Guidance on how to apply for mutual recognition of a plant protection product in Norway

This guidance applies for applications sent after 1 January 2024

The guidance should be regarded as complementary to the EU guidance document on Zonal Evaluation and Mutual Recognition (SANCO/13169/2010, latest version). The EU guidance can be found on the EU Commission’s overview of procedural guidances (food.ec.europa.eu), under the headline Post approval issues. Most of the specific requirements that apply under Norwegian conditions are extensively described in the “Guidance document on work-sharing in the Northern zone in the authorisation of plant protection products» (hereinafter referred to as the Northern Zone Guidance).

The current version of the Northern Zone Guidance may be found here

In addition to authorisation holders, it is possible for official or scientific bodies involved in agricultural activities or professional agricultural organisations to apply for an authorisation through mutual recognition, on certain terms as described in Article 40.2 in the Regulation. A prerequisite is that the authorisation holder has not yet applied for an authorisation in Norway. 

If other than the authorisation holder intends to apply for an authorisation through mutual recognition, it must be demonstrated that: 

• The applicant has been given consent from the authorisation holder to apply for mutual recognition of the plant protection product, and 
• That the use of the plant protection product is of general interest in Norway

Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest.

The required documentation should be submitted either electronically to both postmottak@mattilsynet.no and pesticider@mattilsynet.no

Or by post/courier to

Mattilsynet, region Stor-Oslo, avdeling nasjonale godkjenninger
Glynitveien 30
1400 Ski
Norway

If the product is authorised in the reference Member State through the E-submission Food Chain (ESFC) Platform, you may also use ESFC to apply for mutual recognition in Norway.

1. Application form

The application form on the Norwegian Food Safety Authority’s website shall be filled out. The first page of the application and any letters of access should be submitted in originals.

Application form: Mutual recognition of a plant protection product authorisation in Norway

2. The authorisation certificate from the reference Member State

A certified original copy of the reference Member States’ authorisation certificate of the product should be submitted, together with a translation of the certificate to English or Scandinavian language. 

3. The registration report from the reference Member State

A complete registration report (RR) in English or Norwegian for the concerned product shall be submitted. The RR must be in accordance with the data requirements in force at the time of the application date in the reference Member State. The following must also be in place when submitting the dossier:

• Additional documentation to address specific Norwegian requirements must be included in national addenda or as information transparently highlighted in an updated RR originally evaluated by the reference Member State.
• All documentation relevant for the product approval shall be made available by the applicant, e.g., if reference is made to other product authorisations in the RR. Note that national addenda relied on by the reference Member State should also be submitted.
• The RR should be updated with any new confirmatory data if “taken note” at in SCoPAFF after product approval in the reference Member State. The RR should then be updated with the evaluations conducted by the RMS of the active substance at the EU level and the risk assessment should be updated accordingly.

4. The complete data package used by the reference Member State

The complete data package used by the reference Member State, for both the active substance(s) and the product should be submitted. If necessary, documentation that shows access to such data should also be submitted. 

5. The GAP approved by the reference Member State and the Norwegian GAP 

The reference Member State’s GAP and the GAP for Norway should be submitted. Please note that an application for mutual recognition should be covered by the use approved in the reference member state (see section 2 above) 

6. Label and draft label

The finally approved label from the reference Member State should be submitted, together with a translation of the label to English or Scandinavian language. A Norwegian draft label should also be submitted. 

7. Composition statement and SDS  

A formal statement that the plant protection product is identical to that authorised by the reference Member State must be submitted.

The detailed complete composition shall be provided for all co-formulants. If the applicant does not have access to proprietary data of the co-formulants, the applicant must contact the supplier and ask them to submit the data directly to the competent authority.

A composition statement must:

• Include the trade name and manufacturer of the co-formulant.
• Account for 100% of the chemical compounds in the co-formulant.
• State the concentration, chemical name, and CAS no. and, if possible, function, for each compound
• State the degree of ethoxylation or propoxylation, if relevant
• Include information on unacceptable co-formulants listed in Annex III to Regulation (EC) No 1107/2009, e.g., residue levels of ethylene oxide for ethoxylated alcohols.

Safety data sheet (SDS) of the formulation and of active substances, safeners, synergist and co-formulants shall be provided. The revision date should be two years previous to the date of submission and must be compiled pursuant to Article 31 of Regulation (EC) No 1907/2006 as amended by Regulation (EC) No 453/2010, Regulation (EU) 2015/830 and Regulation (EU) 2020/878.

8. Reference list  

A reference list containing information on test and study reports attached to the application should be submitted, according to article 33.4 in the Regulation. The reference list should include the following information:

• For each test or study report the applicant has claimed data protection for, information listed in articles 8.1 f and 33.3 d must be submitted. 
• A statement confirming that the test or study report has not previously been covered by data protection, or that the test or study report is out of data protection, should also be submitted. 
• A confirmation whether the test or study report is compliant with the principles of good laboratory practice (GLP) or of good experimental practice (GEP) should be submitted. 
• For each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals should be made, articles 8.1 d and 33.3 c. 

The applicant will be given the opportunity to submit missing documentation after

• the completeness check (CC)
• the assessment of the ecotox and e-fate group
• the assessment of the remaining groups

The applicant will have 3 weeks after each of these steps to submit the requested information. The application will be rejected if it is found to be incomplete after these three steps.

