china s pesticides limits system compared to the codex and

Law and Governance Group

Master Thesis Law and Governance

China’s Pesticides Limits System compared to

the Codex and the EU

Is it possible to narrow the gap?

Case study: Codex, EU and China Acetochlor MRLs in maize

Supervisors:

Dr. Hanna Schebesta

Prof. Bernd M.J. van der Meulen

Student:

Kaikai Du

Registration number: 910308-210-010


ii


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Acknowledgement

First and foremost I offer my gratitude to my supervisors: Prof. Bernd M.J. van der Meulen and Hanna

Schebesta for their valuable guidance advice, encouragement, and support. I am appreciative of the

opportunity to work with them.

I would also like to convey my thanks to Maggie for being my surrogate family for more than one year

during my stay in the Netherlands.

To all others that I have not mentioned, who helped me in many ways, thank you.

Finally, my deepest sincere and earnest thanks go to my family for their support, understanding, motivation,

and faith.


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Abstract

Food safety has become a major global issue. Over the past 35 years, rapid economic growth, significantly

increased agricultural productivity changed China's food production, distribution and consumption patterns.

On one hand, the problem of hunger is largely solved. On the other hand, concerns about food safety

increase. Among them, the pesticide residues problem is a major problem.

This is because pesticides, including herbicides, insecticides, rodenticides, and fungicides, are widely used

in modern agriculture. The use of pesticides can lead to the presence of pesticide residues, which are toxic,

in the agriculture products and the environment, Hence, the presence of pesticide residues, especially in

food, is a concern for consumers. The Chinese government has made an effort to establish requirements on

pesticide residues in both domestic and imported agricultural commodities to protect the consumer

against potentially harmful effects. One of these requirements is referred to as the Maximum Residue

Limits (MRLs). Meanwhile, international standards organization; Codex; has also established pesticide

residue standards to be used as a reference for international trade in the member countries of the WTO.

However, some MRLs still vary across countries or regions, and compared to the MRLs of EU and the Codex;

there are still some improvements that can be made in China’s MRLs.

The present study aims to investigate the possibility to improve China’s pesticide limits system. This study

analyzed the reasons for the MRL difference by conducting a comparative case study of Codex, EU and

China MRLs for acetochlor in maize and their risk assessment. This comparative study found differences in

the scientific information used in the establishment of these MRLs even though the EU and China applied

the risk assessment in line with the Codex Guideline and they also take the Codex MRLs and the JMPR

evaluation into account when determining the MRLs. Considering China’s pesticide limit system is still

under constructing, the Codex and EU standards can be the references, and by adopting some reasonable

approaches, the pesticide tolerance gap between EU and China can be narrowed.


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Table of Content

1. Introduction ................................................................................................................................................ 1

1.1 Background information ...................................................................................................................... 1

1.2 problem statement .............................................................................................................................. 3

1.3 Research objective ............................................................................................................................... 5

1.5 Research questions .............................................................................................................................. 6

1.6 Methodology ........................................................................................................................................ 6

2. The differences of pesticides MRLs in China and EU .................................................................................. 7

2.1 Pesticides residue situation in China ................................................................................................... 7

2.2 Pesticides residue situation in EU ........................................................................................................ 8

2.3 Preliminary analysis of the differences between China and EU .......................................................... 9

3. The relevance of Codex, China and EU in Agricultural trade .................................................................... 10

3.1 The global trade negotiations and agriculture policy of WTO ........................................................... 10

3.2 Codex Alimentarius Commission ....................................................................................................... 14

3.3 China .................................................................................................................................................. 17

3.4 EU ....................................................................................................................................................... 18

3.5 The relevance of Codex and WTO members in food safety aspect ................................................... 19

4. The procedures of establishing the maximum residue limits ................................................................... 23

4.1 Application of risk analysis ................................................................................................................. 23

4.2 Risk assessment for establishing the maximum residue limits for pesticide residues ...................... 25

4.3 Risk assessment for establishing the maximum residue limits for pesticides ................................... 28

4.4 Codex MRLs ........................................................................................................................................ 32

4.5 China MRLs ......................................................................................................................................... 35


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4.6 EU MRLs ............................................................................................................................................. 41

4.7 The relevance and differences in the MRLs of the CAC, EU and China ............................................. 46

5. Comparative study .................................................................................................................................... 48

5.1 Acetochlor and its standard in Codex, EU and China ......................................................................... 48

5.2 Comparison in risk assessment .......................................................................................................... 49

5.3 The risk assessment report of the JMPR, EFSA, and ICAMA regarding to acetochlor ....................... 50

5.4 Brief conclusion of Comparison ......................................................................................................... 59

6. Possible reasons of the differences in acetochlor MRL ............................................................................ 62

7. Conclusion and recommendation ............................................................................................................. 65

7.1 Conclusion .......................................................................................................................................... 65

7.2 Recommendation ............................................................................................................................... 67

8. Reference .................................................................................................................................................. 70

Appendices ....................................................................................................................................................... 77


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List of abbreviations

ADI: Acceptable Daily Intake

AMS: Aggregate Measure of Support

AOEL: Acceptable Operator Exposure Level

ARfD: Acute Reference Dose

BBCH: Biologische Bundesanstalt, Bundessortenamt und CHemische Industrie

CAC Codex: Alimentarius Commission

CCPR: Codex Committee on Pesticide Residues

CGAP: Critical GAP

CS: Capsule suspension

EC: Emulsifiable concentrate

EFSA: European Food Safety Authority

EMA: Effective Medium Approximations

EMRLs: Extraneous Maximum Residue Levels

EU: European Union

FAO: Food and Agriculture Organization of the United Nations

GAP: Good Agricultural Practice

GATT: General Agreement on Tariffs and Trade

GLP: Good Laboratory Practice

HR: Hazard ratios

ICAMA: Institute for Control of the Agrochemicals, Ministry of Agriculture (China)

IEDI: International Estimated Daily Intake

JMPR: Joint FAO/WHO Meeting on Pesticide Residue

Comment [B1]: Please make it as

complete as you can

https://en.wikipedia.org/wiki/Effective_Medium_Approximations


viii

kg ai/ha: Kilograms active ingredient per hectare

LOAEL: Lowest observed adverse effect level

LOQ: Limit of Quantification

MOA: Ministry of Agriculture (China)

MOE: Margin of exposure

MRLs: Maximum Residue Limits

PHI: Pre-harvest Interval

SAC: Standardization Administration of the People's Republic of China

SPS: Sanitary and Phytosanitary

STMR: Supervised Trials Median Residue

TMDI: Theoretical Maximum Daily Intake

WHO: World Health Organization

WTO: World Trade Organization


1

1. Introduction

1.1 Background information

There are three aspects of people’s right to food which are Food Security, Food Safety,

and Food Ethics. According to the statistics of FAO, the hungry population of China

from 1990 to 1992 was 272.1 million, which accounted for 22.9% of the total

population. However, the number of hungry population reduced to 158 million,

dropped to 11.4% of the entire population in 2013 (Gu & Wang 2011).

Furthermore, the FAO released a bulletin on February 5th, 2015 in Rome stated that

the food price index continued to fall in January 2015, decreased by 1.9% from the

level of last December. The FAO also predicted that the cereal production will

increase to a high level in 2015 (World food prices hit the lowest level in almost

seven years, UN agency reports, 2015).

Since cereal is one of the major agriculture products in China, and according to the

ongoing improvement of the situation in China, food security seems no longer to be

the biggest problem that affects the people’s right to food.

Food ethics are also improved in China. According to the new released Food Safety

Law of the People's Republic of China, relevant departments could maintain the

confidentiality of information of informers, protect the legitimate rights and interests

of informants. Moreover, all retaliation behaviors are forbidden (2015 top ten

highlights of the latest revision of the Food Safety Law of People’s Republic of China,

2015). The new Food Safety Law of the People's Republic of China also has some

regulations which can regulate the advertisers’ behavior, strengthen the sense of

responsibility of endorsers, and punish acts of false endorsement (Yang, 2015). These

changes show the attitude of the Chinese government and also improve people’s

ethics to a certain extent.

Recent years, food safety becomes the most concerned aspect of Chinese people.

Endless food safety issues continue to emerge, the melamine crisis in 2008, the

gutter oil incident in 2010 (Investigation of Wuhan gutter oil shakes the country

2010); and the expired meat incident in 2014 (Fuxi- the supplier of KFC and


2

McDonald in Shanghai was confirmed use expired meat 2014).

These events not only brought negative impacts to the related companies but also

affects the health of consumers. Therefore, food safety has increasingly drawn the

public attention, control and assurance of food safety issues will inevitably become

the focus (Hou & Yang & Wu, 2010).

Food safety involves a broad range of matters that will happen in all parts of the food

chain from production to consuming. According to the investigation, the people who

do not have a university degree do not concern food safety issues as much as the

people have a college degree. Moreover, through all the food safety problems,

pesticide residues problem is one of the most concerned (Sun.et al., 2006).

The pesticide used in the process of the agriculture products may make the chemical

ingredients which are difficult to decompose gather in the agriculture products and

cause pesticide residues problem. Pesticide Residues not only endanger the health of

the people at home but also have to produce safety concerns and panic. Countries

have put an effort to establish requirements on pesticide residues for both domestic

and imported agricultural commodities to protect the consumers against these

potentially harmful effects. One of these requirements is referred to as the Maximum

Residue Limits (MRLs). Importing countries use the MRL's regulation as the

acceptance criteria for these imported agricultural commodities. This public concern

is also reflected in the system for the registration and assessment of the safety and

efficacy of pesticides before the sale (Raymond, 1979).

The MRLs are set based on the supervised residue trials in which the pesticide is

applied according to Good Agricultural Practice (GAP). Each country is inclined to

establish appropriate MRLs for its local agricultural condition and the usage of

pesticides. Meanwhile, the international standards organization; Codex; has also

established a pesticide residue standard called Codex MRLs to be used as a reference

for international trade among the member countries of WTO. However, Drogué and

DeMaria (2010) stated that international harmonization of MRL does not exist at a

global level. Even though Codex Alimentarius has fixed levels, they are not statutory.

In many cases, MRLs, therefore, vary substantially across countries. Van Eck (2004)

indicated that these MRLs set at the national level are potential barriers to trade.

Also, Wilson and Otsuki (2004) assessed the impact on trade of harmonizing the MRL


3

of acetochlor on banana trade between 21 exporting countries and 11 OECD

importing countries. They found that increasing the stringency of the MRLs of

acetochlor has a negative impact on trade.

1.2 problem statement

1.2.1 China’s problems in pesticide limit system

Over the past 35 years, rapid economic growth, significantly increased agricultural

productivity and changes in consumption patterns have changed China's food

production. On one hand, the problem of starvation is solved, and people have more

choices on food products than ever. On the other hand, the concerns of malnutrition

and food security still remain. At the same time, the new food safety issues are

emerging. Among these issues, the irregular use of pesticides attracted most of the

people’s attentions, and the irregular use of pesticides is mainly caused by the

imperfection of China’s pesticide limit system (Chen, et.al 2014).

From the 1990s till now Chinese government established a national system of limits

for pesticide residues. 2293 MRLs of 322 kinds of pesticides used in 178 of products

is reviewed, preliminary meets the needs of agriculture production and market

regulation. However, there is still some room can be improved. Although there has

been policy requires of systematic detection the research shows that the current

maximum pesticide residue testing is only carried out intermittently (Ma, 2012).

Existing literature is more comprehensive on analyzing the causes of food safety

problems. However, it has limitations in the countermeasures and suggestions to

address food safety issues. In the recent years, some new food safety issues have

already occurred in China, the existing law is still not a good solution to these

problems, and relevant literature is microscopic. Some literature lacks of the use of

specific examples of food safety issues for intuitive analysis and explanation, which

makes the argument insufficient (Liu et al., 2005).


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1.2.2 The differences of pesticide limit system between China and

EU.

China is one of the biggest exporting countries of agriculture products in the world. A

significant amount of surplus food and agricultural commodities from domestic

consumption are exported to worldwide countries, and over half of the population of

China are farmers among all the countries EU is one of the biggest importers.

However, a considerable number of the surplus food and agricultural products of

China are rejected because of the non-compliance with EU MRLs. So the restriction

of access food and agricultural products has significantly influenced Chinese people’s

lives. Maize is one of the products, which were rejected at the borders because of

non-compliance with EU MRLs. Acetochlor, as a very effective pesticide, is always

detected in this commodity. Acetochlor has been classified as a probable human

carcinogen. Human health effects from acetochlor at low environmental doses or at

biomonitored levels from low environmental exposures are unknown. It is necessary

to set maximum residue limits of acetochlor in agriculture products. However, as

mentioned before, MRLs do not have a global level, in some cases of exported maize.

The products were rejected at the border because of the detection of acetochlor at

levels exceeding the EU MRL (no tolerance), even though detected levels complied

with the Codex and China MRLs (0.02 mg/kg) and (0.05 mg/kg) (Xu et.al 2015).

1.2.3 The significance of improving China’s pesticide limit system

and narrow the pesticide tolerance gap between China and EU

With the rapid development of China's national economy and the improvement of

Chinese people’s living limits the awareness of protecting their right to food is

increasing. Securing food safety has significant implications for China. As a result,

Chinese people’s health is threatened, which makes it necessary to improve China’s

pesticide residue limits system.

Furthermore, since the incompliance of pesticide residue MRLs between China and

the advanced international organizations, trade barriers appear frequently. And

these trade barriers always lead to the loss of huge amount of money to both China


5

and other countries. Among all the international organizations in the world, the

European Union has the strictest pesticide residue tolerance. And as granted, there

are lots of agriculture products from China rejected by the EU because of the

problem of pesticide residues (Hou & Yang & Wu, 2010).

To facilitate agricultural food trade, as well as improve Chinese people’s lives and

protect their rights to food, it is necessary to find a way to harmonize the pesticide

residue limits among countries. The MRL of acetochlor in maize is used as the case

study to analyze the reasons which cause the problems and how to access the

harmonization. Recommendations will be made if it is possible to narrow the

tolerance gap of pesticide residues between China and EU.

1.2.4 Hypothesis

Both China and EU take Codex standards into account to set maximum pesticide

residue limits.

Both China and EU have some reasons that based on scientific data, they need to

set different limits to protect their people’s health.

