Board for the Authorisation of Plant Protection Products and Biocides

Guidance documenten

European regulations are further developed in so-called guidance documents. Guidance documents are developed by various stakeholders together; from government to industry.

​The purpose of the guidance document is to support the implementation of the regulations on plant protection products (and biocides) by describing the best way to fullfill these duties within specific frameworks.

There are different types of guidance documents: technical and procedural. In the Evaluation of Manuals Ctgb is constantly referred to underlying guidance documents.

See all EU guidelines on Active Substances and Plant Protection Product.​

Technical guidances

EFSA OPEX model

In 2014 EFSA published the Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products; better known as EFSA OPEX model.

This guidance contributes to a further harmonized process in the EU. Hence, the board decided to apply this Guidance for all (active substances and plant protection products) applications for plant protection products submitted from January 1, 2016.

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more.

Guidances on derivation of soil degradation endpoints and groundwater exposure

On May 1, 2015 the EU Standing Committeee on Plants, Animals, Food and Feed noted two guidelines for the risk assessment of derivation of soil (DegT50 values) and groundwater exposure.

Read more.

Procedural guidances

Guidance draft Registration Report

From January 1,  2016 on a new set of dRR templates applies to all product dossiers.
Read more

Guidance NL addenda

For the composition of the NL addenda Ctgb has adapted the National Guidelines to the Dutch situation; see Guidance NL addenda.

Read also guidance draft Registration Report

Guidance document Efficacy

A more harmonised dRR will lead to more clarity, simplify the assessment and consequently reduce the turnaround time.
What is expected from applicants in the national addendum regarding efficacy is clarified in our additional guidance.

Read more.

Guidance on data protection

The Guidance on data Protection provides Member States and applicants with guidance on the
procedures and policies surrounding various elements of data protection, as related to plant
protection products legislation.
This guideline is intended to help Member States apply the rules in a consistent way, and for applicants to
understand those rules. It does not intend to produce legally binding effects. Nor does it constitute
an official position of the European Commission. This document covers 2 main areas:

  1. Section 1 - explaining the periods of protection applied to studies under different
    circumstances – the ‘why, when and how long’,
  2. Section 2 - clarification of the special procedures and provisions that apply to vertebrate
    data sharing.