GM Free Cymru

Analysis of Draft Regulation reveals EFSA trickery

For the last three years we have been saying, over and again, to the Commission, to EFSA and to national governments, that the new Guidelines and Regulations on GMOs for which EFSA is seeking formal approval are nothing better than a scam, designed to facilitate fast-track and greatly simplified approvals for potentially dangerous GMOs. The documents, sold to the politicians and the media as "a tightening up of regulations" and "enhancing the safety of the people of Europe", are in fact likely to have exactly opposite effects. The documents will allow simplified applications procedures and fast-track approvals, with much lower levels of scrutiny than those applied in the past. Why would EFSA want to endanger the safety of citizens in this way? Well, the problem is that they (GMO Panel members and officials) do not see GMOs as a safety threat, since in their view they are "substantially equivalent" to non-GM products and are therefore equally safe to eat. There is, within EFSA, a pathological refusal to see any dangers in GMOs -- which explains their incomprehension and their fury when confronted with the recent findings of the Seralini study showing toxic effects associated with GM maize and Roundup.

The only ones who benefit from a fast-track and simplified GMO approvals process are of course the applicants themselves -- for the most part multinationals who want to push their latest GMO wonder products into the market place and preferably into the fields of Europe as well. They complain that the EU approvals system is complex, slow and expensive -- and in that they are quite correct. That is because it was designed with public safety in mind. So they want to be able to bring GMOs into the market place much more quickly, smoothly and cheaply -- and EFSA is doing its bit to help, under pressure from the Commission and under intense diplomatic pressure from the USA and the WTO. Monsanto, Syngenta and the other big players in this game claim that 90-day toxicology studies are hugely expensive, and in future they want fewer and fewer of them. (In fact they hardly ever do them anyway, conducting nutritional studies instead, for their own marketing purposes, and dressing them up for EFSA as toxicity tests. That's another fraudulent activity -- but for the moment we'll let that pass.........)

And the GM multinationals are sent into apoplectic fits at the very thought of having to conduct long-term (2 year) or lifetime toxicology studies on the lines pioneered by Gilles-Eric Seralini and his colleagues. They know -- and we all know -- that if such studies were to be made mandatory in Europe, each new GM variety being brought to the market would have its progress delayed by years, not months, and that the costs involved would run into many millions of dollars. From our point of view, why should we worry? We owe these multinationals nothing, and after all, public safety and healthy food are all we are actually concerned about. And if the GMO products created by Monsanto and others are really that wonderful, and are entirely safe, why should they not go through due process with complete confidence that the benefits (and the profits) down the line will far outweigh any costs that have to be met in the short term, during the regulatory and approvals process. Perfectly simple, one would have thought........

But life is very complicated, especially for those poor beleaguered souls who work for EFSA. If the results of the Seralini study are taken seriously, this will inevitably lead to calls for long-term toxicity studies to me made mandatory with all GMO applications. Forget about the simple world of 90-day studies which might or might not be necessary and which can only bring up subtle changes in animal physiology which can always be claimed to be "biologically insignificant" or "within the range of natural variation" or down to "statistically incorrect analytical procedures." Make no mistake about it -- EFSA is worried because if Seralini is right, its whole rule book will have to be torn up and thrown away, and rewritten from scratch. In addition, all those GMO Panel members and officials will have been shown to have been incompetent and negligent over the whole of the last decade. Goodbye to whatever career prospects any of them might have had.........

That is why none of this is actually to do with science. This is all about politics, commercial vested interests and political expediency. Well, EFSA has been well and truly rumbled, and the short document reproduced below confirms this. Written by the French group Inf'OGM, it comes from a detailed line-by-line scrutiny of the Draft Implementing Regulation on GMOs -- the very document which led to the submission of EU Petition 436-10 by 13 independent scientists. The authors of the report make the point, over and again, that although the principles of toxicity testing appear to be laid out clearly (for example, the "mandatory" requirement for 90-day feeding studies) the text continually brings in special provisions or exceptions or discretionary powers which subvert the principles enunciated. Underpinning all of this is the arrogant (and unscientific) assumption on the part of EFSA that GM crops are other products are substantially equivalent to their parent or isogenic non-GM lines, and that they (the regulators) are "familiar" enough with GMOs generally to determine, through a strange process called "comparative analysis" that 90-day studies can simply be dispensed with should they see fit.

Read on, dear reader, and you will see what we are on about. And you will see why we still think that EFSA is an organization which is so corrupt that it cannot be trusted by anybody.

Inf'OGM's opinion – 24th October 2012

Are toxicological analyses still mandatory according to the proposed regulation from EC to Member states on GMP's risks assessment ?

SANCO/12462/2011 Rev. 2 (POOL/E1/2011/12462/12462R2-EN.doc)[...](2012) XXX draft


of XXX

on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Regulations (EC) No 641/2004 and (EC) No 1981/2006 »

Inf'OGM's analysis of the text

Concerning toxicological analysis, the proposed regulation is written with a main paragraph and 4 sub-sections pushing forward « the specific information requirements and testing strategies ».

The main paragraph, which applies to the whole paragraph 1.4., establishes one principle : "The toxicological impact of any changes resulting from the expression of introduced genes or any other type of genetic modification, (such as gene silencing or over-expression of an endogenous gene) shall be assessed".

