Hvordan søke godkjenning av plantevernmidler

New plant protection product

Before you place a new plant protection product on the marked, it has to be approved by the Norwegian Food Safety Authority.

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).

Veiledere - guidance documents

National environmental requirements

Norway has several national environmental requirements to ensure a safe use of pesticides in a Norwegian climate and environment.

You will find our national requirements in the Northern Zone Guidance Document (A1) from our overview of guidance documents.

Applicant's guide to reduction of non-spray buffer zones v1.2 (PDF)

Fees for evaluating applications for plant protection products

After the Norwegian Food Safety Authority has finished evaluating your application of a plant protection product, we will charge you a fee.

The rates may be found here in “vedlegg 1, kapittel III, del A/B”, (Norwegian language only)

The fees shall cover expenses related to the evaluation. All fees are in Norwegian kroner (NOK).

When the Norwegian Food Safety Authority are zonal Rapporteur Member State (zRMS) for your application, we will charge you for 50% of the fee when we have completed 50% of the evaluation. This will apply for applications (art. 33 and art. 43) submitted after 1 November 2019.

Evaluation of applications for authorisation of plant protection products sent before 01.06.2015 will follow the previous Norwegian legislation including fees.

Renewal of approval of a plant protection product

Within its expiration period, an active substance will be re-evaluated in the EU. After the approval of the active is renewed, the Norwegian Food Safety Authority will re-evaluate all plant protection products in Norway containing the active substance

To apply for renewal of an approval of a plant protection product, you have to submit an application according to article 43 in the plant protection products Regulation (EC) No. 1107/2009.

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

Within three months after an active substance is renewed in the EU, the authorisation holder should apply for renewal of approval of the plant protection products containing the active substance in each member state. The application will be handled as a zonal evaluation. Read more about international cooperation and zonal evaluation.

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/2010/13170 (Guidance Document on the Renewal of Authorisations according to Article 43 of 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

1. Pre-notify your application

You should pre-notify your application within two months after EFSA have published their conclusion on the active substance. The pre-notification should be submitted to the zonal rapporteur member state and all concerned member states.

You will find more information on pre-notifications in the latest edition of the EU-guidance SANCO/2010/13170 (Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009) (A6) and the Guidance document on work-sharing in the Northern Zone (A1) from our overview of guidances.

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 six 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.

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 90 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).

Amendment of an authorisation

The authorisation holder may apply for amendments of their authorisation. This could be changes in use, or administrative changes.

In this text, you can read more about:

• Amendments of a product’s area of use requiring a zonal evaluation (label extensions)
• Minor use extensions
• Amendments not requiring a zonal evaluation and administrative changes
• Transfer of products
• Grace periods after amendments

Amendments of a product’s area of use requiring a zonal evaluation (label extensions)

Amendments of a product’s area of use requiring a zonal evaluation could be additional cultures, additional pests or amended PHI.

These types of amendments must be applied and assessed as a zonal evaluation (according to article 33 in the plant protection products Regulation (EC) No. 1107/2009), and will follow the same process as evaluating a new plant protection product.

Read more about new plant protection products

You can also read more about amendments in the latest edition of the Guidance document on work-sharing in the Northern Zone (guidance A1) from our overview over guidance documents

Minor use extensions

A minor use extension allows you to use an already approved plant protection product for other, «minor» uses.

Read more about minor use

Administrative changes and amendments not requiring a zonal evaluation

Amendments not requiring a zonal evaluation should be applied according to article 45 in the plant protection products Regulation (EC) No. 1107/2009.

Such changes could for instance be:

• Amending the plant protection product’s name
• Amendments of the product’s label layout
• Changes in packaging
• Limitations in the product’s area of use
• Amendments of production place

The application should be sent as a formal letter to the Norwegian Food Safety Authority, or as an attachment in an e-mail to postmottak@mattilsynet.no

The applicant will be charged with a fee after the assessment.

Transfer of products

To transfer a product from one authorisation holder to another, both parts should send a formal written confirmation to postmottak@mattilsynet.no

We need to be informed of when the change enters into force, who the importer is and an updated label if relevant.

We will charge you with a fee for transferring products. You will find the fees for «Andre endringer av administrativ art (f.eks. produktnavn) som medfører merarbeid for Norge» in attachment 1, chapter III, part B in forskrift om betaling av gebyrer for særskilte ytelser fra Mattilsynet (Norwegian). If there are several products being transferred in the same letter, you will be charged with one fee per five transfers.