Some of the standards could be harmonized to enhance the trade and the

people’s rights to food.

1.3 Research objective

The main research objectives of the thesis are

To analyze the current situation of the regulations and limits of the pesticides

residues in China and EU

To analyze the implementation of the Codex standards in some regions and

countries

To analyze the reasons why there are some differences in maximum residue

limits in food between China and EU

To analyze the possibilities and recommendations on if it is possible to narrow

the tolerance gap between China and EU


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1.5 Research questions

To accomplish the research objectives above, the following questions need to be

answered:

How are Codex Standard and JMPR risk assessment taken into account by EU and

China?

Why are some pesticide residue tolerances of Codex, EU and China different?

-What kinds of methodology are they used for establishing MRLs?

-What kinds and sources of scientific data are used for establishing MRLs?

Is it possible to narrow the gap of maximum residue limits of pesticides between

China and EU according to the reasons?

1.6 Methodology

The study is mainly a desk study with approaches from qualitative points of view.

The comparative study is used to find differences. This approach is supported by

literature reviews and data analysis.

Literature reviews are summarized from scientific books that are made available by

the Wageningen University library catalogue; related scientific journals are searched

by search engines on the internet; The documents provided from related parties,

such as the Joint FAO/WHO Food Standards Programme (Codex Alimentarius

Commission, CAC), European Food Safety Authority (EFSA), Food and Agriculture

Organization of the United Nations (FAO) are also included.


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2. The differences of pesticides MRLs in China and EU

In this chapter, the differences of pesticides MRLs in China and EU are described. In

order to better understand these differences, the basic situation and the

development of the pesticides in China and EU are introduced first, the legal basis is

also mentioned briefly.

2.1 Pesticides residue situation in China

For most people, the harm of pesticide residues mainly comes from the consumption

of the contaminated food. In the past, the most common pesticide residues found in

food are heavy metals and persistent organic chlorine pesticides. Up to 2009, China

has developed 79 kinds of pesticides 197 pesticide maximum residue limits (MRL) in

32 types of agricultural products (Zeng, 2009). According to statistics, currently, China

has 34 mandatory national pesticide residue standards relating vegetables, involving

58 indicators of pesticide residues in vegetables, 52 kinds of pesticides (Niu et.al,

2011). Wherein, GB 18406-1-2001 includes 46 pesticide residue indicators and 41

pesticides. Since 2001, the Ministry of Agriculture (MOA) has released 33 standards

of the pollution-free food industry. However, the signs of the involved pesticide

residue limits do not exceed the scope of the national standards.

In 2009, the Ministry of Agriculture released the Food Safety Law of the People's

Republic of China which significantly improved the situation of pesticide residues in

China. After that, in 2014, the Ministry of Agriculture and the National Health and

Family Planning Commission jointly issued the "national food safety standard

maximum residue limits for pesticides in food" (GB 2763-2014). It prescribed the 322

kinds of pesticides, 3650 kinds of MRLs in more than 200 types of foods, covered 12

categories of crops or products including vegetables, fruits, cereals, oils and fats,

sugar, beverages, sauces, nuts, edible mushrooms, mammal’s meat, eggs, poultry

and meat. In addition to conventional grains, vegetables, and fruits, it contains

pesticide MRLs for juice, preserved fruit, dried fresh fruit and other primary


8

processing products1 (Xu et.al 2015).

2.2 Pesticides residue situation in EU

The European Union is one of the strictest regions in setting maximum pesticide

residue limits (MRLs) for pesticide residues. EU allows the MRLs to be established on

a scientific basis to ensure the security of the consumer groups including infants and

children. Meanwhile, EU and the member states need to share relevant

responsibilities (Shi, 2007).

July 1991, European Commission released 91/414 / EEC, it re-evaluated the active

ingredients of near 1000 kinds of pesticides sold or used in the market for the sake of

the safety of the environment, animals, and humans, and announced that the

European Commission should manage the pesticides used in the member states.

November 2002, the European Commission released Regulation No. 2076/2002,

announced that utilization and sale of 320 kinds of active ingredients in pesticides in

member states need to be banned from July 25, 2003, and the last use shall not

exceed December 30, 2003.

Over ten years since the European Commission released 91/414 / EEC, the

registration of over 500 kinds of active ingredients have been revoked, accounting for

nearly half of the active ingredients used on the EU market (Lian 2010).

On March 14, 2003, the EU released 2003/0052 (COD), which is a vital legal

document about the maximum allowable pesticide residue limits (MRLs) regarding

plant and animal origin food. It defined the scope and definition of MRLs and made

provisions in principle to the requirements and application of the MRL's approval

procedures; the establishment of MRLs; the authorization of the use of pesticides;

the establishment of temporary MRLs; the standards of export permission; the

establishment of MRLs database; the official supervision, penalties, coordination and

other procedures. The de-registered pesticide ingredients or the ingredients only

allowed to be used in exporting products while do not set MRLs in EU, or the safety

1 For detailed information, see http://www.cirs-group.com/food/news/5757.html


9

of ingredients are not sufficiently clear, use 0.01mg / kg (level of detail, LOD) as

limited standard (Song 2014).

On February 23, 2005， EU released regulation 396/2005, adjusted the pesticide

MRLs of plant origin and animal origin food and feed, opened a new situation in the

EU MRL's management. After that, EU released Regulation 178/2006 on the

establishment of food and fed Classification and Regulation 149/2006 on the

establishment of maximum residue limits, made the further improvement of

regulation 396/2005.

By now EU has established over 145,000 MRLs of 648 kinds of pesticides (Xu et.al

2015).

2.3 Preliminary analysis of the differences between China and

EU

Compared to EU, it is very evident that the numbers of indicators of the pesticides

residues and types of pesticides in China are smaller. For example, the number of

China’s indicators of pesticide residues in vegetables s about 10% of the number in

EU and the number of involved pesticides is 68.4% of EU2. In addition to the

difference in numbers, the differences in the MRLs standards and the treatments to

some situations are also quite notable. For example, in 2015, China’s strawberries

were also detected contains acetochlor, and the concentration was 0.367 mg/kg3,

and it was legal in China because there is no MRLs of acetochlor in strawberries in

China, while acetochlor is not allowed to be used in EU4.

Possible reasons will be analyzed in Chapter 5.

2 See http://epaper.legaldaily.com.cn/fzrb/content/20150713/Articel06002GN.htm

3 See http://www.guokr.com/article/440213/

4 See Article 12 of Regulation (EC) No 396/2005


10

3. The relevance of Codex, China and EU in Agricultural

trade

In this chapter, the agricultural trades of the Codex, EU and China are discussed.

Some WTO policies and negotiations are introduced first to help the audience better

understand the relevance of the three organizations in agricultural trade and the

influences of the pesticide limit system on it.

3.1 The global trade negotiations and agriculture policy of

WTO

WTO Agreements on Agriculture seek to avoid the situation that governments

encourage the export while restricting the import of agriculture products. The

purpose of the WTO Agreements on Agriculture is to eliminate international

agricultural trade distortions and finally achieve liberalization and fair competition in

international trade of farming products. The Agreement on Agriculture reached by

China and other WTO members mainly related to market access, domestic support

and export subsidies and other content (Wang 2010).

3.1.1 The emergence of Agreement on Agriculture and its contents

Currently, the foundation of WTO agriculture trade policy is the “Agreement on

Agriculture” developed at the end of 1993 and implemented on January 1, 2005. The

purpose of the Agreement on Agriculture is to establish a market-oriented based and

fair agriculture trading system. The Agreement on Agriculture is made up of 13

sections and five appendixes. The main idea of the Agreement on Agriculture is:

reducing the special commitment of domestic support and protection; the market


11

access principle and subsidies for export; Improving the operational efficiency of the

GATT rules; concern about food safety and environmental protection and other

non-trade aspects; and special arrangements for agriculture trade in developing

countries (Li 2013).

The main contents are described as follows5 (Li 2013b):

(1) Market access provisions

First, tariff action. Unless there are specified provisions, all of the non-tariff measures

must become tariffed and be reduced. The tariff shall equal the difference between

the domestic and international average market prices of the product.

Second, tariff concessions. All WTO members implement the reduction commitments,

developed members reduce 36% of their tax rates in 6 years calculated by the simple

arithmetic average, and developing members reduce 24% in 10 years. The least

developed members also need to implement tariff action and tariff concessions,

however, they may have the exemption of concessions.

Third, to ensure minimum market access. All parties should ensure that promised

imported agricultural products can enjoy lower or lowest tariff.

Fourth, the special safeguard clause. If a member’s annual import volume is higher

than the average of the previous three years, or the import price lower than the

average of the reference price from 1986-1988 by 10% or more, the importing

country is allowed to impose some additional tariff.

Fifth, the "special treatment." The agreement provides special treatment for any

primary agriculture products and the products resulting from the processing of

primary agriculture products (applicable to all members), and for the primary

agriculture products of the main ingredients of traditional food (applicable to

developing members).

（2）Domestic support provisions

Agreement on Agriculture considers the policies different from ‘Domestic support’ as

5 This study is only concerned with the operation of the Agreement with regard to food safety.


12

a big “box”, and distinguishes the "box" into three types, which are "green box,

yellow box, and blue box."

First, the "Green Box" policies. These policies should be provided by the government,

and the cost should not be passed to the consumers. These policies do not have the

effect of price support, and they have no or only a minor impact on trade-distorting.

As a result, this measure has a slight impact on production.

Second, the "blue box" policies. The main effect of the "blue box" policies are to limit

production. Governments provide subsidies for a fixed area or production (such as

fallow subsidies). However, some subsidized products should not exceed 85% of the

base period.

Third, the "yellow box" policies. All the policies which are considered to distort

production and trade are incorporated into the "yellow box." It usually refers to the

governments’ direct price intervention and subsidies on agriculture products.

Aggregate Measure of Support (AMS) is used to gauge the scale of the subsidy and

concessions. Some of the "yellow box" policies of the developing members are not

included in the statistics if a member reduces domestic support for certain products

since 1986, the member may be exempted from the concession.

(3) The provisions of export subsidies

The export subsidies refer to subsidies based on the amount of export. Members

should reduce the number of subsided agriculture products, guarantee a certain

amount of imported agriculture products.

First, reduce the base period. Use the average level of export subsidies from 1986 to

1990 as a reference, or in some cases that export subsidies has already increased,

use the average level of export subsidies from 1991to 1992 as a reference.

Second, reduce the period. Since 1995, the period for developed members is six

years and the time limit for developing members is ten years.

Third, the concession commitment. All the members, except the least developed

members, need to make concessions every year including the concessions of the

volume of subsidized export agriculture products and the concessions of the

expenditure on export subsidies.


13

Fourth, control of the expansion of subsidies. The member cannot implement the

subsidies on one exported agriculture product in the future if it does not implement

the subsidies on this product within the base period.

(4) "Peace clause"

"Agreement on Agriculture" Article 13 states that the "appropriate restraint," known

as the "peace clause," the purpose of establishing of the "Peace Clause" is to avoid

the situation of “trade war” caused by frequent unilateral retaliatory or

counter-retaliation measures. The "Peace Clause" determines that countervailing

measures be forbidden to support the three types of provisions mentioned in the

“Agreement on Agriculture.”

3.1.2 From the Uruguay Round to Doha Round

(1) The Uruguay Round

September 1986, the GATT ministerial meeting was held in Punta Del Este, Uruguay.

This session aimed at starting a starting a new round of comprehensive reform of the

multilateral trading system, so it was named the "Uruguay Round". The negotiation

lasted seven and a half years and ended in April 1994 in Marrakech. During the

negotiations, agriculture is included in the scope of the multilateral negotiations, and

WTO was established. Also, the core principles of the GATT were extended to the

field of trade in services and intellectual property. The Uruguay Round also revised

and improved the rules for the settlement of disputes (McMahon, 2000).

Since the dispute on agriculture subsidies between the United States and the EU, the

negotiation repeatedly stalled the main participants in the agricultural negotiations is

the United States, the EU, and the Cairns Group. Due to the significant reduction in

agriculture support and export subsidies is extremely beneficial to the United States

but very unfavorable to the EU. Meanwhile, the export subsidies and the protection

of domestic agriculture markets also caused high losses of the Cairns Group, the

tripartite interests opposite to each other.

(2) The Doha Round

Compared with the industrial sector, the level of trade liberalization in the


14

agricultural sector is still very low. At the same time, the reduced tariffs on

agricultural imports were still much higher compared with the industrial goods. Also,

the definitions of constituting the scope of the subsidies of domestic price support

and various types of production were not very clear in the Agreement on Agriculture,

which led to some defects in the implementation of the Agreement on Agriculture.

Therefore, in the launch of a new round of global trade negotiations, agriculture

received wide attention again.

As a continuation of the GATT negotiations on agriculture, the new negotiation

started in March 2000, regarded to Article 20, “ to continue reform process”, of the

Agreement on Agriculture. The purpose of the new round of WTO negotiations on

agriculture is to advance the process of trade liberalization of agriculture products by

the Uruguay Round (Gu 2007).

The purpose of the new round of WTO negotiations on agriculture is to advance the

process of trade liberalization of agriculture products on the basis of the Uruguay

Round "Agreement on Agriculture", which is divided into three objectives:

significantly improve market access, phased reduction of all forms of export subsidies,

and substantial reductions in various domestic support.

On December 7, 2013, the Ninth Ministerial Meeting of the WTO closed in Bali,

Indonesia. The meeting issued the "Bali Ministerial Declaration", and reached the

“Bali package”, the 12-year stalemate of the “Doha Round” finally got a historic

breakthrough.

The “Bali Package” includes ten documents, covering the simplification of customs

procedures and customs clearance, allowing developing countries to have more

choice in food security issues, to assist LDCs in developing trade and so on. It

contains a total of 10 parts agreements including issues of trade facilitation,

agriculture, cotton, developing and least developed countries (He 2014).

3.2 Codex Alimentarius Commission

Codex Alimentarius Commission (CAC) is an inter-governmental organization

established by the Food and Agriculture Organization of the United Nations (FAO)

and the World Health Organization (WHO) to set international food standards for the


15

purpose of safeguarding the health of consumers and ensuring fairness of food trade.

