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Rebutting Industry Science with Knowledge

R.I.S.K. Consultancy

R.I.S.K.

Lobbying Activity

Response to Food and Feed Safety Simplification Omnibus

4 Oct 2025

Plant Protection Products : It takes gall to propose a deregulation of the PPP Reg. when Commission has never implemented its core requirement; indeed its core purpose: to ensure a PPP is safe before allowing it onto the market. That is, just as before this 2009 regulation, the ever-accelerating flood of published toxicity findings from academia is being ignored when re-authorizing PPP except now (since 2011), that is illegal under the PPP [art. 8(5); while art. 4.1 tells you why only that mandate can cause its core purpose to be achieved]. I have looked at compliance with this mandate in 17 petrochemical PPP re-authorisations. Only one did the required literature search (although even in this one, the published toxicity findings were not evaluated for their reliability). A handful didnt even look for a single published toxicity finding, and I have no cause to believe that newer re-authorisations are any different. Even when Commission and Agencies feel pressure to act legally and evaluate risks and do a thorough literature search, as in the glyphosate re-authorisation; you illegally threw away c. 3,400 out of its 3,548 published toxicity studies that were found (as not relevant, a preposterous lie). A significant number were not even read, but just 155 were (poorly) evaluated for reliability. Even EFSAs Guidance on this question says that if it is a toxicity finding, it is relevant, and thus must be evaluated. The NGOs that think glyphosate (or any of the PPP similarly re-authorized) is/are too hazardous to authorize are too moronic to ever complain about this; even when it is spelled out to them, for years: that Commission is failing to implement the very core of it own chemical safety laws (REACh registrations have the same mandateand ignore it, even worse). - By acting to come into compliance with this all available data mandate in the PPPR, you will be automatically promoting non-petrochemical pesticides..which simply lack almost all the hazards that synthetic chemicals do
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Response to Environmental Implementation Review 2025

8 Jun 2024

Both the REACh (EC 1907/2006) and pesticide (EC 1107/2009) regulations contain the unambiguous mandate to evaluate all available data when assessing the risk of these chemicals; most crucially, the hazard (toxicity) publications of academics. Both these mandates find only about 20% of academe's toxicity findings, with thousands of dossiers finding zero of however many that chemical has [based on random selection audits by NGOs, but such massive non-compliance is easily verified!]. This non-compliance is so important that it is obvious that both laws have failed entirely in their fundamental function, to evaluate the risks of chemicals before being allowed onto the market. Only the chemical's manufacturer's toxicity findings are considered (the few published findings evaluated are dismissed for non-scientific reasons, such as the bald assumption that any industry study is automatically more reliable than one from academe). In short, petrochemical risk evaluations occur almost exactly as before the laws came into effect, based on industry's toxicity studies, which are so insensitive that they don't even test their hypothesis ('what effects from our actual exposure?'), while academics are far more rigorous and develop varied methods to investigate that hypothesis. In short, risk assessment is a linear process where the result depends entirely on the upstream step of evaluating all information (as the gold standard guidelines for systematic review say, see the PRISMA-S guideline). Dooh!...Yet no stakeholder gives a flying fart to correct this most fundamental error.
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Response to Restrictions on bisphenol A (BPA) and other bisphenols in food contact materials

11 Feb 2024

EFSA's post-market advisory cmttee. based its bPA 'safe dose' on academe's findings, thus 10,000 stricter than previous [uniquely in the world, if it affects pre-market RA, i.e. RAs done to allow entry onto the market or not]. This has generated controversy. Commission should urgently bear in mind (in this and other decisions), that there are a thousand other published findings of very low dose chronic & developmental exposure toxicity by bPA, which this cmttee. might have deemed reliable enough. REACh Registrations are supposed to be the fundament of the Union's horizontal decisions on petrochemical risks and hazards. About 20,000 chemicals have evaluated not a single of their chemical's published literature, the few that are identified are instantly dismissed with the allowed industry criterion for reliability called Klimisch. bPA's Registration, submitted years ago, still has in total less (dismissed) published findings in total (~850) than the ~1,300 low dose toxicity findings on bPA that have been published (and perhaps six or seven thousand overall). Before you make any decisions on what you have been told about the risks of bPA (or for that matter of any petrochem.), consider that, as the rules for Systematic Review (SR) dictate, 'you can never know what the hazards actually are unless you evaluate all relevant data'; see PRISMA-S, https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-020-01542-z .
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Response to Streamlining EU scientific and technical work on chemicals through the EU agencies

