Proposed policy orientations for ANSES in 2013 The purpose of this - PDF document

Doc CA 12/3.03 BOARD OF ADMINISTRATORS MEETING OF 27 SEPTEMBER 2012 Point 2 of the Agenda Proposed policy orientations for ANSES in 2013 The purpose of this document is to present an initial review of the actions undertaken in 2012 and the Agency’s major policy orientations for 2013. These will be expressed as: - a work programme for 2013 covering all of the Agency’s activities - a proposed budget for 2013 which will be submitted to the Board of Administrators for approval before the end of the year, in line with the new budgetary restraints incumbent on the Agency for the following three years, along with the ‘goals and performance’ contract that must also be finalised by the end of 2012. 1. Initial conclusions concerning the actions undertaken by ANSES over the last 12 months There has been a very high level of activity at the Agency over the last 12 months. Here are a few examples. 1.1 Opinions following formal requests We received 350 formal requests between 1 July 2011 and 30 June 2012, compared with 299 over the previous 12 months, an increase of 17%. To illustrate the variety of subjects dealt with since the start of 2012, we might mention the following: - Publication of the results of the French national study of PCB concentrations in consumers of freshwater fish , carried out by ANSES and InVS at the request of the DGS, which enabled ANSES to determine maximum frequencies of consumption with no long-term risk to humans from fish with high levels of PCB bioaccumulation. - A re-assessment of the risks related to antiparasitic collars for pets , for some of which marketing authorisation was subsequently withdrawn. A risk assessment on talc in the workplace , a study carried out following several - reports of the use in the workplace of a coating produced from talc and suspected of containing asbestos fibres. An expert appraisal of brush fires taking into account pollution of the air and soil, - the toxicity of wood smoke and the exposure and health effects related to air pollution for the population as a whole and for professional fire-fighters in particular. - An expert appraisal for the selection of pollutants to be taken into account in health risk assessments for impact studies concerning road infrastructures and the associated health effects. 1/9 French Agency for Food, Environmental and Occupational Health & Safety 27-31, Avenue du Général Leclerc, F94701 Maisons-Alfort Cedex -Telephone: + 33 (0)1 49 77 13 50 - www.anses.fr

An expert appraisal on the possible impact of growth factors in milk on the risk of - developing cancer. A study to identify the exotic diseases whose introduction in France would - present the highest risk to animal health with recommendations on the most appropriate methods for combating and monitoring these pathogens. An opinion by the Agency on ways of defining endocrine disruptors as part of a - review of European strategy and Community regulations on plant protection products and biocides. This was carried out according to a cross-cutting approach with input from the Regulated Products Department (DPR) and the Risk Assessment Department (DER), with a view to proposing a single, scientific definition of the notion of endocrine disruption, while also making recommendations on the best way to apply it more specifically in the framework of European regulations on plant protection products. A call for reports of any adverse effects related to the consumption of energy - drinks , following reports received as part of the nutritional vigilance scheme and in parallel with the study on the consumption of these drinks carried out by the Agency. A progress report on the risks and nutritional benefits of intense sweeteners - when consumed by pregnant women. A report on the result of a public consultation on substitutes for Bisphenol A. - Opinions on the consequences to be drawn from recent scientific publications on - the sublethal effects of neonicotinoids and the effects when combined with pathogens on bee health. The Opinions recommended reinforcing European regulations on approval of plant protection products. The work was carried out according to a cross-cutting approach with input from the DPR and the DER, in order to take an overall view of the issue of bee health. A risk assessment concerning exposure by the respiratory and mucocutaneous - routes via the reuse of treated wastewater for the irrigation of crops or green spaces. Completion of several urgent opinions on sensitive issues (perchlorate, ethylene - oxide, nitrosamine, etc.). Updating the online CIQUAL table giving the nutritional composition of foods . - Making available a tool for ranking animal diseases , at the request of the DGAL, - one of the measures resulting from the national consultation on the health sector. A study carried out by IRSTEA at ANSES’s request, listing the personal - protective clothing and equipment used by farm workers , with a view to setting up performance tests in the second half of 2012. The goal is to be able to make recommendations, as a result of our internal request, on changes to be made to current regulations. The increased number of requests received, combined with the reinforcement of the rules applied to the collective expert assessment process itself and the reduction in resources, has led to an increase in the number of requests currently underway , which has risen from 181 at the end of June 2011 to 232 at the end of June 2012. The Agency has taken steps for deadlines to be monitored closely to ensure that this backlog of formal requests is dealt with as efficiently as possible : we have a 2/9 French Agency for Food, Environmental and Occupational Health & Safety 27-31, Avenue du Général Leclerc, F94701 Maisons-Alfort Cedex -Telephone: + 33 (0)1 49 77 13 50 - www.anses.fr

contractual obligation to meet 90% of our deadlines and are currently meeting 89.5%. Some of these late deliveries include extremely complex dossiers involving the prior collection of specific data, especially in cases of Research and Development Agreements (CRDs), which can involve very long delays. There are proposals for these deadlines to be monitored systematically by the ministerial liaison committee, in the knowledge that the Agency does its utmost to adapt its schedules to take account of emergencies and mandatory deadlines, which can occasionally affect its longer-term work programme. 1.2 Regulated products 1.2.1 Update on the situation concerning biocides We have two types of activity: - the assessment of active substances requiring decisions at European level but for which the assessment is entrusted to a national agency. This task, begun in 2004, is close to completion: out of 73 dossiers entrusted to the Agency since the start of the European process, 14 have been rejected as inadmissible and 17 draft Competent Authority Reports (CARs) had been completed by 31 December 2011. In the first half of 2012, six dossiers were submitted, leaving a further 36, of which 30 should be dealt with by the end of 2012 and in 2013. All these dossiers must be completed by the end of 2014. - the assessment of biocidal products which require marketing authorisation at national level. Manufacturers file applications once the active substance concerned has received authorisation at European level. The number of applications is increasing, and in the years to come this second activity will make up the majority of ANSES’s workload concerning biocides. A total of 74 Opinions on these products under the terms of Directive 98/8/EC have been issued since the start of 2012. In 2012, 18 initial applications for MAs will have been processed, compared with eight in 2011. This activity is expected to increase in the years to come. The Agency is currently working with the ministries, partly to adjust the fees in line with the costs occasioned by these assessment studies, and partly to adapt the procedures before the new provisions of Regulation 528/2012/EC come into force. Furthermore, 213 Opinions have been issued on applications in the context of national regulations during the transitional period, concerning certain biocidal products for which an MA is required before an active substance can be listed at European level. 1.2.2 Activities concerning plant protection products During the first half of 2012, we received 1173 dossiers for plant protection products (922 of which were covered by a tax) compared with 982 in the first half of 2011, an increase of 19.5%, whereas the first half of 2011 had also seen a high level of activity. This increase in the number of applications is largely the result of the new European regulation coming into force, which divides Europe up into three geographic zones. ANSES, which is in the South Zone, is strongly placed and attracts numerous applications. Therefore this trend should also continue in the second half of 2012. The increase in the number of applications especially concerns applications for marketing authorisation or their re-examination (an increase of 101 dossiers), whose processing imposes a considerable workload. In response to this increase, we boosted our teams at the start of the year with a full time equivalent of 10 (over the course of the entire year), as a result of internal redeployment made possible by a systematic search for economy and efficiency. This extra staff enabled 3/9 French Agency for Food, Environmental and Occupational Health & Safety 27-31, Avenue du Général Leclerc, F94701 Maisons-Alfort Cedex -Telephone: + 33 (0)1 49 77 13 50 - www.anses.fr