to be approved, it has to present EFSA and

the EU institutions with a dossier o studies it has

carried out or commissioned on the substance or

risk assessment.

At the request o the Commission, the relevantEFSA scientic panel examines the industry dossier

and publishes a scientic opinion on the substance.

Based on EFSAs opinion and other considera-

tions, such as the perceived need or the substance,

representatives o the EU member states meet in

specialised committees and vote on the product

application. I the member states are unable to reach

agreement, as has been the case with GMOs, the

Commission can take the decision.

Approval periods vary, depending on the product.

For pesticides, its 15 years,40 or GMOs, ten.4142 At

the end o this period, the company can apply to

renew the approval. EFSA reviews the substance and

writes a new opinion. I the data requirements or

the substance have changed, the company can be

asked to provide new data.

I new inormation comes to light ater a

products approval that throws doubt on its saety,

the Commission can ask EFSA to review it. The

Commission and individual member states have

the power to order an immediate withdrawal o the

product rom the market.

Why the authorisation process does not protect the public

The authorisation system or risky products or

substances oten works in industrys interest, not the

public interest, or a number o reasons (see below).

Some are within EFSAs control, others not.

EFSA bases its evaluations primarily

on studies carried out by industry

EFSA generally bases its risk assessments onthe dossier o studies carried out by the very same

companies that stand to earn enormous prots rom

the products approval.

The problem with this system is that it is biased in

avour o industry. Many scientic reviews compar-

ing industry-sponsored or -afliated studies with

independent studies show that industry studies are

much more likely to conclude that the product is sae.

The best known example is tobacco industry

studies, which successully delayed regulation or

decades by manuacturing doubt about the eects

o smoking.4344 But the same situation aects many

products in everyday use, including the plastic ood

packaging ingredient bisphenol A (BPA),4546 other

chemicals,47 mobile phones,48 pharmaceuticals,49

medical products,50 and genetically modied oods.51

EFSA can decide to initiate its own scientic work

(sel-tasking) i it believes a particular issue requires

urther research. But this does not extend to carryingout or commissioning its own saety testing on a

substance or product. According to Dirk Detken,

head o legal aairs at EFSA, the agency does not

have the resources to do so, adding, That would also

be against the principle whereby it is the [industry]

applicant who has to prove the saety o the product/

substance in question, and not EFSA.52

However, the examples o aspartame and bisphenol

A (see Case studies I and II in this report) show that

the current system to ensure a products saety is

not robust. This is made worse by the act that EFSA

appears unwilling to take on board independent


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12

EFSA relies on industry science to set sae levels

Tony Tweedale, a Brussels-based toxics consultant

who works or civil society organisations, said EFSAs

lack o awareness o independent science directly

threatens public health. Tweedale explained that at

the heart o every risk assessment is the determina-

tion o the acceptable daily intake (ADI) level. Thats

the level o a substance that regulators consider saeor a human to be exposed to over a long period.

EFSA, like other regulatory bodies, uses the highest

dose at which no toxic eect is ound to set the

ADI. But the problem, Tweedale explained, is that

EFSA uses industry studies rather than independent

studies to set the ADI. And independent studies on

any given substance consistently nd toxic eects at

doses at which industry claims no eect.

Tweedale said: EFSA bases its sae dose on what

industry studies say is the no eect dose, not on what

independent studies say it is. I the industry studies

are wrong, as independent studies oten suggest, then

EFSAs sae doses may not be sae ater al l.

EFSA rejects independent studies

or unscientic reasons

The most common reason EFSA gives or rejecting

independent studies is that they are not carried

out according to the norms or industry tests orregulatory purposes Good Laboratory Practice

(GLP) rules and standardised test designs set out by

the Organisation or Economic Cooperation and

Development (OECD).62636465 But these rules and

EFSAs attachment to them are increasingly coming

under re rom independent scientists and public

interest groups.

Good Laboratory Practice:

Certied reliable science?

EFSA and other regulatory bodies oten treat

conormity with Good Laboratory Practice (GLP)

Public health at risk: Glyphosate scandal

A recent case in which EFSA has potentially placed

public health at risk by ignoring independent studies is

an opinion it issued on glyphosate, the main ingredient

in the widely used herbicide Roundup.

Since glyphosate herbicides were rst commer-

cialised, hundreds o independent studies showingharmul eects have been published.56 Recently,

EFSA had the opportunity to take these studies into

account when Monsanto and the German government

asked or an increase in the allowed residue level or

glyphosate in lentils.

In an opinion issued in January 2012, EFSA acted as i

over a decade o research on glyphosate and Roundup

had simply never happened. It ailed to cite a single

independent peer-reviewed study. Instead, EFSA cited

grey literature unpublished documents o unknown

reliability rom bodies including the EuropeanCommission, the OECD, and the Food and Agriculture

Organisation (FAO), which in turn summarised grey

literature rom industry.57

Needless to say, EFSAs opinion gave the green light

to increase the existing limit a massive 100 to 150-old,

rom 0.1 mg/kg to 10 or 15 mg/kg. The hike in the

allowed residue level was needed to accommodate

glyphosate residues ar above the existing limit in

imported lentils.

EFSAs move ollowed an earlier decision by EU

regulatory authorities to raise the limit on glyphosate

residues allowed in soy 200-old, rom 0.1 mg/kg to 20

mg/kg.58 This decision was made in 1997, the year ater

GM glyphosate-tolerant soy was authorised or use in

ood and animal eed in Europe.

