Import Tolerance Japan
Positive list system set in Japan in 2006, and crop residue in all imported food should be less than MRLs or import tolerances. Otherwise they cannot be sold in Japan. If no standard is set, default of 0.01ppm is applied. This is important for pesticide companies who are planning pesticide registration in food export countries to Japan. I would like you to take it into account that Japan imports various foods/crops from the world. And authority checks pesticide residues at about 10% of imported food. Joy Consulting Ltd. helps you who intend to set import tolerance in Japan.

Japan Import Tolerance , system
  • Import Tolerance (IT) is set on ADI/ARfD
  • IT is introduced from MRL set in foreign countries (f-MRL).
  • Total Japanese MRLs and IT should be <80% ADI occupation
  • TDI:Tolerable Daily Intake should be <100%ARfD

ADI/ARfD
  • If ADI/ARfD of your pesticide is not established in Japan, you need tox data to set them in Japan first.
  • If ADI/ARfD of your pesticide is established in Japan, and your tox data is same as those used for Japanese ADI, you submit just submit the list of data, summary reports (Japanese Shoroku, Tier II summary).
  • If your data is not same as already submitted Japanese data, a another set of tox data and summary report (Shoroku) should be submitted for ADI setting.
  • In case of partially different, those different part of data and amended Shoroku should be submitted.

Data requirement for import tolerance
  • IT is introduced from MRL set in foreign countries (f-MRL).
  • So MRL should be established somewhere in the world.
  • MRL is not necessarily of crop production country.
  • If MRL is established in EU using Philippine crop residue trial data, we can use it for Japanese IT.

Schedule of IT setting
  • Dossier preparation 6 months
  • ADI set after dossier submission: 8 months
  • IT set after ADI set: 1.5 year
Joy Consulting Ltd. helps you to set Import tolerance in Japan.
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