Skip to main content
Food Safety

Procedure to apply for authorisation of a PPP

About the procedure

A zonal system of authorisation operates in the EU to enable a harmonised and efficient system to operate.

The EU is divided into 3 zones; North, Central and South. EU countries assess applications on behalf of other countries in their zone and sometimes on behalf of all zones.

Regulation (EU) 1107/2009 sets out the requirements, procedure and timeframes for authorisation of Plant Protection Products (PPPs).

Applicants, EU countries, the European Commission and the European Food Safety Authority (EFSA) can be involved in the process of authorisation.

There are different types of application that can be submitted depending on the intended use of the PPP, the Member State(s) for which the PPP is required and the regulatory status of any existing authorisations. These are explained in further detail here:

First authorisation of a PPP (PPPAMS ready to use)

Articles 28-39 of Regulation (EU) 1107/2009 explain the requirements, contents and procedure for authorisation of PPPs.

Applications are evaluated on a zonal basis, but for some uses the EU is considered a single zone and a single Member State can evaluate a PPP on behalf of the entire EU.

These uses are:

  • Greenhouse uses
  • Post-harvest treatments
  • Treatment of empty storage rooms or containers
  • Seed treatments.

The basic procedure for authorisation of new Plant Protection Products (PPPs) and subsequent Mutual Recognition in other EU Member States is as follows:

  1. An application is made to the EU country/countries where the Plant Protection Product is intended to be placed on the market via the PPPAMS. A zonal Rapporteur Member State (zRMS) is selected for each zone where the PPP shall be authorised (some uses are assessed by a single Member States on behalf of all zones);
  2. zRMS carries out an assessment of the application;
  3. Other Member States in the same zone comment on the zRMS's evaluation;
  4. Zonal RMS makes a decision on whether to grant or refuse an authorisation;
  5. Other Member States make a decision to grant or refuse an authorisation;
  6. If an authorisation is issued and later the applicant wishes to place the same product on the market in another Member State(s), an application is made for 'mutual recognition' of the product in the concerned Member State.

Some parts of the application procedure are managed and handled outside of the PPPAMS by manual or electronic processes in the Member States. The following table shows how the application process works for first authorisation of a PPP .

Mutual Recognition (PPPAMS ready to use)

Mutual Recognition allows for the holder of an existing authorisation to apply for authorisation of the same PPP with the same use(s) and under comparable agricultural conditions.

Articles 40-42 of Regulation (EU) 1107/2009 explain the requirements, contents and procedure for Mutual Recognition. A Guidance Document provides details about the procedure.

Applications for Mutual Recognition can only be made if there is an existing authorisation for the PPP in another Member State. Applications can be made through the PPPAMS for products that have been authorised via the system.

Some parts of the application procedure are managed and handled outside of the PPPAMS by manual or electronic processes in the Member States. The following table shows how the application process works for mutual recognition of a PPP .

Amendment or withdrawal of an existing authorisation

The same requirements and process as for first authorisation is followed for amendment to authorisation. Refer to the section on 'First authorisation of a PPP' for further details.

Applicants can chose to withdraw an authorisation at any time. A request to withdraw should be submitted to the relevant Member State.

Member States can review authorisations at any time if there are indications that the necessary requirements for authorisation are no longer met.

These applications will be made with the PPPAMS in the future.

Renewal of authorisation

Following renewal of approval of an active substance, all plant protection products containing that active substance must also undergo a renewal assessment to make sure that products comply with the updated assessment of the active substance and with new scientific and technical knowledge. Renewals are carried out on a zonal level. Article 43 of Regulation (EU) 1107/2009 gives an overview of the process and timelines whilst an accompanying Guidance Document provides further specific details for this type of application.

These applications will be made with the PPPAMS in the future.

Emergency authorisation (PPPAMS ready to use)

Article 53 of Regulation (EU) 1107/2009 provides for Member States to authorise, in special circumstances, the placing on the market of a PPP for a maximum period of 120 days and for limited and controlled use, where such a measure is needed to control a serious danger that cannot be controlled by any other reasonable means.

The Commission and all other Member States must be informed when an emergency authorisation is granted, and the Commission may ask the European Food Safety Authority for an opinion or scientific/technical assistance.

Applications for emergency authorisations should be made via the PPPAMS. The applications are made either by industry or by the Member State (in cases where the applicant is a grower, trade organisation or Member State local authority, for example).

A Guidance Document provides further details on what information must be provided to support an application.

Some parts of the application procedure are managed and handled outside of the PPPAMS by manual or electronic processes in the Member States. The following table shows how the application process works for applications for emergency authorisation .

