Presentation of the Commission proposal on “General Food Law” to the PEST Committee Vytenis Andriukaitis European Commissioner for Health and Food Safety European Parliament, Brussels Tuesday 19 June 2018

Approval Authorisation Regulating pesticides in Europe Caring for Europeans' safety Approval Authorisation Active substance Formulated Product

Legislation on Plant Protection Products Strict approval criteria have led to: 22 non approval/non renewal decisions since Regulation (EC) 1107/2009 started to apply (2011) 18 substances for which the companies no longer supported applications Restrictions on uses of several substances (such as neonicotinoids)

General Food Law Address findings of the Fitness Check of the General Food Law: Transparency EFSA's capacity Risk communication Address the Commission's reply to the European Citizens' Initiative: Transparency in scientific assessment Quality and independence of scientific studies Governance of EFSA CONCLUSIONS FOR THIS SLIDE: - The fitness check overall has not identified any systemic failures in the risk analysis process. THEREFORE THE SCOPE OF THE INITIATIVE IS TARGETED: focus on addressing the shortcomings identified in the system, especially with regards to the risk assessment of regulated products and in areas of transparency, quality of industry studies, as well as on the sustainability of the EU risk assessment system and the overall risk communication. - Both the findings of the Fitness Check and the Commission Communication on the European Citizens' Initiative 'Ban glyphosate' support and complement each other on being very specific on the issues that have to be targeted via this initiative.

EU register of commissioned studies Transparency of risk assessment Studies/data supporting applications for authorisation to be made public proactively and early on in the risk assessment process, except for confidential info Lists the info that may be considered confidential No prejudice to IPR and data exclusivity Quality and reliability of studies EU register of commissioned studies Pre-submission procedure Consultation on planned studies (renewals only) and submitted studies (renewals and new requests) Commissioning of verification studies in exceptional cases Control & audit of laboratories carrying out studies On transparency: Studies and data supporting applications for authorisation will be proactively made public by EFSA, early on in the risk assessment process, except for confidential info. The proposal lists the info that may be considered as confidential upon verifiable justification. Citizens and independent scientists will have direct access to the studies, which will be available to be downloaded, printed and searched through in e-format. Additional 8 sectorial legal acts are amended to align them with the new approach on transparency (GMO cultivation and GM food and feed, feed additives, smoke flavourings, food contact materials, common authorisation procedure for food additives/enzymes and flavourings, plant protection products and novel foods). No prejudice to IPR and data exclusivity rules Protection of personal data On Quality and reliability of studies: EU register of commissioned studies Notification by business and labs Made public when corresponding application is received General Pre-submission procedure at the request of a potential applicant to inform on the required content of application dossier Specific procedure for renewals: 1) mandatory notification of planned studies by potential applicants. 2) Public consultation by EFSA on planned studies and 3) delivery of advice by EFSA on the content of intended dossier, taking into account the results of the public consultation, Consultation on submitted studies Verification studies (exceptional circumstances of high level of controversy), Control and audit by Commission on studies/testing facilities in cooperation with MS

Long –term sustainability: EFSA to keep its level of expertise Sustainability and governance of the EFSA system Strengthened EFSA's level of independent expertise Alignment with the common approach on decentralised agencies (MS representatives in the Management Board) MS involved in the Panel Members selection process (criteria of excellence and independence to be respected) Improved risk communication Definition of precise objectives General principles General Communication Plan Long –term sustainability: EFSA to keep its level of expertise Alignment with the Common approach on decentralised agencies MS representatives in the Board 2 COMM / 1 EP / 4 civil society and stakeholders MS involved in the process of selecting Panel Members Scientific excellence and multidisciplinarity: pool system Possibility for EFSA to co-opt additional scientists Independence Panels’ work to be supported by staff and national scientific bodies Risk Communication: Definition of precise objectives (Codex) Promoting awareness and public understanding Enhance public confidence Promote involvement of interested parties General Principles Accurate, timely and transparent information Take into account risk perceptions Be accessible also to non-specialists General Communication Plan (DA with 2y) Factors to determine level and type of communication Tools and channels to address specific target groups Mechanisms to ensure coherence among different levels

REFIT - Evaluation of EU pesticide legislation Objectives Are the needs of citizens, businesses and public institutions being met in an efficient manner? Are the general objectives of the legislation being met? Wide consultation for evidence gathering EFSA, Member States and all stakeholder groups Open public consultation (mid-November 2017 to Mid-February 2018) Small and Medium Enterprises

Findings of the Commission's audits in the Member States Final Report of the contractor Commission Staff Working Document and Report due first half of 2019 Scientific advice mechanism (SAM) opinion PEST Committee report ENVI report on the implementation of the Plant Protection Regulation Parliament's research service's report

Sustainable Use Directive Objective: reduce the risks and impacts of pesticides on health and the environment and promote Integrated Pest Management and alternative approaches and techniques. 2017 report from the Commission to EP and Council identified areas for improvement Some aspects of the Sustainable Use Directive (SUD) are now included in the rules of conditionality in the new CAP proposal, published on 1 June 2018

Thank You! @v_andriukaitis facebook.com/vytenisandriukaitis