In the case o glyphosate residues, EFSAs practice

o ignoring independent studies is dangerous. Based

on industry studies, EFSA assumes that the acceptabledaily intake (ADI) or glyphosate is 0.3 mg per kg o

body weight per day (mg/kg bw/d). EFSA then works

out rom current residue testing that the highest daily

intake o glyphosate through the diet will be no more

than 46.7% o this ADI 0.14 mg/kg bw/d. Because

this level is under hal o its assumed ADI, EFSA

considers it sae.

But a report by international scientists published by

Earth Open Source59 showed that taking independent

studies into consideration gives an ADI at least 12

times lower than the gure EFSA uses 0.025 mg/kg bw/d.60 This ADI is calculated rom the results

o two studies that used an animal and an exposure

method approved by EFSA in its guidance on the use

o independent studies in pesticide assessments.61

EFSA ignores the known toxicity o glyphosate

established by independent studies such as these in

setting its new allowed residue limit. But taking these

into account, the 0.14 mg/kg o glyphosate residue

that EFSA allows in our daily diet is a massive 560%

o the ADI based on independent studies some six

times the sae daily dose.


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13

rules as a key indicator that a study is reliable. On

this basis, EFSA dismisses large numbers o inde-

pendent studies, which are not carried out according

to GLP rules.

But GLP is nota hallmark o reliable science. Nor

was it ever meant to be. GLP is a set o laboratory

management rules or how experiments are to be

carried out, recorded, and archived. GLP was rstimplemented by regulators in the 1970s to combat

widespread industry raud in testing or regulatory

purposes.66

GLP is a valuable tool in ensuring that industry

adheres to basic standards o traceability, so that i

raud is later suspected, there is a paper trai l that

enables investigators to see who was responsible.

Consequently industry must never be allowed to

sidestep GLP standards.

But GLP species nothing about what matters

most in cutting-edge science: the quality o the

research design, the sensitivity o the test methods,

or whether the methods employed are current or

out-o-date.67

But GLP is now being mis-used by industry and

industry-riendly regulators as a shield to deend

industrys products against inconvenient ndings in

independent studies.

Proessor Gilles-Eric Sralini rom the independent

CRIIGEN research institute in France said that when

independent scientists publish studies showing harm

rom products, EFSAs response is oten: Well, we

dont believe you because you have not ollowed GLP

guidelines. O course only the industry ollows [those

guidelines], because it is very expensive due to the

high labour costs o the monitoring and recording

required.

Sralini added that in the case o bisphenol

A, EFSA disregarded 250 papers on [the chemical]because they were not done according to GLP

guidelines.68

In 2009 a group o 36 publicly-unded scientists

published a peer-reviewed paper criticising the

regulatory xation on GLP on both sides o the

Atlantic. The researchers pointed out that the real

and long-established measure o scientic reliability

is not GLP compliance but independent replication,

and use o the most appropriate and sensitive state-

o-the-art assays, neither o which is an expectation

o industry-unded GLP research.

The researchers concluded, Public health deci-

sions should be based on studies using appropriate

protocols and the most sensitive assays. They should

not be based on criteria that include or exclude data

depending on whether or not the studies use GLP.

Simply meeting GLP requirements is insufcient to

guarantee scientic reliability and validity.69

Are only OECD test designs relevant?

EFSA and other regulatory bodies also dismiss

independent studies on the grounds that they do not

conorm to standardised OECD test designs and are

thereore not relevant to human risk assessment.

As only industry studies conorm to OECD designs,

independent studies are, by this logic, excluded rom

consideration.

But standardised OECD test designs used or risk

assessment are criticised by independent scientistsor being outdated and insensitive.707172737475

Common criticisms are that OECD tests:

Are not designed to test eects o long-term

exposure to a chemical at the low doses that

humans commonly experience. Such eects are

common with endocrine disrupting chemicals

(chemicals that d isturb the hormonal system

and can aect development and the organs and

unctions o the body)

Assume that toxic eects always increase with the

dose in a uniorm way and ignore evidence that

does not conorm to this model

Ignore the eects o mixtures o toxic substances

(the cocktail eect), in which the whole is oten

much more powerul than the sum o the parts

Ignore vulnerable lie stages, such as develop-

ment in the uterus and during inancy, despite

evidence that exposure during these periods

results in signicant increases in cancer76 and

other diseases. Yet human beings are exposed to

toxins during vulnerable periods.

Kill the animals around two-thirds o the way

through their lives, beore long-term eectscan show up. For example, rats are killed at two

years old the equivalent o only 6065 years

in human terms. The majority o most types o

cancers appear ater this age and so are not seen

in OECD tests.77

In sum, the key chronic toxicity tests that agencies

such as EFSA rely onsimply do not test reality.

Brian Wynne, proessor o science studies at

Lancaster University, said: The OECD standards

are pragmatic compromises. Nobody says this is

the best possible science. Everybody says this is the


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14

best compromise between best science and best

economics.

Because testing is expensive, Wynne said, a

compromise is made in OECD test designs on the

exposure period. Better results would be obtained

i more tests were done, and the eects o exposure

were observed or longer periods.

Wynne added, Some studies have tr ied extend-

ing the test periods, and have ound signicant

indications o harm which were not observed or the

shorter, OECD-advised test periods.78 This reects

the Ramazzini Institute ndings on aspartame in

studies using the lietime protocol (see Case study II).

EFSA has no power to change the OECD test

designs, though the EU member states and the

Commission do.79 OECD member countries must ac-

cept industry studies perormed according to OECDguidelines, under the MAD (Mutual Acceptance o

Data) agreement. But the EU Commission has the

power to authorise any additional testing system it

thinks t, as is made clear in the EUs REACH regu-

lation or chemicals.8081 We suggest that this should

include peer-reviewed research by independent

scientists, screened or industry conicts o interest.