Since created in the 16th World Health Assembly in 1963, 173 member countries and

one member organization (the European Union) have to join the organization,

covering 99% of the global population. (FAO/WHO, 2011a)

In simple terms, "Codex Alimentarius" is a set of standard practices, guidelines and

other recommendations of the collection including detailed requirements related to

a food or class of food and the production process of the operation and management

or governmental food safety management system and consumer protection

operation.

The standards of "Codex Alimentarius" usually involves characteristics of products,

and may involve all appropriate government regulatory features of the product, or

only one characteristic such as maximum residue limits (MRLs) of pesticides or

veterinaries residues in food (FAO/WHO, 2006).

Analysis and sampling methods, including the methods of analysis and sampling of

pesticides and veterinaries residues, are also taken into account in the standards of

"Codex Alimentarius".

Codex codes of practice - including codes of hygienic practice - define the production,

processing, manufacturing, transport and storage practices for individual foods or

groups of foods that are considered essential to ensure the safety and suitability of

food for consumption. For food hygiene, the basic text is the Codex General

Principles of Food Hygiene, which introduces the use of the Hazard Analysis and

Critical Control Point (HACCP) food safety management system. A code of practice on

the control of the use of veterinary drugs provides general guidance in this area (Xu,

et.al 2010).

CAC is empowered to establish subsidiary bodies of 3 types, named Codex

Committees which submit the draft standards to the CAC; Coordinating Committees,

which coordinate food standards activities throughout a region such as the

establishment or development of the regional standards; and Codex ad hoc

Intergovernmental Task Forces, which are established for a fixed period of time for

some specific missions. The difference between Codex Committee and the special

International task force is that the ad hoc Task Force has a specific task and a sunset


16

clause to complete the work (Dawson, 1995).

Besides the three subsidiary bodies, there is also an organization named Executive

Committee, which is an executive organ acts as the CAC’s representative.

There are two kinds of Codex Committees which are General Subject Committees

and Commodity Committees. The CAC may request the General Subject Committees

which are responsible for all sorts of food to provide advice and guidance on any

issue within their terms of reference. Commodity Committees deal with the

standards development for specific subject foods or classes of foods.

The communication and coordination between General Subject Committees and

Commodity Committees are critical. If commodity committees consider that a

general provision does not apply to one or more commodity standards, they may

request the general subject committees recognize the differences between the foods

with the general delivery of the Codex Alimentarius. Such requests should give out

sufficient reasons and supported by scientific evidence and other relevant

information. The parts which contain specific provisions or common standards, food

additives, contaminants, hygiene, labeling and methods of analysis and sampling part

of the specification or the guidelines of the supplementary provisions shall be

transmitted to the relevant general subject committees as soon as possible in the

most appropriate time of "Codex standards and related texts making process".

However, this kind of transition cannot delay the follow-up progress (Xu et.al 2010).

For example, Commodity Committees should research the limits of pesticide and

veterinary drug residues established by the CAC, to get the general reference of the

provisions as they stated in the "Codex commodity standard format." If they consider

that the general reference cannot achieve its purpose, the commodity committee

shall draw up a proposal and submit to the Committee on Residues of pesticides or

the Committee of veterinary drug residues.

The Codex Alimentarius brings the food standards and related texts which are

adopted all over the world and presented in the same manner. These food standards

and relevant texts are intended to protect the health of consumers, ensure fair food

trade, and the purpose of releasing the Codex Alimentarius is to promote the

development of definitions and requirements of food, and encourage their


17

harmonization, and to facilitate international trade (Li 2011).

3.3 China

China locates in East Asia, first referred to Central Plains region around Luoyang Basin.

Nowadays relates to the nation mainly consists of Chinese people and based on

Chinese culture. After the Revolution of 1911, China abolished the monarchy and

implemented republic, yet the conflict between "capitalism" and "communism" led

the Chinese civil war from 1945 to 1949 resulted in the split of the country. Today,

"China" means the People's Republic of China, which is the representative of China in

the United Nations.

Law of the People's Republic of China must obey “Constitution of the People's

Republic of China”. “Constitution of the People's Republic of China” is the supreme

law which prevails over other legislation passed by the State Council of China. Since

the founding of the nation, the legal system of the People’s Republic of China has

been using the cost method system, legal sources are manifested as statutory law,

and case law is not included.

Legal systems in most countries in the world today, can be roughly divided into two

categories, common law, and civil law. Due to historical factors, the Chinese mainland

and the two special administrative regions are using their original legal system

respectively:

Hong Kong: common law (from the UK);

Macau: civil law (from Portugal);

Chinese mainland: civil law, also affected by the socialist law system of the former

Soviet Union. (From Soviet Union)

In 1979, with the reform and opening of China, the Chinese government began to

develop a variety of laws to meet the development of Chinese society. At the end of

1992, the Communist Party of China convened the National People's Congress, which

determined that the planned economy be officially replaced by the socialist market

economy. In 2001, China became a member of WTO.


18

3.3.1 Influences of joining WTO

On December 11, 2001, China became a WTO member and started to fulfill the

obligations of WTO agriculture negotiations, including stop setting his abolition of

non-tariff barriers, reducing tariffs, agricultural export subsidies. The low levels of the

tariff are bound to make the circulation system of the import and export of

agriculture products in China to be severely affected.

After joining the WTO, the circulation of China’s agriculture products has to obey the

general rules of WTO. Also, it has to be conducted under the constraints of China and

other WTO members, which means that China’s agriculture products trade must

comply with international norms. As a result, China’s domestic policy started to

coordinate with multilateral disciplines.

3.4 EU

In December 1991, the Maastricht Summit adopted “the EU Treaty”, commonly

known as "the Treaty of Maastricht" On 1 November 1993, the Treaty of Maastricht

came into effect, and the European Union (EU) was born. The EU is originated from

the European Community, and the six founding members are France, Germany, Italy,

the Netherlands, Belgium, and Luxembourg. The EU now has 28 Member States, and

there are 24 formal official languages.

The EU operates through a system of supranational independent institutions and

intergovernmental negotiated decisions by the member states. Based on "the White

Paper on Food Safety" and "the General food law", the EU started to set relevant

regulations and directives on food safety at the end of 2002.

On 16 December 2002, the EU released COUNCIL DIRECTIVE 2002/99/EC, which

ensured the healthfulness and the specification of the food of animal origin for

human consumption. On 29 April 2004, the EU announced the four supplementary

regulations of “the General food law.” Which are Regulation (EC) No 852/2004, “on

the hygiene of foodstuffs”; Regulation (EC) No 853/2004, “laying down specific

hygiene rules for food of animal origin”; Regulation (EC) No 854/2004, “laying down

specific rules for the organization of official controls on products of animal origin


19

intended for human consumption”; and Regulation (EC) No 882/2004, on official

controls performed to ensure the verification of compliance with feed and food law,

animal health and animal welfare rules (USDA 2012). These regulations consist of a

series of food hygiene measures.

Also, the EU also formulated specific regulations and requirements on feed hygiene,

feed additives, food contaminants, animal drug residues, pesticide residues, food

additives, food labeling, food contact substances, fishery products quarantine, meat

processing products, alcoholic products, genetically modified foods, animal

by-products and other aspects respectively (Lian 2010).

3.5 The relevance of Codex and WTO members in food safety

aspect

3.5.1 GATT and the SPS Agreement

General Agreement on Tariffs and Trade (GATT) is an intergovernmental and

multilateral agreement related to international tariffs and trade rules. Its purpose is

trimmed differential treatment in international trade, the promotion of international

trade liberalization, to take advantage of the world's resources, expand production

and circulation of commodities through the reduction of tariffs and other trade

barriers (Wang 2010).

GATT was signed in Geneva on 30 October 1947 and provisionally applied on 1

January 1948. It should be noted that due to the failure to achieve the requirements

of entering GATT provisions, it has never entered into force. After the

implementation of the GATT, the global multilateral trade negotiations began. In over

40 years, after several tariff reduction negotiations, the tariff of the state party has

substantially reduced, the world trade has grown more than tenfold, and GATT is

playing an important role in the field of international trade.

After modification, GATT has become part of the new WTO agreement. The updated

GATT is the part of the dispute settlement organization, in parallel with "General

Agreement on Trade in Services" (GATS) and the "Agreement on Trade-Related

Intellectual Property Rights" (TRIPS).


20

December 15, 1993, the eighth round of negotiations (the Uruguay Round) achieved

significant progress, the representatives approved a "final document, which

confirmed that WTO would be established to replace GATT meanwhile, reduced the

tariffs of thousands of products. December 12, last meeting of GATT was held in

Geneva. This meeting declared the end of the historical mission of the GATT.

According to the agreement reached in the Uruguay Round, since January 1, 1995,

GATT will be replaced by the World Trade Organization (WTO). GATT no longer exists

as an international organization, but the GATT agreement still exists as the WTO’s

umbrella treaty for trade in goods and updated as a result of the Uruguay Round

negotiations (Crowley, 2003, WTO, 2011).

The SPS Agreement deals with three main issues including food safety, animal health,

and plant health. The SPS Agreement specifies that members shall ensure that any

sanitary and phytosanitary measures should be based on science, any sanitary and

phytosanitary measures without adequate scientific basis are not allowed. Even the

quarantine measures were taken by member states which are higher than

international standards, guidelines, and recommendations, these measures must be

based on science. Also, these SPS measures do not arbitrarily or unjustifiably

discriminate between countries, or in other words; member countries are required to

apply the same legislations/standards to imported food and other product as the

same as they do to food produced domestically. The SPS Agreements states that if

the quarantine measures taken by the exporting country objectively achieve a level

of plant and animal protection of the importing country, the importing Member

should accept this measure. Considering the gap between developing and developed

countries, the SPS Agreement establishes the "special and differential treatment"

and "technical assistance clause.” These measures require developed countries shall

provide technical assistance for the developing countries bilaterally or through

appropriate international organizations, also, developing countries may apply a

longer period of adjustment or the provision of new sanitary measures (Duan 2014).

There are three international organizations recognized in the SPS Agreement to be

the benchmarks namely the Codex Alimentarius Commission (CAC), the World

Organization for Animal Health (OIE), and the Secretariat of the International Plant

Protection Convention (IPPC). The CAC provides the benchmark standards,

recommendations and guidelines for food safety. Though the Codex standards are


21

considered reliable, they are not mandatory to the WTO members. Members can still

set or maintain ‘their appropriate level of protection (ALOP) if they have sufficient

scientific evidence. Nevertheless, they can also extent apply the “precautionary

principle”, a kind of “safety first” approach, where relevant scientific evidence is

insufficient, to deal with the scientific uncertainty that mentioned in Article 5(7) of

the SPS Agreement (Dawson, 1995; Garrett, Jahncke, & Cole, 1998, Van der Meulen,

2010).

3.5.2 The relevance among Codex, EU and China

The Codex standards is a reference that can help China to promote the establishment

of the agricultural standards system. The SPS Agreement clearly points out the

important role of Codex standards in the international food trade and considers the

Codex standards as the basis to resolve international trade disputes and harmonize

international food safety standards (Panpilad 2012).

Many less developed countries have adopted Codex standards with the intent that

they would be more competitive in the global trade. This statement is supported by

the evaluation of the Codex Alimentarius, FAO and WHO Food Standards work

(FAO/WHO, 2002) that members give Codex food standards very high importance.

From 1996-2001, Chinese products barely had no competitive advantage in EU’s

import market, and the scale of EU’s import demand has not changed. One

important reason is that China’s agriculture products cannot meet the requirements

of EU’s standards, especially the level of pesticide residues. After joining the WTO,

the growth rate of China’s agriculture products export is over six times of before. Two

main reasons cause the significant progress (Lu 2011). First, the SPS Agreement

requires developed countries provide technical assistance for the developing

countries bilaterally or through appropriate international organizations, also,

developing countries may apply a longer period of adjustment. Although the

agreement does not explicitly prescribe specific measures China in its capacity of

developing countries can make benefits of technical support and export

opportunities. Second, the SPS Agreement promoted the improvement of China’s

agricultural quarantine system. Especially in setting standards for the agriculture

products, the SPS Agreement declares that the members shall consider the Codex


22

standards as a benchmark, to establish their standards by science, which shows the

direction for China to establish a quarantine system.

Before the WTO agreements came into force in 1995, the work of the CAC was less

important in the world trade. On 1 January 1995, the Agreement on the Application

of Sanitary and Phytosanitary Measures (SPS Agreement) came into force with the

establishment of the WTO. Article 3(1 of the SPS Agreement states that “To

harmonize sanitary and phytosanitary measures on as wide a basis as possible,

Members shall base their sanitary or phytosanitary measures on international

standards, guidelines or recommendations, where they exist, except as otherwise

provided for in this Agreement.” It means that both China and the EU are obligated

to set their standards based on the Codex Alimentarius if there is no scientific data

show that it is necessary to set a standard on a higher level than the Codex

Alimentarius (Hong 2008).

Codex standards are not mandatory in the world trade. However, these standards

will become favorable basis when there is a trade dispute relating to food safety

between WTO members. Many less developed countries use the Codex standards to

take advantage in the global trade. However, the trade barrier between developing

countries and developed countries still exists because the developed countries did

not implement most Codex standards (Jukes, 2000).

EU has the strictest inspection and quarantine measures in agriculture products,

however, many developing countries, such as China, do not have such technical

advantages completely to meet the high inspection and quarantine standards, and

this is so we called the “Green Barriers.” Since the Codex standards are not

mandatory, furthermore, the SPS Agreement does not provide a clear requirement

and standard of the risk assessment, the developed countries may set excessively

high standards to hinder the import from other nations. According to the SPS

Agreement, the members can set their standards if the standards are based on

scientific principles and have sufficient scientific evidence (Wang 2010). This

provision may lead to trade dispute because it is hard to measure “scientific

evidence”, different countries have different views and interpretations the importing

country can choose the most favorable interpretation of their point of view.


23

4. The procedures of establishing the maximum

residue limits

Maximum Residue Limits (MRL) is the most important and the main part of the

pesticide limit system. Whether the MRL is appropriate directly reflects the degree

of perfection of a country. In this chapter, procedures of setting Codex, EU, and

China MRLs are described. Before looking in detail at these procedures, the

paradigm “risk analysis” used for elaborating food safety standards and the risk

assessment applied for setting MRLs also should be well understood. These

methodologies are introduced first.

