Control on Pesticide in China: A lot done, more to do.

CRAC 2013

Prof. Chen Tiechun from ICAMA at Shanghai CRAC on 22 Oct, 2013.

On Day two of the CRAC(REACH24H Chemical Regulatory Annual Conference) 2013 conference in Shanghai, Prof. Chen Tiechun, Division Director of Quality Control from ICAMA (Institute for the Control of Agrochemicals, Ministry of Agriculture), outlined the framework and achievements made in development of China’s pesticide regulations, as well as the challenges facing this sector in the future. Though regulatory developments are still in their infancy, Chen confirmed that the ICAMA is negotiating with U.S EPA on the development of a MAD (Mutual Acceptance of Data)-like system to govern international trade in the agrochemical sector between China and the United States.

Cross Ministry Legislative framework in China

In China the most important regulation is undoubtedly the “Regulation on Pesticide Administration”, which was promulgated on May 8 1997 and revised on November 29 2011. In fact, its regulatory predecessor can be traced back to the “Provision on Pesticide Registration”, which was jointly issued in 1982 by the Ministry of Agricultural, the Ministry of Health and the former Ministry of Chemical Industry.

Important additional regulations include:

  • “Administrative Permission Law”
  • “Standardization Law”
  • "Product Quality Law”
  • “Trademark Law”
  • “Code of Primary Products Quality Security”
  • “Advertisement Law”
  • “Consumer Protection Act”
  • “Regulations on Administrative Protection of Agricultural Chemical Products”
  • “Regulations on the Control over Safety of Hazardous Chemicals (Decree 591)”

Several Ministry/Administrations are also involved in the control of production, marketing, distribution, use and market promoting of pesticide:

Ministry/Administration

Regulatory Duties

Ministry of Agriculture (MoA)

Pesticide registration;

market supervision;

MRLs formulating and monitoring;

Ministry of Industry and Information Technology (MIIT)

Authorization of pesticide manufacturing companies;

issuing the approval certification for pesticide manufacturing to the manufacturing companies when China has not yet established national quality standard or industrial standard for their product;

Quality monitoring of the product, issuing industry quality standard for pesticide products;

General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ)

Issuing the production license to pesticide manufacturing companies when national quality standard industrial standard of the product has been established and monitoring the quality of the product;

issuing national quality standard of pesticide products;

State Administration for Industry and Commerce

Issuing the business license to pesticide manufacturing or marketing companies;

trademark registration;

quality supervising of pesticide circulating on crop protection market;

Ministry of Health

Treatment of pesticide poisoning; issue the MRL standard jointly with the MoA;

Ministry of Environmental Protection

Environmental impact assessment of pesticide manufacturers;

Monitoring pesticide residue in environment;

Before placing a crop protection product on the market companies should obtain various kinds of approvals. The most widely recognized way to verify the authenticity of a pesticide product or the pesticide companies is the “triplex identification” system:

  • certificate of pesticide registration (ICAMA registration);
  • approval certificate for pesticide manufacturing issued by MIIT or the production license issued by AQSIQ;
  • quality standard identification of the product which was issued by AQSIQ (national standard)/ MIIT (industrial standard) or the filling number of the enterprise standard, which was issued by  MIIT(company of pesticide product without national quality standard or industrial standard usually performs its inner quality standard, the enterprise standard, thus it should comply with its enterprise standard to MIIT and obtain a filling number of its enterprise standard );

Pesticide Registration

Pesticide registration is a complicated and time consuming process. A high level of expertise is required to successfully fulfill procedural requirements including, data gathering, testing facility, labeling requirement. A thorough knowledge of the following is necessary to understand obligations.

  • “Measures for Implementing the Regulations on Pesticide Administration” (MoA Order 9 of 2007);
  • “Data Requirements on Pesticide Registration” (Order 10 of MoA);
  • “Provision for the Restriction of Pesticide use” (MoA order 17 of 2002);
  • “List of Banned Pesticide”;
  • “Measure for the Administration on Testing Facility for Pesticide Registration”;
  • “Measures for the Administration on Pesticide Labeling and Instruction”;

Bans and Risk Control on Pesticide

The first concerted effort to phase out excessively hazardous pesticides began at the start of the last decade. 23 kinds of pesticide were banned from 2000 to 2008. In 2011, MoA and other 4 Ministries issued  Announcement 1586, which prohibited the sale and uses of 10 other pesticides. As a consequence, only 551 kinds of highly toxic/hyper toxic pesticide are currently permitted to be registered which has massively reduced the proportion of toxic pesticides permitted in China from 70% in 2000 to less than 2% in 2012. Higher usage restrictions have also been implemented to reduce the environmental impact of the substances which remain on the market. Notable example  are the  paraquat AS restriction and the recently decision to phase out three long residual sulfonylureas. (See Chemlinked News Release on Sept. 22 2013).

