Regulatory Guidance

Emergency Authorisations of Neonicotinoids in Europe

Date: 20 March 2023

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Update on Farm to Fork Strategy

Date: 24 January 2023

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Update on Restrictions of Polyfluorinated Active Substances (PFAS)

Date: 12 January 2023

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General Update on Regulation (EC) 1107/2009 and New Regulations

Date: 16 December 2022

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Changes in EU Regulation for Organic Farming and Organic Agri-inputs

Date: 6 May 2022

In their article for AgroPages, our regulatory experts examine the recent developments and their impact on and meaning for the regulation of organic farming and organic agri-inputs in the EU.  Click on the link to read the full article.

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Current Position of Biostimulants in Europe, and Field Trial Case Studies

By John McKenzie, Theodorus Chirstoglou, Lars Huber
Date: 16 December 2021

The new EU Fertiliser Regulation 2019/1009 has brought several significant changes. Biostimulants and their registration requirements have been integrated in the regulatory framework, moving the national regulations to EU harmonised rules. For more information, please read our joint SCC and Tentamus Group article online on the AgroPage news website or download it directly. 

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Chemical Crop Protection and Biorationals, Part III:
Green Deals

Date: 7 December 2021

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Chemical Crop Protection and Biorationals, Part II:
Biorationals

Date: 7 December 2021

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Chemical Crop Protection and Biorationals, Part I:
Regulation (EC) 1107/2009 and related issues

Date: 7 December 2021

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Regulation of Plant Protection Products in India

Date: 30 November 2021

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Biostimulants and REACH

Date: 14 September 2021

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

Date: 13 July 2021

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

Date: 6 July 2021

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.

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Brexit and Its Impact on Pesticide Regulation

Date: 26 May 2021

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Biorationals

Date: 6 January 2021

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Chemical Crop Protection & Biorationals: Part 5

Regulation (EC) 1107/2009 and Biorationals

Date: 15 December 2020

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Chemical Crop Protection & Biorationals: Part 4

Regulation (EC) 1107/2009 and Brexit

Date: 14 December 2020

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Chemical Crop Protection & Biorationals: Part 3

Regulation (EC) 1107/2009 and political aspects

Date: 11 December 2020

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Chemical Crop Protection & Biorationals: Part 2

Regulation (EC) 1107/2009 and transparency

Date: 10 December 2020

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Chemical Crop Protection & Biorationals: Part 1

Regulation (EC) 1107/2009 and related issues

Date: 9 December 2020

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AIR Procedure

Date: 11 November 2020

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Regulation (EC) No 1107/2009

Date: 26 October 2020

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New and Existing Active Substances

Date: 15 October 2020

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Low risk products  – a critical assessment

Date: 1 September 2020

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Article 43 - industry feedback

Date: 1 September 2020

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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

» Tank mixtures

» General food law and transparency