12 pesticide laboratories were newly approved for MoA GLP Accreditation;
4 Agricultural standards based on GLP testing principles including physical-chemical, residue, toxicological and environmental testing have been established;
The GLP principle of toxicological testing will be implemented during registration management;
China is actively engaged in building international mutual & multilateral data acceptance with other countries;
GLP accreditation will be incorporated into new pesticide regulations in a phased manner
On 31 Aug 2016, China MoA issued Announcement 2443 regarding the GLP accreditation of testing facilities for pesticide registration. 12 laboratories were newly approved, 9 existing GLP labs were approved for expanded study scope and 5 labs were approved for name change.
Table1. List of 12 Laboratories Newly Approved for GLP Accreditation
No. | Name | GLP Study Scope | Certificate No. |
1 | Laboratory of Comprehensive Analysis, Applied Chemistry Department of China Agricultural University | •Full Components Analysis | 药试218 |
2 | Nutrichem Analysis Technology Co., Ltd. | •Full Components Analysis; | 药试219 |
3 | Safety and Evaluation Center of Shenyang Research Institute of Chemical Industry | •Residue Study(indoor); | 药试220 |
4 | National Pesticide Quality Supervision and Inspection Center | •Full Components Analysis; | 药试221 |
5 | FMC(Shanghai) | •Full Components Analysis; | 药试222 |
6 | ACHIEVER BIOCHEM | •Full Components Analysis; | 药试223 |
7 | Shanghai Xiaoming Product Testing Service Co.,Ltd. | •Full Components Analysis; | 药试224 |
8 | Testing Centre of Sinon Chemical(China) Co.,Ltd. | •Physical-Chemical Analysis | 药试225 |
9 | Pilarquim(shanghai)Co.,Ltd | •Full Components Analysis; | 药试226 |
10 | Taicang Rotam Research Laboratory | •Full Components Analysis; | 药试227 |
11 | Laprode(Zhejiang) Analysis Co.,Ltd. | •Full Components Analysis; | 药试228 |
12 | Chemical Testing Center of Zhejiang Research Institute of Chemical Industry | •Full Components Analysis; | 药试229 |
Table2. List of 9 Existing GLP laboratories Approved for Study Scope Inclusion
No. | Name | GLP Study Scope | Certificate No. |
1 | Bejing Eco-Saf Technology Co.,Ltd. | •Environmental Toxicology | 药试009 |
2 | Pesticide Quality Supervision and Inspection Station | •Full Components Analysis; | 药试065 |
3 | Pesticide Quality Supervision and Inspection Center(Nanjing)(Jiangsu Agricultural Product Quality Inspection and Testing Center) | •Full Components Analysis, | 药试074 |
4 | Institute of Agricultural Product Quality Standard, Zhejiang Academy of Agricultural Sciences | •Physical-Chemical Analysis; | 药试085 |
5 | Shandong Academy of Pesticide Science | •Full Components Analysis, | 药试113 |
6 | Pesticide Safety and Evaluation Center , Hunan Research Institute of Chemical Industry | •Full Components Analysis; | 药试133 |
7 | Guizhou Academy of Testing and Analysis | •Full Components Analysis; | 药试170 |
8 | Research Center for Eco-Environmental Sciences, Chinese Academy of Sciences | •Full Components Analysis, | 药试192 |
9 | Jiangsu HOPE Analytech Inc. (HOPE)] | •Full Components Analysis; | 药试200 |
Table3. List of 5 GLP Laboratories Approved for Name Change
No | Former Name | New Name | Certificate No. |
1 | Center for the Bioassay of Pesticide, Shenyang Research Institute of Chemical Industry | Center for the Bioassay of Pesticide, Sinochem Shenyang Pesticide Research and Development Co.,Ltd. | 药试042 |
2 | Shanghai Pesticide Research Institute | Shanghai Pesticide Research Institute Co.,Ltd. | 药试057 |
3 | Wuhan Vegetable Research Institute | Institute of Vegetable Wuhan Academy of Agricultural Science and Technology | 药试129 |
4 | Pesticide Safety and Evaluation Center , Hunan Research Institute of Chemical Industry | Hunan Addition Testing Service Co.,Ltd. | 药试133 |
5 | Guangdong Insect Research Institute | Guangdong Institute of Applied Biological resources | 药试140 |
China has not yet joined the OECD MAD system and the pesticide GLP accreditation system is voluntarily implemented under the “Measures for the GLP Accreditation of Pesticide Laboratories- MoA Announcement 739”. Testing facilities engaged in physical-chemical, residue, toxicological and environmental behavioral testing of pesticides will be evaluated, subjected to onsite inspection and certification by the MoA and undergo additional personnel assessment, test facility assessment, instrument and equipment assessment and operation and management assessment. MoA is responsible for implementing the GLP principles for different testing scope using the following standards:
NY/T1386-2007 Principles of Good Laboratory Practice for Pesticide Physical-chemical Testing
NY/T 718-2003 Principles of Good Laboratory Practice for Pesticide Toxicological Testing
NY/T 1906-2010 Good Laboratory Practice for Pesticide Environmental Testing
NY T 1493-2007 Good Laboratory Practice for Pesticide Residue Testing
Although MoA GLP accreditation of testing facilities is not mandatorily required, some of the GLP principles should be followed for pesticide registration. For example, the “Measures for the Administration on Toxicological Testing Facility for Pesticide Registration” is followed for qualification management, requiring that toxicological laboratories conform to NY/T 718-2003.
MoA also actively promoted the international mutual & multilateral acceptance of testing data. In 2013 China and US EPA sign a LOI on GLP collaboration and exchange visits between MoA and EPA have been successful. In 2014, China and Egypt reached an agreement on the mutual acceptance of data for pesticide registration. Meanwhile, China will incorporate GLP accreditation with its new pesticide regulations in a phased manner: GLP data will be required for new pesticide registration and then all pesticides.
