As you read this article remember you can't get accuracy from EFSA. Going back to aspartame, the European Commission, Scientific Committee on Food did a review. OLAF found instead of a non-bias committee investigating aspartame one person made the decision. OLAF investigates fraud against the EU budget, corruption and serious misconduct within the European institutions, and develops anti-fraud policy for the European Commission. So the Scientific Committee on Food became inactive, and what Europe got in its place was EFSA, the European Food Safety Authority. Here is the whole story: http://www.holisticmed.com/aspartame/scf2002-postscript.htm
If you were to look up the web site of EFSA it would say: "EFSA's scientific advice helps to protect consumers, animals and the environment from food-related risks. What we do. We provide independent scientific advice" ... What a laugh. After the Scientific Committee on Food became inactive then EFSA decides to review aspartame. An EFSA spreadsheet boldly plagiarized a manufacturer-funded review by lifting large sections of the manufacturer-funded review and copying the text with minimal word changes to produce EFSA's own review. http://holisticmed.com.aspartame.EFSA-Draft-Plagiarism.htm
The aspartame industry really fears the Ramazzini Institute because they are world renowned for cancer research. So when they released the studies showing aspartame to be a multipotential carcinogen industry fought to convince the public not to accept them by saying the rats had respiratory disease. Dr. Morando Soffritti told them of course the rats had respiratory disease, this is the dying process. This was a lifetime study and the rats were dying. Did they answer Dr. Soffritti's eloquent rebuttal of their stupidness? No, of course, not. They couldn't. Did EFSA try to protect the public? Of course, not. However, the head of the committee Dr. Herman Koeter resigned from EFSA saying "we were pressured by industry to hijack science". Dr. Soffritti went on to do two more studies showing more and more cancers. The FDA (Fatal Drugs Allowed) followed EPSA and also refused to answer Dr. Soffritti's rebuttal. However, in 2009 some members of the FDA confessed to former president Obama that they were broken, corrupt and whistleblowers feared reprisals. In the meantime, Dr. Morando Soffritti had his studies peer reviewed by 7 world experts and also received a prestigious award only given twice in history.
The point is the public has no protector except for organizations like ours exposing the real facts for those who must have the truth. If you take EFSA seriously you might as well read Micky Mouse. I did turn EFSA over to Olaf based on conflict of interest and Mark Gold of the Aspartame Toxicity Center reported their plagiarism, but the second time around nothing was done. Read on and remember the importance of getting the truth in the matter of Glyphosate.
Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
This is an English translation of the article entitled, "Glifosato: nuovi risultati dell’Istituto Ramazzini su equilibrio ormonale e sviluppo riproduttivo nei topi. Intervista a Mantovani dell’Iss", which may be found at: https://ilfattoalimentare.it/glifosato-istituto-ramazzini-mantovani.html
Exposure to low doses of glyphosate - or, above all, of glyphosate-based herbicides such as the famous Roundup - is associated, in mice, with a series of small but significant alterations in endocrine balance and reproductive development, visible both in males and females. This is the conclusion of a pilot study coordinated by researchers from the Ramazzini Institute of Bologna, with the participation also of the Higher Institute of Health (ISS), the University of Bologna and foreign research centers.
"A study that, even without alarmism, should stimulate a revision of the regulatory state of glyphosate, currently not placed among endocrine disruptors by official bodies such as EFSA, the European authority for food security". Word of Alberto Mantovani, ISS toxicologist and co-author of the study, to whom Il Fatto Alimentareasked to clarify the results and their possible implications in the intricate dispute concerning the safety of glyphosate.
Dr. Mantovani: why take care of glyphosate again, given that according to EFSA's opinion there is no evidence that it can determine endocrine effects? Meanwhile, let's take a step back, to remind you that there are massive public concerns about glyphosate, due to conflicting conclusions from various international agencies, particularly regarding the risk of carcinogenicity. According to the Iarc, the International Agency for Research on Cancer, this substance could be "probably carcinogenic", while on the contrary according to EFSA and the European Chemicals Agency (ECHA) it is unlikely that it could have carcinogenic effects. There has been much debate on this issue, with arguments that are not always convincing and often without considering that Efsa and Echa, as per the mandate, have evaluated the active substance itself (pure glyphosate), while Iarc has focused on products. Therefore, an international group of researchers, led by the Ramazzini Institute, has decided to put aside the controversy and try to collect new data to respond more solidly to public concerns, also filling some uncertainties that emerged from previous research. The Higher Institute of Health also considered it useful and important to participate in this new data collection.
