Before you can sell a plant protection product on the Norwegian market it has to be assessed and approved by the Norwegian Food Safety Authority (NFSA), Here you will find information about application types, standard forms and guidance.
Before autorising products, we will assess possible risks for the environment and our health, and also whether the product is effective for the applied use. The plant protection product must comply with the criteria for health and environment specified in uniform principles: Comission Regulation (EU) No 546/2011 (PDF, europa.eu)
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.
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
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.
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.
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
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.
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.
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.
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.
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.
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
Mutual recognition of an authorisation allows you to apply for approval for a product based on an authorisation of the same product in another member state (reference member state).
The legal basis for mutual recognition is article 40 in the plant protection products Regulation (EC) No. 1107/2009.
New guidance on mutual recognition from January 1, 2024
Wer have created a new guide on how to apply for mutual recognition:
The guide applies to all applications submitted after January 1, 2024.
What are the requirements for an application of mutual recognition?
If you wish to apply for mutual recognition you must demonstrate that the risk assessment (all safety aspects, efficacy and crop safety) supporting the authorisation of the product in the reference member state is relevant to Norwegian conditions and requirements.
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)
Guidance on the application of mutual recognition in Norway under Regulation (EC) No. 1107/2009 (A2)
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)
Who may apply?
The authorisation holder, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for mutual recognition.
How to apply
For planning purposes, you are welcome to pre-notify your application by email some months in advance.
You may share the documentation electronically, or send it by post or courier to:
Mattilsynet, national registrations department
Glynitveien 30
1400 Ski
Norway
If the product is authorised in the reference member state through the EU E-Submission Food Chain (ESFC) Platform, you may also use ESFC to apply for mutual recognition in Norway.
Case handling time
The case handling time for an application of mutual recognition is 120 days from when the application and the documentation is considered complete.
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.
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 mutual recognition (“Godkjenning av preparater» – «Gjensidig godkjenning”) in attachment 1, chapter III, part B in forskrift om betaling av gebyrer for særskilte ytelser fra Mattilsynet (Norwegian)
Minor use
An authorisation for minor use allows an already authorised plant protection product to be applied for in additional uses, provided that these uses are minor in nature.
The legal basis for mutual recognition is article 51 in the plant protection products Regulation (EC) No. 1107/2009.
It is also possible to apply for mutual recognition of a minor use authorisation from another Member State within the Northern zone, as long as the product is authorised for a crop or a pest that is regarded as minor also in Norway.
The Norwegian Food Safety Authority grants a minor use authorisation on the condition that the use with respect to failures concerning the efficacy or to phytotoxicity is under the liability of the person using the plant protection product. It is also possible to apply for mutual recognition of a minor use authorisation from another Member State within the Northern zone, if the crop or the target pest is regarded as minor also in Norway.
The authorisation holder, official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may apply for a minor use authorisation. The extension of authorisation for minor use is not limited to the applicant. The extension is valid for all the professional users.
How to apply for minor use authorisations
The application form should be accompanied by a proposed additional label (LINK) or a proposed extension of minor use on an existing label. Extensions on an existing label shall be separately identified and separate reference shall be made to liability restrictions. Where necessary, data on the magnitude of residues and additional documentation on unacceptable effects on the environment and human health (risk assessment to operator, worker, resident and bystander) shall be provided.
After authorisation
If an authorisation is granted to other official or scientific bodies/professional organisations or users than the authorisation holder, the Norwegian Food Safety Authority will request the authorisation holder to include the additional use on the label of the plant protection product. If this is not accommodated, the authorisation and the use instructions will be published on the Norwegian Food Safety Authority's website. Authorisation period for minor use follows ordinary authorisation period. Therefore a new application for extension of authorisation for minor use shall be submitted when the product is renewed.
Emergency authorisation
The Norwegian Food Safety Authority may authorise, for a period not exceeding 120 days, the placing on the market of plant protection products for limited and controlled use.
The use of emergency authorisations should be exceptional, and restricted to cases of obvious dangers to plant production or ecosystems that cannot be contained by any other reasonable means. It shall not jeopardize a high level of protection for both human and animal health and the environment.
The applicant must submit, in addition to the application form, a recommendation from the Norwegian Institute for Agricultural and Environmental Research.