Meanwhile, EFSAs clear responsibility is to stop

using non-compliance with OECD guidelines as

a reason to reject independent studies o superior

design.

Industry studies are seldom peer reviewed

In the independent scientic community, scientic

rigour has little to do with GLP or OECD rules and

everything to do with peer-reviewed publication. The

peer-reviewed publication system, while not perect,

has important quality control measures that are

missing rom industry science.

In the peer review process, qualied scientists are

invited by a scientic journal editor to examine a

study being considered or publication. The scientists

give eedback to the journal editor, such as their

analysis o the quality o the study, suggestions

or revisions, and recommendations or or againstpublication. Based on this eedback and the editors

judgement, the study will be rejected, published, or

published with the authors revisions.

Once a study is published, other scientists can

examine and discuss it. They can also repeat (repli-

cate) the experiment to see i their ndings are the

same. This repeat-testing is considered a cornerstone

o scientic reliability.

In contrast, most industry studies used in the regu-latory process all into the category o grey literature,

documents that have not been peer-reviewed or

published and are o unknown reliability.

The EU regulatory process causes concern in the

scientic community because while it ignores or

dismisses important scientic ndings in the public

domain, the studies it relies on rom industry are

oten not available because o their unpublished

status and/or commercial condentiality rules and

so cannot be replicated.

Commenting on this situation, Brian Wynne,

proessor o science studies at Lancaster University,

said: There are restrictions both in terms o

independent reading o the companys studies and

peer reviewing them, as you would review a scientic

paper, and also in terms o experimentally repeating

and replicating or testing those results which are

reported in such studies.85

Is EFSA too busy to look at independent studies?

One possible reason why EFSA oten does not

consider independent studies is a lack o capacity. The

MEP Kartika Liotard, who is responsible or liaison

between the European Parliament and EFSA, has

pointed out that EFSA experts are under pressure rom

an enormous workload that they are ill equipped to

deal with.

She told Corporate Europe Observatory: They get

more and more work in a lot o les. Do they have

enough skilled people to handle the questions in

time?82

This may explain why EFSA appears keen to limit the

amount o data that it is required to assess.

Herman Koter, a ormer scientic director o

EFSA,83 was reported as saying when he let the

agency in 2008: We were equipped to do several

hundreds o claims per year. However in the rst

year we received 40,000 claims. [Executive director]

Geslain-Lanelle limits what and how we have to

research. That is practical, but not according to my

standards.


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15

No one is suggesting that industry submit its stud-

ies perormed or regulatory purposes to a scientic

journal or peer-reviewed publication. Scientic

journals are interested in cutting-edge research,

not routine industry tests carried out according

to outdated methods. But it is a simple matter or

regulators to make industry studies available or

scrutiny by publishing them on a website, a practice

now ollowed by the Australian and New ZealandGMO regulator, FSANZ. At the very least, such stud-

ies must be made available to the public on request.

Example o grey literature:

Glyphosate assessment

An example o industry grey literature used in risk

assessment is the EUs 2002 approval o glyphosate,

the main ingredient o Roundup herbicide. This

approval is still in orce today. The assessment o

the industry dossier on glyphosate pre-dated EFSAand was carried out by the German government

consumer protection ofce BVL and a Commission

expert panel.

BVLs list o industry studies taken into considera-

tion in the assessment86 makes clear that all the

studies were unded by industry. Next to each study,

BVL noted the company or companies that unded it

(the owner o the study). For example, the ab-

breviation MOD reers to the chemical companies

Monsanto and Cheminova.

BVL has marked most o the studies as unpub-lished and many as not even having been done

according to Good Laboratory Practice (GLP).

In 2010 Pesticide Action Network asked the

European Commission or access to several o

industrys toxicological studies on glyphosate. The

Commission replied that it did not have them and

passed the request to BVL, which reused to release

the studies on the grounds o commercial condenti-

ality. Pesticide Action Network is continuing to press

or disclosure through the courts.

87

Risky products: What were not allowed to know

I independent scientists want to check industry

test data and replicate the tests themselves, they

need access to the test designs, the industry test

ndings, and the materia ls tested. Access varies

depending on the type o product and the regulatory

agencies involved.

Industry test designs are standardised by the

OECD and can be reely accessed on the internet.

But industry test ndings are oten not available

because they are unpublished. So even i scientists

replicated an industry test design, they would not be

able to compare their ndings with those o industry.

In addition, EU laws allow companies to ask orcertain inormation submitted in the authorisa-

tion dossier to be kept commercially condential.

Companies argue that disclosure o the inormation

would enable competitors to use it or their own

prot. In such cases the data must sti ll be released to

EFSAs experts and other regulators but is not shared

with independent scientists or with the public.

Industry toxicological studies on pesticides are

oten hidden under commercial condentiality

rules. As the studies are oten not held by EFSA but

by the rapporteur member state responsible or the

pesticide, this is outside EFSAs control.

But EFSA does have a policy o transparency or

industry toxicological studies on GMOs. In 2011

EFSA and the Commission said that only a small

amount o the industry data on GMOs is kept

condential, such as details o the genetic sequence

o the GMO. Most other data, including toxicological

studies, can be accessed on request.8889 This may

be due to an important test case on public access to

industry data on GMOs, described below.

