Endocrine Disruptors (EU)

On the 4th July 2017, EU Member States voted in favour of draft criteria to define endocrine disruptors in the area of plant protection products. These draft criteria are here. The criteria are based on the WHO definition of an endocrine disruptor, and apply to human health and also to the environment. 

The criteria will apply after a short transitional period of 6 months. 

EU legislation provides that active substances used in plant protection products are only approved for a limited period of time, and that these approvals are routinely reviewed. EU legislation for plant protection products also provides that active substances which are endocrine disruptors shall not be approved, unless there is negligible exposure in which case they may be approved under restricted conditions.

As regards the criteria for the environment, the specificity of some active substances which have endocrine modalities that affect target arthropods (e.g. insects) but do not affect vertebrates including humans has been acknowledged. These substances, of particular interest for integrated pest management, will be subjected to a specific risk assessment and only approved if there are no unacceptable effects on non-target organisms.

The question whether an active substance is an endocrine disruptor will be assessed each time the substance is subject to an approval or a renewal of approval at EU level.

The legal text setting out the criteria has been sent to the Council and the European Parliament. They will have three months (from July) to examine it before final adoption by the Commission. The text will enter into force 20 days after its publication in the Official Journal and be applicable six months after this (see above). 

In order to be ready to apply the criteria, EFSA and ECHA are preparing a joint Guidance document on endocrine disruptors. An outline was published on 20 December 2016 and a draft guidance document – already consulted with Member States and stakeholders – will be available for public consultation in autumn. After this public consultation, the guidance document will be finalised before the criteria start applying. It is important to recall that the criteria will apply also to the on-going procedures reassessing the substances. This post will be updated at that point. 

Further information is set out in this European Commission press release. Here

UK exits the EU (Notices to Business Operators)

I posted earlier re Medicines. The European Commission has now issued Notices to Business Operators in the following areas :

(1) GMOs – the Notice is here (this post will be updated when the Q&A is available). 

(2) Biocides – the Notice is here and the Q&A is here

(3) Pesticides and Plant Protection Products – the Notice is here and the Q&A is here.

Please pay close attention as the requirements differ with each legal instrument (topic).