Unauthorized plant protection products (e.g. products with new active substances and/or new compositions) that are in the development stage may be tested experimentally through planned trials.
To apply for derogations for research and development, you have to send an application according to article 54 in the plant protection products Regulation (EC) No. 1107/2009.
Plant protection products contain one or more active ingredients aimed at combating the specific plant pests. Here, you can learn more about the evaluation and approval process for these substances.
Active substances are jointly assessed and approved in the EU. The Norwegian Food Safety Authority participates at the EFSA (European Food Safety Authority) expert meetings where the risk assessment of active substances is discussed. The Norwegian Food Safety Authority also participates at the Commission meetings where active substances are approved (SCoPAFF).
To ensure that active substances are assessed according to modern standards, active substances are authorised for a limited period of time and then re-assessed. Applicants are required to submit an application for re-registration no later than 3 years before the end of the approval period for an active substance.
You will find more information on approval of active substances on the European Commission’s webpages:
Adaptations to the regulation and transitional measures
The Norwegian Food Safety Authority is free to limit access of plant protection products containing active substances approved in accordance with Council Directive 91/414/EC or active substances approved in accordance with the Transitional measures in Article 80 of Regulation (EC) No 1107/2009. This is an amendment according to the Decision of the EFTA Joint Committee No 203/2014.
Adjuvants are products which are applied as a tank mix with plant protection products and which improve, for example, wetting or the adhesion of plant protection products, or which prevent foaming.
Adjuvants are defined in Commission Regulation (EC) No. 1107/2009 Article 2 (3) d, as substances or preparations which includes co-formulants or preparations with one or more co-formulant(s), and in the form in which they are delivered to the user and placed on the market with the purpose of being mixed by the user with a plant protection product in order to increase its impact or other pesticidal properties. Its impact is not to be interpreted in the sense of that of a safener/synergist.
Authorisation for the import of a plant protection product that is identical to a product already authorised in Norway.
What is a parallel trade permit?
A plant protection product that is authorised in another Member State and is identical in composition to a plant protection product already authorised in Norway, can be given parallel trade permit in Norway. An approved parallel trade permit is valid only for Norway, and not the rest of the Northern zone, therefore an application must be made in each country for which you wish to obtain a permit.
Regulations
The requirements for parallel trade permits are described in Article 52 of Regulation (EC) No 1107/2009, which is included as Norwegian legislation through the EEA-agreement. Further details is described in the guidance document on parallel trade permits (newest version of SANCO 10524/2012), which must be followed when applying for a parallel trade permit.
What is required to get a parallell trade permit?
An authorisation to import and parallel trade a plant protection product can only be given if the Norwegian Food Safety Authority determines the product to be identical to a product that are already authorized in Norway.
Plant protection products are considered as being identical to the reference product when the following applies:
they have been manufactured by the same company or by an associated undertaking or under licence in accordance with the same manufacturing process;
they are identical in specification and content to the active substance(s), safeners and synergist, and formulation; and
they are either the same or equivalent in the co-formulants present and the packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human health, animal health or the environment.
Requirements of the application procedure
For the Norwegian Food Safety Authority to assess whether the requirements for identicality have been met, the application for a parallel trade permit must contain the following information:
the name and registration number of the plant protection product in the country where the product is registered (Member State of origin);
the Member State of origin;
the name and address of the authorisation holder in the Member State of origin;
the original label and instructions for the plant protection product in the Member State of origin. The Norwegian Food Safety Authority require a translation of the label to English or Norwegian.
the name and address of the applicant;
the name to be given to the plant protection product to be distributed in Norway (Member State of introduction);
a draft label for the product intended to be placed on the market;
a sample of the product which is intended to be introduced if this is considered necessary by the Norwegian Food Safety Authority;
the name and registration number of the reference product in Norway
information on repacking (if performed).
Regulation (EC) 1107/2009 does not prohibit re-packaging of plant protection products. Nevertheless, this is a crucial step in the parallel trade of plant protection products that usually creates the most concerns for MS. It is quite decisive for competent authorities to ensure traceability of the products, and especially whenever re-packaging occurs. A product repacked in a third country and imported to the EU cannot benefit from the provisions on parallel trade. Requirements concerning repacking can be found in the guidance document.
Case processing time
The case processing time is up to 55 days.
