(Utkast) Kommisjonsforordning om fastsettelse av vitenskapelige kriterier for bestemmelse av hormonforstyrrende stoffer og om endring av vedlegg II til forordning (EF) 1107/2009
(Draft) Commission Regulation setting out scientific criteria for the determination of endocrine disrupting properties and amending Annex II to Regulation (EC) 1107/2009
Utkast til kommisjonsforordning sendt til Europaparlamentet og Rådet for klarering og publisert i EUs komitologiregister 21.7.2017
Etter flere års diskusjoner med EU-landenes eksperter, har Kommisjonen fått flertallet av medlemslandenes representanter bak seg for regelverket om kriterier for hormonforstyrrende stoffer i plantevernmidler. Uenigheten har blant annet dreid seg om stoffenes terskelverdi for effekt. Sverige og Danmark ønsker strengere regler og stemte imot, mens Frankrike ga opp sin langvarige motstand. Den omforente teksten må formelt klareres av Rådet og Europaparlamentet før den kan publiseres i EU-tidende og tre i kraft. Kommisjonens forslag om tilsvarende regelverk for biocider er fortsatt til behandling i ekspertkomiteen.
BAKGRUNN (fra Kommisjonens pressemelding 4.7.2017)
Endocrine disruptors: major step towards protecting citizens and environment
Today, Member States representatives voted in favour of the European Commission's proposal on scientific criteria to identify endocrine disruptors in the field of plant protection products. This is an important step towards greater protection of citizens from harmful substances.
Commissioner for Health and Food Safety, Vytenis Andriukaitis, said: "Today's vote represents our determination to devise a real EU policy on endocrine disruptors. After months of discussion we are advancing in the direction of the first regulatory system in the world with legally binding criteria to define what an endocrine disruptor is. This is a great success. Once implemented, the text will ensure that any active substance used in pesticides which is identified as an endocrine disruptor for people or animals can be assessed and withdrawn from the market. We now count on the support of the European Parliament and the Council, involved in the decision making process, for a smooth adoption and entry into force of the criteria."
The adopted criteria will provide a stepping stone for further actions to protect health and the environment by enabling the Commission to start working on a new strategy to minimise exposure of EU citizens to endocrine disruptors, beyond pesticides and biocides. The strategy will aim to cover for example toys, cosmetics and food packaging. In parallel, a substantive new research on endocrine disruptors with an important budget of approximately 50 million euro will be allocated in 2018 to around 10 projects in the next Horizon 2020 work programme.
As for pesticides and biocides, the Commission will not delay any action and will already apply the criteria to substances for which assessment or re-evaluation is undergoing or for which confirmatory data concerning endocrine properties have been requested.
The criteria endorsed today concerning substances falling within the plant protection products legislation are based on the World Health Organisation (WHO) definition. They identify known and presumed endocrine disruptors. They also specify that the identification of an endocrine disruptor should be carried out by taking into account all relevant scientific evidence including animal, in-vitro or in-silico studies, and using a weight of evidence-based approach. The Commission intends to adopt the same criteria for biocides. This is important because the properties which make a substance an endocrine disruptor do not depend on the use of the substance.
The Commission text foresees that the Commission will present in due time an assessment of the criteria which will also cover the derogation for growth regulators in the light of experience gained.
The criteria will apply after a short transitional period of six months during which the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) - mandated by the Commission – will be finalising a joint guidance document for the implementation of the criteria. An outline was published on 20 December 2016 and a draft guidance document will be available for public consultation in autumn.
The criteria will apply also to the on-going procedures reassessing the substances.
Lastly, a REFIT evaluation on the functioning of the plant protection products EU legislation is underway and its conclusion will pave the way for a probable modification of the overall EU framework.
For more information
Details on the decision making process are available online
Frequently Asked Questions on endocrine disruptors available online
 Growth regulators are active substances with specific modes of action targeted at some organisms (e.g. arthropods). From a biological point of view they are not expected to pose a risk to humans and vertebrates in the environment and are therefore particularly effective and useful in integrated pest management.
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