4.1 Application of risk analysis

In setting the MRLs, the SPS Agreement requires "Members [to] ensure that their SPS

measures are based on an assessment, as appropriate to the circumstances, of the

risks to human, animal or plant life or health, taking into account risk assessment

techniques developed by the relevant international organizations". The elaboration

of this provision can be conducted as the risk-based approach, and risk analysis is

one of the paradigms.

Risk analysis is widely recognized as the fundamental methodology underlying the

development of food safety standards (Horton, 2001). In 1991, FAO, WHO, and the

CAC officially introduced the risk analysis techniques in the evaluation of food safety

hazards. In 1993, the 20th meeting of CAC requested that risk analysis should be

used on the assessment of chemical hazards in food. Afterward, the CAC made a

serious of resolutions and provisions on risk analysis in food safety, which made risk

analysis to be the scientific principles and technical foundation of setting Codex

standards. (Wang et.al 2006).

Risk analysis consists of three components: risk assessment, risk management, and


24

risk communication. The CAC defined these risk analysis terms related to food safety

in the Procedural Manual (FAO/WHO, 2011b).

Figure 1: relationship between the three components of risk analysis

a) Risk assessment: a scientifically based evaluation of potential adverse health

effects resulting from human exposure to hazards consisting of the four

following steps: (i) hazard identification: the identification of biological, chemical,

and physical agents capable of causing adverse health effects and which may be

present in a particular food or group of foods; (ii) hazard characterization

(including dose–response assessment): the qualitative and/or quantitative

evaluation of the nature of the adverse health effects associated with biological,

chemical and physical agents which may be present in food; (iii) exposure

assessment: the qualitative and/or quantitative evaluation of the likely intake of

biological, chemical, and physical agents via food as well as exposures from other

sources if relevant; and (iv) risk characterization: the qualitative and/or

quantitative estimation, including attendant uncertainties, of the probability of

occurrence and severity of known or potential adverse health effects in a given

population based on hazard identification, hazard characterization and exposure

assessment (FAO/WHO, 2013).


25

b) Risk Management: the process, distinct from risk assessment, of weighing policy

alternatives, in consultation with all interested parties, considering risk

assessment and other factors relevant for the health protection of consumers

and for the promotion of fair trade practices, and, if needed, selecting

appropriate prevention and control options. 3. Risk Communication: The

interactive exchange of information and opinions throughout the risk analysis

process concerning risk, risk-related factors, and risk perceptions, among risk

assessors, risk managers, consumers, industry, the academic community and

other interested parties, including the explanation of risk assessment findings

and the basis for risk management decisions (FAO, 2013).

c) Risk communication: Risk communication refers to the exchange of real-time

information, advice and opinions between experts and people facing threats to

their health, economic or social well-being. The ultimate purpose of risk

communication is to enable people at risk to take informed decisions to protect

themselves and their loved ones. Risk communication uses many

communications techniques ranging from media and social media

communications, mass communications and community engagement. It requires

a sound understanding of people’s perceptions, concerns, and beliefs as well as

their knowledge and practices. It also requires the early identification and

management of rumors, misinformation, and other challenges. (FAO/WHO,

1998).

4.2 Risk assessment for establishing the maximum residue

limits for pesticide residues

4.2.1 The application of risk assessment in food safety aspect

Risk assessment can be used to make (revise) food safety standards and in the

development of other management measures, determining priority areas for

international food safety supervision, assessing the effect of the implementation of

regulatory measures, and providing scientific information for risk communication. For

example, the health-based guidance values derived from the assessment of various

risk factors are the basis of developing the index limits of food safety. The CAC


26

expressly provides that the formulation of Codex standards shall base on the results

of risk assessment, the SPS Agreement also stipulates that member states should

formulate food safety standards based on risk assessment (Chen 2009).

4.2.2 Introduction to the procedures of risk assessment

Risk assessment refers to the risk of an event before or after, the possibility of such

events to the various aspects of people's lives, life, and property caused by the

impact and the cost of quantitative assessment work. In other words, risk

assessment is to quantify the extent of the evaluation of an event or thing which may

has impact on assuring an appropriate level of protection.

The risk assessment of pesticide residues in food (including edible agriculture

products) is through the analysis of pesticide residues by toxicology and chemical

test results. According to the consumer dietary structure, produce the scientific

evaluation of the likelihood and extent of health risks due to the dietary intake of

pesticide residues (Zou et.al 2008). Risk assessment is performed in a four-step

process.

(1) Hazard identification: To confirm whether there are factors (chemical, physical,

biological) which have adverse effects on human health in food, and make the

qualitative and quantitative description regard to their characteristics. The main

methods of hazard identification include epidemiological studies, toxicology

studies, foodborne disease surveillance and food contamination monitoring.

Epidemiological studies are the most direct and accurate reflection of the

relations between the hazards and the damage to human health but the costs are

very high, and the data are difficult to obtain. Therefore, toxicology studies

(especially animal testing) are the primary basis for hazard identification in

practical work (Hamliton & Crossley, 2004, Renwick, 2002).

(2) Hazard characterization: Hazard characterization is the qualitative and (or)

quantitative evaluation of the biological, chemical and physical adverse health

effects that may be present in food. The purpose of hazard characterization is to

know the severity and the length of affect time. It focuses on the establishing the

dose-response model between the different exposure levels and a variety of

adverse health effects in various links in the food consumption. The data which

Comment [B2]: ?

Comment [B3]: ?


27

can be used to establish the dose-response model include animal toxicity studies,

clinical human exposure studies, and epidemiological survey data obtained by the

diseases. In most cases, the toxicological or epidemiological data are used to

analyze the dose-response model and build the mathematical simulation model.

Reasonable establishment and analysis of dose-response model depend on

available laboratory data (such as dose level, toxic or harmful reaction measuring

end, etc.) and the adopted mathematical and statistical methods. By the analysis

of dose-response model, the recommended health-based level of value can be

obtained, including acceptable daily intake (ADI), the provisional tolerable daily

intake (PTDI), the provisional tolerable weekly intake (PTWI) and acute reference

dose (ARfD) and the like; and exposure assessment can be combined to expose

the boundary value (MOE). As a result, quantifying the hazard/health effect

under a particular exposure level.

(3) Exposure assessment: Exposure assessment refers to the qualitative and (or)

quantitative evaluation by possible direct food intake and the intake by other

routes of exposure of biological, chemical and physical factors. The basic data

needed in exposure assessment is the contents and the amount of consumption

of microbiological, chemical or physical hazards in food. Depending on the

concerns of the adverse health effects, exposure assessment can be divided into

short-term (acute) and long-term (chronic) exposure. Chronic exposure (daily

assessment of the entire life cycle of exposure scenarios) is usually considered

regarding the evaluation of chemical hazards. For certain contaminations such as

pesticide residues and veterinary drug residues, acute exposure (mainly for

assessment of exposure to harmful factors in foods within 24 hours) also needs to

be considered. By comparing the results of dietary exposure and health-based

guidance values of corresponding chemical hazards, the degree of the risks can

be determined. The microbial exposure assessment, which describes the

distribution and consumption of pathogenic microorganisms in the foods when

being consumed, typically for a single exposure to a contaminated food. The

various types of environmental conditions (such as temperature, humidity, etc.)

and even the storage time can significantly change the hazard level of the

bacteria thus increasing the complexity of the assessment.

(4) Risk characterization: Risk characterization means the qualitative and (or)

quantitative estimation and the accompanied uncertainties of the likelihood and

severity of known or potential adverse health effects for a given population,

based on the results of hazard identification, hazard characterization, and


28

exposure assessment. For the chemicals which have the threshold, the risk

depends on the ratio of the amount of exposure and the measurements which

are called health-based guidance values such as acceptable daily intake (ADI),

tolerable daily intake (TDI), provisional tolerable weekly intake (PTWI), etc. For

chemicals which do not have the threshold, the calculation of population risk is

needed, which means to evaluate whether increased number of cancer cases is

acceptable (not a risk) or unacceptable (risk) based the estimated intake. The

microbial risk estimation could be a qualitative description. Such as dividing the

risk of a certain pathogen into high, medium and low levels; or could be a

quantitative description, such as cumulative frequency distribution of risk per

serving, risks happen to the target population each year, and the relative risk of

different food pathogens, etc. Risk characterization should also explain both

quantitative and qualitative uncertainties of extrapolating the results of animal

experiments to human beings. In practical works, these uncertainties can be

overcome by taking additional experiments (such as the human test) or by the

judgment of the experts. For the situation that the data are insufficient to

establish health-based guidance values or mode of action of a substance the

absence of a threshold, the evaluation is based on the margin of exposure (MOE)

between an estimated human dietary exposure doses and the dose which

produces toxic effects in animals (Dun et.al, 2005).

4.3 Risk assessment for establishing the maximum residue

limits for pesticides

The exposure to artificially added materials (such as pesticides and additives) in

foods is controllable, while the exposure of most contaminants is unavoidable, and in

general, most of these substances have a threshold (not genotoxic or carcinogenic).

Therefore, the most common method of the dose-response assessment is setting

health-based guidance values to describe the characteristics of risks to assess the risk

of certain substances.

4.3.1 Health-based guidance values of pesticide residues in food

The most common health-based guidance value of pesticide residues in food is called

acceptable daily intake (ADI). ADI is defined as “a person ingests a certain substance

every day until a lifetime. While the substance cannot produce the amount of

adverse health effects which can be detected”, and it is represented in many


29

substances which can be ingested per kilogram of body weight (mg/kg BW), ranging

from 0 to an upper limit (Jia 2011). It is emphasized that ADI is determined based on

currently available scientific data, that is to say, we cannot guarantee the safety of

chemical substances ADI needs to be constantly modified according to the new

toxicity data. By the same token, even if the amount of exposure is slightly more than

the ADI, it does not mean it will constitute a hazard to health, various factors are

necessary to be considered to make further modifications. JMPR also use acute

response dose (ARfD) as the health-based guidance value. ARfD usually expressed in

weight, means the amount of the intake of a substance from food and/or drinking

water in 24 hours, which does not produce significant amounts of health risks to a

human body.

4.3.2 Derivation of health-based guidance values

To better illustrate the derivation of health-based guidance values, it is necessary to

first understand the following concepts.

No observed adverse effect level (NOAEL): NOAEL means under the same exposure

conditions, compared to the same strain of the control group, by animal

experimentation or observation, found no maximum concentration or amount of

harmful effects of the test substance-related form, function, growth, development,

etc

Benchmark Dose (BMD): Dose-response curves obtain BMD, reaches a

pre-determined damage effects incidence (usually 1% to 10%) of the statistical

confidence interval of dose. Usually, use 95% of the BMD (Lower Confidence Limit),

also expressed as BMDL as a benchmark.

Reference point or the point of departure (POD): a value determined by the

dose-response based on the most sensitive and human-related indicator, such as

NOAEL and BMD, etc.

Uncertainty factor (UF)/ safety factor: A composite coefficient applied by the risk

assessors in deriving health-based guidance values. This coefficient depends on the

nature of the test substance toxicity, scope and amount of test substance applied for

the crowd, as well as factors such as the quality of toxicological data. The UF is

considered as 100 the main considerations are interspecific differences and

intraspecific differences. I.e. assume that humans are ten times more sensitive than

the experimental animals, and the difference of sensitivity within a population is ten

times. 100-fold uncertainty factor is mainly based on experience; it is not fixed.


30

The calculation of health-based guidance values can be simply described as follows:

HBGV = POD / UF

As mentioned earlier, HBGV represents health guidance values, POD includes NOAEL

or BMD / BMDL, UF represents an uncertainty factor (or safety factor)

Health-based guidance values can be derived in two ways: NOAEL method and the

BMD method.

a) NOAEL method has been used more than 50 years, including the following steps:

First, select the appropriate data: a sufficient sample volume, at least one dose group

was not statistically significant difference; related strains have relevant end points of

observation, etc. Second, the statistical analysis: pairwise statistical comparison

between each test substance group and the control group. Third, determine NOAEL:

after the first step and the second step. Basically, a no observed adverse effect level

of the maximum dose can be determined, which is NOAEL. Fourth, determine the UF:

use the default value of 100. As described above, this value is not static, if the

information is not sufficient, the UF can be further modified. Fifth, Calculate

health-based guidance values: HBGV = NOAEL / UF.

The key steps of NOAEL method are first and third steps, which are choosing the

appropriate data and determining NOAEL. The main challenge faced by this method

is that it extremely relies on the sensitivity of the experimental method. The second

step determines whether the comparison of the statistical analysis of each dose

group and the background (such as the control group) can produce a significant

statistic effect. If there is no statistical significance, the intake level is considered will

not have a harmful biological effect, the highest dose level which does not produce

adverse effects is determined as NOAEL.

b) The determination of NOAEL mainly depends on the following elements of

experimental design: (1) Number of samples in dose groups: the intensity of

determining a certain dose level as NOAEL directly depends on the number of

samples of the chosen dose level, the bigger the number, the smaller the NOAEL.

(2) Dose selection: NOAEL must be a dose level set in an experiment. Therefore,

the real threshold may be higher or lower than the NOAEL, if the threshold is

higher than NOAEL, the difference between them may be very limited (related to

the selected pitch of the dose), once the real threshold is lower than the NOAEL,

the difference between them may be unlimited. (3) Experiments related

differences: including biological differences between individuals (such as genetic),

the difference of the experimental conditions (such as feeding time, laboratory


31

site, etc.), and deviation of related measures. The bigger the differences between

individuals, the lower the statistical power, thereby the obtained NOAEL is bigger.

The BMD method is usually used as an alternative method of NOAEL, including

following steps:

First, select the appropriate data, including adequate and sufficient dose group

regard to different response level, and an adequate number of individuals. Second,

select the appropriate model, and simulate the dose - response model. Third,

statistical analysis, the expected results, and observed results must be consistent, the

difference between them can be narrowed by optimizing some standard functions.

Fourth, determine the BMD (or BMDL). Select an appropriate response in the range

of response experiments, often reoffered to the benchmark response (BMR), then

calculate the BMDL. Fifth, determine the UF: same as NOAEL method. Sixth, calculate

the health-based guidance values: HBGV = BMDL / UF. As a potential alternative to

the NOAEL.