Grace periods after amendments

After an approval of a plant protection products are withdrawn or amended, the Norwegian Food Safety Authority may grant a grace period for disposal, storage, placing on the market and use of existing stocks.

Read more about grace periods.

Requirements for the authorisation holder and importer after the decision

The authorisation holder completes the product’s label for assignment of registration number.

When you apply for authorisation of a plant protection product, you should include a Norwegian draft label with the application. After the Norwegian Food Safety Authority have approved the product, the applicant should correct the draft label to be in accordance with the requirements in the decision letter, and send it back to the Norwegian Food Safety Authority. When the label is in accordance with the decision letter, we will assign the product a unique registration number, which you must add to the completed label. Not until then you may place the plant protection product on the marked.

The authorisation holder should always submit a pdf-copy of the print-ready label with the registration number to the Norwegian Food Safety Authority. We will then add the label to our list of approved chemical and microbiological plant protection products.

The authorisation holder must keep the Norwegian Food Safety Authority informed of the product’s importer

As the authorisation holder of a plant protection product, you need to inform the Norwegian Food Safety Authority about which companies will import the product. You also need to keep us informed if the importer changes.

The importer must register with the Norwegian Food Safety Authority

Enterprises must register with the Norwegian Food Safety Authority in order to import plant protection products to Norway.

The importer must report the imported amount of the plant protection product and pay taxes for imported product

The authorisation holder needs to keep the importers and distributers informed

If the authorisation of a plant protection product is amended or withdrawn, the authorisation holder should keep the importers, distributers and retailers informed.

The authorisation holder shall notify of any potential harmful or unacceptable effects

The authorisation holder shall notify the Norwegian Food Safety Authority of any information that suggests that the plant protection product no longer complies with the criteria’s of approval.

The authorisation holder shall also record and report all suspected adverse reactions in humans, in animals and the environment related to the use of the planet protection product.

This is described in article 56 in the Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market.

Withdrawal of an approval

The authorisation holder may withdraw the product from the market.

The withdrawal should be done in a formal written letter to the Norwegian Food Safety Authority, or as an attachment to an e-mail to postmottak@mattilsynet.no. The withdrawal should state from what date the withdrawal applies.

The Norwegian Food Safety Authority may withdraw or amend an authorisation if the requirements for the authorisation no longer are fulfilled. In such cases we will inform the authorisation holder of the withdrawal and the grace period in a decision letter. It is the responsibility of the authorisation holder to inform the importer, distributes and retailers of the decision.

The Norwegian Food Safety Authority will grant a grace period when a plant protection product is withdrawn or amended.

Grace periods

If the authorisation for a plant protection product or an active substance is amended, withdrawn or not renewed, the Norwegian Food Safety Authority may grant a grace period for the disposal, storage, placing on the market and use of existing stocks.

Grace periods after amending an authorisation

If the authorisation of a plant protection product is amended, the Norwegian Food Safety Authority may assign a new registration number for the new approval. The authorisation with the old registration number will be granted a grace period.

The grace period for the old registration number should be limited, and not exceed six months for sale and distribution, and additionally one year for the disposal, storage, and use of existing stocks of the plant protection product.

Examples of amendments where products with an old registration number will be granted a grace period:

• After a renewal of an authorisation
• Amendments of hazard statements and/or precautionary statements
• Amendments of the product’s area of use, where the new authorisation is limited
• Amendments of the terms of use, where the terms are more restricted

Amendments, which do not require a grace period

Certain amendments do not require a grace period. After such amendments, you can no longer produce the old label anymore, but you may sell products in stock with the old label as long as the new label is authorised.

Examples of amendments which do not require grace periods:

• Amendments of the product’s area of use, where the authorisation is expanded and the old authorisation still is covered by the new authorisation
• Amendments of the terms of use of a product, where the old terms still are covered by the new authorisation
• Amendments of a product’s name
• Amendments of the product’s authorisation holder (transfer of a product)

Grace periods after withdrawal of an authorisation

When a product loses its authorisation, or when the authorisation is not renewed, the grace period shall be limited and not exceed six months for sale and distribution, and additionally one year for the disposal, storage, and use of existing stocks of the plant protection product.

In the case of withdrawals or non-renewals caused by immediate concerns for human health, animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately.

If the authorisation is withdrawn, the Norwegian Food Safety Authority will inform the authorisation holder of the grace period in a decision letter. It is the responsibility of the authorisation holder to inform the importer, distributes and retailers of the decision.

Grace periods when active substances are not renewed in the EU

If an active substance loses its approval in the EU, the same will apply in Norway. The Norwegian Food Safety Authority still needs to make a national decision regarding grace periods of the products containing the relevant active substance. Generally speaking, if the EU-commission decides on a common grace period for the whole of EU, Norway will follow the same grace period.