After receiving a parallel trade permit
A plant protection product under a parallel trade permit may only be placed on the market and used in accordance with the authorisation of the original product. The parallel trade permit will expire at the same time as the authorisation of the original product. If the authorisation of the original product is withdrawn for reasons other than safety reasons, the parallel trade permit will be similarly affected. The parallel trade permit can be withdrawn if the conditions of the permit are no longer met, which includes withdrawal of the original product authorisation for safety or efficacy reasons.
A list of approved parallel trade permits will be published on our website.
How to apply?
Application form
A complete application form, in accordance with the guidance document, must be filled out and sent to the Norwegian Food Safety Authority. Details on how to submit the application is included in the form.
The authorisation holder of a plant protection product authorized in Norway may apply for additional trade name for the relevant product.
The product with the additional trade name is called a clone product. To apply for additional trade name, you have to send an application according to article 45 in the plant protection products Regulation (EC) No. 1107/2009.
What are the requirements for being granted an additional trade name?
An additional trade name may only be granted for products identical with an already authorized plant protection product in Norway (reference product). The only difference allowed between the two products could be the trade name and importer.
Requirements for the application
You can apply by sending us a formal letter. The application should include:
Name and registration number for the already approved plant protection product (the reference product)
Your invoice address
Print-ready draft label for the product with the new trade name (the clone product)
After the product has been granted additional trade name
The authorisation holder must ensure that the label and packaging of the clone product and reference product are in accordance.
After the label of the clone product is approved, the clone product will receive a registration number. Not until then, you may place the clone product on the market.
A clone product can only be placed on the market and be used in accordance with the approval of the reference product. The authorisation of the clone product will expire at the same time as the authorisation of the reference product expires. If the authorisation of the reference product is amended, the same will apply for the clone product.
The approval of invertebrate biological control agents (IBCA) including insects, mites and nematodes is regulated by the Norwegian regulation on plant protection products.
The Norwegian Food Safety Authority will make an assessment of the possible environmental and health risks of the IBCAs, and assess whether the product is agronomically effective for the use applied for.
The plant protection product regulation requires that the Norwegian Food Safety participates in an international cooperation with the EU member states.
We cooperate both with the whole of EU, as well as Nordic and Baltic member states (the northern zone). This applies for both approval of plant protection products, and the product’s active substances.
Active substances are assessed jointly in the EU
Active substances in plant protection products are assessed and authorized jointly for the member states in the EU/EEA. The Norwegian Food Safety Authority participate in the expert meetings in the European Food Safety Authority (EFSA) where the risk assessments of the active substances are discussed, and we also participate as observers on the meetings in the EU commission where approvals are decided for.
Plant protection products are assessed in a zonal cooperation
While the active substances are authorised jointly for the EU, the product(s) containing the active substance must be applied for and nationally authorized in every member state.
In connection with assessments of the plant protection product application, the EU is divided into three zones: The Northern zone, the Central zone and the Southern Zone. Norway is a part of the Northern zone with Sweden, Denmark, Finland, Estonia, Latvia, Lithuania and Iceland. One of the countries in the zone (zonal rapporteur member state - zRMS) does the main part of the assessment of the plant protection product. During the assessment, the other member states comment on the zRMS’s assessment. All member states where the product is applied, makes national decisions based on the zRMS’s assessment.
The application of authorisation of a plant protection product must be sent to all countries where the product is intended to be placed on the market.
Products for greenhouses, post-harvest and seed treatment
Greenhouse products, products for seed treatments and products for use in storage (post-harvest) are jointly assessed in the EU. This means that a member state will do the risk assessment on behalf of all other member states in 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.
Guidance document on work-sharing in the Northern Zone
The Northern Zone have developed a guidance document describing the application processes and national requirements. The guidance document is updated as needed. The edition of the guidance document that was in effect at the time of application date should be used.
You will find the Guidance document on work-sharing in the Northern Zone (guidance A1) in our our overview of guidance documents
Pesticide risk assessment for birds and mammals
The pesticide risk assessment for birds and mammals is based on the EFSA guidance document on Risk Assessment for Birds & Mammals. In addition the Northern Zone have developed a guidance for higher tier risk assessment included species and scenarios relevant for Northern Zone agricultural areas.
