Regulatory guidance

 Agrochemcials & Biorationals

 

Biostimulants and REACH

Date: 14 September 2021

SCC video guidance on Biostimulants and REACH


The EU Green Deal – Implications on Agriculture and Plant Protection Product Regulation

Date: 13 July 2021

SCC video guidance on brexit


The Core and Changes in Registration Regulation for Biopesticides and Biostimulants in Key Markets: EU, US, India and Japan

Date: 6 July 2021

Polymer registration in South Korea

With increasing demand for sustainable alternatives to conventional chemicals in plant protection,  biopesticides have been recently on the rise, gaining recognition from producers and farmers for their lower costs and environmental compatibility. The law and policies regulating the use of biological plant protection products and growth stimulants have aslo been in motion, showing, however, partly notable differences in various countries. In the article for AgroPages SCC with its colleagues and partners outside Europe examin the regulatory situation with biopesticides and biostimulants in the EU, US, India and Japan. Read the full article.


Brexit and Its Impact on Pesticide Regulation

Date: 26 May 2021

SCC video guidance on brexit


Biorationals

Date: 6 January 2021

SCC video guidance on biorationals


Chemical Crop Protection & Biorationals: Part 5

Regulation (EC) 1107/2009 and Biorationals

Date: 15 December 2020

SCC video guidance on new and existing active substances


Chemical Crop Protection & Biorationals: Part 4

Regulation (EC) 1107/2009 and Brexit

Date: 14 December 2020

SCC video guidance on new and existing active substances


Chemical Crop Protection & Biorationals: Part 3

Regulation (EC) 1107/2009 and political aspects

Date: 11 December 2020

SCC video guidance on new and existing active substances


Chemical Crop Protection & Biorationals: Part 2

Regulation (EC) 1107/2009 and transparency

Date: 10 December 2020

SCC video guidance on new and existing active substances


Chemical Crop Protection & Biorationals: Part 1

Regulation (EC) 1107/2009 and related issues

Date: 9 December 2020

SCC video guidance on new and existing active substances


AIR Procedure

Date: 11 November 2020

SCC video guidance on new and existing active substances


Regulation (EC) No 1107/2009

Date: 26 October 2020

SCC video guidance on new and existing active substances


New and Existing Active Substances

Date: 15 October 2020

SCC video guidance on new and existing active substances


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