BMD method has the following advantages: (1) BMD methods uses the statistical

analysis of entire dose - response data, which can quantify the uncertainties. The

NOAEL value is based on a single test dose, since that the uncertainties cannot be

qualified, the reliability and accuracy of NOAEL are difficult to assess. (2) BMD

method uses BMDL as the POD OF health-based guidance values, makes the

processing of the amount of sample more reasonable. For example the smaller the

sample size, the greater the uncertainty in the model estimation results, the greater

the confidence limit of the range, so that the corresponding BMDL reduced. The

NOAEL method highly depends on sample size, small sample size experiments tend

to have bigger NOAEL values, and this will lead to errors caused by the experimental

design deficiencies (Wang 2013).

4.3.3 Dietary exposure6

When making dietary exposure assessment, the data of food consumption and

chemical contents in food are used to obtain the estimated dietary exposure. Then

the estimated dietary exposure is used to compare with the relevant health-based

guidance values or toxicological POD (NOAEL; BMDL) to conduct the risk

characterization. The assessment can be divided into acute (short-term) or chronic

6 Since all organizations carry out the estimation of dietary intake according to the WHO guidelines

for predicting the chronic and acute dietary intakes (WHO, 1997).


32

(long-term) exposure assessment. Dietary exposure assessment should cover the

general population and key populations. Key population refers to the people who are

more sensitive to chemical hazards or exposure levels of whom are significantly

different from the general people, such as infants, children, pregnant women, the

elderly and vegetarians. Dietary exposure assessment is a crucial element of the risk

assessment of pesticide residues. The equation of dietary exposure is:

the exposure amount = ∑(𝐶𝑜𝑛𝑐𝑒𝑛𝑡𝑟𝑎𝑡𝑖𝑜𝑛𝑠 𝑜𝑓 𝑐ℎ𝑒𝑚𝑖𝑐𝑎𝑙 𝑟𝑒𝑠𝑖𝑑𝑢𝑒𝑠 𝑖𝑛 𝑓𝑜𝑜𝑑 × 𝐹𝑜𝑜𝑑 𝑐𝑜𝑛𝑠𝑢𝑚𝑝𝑡𝑖𝑜𝑛)

𝐶𝑜𝑛𝑠𝑢𝑚𝑒𝑟′𝑠 𝑏𝑜𝑑𝑦 𝑤𝑒𝑖𝑔ℎ𝑡

The risk of dietary exposure is determined by the amount of exposure and the

toxicological reference values of the chemicals (such as ADI and ARfD), and the

equation is: risk(%) =𝑡ℎ𝑒 𝑒𝑥𝑝𝑜𝑠𝑢𝑟𝑒 𝑎𝑚𝑜𝑢𝑛𝑡 𝑖𝑛 𝑑𝑖𝑒𝑡𝑎𝑟𝑦

𝐴𝐷𝐼 𝑜𝑟 𝐴𝑅𝑓𝐷× 100

4.4 Codex MRLs

In dealing with the Codex Pesticide Residues, Codex Alimentarius Commission (CAC)

and the Codex Committee on Pesticide Residues (CCPR) are responsible for providing

advice on risk management and decision-making, The Joint FAO/WHO Meeting on

Pesticide Residues (JMPR) is responsible for risk assessment (FAO/WHO, 2011c).

The start of MRL's determination process is that a member state or an observer

nominates a pesticide for evaluation by the JMPR. After the consideration with the

JMPR Joint Secretaries, the pesticide may be prioritized and scheduled for evaluation.

Second, the WHO Core Assessment Group considers available data for a broad range

of toxicological endpoints. If the data are sufficient, an acceptable daily intake (ADI)

and an acute reference dose (ARfD) where necessary can be estimated. Third, The

FAO Panel of Experts on Pesticide Residues in Food and the Environment considers

data on registered use patterns, the fate of residues, animal and plant metabolism,

analytical methods and residue data derived from standardized residue trials, to

propose the definition and maximum residue levels for the pesticide in food and feed.

Fourth, the JMPR risk assessment. The JMPR risk assessment includes the estimation

of both short-term (single day) and long-term dietary exposures and their

comparison with the relevant toxicological benchmarks (FAO/WHO 2014). MRLs in

food and feed are based on good agricultural practices (GAP) as well as taking into

account the dietary intake. Products produced by the foods which comply the MRLs

standards are considered toxicology acceptable. Fifth, the CCPR considers the

recommendations proposed by the JMPR according to the information provided in


33

the relevant JMPR reports and monographs. MRL recommendations accepted by the

CCPR are submitted to the CAC for adoption as Codex MRLs (CXLs). An active periodic

review program complements this process (FAO/WHO, 2011d). Extraneous Maximum

Residue Limits (EMRLs)

EMRL refers to an environmental pesticide residue or a contaminant due to the

former agricultural use of a pesticide. It is not arising from the direct or indirect use

of a pesticide on food or feed. It is the maximum concentration of a certain pesticide

residue in food or feed that is recommended by the CAC to be legally permitted or

recognized.

The Codex’s procedures of establishing MRLs can be concluded in the following table:

MRL acceleration procedure

To accelerate the approval of proposed MRL, Step 6 and 7 in the table above, and the

proposed pesticide is adopted at Step 8. This procedure is called “Step 5/8-

procedure”. The preconditions for utilization of Step 5/8 Procedure are:

a. The new proposed MRL is circulated at Step 3;

b. The JMPR report is available electronically by early February;


34

c. No intake concerns were identified by JMPR.

The Joint FAO/WHO Meeting on pesticide Residues (JMPR)

The Joint FAO/WHO Meeting on Pesticide Residues (JMPR) is an independent

scientific expert body is constituted by the FAO Panel of Experts on Pesticide

Residues in Food and the Environment and the WHO Core Assessment Group. It is

convened by both Directors-General of FAO and WHO according to the rules of both

organizations, charged with the task of providing scientific advice on pesticide

residues (FAO/WHO, 2011f). JMPR is primarily responsible for risk assessment and

proposing MRLs. JMPR also gives advice on the median residues found in supervised

trials (STMR) and highest residue in the composite sample of edible portion (HR) of

the dietary intake. The result is the basis for CCPR and CAC to make their risk

management decisions. The risk assessment provided by JMPR is the basis for CCPR

discussion (CAC 2015).

The JMPR procedures for recommending MRLs are summarized in the following

figure:

Figure 1: JMPR evaluation of the residue data and recommendation of MRLs (IPCS

2009)


35

JMPR should clear and inform the CCPR the applicability and constraints of both

general population and specific groups in its assessment. It should also determine

potential risks and may increase the vulnerability of people (such as children) to the

extent possible. JMPR should strive to conduct dietary exposure assessment and risk

assessment, including data from developing countries in the global database. In

addition to the Global Environment Monitoring System (GEMS), food data, data from

consumption monitoring and exposure studies may also be used. JMPR uses the

WTO and FAO guidance documents when processing the dietary exposure risk

assessment. JMPR determines the ADI and calculates international daily intake

estimates (IEDI). It also determines the ARfDs, after the determination of ARfDs,

JMPR can estimate the International Estimate of Short-term Intake (IEST) for the

general population and children (under six years old).

It should be noticed that even the Codex standards are considered the guidelines for

pesticide MRLs all over the world they do not cover all kinds of pesticide residues in

every agricultural product. Moreover, since the Codex standards are not mandatory,

there are no provisions or regulations which prescribe that the pesticide should be

forbidden, if is not included in the Codex standards. As a result, there are still some

“missing parts” of the Codex standards, for example, there is no codex standards for

acetochlor in soybeans (Ma 2008).

4.5 China MRLs

4.5.1 Risk assessment of pesticide residues in food or food

products

China’s risk assessment of pesticide residues in food or food products includes the

following aspects (Zhang 2013):

1) Toxicological assessment

The toxicology assessment of pesticide residues is to identify the hazards of the

pesticide residues and describe their hazard characterization, by evaluating the toxic

kinetics and the results of toxicology trials, derive the recommended ADI and ARfD.

2) The chemical residues assessment


36

The chemical residues assessment is the evaluation of pesticides and their toxic

metabolites’ residue behavior in food or the environment. The STMR and HR can be

derived by evaluating the results of animal and plant metabolism trials, field residue

trials, feeding trials, processing and environmental behavior trials. There are three

steps: First, refer to the toxicological assessment, process the animal and plant

metabolism studies, and assess the metabolism and the final product of the pesticide,

to determine the residue. Second, evaluate the effectiveness of the residue analysis,

the storage stability of the samples, the administration dose, safety interval, sample

collection, transport and pretreatment and test results, to propose normal STMR and

HR. Third, evaluate the variation of the pesticide residue before and after food

processing, calculate the processing factors, and evaluate the change like the

pesticide during the process if necessary.

3) The dietary intake assessment

The dietary intake assessment is based on the chemical and toxicological evaluation

of the residue. According to dietary consumption of Chinese residents, estimate the

dietary intake of pesticides, including long-term and short-term dietary intake.

The long-term dietary intake assessment is based on China National Nutrition and

Health Status Monitoring Survey published by the National Health Administration of

China or the relevant reference materials, calculate the national estimates daily

intake (NEDI) by the STMR. The equation is: NEDI =∑［STMRi（STMR-Pi）× Fi）］

STMRi – the Supervised Trials Median Residue of a certain pesticide in food of food

products

STMR-Pi – the STMRi calibrated with the processing factor

Fi – the consumption of a certain food of the general population

If there is no appropriate STMR STMR-P, the corresponding MRL can be used in

calculating NEDI.

The short- term dietary intake assessment

The acute dietary intake assessment is based on the China National Nutrition and

Health Status Monitoring Survey released by the National Health Administration of

China or the relevant reference materials, calculate the national estimates of

short-term intake (NESTI) by the STMR or the HR.

4) The results of assessment

Under normal circumstances, when the NEDI is below the ADI or the NESTI is below


37

the ARfD, the recommended maximum pesticide residue limit is considered will not

produce an unacceptable health risk, and can be proposed to the risk management

organization.

4.5.2 General procedures of establishing MRLs

Draft standards of MRLs

The start of establishing MRLs for pesticides is the draft standards of MRLs, including

following steps (MOA 2015):

1) Determination of Supervised Trails Median Residue (STMR) and Highest Residue

(HR)

Carry out the supervised field trails under the conditions of good agricultural practice

(GAP) for pesticide application in accordance with the requirements of the

"Regulations on Registration Information of Agricultural Pesticides" and the "Criteria

on Pesticide Residue Field Trails" (NY/T 788), and determine the supervised trails

median residue (STMR) and highest residue (HR) based on the results of the field

trails.

2) Determination of Acceptable Daily Intake (ADI) and / or Acute Reference Dose

(ARfD)

Formulate the ADI according to the results of metabolic kinetics and toxicological

evaluations. For pesticides with acute toxicity, formulate the ARfD.

3) Proposing the Maximum Pesticide Residue Limits (MRL)

Determine the maximum residue level according to China's dietary consumption data,

calculate the NEDI, or NESTI according to the supervised field trails data, in order to

carry out the risk assessment of dietary intake and propose the national standards of

MRL for food safety.

Temporary MRLs

When the following situations occur, temporary MRLs can be implemented:

1) When the daily intake in temporary;

2) When there are no reliable dietary data


38

3) When there is no required standard of field trail method;

4) When there is international trade and import inspection needs as the pesticides

or pesticide/crop combinations are not registered in China;

5) In emergency cases, the pesticide has been approved for use on an unregistered

crop, an emergency limit standard should be formulated and the scope and time

of its application should be defined;

6) When other information doesn't fully meet the requirement of the assessment

procedure.

The establishment of the temporary limits shall refer to the procedures for

formulation of the maximum pesticide residue limit. When new data are obtained,

the amendment should be made in time.

After that, the proposed MRLs are examined by the Institute for Control of the

Agrochemicals, Ministry of Agriculture (ICAMA)7. When the proposal is approved,

ICAMA will put it on record, and notify the WTO. Finally, the standard of MRL will be

released by the Ministry of Health and the Ministry of Agriculture jointly, and the

Standardization Administration of the People's Republic of China (SAC)8 will provide

the national standard number (USDA 2015).

Supervised Field Trials: refer to the trials which are conducted to obtain the highest

possible residual value and the degradation dynamics of the recommended pesticide

in edible (or feeding) primary agricultural products or soil (or water).

Supervised Trials Median Residue (STMR): the median of the data set consisting of

plurality of registered residue trials under the condition of the Good Agricultural

Practice (GAP) and Good Laboratory Practice (GLP) or similar conditions.

7 ICAMA, as mandated by MOA, specializes in nationwide pesticide registration and administration with the main

responsibilities for registration, quality control, bioassay and residue monitoring of pesticides, supervision of

pesticide markets, information-sharing, international cooperation and other services.

8 The Standardization Administration of the People's Republic of China is the standards organization authorized

by the State Council of China to exercise administrative responsibilities by undertaking unified management,

supervision and overall coordination of standardization work in China.


39

Highest Residue (HR): highest residue in composite sample of edible portion found in

data from supervised trials data from which the MRL or STMR was derived

National Estimated Daily Intake (NEDI): the estimate of the long-term intake of

pesticide residues, the calculation of which is based on the average daily food

consumption per person and the STMR (in mg/kg bw commodity).

National Estimated Short Term Intake (NESTI): the estimate of the short-term intake

of pesticide residues, the calculation of which is based on the average daily food

consumption per person per day and the data from supervised field trials. The main

consideration is the residues in edible parts of the food, including the transformation

products which have toxicological significance (in mg/kg bw commodity).

Good Agricultural Practice (GAP) for pesticide application: refers to the use, scope of

use, dosage, frequency of use and safety interval of the pesticides approved by

China’s pesticide registration.

Good Laboratory Practice (GLP): a quality system related to design, implementation,

inspection, recording, archiving and reporting of the non-clinical human health and

environmental experiments.

The procedures of setting pesticide MRLs in China are summarized in the following

figures


40

Figure 2: Procedures of setting China’s pesticide MRLs

Figure 3: Procedures of publishing China’s proposed MRLs

As mentioned in chapter 2, by 2014, China’s standards for pesticide residues included

322 kinds of pesticides, 3650 kinds of MRLs in more than 200 kinds of foods, and the

number did not change much by the end of 2015 (ICAMA 2016). For the pesticides

which are not banned, or do not have formal or temporary standards on a certain

agricultural product, it seems that the Chinese government will not intervene the use

of this kind of pesticide, and this means that the farmers can use the pesticide on the

certain product freely.

