Today, food manufactures no longer produce their commodities only for local markets but export these worldwide. Most food manufacturers use locally approved pesticides, which are not necessarily approved for use in other markets of their choice. If such food treated with locally approved plant protection products is to be exported internationally, it needs to meet Maximum Residue Levels (MRL) accepted in target markets.
A maximum residue level (or limit) is “the highest amount of pesticide residue legally tolerated in or on food or feed when pesticides are applied correctly (Good Agricultural Practice)”. The residue levels remaining in food must be safe for consumers and as low as possible.
In the EU, the basic rules for MRL setting are stipulated in Regulation (EC) No 396/2005. Many countries worldwide rely on the Codex Alimentarius MRLs for a wide variety of pesticides. The Codex Alimentarius Commission (CAC) is an intergovernmental body to implement the Joint FAO/WHO Food Standards Programme and is responsible for setting up Codex MRLs.
Therefore, it is essential to rely on internationally recognised and accepted MRLs (Codex MRLs) in order to reduce trade barriers and enable worldwide trade of safe products. The setting of Codex MRLs could allow internationally produced and traded food to enter foreign markets, even if the compound does not yet have approval in the target markets.
Over decades, we have been successfully handling all kinds of MRL applications, including applications for crops traded within the EU, applications for imported products to meet the level of international trade, such as import tolerance applications, as well as setting worldwide MRLs, e.g. Codex Alimentarius MRLs.
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Plant protection 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.
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:
Import tolerance is a system used to set maximum residue levels (MRL) in agricultural products for plant protection products not registered in Japan and entering the market. Any agricultural product imported to Japan, where non-approved plant protection products have been applied too, needs to meet MRL setting in Japan.
Japan has adopted a positive list system, with MRL being set to 0.01 ppm if there is no specific request for MRL setting from applicants, such as importers, food manufactures and agrochemical companies. Applicants can request setting a specific Japanese MRL based on the “Guideline for Application for Establishment and Revision of Maximum Residue Limits for Agricultural Chemicals used outside 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).
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