The Nineteenth Seminarfor
Visiting Food Hygiene Experts－2006－

Policy Planning and Communication Division
Standards and Evaluation DivisionInspection and Safety Division
Department of Food Safety
Pharmaceutical and Food Safety Bureau
Ministry of Health, Labour and WelfareContents
Part II

Establishment of Specifications and Standards Based on the Food
Sanitation Law

Introduction
1. Food(1)

Historical background<In general><Milk and milk products>(2)

Specifications and standards for fresh fish and shellfish<Preventive measures for foodborne infections caused by Vibrio

Parahaemolyticus>(3)

Revision of specifications and standards for milk and milk products(4)Standards for contaminants in food
<Standards for cadmium in rice><Standards for mycotoxins >2.

Pesticide Residues in Food
(1)

Historical background(2)

Relationship between the registration of pesticides and the regulations
on pesticide residues in foods

3.

4.

(3)

Legal nature of pesticide residue standards(4)

Establishment of maximum residue limits (MRLs) for pesticides(5)

Harmonization with Codex standards(6)

Investigation of pesticide residues in foods(7)

Survey on pesticide intakes (Market Basket Study)(8)

Information disclosure

Veterinary Drugs in Food
(1)

Historical background(2)

Establishment of residue standards (MRLs)(3)

Investigation of veterinary drugs in foods(4)

Information disclosure

Food Additives(1)

Historical background(2)

Regulation of food additives under the Food Sanitation Law(3)International safety assessment of food additives(4)

Safety measures for non-synthetic food additives(5)

Survey of daily intakes of food additives

5.

Apparatus and Containers/Packages, Toys

<Apparatus and Containers/Packages>(1)

Historical background(2)

Definitions(3)

Establishment of specifications and standards<Toys>
6.

Food Labeling(1)

In general(2)

Labeling of allergenic substances in foods(3)

Labeling of genetically modified foods

Annexes
1.

Regulatory status on pesticide residues by the Food Safety Basic Law,
the Food Sanitation Law, and the Agricultural Chemicals Regulation Law

2.

Positive List System for Agricultural Chemical Residues
Appendix

Implementation of the positive list system for agriculturalchemical residues in foods

3.

Basic principles for establishment of maximum residue limits for pesticides
in agricultural products (including Diagram )4.

Pesticide Registration and Establishment of MRLs

5.

Guidelines for designation of food additives, and for revision of standards
for use of food additives (excerpt) (including table and diagram)

6.

Change in the number of designated food additives

Part II

Establishment of Specifications and Standards
Based on the Food Sanitation Law

1

Part II

Establishment of Specifications and Standards Based on the Food
Sanitation Law

Introduction
The Food Sanitation Law establishes a wide variety of standards not only for foods
themselves but also for food related items. These standards include food labelingstandards and standards for the safety assessment of foods and food additives produced
by recombinant DNA techniques. This text mainly describes the establishment ofstandards and specifications for food, pesticides, veterinary drugs, and foodcontainers/packages.

1.

Food

(1)

Historical background<In general>
All foods distributed in the domestic market are subject to the law (enacted in1947). They are regulated by compositional specifications, and standards for
manufacturing, processing/preparation, and storage that have been established basedon the law.
The Ministry of Health, Labour and Welfare (before 2001 the Ministry of Healthand Welfare) establishes specifications and standards for foods whose quality should beassured at certain levels and for perishable foods whose safety cannot be ensured
without specifications and standards. For example, these foods include milk products,
meat products, fish paste products, oysters for raw consumption, and frozen
fish/shellfish for raw consumption. The MHLW established specifications and standards
for milk and milk products in 1950 (Ministerial Ordinance concerning Compositional
standards for milk, milk products, and similar products; former Ordinance), for meatproducts in 1954, for frozen oysters for raw consumption and fish paste products in 1962,
and fish/shellfish for raw consumption in 1971. Thereafter, new types of foods started tobe distributed as technology advanced. In 1977, the MHLW established specifications
and standards for foods that are packed into containers/packages and pasteurized underpressure. Since then, the MHLW has revised the specifications and standards as needed.
The following are specifications and standards established or revised after 1977:
1982

Unheated meat products
The new food category, unheated meat products, was established.
Specifications and standards were newly established for this category,targeted at raw hum and similar products.

2

1986

Mineral waterSpecifications and standards were made into the present form by adding
new ones.

1993

Heated meat products
Specifications and standards were established for heated meat products.

1998

Chicken egg and liquid egg
Specifications and standards were established as preventive action against
food poisoning caused by salmonella.

2001

Fish and shellfish consumer raw
Specifications and standards were established as preventive action against
food poisoning caused by Vibrio parahaemolyticus

2002

Specifications and standards were established for skimmed milk powder as
the preventive measure for food poisoning caused by Staphylococcus

aureus2006

Agricultural chemical residues
Based on the 2003 amendment of the Food Sanitation Law, a positive
list system for agricultural chemicals was implemented.

<Milk and milk products>
Separately from other foods, milk and milk products are regulated by the“Ministerial Ordinance concerning Compositional Standards Etc. for Milk and Milk
Products,” (Promulgated in 1951, Ministry of Health and Welfare Announcement No.
52), based on the law. The Ministerial Ordinance targets milk and milk products thatare considered to be consumed in large amount by infants, young children, and sick andinvalid people. Considering the special nature of those products, then Ministry of
Health and Welfare decided that it is necessary to manage the hygiene of products toimprove public health.
Ministerial Ordinance concerning Compositional Standards Etc. for Milk and
Milk Products
In 1951, the Ministerial Ordinance Concerning Compositional Standards
Etc. for Milk and Milk Products was established under the law and the former
Ordinance was abolished. The new Ordinance targets milk and milk products,
which are needed especially for infants, young children, and sick and invalid
people.
In 1959, all products made mainly of milk and milk products were placed3

under the jurisdiction of the Ministerial Ordinance, and the Ordinance waschanged into its present form. The milk products include butter, cheese, cream,
and fermented milk.
The Ordinance covers not only specifications for individual products andtesting methods, but also specifications for containers and packages of milk andmilk products. The Ordinance has been amended several times. The recent
amendments were made in 2002 and 2003. See Section (3) “Revision of
specifications and standards for milk and milk products.”(2)

Specifications and standards for fresh fish and shellfish<Preventive measures for foodborne infections caused by Vibrio parahaemolyticus>
In June 2001, Japan newly established specifications and standards for seafood,mainly fish and shellfish for raw consumption. This activity was based on social
background and dietary preference. Food poisoning incidents caused by Vibrio

parahaemolyticus had been increasing since 1996. Japanese people like eating seafood
raw and its consumption is very large. Under such circumstances, the MHLW initiatedthe establishment of specifications and standards from the viewpoint of public health,taking the lead from other countries.
Standards and requirements newly established for seafood
The following were newly established: preparation standards for all seafood
products for raw consumption; compositional specifications and processing, storage andlabeling standards for boiled crabs and fish fillets and shucked shellfish for raw
consumption. The following were added to the existing standards: compositional
specifications and processing standards for boiled octopus, raw oysters, and frozen fishand shellfish for raw consumption. See the separate document, Specifications andStandards for Foods, Food Additives, etc. under the Food Sanitation Law (Abstracts),
published by the Japan External Trade Organization (JETRO).
In addition, the MHLW issued recommendations about storage temperature andfood handling to seafood-related businesses and consumers.
(3)

Revision of specifications and standards for milk and milk products

Introduction
In June 2000, there were mass food poisoning outbreaks associated with low-fat
milk and other milk products produced by a Japanese manufacturer. This was themost serious case in the past few decades. The Subcommittee on Food Poisoning in the
Food Sanitation Committee under the Pharmaceutical Affairs and Food Sanitation

4

Council suggested at the session held on March 14, 2001 that the MHLW should review
sanitary standards for skimmed milk powder in order to prevent the recurrence of suchfood poisoning. After due review, the MHLW amended the Ministerial Ordinanceconcerning Compositional Standards Etc. for Milk and Milk Products in December 2002
and June 2003. The following section outlines discussions at the subcommittee and therevision of standards.
Standards for manufacturing of skimmed milk powder(a)Contamination of raw milk by Staphylococcus aureus.
Investigation of literature found that roughly 50% of the raw milk had been

contaminated by Staphylococcus aureus bacteria of 10–103 cfu/ml with a maximumof 104 cfu/ml. A few percentage points to 25 percent of the detected Staphylococcus

aureus bacteria could produce enterotoxin A.
The subcommittee assumed that since raw milk collected from farmers wasusually mixed and held in storage tanks, if raw milk from any farmer wascontaminated, the contamination would spread to the whole volume. The
subcommittee decided that sanitary standards should be established, on theassumption that the raw milk is already contaminated by Staphylococcus aureus
capable of producing enterotoxin.
(b)Enterotoxin production and quantities to develop food poisoning
In laboratory tests on enterotoxin production by adding Staphylococcus aureus

bacteria, Staphylococcus aureus bacteria at 102 cfu/ml produced enterotoxin A in six
hours, and at 105 cfu/ml in three hours. Additional tests using concentrated milk
also showed similar results.
Usually, 100 ng of enterotoxin A was known to be required to cause