4.5.3 Legal basis of China MRLs

Food Safety Law of The People's Republic of China regulates the publication and

implementation of the National Food safety standards of Maximum residue limits for

pesticides in food (GB 2763) and confirms its legality. Article 26 of the Food Safety

Law of The People's Republic of China confirms the necessity of pesticides MRLs in

China: ‘Food safety standards shall include the following: (1) The limits of pathogenic

microorganisms, pesticide residues, veterinary drug residues…’. Article 27 recognizes

the authorized organizations of the food safety standards: “The executive


41

department of health under the State Council together with the state council

department for food and drug administration shall formulate and release national

food safety standards; … The limits of pesticide residue and veterinary drug residue

in food and their testing methods and procedures shall be developed by the

executive department of health and agriculture under the State Council together

with the state council department for food and drug administration…”. Article 25

emphasizes the legality of the food safety standards: “Food safety standards are

compulsory standards. Outside of the food safety standards, other compulsory

standards for food must not be developed”. These articles show that the national

standards of pesticide residues are compulsory, unique and unified. In addition, Law

of the PRC on quality and safety of agricultural products further specify the necessity

of the standards of the agricultural products, as well as their requirements, which are

stated in Article 11: “The quality and safety standards of agricultural products

provide the compulsory technical specifications. The quality and safety standards of

agricultural products shall be formulated and published in accordance with the

provisions of the relevant laws and administrative regulations” (MoA, 2006).

4.6 EU MRLs

European Union (EU) legislation fully regulates the use of plant protection products

(PPPs) and their residues in foods by Regulation 1107/2009 and Regulation (EC)

396/2005 respectively.

Regulation (EC), 396/2005 on maximum residue levels of pesticides in or on food and

feed of plant and animal origin, lays down the rules and procedures of setting,

monitoring and control of the pesticide residues in foods and feeds (DG SANCO,

2011b).

The PPPs or Pesticides cannot be placed on the EU market unless it is authorized by

Regulation 1107/2009, concerning the placing of plant protection products (PPPs) on

the market; and Directive 91/414/EEC. However, Directive 91/414/EEC can only apply

on the procedure and conditions for approval (a) to active substances for which a

decision has been adopted by Article 6(3) of Directive 91/414/EEC before 14 June

2011; .....” The authorized active substances are listed in Annex I of this Directive. The

list of EU definitive MRLs is laid down in Annex II. The so-called EU temporary MRLs


42

(pesticides for which, before 1 September 2008, MRLs were only set at a national

level), are listed in Annex III. The list of pesticides for which no MRLs are needed

because of their low risk is included in Annex IV. Annex V, which will contain the list

of pesticides for which a default limit other than 0.01 mg/kg will apply and Annex VI,

which will contain the list of conversion factors of MRLs for processed commodities,

have not been published yet. Annex VII contains a list of pesticides used as fumigants

for which the Member States are allowed to apply special derogations before the

products are placed on the market.9

4.6.1 Procedures for setting EU MRLs

The MRLs are set based on the authorized active substances listed in Annex I of

Directive 91/414/EEC. When the applicant wants to make an application for MRL,

according to Article 7 of Regulation (EC) No 1107/2009, an application for the

approval of an active substance or for an amendment to the conditions of an

approval shall be submitted by the producer of the active substance to a Member

State (the rapporteur Member State), and according to Article 11 of this regulation, if

the application is admissible, the rapporteur Member State shall prepare and submit

a draft assessment report to the Commission (Regulation 1107/2009). The

Commission further informs the other Member States and forwards the application,

the evaluation report, and the supporting dossiers to EFSA. Then EFSA will assess the

implementation and the assessment report and give reasoned opinions, and submit

to the Commission. Then according to Article 13, the Commission shall present the

review report and draft Regulation to the Standing Committee, which is the

Commission working group on pesticide residue, composed of all MSs’

representatives after taking in to account the draft assessment report by the

rapporteur Member State and the conclusion of EFSA. After that, the Standing

Committee shall give out its opinion about the proposed regulation. The decision can

be one of the following;

9 For more information, see:

http://exporthelp.europa.eu/thdapp/taxes/show2Files.htm?dir=/requirements&reporterId1=EU&file1=ehir_eu14

_02v001/eu/main/req_heapestires_eu_010_1003.htm&reporterLabel1=EU&reporterId2=NL&file2=ehir_nl14_02

v001/nl/main/req_heapestires_nl_010_1003.htm&reporter


43

- set new or modified MRLs and list them in the Annex II to Regulation 396/2005 (in

case the active substances have been included in the list of active substances

approved under Regulation 1107/2009); or

- set or modify temporary MRLs and list them in the Annex III to Regulation396/2005

or

- reject the application

If approved, the draft Regulation will be presented to the Parliament and Council,

who have the right to scrutinize the rationality of the proposed regulation based on

the decision of the examination procedure committee, composed of all MSs’

representatives and chaired by the Commission. If the Parliament and Council

approve the draft Regulation, the formal Regulation will be adopted and published

by the Commission. If not approved or there is no opinion, an amended version of

the proposed regulation may be submitted to the same committee, or the draft

Regulation may be presented to the appeal committee, which is also composed of all

MSs’ representatives. And if the appeal committee approve the proposed regulation

it can be adopted and published by the Commission.

Finally, the proposed MRL will be published in the Official Journal of the European

Unions.

Temporary MRLs

There were some pesticide residue limits in some agricultural products which do not

have Community MRLs, and the Member States could set MRLs at a national level.

Until September 2008, Regulation 396/2005 was enforced to harmonize the MRLs

among MSs in the EU. In this case, the EU temporary MRLs listed in Annex III of this

Regulation are set to harmonize these MRLs according to this Regulation. EFSA is

responsible for evaluating these national MRLs and providing its reasoned opinion to

the Commission. Such temporary MRLs should be set based on the existing national

MRLs and those temporary MRLs do not have an adverse effect on human and

animal health. The procedure for setting temporary MRLs is laid down separately in

Article 16 of Regulation 396/2005.

For pesticides on certain products which are not banned or do not have formal or

temporary limits, the EFSA will set a default MRL. Normally the default MRL is 0.01


44

mg/kg, for specific cases, if there are scientific evidence that proves the reasonable

default limits are other than 0.01 mg/kg, EFSA will give out reasons and list them in

Annex VI of Regulation 1107/200910.

The procedures for setting EU MRLs are summarized in the following Figure

Figure 4: The summarized procedures for setting EU MRLs

4.6.2 The European Food Safety Authority (EFSA)

In the late 1990s, a series of European food safety incidents threated the European

food safety. Thus, Mr. David Byrne, the member of Directorate-General for Health

and Consumers (DGSANCO) started to establish a new EU food safety management

10

For detailed lists, see http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=URISERV:sa0016&from=EN


45

system. January 2000, the European Commission released the “White Paper”,

proposed the establishment of the European Food Safety Authority (EFSA) to

coordinate the Member States and create new food regulations at European level.

Based on the purpose of letting consumers get a complete protection in food safety

aspect, the EFSA was established in 2002 in Article 22 of the General Food Law as an

independent source of scientific advice and communication on risks associated with

the food chain (van der Meulen, 2008). The main purpose of the establishment of

the EFSA is to provide independent scientific advice, to help the EU decision-making

unit make appropriate decisions regarding direct and indirect issues risks in the food

chain. The establishment of the EFSA enhances consumers’ confidence. The main

tasks of the EFSA are as followings:

(1) In accordance with the requirements of the European Commission, the European

Parliament (EP) and the Member States on food safety issues and other related

matters, such as animal health / welfare, plant health, GMO (genetically modified)

and nutrition, provide independent scientific advice, and as a basis for the

decisions of risk management.

(2) Provide technical advice on food related issues, in order to promote the

development of the food chain-related policies and regulations;

(3) Collect and analyze the data on food and essential information associated with

any potential hazards;

(4) Emergency hazard identification and early warning;

(5) Support the work of the European Commission at a critical moment;

(6) Consult comments on all matters within its purview to the public.

The EFSA is organized in five directorates overseen by EFSA’s Executive Director

(EFSA, 2011a);

- Three science directorates namely Risk Assessment and Scientific Assistance,

Scientific Evaluation of Regulated Products and Science Strategy and Coordination;

- The Communications Directorate; and

- The Resources and Support Directorate.

The Scientific Evaluation of Regulated Products Directorate is responsible for


46

evaluating the substances, products, and claims intended to be used in the food

chain in order to protect public, plant and animal health as well as the environment.

It consists of several units and Panels focusing on specific areas including food

additives, and pesticide residues. For the establishment of the MRLs, Pesticide Risk

Assessment Peer Review Unit (PRAPeR) will organize and conduct the review of the

initial pesticide risk assessments for setting MRLs provided by designated Member

states. If questions are found during the assessments for certain MRLs and/or active

substances that cannot be resolved by the team of the PRAPeR Unit, it may consult

the PPR Panel for a scientific opinion (EFSA, 2011b).

4.7 The relevance and differences in the MRLs of the CAC, EU

and China

As described in Chapter 3, on 1 January 1995, the SPS Agreement came into force

with the formation of the WTO. In the Article 3(1 of this Agreement, there is the

requirement that member countries base their SPS measures on recognized

international standards, guidelines, and recommendations. For food safety, the

members should set their measures on a basis of Codex standards. The European

Union became the member of the WTO and started to implement the SPS

Agreement at the first time, and for granted, began to set the pesticide MRLs by

Codex standards. China joined the WTO in 2001, after being a member of the WTO, it

also set the pesticide MRLs by Codex standards just like other WTO members.

Furthermore, as mentioned before, Art. 5(1) of the SPS Agreement also requires the

members ensure their SPS measures are based on an assessment, taking into

account risk assessment techniques developed by the relevant international

organizations. In other words, as the members of SPS Agreements, both China and

EU should ensure their measure of setting pesticide MRLs are based on risk analysis,

which is widely recognized as the fundamental methodology underlying the

development of food safety standards. The widely used risk analysis related to food

safety is defined by the CAC in the Procedural Manual (FAO/WHO, 2011b).

Despite that the codex, EU and China all use risk analysis in setting the pesticide

MRLs, the value of the MRLs may be different; this is because China and EU need to


47

take into account the situation of their territory while the codex needs to take into

account the situation all over the world. Furthermore, the three organizations’

treatments to the pesticides which are not in their lists of pesticide MRLs are totally

different.

Since the Codex standards are not mandatory, for those pesticide residues in certain

products which are not included in the Codex standards, the CAC will not interfere

the use of them. For EU and China, there are two situations that may happen if the

pesticide residues in certain products which are not included in their standards. First,

the pesticide is banned in the certain products. When it comes to this situation, both

China and EU do not allow the use of the pesticide in the products in their territory.

Second, the pesticide is not banned to be used in certain products, and it is not

included in the list of pesticide MRLs. When facing this situation, the EU has a default

MRL for that kind of pesticides, and normally the default value is 0.01 mg/kg. While

the Chinese government will not interfere the use of this kind of pesticides, and the

reasons that may cause the differences will be discussed in the following chapter.


48

5. Comparative study

The reasons of the MRL difference are analyzed in this chapter by investigating the

case “MRL of acetochlor in maize” of Codex, EU and China. It is early mentioned that

risk assessment is the crucial component of risk analysis. This risk assessment step

directly affects the level of proposed MRL, and consequently, the reports of the risk

assessment of acetochlor are studied to find the reasons of this difference.

5.1 Acetochlor and its standard in Codex, EU and China

Acetochlor is a widely used herbicide. It is one of the world's most important

herbicides at present and is commonly used by farmers in China. Acetochlor is

authorized by the CAC and the Chinese government to be used in certain agricultural

products. According to the National Food safety standard--. Maximum residue limits

for pesticides in food (GB 2763-2014), acetochlor, has its maximum residue limits in

peanuts, soybeans, maize, sunflower seeds and brown seeds. According to the

Summary Report from the 2015 Joint FAO/WHO Meeting on Pesticide Residues

(JMPR), the Codex has standards of acetochlor residues in maize. (JMPR 2015).

However, considering the potential harm to human health, according to the

Conclusion on the peer review of the pesticide risk assessment of the active

substance acetochlor (EFSA 2013), the European Commission decided not to allow

the re-registration of acetochlor, and all Member States should cancel the

registration of acetochlor before July 23, 2012, and the grace period of the use of

existing stock should not exceed 12 months. Nevertheless, the EU MRL can be

established as importance tolerance if the data supporting the Codex MRL are

available and if the proposed MRL does not post the risk to the European consumers’

health (EFSA, 2008). Based on the information above, the Codex, EU and China’s

tolerance of acetochlor in maize can be set.

China established the specific MRL of acetochlor in maize at 0.05mg/kg, whereas,

Codex established the MRL of acetochlor in maize at 0.02mg/kg.

From a legal point of view, the EU and China’s tolerance of acetochlor residues in


49

maize are enforced regarding both domestic and import food, on the other hand, the

Codex MRLs comprises only voluntary standards that have been set as a reference in

national legislation and in international /regional trade.

5.2 Comparison in risk assessment

The reports of the risk assessment for setting the Codex, EU and China’s MRLs of

acetochlor residues in maize were studied to find out the technical differences, the

reports of Codex, EU and China are carried out by JMPR, EFSA, and ICAMA

respectively.

It can be found that every organization carries out the risk assessment according to

the guideline provided by the JMPR, including the hazard identification, hazard

characterization, exposure assessment, and risk characterization. In principle, the

toxicological and chemical studies of the pesticide are performed for identifying the

potential of the active substance to cause adverse health effects (hazard

identification), and the results from these studies are further used to determine an

acceptable level of human exposure (hazard characterization). Afterward, the dietary

intake regarding the pesticide residue according to the GAP is estimated (exposure

assessment). The comparison of estimated intake with the acceptable level of

human exposure is finally conducted (risk characterization).

The exposure assessment step is the main step which may cause the differences

between the risk assessment of Codex, EU and China. The methods used by Codex,

EU and China to estimate the long-term and short-term dietary intakes assessment

are described as follows.

