ANALYSIS - As the European Commission launched its consultation on endocrine disruptors as pesticides, crop protection industry experts spelt out concerns that a catch all hazard based approach to the issue was being taken rather than a scientific risk based approach.
The European Commission has launched an on-line consultation to help define criteria for endocrine disruptors as required by the regulations on biocidal and plant protection products.
Endocrine disruptors are chemicals that interfere with hormone systems, which may lead to harmful effects on health and the environment. Input is sought from stakeholders and the public on various options for the criteria and for their implementation.
Launching the consultation, European Commissioner for the Environment Janez Potocnik said: "Endocrine disrupting chemicals have triggered a substantial debate: there are strong signals from science, there is increasing public and political concern and awareness, while some stakeholders still have doubts.
“Europe is watching – we need these criteria to improve protection and give industry the certainty it requires.
“Citizens and stakeholders can help us make an informed decision."
EU Commissioner in charge of Health, Tonio Borg said: "I am delighted to announce the launch of an online public consultation on endocrine disruptors. This is an opportunity for all parties to openly share their views on this complex issue and marks another important step in the policy-making process."
Chemicals with endocrine disrupting properties are used in various industrial and service sectors, and may be found in the environment after their use.
Current legislation for biocidal products and plant protection products requires the European Commission to specify scientific criteria for the determination of endocrine-disrupting properties of chemical substances.
Because of the potential socio-economic impacts linked to how the criteria will be defined and the complexity of the issue, the Commission needs to carry out an impact assessment, and to consult the public.
The scope of the impact assessment is set out in a roadmap. Until the new criteria are set, protective interim criteria are in place.
However, at the British Crop Production Council Congress in Brighton this week, major concerns were raised that the criteria for judging would be over-reaching non-scientific and hazard based rather than risk based.
Dr James Wheeler, the regulatory ecotoxicologist with Dow AgroSciences said that the World Health Organisation definition of an endocrine disruptor was “an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse effects in an intact organism, or it’s progeny, or (sub)populations”.
However, he added that this had not been set down as a regulatory definition.
The European Food Safety Authority has defined an endocrine active substance as “any chemical that can interact directly or indirectly with the endocrine system and subsequently result in an effect on the endocrine system, target organs and tissues”.
But he said that many substances – both natural and synthetic- are capable of interacting with endocrine system and this interaction does not necessarily cause adverse effects.
Dr Wheeler said that under the EU pesticides regulations the cut off criteria for endocrine active substances was hazard based and that an active substance will only be approved if it is not considered to have endocrine disrupting properties that may cause adverse effects in humans/non-target species.
He said the European Food Safety Authority, the US administration and countries such as Japan took a risk based approach to endocrine disruptors while the European Commission took a hazard based approach.
Dr Wheeler said that pesticide endocrine regulation in the EU is hazard based
“Industry would prefer a full risk assessment approach using all available data,” he said.
He said that the Commission roadmap that has been set out for consultation helps to clarify the process and it considers some aspects of risk assessment and socioeconomic impact.
But he warned that the options do not include a full risk assessment option and these are only considered as a possible option for a derogation for regulatory decision making.
The way the options have been set out make the hazard characterisation option the preferred option.
He added that a range of toxicology and ecotoxicology studies relevant to endocrine disruption have already conducted and that in the end weight-of-evidence procedures for all the available information will be necessary to come to robust scientifically defensible conclusions on endocrine disrupting properties.
Commission process is expected to see the criteria to enter into force by the second quarter of 2016
All EU citizens and organisations have now been invited by the Commission to contribute to the consultation, which will be open until 16 January 2015. Replies to the public consultation will, subject to confidentiality rules, be published following the closure of the consultation.