The following Quick Reference Guides are handy tools to explain the process for submitting applications for emergency authorisation using PPPAMS:

Application for Minor Uses

Article 51 of Regulation (EU) 1107/2009 allows for applications to be made to extend an existing authorisation to include minor uses not already covered by the authorisation. More information on the procedure can be found here.

These applications will be made with the PPPAMS in the future.

Parallel trade permits

One of the key pillars of the European Union is the free circulation of goods within the internal market.

The free circulation of PPPs within the EU must be facilitated without posing any unnecessary barriers but at the same time safeguarding that the provisions in place do not pose any risk for human health, animals or the environment.

Parallel trade permits allow a product that is authorised in one Member State (origin MS) to be introduced into another Member State (introduction MS) if the Member State of introduction determines that an identical product is already authorised in its territory. A simplified procedure allows this to occur within 45 days.

Article 52 of Regulation (EU) 1107/2009 explains the process for applying for a parallel trade permit.

Three basic conditions must be met in order for a MS to grant a parallel trade permit:

  1. The plant protection product for which an application is submitted is authorised in the MS of origin and the reference product in the MS of introduction;
  2. The product from the MS of origin and the reference product in the MS of introduction are of identical composition
  3. An application is submitted in the MS of introduction

A Guidance Document is available which explains how applications for parallel trade should be carried out by Member States.

These applications will be made with the PPPAMS in the future.

Assessment of technical equivalence

For the same active substance produced by different methods or from different sources, the level of hazard posed for health and the environmental must be comparable.

When the hazard from a new source is considered greater than the reference source a risk assessment must be performed to determine if PPPs containing the new technical material will fulfil the safety requirements laid down in Regulation (EU) 1107/2009.

Article 38 of Regulation (EU) 1107/2009 explains the process for the assessment of equivalence of active substances.

Guidance Document are available which explain how technical equivalence is conducted for chemical substances and microbial substances.

Under EU rules, it takes up to 1.5 years from the date of application to the granting, amendment or withdrawal of on authorisation. This time varies depending on how complex and complete the application is and the type of application.

How are applications for PPPs submitted?

Applicants who wish to have a PPP authorised in the EU must submit their applications to Member States via the Plant Protection Products Application Management System (PPPAMS). This online system manages the workflow of applications and will populate an EU wide public database of authorised PPPs.

Dossiers are not submitted via the PPPAMS and other manual processes (e.g. invoicing/charging and evaluation work) in each EU country compliment the System.

The PPPAMS manages the workflow of applications, enabling applicants and EU countries to communicate with each other through the application process, primarily by changing the status of the application.

The PPPAMS can send notifications for information and action based upon status changes through the application process.

How does the PPPAMS link to the actual application process in Member States?

The PPPAMS does not replace the processes that exist in EU countries; it works alongside the other electronic and manual processes that EU countries operate outside of the PPPAMS. In the sections above that explain the different application types for PPPs, you will find tables providing an overview of what steps happen inside and outside of the PPPAMS

Each Member State has their own procedures and below is a list with links to national procedural guidelines.

Member State procedural guidelines

Member State

Procedural Guidelines

flag_aut.png
Austria
flag_bel.png
Belgium
flag_bgr.png
Bulgaria 
flag_hrv.png
Croatia
flag_cyp.png
Cyprus
flag_cze.png
Czech Republic
flag_dan.png
Denmark
flag_est.png
Estonia
flag_fin.png
Finland
flag_fra.png
France 
flag_deu.png
Germany
flag_grc.png
Greece
flag_hun.png
Hungary
flag_irl.png
Ireland
flag_ita.png
Italy 
flag_lva.png
Latvia 
flag_ltu.png
Lithuania
flag_lux.png
Luxembourg
flag_mlt.png
Malta 
flag_nld.png
Netherlands
flag_pol.png
Poland 
flag_prt.png
Portugal 
flag_rou.png
Romania 
flag_svk.png
Slovakia
flag_svn.png
Slovenia
flag_esp.png
Spain
flag_swe.png
Sweden
flag_nor.png
Norway

Fees

EU country charge a fee to applicants to carry out the work required for evaluating an application.

Fees vary between EU countries. Further information is available directly from EU countries. You can find contact details here .

Draft Registration Report

All applications (new product, amendment and renewal) for PPPs should be made in the form of a draft Registration Report (dRR).

The dRR is split into 3 sections:

  • Part A – risk management
  • Part B – data evaluation and risk assessment
  • Part C – confidential information

Further Guidance on the use of dRR can be found in the "Dossier and draft assessment report" part of the "Procedural guidance" section of the Guidelines page

Guidance

To learn more on how to prepare and submit applications, please go to Guidelines on Active Substances and Plant Protection Products. Authorised system users can access a comprehensive help system within the PPPAMS.