Staphylococcus aureus food poisoning in humans. In this case, food poisoning could
be caused at a few tens of nanograms, according to calculation.
(c)

Basic principles of sanitary standards
The subcommittee decided that sanitary standards should be based on thebasic principles below.
i. Preventive measures should be taken on the assumption that raw milk
is contaminated by Staphylococcus aureus.
ii. Product temperature and time during which products are kept at eachtemperature range should be controlled, in order to prevent the growth ofStaphylococcus aureus in the whole course from the arrival of raw milk
5through the pasteurization and concentration processes (before drying).
iii. Secondary contamination at each process should be prevented andspecial importance should be placed on the prevention of contamination of
products after pasteurization.
(d)Sanitary standards for skimmed milk powder
Based on the above principles, the MHLW established standards including thefollowing stipulations.
z Ingredient milk must be kept at 10℃ or lower, or higher than 48℃ in
the process before pasteurization. However, this does not apply in the casewhere the manufacturing process is continuously conducted so that the
ingredient milk cannot stagnate.
z Ingredient milk must be pasteurized as directed for cow’s milk.
z The milk that is skimmed must be kept at 10℃ or lower, or higher
than 48 ℃ in the process after pasteurization through dehydration.
However, this dose not apply in the case where the structure of all
machines that are used in the manufacturing process can avoid
contamination by the microorganisms from outside or where the product isleft in temperatures over 10℃ and up to 48℃ for shorter than six hours.
(e)Others measures
The MHLW instructed the related businesses about the following points aswell as the above-mentioned requirements.
z Raw milk should be cooled immediately after milking to 10℃ or lower.
z Raw milk should be received at 10℃ or lower.
z The final product (skimmed milk powder) should be stored with care, sothat it cannot get damp.
z Similarly, whole milk powder, sweetened milk powder, and formulated
milk powder should be handled, based on the hygienic standards above andother related instructions.
The MHLW advised ordinary consumers to store the product in a dry place, sothat it cannot get damp.

6

Standards for pasteurization of milk and milk products
Before 2002, the Ministerial Ordinances concerning Compositional Standards
etc. for Milk and Milk Products (Ministerial Ordinance No. 52, 1951) had been imposing
the following standard on cow milk, pasteurized goat milk, partially skimmed milk,skimmed milk, and processed milk: Raw milk must be pasteurized at 62–65℃ for 30
minutes, or by using a method providing a comparable or superior pasteurizing effect.
This stipulation was based on data on the thermal stability of Mycobacterium

tuberculosis as an indicator. Studies conducted from 1998 to 2000 under the Health
Sciences Research Program found new knowledge on contamination by Q fever of raw
milk and marketed milk and lethal temperature.
(a)Lethal temperature of Q fever pathogen (Coxiella burnetii)
The studies confirmed that Coxiella burnetii died completely when heated at

65℃ for 30 minutes, but some of the pathogen remained alive when heated at 62℃
for 30 minutes or at 63℃ for 30 minutes. When heated for 20 minutes or longer
until the temperature reached 63℃, then heated at 63℃ for 30 minutes, allpathogens were found to die. These results showed that 30-minute heating at 63℃
using the batch method could completely kill the pathogen.
(b)Standards for pasteurization of milk
Based on the abovementioned findings, the MHLW established standards forpasteurization of milk as given bellow, in the view of the prevention of theoccurrence of Q fever and global harmonization.
zStandards for manufacturing of cow milk, pasteurized goat milk, partiallyskimmed milk, skimmed milk, and processed milk
Raw milk must be pasteurized at 63℃ for 30 minutes by the batch

pasteurization or using an appropriate pasteurization method comparable orsuperior to this method in pasteurizing effects.
z Standards for manufacturing, processing and preparation of general foods
When a food is manufactured using raw cow milk or raw goat milk, the raw
cow milk or raw goat milk must be pasteurized at 63℃ for 30 minutes by thebatch pasteurization or using an appropriate pasteurization method
comparable or superior to this method in pasteurizing effects, during the
manufacturing process.

7

Standards for containers and packages for milk and milk productsStandards were newly established for the following containers and packages formilk and milk products.
z Cow’s milk, special milk, pasteurized goat’s milk, partially-skimmed
milk (low-fat milk), skim milk (nonfat milk), processed milk, andcream.
—Laminate-form synthetic resin containers and packages using nylon—Laminate-form synthetic resin containers and packages using
polypropylene
Nylon and polypropylene shall not be used for the surfaces coming into
direct contact with the contents.
z Fermented milk, lactic acid bacterial drinks, milk drinks—Synthetic resin containers and packages consisting mainly ofpolypropylene—Synthetic resin containers and packages consisting mainly ofpolyethylene terephthalate.

z Formulated milk powder
Containers made by the combination of a metal can and synthetic
resin laminate(4)Standards for contaminants in food

<Standards for cadmium in rice>(a)Standards for cadmium based on the Food Sanitation Law
In July 1970, the Ministry of Health and Welfare (the present Ministry of

Health, Labour and Welfare) established the safety standard for cadmium in brawn
rice at less than 1.0 ppm (less than 0.9 ppm in polished rice) based on the law, as theresult of the assessment of cadmium contained in rice. Separately from regulation
under the law, the National Rice Wheat and Barley Improvement Association
purchases home-grown brawn rice containing 0.4 ppm or more and less than l.0 ppm
of cadmium with the support of the Japanese Ministry of Agriculture, Forestry and
Fisheries and utilizes it for non-food purposes (such as starch for production oflaminated wood). This is based on the decision that if brawn rice contains cadmium
exceeding 0.4 ppm, the producing area may have somehow been contaminated bycadmium. MAFF’s action is in consideration of consumers’ sentiment.
(b)Discussion by the Joint FAO/WHO Codex Alimntarius Commission

8

BackgroundIn 1998, the Codex Committee of Food Additives and Contaminants (CCFAC),
a subsidiary body of the Joint FAO/WHO Codex Alimntarius Commission (CAC),
proposed a draft maximum level of 0.2 ppm for cadmium in polished rice (thecurrent draft Codex level is 0.4 ppm). Thereafter, discussions have been conducted
as follows:i.

At the 36th session in March 2004, the CCFAC agreed to revise theproposed draft level for polished rice from 0.2 ppm to 0.4 ppm, based on theJapanese proposal, which was accompanied by probabilistic intake assessment data
for Japanese people, and to seek CAC’s judgment at step 5.1
ii. At the 27th session in late June in 2004, the CAC asked the CCFAC tore-discuss the draft level of 0.4 ppm at step 3, in consideration of the comment fromsome countries that the level could result in consumption exceeding the PTWI
(Provisional Tolerable Weekly Intake) 2 in some regions where rice is consumed inlarge quantities.
iii. At the 64th session in February 2005, the Joint FAO/WHO Expert
Committee on Food Additives (JECFA) 3 concluded, as the result of the assessmentof effects on the cadmium intake of three different levels (the current draft Codex
level of 0.4 ppm and certain levels both above and below 0.4 ppm), that these levels
would make little difference in the total intake of cadmium and would be unlikely topose adverse effects on human health.
iv. At the 37th CCFAC session in April in 2005, many countries supported thedraft level of 0.4 ppm for polished rice. Although some countries including the EUreserved its decision, the CCFAC agreed to seek CAC’s judgment again at step 5.
v. At the 28th session in July 2005, the CAC adopted the draft maximum levelof 0.4 ppm for polished rice at Step 5.
vi. At the 38th session in April in 2006, the CCFAC agreed to seek CAC’s
judgment at step 8.
vii. At the 29th session in July, the CAC adopted a draft level of 0.4 ppm andestablished it as the Codex standard.
Note:
1. Step (Procedure for the elaboration of Codex standards)
The procedure for the elaboration of Codex standards—in the case of cadmium,maximum level—consists of the following eight steps.
Step 1: The CAC decides to elaborate a Codex standard.

9

Step 2: The secretariat arranges for preparation of a proposed draft standard.
Step 3: The proposed draft standard is sent to the member countries to seek
comments.
Step 4: The proposed draft standard is sent to the subsidiary body concerned toseek consideration.
Step 5: The proposed draft standard is submitted to the CAC to seek consideration
on whether the proposed draft standard should be adopted as the draft
standard.
Step 6: The draft standard adopted at step 5 is sent to the member countries toseek comments.
Step 7: The comments are sent to the subsidiary body concerned to seek
consideration on the draft standard.
Step 8: The draft standard is submitted to the CAC to seek consideration. The
draft standard is adopted as the codex standard after consideration based on
the comments received.
2.

PTWI (Provisional Tolerable Weekly Intake)An estimate of the amount of a contaminant that can be ingested over a lifetime
without appreciable risk, expressed as a weekly amount.

3.

The Joint FAO/WHO Expert Committee on Food Additives
An international body established jointly by the Food and Agriculture
Organization of the United Nations and the World Health Organization. It
considers various things including the acceptable daily intake or tolerable daily
intake for food additives, pesticides, veterinary drugs, and contaminants.
Evaluations by the JECFA are reflected in the establishment of Codex standards.

