Interpreting the GB 2763-2019 and Forecasting China’s Pesticide MRLs Regulation

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China is making steady progress toward the goal of 10,000 statutory pesticide MRLs by the end of 2020 and animal-derived food and specialty agricultural products will be developed with more MRLs. In the future MRL system, how will China maintain its healthy trade of agricultural products and the supply of affordable and safe food for its citizens?

 Interpreting the GB 2763-2019 and Forecasting China’s Pesticide MRLs RegulationOn 15 Aug 2019, the National Health Commission, the Ministry of Agricultural and Rural Affairs and the State Administration of Market Regulation jointly issued the “GB 2763-2019 National Food Safety Standard: Maximum Residue Limits of Pesticides in Foods”, which will take effect on 15 Feb 2020. The one major new feature in this release is that the number of MRLs in GB 2763-2019 for the first time exceeds those developed by Codex Alimentarius Commission (CAC standard), the most universally recognized pesticide MRL standard in the world, marking another new step forward in food safety and agricultural trade. In this article, we will explain the evolution if this regulation and introduce its main features based on comparative analysis, sharing some prospects on the future trend of China's pesticide MRL regulation.

Numbers of MRLs for Food Categories Specified by GB 2763-2019

Recent Updates

In the past, the former Ministry of Health (now referred to as NHC) was mainly responsible for developing pesticide MRLs in the form of food hygienic safety standards, while the Ministry of Agriculture (now referred to as MoARA) also developed a series of MRLs as quality standards for agricultural commodities. Until 2009, China enacted the Food Safety Law and MoA was designated to develop pesticide MRLs and relevant testing methods. The ministry began to organize the previously disparate MRLs and released the first unified MRL regulation,  GB 2763-2012, which has then been revised amost every 2 years:

Development of GB 2763 Series: a Full Timeline

Code

year of issue

Number of Pesticides

Number of MRLs

GB 2763-2012

2012

322

2293

GB 2763-2014

2014

387

3650

GB 2763-2016

2016

433

4140

GB 2763-2018 (supplement to GB 2763-2016)

2018

43

302

GB 2763-2019

2019

483

7107

Key Features and Implications

Compared to its predecessor, 2967 MRLs were newly added, most of which were for common diet commodities including cereals (306 MRLs), vegetables (780 MRLs), fruits (641 MRLs) and animal-derived food (660 MRLs) and their percentages in total food categories were 14.6%, 31.9%, 26.1% and 9.9% respectively. Furthermore, 28 existing MRLs were later due to the newly obtained trial data or redefined pesticide residue.

Notably, 27 animal-derived food have been developed with 703 MRLs of 109 pesticides, almost septupled than 3 years ago, which signifies China’s priority in MRL development has turned from plant-sourced food to animal-derived food such as meat, eggs and dairy products, etc. Second, the number of MRLs for minor crops also doubled from 804 to 1602, most of which are for specialty agricultural products, such as red bayberry, ginseng and Chinese date, etc. These safeguards are expected to facilitate China's agricultural quality improvement through the rational use of agricultural inputs.

The national standard combined haloxyfop-methyl and haloxyfop-P-methyl as the same pesticide and 51 new pesticides were added. 11 low-risk pesticides were added as the “Pesticides Exempted from Developing Food MRL”. The scope of GB 2763 can basically satisfy the commitment that all pesticides registered in China have been developed with MRL. As the MoARA has cleared its preferential policies for biopesticides after its pesticide regulatory reform, especially in the “data requirements on pesticide registration” and more biopesticides are expected to be exempted from MRL development after a thorough scientific assessment. Additionally, the high-risk pesticides are new received specific and differentiated treatment: GB 2763-2019 contains 585 MRLs for 27 prohibited pesticides and 311 MRLs for restricted pesticides.

