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Regulation (EC) No 1107/2009: progress on determination of endocrine disrupters

The UK regulatory authority (CRD) has recently provided an update on progress within the EU on the establishment of criteria for determining active substances, safeners and synergists as endocrine disrupters (EDs). Regulation 1107/2009 required that the European Commission should present proposals for definitive criteria by 14 December 2013.

Progress to date

Work on developing the criteria is being led by the Commission’s DG Environment, supported by an expert scientific group, chaired by the Joint Research Centre (JRC). A key issue is whether these substances should be regulated in the same way as most chemicals by assuming that they have a threshold of effect, or should be treated as if any exposure were unacceptable. The JRC published a report on the key scientific issues on its website but could not reach consensus. The European Food Safety Authority (EFSA) also published an opinion on the hazard assessment of EDs on its website, which concluded that they can be regulated as threshold chemicals.

Postponement of proposals/consultation

In light of these uncertainties and their potential regulatory consequences, the Commission has postponed publication of its final proposals whilst it conducts an impact assessment. It is expected to consider the implications for plant protection products, biocidal products, the REACH Regulation, cosmetics and the Water Framework Directive and to include a public consultation. Timing is unclear, but the Commission does not expect to publish the outcome until the second half of 2014.

Impact assessments/EU negotiations

In the meantime, CRD commissioned two impact assessments which have now been published on Defra’s website. The first considers the ED status of around 100 active substances considered to be of most importance to UK agriculture and horticulture. It is important to stress that this is not a definitive assessment and will not have regulatory effect: final determination will be possible only when full dossiers are considered at the renewal of approval of active substances against the EU criteria. The second report considers the agronomic effect of withdrawing substances identified as EDs under various regulatory scenarios, essentially determined by whether potency is taken into account as a factor or not. Annual costs ranged from £160 million in the lowest impact scenario (only confirmed, high potency EDs withdrawn) to £440 million in the highest impact scenario (known and suspected EDs withdrawn, regardless of potency). These analyses show that eliminating substances as EDs will have significant effects, but that these are far greater if potency is not taken into account. CRD agrees with comments made by EFSA in concluding that EDs can be regulated in the same way as other threshold chemicals and that potency should be taken into account. CRD have stated that they will continue to press the case for this approach in EU negotiations.

Please contact JSC if you require further advice on endocrine disruptors on +44(0)1423 520245, enquiries@jsci.co.uk

Published 24th January 2014
Categories Agrochemicals, Legislation
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