Monsantos GM maize study: Test

case on hidden industry data

In 2002 Monsanto applied or market authorisa-

tion or its genetically modied MON863 maize in

Germany. Its dossier included a rat eeding study.EFSA examined Monsantos study and in April 2004

published a avourable opinion, which concluded that

the results do not indicate adverse eects and that

there are no concerns over the saety o the maize.90

In May 2004 Greenpeace asked the authorities in

Germany, where Monsanto had applied to com-

mercialise the GMO, to release the rat eeding study.

EFSA, which was only ounded in 2002, did not hold

the documents. So Greenpeace applied or disclosure

to the German authorities. Monsanto tried to

prevent disclosure by going to court. But in June


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16

2005, an Appeal Court in Germany declared that the

study must be released.91

In 2005 the EU authorities approved Monsantos

MON863 GM maize or import as ood and animal

eed. The ollowing year Monsanto published its own

interpretation o its rat eeding study, concluding

that MON863 was sae to eat.92

Proessor Gilles-Eric Sralini o CRIIGEN analysed

the disclosed Monsanto data and reached a radically

dierent conclusion. He ound that the data showed

clear toxic eects, notably liver and kidney toxicity, in

rats ed the GM maize or only 90 days. His verdict:

It cannot be concluded that GM corn MON863 is

a sae product.93 Sralini added that in the public

interest, such health data should not be secret or

condential.94

Since the GM maize aair, the EU authoritieshave overhauled their transparency perormance on

industry toxicological studies on GMOs.

Were the EU authorities orced to change their

stance by the GM maize aair? Christoph Then,

who worked or Greenpeace at the time it applied

or disclosure, said: Ater the MON863 case, the

Commission came up with statements that made

clear that these documents have to be made public.

So it was a stepwise process that inuenced acces-

sibility o these data in the EU. I think the MON863

case was important in that process.

As well as deceiving the public over health r isks,

keeping industry studies secret can conceal ailings

on the part o the regulators. The GM maize aair

brought into question EFSAs objectivity in reviewing

and interpreting industry studies, since the com-

panys own study had shown toxic eects that EFSA

had dismissed as irrelevant.95 Unless such studies

are made public, there is no way or the public or

independent scientists to know whether EFSA or

any other public body is accurately reportingindustry ndings.

No access to GMO research materials

While European cit izens can access industry

data on GMOs rom EFSA, the materia ls needed

or independent testing are not available, as these

are in the control o the biotech industry which

seemingly does not want them to be investigated by

independent scientists.

To carry out an investigation, scientists need access

to the whole GM plant that is to be commercialised

and the original non-GM plant rom which the GMO

was produced. In order to nd out whether the GM

process has caused any changes in the makeup or

toxicity o the plant, scientists need to compare the

GM plant with the non-GM original.

But biotech companies prevent such research by

restricting access to the materials. Former biotech

advisor to the US Environmental Protection AgencyDr Doug Gurian-Sherman explained that biotech

corporations such as Monsanto and Syngenta have

oten reused to provide independent scientists

with seeds, or theyve set restrictive conditions that

severely limit research options.96

This applies not only to the GM seeds but to

the non-GM original plants. Increasingly, biotech

companies will not even release these to regulators.

This situation has led EFSA to a llow or situations

where the non-GM original is simply not available

or comparative research.97

The restrictions placed by the biotech industry

on independent researchers have been condemned

by the editors o Scientic American, who wrote,

Unortunately, it is impossible to veriy that

genetically modied crops perorm as advertised.

That is because agritech companies have given

themselves veto power over the work o independent

researchers.98

In contrast, commercialised pesticides are availableto independent researchers, as is evident rom the

large number o independent studies in the literature.


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18

2010. Testbiotech warned that EFSAs guidance was

inadequate in providing consumer and environmen-

tal protection.110

Testbiotech argued that the problem originates in

EFSAs assumption that GM plants are equivalent to

non-GM plants. The process o genetic engineering

changes plants in unpredictable ways that can lead

to health and environmental risks. But the guidanceonly requires comparison o the levels o a ew

basic nutrients, such as protein and at, in the GM

plant with the levels in a non-GM plant. As a result,

unexpected changes will be missed.

This approach, known as comparative assessment,

was, in act, developed by industry and ILSI between

2001 and 2003. During this period, Harry Kuiper and

Gijs Kleter (both members o the EFSA GMO panel

since 2003) were active within the ILSI Task Force

that developed this concept (see section 2, ILSI notan industry lobby group?).111 In 2004, EFSA adopted

the concept in its GM ood and eed guidance.112

So the same people who developed this concept or

industry lobby group ILSI sit on the same EFSA GMO

panel that makes the rules on GMO risk assessment.

This story was repeated in 2008, when EFSA pub-

lished a review arguing that animal eeding studies

on GMOs should not be mandatory but should only

be conducted i the comparative assessment showed

that they were needed113 an unlikely scenario, given

the weakness o the comparative assessment process,

as explained above.

Testbiotech compared the EFSA review with a key

ILSI text and ound substantial parts o the text in

both documents to be almost identical (see extracts

below). Testbiotechs report concluded, The docu-

ment published by EFSA to explain why eeding trials

are not necessary, was at least partially plagiarized

rom an ILSI paper.114

ILSI EFSA

In addition,

livestock eeding studies

with target species are

sometimes conducted

to establish the eect o

the new eed resource on

animal perormance with

endpoint measurements

such as eed intake, level

o animal perormance,

eed conversion efciency,

animal health and welare,efcacy, and acceptability

o the new eed ingredient.

Livestock eeding studies

with target species are

sometimes conducted

to establish the eect o

a new eed material on

animal perormance with

endpoint measurements

such as eed intake,

animal perormance,

eed conversion efciency,

animal health and welare,efcacy, and acceptability

o the new eed material.

