Last week another milestone was reached in Europe`s slow and ineffective process to protect our health and environment by reducing exposures to pesticides and biocides with harmful endocrine disrupting (ED) properties. On January 31st a public consultation on the draft guidance document for identifying endocrine disrupters closed. This guidance is important because describes how industry and regulators should look at the scientific evidence available for identifying ED chemicals (EDCs).
Two European Agencies – the European Food Safety Authority (EFSA) and the European Chemical Agency (ECHA), in collaboration with the Commission’s Joint Research Centre (JRC) – are currently in the process of drafting this technical guidance.
The slow EU process of identifying ED biocides and pesticides has meant that ED biocides and pesticides are not currently being properly regulated. In the meantime, the EU’s main chemicals law has identified several EDCs and they have been added to the REACH candidate list.
Bottlenecks and stumbling blocks
CHEM Trust is very concerned that the high level of evidence required in the draft guidance document will hinder rather than enable identification of EDs. We made these arguments in our detailed comments submitted to the public consultation.
During a workshop last week in Brussels organised by the Commission`s Directorate General Sante (DG Health) we made the following recommendations:
- The level of detail that seems to be required for the mode of action (MoA) linking the endocrine activity with the adverse effects is overly burdensome. We therefore conclude that the requirement for such a detailed knowledge of the MoA and key events must be changed.
- The guidance needs to be amended to enable identification of ED substances acting via multiple MoAs as in many cases it will not be feasible to show one clear activity.
- The guidance needs to better ensure that false negatives are avoided and clarify the process for dealing with inconclusive cases due to lack of data.
CHEM Trust`s Ninja Reineke said:
This guidance is missing the wood for the trees. The task is to identify substances with hormone disrupting properties, so that their use can be controlled. However, this proposal has become so laborious that it will end up in paralysis by analysis.
CHEM Trusts presentation to the workshop can be found here.
Submissions from organisations such as HEAL, PAN Europe and the Endocrine Society expressed similar concerns and recommendations.
Following the public consultation the guidance document will be revised over the next few months. The next discussion will be among technical experts from EU Member States (the Competent Authorities for biocidal products and the Standing Committee for Plants, Animals, Food and Feed). The criteria for identifying EDs in biocidal products will enter into force in June, and the aim is to have the guidance document ready by then.
- For more about this long and painful process see our other blogs on the EDC criteria.
- Chemical Watch has covered CHEM Trust’s submission to this consultation.