Guides - Crop Protection

Guidance for the applicant of an authorisation of a plant protection product in Belgium

Procedures and administrative requirements to obtain and/or modify an authorisation for a plant protection product

Guidance for the applicant of an authorisation of a plant protection product in Belgium - March 2020

Guidance authorisation of plant protection products for non-professional (garden) use

Guidance for the evaluation of active substances at EU level

A detailed procedure for the evaluation of active substances with Belgium involved as Rapporteur Member State (RMS) or co-RMS

Evaluation of active substances at EU level (v.2.0)

Procedure application EU MRL / import tolerance

One of the prerequisites to authorize a plant protection product (PPP) is that potential residues in food and feed resulting from the intended use of the PPP are covered by EU Maximum Residue Limits (EU MRLs).

The procedure for the application and setting of an EU MRL (incl. import tolerance) is clarified in Guidance Document SANTE/2015/10595 prepared by the European Commission.

The submission and evaluation of confirmatory data for an EU MRL following the MRL review follows more or less the same procedure as a standard application for setting/modification of an EU MRL (see above). Additional guidance is available in Working Document SANTE/E4/VW 10235/2016 prepared by the European Commission.

Additional practical information and particular guidance regarding the implementation of this procedure in Belgium is included in a separate document (see pdf below).

Implementation procedure in Belgium (18/11/2020)
Guidance Document SANTE/2015/10595 (MRL-setting procedure)Working Document SANTE/E4/VW 10235/2016 (MRL confirmatory data)

Guidance : environmental fate and behaviour

This guidance provides an overview of the requirements for environmental fate and behaviour for the authorisation of a plant protection product.

Guidance on the technical requirements for the section Fate and Behaviour in the Environment (v.2.5)

OECD Guidance document on botanical active substances used in plant protection

OECD Guidance document on botanical active substances used in plant protection

Instructions for the renewal under Regulation (EU) No 1107/2009

A list of instructions for the renewal of active substances under Regulation (EU) No 1107/2009.

1-MCP - instructions Art. 43 2,4-D - instructions Art. 43 2,4-DB - instructions Art. 43 acetamiprid - instructions Art. 43 acibenzolar-S-methyl - instructions Art. 43 Akanthomyces muscarius strain Ve6 - instructions Art. 43 alpha-cypermethrin - instructions Art. 43 Ampelomyces quisqualis strain AQ10 - instructions Art. 43 bentazone - instructions Art. 43 benzoic acid - instructies Art. 43 carfentrazon-ethyl - instructions Art. 43 Clonostachys rosea strain J1446 - instructions Art. 43 clopyralid - instructions Art. 43 Coniothyrium minitans Strain CON/M/91-08 (DSM 9660) - instructions Art. 43 copper compounds - instructions Art. 43 cyazofamid - instructions Art. 43 cypermethrin - instructions Art. 43 dimethenamid-P - instructions Art. 43 esfenvalerate - instructions Art. 43 ethofumesate - instructions Art. 43 etoxazole - instructions Art. 43 fenhexamid - instructions Art. 43 ferric phosphate - instructions Art. 43 florasulam - instructions Art. 43 foramsulfuron - instructions Art. 43 garlic extract - instructions Art. 43 imazamox - instructions Art. 43 iodosulfuron - instructions Art. 43 isoxaflutole - instructions Art. 43 kiezelgoer - instructions Art. 43 laminarin - instructions Art. 43 lambda-cyhalothrin - instructions Art. 43 mesosulfuron - instructions Art. 43 metalaxyl-M - instructions Art. 43 methoxyfenozide - instructions Art. 43 metsulfuron-methyl - instructions Art. 43 picolinafen - instructions Art. 43 potassium hydrogen carbonate - instructions Art. 43 propoxycarbazone - instructies Art. 43 propyzamide - instructions Art. 43 pyraflufen-ethyl - instructions Art. 43 pyriproxyfene - instructions Art. 43 silthiofam - instructions Art. 43 Streptomyces strain K61 - instructions Art. 43 sulfosulfuron - instructions Art. 43 tolclofos-methyl - instructions Art. 43 tribenuron - instructions Art. 43 trifloxystrobine - instructies Art. 43 zoxamide - instructions Art. 43

Guidance dose expression for vertical crops

This guidance document on the dose expression for vertical crops contains all the information necessary for applicants of authorisations for plant protection products to calculate the dose per hectare leaf wall area (LWA).