(c)

Establishment of national standards
The MHLW has asked the Food Safety Commission, which was established on

July 1st, 2003, to conduct risk assessment on the assurance of food safety in light ofthe current situation of cadmium intakes from food. This matter is under theconsideration at the special committee on contaminants.
<Standards for mycotoxins>
Mycotoxins are metabolites produced by mold. They are known to have adverse
effects on humans and animals. It is very important to take appropriate measuresagainst mycotoxins from the viewpoint of food safety. In recent years, some cases ofacute poisoning of livestock have been reported. These circumstances require adequate
measures to protect human health.
In recent years, the world has come to recognize the seriousness of thecontamination of mycotoxins. The CAC has conducted lively discussion on mycotoxins infood, and established Codex standards for some micotoxins. In response to a request of
10

the CAC, the JECFA conducted safety evaluation on various mycotoxins in February
2001. It is expected that approaches towards the development of standards will
accelerate in the near future.
Establishment of standards in Japan
Basically, standards are established through in-depth discussion at the Food
Safety Commission and the Pharmaceutical Affairs and Food Sanitation Council.
First, the Commission conducts toxicity evaluation based on evaluations by the
JECFA

and

establishes

no-observed-adverse-effect

the

level

no-observed-effect

level

for

mycotoxin.

(NOAEL)2

each(NOEL)1
Then,

or
the

Commission determines the tolerable daily intake (TDI) by applying appropriate
safety factors.3

In light of the evaluation by the Commission, the Council

establishes standard limits for individual foods. In the standard setting, the Council
takes account of food consumption, loss during food preparation, and Codex
standards. Standard limits are established so that the sum of limits on individual
foods for a mycotoxin does not exceed the tolerable daily intake (TDI).4
Notes:
1. No-Observed Effect Level (NOEL)
The highest dose of a substance that does not cause any changes distinguishable
from those observed in normal animals.
2. No-Observed-Adverse-Effect Level (NOAEL)The highest dose of a substance at which does not cause any detectable toxic
effects in experimental animals.
3. Safety factor
A factor that is obtained, considering inter-species variability in between
experimental animals, intra-species variability between humans, and otherconditions.

4.

Torelable Daily Intake (TDI)
An estimate of the amount of a contaminant that can be ingested daily over a
lifetime without appreciable risk.

(a)Discussion on the establishment of standards for deoxynivalenoli.

Deoxynivalenol (DON) is a mycotoxin produced by fungi of genus Fusarium.

It contaminates cereal grains, like barley, wheat, and oats. This family of fungi
causes Fusarium head blight in barley when a humid climate, like rainy season,coincides with the timing of flowering-to-maturing. The DON poisoning of humans
is characterized by gastrointestinal symptoms such as nausea, vomiting, anddiarrhea. In dosing tests in mice, effects on thymus, spleen, heart, and liver werereported. DON is highly thermo-stable and is not reduced in ordinary cooking

11

processes.
ii.

The MHLW conducted an investigation to identify the contamination ofgrains with DON in 2001, and considerably high levels of DON were detected insome samples. The following are investigation results.
iii. The Joint Subcommittee of Food Standards and Toxicity under the
Pharmaceutical Affairs and Food Sanitation Council discussed, in May 2002,
whether standards for DON should be established.
iv．The Joint Subcommittee concluded that standards under Article 11 of the∗law were necessary to reduce health risk from the intake of DON and to prevent
health hazards. The Subcommittee stated that a guideline level of 1.1 ppm should
be applied for wheat until the standard is set.
v.

The Joint Subcommittee concluded at a meeting held in 2003 that

additional investigations targeted at wheat, household-use wheat flour, and baby
foods were necessary to obtain enough data for establishing standards. The
subcommittee mentioned that investigations for wheat should be focused on yearlychanges in DON concentration in crops. The MHLW will establish standards after
the results of additional investigations become available, taking discussion by the
CAC into account.
(b)

Establishment of standards for patulin in apple juicei.

Patulin is a mycotoxin produced by certain fungi of the genera Aspergillus

and Penicillium. This mycotoxin is usually found in foods that are contaminated bythese fungi, including fruits, vegetables, cereal grains, and animal feed. Apple juice
is known to be a food that is most likely to be contaminated by patulin.
ii. A national investigation conduced in fiscal 2002 on patulin contaminationin apple juice showed that the mycotoxin was detected in some samples at as highlevels as those that become targets of regulation in other countries.
iii. In response to the result, the Joint Subcommittee discussed theestablishment of standards for patulin in December 2002.

iv. The joint subcommittee concluded that the standards given below shouldbe established under Article 11 of the law in order to prevent health hazards by
reducing health risk occurring through patulin consumption and to harmonize withinternational standards.
∗

Provisions of the Food Sanitation Law that appear in this text are given in Annex 8 to Part
I Administration of Food Safety.

12

Standard: Patulin concentration must not exceed 50 ppb in apple juice andapple juice ingredients for other nonalcoholic beverages.
v. The MHLW will investigate the state of contamination to identify effects
on subpopulations such as young children. The MHLW will review the establishedstandards if it determines that the action is necessary based on evaluation by the
CAC.

13

2.

Pesticide Residues in Food

(1)

Historical backgroundIn 1956, residue limits for pesticides were established for the first time in Japan,

coinciding with a rapid increase in the use of pesticides after the war. These limits wereset for arsenic, lead, copper, and DDT on apples.
However, it is not until 1968 that maximum residue limits (MRLs) for pesticides
were established under the Food Sanitation Law. MRLs were established for five
pesticides (arsenic, BHC, DDT, lead, and parathion) on four crops (apple, cucumber,grape, and tomato).
By 1978, the number of pesticides with MRLs had increased to 26 substances.
Thereafter until 1991, no MRLs were established.
After 1991, MRLs have been established annually for several pesticides on
individual agricultural commodities. By the end of 2005, MRLs were established for 250
pesticides.
In 2003, the law to amend the Food Sanitation Law required the introduction of apositive list system for regulation of agricultural chemicals (pesticides, veterinary drugs
and feed additives).
On May 29, 2006, the positive list system took effect.
(2)

Relationship between the registration of pesticides and the regulations on pesticide
residues in foods (mainly concerning responsibilities of the three ministries)
In Japan, three major laws are related to the regulation of pesticides. These laws

are the Agricultural Chemical Regulation Law (ACRL), the Food Sanitation Law (FSL),
and the Food Safety Basic Law (FSBL), which was enacted in May 2003. The ACRL, theFSL, and the FSBL are under the control of the Ministry of Agriculture, Forestry and
Fisheries , the Ministry of Health, Labour and Welfare, and the Cabinet Office,respectively.
All pesticides including imports must be registered under the ACRL before they
can be used or sold in Japan. MAFF is responsible for the registration of pesticides.
Before a pesticide is registered, MAFF will discuss the adequacy of approval of thepesticide. The discussions include the physical nature and the effectiveness of thepesticide. In addition, the ACRL requires the Ministry of Environment to discuss theenvironmental effects of the target pesticide, such as those of residues in foods and feeds
on humans, animals, soil, and water.
Health risk assessment is conducted by the Food Safety Commission, which wasestablished under the FSBL in July 2003. The commission establishes the ADI(Acceptable Daily Intake)*. The MHLW establishes MRLs for the pesticide, taking into
consideration the risk assessment result reported by the commission.

14

Annex 1 outlines the responsibilities of the MHLW, the Ministry of Agriculture,
Forestry, and Fisheries, and the Ministry of the Environment under the three laws.
Note:
ADI (Acceptable Daily Intake)An estimate of the amount of a substance that can be ingested daily over lifetime
without appreciable health risk, usually expressed on a body weight basis (mg/kg/day).

(3)

Legal nature of pesticide residue standards
Article 11, Paragraph 1 of the Food Sanitation Law stipulates that the Minister of

Health, Labour, and Welfare may establish specifications for components of foods toprotect the public health. The law treats pesticide residues as part of components offoods. Pesticide residue standards are usually called maximum residues limits, or MRLs.
They refer to the maximum concentrations that may remain in or on target commodities.
Foods containing pesticides above the MRLs are enjoined from domestic distribution
and import.
Before the implementation of the positive list system, crops containing pesticides
without MRLs were not under the control of Article 11 of the law and could be
distributed in the domestic market unless they posed health hazards to humans underthe meaning of Article 6 of the law.
Based on the 2003 amendment of the law, on May 29, 2006 the MHLW
implemented the positive list system for pesticide residue regulation. Under the system,
any food that contains a pesticide without residue standards is basically enjoined fromdomestic distribution. Pesticides, however, may remain in foods as long as residue levels
are below a certain level that is determined to pose no adverse health effects. A similarsystem is already being carried out in other countries, like Australia, Germany, and theUnited States.
As of the end of 2005, the number of chemicals with MRLs was 250 in Japan. On
the other hand, some 700 pesticides were in use in the world for food-use crops.
Therefore, the MHLW provisionally established MRLs (provisional MRLs) for pesticides
without MRLs for individual foods. In setting provisional MRLs, the MHLW took into
consideration Codex standards and other standards that were based on scientificevaluation. The newly established MRLs became effective along with the positive list
system on May 29, 2006. Basically, provisional MRLs and exiting MRLs are equallytreated under the law. Consult Annex 2 (which illustrates the previous system and thepositive list system) and Appendix to Annex 2 (which outlines the establishment ofprovisional MRLs).
The MHLW plans to have the Commission conduct safety assessment of chemicals
for which provisional MRLs have been established. In light of the assessment results,
the MHLW will review provisional MRLs as required.
The effective MRLs, including the provisional MRLs, are available at15http://www.mhlw.go.jp/english/topics/food safety/positovelist060228/index.html(4)

Establishment of MRLs for pesticides
Related laws have been amended in step with the enactment of the Food Safety

Basic Law in May 2003. This has enabled the MHLW to establish MRLs for pesticides
at the time of registration by the Ministry of Agriculture, Forestry and Fisheries.
The establishment of an MRL begins with the submission of an application forregistration to the Ministry of Agriculture Forestry and Fisheries(see Annex 3).