Based on this evidence, it seems that EFSAs ap-

proach meets the needs o industry by providing an

easier and cheaper approval process at the expense o

the protection o public health.


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Case study I Whos (not) araid o bisphenol A?

19

Case study IWhos (not) araid o bisphenol A?

Some o EFSAs most controversial saety assess-

ments have been on a chemical called bisphenol A

(BPA). BPA is used to make shatter-proo plastic and

coatings. It is ound on the inside o almost all ood

and beverage cans and in dental llings.

BPA is an endocrine disrupting chemical a

hormone disruptor. Endocrine disruptors have been

ound to cause cancer, birth deects, developmental

problems, heart disease, disorders o the thyroidgland and nervous system, and even obesity, oten at

very low doses.115

The evidence against BPA is overwhelming yet

EFSA has repeatedly dismissed it. In 2009 EFSA

(along with its US counterpart, the FDA) was

criticised by 36 publicly-unded scientists in a

peer-reviewed paper or rejecting hundreds o

independent studies showing harm rom low doses

o BPA in avour o only two industry-unded studies

showing saety.116

The scientists blamed EFSAs decision on its

xation on Good Laboratory Practice or GLP. The

two industry-unded studies adhered to GLP, while

the independent studies, as is usual or non-industry

studies, did not.

Scientic monitoring since 2009 by the French

organisation Rseau Environnement Sant shows

that o 193 published studies on BPA, 96% nd

worrying eects. In many o these studies (31 o 118),eects are ound at doses below the acceptable daily

intake (ADI) level deended by EFSA.117

Dr Andr Cicolella, a spokesman or Rseau

Environnement Sant and toxicologist at INERIS

(the French institute or industrial risk assessment),

explained: The current ADI supported by EFSA is

50 micrograms/kg/day. But a study in mice ound

precancerous changes in mammary glands at only

0.025 micrograms/kg/day.118 Thats 2000 times lower

than the current ADI.

P

hoto:nerissa

sring


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Case study I Whos (not) araid o bisphenol A?

20

No no-eect dose was ound in this study. So

taking into account the usual saety margin,

Cicolella said, The ADI should be no more than 25

picograms/kg/day 2 million-old below the current

ADI. Clearly this is grounds or a ban.

While EFSA did recommend a ban on BPA in

babies bottles, it reused to lower its ADI or to ban it

altogether. Instead it issued a series o opinions andstatements reafrming BPAs saety.119120121122

But many members o EFSAs ood additives (ANS)

panel who wrote two such opinions on BPA123124

have ties with industry (Sandro Grilli , Fernando

Aguilar) and links to ILSI (John Christian Larsen,

Iona Pratt, Susan Barlow, Riccardo Crebelli, Ivonne

Rietjens, and Jean-Charles Leblanc).125

In September 2011 EFSAs stance was directly

challenged when the French ood saety authorityANSES published two revolutionary reports on

BPA.126127 These concluded that health eects rom

BPA had been proven in animals and suspected in

humans, even at lower levels o exposure than the

so-called sae dose allowed by EFSA. On the basis

o these ndings it recommended no exposure to

BPA or inants, young children, and pregnant or

breasteeding women identied by ANSES as the

most susceptible populations.

ANSESs verdict stood in stark contrast to EFSAs,

mainly because ANSES took into consideration all

the available evidence on BPA, including independent

studies.

EFSA responded to ANSESs reports by continuing

to deny that there were any grounds or concern.128

In this case EFSAs response came rom the CEF

panel, which covers ood packaging. In a pattern that

has become amiliar, at least our CEF panel mem-

bers have been involved in ILSI activities on ood

packaging. Roland Franz is a member o the scientic

committee o ILSIs International Symposium onFood Packaging and Laurence Castle co-authored

an ILSI study on Estimating consumer exposure to

chemicals migrating rom packaging materials.129

EFSAs decision was condemned by Dr Cicolella

rom Rseau Environnement Sant: ANSES chooses

to endorse 21st century toxicology, when EFSA sticks

to good old 1960s toxicology, Cicolella said. By

denying the reality o scientic data and accepting

only two industry-unded studies relying on an

obsolete protocol, EFSA behaves like a commercial

agent or the industry. 130

Rseau Environnement Sant is urging the

European Commission and Parliament to intervene

to orce EFSA to operate in a way that guarantees the

protection o public health.131

Following ANSESs reports, on 12 October 2011, the

French National Assembly voted to ban BPA in all

ood contact materials rom 2014. Containers aimed

at children under three will have to be BPA-ree by

the beginning o 2013 and all products will have to be

labelled to warn sensitive populations o the dangerso exposure to the substance.132 Belgium is ollowing

the same path.133

The CEF panel did admit that there is a lack o data

on low-dose exposure, and is awaiting publication o

new low-dose studies being conducted in the United

States in 2012. Meanwhile many Europeans, thanks

to EFSAs deence o BPA, will continue to be exposed

to potentially dangerous levels o the chemical.


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Case study II The not-so-sweet truth about aspartame

21

Case study II

The not-so-sweet truthabout aspartame

Aspartame also known in Europe as E951 is

one o the most widely used articial sweeteners. It

is ound in over 6000 ood products, including low

calorie sot drinks, and around 500 medicines.

EFSA based its ADI (acceptable daily intake) or

aspartame on our industry studies, carried out by

the manuacturers in the 1970s. But more recently, a

number o large-scale studies on rats and mice have

indicated that it causes cancer. EFSA has dismissed

these ndings, maintaining its position that aspar-tame is sae.

