Endocrine disruption of organisms, especially in nature like the example of alligators with small penises, is known already for more than 15 years by independent scientists and ‘coined’ by Theo Colborn as such. In the meantime an enormous amount of scientific studies have been published showing this is a very serious effect, demonstrating the need for politicians to act. Many negative human effects like low sperma counts, mental disorders, cancers and reproductive effects have been linked to endocrine disruption and to chemicals being one of the causes of this effect. Notably is the website of Theo Colborn showing the potential effects on the developing child. Low doses are also an element in endocrine disruption disregarded for a long time in decision-making. The science group of prof kortenkamp fi. showed that even at official No Effect Levels of chemicals, endocrine disrupting effects can be shown (Nissanka Rajapakse, Elisabete Silva, and Andreas Kortenkamp, Combining Xenoestrogens at Levels below Individual No-Observed-Effect Concentrations Dramatically Enhances Steroid Hormone Action, Environmental Health Perspectives 110 (9), September 2002).
On the plastic monomer Bisphenol-A hundreds of scientific studies have been published, many of them showing positive effects at low doses and still the reaction of governments is slow and inadequate. Denmark finally took the lead in banning baby bottles, in the end followed by European Commission. This conclusion was reached after years of controversy, fuelled by chemical industry, where science seemed to be less and less important and politics & power dominated the arena.
For pesticides we only can hope for a science-based approach of regulators and –in case of doubt- no hesitation to use the precautionary principle. Given the amount of effort chemical industry put in exactly this topic by organising ‘scientific meetings’ of their lobby clubs like ECETOC, supported this time by German Health institute BfR, it can be expected politics & power will again dominate the arena.
The legal text of pesticide Regulation 1107/2009 states in Annex II, 3.6.5:
3.6.5. An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines or other available data and information, including a review of the scientific literature, reviewed by the Authority, it is not considered to have endocrine disrupting properties that may cause adverse effect in humans, unless the exposure of humans to that active substance, safener or synergist in a plant protection product, under realistic proposed conditions of use, is negligible, that is, the product is used in closed systems or in other conditions excluding contact with humans and where residues of the active substance, safener or synergist concerned on food and feed do not exceed the default value set in accordance with point (b) of Article 18(1) of Regulation (EC) No 396/2005.
By 14 December 2013, the Commission shall present to the Standing Committee on the Food Chain and Animal Health a draft of the measures concerning specific scientific criteria for the determination of endocrine disrupting properties to be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(4).
Pending the adoption of these criteria, substances that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered to have endocrine disrupting properties.
In addition, substances such as those that are or have to be classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered to have such endocrine disrupting properties.
Quite complicated and much will depend on the implementation, especially the criteria presented December 14, 2013.
Sweden, based on regulation 1107/2009, presented already in 2008 their list of pesticides which would meet the criteria and need a ban..
For chemicals at large, Consultant BKH was commissioned by Dg Environment to compile research from open literature, already quite some time ago, and came up with a list of 146 substances evaluated, and a priority list of 66 substances with high, medium or low concern. Concern or no concern, this will not lead to any action of the regulators yet, and an individual assessment seems unavoidable.
Ultimately, testing and the evaluation of the testing results will be necessary to get to a decision for every individual substance. Tests are already underway in the US where a first list of chemicals need to be tested by chemical industry (tier 1). OECD is working on it for many years, but is as always incredibly slow. The deadline in pesticides Regulation is therefore of major importance to speed up the process.
PAN-Europe in 2009 presented a first position paper to Commission on the criteria to be developed. Industry pushes very hard (ECETOC) proposing criteria which will in effect undermine the EU-“cut-off” criteria and return policy to full risk assessment. German national Health institute BfR is remarkably active on this topics and looks like wanting to take the lead on this in Europe. This would not be very positive because BfR supports industry in turning the cut-off criteria back into the regular risk assessment they are used to. No matter the political decision taken in the Regulation on endocrines. BfR places mechanisms of action on a platform, which is not in the definition, as well as relevance for humans, which is again not in the definition.