Upon receiving notification from MAFF of the application, the MHLW will request
MAFF to provide the documents required for safety evaluation under Article 12 of thelaw. These documents include acute toxicity, subacute toxicity, chronic toxicity,
carcinogenicity, reproductive toxicity, teratogenicity, genetic toxicity, pharmacokinetic
and general pharmacological parameters, animal metabolism, and plant metabolism aswell as residue data for commodities treated with target pesticides.
The MHLW will ask the Commission for opinions concerning health effects after
obtaining the necessary documents. In response to the consultation, the commission willconduct a health risk assessment and establish the ADI (Acceptable Daily Intake). In
establishing the ADI, the NOAEL (No-Observed-Adverse-Effect Level),1 which isbasically determined from animal studies, and the safety factor 2 are used. The MHLW
will have the Pharmaceutical Affairs and Food Sanitation Council establish MRLs.
MRLs will be established based on an exposure assessment, using the ADI establishedby the Commission.
Currently, Japan uses the theoretical maximum daily intake (TMDI) method andestimated daily intake (EDI) method for the exposure assessment (see Annex 4). The
MRLs for a pesticide are allocated to individual foods so that the calculated daily intakeof the pesticide does not exceed its ADI. Residue data obtained from field trials in which
the pesticide was used in accordance with the use direction claimed at registration
application are the basis for the MRL on the target crops.
When the commission determines that no ADI can be set for a pesticide, the MRL
will be established for the pesticide as N.D. (no detection) meaning the limit-ofdetection level.
The process of establishing MRLs for pesticide is described in Annex 3.
Notes:
1. NOAEL (No-Observed-Adverse-Effect Level)
2. Safety factor
See the Section 4 “Standards for mycotoxins in food” under the heading of “1. Food.”

16

(5)

Harmonization with Codex standards (international standards)
The SPS (Sanitary and Phytosanitary) Agreement of the WTO Agreement requires

each member country to harmonize its food safety regulations with international
regulations, in order to minimize the impact of discrepancies in regulation between
member countries on trade. Based on this principle, Japan accepts Codex standards as
far as possible when establishing MRLs, as long as the acceptance is unlikely to pose amajor problem.
(6)

Investigation of pesticide residues in food
Monitoring tests
Monitoring tests target pesticides with MRLs. The purpose of monitoring tests is

to check whether agricultural products in the marketplace comply with the established
MRLs. Quarantine stations and local governments are responsible for monitoring tests.
Quarantine stations monitor imported products, and local governments monitor
products on the domestic marketplace.
Products that do not meet the standards will be recalled, discarded, reshipped, orotherwise disposed of.
(7)

Survey of pesticide intakes (Market Basket Study)
Then Ministry of Health and Welfare started to conduct surveys on pesticide

intakes (Market Basket Method) in 1991, in order to estimate intakes of pesticides
through the daily diet. These surveys may enable more precise estimation of the intakeof pesticides, since samples are prepared/cooked before analysis as they would benormally. Most of the pesticides remaining in or on foods are assumed to be reduced,
removed, or degraded through preparation processes such as washing, peeling, cutting,boiling, frying, and steaming.
The survey results determined that dietary intake is unlikely to pose healthproblems in the current situation, because the estimated intakes were well below thecorresponding ADIs.
In 1991–2003, 160 pesticides were tested, and 28 pesticides out of them weredetected in one of the food groups tested. The 28 include DDT, azinphos-methyl,
acephate, chlorpyrifos, fenvalerate, and malathion. The estimated daily intakes ofpesticides detected were in general way below the corresponding ADIs, except forbromine, which naturally occurs. Even some estimated daily intakes that wereconsiderably large were about 27% of the corresponding ADIs.

17

(8)

Information disclosure
Summary results of evaluation by the Council, and monitoring tests are madepublic on the MHLW web site. Also, results of pesticide residue surveys and total dietstudies are published in writing.

18

3.

Veterinary Drugs (including Feed Additives) in Food

(1)

Historical background
Veterinary drugs are used to prevent and treat illnesses of livestock, such as cows

and pigs, poultry, and finfish/shellfish. These drugs include chemically-synthetic
antimicrobials, antibiotics, and anthelminthics. Feed additives are added to feed mainlyfor preventing feed quality.
The Food Sanitation Law stipulates that in principle, foods must not containantibiotics. It also stipulates that in principle, meat, fowl eggs, and fish and shellfish
must not contain chemically synthesized antimicrobials. These provisions were
established, considering problems with the safety of these drugs and health effects ofdrug-resistant microorganisms, which may appear as a result of the use of these drugs.
The law permits foods to contain these drugs only when the drugs comply withindividual standards established under the law.
In December 1995, Japan established first residue standards for veterinary drugs(six substances). By the end of 2005, standards were set for 33 drugs. The followingshows the breakdown:zAntibiotics and chemically synthesized antimicrobialsz

Anthelminthicsz

Hormones 2 itemszFeed additive

17 items

13 items
1 itemAs mentioned in section 2 (1) of this document, veterinary drugs are also subject tothe positive list system for regulation of agricultural chemicals (effective on May 29,2006).
Related laws have been amended in the wake of the May 2003 enactment of theFood Safety Basic Law. This enabled the MHLW to establish residue standards forveterinary drugs and feed additives at the time when MAFF approves these drugs ordesignates feed additives.
(2)

Establishment of residue standards (MRLs)
Process of establishment of MRLs
Basically, MRLs for veterinary drugs are established in the same manner as for

those for pesticide residues. Please consult section 4 “Establishment of MRLs forpesticides.” In this section an outlined is just given.
First, the Food Safety Commission conducts a health risk assessment of target
substances. During the risk assessment the NOEL (No-Observed Effect Level) 1 or the
NOAEL (No-Observed-Adverse-Effect-Level) 2 is established using results of several
toxicity studies including chronic study, teratotoxicity study, and carcinogenicity study.

19

Second, the ADI (Acceptable Daily Intake) 3 is obtained by multiplying the
NOEL/NOAEL by the safety factors. For antibiotics and chemically synthesized
antimicrobials, the microbiological ADI is also taken into account in order to consider
effects on human intestinal flora.
Third, MRLs are set, taking residue data and Codex standards into consideration.
Then, the TMDI (Theoretical Maximum Daily Intake) is obtained using the MRLs
and the total intake of the target foods (based on the National Nutrition Survey). When
it is confirmed that the TMDI is less than the ADI and that there is no specific problem,
the MRLs are adopted. (Annex 4)
The positive list system was also implemented for veterinary drugs and feed
additives. Basically, the system prohibits any food that contains a drug or feed additive
without residue standards from being distributed in the domestic market. These drugs
or additives, however, may remain in foods as long as residue levels are below a certain
level that is determined to pose no adverse health effects. This provision does not apply
to antibiotics and antimicrobials even after the implementation of the system.
Given veterinary drugs and related chemicals that are distributed abroad, the
MHLW provisionally established residue limits for substances whose safety wereconfirmed at certain levels in the same manner as for pesticides residues. The newly
established limits became effective on the date of the enforcement of the system. See
Appendix 4. Registration withholding limits are not established for veterinary drugs
and feed additives. The effective MRLs, including the provisional MRLs, are available
at http://www.mhlw.go.jp/english/topics/food safety/positovelist060228/index.html
Notes:
1. NOEL (No-Observed Effect Level)
2. NOEEL (No-Observed-Adverse-Effect-Level)
3. ADI (Acceptable Daily Intake)See the section “4. Standards for mycotoxins in food” under the heading of “I. Food.”(3)

Investigation of veterinary drugs in foods
Monitoring tests
Veterinary drugs are monitored in the same manner as for pesticides residues.

Monitoring tests target drugs with MRLs. Food products that do not meet the standards
will be recalled, discarded, reshipped, or otherwise disposed of.
(4)

Information disclosure
Summary results of safety evaluations by the Pharmaceutical Affairs and Food

Sanitation Council and monitoring test results are made public on the MHLW website.

20

4.