Yet at a public hearing in the European Parliament

in March 2011 EFSA was orced to admit that the

EUs scientic committee on ood, which did the

original evaluation in 1984 beore EFSA existed, did

not actually have the our industry studies, let a lone

review them, when it gave approval.134

Dr Morando Soritti, director o the European

Foundation o Oncology and Environmental

Sciences at the Ramazzini Institute in Bologna, Italy,

published the ndings o his initial study on rats in

2005 and 2006.135136

Soritti said: The previous [industry] studies were

perormed in the seventies and we were suspicious

about the correctness o how the experiments were

conducted.137

To overcome the limitations o OECD industry test

designs, Soritti used a human-equivalent model

that mirrors how humans are exposed to carcinogens(cancer-causing substances). The animals were

allowed to live out their natural liespan, rather than

being killed two-thirds o the way through their lives,

as OECD protocols demand. As most cancers show

up in old age, years ater the exposure that triggered

them, this lietime protocol enables all cancers

triggered by the chemical to be seen.

Under these realistic conditions, Sorittis team

ound that aspartame causes an increase in cancer

in rats at dose levels ar lower than the acceptable

daily intake level (ADI) set by EFSA. The research-

ers concluded, On the basis o these results, a

reevaluation o the present guidelines on the use and

consumption o [aspartame] is urgent and cannot be

delayed.138

EFSA rejected Sorittis study mainly on the

grounds that it did not conorm to OECD and GLP

norms139 (which only industry studies conorm

to). But this was precisely the studys strength it

reected real human exposures. In real lie, humans,

unlike the rats in OECD tests, are not killed two-

thirds o the way through their lives.

EFSA also objected to the act that many old rats

had lung inections, which it saw as a conusing

actor that helped invalidate the ndings140 even

though this reects the reality o human old age,

when lung inections are common.

Soritti went on to conduct urther experiments,

rst on rats141 and then on mice.142 He explained:

To test the potency o one carcinogenic agent it is

necessary to test it in at least two species, rat and

mice. Because i the result is that it is carcinogenic in

two species o animals, there is more probability that

it is also carcinogenic in humans.143

This time, Soritti extended the human-

equivalent model to include exposure during oetal

development. Again, this reects the way humans are

exposed to carcinogenic chemicals. Soritti ound

that aspartames cancer-causing eects increase even

more when exposure begins in the womb.144145

The European Commission asked EFSA to com-ment on Sorittis new mouse study. EFSA rejected it,

chiey and predictably because it did not conorm

to OECD norms. EFSA said in a statement that two

o its panels concluded that there was no indication

o any genotoxic [damaging DNA] or carcinogenic

potential o aspartame and thereore no reason to

revise the acceptable daily intake or aspartame.146

EFSA said the tumours could have occurred

spontaneously and that such tumours in mice are

irrelevant to human risk assessment. EFSA cites an

impressive-looking list o ve scientic papers to back


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Case study II The not-so-sweet truth about aspartame

22

up this claim, but closer examination reveals that

these are :

A non-peer-reviewed piece o grey lit-

erature summarising the outcomes o an ILSI

workshop147

A paper sponsored by the chemical company

Rhne-Poulenc148

A paper authored by Alan Boobis,149 a long-term

ILSI insider who has also served on EFSA expertpanels or many years,150 which cites ILSI as a

main authority or its argument

An ILSI paper151

A paper sponsored by the chemical company Dow

AgroSciences.152

Far rom representing an independent scientic

consensus or even a reasoned debate, this list o

papers is little more than an industry chorus. All

ollow the time-honoured industry-ILSI line o

argument that mandatory cancer testing in micein addition to rats should be abolished in regula-

tion without oering an eective alternative. Their

reasoning? Tumours such as Soritti ound in

aspartame-exposed mice are irrelevant to human

risk assessment.153 EFSA uncritically adopted the

same line o argument promoted by industry and

ILSI.

Soritti has rejected EFSAs criticisms, but argues

that the key issue is that a proper evaluation is

carried out: What I think should be pushed very

strongly is an evaluation o the saety o aspartame

and the carcinogenicity o aspartame. You cannot

avoid a review o the documents, the raw data o the

past experiments. I, on reviewing that data, you nd

that the adequacy o that experiment is very poor,

you cannot say, Well, that data is poor but we dont

believe the result o the Ramazzini Institute, because

in that case you have to repeat the study. The [EFSA]

opinion is not enough.154

In Marie-Monique Robins lm Notre Poison

Quotidien, Soritti reveals that one day, a high

ranking EFSA ofcial had told him: Doctor Soritti,

i we admit that the results o your study are valid,

we would have to ban aspartame rom tomorrow

morning. You are well aware that that is not possible.

In a March 2011 hearing in the European

Parliament, Corinne Lepage MEP and AntonyiaParvanova MEP criticised EFSAs reusal to re-evalu-

ate its advice in the ace o the new evidence. Lepage

expressed shock at the ailure to examine the subject

more thoroughly.155 Following this meeting, the new

deputy general o DG SANCO Ladislav Miko wrote

to EFSA asking or a new assessment by 2012. 156

Hugues Kenigswald, the head o EFSAs ood

additives (ANS) panel, indicated in a letter to Rseau

Environnement Sant in May 2011 that this would

be difcult because EFSA did not have the dossiero original experimental data, and as ar as he was

aware, nor did the European Commission.157

This revelation raises an important question: On

which inormation did EFSA base its original ap-

proval decision? On science, or on wishul thinking?

