Guidelines of MRLs Setting and Risk Assessment in China

15. Oktober 2015

Ministry of Agriculture (MoA) issued “Announcement No.2308” on October 8 in 2015, which releases Chinese guideline for risk assessment of residues in food and setting MRLs in food. These two guidelines are the first two technical guideline documents for processing of evaluation of pesticides residues and establishment of MRLs which are not existing in accordance with New Food Safety Law that came into force on October 1 in 2015.

Key points of these two guidelines are summarized below.

Guideline for Risk assessment of pesticides residues in food

The guideline mainly focuses on identification and characterization of hazardous properties of the pesticide residue of which MRLs do not exist in China. The assessments are covered by three types of assessments, they are toxicological assessments, residue chemistry assessments and dietary intake assessments. The aim of toxicological assessments is to obtain Acceptable Daily Intakes (ADI) and\or Acute Reference Doses (ARfD) based on the data of toxicokinetics studies and studies of acute-, sub-chronic, chronic toxicities, carcinogenicity, teratogenicity, genotoxicity and reproduction toxicity. In residue chemistry assessments, supervised trials median residues (STMR) and highest residues (HR) are the main values derived based on metabolism studies in animals and crops, residues studies, e-fate studies, and animal feeding studies and evaluation of the manufacturing process. The last one is a dietary intake assessment with the purpose of getting National Estimated Daily Intakes(NEDI)and National Estimated Short Term Intakes(NESTI)by long term and short-term dietary intake assessments respectively. In conclusion, if the health risk is acceptable or not could be acquired after comprehensive analysis of ADI, ARfD, STMR, HR, NEDI and NESTI, which are the critical references to provide risk management suggestions to the authority.

Guideline for setting MRLs in food

Following up the guideline for risk assessment this guideline conveys MRLs setting contains three steps. First, determine STMR and HR based on residue studies which are conducted under GAP and guidelines of residue studies (NY/T 788). Second, ADI and\or ARfD are determined based on toxicokinetics studies and toxicological studies. Finally, the proposal of recommended MRL could be obtained after combining evaluations of ADI, ARfD, STMR, HR, NEDI and NESTI. The valid period of MRLs is 15 years if no re-evaluation is required.

In sum, residues risk assessments and MRLs setting guidelines are the significant promotion in Chinese agrochemical management. It indicates that food safety is paid more and more attention by the Chinese authority and the end of black box period of residue and MRLs management in China.

Dr. Xiaohua He Managing Director
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