Brussels, 13 May 2013

Key concerns of the Biocides industry on the proposal for determining substances with endocrine disruptingproperties

The European Biocidal Products Forum – EBPF, the sector group of Cefic representing the biocides industry, would like to highlight some of its key concerns regarding the Commission’s draft proposal (see Annex I) for determining substances with endocrine disrupting properties.

EBPF is concerned by the proposal for two categories of endocrine disruption with the second being ‘suspected’ endocrine disruptors.We believe that a single category concept more appropriate as it will allow endocrine disruptors (ED) to be clearly identified (in the same way as for the PBT criteria) and handled in a way that avoids any stigmatisation of substances prior to their assessment.For example, the initial work on the EU strategy for ED noted that deltamethrin should be placed in group III as priority for assessment. Despite Sweden evaluating all the toxicological and ecotoxicological data for deltamethrin in PT18 and finding no concern for ED,the wording in the assessmentreport still indicates that the substance may potentially be an ED. This example confirms our concern that once a substance has been identified in any list,it remainsstigmatised despite the scientific evaluation concluding the contrary.

Moreover, a ‘suspected’ category concept leads to ambiguityabout where the regulatory line will be. For example, if a substance is placed in Category 2, will that substance be subject to the Article 5 exclusion criteria in the Biocidal Products Regulation (BPR)? Even if it is not, it will be subject to pressure from NGOs and become ‘black listed’ such that it might not be available on the market anymore.

We are concerned that thecriterion focuses on hazard identification without considering hazard characterisationand risk assessment. EBPF believes that the objective of the future regulatory framework on ED is to properly manage the risks from harmful substances safely.We therefore argue that hazard identification should necessarily be combined with hazard characterisation to focus on the substances that could pose a potential risk to humans and the environment.This approach is promoted by the recent scientific opinion delivered by EFSA stating that hazard characterization is an essential part of hazard-based assessment[1]. It is vital to ensure that all the data submitted in support of the approval of a biocide active substance is fully assessed against the WHO/IPCS definition[2] of ED (which has generally been accepted by the European Food Safety Authority, The European Parliament, Joint Research Centre and the Commission).

In order to carry out an effective hazard characterisation for EDs,EBPF believes that important toxicological characteristics should be included such as lead toxicological effect, reversibility, potency and severity.As no single toxicological endpoint can characterise a substance as ED, a weight-of-evidence approach of all the scientific data submitted as part of the biocides regulatory regime is necessary.

In addition, we believe that safe levels can be defined for substances which areendocrine disrupters. In our view, there is ample scientific evidence that a thresholdapproach for risk assessment is warranted, a non-threshold approach as advocated by some is also biologically implausible.

No assessment has been carried out by DG Environment to assess the impact of the proposed criteria on biocides (or general chemicals or pesticides). Due to the lack of an assessment from the Commission, the European Crop Protection Association (ECPA) in April 2013 carried out its own impact assessment of the criteria for pesticide active substances[3].ECPA’s assessment was based on an evaluation carried out by The UK’s Chemicals Regulation Directorate ((CRD) Pesticide Safety Directorate) in 2009[4]. In this evaluation CRD had highlighted 39 substances which were ‘likely’ or ‘maybe’ impacted by the criteria.Out of these 39 substances, 8 are also biocidal active substances. However, we believe that many more biocidal active substances will be affected by a “suspected category” approach.

What is critical to understand is how the use of read-across may also impact groups of chemicals.For example, the ECPA assessment notes that whole groups of chemicals (not just individual substances) could be impacted due to the reference to read-across in the Commission’s criteria.Therefore, if cyproconazole (a substance assumed by the UK as likely to be affected) was impacted by the criteria, then all of the triazoles could also be affected.This is the same for all the pyrethroids based on the UK evaluation that deltamethrin may be affected.Read-across of a chemical category or a group of chemicals bears the risk of individual substances being incorrectly categorised as an ED. Categorisation as an ED should be based on the data submitted for each individual substanceand evaluated as part of the biocides regime.

As the UK’s original evaluation and the ECPA assessment only considered the socio-economic impact of substances covered by 1107/2009, the effect on the biocides regime has not yet been considered.