Food Additives(1)

Historical backgroundIn 1947, then Ministry of Health and Welfare enacted the Food Sanitation Law as

the first comprehensive law for food safety/hygiene, and introduced a positive list
system for food additives. Under the system, only food additives designated as safe by
the Minister of Health, Labor and Welfare may be used in foods. Since 1947, all foodadditives have been regulated by this law. However, designation system had been
applied only to chemically synthesized food additives until 1995 when the law wasamended. Currently, all food additives are equally subject to the designation system,
synthetic or non-synthetic, with minor exceptions.
(2)Regulation of food additives under the Food Sanitation Law(a)Definition of“food additive”
The law, in the first Chapter, defines“food additive”asi.

substances used in or on food in the process of manufacturing food, orii. substances used for the purpose of processing or preserving food.
Consequently,“ food additive ” includes both substances remaining in thefinished food products, such as food colors and preservatives, and substances notremaining in the finished products, such as infiltration-supporting agents.
(b)

Designation of food additives
Designation of a food additive is normally in accordance with the procedure

given below, based on an application from a person who wishes to use it.
When an application for designation of a food additive is submitted to the
Minister, the Minister will ask the Food Safety Commission for opinions concerning
health effects of the food additive. At the request for opinion, the necessary
documents obtained are submitted to the commission. The Commission will make ascientific health risk assessment and establish the ADI. After the MHLW receives
the Commission’s report and recommendation, it will have the Pharmaceutical
Affairs and Food Sanitation Council discuss the adequacy of draft standards. In
discussion by the Council, international evaluations were taken into account. If the
discussion proves that the food additive is safe and effective, it will be designated asa food additive approved for use.
Documents accompanying an application should comply with the directions
given in the “guidelines for designation of food additives and for revision ofstandards for use of food additives.” The safety and effectiveness of a food additive
must be scientifically confirmed (see Annex 5).

21

As of the end of July 360 food additives were designated as approved by the
Minister of Health, Labour and Welfare under Article 10 of the law (see Annex 6).
Separately from the designation process described above, the MHLW
evaluates certain food additives with intent to designate them without any
application from a person who wishes to use them. This program targets substancesthat meet the standards given below. This program aims to take internationallyharmonized measure for substances that are proven safe and widely used abroad.
This action underlies the following background. In recent years, global food trade
has been expanding, and imported foods account for some 60 percent of the foods
distributed in the Japanese market. In addition, there is a growing possibility thatimported foods contain food additives that are authorized in other countries but
unauthorized in Japan.
Currently, 46 substances and some flavoring agents are targeted by the
program. Discussion is being conducted on substances for which the full documents
on safety and usefulness are prepared.
Standards
Substances:¾ for which a safety assessment has been finished by the JECFA (Joint
FAO/WHO Expert Committee on Food Additives) and whose safety has been
confirmed within a certain level, and¾ that are widely used in the United States and EU countries and whosenecessity is considered to be high.
Exemption from the designation system
There are three substance categories that are exempted from the designation
system.
i.

Existing food additives (i.e., substances that were already marketed orused on the date of the amendment of the law and appear in the List of
Existing Food Additives).
ii. Natural flavoring agents.
iii. Substances that are both generally provided for eating or drinking as foods
and used as food additives have been excluded from the designation system.

(c)

Establishment of specifications and standards
Usually, people continue to consume food additives throughout their lifetime.

Thus, food additives must be subjected to stringent regulations.
All designated chemicals, with a few exceptions, and some natural food22

additives (existing food additives) are currently regulated by specifications and/or
standards. These specifications and standards include specifications concerningchemical and physical characteristics, and standards for manufacturing, storage,
and use. These standards, along with labeling and storage standards, are publishedin an official compilation of food additives, entitled “Japan’s Specifications andStandards for Food Additives.”(d)

Official compilation of food additives
In 1957, the law was amended, and a provision about an official compilationof food additives was newly established in order to collect the specifications andstandards for food additives. Based on this provision, then Minister of Health andWelfare, on March 15, 1960, prepared the first edition of an official compilation offood additives.
Since the first edition was published, the publication has been updated
periodically to keep pace with scientific advances and harmonize Japanesestandards with international ones. The latest edition (seventh) was published in
April 1999. Its English translation was published in September 2000. The MHLW is
working to prepare the eighth edition.
(e)Food additive labelingLabeling of food additives and their preparations
Any food additive and its preparations intended for sale in Japan must belabeled with required information as prescribed in the law. The information
includes product name, manufacturer’s name, the address of the manufacturing
plant, and standards for use.
Labeling of food containing food additives
The law requires all foods containing food additives, with some exceptions, tobe labeled with the substance name without discriminating between synthetic andnonsynthetic (so-called natural).
Before the current enforcement regulations under the law came into effect inJuly 1991, only certain kinds of synthetic chemicals had been subject to labeling
regulations. However, due partly to consumers' requests, the current labelingsystem was established. This was based on the conclusion that the declaration of
every food additive used in food would be necessary to provide consumers with
important information in choosing food.
In principle, the substance names used for labeling should be individual
chemical names, but widely used common names may be used as well. Any food23

additive used for one of the eight usages (as sweetener, food color, preservative,
thickening agent, antioxidant, color fixative, bleaching agent, fungicide) must belabeled with the name of that usage as well as with its chemical name, for example,
preservative (Sorbic Acid). In addition, any food additive used for one of 14 specificusages, such as flavoring and pH regulation, may be exempted from the labelingwith its substance name, and may be labeled only with the name of that usage; e.g.,
flavoring agent, pH regulator.
(f)

Product examination of food additives
Official examination
The law requires certain food additives to undergo official examination. The

examination system targets food additives that require legal quality control toassure the safety. Under the current regulations, only tar colors are subject to thesystem. Products that have passed the examinations are given certificates.
Voluntary certification system
Separately from the official examination system mentioned above, the additive
industry operates a voluntary certification system. The system applies to Kansui(alkali), which are used in Chinese noodles, and tar color preparations.
Examinations are conducted by public laboratories or registered laboratories (thoseregistered with the Minister). The Japanese Food Additives Association issues acertificate to products that have passed the examinations.
(3)International safety assessment of food additives
Most countries are commonly interested in securing food safety and improving

consumer’s health. The Food and Agriculture Organization of the United Nations (FAO)
and the World Health Organization (WHO) have jointly established the Joint
FAO/WHO Expert Committee on Food Additives (JECFA) to evaluate the safety of foodadditives. The JECFA is comprised of experts in food additive standards andtoxicologists from various countries. They evaluate the results of safety tests conductedby individual countries and determine the acceptable daily intake (ADI) of each of theadditives for which data are sufficiently accumulated and that are proved to be safe forhuman consumption. The report of each JECFA meeting is publicized in the WHO
Technical Report Series every year.
(4)

Safety measures for non-synthetic food additives
Non-synthetic food additives have been regulated in the same manner as synthetic

24chemicals since May 24, 1996, to assure the safety of such food additives. However,non-synthetic food additives (450 existing food additives as of July 1, 2006), which werealready distributed before the amendment of the law, have been permitted for free
distribution even after May 24, 1996. Such food additives are not subject to Article 6 of
the amended law.
The MHLW is working to confirm the safety of these substances by conducting
toxicity studies or examining related literature.
As part of its safety program, the MHLW is working to establish quality
specifications,taking

into

consideration

harmonization

withinternational

specifications.
The 2003 amendment of the law has enabled the MHLW to prohibit the use ofexisting food additives by deleting them out of the list of existing food additives, when
they are considered to be fall into one of the following categories.
Target substances
i. Those that are considered to have problem with safety.
ii. Those that are no longer in use.
Based on the amended law, the MHLW published in February 2004 a list of 38
existing food additives, which were no longer in use. In July 2004 the MHLW delisted
madder color—a coloring agent obtained from plant root—and prohibited its use in food.
This action was taken in response to the interim report of a carcinogenicity study thatfound madder color to be carcinogenic to the rat kidney.

Before the action was taken,

the MHLW took into account discussions by the Commission and Pharmaceutical
Affairs and Food Sanitation Council. The abovementioned 38 substances were delisted
in December to prohibit their use.
(5)

Survey of daily intakes of food additives
Survey of daily intakes of food additives is one of the most important programs

concerning food additive safety. The MHLW estimates the dietary intakes of foodadditives by the Market Basket Survey.
The Market Basket Survey is conducted by purchasing foods distributed on themarketplace, analyzing food additives included in these foods, and determining eachamount in individual foods. Then, the total intake per capita of a target food additive isestimated by multiplying the obtained amount by the consumption of the corresponding
food and obtaining the sum of all intakes for the target foods.
The 10-year study report (1976–1985) and the latest study result (1999, 2002, and2003) concerning daily intakes of food additives shows that the per capita intake of eachfood additive is below its ADI.

25

5.

Apparatus and Containers/Packages, Toys

<Apparatus and Containers/Packages>(1)

Historical background
Legal control over apparatus and containers/packages began from the standpointof food safety in step with the enactment of the Food Sanitation Law in December 1947.
In 1948, first standards and specifications for food, food additives, apparatus andcontainers/packages were established under the law. In 1959, the existing standards
and specifications were withdrawn and replaced by integrated ones including testing
methods (Ministry of Health and Welfare Notification No. 370).
To this date, there have been several establishments and revisions of standards
and specifications.
(2)

Definitions
All apparatus and containers/packages that come into direct contact with foods

are subject to regulation of the law. “Apparatus” means articles used for manufacturing,processing,

preparing,storing,transporting,orotherwise

handling

foods.

