4. Required documentation

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.