Kartika Liotard, the Member o the European

Parliament responsible or liaison between EFSA and

the Parliament, commented: The Parliament and

I was one o the initiative takers asked over and

over again or new research. Not only to make an

evaluation o research done by other research centres,

but or EFSA to do its own new research i they say

they cant use the data rom the other scientists. We

have been asking or this in the Parliament or the

past six years.158

P: j


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4. Conicts o interest and revolving doors: How independent are EFSA experts?

23

4. Conicts o interestand revolving doors: Howindependent are EFSA experts?

EFSAs reliance on industry science operates

against the public interest. But this bias is reinorced

perhaps even caused by industry conicts o

interest among EFSA sta and experts. It has come

to light that many panel members are too close to

industry.

We have already looked at the systematic inltra-

tion o EFSA panels by the industry lobby group

ILSI. In this section we look more deeply into the

problem o conicts o interest on EFSA panels andthe lack o rules in place at EFSA to prevent them.

We also consider the problem o the revolving door,

when people move jobs rom a public body like EFSA

to industry, or vice versa, resulting in a conict o

interest.

What is a conict o interest?

A conict o interest is a situation where an indi-vidual in a position o trust aces a conict between

their private interests and their ofcial responsibili-

ties.159 Until December 2011, EFSA did not even have

a clear denition o conict o interest. Corporate

Europe Observatory and Earth Open Source use the

denition proposed or the public sector in 2007 by

the Organisation or Economic Co-operation and

Development (OECD), since it is broad enough to

cover any problematic tie with industry:

Conict o interest occurs when an individual or

a corporation (either private or governmental) is in

a position to exploit his or their own proessional or

ofcial capacity in some way or personal or corporatebenet.160

By this denition, the simple act o being in such

a position, even i no unethical or improper act

results, represents a conict o interest. The conict

can be mitigated through disclosure, but it can only

be resolved by removing the individual rom the

position.161

In December 2011 EFSAs management board

adopted the OECD denition as part o its new

independence policy. However, it is not clear whether,

or how, this will aect EFSAs practices.


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24

Reported conficts o interest at EFSA 20102011

When? Who? What?

24 March 2010 Suzy Renckens

(GMO panel)

Head o the secretariat to the EFSA GMO panel takes lobbyist

job at Syngenta (revolving door case). Testbiotech/ Corporate

Europe Observatory joint complaint.164

29 September 2010 Diana Banati

(management board)

EFSA management board chair Diana Banatis conict o

interests case with ILSI Europe. Jos Bovs press conerence,

Brussels.165 Banati resigned rom the board o ILSI Europe

and was re-elected chair o EFSAs management board on 21

October.166

29 November 2010 Laura Smillie(risk communication unit)

EUFIC revolving door case. Corporate Europe Observatoryreport, Corporate Europe Observatory /Testbiotech/Food &

Water Europe joint complaint.167

1 December 2010 Harry Kuiper

(GMO panel)ILSI conict o interests case. Testbiotech report.168

23 February 2011 Milan Kovac

Matthias Horst

Jiri Ruprich

Piet Vanthemsche

(management board)

Conicts o interest o our management board members

with Danone, ILSI, EUFIC and COPA. Corporate Europe

Observatory report.169

7 April 2011 Angelo Moretto

Alan Boobis

Theodorus Brock

(PPR panel)

Conicts o interest rie with Europes pesticide and ood saety

regulators. Report by Earth Open Source.170

15 June 2011 ANS panel Eleven out o 20 experts on panel on ood additives have a

conict o interest, as dened by the OECD. Four members

o the panel ail to declare active collaborations with ILSI

Europe.171

13 September 2011 Ursula Gundert-Remy

Riccardo Crebelli

(ANS panel)

Two o ve newly-appointed experts in July were ound to be

in violation o internal EFSA rules because they had ailed to

disclose consulting activities or ILSI.172

27 October 2011 Albert Flynn

(chair o NDA panel)

NDA panel chair Albert Flynn has conict o interest related to

Krat Foods; investigation by Sddeutsche Zeitung.173

7 November 2011 GMO panel Twelve out o 21 experts on GMO panel have conicts o inter-

est, as dened by the OECD. Corporate Europe Observatory

report.174

19 December 2011 EFSA working group on TTC Ten out o 13 members o EFSA TTC working group have a

conict o interest. Pesticide Action Network report.175

Conicts o interest exposed

An avalanche o reports on conicts o interest and

revolving doors cases involving EFSAs management

board and panels appeared in 201011 (see table be-

low). But these were not the rst. In 2004 Friends o

the Earth Europe reported on the GMO panel162 and

in 2008 the Swedish newspaper Svenska Dagbladet

investigated the ANS (ood additives) panel.163


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25

Industry on EFSAs management board

In October 2010 the French Member o the

European Parliament and armer activist Jos

Bov discovered that the Chair o the Board Diana

Bnti - was a lso on the board o directors o the

industry body, the International Lie Sciences

Institute (ILSI).

As a result, Bnti resigned rom ILSI but kept

her position at EFSA. Civil society groups criticised

this outcome, saying that her ties with industry

had been demonstrated so strongly that she should

have resigned rom EFSA. Bnti was appointed to

the ILSI board o directors in Apri l 2010 but did not

declare it until 28 September, ater Bov held a press

conerence to expose her conict o interest.

According to EFSAs ounding regulation, ourmanagement board members are supposed to be

drawn rom organisations representing consumers

and other interests in the ood chain. EFSA says

that out o these our board members, two are rom

industry:176 Matthias Horst, the German ood

industrys chie lobbyist; and Piet Vanthemsche,

who leads the Flemish union o industrial armers

and holds an executive position in Agri Investment

Fund, which has shares in 19 agribusiness-related

companies.