As for the fact that EFSA has already issued an opinion that does not consider glyphosate as an endocrine disruptor, it must also be emphasized that this is an opinion issued in 2017, ie before new criteria were defined with the contribution of Efsa itself. stringent on endocrine interference of biocides and pesticides. This is why I do not find it out of place to go back to the question.
You spoke of both carcinogenicity and endocrine interference, ie alterations in hormonal balance: what is the relationship between the two areas?
There are many cases in which the carcinogenicity is not directly caused by a substance, but in an indirect way, mediated by other effects among which hormonal imbalances due to endocrine interference are important. Glyphosate could fall into this situation, which is why it is worth focusing on any endocrine effects.
The study compared the reproductive and endocrine development of two groups of mice: some exposed from pregnancy to adulthood at low doses of both pure glyphosate and Roundup, a glyphosate-based herbicide, others not exposed to this substance. What are the results you have achieved?
To begin with let me underline the importance of exposure to low doses of glyphosate, which can be considered one of the strengths of the study, together with the fact that the effects on development have been evaluated also in the long term, during the adult life of the animals. One of the criticisms made of many studies carried out with animals on glyphosate concerns exposure to very high doses of the substance, which have nothing to do with what could happen in humans. That's why we decided to focus on the dose per kilogram of body weight that the EPA, the United States Environmental Protection Agency, considers to be safe for humans even in the case of chronic exposure, equal to 1.75 milligrams per kg per day.
What we have observed in individuals (both males and females) exposed to glyphosate is an increase in anogenital distance compared to unexposed individuals. This is a parameter that the scientific community considers a valid indicator of reproductive development disorders. Not only: in females a delay in the appearance of the first estrus (puberty) was also observed, another indicator of possible negative repercussions on reproductive life. Finally, in both sexes we have recorded imbalances in the hormonal system, such as an increase in testosterone levels and alterations - albeit less clear - of thyroid hormone levels. But above all we have observed that these effects are decidedly more significant with the commercial herbicide than with pure glyphosate.
What might this difference depend on?
We do not know yet: it could depend on the presence of particular additives that we do not know (the detailed composition of the product used is covered by trade secrets), by the presence of impurities or by the fact that in the derived product glyphosate is absorbed or metabolized in a different way. In any case, this is one of the aspects that should be the subject of further investigations on the subject.
So the search shouldn't stop there?
Absolutely not. This is a pilot study, which provides guidance on whether to continue investigations, but does not in itself lead to definitive conclusions. Of course, if we had not observed any effect, it would have been enough to confirm the opinion of Efsa and Echa and to close the matter, but this was not the case. On the contrary, we have seen effects that should not occur at a dose considered safe. Of course, being a study with animal models does not mean that the results are immediately transferable to the human being, but we believe that they are still worthy of further study. Among other things, it is also necessary to understand if there is a gradation in the responses following exposure to different doses and to identify, if there is one, a dose with no observable effects.
What do you hope for at this point?
That the research continues and that the regulatory situation of glyphosate is revised out of the yes / cancer carcinogenic diatribe, but instead looking at these new evidence concerning the risk of endocrine interference, also in light of the new criteria for defining risk. There are knowledge gaps that need to be filled and regulatory agencies should take this into account. Then, if the industry wants to fill them, there are no problems for me, as long as it carries out serious and verifiable studies. We are talking about a substance that is certainly useful and important in agriculture, which the industry has every right to defend, but it must produce data that can really do it.
To close, what do you think of the much-disputed renewal of the glyphosate trade authorization voted in 2017 by the European Union?
That when, on the basis of the criteria and data available up to 2017, Efsa and Echa defined a safety of use of this substance, there were no solid reasons to avoid a renewal, even if obviously the legislator would have all the right to apply the precautionary principle, where it deems it appropriate. At the same time, however, I think that EFSA should now consider the new data available. On the other hand, the task of the scientific community is certainly not to insolent the regulatory authorities (who cannot produce data), but to provide new and updated ones, where there are shortcomings, to allow more accurate decisions.