Dose expression for vertical crops

Guidance application for a basic substance

The European Commission has drafted a guidance document that describes the procedure for an application for a basic substance including the format, required documents, ...

EU guidance for an application for a basic substance

Guidance: ecotoxicology

A detailed overview of the data requirements and the required risk evaluations for ecotoxicology.

Guidance Ecotoxicology Belgium (v.2.3) Calculation tool: Mixture toxicity (Belgium, v.2) Calculation tool: Moving time window determination (Belgium, v.2)

Requirements for the authorisation of adjuvants

National requirements applied in Belgium to an application for authorization of an adjuvant for agricultural use

Requirements for the authorisation of adjuvants (v.1.3)

Guidance: Physico-chemistry

An overview of guidance documents available for the assessment of the physico-chemical characteristics of plant protection products, incl. information about the possibility to extrapolation packaging materials, the FAO and WHO specifications and the European guidance document on the validation of analytical methods.

Technical requirements physico-chemistry Extrapolation of packaging materials
Manual on development and use of FAO and WHO specifications for pesticides (2016, 3rd revision)Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post-approval Control and Monitoring Purposes

Guidance on parallel trade

Guidance document concerning the parallel trade of plant protection products

EU guidance on parallel trade

Overview recent guidance documents

New European technical and procedural guidance documents are entering into force. This has repercussions on the applications for authorisation of plant protection products and on the dossiers for the approval of active substances at European level. The timing for these new guidance documents to be applied is given in the document below.

Unless indicated otherwise in the document here under, these guidelines are available on the website of DG Health and Food Safety.

Overview recent guidance documents (07/2018)

Guidance evaluation of the equivalence of active substances

Guidance equivalence evaluation of chemical active substancesGuidance equivalence evaluation of micro-organisms

Spreadsheet PECs

The basic spreadsheet for PEC values. Other spreadsheets (multiple application PEC calculator; first-order multiple application accumulation PEC) are available on the website of the Chemicals Regulation Directorate (CRD) from the United Kingdom.

pecsol.xls

Evaluation of new drift-reducing equipment

Evaluation of new drift-reducing equipment (20210429)

CLP - Safety recommendations in Belgium

Guidelines for the selection and application of the precautionary statements (P statements) for plant protection products in Belgium (as applied by the Registration committee from 1/4/2016). Note that P statements can be assigned by the committee if it deems to be necessary based on the risk evaluation.

Precautionary statements for plant protection products in Belgium

CLP - Classification and labelling

CLP Classification and labelling

CLP - Procedure and checklist

CLP - Procedure and checklist

First aid

Instructions on how to notify your product to the Belgian Poison Centre concerning first aid.

Notification to the Poison Centre (27/04/2021)
Instructions pour la rédaction des conseils de premiers secours (FR, 01/12/2020)Instructies voor het opstellen van de eerste-hulpaanwijzingen (NL, 01/12/2020)

National requirement per member state (central zone)

National requirements - Central Zone (2021/06)

Application of the European guidance concerning the emissions from protected crops to the environment in Belgium

Emissions from protected crops to the environment in Belgium

List of minor crops

A list of cultures considered as minor uses in Belgium.

List of minor crops (FR)List of minor crops (NL)

Guidance for comparative assessment in Belgium

This guidance has the purpose to explain how the Belgian competent authority (the Service Plant Protection Products and Fertilisers, SPF) will undertake comparative assessment and substitution, a requirement for certain plant protection products introduced by EU Regulation 1107/2009, and to announce new guidance for applicants. Furthermore, we propose applicants a form in annex 2, specific for Belgium, for submitting information to support the process of comparative assessment.

Guidance for Comparative Assessment in Belgium (02/02/2018 v.1.1)

List of plant protection products for organic agriculture in Belgium

This list contains the plant protection products which are authorised in Belgium and can be used in organic farming in accordance with annex II of Commission Regulation (EC) 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control.

List of plant protection products for organic agriculture (FR)

Data requirements and procedure for the risk assessment for bees

Belgian national approach for the risk assessment for bees (30/11/2021)

List of active substances authorized in organic farming

List of active substances authorized in organic farming (FR)