Pesticide Active Ingredients Newly Developed with Chinese MRLs

No

Generic Name

Number of MRLs

1

2, 4-D-dimethylamine

3

2

MCPA-dimethylammonium

1

3

Picloram-tris(2-hydroxypropyl )ammonium

1

4

Amicarbazone

2

5

Benzovindiflupyr

9

6

Metrafenone

26

7

Topramezone

2

8

Penthiopyrad

44

9

Isopyrazam

14

10

Propyrisulfuron

2

11

Pyridaphenthion

1

12

Napropamide

2

13

Dichlobenil

18

14

Cyflumetofen

10

15

Tebuthiuron

1

16

Dufulin

3

17

Flurtamone

1

18

Furan tebufenozide

1

19

Triflusulfuron-methyl

1

20

Flumetralin

1

21

Flufenacet

1

22

Sedaxane

11

23

Fluxapyroxad

26

24

Silthiofam

1

25

Quizalofop-P-tefuryl

2

26

Streptomycin sesquissulfate

1

27

Aminocyclopyrachlor

4

28

Chloroisobromine cyanuric acid

4

29

Fenamidone

28

30

Imazapyr

13

31

Pyriminobac-methyl

2

32

Dazomet

2

33

Metazosulfuron

2

34

Cycloxydim

30

35

Thiediazole copper

2

36

Thiencarbazone-methyl

2

37

Pyridalyl

1

38

Tralkoxydim

1

39

Phenazino-1-carboxylic acid

2

40

Bispyribac-sodium

2

41

Tetraconazole

2

42

Methoprene

1

43

Meptyldinocap

5

44

Bronopol

2

45

Moroxydine hydrochloride

1

46

Disulfoton

7

47

Bupirimate

1

48

Ethofumesate

1

49

Isoxaflutole

5

50

Amisulbrom

2

51

Ipconazole

3

To ensure the scientific and reasonable use of the data aimed for dietary risk assessment, GB 2763-2019 redefined the residue substances of 6 pesticides and modified the Acceptable Daily Intake values of 21 pesticides, most of which were from the residue trial data and FAO/WHO JMPR’s final conclusion.

Redefined Pesticide Residues and Modified Pesticide ADIs

No.

Active ingredient

GB 2763-2016

GB 2763-2019

Pesticide Residue Definition

1

2,4-D-ethylhexyl

The sum of 2, 4-D-ethylhexyl and 2, 4-D, expressed as 2, 4-D

The sum of 2, 4-D-ethylhexyl and 2, 4-D, expressed as 2, 4-D-ethylhexyl.

2

Abamectin

The sum of Abamectin Bla and Abamectin Blb

Abamectin Bla.

3

Prothioconazole

Desulfurized metabolite of Prothioconazole, expressed as Prothioconazole

desulfurized Prothioconazole

4

Fipronil

The sum of Fipronil, MB46513, MB46136 and MB 45950, expressed as Fipronil

the sum of Fipronil, Fipronil-desulfinyl; Fipronil-sulfone and Fipronil-sulfide, expressed as Fipronil.

5

Emamectin benzoate

The sum of Emamectin benzoate Bla and Emamectin benzoate Blb

Emamectin benzoate Bla.

 

6

Zinc thiazole

thiadiazole

2-amino-5-ryukyl-1, 3, 4-thiadiazole.

Pesticide ADI(mg/kg bw)

1

Abamectin

0.002

0.001

2

Fluazifop and Fluazifop-P-butyl

0.0074

0.004

3

Prothioconazole

0.05(Prothioconazole)

0.01(desulfurized Prothioconazole)

4

Isoprothiolane

0.016

0.1

5

Pendimethalin

0.03

0.1

6

Quinclorac

0.3

0.4

7

Flonicamid

0.025

0.07

8

Triflumizole

0.035

0.04

9

Imazamox

9

3

10

Trinexapac-ethyl

0.32

0.3

11

Fenazaquin

0.005

0. 05

12

Imazethapyr

2.5

0.6

13

Triforine

0.02

0.03

14

Cyazofamid

0.17

0.2

15

Fosetyl-aluminium

3

1

16

Lufenuron

0.015

0.02

17

Metaldehyde

0.01

0.1

18

Mesotrione

0.01

0.5

19

Acetochlor

0.02

0.01

20

Pinoxaden

0.3

0.1

21

Thiophanate-methyl

0.08

0.09

Of all the 2941 overlapped MRLs(which refers to a MRL that targets the same pesticide in the same food commodity) with the CAC standard, 90% were found to be equal to or tighter than those developed by CAC, including 1109 MRLs for 77 pesticides not yet registered in China but widely used overseas. GB 2763 can satisfy the safety supervision of imported food while maintaining compatibility with  internationally accepted practices.

Chinese Characteristic PLS Management

Both Japan and Korea have implemented the Positive List System (PLS): an extremely low limit will be uniformly (excepting the “exempted substance”) adopted on pesticides/commodities not yet established with statutory MRL, especially imported food. Whereas, when commodities are exported to other countries, the international MRLs (CAC standard) or statutory MRLs developed by the export destination will be adopted. Such “double-standard” can be an excellent way to expand profits from the international market and protect domestic agriculture, but may not help to minimize trade protectionism or contribute to affordable and higher quality food. Although Japan is one of the top developed countries in the world, a historical high Engel Index (percentage of food expenditure in total expenditure) of 26 was recorded in 2016. The figure is more than twice as the US and almost the same with China, who has only a quarter of Japan’s per capita income but a country currently facing many issues such as economic transition, income pyramid, as well as the backward situation in agricultural practice and quality management.

In recent years, MoARA agronomists have made a comprehensive study on the PLS and a 4-component MRL system is expected to be gradulay established in the future:

  1. General MRLs-MRL developed for general pesticides/commodities;
  2. Exempted Pesticides-Low risk biochemical pesticides, microbial pesticides and botanical pesticides designated after thorough scientific review;
  3. Uniformed MRLs-pesticide/commodity not yet developed with statutory MRL (Priority: pesticide used overseas but not yet registered in China, the most MRL-deficient food commodities and group MRL for certain pesticide or commodities);
  4. MRLs for imported food

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English Translation of GB2763-2019

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