The EU-commission will publish information on withdrawals in the Official Journal of the European Union.

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Data protection

Data protection allows for a period of exclusivity of interest for data owners who have invested in the generation of data to support authorisations. 

Where appropriate, data submitted in support of an application and used to make a regulatory decision will be protected in line with the provisions of the legislation under which the application was evaluated. The protection periods vary depending on the type of authorisation issued.

The rules for data protection under Regulation (EC) 1107/2009 are set out under Article 59-62. Concerning data protection, Norway has no specific national requirements. The following data sheets are to be used for data submitted to support authorisations in Norway:

• Data sheet for references for the active substance
• Data sheet for references for the plant protection product.

During the course of the protection period, a third party cannot use protected data in support of an application for authorisation of their product, without the permission of the data owner (via a letter of access). When the data protection period has expired, we can use the data on behalf of a third party, without gaining permission to do so from the data owner.

The Regulation lays down rules for data protection for both active substance and product data, for the avoidance of duplicate testing, and for sharing of tests and studies involving vertebrate animals. The protection periods applied to data submitted and used to support authorisations under Regulation (EC) 1107/2009 are summarised in the table below:

Data protection periods under Regulation (EC) 1107/2009

Treated seeds and products for greenhouses, post-harvest and seed treatment

For placing treated seeds on the market in Norway, the plant protection product used in the seed treatment must be approved in at least one EU member state. Plant protection products for use in greenhouses, post-harvest treatments, treatment of empty storage rooms or seed treatments are jointly assessed in the EU.

The placing on the market of treated seeds is described under Article 49 in regulation 1107/2009/EC. 

The actual seed treatment must be done in the member state where the plant protection product is authorised. The following labelling is required for treated seeds on the Norwegian market:

• The name of the plant protection product used for the seed treatment.
• The active substance in the plant protection product.
• Standard safety phrases according to directive No 99/45/EC (will be replaced by regulation No 1272/2008 from the 1st of June 2015).
• The risk reducing measures identified during the risk assessment of the plant protection product.

Products for greenhouses, post-harvest and seed treatment

Plant protection products for use in greenhouses, post-harvest treatments, treatment of empty storage rooms or seed treatments are jointly assessed in the EU. This means that a member state will do the risk assessment on behalf of all other member statesin the EU/EEA.

However, the requirements specified in the guidance document for the Northern zone, including the national requirements, still applies. Protected crops are assessed as closed systems until a guidance document from EFSA is available.

UFI codes are not a part of The Norwegian Food Safety Authority’s assessment of pesticide labels

This applies from 1 January 2021 with a transitional period until 1 January 2025. It applies for all chemicals for professional and non-professional uses, including pesticides.

Products defined as hazardous mixtures on the basis of their health or physical effects should be notified through ECHA* and a UFI code should be included on the label. 

UFI codes are not a part of the Norwegian Food Safety Authority’s evaluation of the pesticide’s label.

What is a UFI code?

A UFI code (Unique Formula Identifier) is a 16-digit alphanumeric code, which connects information of a chemical mixture together with the marketed product. This information will be available to Poison Centres, so that they can easily identify the product and inform about the hazards of the mixture in the case of a medical emergency.

Should pesticide labels with the UFI code be sent to The Norwegian Food Safety Authority?

It is the applicant/authorisation holder’s responsibility to make sure a pesticide is marked with the correct UFI code. It is not necessary to send a pesticide label with a new or amended UFI code to The Norwegian Food Safety Authority. Any other label amendments than the UFI-code must be applied for.

Should pesticides be declared to The Product Register?

If you want your product to be a part of the transitional arrangement for notifying Poison Centres according to article 45 in the CLP Regulation, the product must be declared in the Product Register in Norway. It is however not compulsory to declare pesticides according to the Norwegian Declaration Regulation.

You may voluntarily declare pesticides to The Product Register before 1 January 2021. These products will then be covered by the transitional arrangement. This way you will not have to notify the product according to the new harmonized requirements in the CLP regulation, appendix VIII, and may wait until 1 January 2025 if the product is not otherwise amended.

The Norwegian Poison Information Centre (Giftinformasjonen) has direct access to The Product Register.

Legislation and guidance

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures (The CLP regulation)

The Declaration Regulation (Norwegian)

Read more about the Product Register in Norway

ECHA - Steps for industry

*According to new harmonized requirements in the CLP Regulation, appendix VIII