“Containers/packages” means articles used for wrapping and packing foods fordelivering. Apparatus and containers/packages include a wide variety of articles such as
kitchen utensils, gloves for food-handling, tableware, and wrapping film.
(3)

Establishment of Specifications and Standards
The specifications for apparatus and containers/packages are divided into three

categories: a) specifications applying generally to apparatus and containers/packages
and their raw materials, b) specifications for apparatus and containers/packages bymaterial and c) specifications for apparatus and containers/packages by use. The
standards are established for manufacturing.
(a)Specifications applying generally to apparatus and containers/packages andtheir raw materials
These

specifications

apply

to

mainlymetalsandcolorsusedasmaterials/ingredients of products. The metals include tin for plating, solder, andproducts containing copper, lead, or antimony.
The specification for colors applies to all products. Coloring agents used forapparatus and containers/packages must be food colors designated by the Ministerof Health and Welfare under Article 10 of the law. However, this does not apply
where target products are processed in an appropriate way so that no color may

26

dissolve or migrate in foods.
The MHLW newly established specifications for apparatus, containers, andpackages that are intended for edible fats or oils or oily foods in August 2002 andput them into force in August 2003. Polyvinylchloride resins containing
di(2-ethylhexyl) phthalate (DEHP) must not be used as materials of apparatus,
containers, and packages for these foods. Any person is prohibited from marketingor using these PVC products containing DEHP.
(b)

Specifications for apparatus and containers/packages by material
There specifications target six material categories:

glass, ceramics, enamel,

11 types of synthetic resins, rubber, and metal. There are no specific specifications
for products made of paper or wood, which are subject to Article 9 of the law in thesame manner for other apparatus and containers/packages. Based on Article 9, any
product is enjoined from manufacture, sale, and use, when determined to be toxic orharmful.
These specifications consist of material tests and migration tests. Material
tests aim to determine constituents derived from raw materials used. The test items
include metals (e.g., cadmium and lead) and volatile substances.
Migration tests aim to determine amounts of substances that dissolve insolutions meeting the specified conditions, from different facets. These tests include
various items, such as residues on evaporation, heavy metals, consumption ofpotassium permanganate. For individual specifications, consult the separate
document (Specifications and Standards for Foods, Food Additives, etc. under the

Food Sanitation Law: Abstracts).
(c)Specifications for apparatus and containers/packages by use
The law also provides specifications for products by use. These specifications

include necessary requirements according to purposes of use. The specifications
include strength tests, such as water leak tests and pinhole tests.
The following are product categories by use:i. Containers and packages for foods that are packed into containers andpasteurized under pressure
ii. Containers and packages for nonalcoholic beveragesiii. Food-vending machines and containers that accompany a vending machine
and with which the food is soldiv. Apparatus that are used for manufacturing edible ices or for other uses ofedible ices27

v. Apparatus or containers/packages that are used for delivery ofconcentrates of nonalcoholic beverages for cup-unit vending machines orfull-automatic nonalcoholic-beverage preparing machines<Toys>The law applies to toys designated by the Minister as those that may pose healthhazards to young children through direct contact with the mouth. Young children
normally refer to those of preschool age. The law establishes specifications andstandards for toys. They include specifications for toy products and raw ingredients andstandards for manufacturing.
(1)

Specifications for toys and raw ingredients
The specifications apply to toy products themselves (rub-on pictures and origami

paper, or folding paper) and raw ingredients (polyvinyl chloride paints, materials
consisting mainly of PVC, and materials consisting mainly of polyethylene). Rubber
pacifiers are also subject to specifications.
In August 2002, specifications were newly established for toy ingredients as well
as for plastic apparatus and containers. PVC resins containing DEHP must not be used
as toy ingredients. In addition, PVC resins containing diisononyl phthalate (DINP)
must not be used as ingredients of certain types of toys (i.e., toys intended to come into
direct contact with the mouth of young children, including pacifiers and teething rings).
Any person is prohibited from marketing or using PVC toy products containing DEHP
or DINP.
(2)Standards for manufacturing
The law regulates coloring agents used for toys. If toys are painted with syntheticcoloring agents, the agents must be food colors designated by the Minister based on
Article 10 of the law. However, this requirement does not apply to the case where thecoloring agents do not dissolve in the test specified by Ministry of Health and Welfare
Notification, No 370, 1959.

28

6.

Food labeling(1)

In general
Food, food additives, and apparatus, and containers/packages with intent to sell

are required to be labeled with information as specified under the Food Sanitation Law
from the viewpoint of public health. The required information includes substance name,best-before date, ways of storing, and manufacturer. Any food containing food additives
must be basically labeled with the names of all food additives included in it.
(2)

Labeling of allergenic substances in foods
On April 1, 2001, labeling provisions for foods containing allergenic substancescame into effect, based on the law. These provisions require certain types of foodingredients to be declared. In the recent years, many health hazards associated withfoods containing allergenic substances have been identified. The allergy labeling aims toprovide consumers with necessary information, in order to prevent potential healthrisks.
The allergy labeling targets packed processed foods containing 25 types of
products given below. These 25 are categorized into two groups: 1) foods that can cause
sever allergic symptoms and on which the yearly number of cases is large, 2) foods
which can cause health hazards but on which the yearly number of cases is small. The
Ministerial Ordinance requires the five foods categorized into group 1 to be labeled. For
the remaining 20 foods categorized into group 2, labeling is recommended by the
Department of Food Safety Notice but not compulsory.
z Five foods for which labeling is compulsory
Buckwheat, eggs, milk, peanuts, and wheat.
z Twenty foods for which labeling is recommended
Abalone, apple, banana, beef, chicken, crabs, gelatin, kiwifruits, mackerel,matsutake-mushroom, oranges, peach, pork, prawn, salmon, salmon roes,
soybeans, squid, yam, walnuts.
The MHLW is reviewing the labeling system for allergenic substances.
(3)

Labeling of genetically modified foods
In April 2001, the labeling for genetically modified foods became mandatory inJapan. The labeling is under the jurisdiction of two ministries: the Ministry ofAgriculture, Forestry and Fisheries and the Ministry of Health, Labour and Welfare.
MAFF intends to provide consumers with information in choosing food under theJapanese Agricultural Standards Law. The MHLW intends to publicize the fact that the29

product has undergone the safety assessment. Currently, the safety assessment is
mandatory under the law and only genetically modified foods that have undergone thesafety assessment may be distributed in the domestic market. The labeling is part of thelegal safety assessment system under the law.
The labeling should be as follows:i. Genetically modified crops, and their processed foods: A statement to theeffect that this is a genetically modified food (mandatory labeling)ii. Crops that have not been separated from genetically modified crops and thatmight include genetically modified crops, and their processed foods: A
statement to the effect that this is a non-separated food (mandatory labeling)iii. Non-genetically modified crops that have completely been separated fromgenetically modified crops, and their processed foods: A statement to theeffect that this is a non-genetically modified food (voluntary labeling)
Foods that require labeling:z CropsSoybeans, corns, rape seeds, potatoes, cotton seeds, and alfalfa
z Processed foods (As of April 2004)
1. Tofu (soybean curd) and fried Tofu.

2. Frozen Tofu, Okara (bean curd

refuse ), and Yuba (film-formed products obtained by heating soybean milk).
3. Natto (fermented soybeans).

4. Soybean milk and its similar products.

5. Miso (fermented soybean paste: seasoning). 6. Simmered soybeans.
7. Canned and bottled soybeans.

8. Soybean flour.

9. Roasted soybeans.

10. Products that are made mainly of foods listed in 1 through 9.
11. Products that are made mainly of soybeans, excluding foods listed in
sections 1 through 11.

12. Products that are made mainly of soybean flour.

13. Products that are made mainly of soybean protein. 14. Products thatare made mainly of succulent soybeans. 15. Products that are made mainlyof soybean sprouts.

16. Savory that are made mainly of corns.

starch. 18. Pop corns.

19. Frozen corns.

20. Canned and bottled corns.

21. Products that are made mainly of corn flour.
mainly of corn grits.

17. Corn

22. Products that are made23. Products that are made mainly of corns, excluding

foods listed in 16 through 22.

24. Products that are made mainly of foods

listed in 16 through 20.

25. Frozen potatoes.

27. Potato powder. 28. Savory made of potatoes.

26. Dry potatoes.
29. Products that are

made mainly of foods listed in 25 through 28. 30. Products that are mademainly of potatoes, excluding foods listed in 25 through 29.

30

31. Productsthat are made mainly of alfalfa.
Processed foods given below are exempted from mandatory labeling and can belabeled voluntarily.
z Products from which recombinant DNA and protein are removed.
z Products in which the crops listed above are not used as major ingredients(“major ingredients” refers to the three major ingredients of the product interms of weight, and the proportion of each ingredient is 5% or more byweight).