The Commission’s own Impact Assessment Guidelines (2009)[5] indicate that “measures” which are likely to have significant impact should first be subject to an Impact Assessment by the Commission.EBPF therefore asks that the Biocides Competent Authoritiesrequest the Commission to carry out such an impact assessment for biocides.We consider that as the Biocides Competent Authorities will not vote (as the criteria will be implemented via a delegated act) on the criteria that they (and industry) should understand the impact that the proposed criteria may have on the whole of the biocides industry.

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For further information, please contact:

Raf Bruyndonckx – Phone: +32 2 676 7366 – Email:

Annex I –Background

Under Regulation 528/2012 active substances considered as having ‘endocrine disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties’ shall not be approved unless the active substance meets one of the derogations to the exclusion criteria (Art.5(2)).

DG Environment has the responsibility, on behalf of the Commission, for preparing the over-arching scientific criteria that will be applied to biocides, general chemicals (REACH) and pesticides (1107/2009).

On the 19th February 2013 DG Environment released a revised proposal for these criteria in their document entitled: ‘Revised version of possible elements for the criteria for identification of endocrine disruptors’[6].The proposal from the Commission establishes a system of two categories for endocrine disruption:

Category 1 –Endocrine disruptors

Substances are placed in category 1 when they are known to have caused endocrine mediated adverse effects in humans or population relevant effects on animal species living in the environment or when there is evidence from experimental studies, possibly supplemented with other information (e.g. in vitro, in silico, read across), to provide a strong presumption that the substance has the capacity to cause endocrine mediated adverse effects in humans or population relevant effects on animal species living in the environment.

The experimental studies shall provide clear evidence of endocrine-mediated adverse effects in the absence of other toxic effects, or if occurring together with other toxic effects, the endocrine-mediated adverse effects should be considered not to be a secondary non-specific consequence of other toxic effects.

However, when there is (e.g. mechanistic) information demonstrating that the effects are clearly not relevant for humans and population of animal species living in the environment, category 2 may be more appropriate.

Substances can be allocated to the category 1 based on:

  • Evidence from humans or from animal species living in the environment where it is plausible that the observed adverse effect is endocrine-mediated, or
  • Experimental studies where it is plausible that the observed adverse effects are caused by an endocrine mode of action, or
  • Experimental animal studies showing an endocrine activity in vivo which is clearly linked to adverse effects in vivo (e.g. through read-across).

Category 2 – Suspected endocrine disruptors

Substances are placed in category 2 when there is some evidence for endocrine mediated adverse effects from humans, animal species living in the environment or experimental animals, and where the evidence is not sufficiently strong to place the substance in category 1. If, for example, limitations in the study (or studies) make the quality of evidence less convincing, category 2 could be more appropriate.

These endocrine disrupting effects should be observed in the absence of other toxic effects, or if occurring together with other toxic effects, the endocrine mediated effect should be considered not to be a secondary non-specific consequence of other toxic effects.

Substances can be allocated to this category based on:

  • Evidence from humans or from animal species living in the environment where it is suspected that the observed adverse effect is endocrine-mediated, or
  • Experimental studies where it is plausible that the observed adverse effects are caused by an endocrine mode of action but that specific weaknesses in study design or execution weaken this conclusion, or
  • Experimental studies where it is suspected that the observed adverse effects are caused by an ED mode of action, or
  • Experimental animal studies showing endocrine activity in vivo which is suspected to be linked to adverse effects in vivo (e.g. through read-across), or
  • in vitro studies showing endocrine activity, combined with toxicokinetic in vivo data which is suspected to be linked to adverse effects in vivo (e.g. through read-across, chemical categorisation and QSAR predictions

1

[1]Scientific Opinion on the hazard assessment of endocrine disruptors:Scientific criteria for identification of endocrine disruptors and appropriateness of existing test methods for assessing effects mediated by these substances on human health and the environment’EFSA Journal 2013;11(3):3132

[2] WHO/IPCS definition: ‘An endocrine disrupter is an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.’

[3] ‘Potential impact of current draft proposal for endocrine disruption criteria’ European Crop Protection Association (PP/13/AP/22658 – Rev. 2)

[4]http://www.pesticides.gov.uk/Resources/CRD/Migrated-Resources/Documents/O/Outcomes_paper_-_summary_impact_assessment_(Jan_09).pdf UK Chemicals Regulation Directorate

[5]

[6] ‘Revised version of possible elements for criteria for identification of endocrine disruptors’ Commission document (ED-AD-HOC-6/2013/02)