Japan Regulatory Services

Registration of Crop Health and Plant Nutrition Products in Japan

Plant health and nutrition products in Japan are regulated under the Agricultural Chemicals Regulation Act and approved if deemed safe in line with Good Agriculture Practice (GAP). Agrochemicals and biorationals are authorised strictly in accordance with their intended use, by specifying “application crop”, “application timing” and “application rate”. Farmers are only allowed to use plant protection products under the approved conditions of use.

Re-evaluation programme

Until recently, agrochemicals in Japan were subject to re-registration every three years. With time, the necessity for the regulatory plant protection reform in Japan became pressing,  as the market required more flexibility from the regulatory regime to integrate the latest scientific approaches and common agricultural practices. This was further accelerated by the widening gap between the regulatory requirements in Japan and new harmonised assessment guidelines increasingly applied internationally. Countering this, the Japanese government amended its Agricultural Chemicals Regulation Act on December 1st, 2018 by introducing a re-evaluation programme for active substances in the existing plant protection products.

The re-evaluation programme regulates the revision process by setting out clear timelines:

  • Plant protection products registered after enforcement of the amendment act require re-evaluation approximately every 15 years
  • Existing plant protection products are re-evaluated from 2021 according to a priority order.

Our Regulatory Services for Plant Health and Nutrition Products in Japan

Our experts offer full-scale scientific and regulatory services helping you register your crop protection products in Japan.  This also include support with all kinds of import tolerance applications and meeting the Japanese requirements for maximum residue levels (MRLs). For more details on Codex MRLs, visit our MRL website.

Our services at one glance:

  • Evaluating the adaptability of the existing data package to the Japanese guidelines for plant protection products
  • Examining the possibilities for read-across of available registration data authorised outside Japan
  • Designing, contracting all necessary studies at contract laboratories in and outside Japan best suited to your needs
  • Study monitoring and coordination
  • Preparing and submitting registration dossiers to the Japanese competent authorities
  • Compiling and submitting re-evaluation dossiers based on the Japanese “Shoroku” format
  • Generating and filing registration / re-evaluation dossiers based on non-Japanese dossier formats (e.g. EU, U.S.)
  • Liaising with and handling requests and comments by the Japanese authorities
  • Handling all kinds of import tolerance applications and MRL setting.

Don't hesitate to contact our experts to learn how we can help you register your products in Japan.