31

Annexes
1.

Regulatory status on pesticide residues by the Food Safety Basic Law, the Food
Sanitation Law, and the Agricultural Chemicals Regulation Law

2.

Positive List System for Agricultural Chemical Residues
Appendix

Implementation of the positive list system for agricultural chemical
residues in foods

3.

Pesticide Registration and Establishment of MRLs

4.

Basic principles for establishment of maximum residue limits for pesticides inagricultural products (including Diagram)

5.

Guidelines for designation of food additives, and for revision of standards for use offood additives (excerpt) (including table and diagram)

6.

Change in the number of designated food additives

32Regulatory Status on Pesticide Residues under the Food Safety Basic Law,
the Food Sanitation Law, and the Agricultural Chemicals Regulation Law[Food Safety Basic Law]
Food Safety Commission(Risk assessment, Establishment of ADI)

[Food Sanitation Law]
Business persons(Persons
who
manufacture,import, process, prepare, store,transport, or sell food)Business
licenseCollection
Food inspection
Disposal order

Ministry of Health, Labour and Welfare* Establishment of standards/specifications for food(Residue standards: MRLs)
Prevention of health hazards arising from foodconsumption* Prohibition of sale/import of food in violation ofstandards
Pharmaceutical Affairs and Food Sanitation Council[Agricultural Chemicals Regulation Law]
Pesticide manufacturers/importers
Overseas pesticide manufacturers
Pesticides imported to Japan
Application for registration(Accompanying data on efficacy,
toxicity, residue property, etc.)
Ministry of Agriculture, Forestry and Fisheries* Pesticide registration* Labeling regulation of pesticides* Establishment of use standards for pesticides*Sales control/prohibition of pesticides* Cancellation of pesticide registration
Agricultural Material Council

Ministry otf he Environment
Establishmentofregistration
withholding limit (RWL)
Note: The Food Sanitation Law prohibits the distribution of foods that do not meet the
MRLs. The Agricultural Chemicals Regulation Law prohibits the registration ofpesticides that do not meet the RWLs. The MRLs established by the MHLW are
also used as RWLs.

Appendix to Annex 2

Implementationof the Positive List System for Agricultural Chemical Residues in Foods

I.

Introduction of the positive list system
On May 29, 2006 the Ministry of Health, Labour and Welfare (MHLW) introduced thepositive list system for agricultural chemicals remaining in foods—a system to prohibit the
distribution of foods that contain agricultural chemicals above a certain level if maximum
residue limits (MRLs) have not been established. The agricultural chemicals include
pesticides, feed additives and veterinary drugs. This activity has been based on the Law toPartially Amend the Food Sanitation Law (Law No. 55, 2003). The Law No. 55 has required
the MHLW to take the following measures within three years after the publication of theamended Food Sanitation Law (May 30, 2003).
Measures the Law required the MHLW to takei.

To establish a certain limit stipulated in Article 11 Paragraph 3 of the amended Food
Sanitation Law∗ as a limit that is unlikely to pose adverse health effects (hereinafterreferred to as the “uniform limit”)

ii. To designate substances stipulated in Article 11 Paragraph 3 of the amendedd FSL as
those that will not pose adverse health effects (hereinafter referred to as “exempted
substances”)
iii. To establish maximum residue limits stipulated in Article 11 Paragraph 1 of the FSL,
which are provisionally established as compositional specifications for food (hereinafterreferred to as “provisional MRLs”)—as maximum levels of chemicals that can remain
foods—in order to protect public health and smoothly implement the positive list
system.

II.

Specifics of uniform limit, exempted substances, and provisional MRLs

A.

Uniform limit
The uniform limit has been established for agricultural chemicals without MRLs.

Basically, before a chemical is authorized, discussions are conducted on toxicity and othernecessary matters. Based on the discussion results, restrictions are set on target crops anduse amounts. Also, applications to the target crops and maximum limits that can remain infoods are established. This activity is conducted in the similar manner, regardless of country.
∗

Article 11 Paragraph 3 was newly added based on the Law to Partially Amend the Food Sanitation Law(Law No. 55, 2003). The added provision took effect on May 29, 2006.

Appendix to Annex 2

The MHLW has decided that it is appropriate to use a toxicological threshold of 1.5
μg/day as a basis for determining the uniform limit. The threshold has been based on:–the acceptable exposure levels which have been used in evaluations of flavoring agentsby JECFA (Joint FAO/WHO Expert Committee on Food Additives) and in evaluations of
indirect additives by the USFDA (Food and Drug Administration), and–the ADIs (Acceptable Daily Intakes) of chemicals that had been already evaluated by
JMPR (Joint FAO/WHO Expert Meeting on Pesticide Residues) or JECFA or in Japan.
The uniform limit has been set at 0.01 ppm so that the estimated intake of agriculturalchemicals to which the limit would be applied does not exceed 1.5 μg/day when based on thefood consumption of Japanese population. In January 2005 the European Union (EU), whichplans to introduce a positive list system, established the uniform level at 0.01 ppm.
Considering such circumstances, the MHLW has decided that the limit is reasonable.
For chemicals for which the ADIs set by JMPR or JECFA are extremely low, MRLs havebeen established at ND (not-detected level), instead of the uniform limits. For substances forwhich determination limits for analytical methods used in monitoring tests conducted by theJapanese local governments exceeds 0.01 ppm, the corresponding LOD of the analyticalmethods has been set.
B.

Exempted substances
Exempted substances target pesticides, veterinary drugs, and feed additives which areused during the production of crops and aquatic products, and substances which are producedby chemical changes of these agricultural chemicals in food. The selection of exempted
substances has been based on the following concepts when these agricultural chemicals
themselves and their decomposition products could remain in food as a result of application infood production.
i.

Agricultural chemicals and their decomposition products which are determined not topose adverse health effects, given residue levels and forms, even if these chemicals
remain in crops and animal products, including sea foods, to certain levels.

ii. Specified agricultural chemicals shown in the Agricultural Chemicals Regulation Law,
and chemicals for which registration withholding limits are not established and which
are determined not to pose adverse health effects even if crops exposed to thesechemicals are consumed.
iii. Agricultural chemicals which are determined not to require any MRL in foreigncountries and whose uses are not restricted.
C.

Provisional MRLs
MRLs which had been established before the FSL was amended in May 2003 did notcover all standards, including Codex standards and registration withholding limits forAppendix to Annex 2

substances which are permitted for use in Japan. From the viewpoint of protection of publichealth and smooth implementation of the system, it was necessary to provisionally establish
MRLs for chemicals without MRLs. In establishing provisional MRLs, Codex standards andother necessary information have been considered.
Provisional MRLs have been established taking into consideration:i.

Codex standards,

ii. Registration withholding limits based on the Agricultural Chemicals Regulation Law,limits of determination for veterinary drugs at the time when they were authorizedbased on Pharmaceutical Affaires Law (Law No. 145, 1960), or limits of determination
for feed additives at the time when they were authorized based on the Law for Safety
Assurance and Quality Improvement of Animal Feed (Law No. 35, 1953), andiii. Standards established by countries where MRLs are assumed to be established based on
toxicity study data equivalent in quality to those used in scientific evaluations by JMPR
and JECFA. These countries are Australia, Canada, EU, New Zealand, and UnitedStates.
For those chemicals categorized in either of the following two types, ND has been set
instead of numerical limits: 1) genotoxic carcinogens and 2) chemicals that have been
determined by JMPR or JECFA as those for which the ADI cannot be set. Separately fromnumerical limits, requirements/restrictions have been imposed on certain types of substances,including antibiotics, antibacterials, substances naturally occurring in foods, and chemicals
for which standards are already set for food additive uses, and on applications of MRLs toprocessed foods.
The proposed provisional MRLs took effect on the date of implementation of the positive
list system as compositional standards for food stipulated in Article 11 Paragraph 1 of the
FSL. Basically, no change has been made for MRLs already established based on Article 11
Paragraph 1.
<Progress of the activity>
October 2003
The first draft published (draft provisional MRLs only).
August 2004
The second draft published (uniform level, exempted substances, and provisional MRL).
June 2005
The final draft published (uniform level, exempted substances, and provisional MRL).
October 24, 2005
As the result of discussion based on the above concepts, the Pharmaceutical Affairs andFood Sanitation Council reported to the Minister of Health, Labour and Welfare that(1) the uniform limit should be established at 0.01 ppm,
(2) 65 exempted substances should be designated, andAppendix to Annex 2(3) provisional MRLs should be established for 758 chemicals.
November 29
Notifications on the positive list system were published in the official gazette Kanpo:
MHLW Notification No. 497 (Uniform limit)∗

MHLW Notification No. 498 (Exempted substances)
MHLW Notification No. 499 (Provisional MRLs, etc.)
May 29, 2006
The Positive List System took effect.
The MHLW intends, on a systematic basis, to ask the FSC to conduct safety evaluation for
agricultural chemicals for which provisional MRLs have been established.

∗

The uniform limit, exempted substances, and provisional MRLs are accessible in English at:

http://www.mhlw.go.jp/english/topics/foodsafety/positivelist060228/index.html
http://www.ffcr.or.jp/zaidan/FFCRHOME.nsf/pages/MRLs-p

Annex 2.

