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Frequent deficiencies in mutual recognition applications

Published

General

  • Tables in all B sections shall be in an editable format.
  • All relevant endpoints shall be mentioned in the B section, a reference to EFSA LoEP is not sufficient.
  • Explanations and conclusions on the risk assessments shall be given in all B sections.
  • The risk assessment must fulfil the national and zonal requirements and methodology specified in the Northern Zone Guidance Document applicable at the application date in Norway.
  • The application must comply with restrictions in the Commission Implementing Regulation for the active substance.
  • Relevant data gaps identified in the EFSA conclusion shall be addressed.
  • Annex II and Annex III studies shall be submitted in a manageable format and shall include all studies used in the assessment.

Physical and chemical properties (Section Part B 1,2,4)

  • If it is mandatory for the product to be in a tank-mix, this shall be clear in column 14 in the GAP table, and the tank mix shall be a part of the product evaluation.
  • The test concentration for dilution stability, emulsion stability, dispersion characteristics, persistent foam and suspensibility should cover the lowest and/or highest recommended use rates in the GAP.
  • If the formulation is to be applied via a trigger sprayer, then the satisfactory operation on the trigger sprayer, herein spray pattern, prior to, during – if applicable – and after storage shall be demonstrated.
  • If the product is formulated in flexible packs, a stacking test shall be performed. The stacking undertaken must reflect those encountered in commercial practice.
  • Test for explosive, oxidizing and corrosive properties shall be performed, unless a waiving in line with CR (EU) No 1272/2008 is presented.
  • If chemical and physical compatibility of a tank mixing partner is based on evidence from a field study evaluated in the efficacy section of the (d)RR, then a reference to this efficacy study, should be included in the Phys-Chem section under annex point 2.9. An explanation to justify that the efficacy study is relevant for the actual real-life operating conditions should be provided, e.g., taking into consideration the differences in time scale between the efficacy study and actual real-life application. The ambient temperature stability test is required before authorisation may be granted; The packaging type and size used in the stability test must be representative of the intended commercial packaging.
  • Packaging intended for use shall be fully described and specified in terms of the materials used, shape and dimensions, size of opening, type of closure and seals, manner of construction, and UN/ADR compliance.

Analytical methods (Section Part B5)

  • All analytical methods, both for active substance and impurities, shall be validated in accordance with SANCO/3030/99 rev.5 and the requirements shall be fulfilled and described.

Mammalian Toxicology (Section Part B6)

  • Dermal absorption values shall be recalculated in accordance with EFSA Journal 2017;15(6):48731.
  • If it is mandatory for the product to be in a tank-mix, this shall be clear in the B6 section and the tank mix shall be a part of the product evaluation.
  • With respect to cases in which an inhalation study has not been submitted, please note that we do not support the pre-evaluation approach specified in Appendix VIII in version 10.0 of the Northern Zone Guidance Document (NZGD). According to our national requirements in appendix IV (summary of national requirements) of the NZGD, we do not per default request an acute inhalation study: “Until a change in condition i) of the data requirement for inhalation toxicity of Regulation (EU) No 284/2013 has been made, or a harmonised EU interpretation of this condition has been established, an acute inhalation toxicity study should be required according to the old data requirement on testing for inhalation toxicity (Regulation (EU) No 545/2011)”. According to the old data requirements an acute inhalation study may not be needed when taking into account information provided on the size distribution of the particles/droplets. Consequently, in order to cover our national requirements with respect to inhalation toxicity, information concerning the size distribution of the particles/droplets should be provided when no inhalation study has been submitted.

Environmental fate (Section Part B8)

  • In-/output files for modelling in line with requirements specified in the applicable Northern Zone Guidance Document must be submitted.

Assessment of substances in soil:

  • The input must be in accordance with the applicable Northern Zone Guidance Document.
  • PECmax and PECacc must be reported for all active substances and metabolites.

Assessment of substances in groundwater and surface water:

  • PECgw national requirements must be fulfilled.
  • PECsw national requirements must be fulfilled.
  • The modelling endpoints should be identical to the endpoints used in the assessment by the reference MS.
  • Application dates used for risk assessment must cover the application time specified in the GAP.

Ecotoxicology (Section Part B9)

General

  • An assessment of the cumulative risk must be performed according to the Northern Zone Guidance Document for the concerned non-target species if the PPP contains more than one active substance.

  • Risk assessments must be performed for all relevant metabolites in the various compartments (soil, water, sediment).
  • When field studies are included in the risk assessment, a justification of the relevance of the studies for Norwegian environmental conditions should be provided.

Birds and mammals:

  • Higher tier risk assessments must be performed according to the Northern Zone Birds and Mammals Guidance Document.

Aquatic organisms:

  • Both a risk assessment with the single substances and a cumulative risk assessment needs to be performed with all relevant FOCUS scenarios required in Norway.
  • Risk assessment based on detailed FOCUS exposure profiles is not accepted in the Northern Zone.
  • The risk assessment must be conducted with risk mitigation measures accepted in Norway.
  • Only ETO-RAC from micro/mesocosm studies is accepted.  

Soil meso- and macrofauna:

  • Endpoints must be corrected by a factor of 2 if the log Kow is greater than 2, also if the toxicity tests are performed with soil containing less organic matter than 10%, unless it can be demonstrated by soil sorption data or other evidence that the toxicity is independent of organic carbon content in soil.

Arthropods other than bees:

  • If a higher tier risk assessment is triggered, studies on a sufficient number of species must be submitted according to the data requirements.
  • The VDF specified in the Northern Zone Guidance Document must be used.

Bees:

  • All toxicity data for bees required according to the data requirements set in Regulation (EC) 284/2013 must be submitted when the evaluation originally was carried out according to these requirements in the reference Member State. The risk assessment must then be performed according to the Northern Zone Guidance Document.

Confidential information (Section Part C)

  • All relevant impurities in the product shall be addressed in section Part C.
  • The co-formulants, i.e., the tradename, corresponding to those used in product batches for which a complete risk assessment was performed and relied on should be highlighted in bold.
  • The detailed complete (100 %) composition shall be provided for all co-formulants, including those defined as substances
  • Up-to-date safety data sheets (SDS) pursuant to Article 31 of Regulation (EC) No 1907/2006 as amended by Regulation (EC) No 453/2010 shall be provided.
  • A description of the formulation process shall be provided.