Pesticide Assessment Report

March 24, 2016, 134th Review Coordinators Meeting, Pesticides Expert Committee

Glyphosate Assessment Report (draft)

Document 4

(Draft)

Pesticide Assessment Report

Glyphosate

March 24, 2016 Pesticides Expert Committee, Food Safety Commission of Japan

Contents
Page

3

6

7

1. Summary of subject pesticide 11

2. Summary of assessment of glyphosate (1) 14

3. Summary of assessment of glyphosate (2) 15

4. Summary of assessment of glyphosate (3) 16

5. Summary of assessment of glyphosate (4) 16

6. Summary of assessment of glyphosate (5) 17

7. Summary of studies related to residues in livestock products 18

(1) Animal metabolic fate test in livestock 18

(2) Residues in livestock products test 18

(3) Definition of residue: Substance for dietary exposure evaluation in livestock products 18

8. Assessment by international organizations, etc. (carcinogenicity) 18

(1) Assessment by IARC 18

(2) Assessment by EFSA 18

9. Overall assessment 20

- Matters concerning soft drinks -

July 1, 2003: Request by the Minister of Health, Labour and Welfare on Assessment of the Effect of Food on Health concerning the revision of the standard for soft drinks (Shoku-An No. 0701015, Safety Division, Department of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare)
July 3, 2003: Receipt of relevant documents (Reference (1)-(5) 1)
July 18, 2003: 3rd Meeting of Food Safety Commission of Japan (explanation on requested matters)
October 8, 2003: Receipt of additional documents (Reference (1)-(5) 2)
(Identification of 93 requested pesticides including glyphosate)
October 27, 2003: 1st Meeting of Pesticides Expert Committee
January 28, 2004: 6th Meeting of Pesticides Expert Committee
January 12, 2005: 22nd Meeting of Pesticides Expert Committee
April 9, 2013: Withdrawal by the Minister of Health, Labour and Welfare on Assessment of the Effect of Food on Health concerning the revision of the standard for soft drinks (Shoku-An 0409 No. 1, Department of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare), and receipt of relevant documents (Reference (1) 13, (2)(3) 15, (4)(5) 11)
April 15, 2013: 471st of Food Safety Commission of Japan (explanation on withdrawal)
- Matters concerning the positive list system -
September 22, 1980: First agricultural chemical registration
November 29, 2005: Notification concerning Maximum Residue Limits (Reference 3)
December 19, 2008: Request concerning the establishment of import tolerance (recombinant soybean) ²⁾
February 15, 2010: Request by the Minister of Health, Labour and Welfare on Assessment of the Effect of Food on Health concerning the establishment of the maximum residue limit (Shoku-An 0215 No. 80, Department of Food Safety, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare)
February 16, 2010: Receipt of relevant documents (References (1) 4, 5, (2)-(4) 4-6, (5) 4)
February 18, 2010: 320th Meeting of Food Safety Commission of Japan (explanation on requested matters)
March 10, 2010: Request concerning the establishment of import tolerance (recombinant maize) ²⁾
April 7, 2010: Request concerning the establishment of import tolerance (adzuki beans, grapes and sugar beets) ¹⁾
May 17, 2010: Receipt of additional documents (Reference (1) 6-8, (2) 7, 8)
June 18, 2010: Contact from the Ministry of Agriculture, Forestry and Fisheries to the Ministry of Health, Labour and Welfare concerning application for pesticide registration and request for the establishment of the standard (New: wheats, cabbages, etc.) ⁵⁾
June 24, 2010: Receipt of additional documents (Reference (5) 6, 7)
June 21, 2010: Request by the Minister of Agriculture, Forestry and Fisheries on Assessment of the Effect of Food on Health concerning the establishment of the maximum residue limit in feed (22 Sho-an No. 2702, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries)
June 22, 2010: Receipt of relevant documents (Reference (1)(2) 9, 10, (3)(4) 7, (5) 5)
June 24, 2010: 337th Meeting of Food Safety Commission of Japan (explanation on requested matters)
October 13, 2010: 2nd meeting, Assessment Subcommittee 4, Pesticides Expert Committee¹⁾
October 22, 2010: 3rd meeting, Assessment Subcommittee 1, Pesticides Expert Committee²⁾
November 2, 2010: 3rd meeting, Assessment Subcommittee 4, Pesticides Expert Committee³⁾
November 17, 2010: 4th meeting, Assessment Subcommittee 3, Pesticides Expert Committee⁴⁾
December 22, 2010: 4th meeting, Assessment Subcommittee 1, Pesticides Expert Committee⁵⁾
April 5, 2011: Receipt of additional documents (Reference (1) 11-13)
August 8, 2011: Receipt of additional documents (Reference (2) 11-13)

November 9, 2011: Receipt of additional documents (Reference (4) 9, 10)

November 14, 2011: Receipt of additional documents (Reference (5) 9, 10)
December 4, 2012: Receipt of additional documents (Reference (3) 9-11)
December 20, 2012: 23rd meeting, Assessment Subcommittee 4, Pesticides Expert Committee ³⁾
February 7, 2013: Request concerning the establishment of import tolerance (recombinant canola) ²⁾
February 12, 2013: Receipt of relevant documents (Reference (2) 14)
February 26, 2015: Receipt of additional documents (Reference (3) 12, 13)
March 19, 2015: 43rd meeting, Assessment Subcommittee 4, Pesticides Expert Committee ³⁾
January 27, 2016: Request concerning the establishment of import tolerance (cottonseed, sunflower, etc.) ¹⁾
January 28, 2016: Receipt of additional documents (Reference (1) 14, 15)
February 8, 2016: 133rd Review Coordinators meeting, Pesticides Expert Committee
March 24, 2016: 134th Review Coordinators meeting, Pesticides Expert Committee
^1-5): Respectively concerning glyphosate (1)-(5)