Although this principle seems quite clear, one question needs relevantly to be answered : do the word "changes" concern those directly linked to the newly introduced gene (the new property conferred to the plant) or do it concern all the possible changes in the plant following the gene's introduction ? For those latter, as the companies usually conclude to the substantial equivalence of the GM plant with its isogenic comparator, the answer will certainly be that no changes are coming from the gene's introduction. Considering that the new protein is analysed, will companies be able to read this principle as not making mandatory analysis on the whole plants, in addition to the comparison of composition analysis ?

Reading the proposed regulation, the main principle appears to be subjected to special provisions (or to be confirmed depending on the answer to the first question quoted above) :

- "The applicant shall consider the need of toxicological testing based on the outcome of the molecular and comparative analysis referrer to in Section 1.2 and 1.3, namely the differencies identified between the GM products and its conventional counterpart, including intended as well as unintended changes"

The applicant will therefore decide on the need and relevancy to conduct a toxicological analysis. To do so, it will use the results of comparative analysis (also called substantial equivalence). To Inf'OGM, this is a serious limitation of the main principle if this latter should make mandatory those analysis.

- "As regards applications of which the scope include or is restricted to genetically modified food and feed produced from genetically modified plants, toxicological studies with the processed products shall not be provided under the condition that the applicant provides a risks assessment of the genetically modified plants (or relevant parts of it) demonstrating its safety and provided that there are no indications that the processed genetically modified food and feed would be any different from their respective conventional counterpart. The applicant shall provide adequate justicication in this regard".

Concerning processed products, toxicological analysis won't be requested if the applicant provides a risk assessment which conclude to the absence of risk associated with the GMP, and under condition of substantial equivalence.

The sub-section of the main paragraph works the same way : establishing a principle which is then subjected to special provisions :

1.4.1. Testing of newly expressed proteins

Principle : "The applicant shall provide an evaluation of all newly expressed proteins."

Exceptions : "As regards proteins expressed in the genetically modified plant, in the case where the history of safe use for consumption as food and/or feed of both the plant and the newly expressed proteins is duly documented, specific toxicity testing as provided for in this Section shall not be required."

"Acute toxicity testing of the newly expressed proteins of genetically modified plants is of little additional value for the risk assessment of the repeated human and animal consumption of genetically modified food and feed and shall not be provided as part of the studies performed under this Point."

1.4.2. Testing of new constituents other than proteins

"The applicant shall provide a risk assessment of identified new constituents other than proteins. This shall include, on a case-by-case basis an evaluation of their toxic potency and of the need of toxicological testing as well as a determination of their concentration in the genetically modified food and feed."

The need of toxicological analysis is here to be considered. It seems that this paragraph 1.4.2. doesn't make it mandatory, with the exception that it is considered needed (who's deciding that ?).

1.4.3. Information on altered levels of food and feed constituents

This paragraph applies only when "the intended or unintended effect of the genetic modification would result in an alteration of the levels of food and feed constituents beyond the natural variation."

The toxicological analysis is to be conducted based on the results of the risk assessment : "The result of that risk assessment shall determine if, and to what extent, the applicant shall provide toxicological tests on selected food and feed constituents.".

1.4.4. Testing of the whole genetically modified food and feed

The circumstances for specific toxicological analysis are to be conducted are described here : "Under the circumstances set out in Points, and of this Section, specific toxicological studies with the whole genetically modified food and feed shall be carried out."

The sub-paragraph of this one are providing, on a case by case basis, the situations where toxicological analysis are required. This sub-paragraph is subjected to the main paragraph 1.4. and the special provisions of this latter. 90-day feeding study in rodents with whole genetically modified food/feed:

This paragraph list the situation when toxicological analysis are required. But this sub-paragraph is subjected to the main paragraph 1.4. and the specific provisions of this latter.

« The applicant shall include a 90-day feeding study with whole food and feed in rodents for the assessment of food and feed containing, consisting of or produced from genetically modified plants with a single transformation event or with stacked transformation events which are not obtained by conventional crossing of genetically modified plants containing a single transformation event ».

Once again, if this paragraph seems to imply that toxicological analysis on whole plants (with one transgenic event) are to be done, it is nonetheless subjected to the main paragraph 1.4. and the special provisions of this latter.

« In the case of stacked transformation events obtained by conventional crossing of genetically modified plants containing one or several transformation event(s), a 90-day feeding study with whole food and feed in rodents shall be included for each of the genetically modified plant with a single transformation event which was used. An additional 90-day feeding study with whole food and feed in rodents with the genetically modified plant with the stacked transformation events shall be included where indications of potential adverse effects are identified during the assessment of (i) the stability of the inserts, (ii) the expression of the inserts and (iii) the potential synergistic or antagonistic effects resulting from the combination of the transformation events. »

This paragraph states that toxicological analysis are not mandatory for stacked GM plants, meaning containing more than one transgenic event, all introduced by conventional crossing, and considering that single event GM plants have been assessed (still under the main paragraph 1.4). The question to be raised here is the number of transgenic events that can be considered (two, three, eights, more ?).


This regulation seems to establish one principle : toxicological analysis are mandatory. But it needs to be clarified.

This principle is subjected to many and important special provisions (or is confirmed, depending on its understanding), notably those stated in the main paragraph which are referring to substantial equivalence, which applies in a broader way and limit the sub-paragraph. Those special provisions cancel the main principle in its potential objective to make toxicological analysis mandatory.