The number of surface water scenarios is reduced from nine to six
We have reduced the number of required surface water scenarios from nine to six starting November 2023. The eliminated scenarios are D5, D6, and R3. The amendments are effective immediately and applies for already received applications and ongoing assessments.
Whether a plant protection product (active substance and its metabolites) will leach to groundwater depends on a number of factors, e.g. topography, climate, properties of the active substance/metabolites, and parameters related to the use of the product such as application rate, application timing and crop type.
We use the model MACRO 5.5.4 and Norwegian and Swedish scenarios to assess the risk of leaching of the active substance and metabolites of a plant protection product to groundwater under Norwegian conditions. You can download the MACRO 5.5.4 model from the FOCUS web page. You will find the necessary files (two .mdb files and two .bin files) for the Norwegian scenarios below:
The database files (crops.mdb and focus.mdb) can only be used to run the Norwegian scenarios in MACRO 5.5.4. For scenarios other than the Norwegian scenarios, the databases that are included in the FOCUS MACRO 5.5.4 installation package should be used. Therefore, after running Norwegian MACRO scenarios, be sure to reinstate the FOCUS database files in MACRO 5.5.4 before running anything else than Norwegian scenarios.
The simulations for the scenarios are correct when running the simulations from within the MACRO-FOCUS GUI. However, when exporting the simulations to a parameter file and running the simulation outside of the MACRO-FOCUS GUI (using the “exeparfile.exe” tool), wrong output variables are selected. Therefore, make sure that the simulations are run within the MACRO-FOCUS GUI.
The instructions for the installation of the scenarios and more background information can be found in the following report by Geosigma:
If the metabolites of an active substance are predicted to reach groundwater above concentrations of 0.1 µg/L, an assessment of the relevance of the metabolites according to the Guidance Document on the relevance of metabolites in groundwater (SANCO/221/2000 – rev.10) must be delivered.
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 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.
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 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:
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
Type of data
Period of protection
Active substance and product data necessary for authorisation or amendment of an authorisation.
Ten years from the date of the authorisation in each Member State, therefore different periods of protection will apply in each Member State.
This will be extended to 13 years for products covered by Article 47 (low risk plant protection products).
The above periods shall be extended by 3 months for each minor use as defined in Article 51(1). The minor use application must be made by the product authorisation holder and the minor use must be supported by data and not based on extrapolation. The application must be made within 5 years of the first product authorisation in the UK and the total data protection period for the product may not exceed 13 years which is extended to 15 years for products covered by Article 47.
Active substance and product data for renewal or review of an authorisation.
30 months from the date of the first authorisation in each Member State. This only applies to tests or studies necessary to support the continued/varied approval.
Data submitted in support of minor uses.
Ten years from the date of the first product authorisation in each Member State, therefore different periods of protection will apply in each Member States.This will be extended to 13 years for products covered by Article 47 (low risk plant protection products).
Comparative Assessment of plant protection products
In certain cases, the Norwegian Food Safety Authority will perform a comparative assessment between a given plant protection product and alternative chemical products, non-chemical products, or other methods.
The legal basis for comparative assessment is article 50 in the plant protection products Regulation (EC) No. 1107/2009.
Comparative assessment (CA) is a national issue, and the Norwegian Food Safety Authority will perform the assessment for the candidate product. The steps of the CA will be included it in the final Part A of the Registration Report. The applicant will be given the possibility to comment, if the conclusion of the CA is negative for the applicant.
Mandatory Comparative Assessment - Article 50.1
If a plant protection product contains an active substance approved as a candidate for substitution, the Member State shall perform a comparative assessment when evaluating the application for authorisation.
The applicant should submit the information to support the process of comparative assessment, by using the template in the Appendix of SANCO/11507/2013.
Optional Comparative Assessment - Article 50.2
The Member State may in exceptional cases also perform an optional CA when evaluating an application for authorisation of a plant protection product not containing a candidate for substitution or a low-risk active substance, if a non-chemical control or prevention method exists for the same use and it is in general use in that Member State.
The applicant should address the following question in the application for the plant protection product:
Does a non-chemical control or prevention method exist for the same use and is it in general use in the Member State?
This information could be included in the Part A of the Registration Report, chapter 4.
Treated seeds, products for greenhouses, post-harvest, 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.