JMPR uses the WHO Guidelines for estimating dietary intake of pesticides residues

(revised) (FAO/WHO, 2011f). EFSA also uses the general agreed methodologies for

long-term exposure developed by WHO as the basis of the procedures and practices

used within the EU to ensure that MRLs are safe (EFSA 2007). The same also happens

in China as mentioned before, and the methods and the results of China’s proposed

MRLs will also be reviewed by the WTO and WHO panel before entering into force. It

can be concluded that all organizations (JMPPR, EFSA, and ICAMA) perform the

long-term exposure assessment according to the WHO Guidelines for predicting

intake of pesticide residue (WHO, 1997).


50

According to the FAO guidelines, the JMPR conducts the acute dietary by using the

WHO guideline about the risk assessment of acute hazards and estimating dietary

intake of acutely toxic pesticide residues (JMPR 2003). The WHO developed

guidelines for the exposure assessment of pesticides from food intake, which was

revised in 1997 and can be applied in all the Member States at the national level in

Europe, the new guidelines provide instructions on how to carry out short-term

exposure assessment (Wang et.al 2009). As mentioned before, China started to

develop its pesticide limit system from the 1990s. The method is based on the WHO

guidelines.

5.3 The risk assessment report of the JMPR, EFSA, and ICAMA

regarding to acetochlor

Data used in the risk assessment of acetochlor MRLs

Since the Codex, EU and China all use the same methodology of risk assessment of

acetochlor, to find out the reasons for the difference of the Codex, EU and China the

scientific data influenced the level of the proposed MRLs should be indicated.

All the organizations use risk assessment in establishing acetochlor MRL, and use the

WHO guidelines to estimate the chronic and acute dietary intakes as the reference

for conducting the exposure assessment. Therefore, the WHO guidelines are used to

analyze the scientific data that may cause the differences in the value of proposed

MRLs.

Based on the information of the process of MRLs elaboration described in the

previous chapter, it can be seen that there are many data used for the establishment

of the MRLs. The data that mainly influence the proposed level of MRL can be

pointed out as follows;

- Good Agricultural Practices and supervised residue trial;

- Toxicological data including an ADI, an ARfD, and a safety factor;


51

- Residue definition;

- Consumption data;

- Body weight;

- Correction factor for refining the estimate intake; and

- Variability factor.


52

Table 2: The summary of the scientific data used in risk assessment of acetochlor in

main crops (including maize)

Comment [B4]: Something missing in

the top right window?

Comment [F5]: The top right window

means that China does not have

specific residue definition of

acetochlor, and the definition of

acetochlor completely refers to the

definition in the standard of MRL.


53

5.3.1 Good Agricultural practices (GAPs) and the supervised

residue trial data

The GAP information includes the pesticide formulation, application rate, number of

applications, interval between applications, method of the application, and

preharvest interval (PHI). GAPs of the use of pesticide normally are officially

recommended or authorized usage of pesticides under practical conditions at any

stage of production, storage, transport, distribution, and processing of food and

other agricultural commodities, bearing in mind the variations in requirements

within and between regions and taking into account the minimum quantities

necessary to achieve adequate control (WHO, 1998). The GAPs are the prerequisites

which must be applied before the establishment of pesticide MRLs in all the

organizations.

The presence of residues on and in plants and plant products is normally unavoidable,

even when the application of the pesticide has followed recommended procedures

and GAP. Therefore, trials on residue behavior are necessary to conduct the complete

risk assessment refers to the residues of a certain pesticide and to determine the

level of residues, in order to propose the recommended MRL.

The establishment of MRL is based on both the GAP data and the supervised trial

data, these data mainly affect the level of the recommended MRL.

The data used in the evaluation of acetochlor in maize are presented below.

(1) Codex (data provided and analyzed by the JMPR)

The JMPR takes into consideration the data from the USA when analyzing the GAP

data and the supervised trial data. The JMPR considered the trials with the capsule

suspension (CS) formulation where the last application can be made closer to

harvest but at a lower rate compared to the emulsifiable concentrate (EC) trials

where applications are made earlier but at a higher rate to give rise to higher

residues and represent critical GAP. Critical GAP (cGap) was considered to be a

pre-emergent application at 0.9 kg ai/ha followed by the post-emergence application

at 2.5 kg ai/ha. The JMPR agreed to utilize the proportionality approach to estimate


54

residues matching cGAP noting that residues from preemergence applications do not

contribute to final residues and that a single post-emergence application at 2.5 kg

ai/ha should be targeted for use in estimating maximum residue levels. The following

scaled residues (n=21) matched cGAP:

Table 3: The summary of the supervised residue trials used by JMPR

In addition, the JMPR also takes into account the 2011 EFSA report, and the data will

be presented in the next table.

The JMPR estimated a maximum residue level, STMR and HR of 0.02 and 0.002

mg/kg respectively for maize.

(2) EU (data provided and analyzed by the EFSA)

In the 2011 EFSA report, a total of 46 supervised residue field trials were provided,

conducted on maize in several European countries in Northern and Southern Europe

from 1996 to 2000 and representing a large range of climatic and agronomic

conditions. Acetochlor formulated as CS and EC were applied at a dose rate ranging


55

from 1890 to 2100 g/ha, either as pre-emergence or post-emergence (BBCH 14 to

18), by the critical GAP. Since most of the samples from the residue trials were

analyzed with an analytical method achieving an LOQ of 0.02 mg/kg for EMA (total

LOQ 0.04 mg/kg), an MRL of 0.05* mg/kg is proposed for maize grain. And the data

are shown in the table below.


56

Table 4: The summary of the supervised residue trials used by EFSA

In this report, EFSA considered that sufficient analytical methods, as well as methods

and data relating to physical, chemical and technical properties, are available to

ensure that quality control measurements of the plant protection product are

possible. However, the data used at that time to set the Codex MRL was insufficient

to derive a residue limit according to the European standard. Therefore, the EFSA

estimated representative formulations with the German and UK models and

determined that the acceptable daily intake (ADI) be 0.0036 mg/kg BW/day using the

LOAEL from the 78-week mouse study with a safety factor of 300. The acceptable

operator exposure level (AOEL) is 0.02 mg/kg BW/day based on the 1-year dog study,

with the use of a safety factor of 100. The acute reference dose (ARfD) is 1.5 mg/kg

BW, derived from the acute rat neurotoxicity study with the application of a safety

factor of 100 (EFSA 2011).

According to the “Reasoned opinion on the review of the existing maximum residue

levels (MRLs) for acetochlor according to Article 12 of Regulation (EC) No 396/2005”

(2013), either the specific LOQ of 0.04 mg/kg for the sum of all compounds forming

EMA on hydrolysis, or the default MRL of 0.01 mg/kg, as defined by Regulation (EC)

No 396/2005, for parent acetochlor or sulfinyl lactic acid, provide a satisfactory level

of protection for the European consumer, noting however that, in case of illegal use,

the occurrence of metabolites containing the EMA moieties cannot be excluded,

even if parent residues levels remain below the default MRL (EFSA 2013). As a result,

acetochlor is completely banned in Europe.

(3) China

For China MRLs, they used the supervised residue data and the STMRs from the

JMPR evaluation for conducting the exposure assessment.


57

5.3.2 Residue definition

In the evaluation report of JMPR in pesticide residues in food (2015) and the

‘Reasoned opinion on the review of the existing maximum residue levels (MRLs) for

acetochlor’. According to Article 12 of Regulation (EC) No 396/2005 (2013), the

residue definitions of acetochlor for compliance with MRLs and estimation of dietary

intake are the same as the sum of compounds converted to EMA, expressed

regarding acetochlor. There is no specific residue definition of acetochlor for

estimating dietary intake in China. However, based on the risk assessment reports,

China also evaluates EMA to estimate the dietary intake.

5.3.3 Acceptable Dietary Intake (ADI) and Acute Reference Dose

(ARfD)

It can be seen from the table above that Codex and EU use the different toxicological

studies for elaborating the ADI and ARfD. The NOEALs in the chronic study of JMPR

and EU are 1.10 and 9.4 mg/kg BW respectively. It shall be noticed that the safety

factors for deriving the ADI are different also. The Codex used the normal safety

factor of 100, while the EFSA used the safety factor of 300 because the EFSA took the

lowest observed adverse effect level into consideration while the Codex does not

(LOAEL) (EFSA 2011). Even JMPR used the lower NOAEL, the ADI of EFSA (0.0036

mg/kg BW) is still less than the maximum ADI of JMPR (0.01 mg/kg BW). It may be

because the EFSA used a higher safety factor. The NOAELs in the acute toxicity study

of JMPR (1 mg/kg BW) is also different from the EFSA (1.5 mg/kg BW) although the

same safety factor of 100 was applied. This may be because the JMPR ARfD of 1

mg/kg BW was established on the basis of a NOAEL of 100 mg/kg BW per day in a

study of developmental toxicity in rabbits (JMPR 2015), while the EFSA ARfD was

derived from the acute neurotoxicity study with rats (EFSA 2011). China used both

the ADI and ARfD of acetochlor from JMPR as a reference.

5.3.4 Food consumption data

The JMPPR used the WHO GEMS/Food Consumption Cluster diets to estimate the

Comment [B6]: Explain why this is a

reason.


58

chronic dietary exposure all over the world, the consumption data is provided by

members, dietary intakes were calculated for the 17 GEMS/Food Consumption

Cluster Diets (JMPR 2015). 97.5th percentile11 consumption data were used to the

risk of acute exposure for acetochlor. In the EU, the average consumption data (per

capita) provided by EU members and the WHO GEMS/Food cluster diets B were used

by EFSA to conduct the chronic exposure assessment for consumers (EFSA 2011). For

the acute dietary exposure, the calculation is based on the highest reported EU

Member State large portion consumption (eaters only). China uses the average

consumption data provided by the National Nutrition and Health Survey and the

WHO GEMS/Food cluster diets G to establish the chronic exposure assessment and

the 97th percentile of Chinese residents (eaters only) consumption to conduct the

acute exposure assessment.

5.3.5 Body weight

All organizations used different data for body weight, the Codex, EU and China used

the average body weight at 60 kilograms, 75.2 kg, and 50 kilograms respectively. This

might be because the JMPR took into account the body weight of all the consumers

in the world, whereas, the EFSA only took into account the body weight of the EU

Members that have the highest consumption and China only took into account the

body weight of Chinese residents.

5.3.6 Correction factors

(1) Edible portion

The edible portions of maize and other commodities were not used for refining the

dietary intake calculation in the risk assessment of acetochlor. Their edible portions,

therefore, cannot be compared.

(2) Processing factor

For acetochlor in maize, none of the organizations applied the processing factor

11

a measure used in statistics indicating the value below which a given percentage of

observations in a group of observations fall

Comment [B7]: ?

Comment [B8]: ?

Comment [F9]: I added the footnote

to explain it

https://en.wikipedia.org/wiki/Statistics

https://en.wikipedia.org/wiki/Percentage


59

while estimating the dietary intake because none of them established the dietary

assessment for products processed from maize. Therefore, the comparison of the

processing factors between these organizations cannot be conducted.

5.3.7 Variability factors

In the case of maize, the EFSA used a variability factor of 3 to estimate both the acute

and chronic dietary intake while the JMPR did not apply a variability factor in

estimating the dietary intake of acetochlor in maize. Since China used the JMPR

assessment as a reference, it did not use a variability factor either. That is to say, the

differences in calculations among Codex, EU and China may be related to different

variability factors/ or not use variability factors.

5.4 Brief conclusion of Comparison

Based on the comparative study, all organizations use the risk assessment

methodology for the establishing the MRLs standards based on the WHO guidelines.

It can be implied that there is less difference in the methodology of establishing

MRLs. However, compared to EU, China is more inclined to accept the Codex MRL

and JMPR evaluation.

The comparison is more focused on the technical areas and the possible reasons

which cause the differences are discussed below.

5.4.1 Good Agricultural Practices and Supervised trial data

Based on the table about the GAP data, GAPs are different among countries, even

the countries in EU. The reasons may be the climate, the pests, the soil situation and

their severities differ among countries. These differences may lead to the differences

in pest control and weeding practices among countries. The study of Raymond Bates

(1979) also pointed out that the uses of an active substance against a pest on

particular crop vary from region to region, owing to differences in ecology, climate,

and cultural practices.

Various GAP information, such as PHI and application rate, can influence the level of

pesticide residues in agricultural commodities. These GAP data regarding each region


60

or country mainly depend on the efficacy study in each country. The degradation of

pesticide is another reason that influences the level of the pesticide residues on the

agricultural commodity. Among all the ways of degradation, under natural field

conditions, volatilization is the main process of the degradation that affects pesticide

residues (Celik et al. 1995). The speed of volatilization mainly depends on

environmental factors. According to Keikotlhaile & Spanoghe (2011), faster wind

speed and the higher temperature, lead to more evaporation of the pesticide. It can

be seen in the comparative study that the supervised residue trail data differ from

country to country. As the recommended MRLs are based on the supervised residue

trials data carried out by the critical GAP, different GAPs may cause the differences in

MRLs.

EU requires a minimum of 8 trials representative of the proposed growing area for

major crops, and the data should be provided for two growing seasons (DG SANCO,

2011a). The Codex also has a requirement on the number of trials, which is 6 to 10,

and the residue data should be carried out in at least two years or at least

representative of different weather conditions (FAO, 2009a). We can see that the

requirements of EU and Codex do not differ much.

Nevertheless, even the use of the same supervised trial data can result in different

MRLs, China accepted most of the Codex data, while the China MRL for acetochlor in

maize is still different from Codex, the reasons in addition to the GAP data and

supervised trial data will be discussed in the following sections.

5.4.2 Toxicological data

The values of ADI and ARfD of China and Codex are the same because China used the

Codex data as reference. However, the differences of the ADI and ARfD of acetochlor

between Codex and EU are huge. The ADI and ARfD are derived from the results of

toxicological studies, such as NOAEL and AOEL and the safety factor. Different

toxicological studies may lead to different values of ADI or ARfD for one substance.

As mentioned in the previous chapter, there are many factors which may influence

the toxicological study, such as the experimental animals, appropriate end-points,

and dose levels administered during the study, differences in these factors may lead

to different NOAEL and further cause the differences in the values of ADI or ARfD.

Comment [B10]: Maybe put it in a

table?

Comment [F11]: I summarized the ADI,

ARfD, the safety factor, and other data

in the table in 5.3.1. I made some

explanations in this section, and I

think it is important to explain the

reasons which cause the differences to

the audience here.


