New plant protection product

Published

11.12.2023

To apply for a new plant protection product, you have to send an application according to article 33 in the plant protection products Regulation (EC) No. 1107/2009.

If the plant protection product already is approved in another EU-member state, you may also apply for mutual recognition of the approval. Read more about mutual recognition of an approval here.

You may also pre-notify and submit your application through the EU PPPAMS database

What are the requirements to get a plant protection product authorized?

First, the plant protection product’s active substance needs to be approved in EU. You can check if the active substance is approved in the EU pesticide database. Second, you have to apply for approval the plant protection product through a zonal assessment. Read more about international cooperation and zonal evaluation.

In the assessment, we evaluate if the plant protection product fulfil certain requirements to protect the environment and the health of humans and animals. We also evaluate whether the product is efficient for its intended use or toxic to other plant cultures.

You will find the requirements as well as description of the procedure in the following guidances from our overview of guidances:

• The latest edition of the Guidance document on work-sharing in the Northern Zone (A1)
• Northern Zone Guidance document - Higher tier risk assessment for birds and mammals, with spreadsheet for birds and mammals (A1.1 and A1.2)
• The latest edition of the EU-guidance SANCO/13169/2010 (Guidance document on zonal evaluation and mutual recognition under Regulation (EC) No 1107/2009) (A6)
• The latest edition of Northern Zone guidance paper efficacy version (A2.1)
• Guidance of number of trials in the northern zone (A2.2)

Overview of the application procedure for zonal assessments

1. Pre-notify your application

Use the form below:

• Pre-notification form

Six months before you submit your application, you should pre-notify the application to the zonal rapporteur member state and all concerned member states.

You may contact us by emailing postmottak@mattilsynet.no if you have any questions or if you need a pre-submission meeting.

2. Submit your application

Use the forms below:

• Application form
• Reference list, product
• Reference list, active substance
• Completeness check form

Submit the application to the zonal rapporteur member state and all other concerned member states in the zone.

Submit the application digitally to postmottak@mattilsynet.no

Submit the documentation by post or courier to:

Mattilsynet, national registrations department
Glynitveien 30

1400 Ski

Norway

3. Processing your application

The zonal rapporteur should complete the evaluation within 12 months.

The zonal rapporteur member state starts by doing a completeness check. Based on the completeness check, the zonal rapporteur member state will decide whether the application is admissible or not.

If the application is deficient, the zonal rapporteur may “stop the clock”. This will pause the 12 months deadline of handling the application. This period cannot be longer than six months in total. If the application still is not complete after six months, the application may be denied or refused.

The zonal rapporteur drafts a registration report (dRR), which will be circulated between the concerned member states and the applicant for comments. After the commenting period, the zonal rapporteur completes the registration report (RR) and makes a national decision whether to approve the product or not.

After the zonal rapporteur has completed the RR, the concerned member states have 120 days to complete their evaluation and make a national decision of approval. The concerned member states may also decide for national risk-reducing measurements.

After you have received a decision from the Norwegian Food Safety Authority

As an authorisation holder or importer of a plant protection product, you have some obligations after the assessment is completed.

Read more about requirements for the authorisation holder and importer after the decision.

If you wish to make an appeal against our decision, you may do so within three weeks after you receive the decision. The appeal should be directed to the Norwegian Food Safety Authority, Greater Oslo Region –postmottak@mattilsynet.no

Fees

We will charge you with a fee for evaluating your application of approval of a plant protection product. You will find the fees for approval of products (“Godkjenning av preparater”) in attachment 1, chapter III, part B in forskrift om betaling av gebyrer for særskilte ytelser fra Mattilsynet (Norwegian).