Low risk products  – a critical assessment

Date: 1 September 2020

Brielbeck Low Risk Products

Article 43 - industry feedback

Date: 1 September 2020

Karin Lauber_Article 43

Online Academy Collection

Publishing period: 1 April - 9 June 2020

Overview – Topics covered:

» REGULATION (EC) No 1107/2009

» New active substances (NAS) and existing active substances (EAS) under Directive 91/414/EEC and REGULATION (EC) No 1107/2209

» AIR procedure – when, how and why you have to apply for a renewal of approval of active substances (REGULATION (EU) No 844/2012)

» Annex-I-renewal third stage – AIR-3

» Annex-I-renewal fourth stage – AIR-4

» Beyond AIR-4

» Biorationals

» EU voting procedure

» Caddy

» Zonal approach

» Article 43 – Renewal of authorisation(NAS)

» Efficacy requirements for new active substances (NAS)

» Data matching

» Candidates for substitution

» Comparative assessment of plant protection products containing candidates for substitution

» The Good Laboratory Practice (GLP)

» Cut-off criteria

» Negligible exposure

» Article 34

» Low Risk active substances and products

» Category 4 studies (CAT 4)

» Fertilisers

» Article 53 – Emergency situations in plant protection

» Efficacy requirements for existing active substances (EAS)

» Serious danger to plant health

» Seed treatment

» Mutual recognition – A time saving approach

» Article 51 – minor uses

» Data Archiving

» Data Protection

» Data Sharing and vertebrate studies

» Micro-organisms

» Safeners & Synergists

» BREXIT – Influence on EU procedures and national UK proceduress

» EU “institutions”

» Basic substances

» Maximum Residue Levels (MRL)

» Withdrawal or amendment of an authorisation(MRL)

» Short introduction to the Japanese system to register agrochemicals

» Adjuvants

» Co-formulants

» Unacceptable co-formulants

» A harmonized system for product notifications across the EU – timeline, procedure and pitfalls

» Technical equivalence

» Article 36 (3) Zonal examination for product authorization and the possibility of an individual rejection of a cMS due to an unacceptable risk

» Article 52 - Parallel trade

» Changes of the chemical composition of authorised plant protection products

» Article 37(3) 6 months authorization period reduction for the initial product authorization containing a new active substance under approval

» Article 37(3) 6 months authorization period reduction for the initial product authorization containing a new active substance under approval

» General food law and transparency