An Insight into China’s New Pesticide MRL Regulation (GB 2763-2021)

On September 3, 2021, China began enforcing its new pesticide MRL regulation, “GB 2763-2021”, consisting of 10092 MRLs for 564 pesticides in 13 main food categories. The transformation from GB 2763-2019 to GB 2763-2021 represents by far the greatest variance compare to previous updates since 2012m, as 81 pesticides and 2985 MRLs were newly added. Besides, 16 banned/ restricted pesticides have their MRLs developed/amended in line with the detecting limit covering all plant-derived food/prohibited crops, which brings greater influence on the food supply chain. By combining the ideas and comments from MoARA drafters and food quality inspectors, this paper tries to characterize the main features of GB 2763-2021 and offer practical advice to the food-related sectors.

Broader Coverage but Highlighted Priorities

Of all the 564 pesticides established with MRLs, 428 pesticides have been registered with MoARA, 49 pesticides have been banned or restricted and 87 pesticides have not yet been registered in China but widely used overseas, as well as other 44 low-risk pesticides exempted from MRL developing. the number of pesticides established with MRLs has already exceeded that of the CAC standard or the US regulation and approach to the EU regulation.

792 MRLs have been developed for 29 banned pesticides and 345 MRLs have been developed for 20 restricted pesticides. 16 pesticides have had MRL developed/revised down following the detecting limits referenced testing methods and universally applied on 12 categories of plant-derived food or prohibited crops. 1742 CAC MRLs for 87 unregistered pesticides have been evaluated and transformed into national MRLs in response to the increasing demand for imported food.

Excess pesticide residue in vegetables and fruits has long been a worldwide puzzle for the low availability of residue data due to the poor profitability for agrochemical companies. Since the reform of pesticide regulation in 2017, China MoARA has enforced concrete preferential policies to facilitate pesticide registration on minor crops including fruit, vegetables, Chinese medicinal plants and other cash crops, notably the waived field trial data for crop expansion, cost-sharing mechanism among different applicants and the fast-track process introduced last year. By 2021, 5766 MRLs have been developed for vegetables, fruits, and other fresh commodities, accounting for 57.1% of the MRLs in GB 2763-2021.

Main Changes and Background

194 existing MRLs of 46 pesticides in 106 food commodities have been modified owing to the availability of new trial data and risk assessment results, normalization of residue definition and the enforcement of new pesticide injunction/prohibition. 176 temporary MRLs of 17 pesticides have been modified into regular ones as a result of newly developed testing methods and 19 regular MRLs have been revised to temporary ones due to lack of competent testing methods.

It's important to note that 7 banned pesticides and 9 restricted pesticides have the whole-cover MRLs equivalent to the detecting limits of testing methods, consequently, some existing MRLs have been significantly revised down. For example, the MRL of Chlorpyrifos in head cabbage has been revised from 1 mg/kg to 0.02 mg/kg and expanded to brassica vegetables and that of Dimethoate in flower Chinese cabbage has been modified from 3 mg/kg to 0.01 mg/kg and extrapolated to all brassica vegetables, lowered by more than an order of magnitude.

To keep up with the latest scientific findings, GB 2763-2021 revised residue definition and Acceptable Daily Intakes (ADI) for 12 and 4 pesticides respectively, mainly adopted from the latest  JMPR opinions.

Considering the form and purpose of food commodities and the presence/absence of MRLs, 20 commodity names were added and 15 existing names were revised, which mostly involves dried vegetables, condiments, and medicinal plants.

7 standards for testing method were newly designated as the referenced standard for testing method and 4 existing standards were revised or removed as a result of technological upgrading and use of hazardous chemicals during test pretreatment.

Noteworthy Points in Observing GB 2763

If the pesticide was registered in China and the residue trial data satisfies the requirements for risk assessment and the testing method is available, a 15-year regular MRL can be established, otherwise, the MRL will be developed in the form of temporary MRL, which is valid for only 5 years. Nevertheless, not all the regular MRLs have been established with testing methods.

While the promulgation of GB 2763-2021, China enacted 4 method standards under the GB 23200 series, offering broad-spectrum solutions for over 1000 MRLs. These standards are not yet included in “Chapter II-Normative Reference” of GB 2763-2021, but they have the same enforceability as the listed referenced standards. The same goes in the future if other GB 23200 standards were newly enacted before the next update of GB 2763-2021.

GB 2763-2021 offers a hierarchical relationship for all food categories in its Annex A and one critical aspect is to determine the food commodities for group MRLs, a single tolerance value apply to multiple commodities in the same group. Hence, soybean oil enterprises should look at not only the MRLs for soybean oil but also the group MRLs for vegetable oils.

It should be noted that some categories/commodities have different classifications with other national food safety standards and common sense. For example, celery is sorted as leafy vegetables under GB 2763, but it is classified as stem vegetables under GB 2762, an MRL regulation for other food contaminants. Fresh goji berry is grouped into berries and other small fruits, while dried goji berry is classified as medicinal plants. Instead of belonging to vegetable or medicinal plants, agaric is classified as another parallel group called edible fungi.

GB 2763 may recommend more than one referenced standard for some MRLs, but it is for the testing institutions to select the correct method considering food classification and pesticide, as well as the performance parameters of the method, especially the detecting or quantitative limit. Take Acephate for example, the MRL in vegetables has been revised down from 1 mg/kg to 0.02 mg/kg, but GB 2763 also designated an agricultural standard NY/T 761 as one of the referenced standards, with a higher detecting limit of 0.03 mg/kg. If the NY/T 761 methodology was utilized for quality inspection, the result can never be recognized.

In general, GB 2763-2021 has relative comprehensive coverage on agricultural commodities and growers may apply GB 2763-2021 on final products directly, whereas MRLs for processed food are very scarce and food producers need to minimize the risk at the raw material sourcing stage, especially the commodities with lowered MRLs.

For years to come, China will continue its evolution of MRL regulation, but the increasingly standardized and transparent process can be harnessed to offer more prognoses. For instance, before each replacement of GB 2763 every 2 or 3 years, MOARA is scheduled to consult on new MRLs in a few batches specifying which MRLs will be added or revised and food enterprises may develop the strategy in advance.

Reference Links

Ebook: English Translation of GB 2763-2021 National Food Safety Standard-Maximum Residue Limits for Pesticide in Food

Ebook: GB 2763-2021 Restructuring Plus (by Food Commodity)