Current Status

According to statistics, 2229 manufacturers have successfully registered with ICAMA for their products, including 102 overseas companies. As of August 30 2013, 29,019 pesticide registrations of 620 active ingredients remain valid consisting of 26,827 registrations (1055 temporary registrations and 25,772 full registrations) for agricultural applications and 2264 registrations (245 temporary registrations and 2,019 full registrations) for household applications. With 11,423 registration entries, insecticides lead the position as the largest product category, followed by fungicides (6,782 registrations), herbicides (6,482 registrations) and PGRs (640 registrations).

By the end of September 30 2013, agrochemical exports rose by 13.68% to some 6.54 billion USD (1.27 million tons) compared with the same period last year. Imports amounted to some 535 million USD (47,100 tons), growing by 15.35%. The increase in exports is primarily related to the price advantage Chinese products offer in comparison to their global competitors rather than innovation resulting in development of novel products.

GLP and MAD

China has accepted data from OECD’s GLP-compliant testing facilities since 1982 although the data from China’s GLP-compliant testing facilities are not accepted under the OECD’s system, as China is not an OECD member and has not joined its MAD system yet. This technical barrier seriously hinders global market access for Chinese pesticide products. Interestingly, the MoA has stepped up inspection and approval of Chinese-GLP facilities many of which are eager to be also accredited by OECD.

MoA approved 35 toxicology labs, 13 environmental toxicology labs, 73 residue testing facilities and 20 labs comprehensive testing facilities. 13 labs in China have received GLP inspections from 3 OECD members in Europe:

Lab

Testing Item

Date of Inspection

Belgium authorized labs

Covance, Shanghai, Pharmaceutical R&D

toxicology;

analytical and clinical chemistry;

04-07/07/2011

FMC,Chemical Technology Consulting Co, Shanghai, FMC Agricultural Products

analytical and clinical chemistry;

29/02-3/03/2012

Laprode (Zhejiang) Analysis Co.,Ltd., Hangzhou,

physic-chemistry;

analytical and Clinical chemistry;

full-component and stability

5-7/10/2011

NutriChem Beijing

Physic-chemistry;

analytical and clinical chemistry;

full-component and stability;

15-18/06/2010

Pilarquim (Shanghai) Co., LTD

Physic-chemistry;

12-13/05/2011

Wuxi AppTec Shanghai

ADME test;

toxicokinetics and pharmacokinetic;

hERG and biomarkers test;

9-11/05/2011

Wuxi AppTec Suzhou

toxicology and gene mutation assay

5-8/03/2012

Netherlands authorized labs

Micro Constants China Ltd

analytical and clinical chemistry;

01/2011

Achiever Biochem Co., Ltd

physic-chemistry;

analytical and clinical chemistry;

09/2011

Shenyang Institute of Chemical Industry

Safety Evaluation Center

toxicology;

analytical and Clinical chemistry;

01/2011

Shenyang Institute of Chemical Industry

Pesticide Quality Center

analytical and clinical chemistry;

09/2011

NCDSER/Innostar

toxicology;

gene mutation assay

analytical and clinical chemistry;

02/2012

Germany authorized labs

Rotam CropSciences Ltd

analytical and clinical chemistry;

05/2007

GLP qualifications issued by OECD Member State confer considerable benefits to products which have their testing conducted in these facilities. The most obvious one is increased access to the market of the OECD member state. However the counterpoint to this benefit is the extended accreditation period, the stringency of the inspection launched by the member on the Chinese lab not to mention the inherent financial costs. Professor Chen also advised that even though a lab can be authorized by individual OECD members it does not hold that all member states will accept this data. Chen however finished on a particularly promising note revealing that the MoA is actively cooperating with the US EPA and a China-US mutual data acceptance system would probably be achieved in near future.

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