25 Jan 2024

Concerning the Commission's ambition of: "establishing a common, open data platform on chemicals and tools for accessing relevant academic data." ...perhaps you could also propose that the data produced by academia be evaluated across all the legislation that you will be modifying (that which requires evaluation of the safety of petrochemicals (which includes medicines). After such a rationalization of legislation, consider that academe's hazard data (the core need) is largely on three databases, PubMed, Web of Science (paywalled), and Google Scholar. It has been found/* that the first two work well together, whereas the remaining large database, Elsevier's ScienceDirect (paywalled), is not as good as the other two at returning journal-published hazard findings of academics (Google Scholar is separated, good in general at finding diverse types of data). [/*: I read that peer reviewed finding, but for years I have been unable to find it in my papers, or in searches!) Most important, there needs to be a legislative principle, and a direct mandate, to evaluate academia's findings in the same manner as industry's own hazards findings. Currently, even when dossiers bother to search for academia's findings, they dismiss the large majority without evaluation. In REACh Registrations, especially, any finding from academia always is given a lower Klimisch score (2 or 3) than industry's hazard findings are (a K score of 1, "most reliable"). Actual reliability is not evaluated at all. Tens of thousands of published findings are thus dismissed, and hundreds of thousands more are never found at all. Ditto in the pesticide regulation.
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Response to Common rules on the plant protection product use records to be kept by professional users under Regulation 1107/2009

25 Oct 2022

I welcome the draft Commission Implementing Regulation "as regards the content and format of registers of plant protection products kept by professional users in accordance with Regulation (EC) No 1107/2009" (Ares(2022) 6918124), to ensure the digitization of pesticide use records across the EU. The Commission's pesticide policies rely entirely on pesticide data, and notably on use data. It is thus necessary to require EU-wide the electronic submission of data. Professional pesticide applicators should have zero problem complying with electronic use reporting.
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Response to Introducing new hazard classes–CLP revision

30 Sept 2022

I thank the Commission for this initiative; I also urge the creation of sufficient EDC hazard classes (e.g., 'proven, suspected & potential'). While industry is correct that different species respond differently to EDCs, I am unsure that there is a need to keep the often-artificial distinction between human and all other species("environmental effects"–so long as both have to be evaluated. For example, just out: Genomics study finds shared disease pathways for humans and environmental test organisms Blurs the line between human toxicology and ecotoxicology 29 September 2022 https://chemicalwatch.com/571185/genomics-study-finds-shared-disease-pathways-for-humans-and-environmental-test-organisms Nevertheless, many species are very different from humans, and "environmental" hazard classes can be very effective. The label language tables (e.g. Table 3.11.3) omit the proposed hazard statements 'known', 'presumed' in favor of "May Cause...". Unless I misread the text, or this is a typographic error, it seems to completely eviscerate the purpose of CLP, to inform of hazards. Otherwise, my main concern are the criteria for determining EDC–please see my uploaded 1 pg. comment; but in brief: "relevant" is a loophole the size of Europe! Thank you for implementing this element of the Green Deal, again.
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Response to Sustainable use of pesticides – revision of the EU rules

3 Sept 2022

The simplest way to fulfill this commitment, with no additional effort, is to simply begin to comply with the PPP Regulation (EC 1107/2009). Since it came into effect, about a hundred thousand published pesticide toxicity findings from academia, have been ignored, in each pesticide's respective evaluation (and the few thousand that have been found and evaluated; receive a perfunctory, useless evaluation). Since thousands of these findings show toxicity at low doses (in vertebrates), any scientifically sound evaluation of their relevance and reliability would conclude that the pesticide cannot be authorized for sale. Adter all, the PPPR states that only a complete dossier enables the evaluation of whether a pesticide is safe. Presto, your 50% goal of reduction of these poisons would be achieved, without any further effort than complying with your own law. That would give you all the political justification you could ever want. I remain available to substantiate any of these claims.
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