G/SPS/N/JPN/607  
 
19 December 2018  
(18-8031) Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
1. Notifying Member: JAPAN  
If applicable, name of local government involved:  
2. Agency responsible: Ministry of Health, Labour and Welfare (MHLW)  
3. Products covered (provide tariff item number(s) as specified in national 
schedules deposited with the WTO; ICS numbers should be provided in addition, 
where applicable):  
 Meat and edible meat offal (HS Codes: 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 
02.07 , 02.08 and 02.09)  
 Dairy produce and birds' eggs (HS  Codes: 04.01, 04.07 and 04.08)  
 Animal origi nated products (HS Code: 05.04)  
 Edible vegetables and certain roots and tubers (HS Codes: 07.01, 07.02, 07.03, 
07.04, 07.06, 07.08, 07.09, 07.10, 07.13  and 07.1 4) 
 Edible fruit and nuts, peel of citrus fruit (HS Codes: 08.03, 08.04, 08.05,  08.08, 08.10, 
08.11 and 08.14)  
 Coffee and spices (HS Codes: 09.01, 09.04, 09.05, 09.06,  09.07, 09.08, 09.09 and 
09.10)  
 Oil seeds and oleaginous fruits, miscellaneous grains, see ds and fruit (HS Codes: 
12.01, 12.02, 12.06, 12.07 and 12.12)  
 Animal fats and oils (HS Codes: 15.01, 15.02 and 15.06)  
4. Regions or countries likely to be affected, to the extent relevant or practicable : 
[X] All trading partners  
[ ] Specific regions or countries:  
5. Title of the notified document: Revision of the Standards and Specifications for Foods 
and Food Additives under the Food Sanitation Act (Revision of agricultural chemical 
residue standards) . Language(s): English.  Number of pages: 3 
https://members.wto.org/crnattachments/2018/SPS/JPN/18_6521_00_e.pdf  
6. Description of content: Proposed maximum residue limits (MRLs) for the following 
agricultural chemical:  
Pesticide: Fluazifop -butyl.  
7. Objective and rationale: [X]  food safety, [  ] animal health, [  ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [  ] protect territory from 
other damage from pests .  
8. Is there a relevant international standard? If so, identify the standard:  
[X] Codex Alimentarius Commission (e.g.  title or serial number of Codex 
standard or related text) : Pesticide Residues in Food and feed - pesticide Index 
- 283 - Fluazifop -butyl G/SPS/N/JPN/607  
 
- 2 - 
 
  [ ] World Organization for Animal Health (OIE) (e.g.  Terrestrial or Aquatic 
Animal Health Code, chapter number) :  
[ ] International Plant Protection Convention (e.g.  ISPM number) :  
[ ] None  
Does this proposed regulation conform to the relevant inter national standard?  
[ ] Yes   [X] No  
If no, describe, whenever possible, how and why it deviates from the 
international standard:  
Soybeans, dry, onion and garlic  
The dietary exposure of fluazifop -butyl estimated by using the STMR of the supervised 
residue  trials submitted to the JMPR and national food consumption data of these 
commodities would exceed an ADI of 0.0044 mg/kg bw/day which was set by the Food 
Safety Commission of Japan (FSC). Therefore, the Ministry of Health, Labour and Welfare 
of Japan (MHL W) has decided to set the MRLs for these commodities based on the residue 
data from the USA or domestic supervised residue trials.  
Sugarcane, lettuce (including cos lettuce and leaf lettuce), apple, quince, nectarine, 
apricot, japanese plum (including prun e), cherry, other berries, grape, other fruits pecan, 
almond, walnut and other nuts  
The dietary exposure of  fluazifop -butyl estimated by using the STMR of the supervised 
residue trials submitted to the JMPR and national food consumption data of  these 
commodities would exceed an ADI of 0.0044 mg/kg bw/day which was set by the FSC. 
Therefore, the MHLW has decided to maintain the current MRLs (i.e. the uniform limit of 
0.01 ppm) in these commodities.  
Milk 
The dietary exposure of fluazifop -butyl estimated by using the STMR of the supervised 
residue trials submitted to the JMPR and national food consumption data of milk would 
exceed an ADI of 0.0044 mg/kg bw/day which was set by the FSC. Therefore, the MHLW 
has decided to set the MRL for milk based on the resid ue data estimated from the domestic 
maximum dietary burden (MDB).  
Loquat (Pome fruits)  
The portion of commodities to which MRLs apply and which are analyzed are different 
from that of Codex for some commodities such as loquat. The portion of the commodity 
to which is analyzed in Japan is "whole commodity after removal of stems, skins and 
stones", while that of Codex is "whole commodity after removal of stems". As such, Japan 
has decided to delete the current MRL in loquat because information necessary for s etting 
MRLs (i.e. the use of this pesticide and residue trial data for such commodities) is not 
available, and the uniform limit (0.01 ppm) will be applied to loquat.  
Peach (Stone fruits)  
The portion of commodities to which MRLs apply and which are analyze d are different 
from that of Codex for some commodities such as peach. The portion of the commodity 
to which is analyzed in Japan is "whole commodity after removal of skins and stones", 
while that of Codex is "whole commodity after removal of stems and sto nes". As such, 
Japan doesn't set MRL in peach because information necessary for setting MRL (i.e. the 
use of this pesticide and residue trial data for such commodities) is not available.  
9. Other relevant documents and language(s) in which these are available: Food 
Sanitation Act (available in English). When adopted, these MRLs are to be published in 
Kampo (Official Government Gazette) (available in Japanese).   
10. Proposed date of adoption (dd/mm/yy) : As soon as possible after the final date for 
the comment period.  G/SPS/N/JPN/607  
 
- 3 - 
 
  Proposed date of publication (dd/mm/yy) : As soon as possible after the final date 
for the comment period.  
11. Proposed date of entry into force: [  ] Six months from date of publi cation , 
and/or  (dd/mm/yy) : These proposed standards will take effect after a certain period 
of grace.  
[ ] Trade facilitating measure  
12. Final date for comments: [X]  Sixty days from the date of circulation of the 
notification and/or (dd/mm/yy) : 17 February 2019 . Comments only to updated MRLs 
(marked with black circles and white circles in attached annexes).  
Agency or authority designated to handle comments: [  ] National Notification 
Authority, [X]  National Enquiry Point. Address, fax number and e -mail address 
(if available) of other body:  
13. Text(s) available from: [  ] National Notification Authority, [X]  National Enquiry 
Point. Address, fax number and e -mail address (if available) of other body:   
Japan Enquiry Point  
International Trade Division Economic Affairs Bureau Ministry of Foreign Affairs  
Fax: +(81 3) 5501 8343  
E-mail: enquiry@mofa.go.jp