But Corporate Europe Observatory ound that

another two board members also had industry ties:

Milan Kov (director o ILSI Europe until July 2011);

and Ji Ruprich (Danone Institute). In allowing so

many industry-linked people on the management

board, the EU institutions are v iolating their own

rules.

As Corporate Europe Observatory pointed out

in a letter to EU Commissioner John Dalli, it is not

credible to claim that people with industry interests

will act purely in the public interest on the EFSA

management board.177 Dallis ofce admitted that

these were legitimate concerns and that the

Commission has a governance responsibility with

regard to agencies like EFSA.178

The European Court o Auditors too said in late

2011 that the scrutiny o conicts o interest ormembers o EFSAs management board was insu-

ciently rigorous. The Court o Auditors is expected

to publish an audit o conicts o interests at EFSA in

early 2012.179

Conicts o interest in EFSAs management can

only be banned by a drastic change in the ounding

regulation to require only people without industry

ties to sit on the management board. It is up to the

European Commission to take this initiative.

Exposed: Conficts o interest on EFSA panels

In June 2011 Corporate Europe Observatory

published a report showing that 11 out o 20 members

o the ANS (ood additives) panel had a conict o

interest.180 Six o them have active collaborations

with ILSI, including the vice-chair (now the chair),

Ivonne Rietjens. Four o them ailed to declare

these ILSI interests John Christian Larsen (chair),

Gerrit Speijers (rapporteur), Iona Pratt, and Jrgen

Knig.181 Under EFSA rules, ailure to disclose advice

or services in a particular eld alling within EFSAs

remit, even i unpaid, can lead to the experts

dismissal but in these cases did not.182

The story was repeated in July 2011 when some

members o the ANS panel were replaced ater their

mandates expired. Corporate Europe Observatory

ound that two o the ve newly appointed experts,

Riccardo Crebelli and Ursula Gundert-Remy, ailed to

disclose consulting activities or ILSI.183

Harry Kuipers vanishing ILSI connection

Harry Kuiper has been active with ILSI or at least

a decade. From around 2001 he was an important

member o the biotech taskorce set up by the ILSI

International Food Biotechnology Committee and was

still involved with ILSI as recently as 2010. The ILSI

taskorce was headed by a Monsanto employee and

included employees o Cargill, Bayer and Syngenta.

Kuiper has been chair o EFSAs GMO panel since

2003.189

But Kuiper has changed his EFSA declaration o

interest (DoI) to exclude his most recent ILSI con-

nections. In his 2010 declaration (beore criticism o

EFSA-ILSI connections went mainstream), he lists an

ILSI interest rom 2000 to now as an independent

expert on GM oods. But in his 2011 declaration o

interest, Kuiper states his most recent ILSI involve-

ment as 2005.190


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26

A report by Earth Open Source exposed how two

recent members and one current member o the

pesticide (PPR) panel Angelo Moretto, Alan Boobis

and Theodorus Brock had close ties to ILSI.184

Another report by Corporate Europe Observatory

showed that 12 out o 21 members o the GMO panel

had a conict o interest, mostly with the biotech

industry.185 This panel is responsible or severalcontroversial guidance documents and opinions (see

Case study III). Five members have past or current

ties to ILSI: Harry Kuiper (chair), Gijs Kleter, Hans

Christer Andersson, Jeremy Sweet, and Jean-Michel

Wal. Collaborations ranged rom authoring key

reports to being a scientic contributor or a member

o an ILSI working group.186187188

A report by Pesticide Action Network revealed that

10 out o 13 members o the EFSA working group

on TTC (threshold o toxicological concern) havea conict o interest.191 TTC is an industry-driven

approach to allow chemicals market access without

toxicological testing. These members have developed

or promoted TTC in the past jointly with industry.

Internal emails requested by Pesticide Action

Network rom EFSA and reported by Le Monde

showed that Susan Barlow, chair o this working

group, had a large say in the selection o the TTC

working group members.192 Barlow is a private

consultant whose clients include ILSI, Pzer and

Pepsico, and is at the same time a member o EFSAs

scientic committee.

An investigation by the German newspaper

Sddeutsche Zeitung highlighted the case o the

nutrition (NDA) panel, chaired by Albert Flynn,

who is also a member o an advisory board at Krat

Foods.193 The NDA Panel decided in avour o a

health claim made by Krat on one o its products,

and EFSA did not seem to see a problem with Flynns

conicting role at the company.

Wrapped by industry? EFSA

panel on ood packaging

Three o the current 18 members o the EFSA Panel

on ood packaging materia ls mention connections

to ILSI in their declarations o interest.194 Chair

Iona Pratt (moved in September 2011 rom the ANS

panel on ood additives, see section above) has now

declared her collaborations with ILSI chairingat an ILSI workshop and reviewing case studies.

Laurence Castle declares that he was part o two ILSI

expert groups and co-authored one ILSI publication.

Svensson Kettil authored a 2002 publication by an

ILSI task orce on packaging materials, which had

employees o BP, Coca-Cola, Nestl and Dow among

its members.195

Some members have not declared their links to

ILSI, indicating that the links could be much more

requent than EFSA documents reveal. This alsoshows that EFSA does not check the declarations

o interest o the panel members. Roland Franzs

declaration o interest on EFSAs website is outdated

(November 2010) and ails to show his membership

o the scientic committee o ILSIs 5 th Symposium

on Food Packaging, scheduled or November 2012

in Berlin.196 Similarl

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