International Regulations on Chemical Residues

Japan

Important changes to Japanese Government regulations on chemical residues

Japan's Ministry of Health Labour and Welfare (MHLW) will change the way it regulates residues of agricultural chemicals and veterinary medicines from 29 May 2006. The current Japanese law only enables the Ministry to act against residues found to be above prescribed levels (maximum residue limits or MRLs) for approximately 283 chemicals. This approach will change to one where residues of all agricultural chemicals and veterinary medicines are regulated, therefore, a positive list will be put in place.

From the 29 May 2006 two separate listings for residues of agricultural and veterinary chemicals will come into effect with the combination of both forming the 'Positive List'. To obtain the full listing of MRLs for 799 chemicals that will apply after 29 May, you will need to look at both the existing MRLs and the provisional MRLs concurrently.

Details of the new system were published in the Japanese Government Gazette, Kampo on 29 November 2005 and an English [1] translation of the full list of MRLs was made available on 28 February 2006. Details of the English translation of the Japanese official documents on provisional MRLs are now available via the MHLW website.

The new regulations include:

  • a 'MRL List' which details existing MRLs, including the 41 chemicals that have no new provisional MRLs
  • a 'Provisional MRL List' that details new "provisional" (though legally binding) MRLs for 743 chemicals
  • 15 chemicals - the residues of which are not to occur in food
  • MRLs for 75 chemicals in certain [2] processed foods (other processed food-chemical combination MRLs are calculated from their ingredients’ MRLs)
  • 65 substances (vitamins, minerals etc) which are exempt
  • adoption of WHO residue standards for bottled water and
  • a default MRL for all other chemicals of 0.01 ppm (ie.10 ppb).

The provisional MRLs are based on Codex standards or withholding limits that are already Japanese law. If these do not exist, the MHLW has referred to certain [3] MRLs established in Australia, Canada, the European Union, New Zealand and/or the United States. The provisional MRLs will be reviewed over coming years and ongoing change is expected.

If imported foods are found with residues above the relevant Japanese MRL, the MHLW will increase its own monitoring to 50 per cent of all shipments of that commodity from the source (usually a whole country for unprocessed or semi-processed products). If a second breach is detected 100 per cent testing becomes mandatory (at the trade's expense) and all shipments will be held in bond pending the results. This requirement would remain in place until the ministry is convinced that further breaches will not occur.

The Japanese Agricultural Chemical Residues in Foods website is more user friendly but the site owners (FCG Research Institute, Fuji Television Merchandise Research Centre) do not vouch for its accuracy. Japan's existing MRLs can be found at the The Japan Food Chemical Research Foundation website.

Stockfeed MRLs

In response to the adoption of a positive list approach in food by the MHLW, Japan's Ministry of Agriculture, Forestry and Fisheries is amending its residue requirements for feeds and feed additives. The amended MRLs for 60 agricultural chemicals in feed and feed additives and aflatoxin in cattle, pig and chicken feed are expected to be implemented on 29 May 2006 to coincide with the new food regulations.

Information on Australia's system for managing chemicals

The Department has prepared an overview of Australia's national system for managing agricultural and veterinary chemicals in Japanese and English. This document can be provided to Japanese importers in response to any enquiries on regulation and use of agricultural and veterinary chemicals in Australia. the Department has also prepared a document which details how Australian exports will meet Japan's positive list.

Please feel free to widely distribute these documents and provide to importers in response to any enquiries on regulation and use of agricultural and veterinary chemicals in Australia.

Further information

About Japan's changes to regulations on chemical residues contact the Food Safety Branch in the Product Integrity, Animal & Plant Health (PIAPH) Division by phoning (02) 6272 5507.

[1] Even though the PDF PDF Icon documents will be in English, you may need to download an Asian language pack (Japanese) for Adobe Reader to read them.

[2] Most are cereal fractions, oils or dried fruits

[3] Only MRLs which are based on risk assessments conducted to international standards.