1. 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

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

3. 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)

4. 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.

5. 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

6. 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

7. 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

8. 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

9. 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

10. Thank You!
@v_andriukaitis
facebook.com/vytenisandriukaitis