See examples of frequent deficiencies

Procedural steps of the assessment of mutual recognitions in Norway: 

General requirements

The risk assessment must fulfil the national and zonal requirements and methodology specified in the Northern Zone Guidance applicable at the application date in Norway. In principle the assessment procedure of mutual recognitions should be a simplified process. Of this reason we do not accept or evaluate additional new studies which have not been evaluated or taken into account by the reference Member State (please see exemptions for bees in the section "*Environmental risk assessment"). However, the risk assessment should be updated to be in accordance with the methodology specified in the Northern Zone Guidance. This means that the product only will be approved if the risk is acceptable with the data/endpoints already evaluated in the original RR at the same time as the national and zonal requirements in the Northern Zone Guidance applicable at the application date in Norway are met.

If new data is necessary for approval of the product, the applicant should instead apply for approval of a new product according to article 33 in the Regulation.

As an EFTA state we are free to limit products containing active substances approved under Council Directive 91/414/EEC or the transitional measures in Article 80 of Regulation (EC) No 1107/2009 access to the market. These criteria will apply when assessing such substances.

Specific requirements for the different parts of the evaluation are given below.

Environmental risk assessment 

The environmental risk assessment (e-fate and ecotoxicological risk assessment) needs to address the general zonal and specific national requirements specified in the Northern Zone Guidance applicable at the application date in Norway. A safe use with these approaches should be demonstrated in the risk assessment.

Please note that there are specific Norwegian requirements for soil, groundwater and surface water modelling which must be fulfilled. If additional modelling is required, the risk assessment must be updated accordingly with PEC-values relevant for environmental conditions in Norway with accepted risk mitigation measures.

All focal species relevant for Norway needs to be included if a higher tier risk assessment for birds and mammals is required, as described in the guidance document on higher tier risk assessment for birds and mammals in the Northern Zone. The current version of the guidance document may be found here. (eng.mst.dk)

Data and risk assessment for bees as described in The Northern Zone Guidance will be required when the product originally was evaluated according to the data requirements in Commission Reg. (EU) No 284/2013. In these cases, we allow submission of additional studies when the original submission is not in accordance with the data requirements and the methodology in the Northern Zone. Product applications originally evaluated according to the data requirements in Commission Reg. (EU) No 545/2011, containing active substances approved under Council Directive 91/414/EEC or according to the transitional measures in the Regulation, will be assessed on a case-by-case basis and may be dismissed if available data (also from e.g. ongoing a.s. assessments or other product assessments) indicate unresolved or high risk to bees.

When field studies are included in the risk assessment, a justification of the relevance of the studies for Norwegian environmental conditions should be provided. Climate, persistence of the active substance and/or metabolites, the ecosystem’s ability to recover, species and life stage composition are examples of factors which may impact the outcome of a field experiment and may differ between different parts of Europe. Results from field studies not considered relevant to Norwegian conditions may be disregarded.

Residues  

A calculation of the risk for established MRLs to be exceeded when the product is used as suggested should be submitted. For outdoor use, the calculation shall only be based on results from residue trials performed within the Northern and Central Europe residue zone (NEU). For indoor use, one residue zone applies for all of the EU.

A compilation of the residue studies carried out within the Northern and Central Europe residue zone (NEU), corresponding to the use applied for, should be submitted unless included in the reference Member States’ registration report. The compilation shall include information on the application rate that has been used in the studies, the number of treatments and growth stage at application and at what pre-harvest intervals possible residues were measured.

Health hazard

The health risk assessment must fulfil the national and zonal requirements and methodology specified in the Northern Zone Guidance applicable at the application date in Norway. A safe use with these approaches should be demonstrated in the risk assessment.

In addition, the following should be considered:

• If field studies are used in the risk assessment, these must have been carried out under conditions relevant to Norway. This must be justified.
• A reduction in doses by application of higher dilutions of the product can be accepted, as long as this reduction will not increase the dermal absorption in such extent that this will result in an unacceptable exposure level.

A plant protection product can only be mutually recognised if it has been granted an authorisation in the reference Member State according to article 29 in the Regulation. The procedure of mutual recognition means that the authorisation holder of a plant protection product may apply for an authorisation for the same plant protection product, for the same use and under comparable agricultural practices in another Member State, according to Article 40.1. It is our understanding that this should be interpreted the following way:  

• “The same plant protection product” means identical in terms of: Manufacturing process and composition of the formulation; Sources of the technical active substance, safeners and synergists, as well as co-formulants. Please note that an equivalent product is not considered to qualify as being the same plant protection product. 
• “The same use” means that it is not possible to extend the use to additional crops other than those authorised by the reference Member State. It is however possible to limit the use to certain crops. 
• “Comparable agricultural practices” means that an authorisation through mutual recognition can only be granted based on the prerequisites and conditions adopted by the reference Member State. This means that the application technique and time of application cannot be changed. The number of applications and dose rates can be reduced if efficacy data, the risk through dermal exposure (please see in the section "Health hazard") and the test concentrations for each technical property still supports the change.

If anything is unclear, or you have a suggestion for making this guidance document better, please contact us at postmottak@mattilsynet.no.