61

Moreover, the difference can be greater if the safety factors applied for the

derivation is different. The safety factor is assumed as 100. However, the safety

factor can vary from 10 to 2000, or in some cases, it can be 5000 (Hamliton &

Crossley, 2004), the safety factor depends on the opinion of the experts and the

available toxicological database.

For ADIs, EFSA used the safety factor of 300 while JMPR used 100, the higher safety

factor may cause the lower EFSA’s ADI. The EFSA report of acetochlor MRL was

carried out in 2011, while the JMPR report was conducted in 2015, the toxicological

data and its analytical method may be updated and more sensitive than the previous

one, that may be the reason that the NOAEL of EFSA is higher than the JMP’s

evaluation. All the differences in toxicological data may cause the differences in

setting MRL.

5.4.3 Food consumption data

All the three organizations used their consumption data combined with the WHO

GEMS/Food cluster diets in the dietary exposure assessment. In addition, the EFSA

used the consumption data from northern Europe and southern Europe, and China

also separated the data into the north part and south part, this is because food

consumption patterns vary considerably from country to country and even within a

country. Each country must estimate their consumption data to estimate the

acceptance of the proposed MRLs in real situation (Gracia & Albisu, 2001, WHO,

1997). The WHO GEMS/Food cluster diets can be considered the reference to each

country or it can be used in case the national data are not available. Use in different

consumption data influence the difference in the acceptance of proposed MRLs. High

level of residues can be accepted if the consumption is very low while low level may

not be accepted if the consumption is very high.

5.4.4 Body weight

Since the units of TMDI and IEDI (mg/person) and the ADI (mg/ kg BW) are different

in the chronic risk assessment, the body weight is necessary for the formula used for

predicting the acute dietary intake (WHO, 1997). As presented in the table above, all

the organizations used different body weights. Despite the WHO guidelines to use

Comment [B12]: ?


62

the body weight at 60 kilograms for predicting dietary intake of pesticide residues at

the international level. It is clearly stated that the average body weight of the

population in the certain region may differ significantly from 60 kg, and for specific

regions or countries, the correct body weight should be more appropriate to reflect

the acceptable intake per person more accurately (WHO, 1997). Therefore, the MRLs

can be different if the different body weight is applied.

6. Possible reasons of the differences in acetochlor

MRL

The main objective of this research was to analyze reasons of differences of

maximum residue limits of pesticides between China and EU. And to find out the

possibility to improve China’s pesticide residue limit system or the harmonization

between the systems of China, Codex and the EU. To achieve the objective, a

comparative study was conducted to point out what the differences are. In this

chapter, the reasons of the differences that exist in the comparison of the Codex, EU,

China MRLs of acetochlor in maize and the possibility of harmonization of the

pesticide residue tolerance are discussed.

Based on the information described in the previous chapters, the main reasons that

may cause the differences in the establishment of the acetochlor MRL can be listed

as followings.

(1) Legal reasons and other aspects

Both the EU and China require the authorization or the approval before setting an

MRL for a certain pesticide. However, because of the differences of climate, the pests,

and their severity among countries, the pest controls practices and the risks caused

by the pesticide residues are different among countries. Therefore, lists of approved

active substances of these countries are not the same, and the procedures of

Comment [B13]: Maybe put the actual

differences you found in a table?


63

authorization and approval are different from a country to another. Furthermore, the

strictness of the requirements for the establishment of MRLs, can influence the

interpretation of the data. The situation that JMPR’s evaluation is usually not

accepted by the EFSA, while the ICAMA was accepting it is a good example. Also,

different attitudes to the uncertainty of the risks of pesticide residues may also cause

differences in the establishment of MRLs. Even both EU and China set temporary

MRLs for the pesticides which already caused the adverse effects on human health,

or which have the potential hazards to human health. Nevertheless, for the pesticide

residues which do not have an MRL, and are not on the ban list, the EFSA advises a

default MRL of 0.01 mg/kg, while the ICAMA do not set rules for the use of the

pesticides. Finally, the EU considers the importance of the protection of consumers’

health and the environment more than other aspects such as economy and food

security. While China, as a developing country, considers the importance of the

protection of consumers’ health and the environment as much as the development

of economy and society. As a result, for some substance whose risks cannot be

completely determined, EU tends to forbid the substance to fully protect the health

of the consumers while China tends to make decisions taking into account more

aspects. The ban on using acetochlor in the commodities in Europe according to

“Reasoned opinion on the review of the existing maximum residue levels (MRLs) for

acetochlor according to Article 12 of Regulation (EC) No 396/2005” is a good example

of the EFSA’s decisions.

(2) The variability of the nation

A considerable amount of scientific data is different from country to country,

including the GAPs, supervised trials data, food consumption data, and body weight.

The differences of climate, environment and culture make the scientific data specific

for a certain country or region, which finally lead to the differences in MRLs between

different countries or regions.

(3) The data update reason

As the development of science, the data used for the establishment of MRLs is also

updated, and the risk assessment, therefore, is renewed. In the case of acetochlor in

maize, the EFSA reported in 2011 and 2013 separately, the JMPR evaluated the

acetochlor in 2015, and the latest China National Standards for acetochlor were


64

released in 2014, it is obvious that some scientific data was updated in these years.

The update may affect the result of the risk assessment of the proposed MRLs.

Table 5: The summarized reasons which may cause the differences among the


65

Codex, the EU and China

7. Conclusion and recommendation

7.1 Conclusion

As mentioned in the previous chapter, the risk assessment applied for the

establishment of MRLs is based on the Codex Guideline in all the three organizations,

and by comparing the steps of setting MRLs in China, EU and Codex we can find that

their methodology used for conducting the risk assessment are quite similar. For the

differences in the values of MRLs, differences in the scientific information are a

crucial cause. Among the reasons that may cause the differences in scientific data

arethe legal reasons, the variability of the nation and the data update reason. As

mentioned before, basically China uses the Codex data as reference, while the EU

trusts its own evaluation more, and does not set the MRLs totally based on the

Codex data as China does.

Nevertheless, the gap between the pesticide limit system between China and the

advanced regions or organizations, such as EU is not only the interpretation of the

data. As mentioned in chapter 2, there are no limits on the use of acetochlor in

strawberries in China, while the EU totally bans it. It does not mean that acetochlor is

entirely safe or unsafe. Though there is no data showing that the consumption of

acetochlor containing strawberries can cause adverse effects to human health.

Which means whether the acetochlor can cause cancer is still unknown (EFSA 2013),

the use of acetochlor should be more cautious, and the MRLs of acetochlor should

be complete.

The causes why acetochlor is not registered on strawberries could be the result of

inadequate levels of pesticide registration and market conditions combined action.

Currently, many of the agricultural products do not have any pesticides registered to

be used on them. It is not to say that these agricultural commodities do not need

pesticides to prevent pests or pesticides used on these agricultural products will


66

threaten food safety. It may be that agrochemical companies consider it costs too

much time and money to register their pesticides on these agricultural products. For

the medication level of the pesticide on a certain agricultural product which is not

high enough to prop up the market, while the registration costs money and time, the

company may not choose to register it on the agricultural products. At the meantime,

since the pesticide is not banned in China, the use of such pesticide will not cause

the punishment of the legal system unless some serious incidents occur because of

the pesticide residues. So there is no registration of acetochlor for strawberry

probably for reasons other than food safety. The Institute for Drug Control,

companies, and farmers want to see more pesticide registration on a wider variety of

products; the problem is how to balance the gains and the costs. The main problems

of China’s pesticide limit system can be concluded as follows.

(1) Pesticides registration system

In 2008, more than 500 pesticides were registered used in nearly 200 kinds of crops,

but only less than 1000 limits are set. While the Codex Alimentarius Commission

(CAC) has 3338 limits, the EU has more than 140,000 and the US have more than

10,000. Meanwhile, China's existing limits for pesticides are basically outdated (Ma,

2008). These numbers have greatly increased in recent years. However, the gap

between China and the advanced organizations still exists, as mentioned before, to

balance the gains and the costs of the registration of the pesticides is necessary to

solve the problem.

(2) The pesticide limit supervision system

There are more than 200 million households, 760,000 enterprises are producing

agriculture products and inputs in China. The small-scale, scattered production and

the wide range of circulation make output and distribution of prohibited pesticides

or highly toxic pesticides difficult to find, which leads to lack of traceability and basis

for enfrocement. China’s agricultural products quality and safety supervision include

agriculture, business, public health, environmental protection and other

departments so that it is hard to achieve a clear division of labor and make concerted

efforts, sometimes there will be evading responsibility phenomenon (Yuan et.al.

2011).


67

Although the majority of Chinese public concern about food safety and pesticide

residues problem due to their limited knowledge and the scope of propaganda and

education, they lack an objective understanding of pesticide residues, which brings

new challenges to management (Luo, 2009)

7.2 Recommendation

Consider that China does not have enough experiences on dealing with problems in

pesticide limit system, comparative study is helpful to enhance the current situation.

However, the differences should also be considered (e.g population, land and water

resources) when analyzing what can China learn from developed countries such as

EU.

Based on the previous chapters, the reasons that cause the gap between pesticide

limit system between China and advanced organizations such as EU can be divided

into two categories, which are technical reasons and management reasons.

Technical reasons mainly refer to the significant differences of the data including the

differences in climate, culture of consumption, the integration, and acceptance of the

Codex MRLs.

The climate and the culture of consumption are different from country to country, so

the integration and acceptance of the Codex MRLs are very necessary to narrow the

gap of pesticide residue limits between countries. Though it’s hard to harmonize the

pesticide MRLs at the international level facilitating the agricultural trade and

reducing the trade problem can be focused as another way to narrow the gap of

pesticide residue limits between countries such as China and EU, to ensure Chinese

people’s right at the food safety level. The following recommendations are some

suggestions.

On the international level, the Codex members could update the food consumption

data to the WHO more frequently, so that the evaluation of the JMPR can be more

sufficient and the results can be more acceptance to the countries. The WTO

members could be more confident on Codex MRLs, and accept the evaluation of the

JMPR if there are no chronic and acute risks to their populations according to their

risk assessment report. The exporting countries could more consistent with the food


68

safety standards of the importing countries.

On national level, though the data from other countries cannot be matched directly

discussing the findings from different data can be helpful to identify priority. For

example, if the MoA can identify which pesticide residues have the highest morbidity,

they can develop appropriate measures, including set stricter MRL or forbid the use

of such pesticide. Besides, related departments could hold interdisciplinary seminars,

in order to identify the priority point of collaborative research as well as find out

what the researchers can do based on the current data and technology.

Management reasons are mainly the insufficiencies of China’s pesticide residue limit

system. Regarding to the problems described in the previous section, the

recommendations for improving China’s pesticide residue limit system are discussed

as below.

(1) A complete and mature registration system could be established. To Achieve that,

the management experience of developed countries and international

organizations can be consulted, and the needs of China’s agriculture trade could

also be considered. The Chinese government could also comprehensively

upgrade the existing national pesticide residue limits and accelerate the

establishment of urgent limits of main agriculture products. Then expand the

scope of limits setting by referring to internationally accepted limits of pesticides

residues and the China’s relevant regulations.

(2) Pesticide residue supervision and monitoring could be strengthened. To achieve

that purpose, sufficient regional agriculture regulatory agencies could be

established, the funds could be guaranteed, and the regulations could be

enforced. Meanwhile, the Chinese government could also increase investment in

pesticide residue monitoring to improve the testing instruments. Furthermore,

the certification of detection organizations could be stricter, and the testing limits

could be uninformed. Last but not least, the personnel training of inspectors

could be enhanced to improve the quality of inspection.

(3) The Chinese government could enhance the safety guidance of medication and

technical training, building promotion, education and training programs. It can

also construction consulting and service platform, which makes the release of


69

information transparent and efficient. The Chinese government could enhance

the safety guidance of medication and technical training, building promotion,

education and training programs. It can also construction consulting and service

platform, which makes the release of information transparent and efficient.

Considering that China is still establishing its pesticide limits system and trying to

refine it, it could be feasible that the Chinese government could temporarily adopt all

the Codex standards to fill the blanks of the products list. At the same time, set a

default MRL for the pesticides used in certain products which do not have MRLs, and

finally adjust these MRLs according to the results of risk analysis when the scientific

evidence is sufficient.


70

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77

Appendices


78

Ministry of Agriculture of the People's Republic of China

Departments Subordinate Institutions

The General Office

Department of Personnel and Labor

Department of Sectoral Policy and Law

Department of Rural Economic System and

Management

Department of Market and Economic Information

Department of Development Planning

Department of Finance

Department of International Cooperation

Department of Science, Technology and

Education

Department of Crop Production

Bureau of Seed Management

Department of Farm Mechanization

Department of Livestock Production

Veterinary Bureau

Bureau of State Farms and Land Reclamation

Bureau of Produce Processing

Bureau of Fisheries

Bureau of Quality and Safety Supervision for

Agro-products

CPC Committee of MOA

Bureau of Retired Cadres

General Service Center, MOA

Chinese Academy of Agricultural Sciences

Chinese Academy of Fishery Sciences

Chinese Academy of Tropical Agricultural

Sciences

China Agriculture Film and Television Center

Agricultural Management Institute, MOA

Human Resources Development Center, MOA (China

Association of Agricultural Science)

Research Center for Rural Economy, MOA

China Agricultural Science, Technology and Education

Foundation

Foreign Economic Cooperation Center, MOA

Agricultural Trade Promotion Center, MOA

Center of International Cooperation Service,

MOA

Rural Energy & Environment Agency, MOA

National Agricultural Technology Extension and

Service Center

Institute for the Control of Agrochemicals, MOA

Development and Service Center for Quality Farm

Products, MOA

National Fisheries Technical Extension Center

China Green Food Development Center

http://english.agri.gov.cn/aboutmoa/departments/201301/t20130115_9501.htm





















http://english.agri.gov.cn/aboutmoa/ium/201301/t20130115_9527.htm










79

Yangtze River Fisheries Administration, Ministry of

Agriculture

Inspection Bureau, Discipline Inspection Group of the

CPC Central Commission for Discipline Inspection at

MOA

Permanent Representation of the People's Republic

to the UN Agencies for Food and Agriculture

Center for Agri-food Quality & Safety, MOA



china s pesticides limits system compared to the codex and

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