Positive List System for Agricultural Chemical Residues【Before Implementation】【After Implementation】

Pesticides,
Pesticides, Feed
Feed Additives,
Additives, andand
Veterinary
Veterinary Drugs
Drugs

Pesticides,
Pesticides, Feed
Feed Additives
Additives andand Veterinary
Veterinary Drugs
Drugs

Chemicals for which
MRLs are established
MRLs for 250 pesticides
and 33 Veterinary Drugs

Foods containing chemicals
above the MRLs are enjoinedfrom domestic distribution.

Chemicals for which
MRLs are establishedEstablishment ofprovisional MRLs for
agricultural chemicals,considering Codex
standards, Japaneseregistration withholding
limits, and other standards
established based upon
scientific evaluation

Chemicals for which
MRLs are notestablished

Chemicals
designated by
MHLW

Establishment of acertain level that isdetermined to poseno adverse healtheffects

Chemicals that
do not poseadverse healtheffects＋
Chemicals for which MRLs
are not established.

Basically, even foods foundto contain chemicals are
not enjoined from
distribution.

Acceleration of theestablishment of MRLs

Foods containing chemicals
above the MRLs areenjoined from domestic
distribution.

Foods found to containchemicals above thecertain level (0.01 ppm)
are enjoined fromdomestic distribution.

Noｔ subject tothe positive list
systemAnnex 3.

Pesticide Registration and Establishment of MRLs
Ministry of Health,Labour and Welfare

Food Safety
Commission

Ministryof Environment

Ministry of Agriculture,
Forestry and Fisheries

Notification of application

Confirmation of Application

Provision of documents

Hearing of opinion（Food Safety Basic Law）

Risk Assessment

Receipt of Registration
Application

Request for documents

Obtainment of Documents

Confirmation ofApplication

CouncilPublic Comments(Subcommittee)(Discussion on draft MRLs)

Report/Recommendation

Establishment of ADIWTO Notification
Public Comments

3－4 months

Registration
Examination

Councilreferencing(Food Sanitation Committee)
ReportBased on limits

Announcement of MRLs
MRLs will be enforced on the dateof announcement or a few months
after that date.

Enforcement

Registration
Withholding Limits

MRLs are adopted as registration
withholding limits

Registration

Sale/Use

Annex4.

Basic principles for establishment of maximum residue limits
for pesticides in agricultural products

1.

The “ADI” and “exposure estimate” are at the core of setting residue standards

for pesticides in food (maximum residue limits: MRLs).
z

The determination of the ADI 1 is globally based on the following method:First, a no-observed-adverse effect level (NOAEL) is obtained, based on
results of long-term animal safety studies. The NOAEL refers to a level that
does not have any adverse effect on the health of the experimental animals.
Then, the ADI is calculated by dividing the NOAEL by a safety factor (usually100) obtained from inter-species variability between humans and test animals
and intra-species variability between human individuals.

z

In Japan, the expected exposure level of a pesticide is estimated on the basisof the Theoretical Maximum Daily Intake (TMDI) method (TMDI: the sum of
all intakes obtained by multiplying MRLs 2 by the average intake 3 ; see thediagram below) of each target agricultural product and the Estimated Daily
Intake (EDI) method.
The setting of MRLs is normally based on the following step:First, it is evaluated whether the acceptable daily intake (ADI) can beestablished for a target pesticide, based on the results of safety studies. If theevaluation indicates that an ADI can be established, then draft MRLs for which
pesticide are set, based on residue study results, and international standards and othercountries’ standards.
Second, the expected exposure level 4 is estimated using draft MRLs.
Third, if the estimated exposure level does not exceed the acceptable intake
based on the ADI, the draft MRLs are adopted as national MRLs, because it isdetermined that this level of consumption of the pesticide will not affect the health ofJapanese people. If the estimated exposure level exceeds the acceptable intake, allfactors involved in the estimation of pesticide intake are reviewed to correct a possible
overestimate. If it is determined that an ADI cannot be established, MRLs are set as“no detection,” or ND for each. In practice, the pesticide is not allowed to remain inagricultural products.
2.

Japan uses a new method for exposure estimation, in which the TMDI method and

EDI method are combined.

The EDI method was introduced in 2000 to improve amajor drawback of the TMDI (an expected exposure level based on the TMDI method isusually an overestimate of the true pesticide intake).

For example, the TMDIs of two

pesticides (fenitrothion and malathion) out of 246 pesticides having MRLs exceed 80%of the corresponding ADI. However, it is reported that the Market Basket Survey5) for
these two chemicals found that the estimates of exposure levels for the chemicals fell
between 0.1–2.9% of each ADI.
3.

The EDI method, published by the WHO (World Health Organization) in 1997, isa more practical method, which is suitable for estimating actual exposures. The EDI
method is based on residue test results for pesticides in agricultural products. The
United States has already adopted a similar method.
Currently, Codex MRLs established by the Joint FAO/WHO Codex Alimentarius
Commission are based on this method. Safety will be confirmed by comparing the ADI
with exposure estimates obtained using the method.
4.

In the new Japanese method, as long as the exposure estimate obtained based on

the new method does not exceed the acceptable intake, international standards are
adopted as Japanese MRLs. Otherwise, appropriate action is taken, in light ofJapanese dietary patterns, such as the adoption of MRLs stricter than theinternational standards.
5.

The new exposure assessment method is basically similar to the TMDI method

for the estimation of the dietary intake of pesticides (a sum of all intakes obtained bymultiplying the residue of the target pesticide in each crop by the average consumptionof each crop). However, various factors below are considered in estimating residue
levels in crops and consumption of crops.

a.

Mean residue levels from supervised trialsb.

Residue in edible portionsc.

Effect of processing and cooking on residue levelsd.

Food consumption data, including subgroups of the population, such as
infants and young childrene.

Exposure through pathways other than target crops for MRLs, including

other foods, water, and air
In practice, the exposure estimate of a pesticide from target crops is comparedwith the acceptable daily intake of the pesticide to confirm that the estimates do
not exceed each acceptable intake. This procedure enables the safety assuranceof pesticide residues for the entire nation including certain subgroups: infants
and young children, pregnant women, and the elderly. Both exposure estimatesand acceptable intakes are obtained, as given below, separately for the entire
nation and for the three subgroups.

Exposure=

Residue level of crop A 6

Residue level of crop B

×Intake of crop A 7＋

×Intake of crop B＋．．．．．．．．．．．．．．

＋(Exposure = Sum of each intake of a pesticide)

Acceptable intake=
from crops

ADI mg/kg ofbody weight×

Average bodyweight 8

×

Factor9 based on
exposure from otherpathways, such as
water

Outline of the new exposure assessment method
First step
To compare the TMDI with the acceptable intake of a pesticide for four groups: theentire nation and three subgroups (infants and young children, pregnant women, andthe elderly). The acceptable intake is set, taking into account exposure from otherpathways such as water and air.
If the TMDI is less than the acceptable intake for each of the four groups, the draft
MRLs are adopted.

In this case, the second step is not taken, because the safety of thepesticide residues is considered to be secured. If the TMDI exceeds the acceptableintake for one of the four groups, assessment proceeds to the second step.
Second step
To use refined exposure estimates based on the Japanese EDI method for comparing
with each acceptable intake. Comparison is conducted separately for each estimate
obtained for the entire nation and three subgroups (infants and young children,
pregnant women, and the elderly).
If the Japanese EDI (estimated daily intake) is less than the acceptable intake for eachof the four groups, the adopt draft MRLs are adopted because the safety of pesticide
residues is considered to be secured. If the EDI exceeds the acceptable intake for one of
the four groups, assessment proceeds to the third step.
Third step
Appropriate measures, such as adoption of stricter MRLs are taken, because theadoption of the draft MRLs could give rise to adverse effects on the protection of publichealth.

Note:
1.

“Acceptable Daily Intake” (ADI) refers to the estimate of the amount of a substancethat can be ingested daily over a lifetime without appreciable health risk to theconsumer. It is normally expressed in milligrams of the substance per kilogram of bodyweight.
2.

“Average intake” refers to the amount of a food consumed per person per day,obtained from the National Nutrition Survey (food intake survey).
3.

Draft MRLs are established based on international standards and residual levelsof a target pesticide in crops obtained from field tests.
4.

“Expected exposure level of a target pesticide” refers to the amount of a pesticide

received by consuming crops that were treated with the pesticide.
5.

“Market Basket Survey” refers to a survey to identify actual intakes of pesticides

from crops in the marketplace, based on data from the National Nutrition Survey (foodintake survey). Chemical analyses are conducted after samples are prepared/cooked asthey would be normally.

6.

As a residue level, use the amount of pesticide residues, based on residue tests forcrops, residue data for edible portions, and the effects of cooking and processing on
residue levels.
7.

As the intake of a target crop, use the consumption of each crop for the whole

population (per capita) and three subgroups (infants and young children, pregnant
women, and the elderly) separately, based on data from the National Nutrition
Survey .
8.

As a mean body weight, use the mean of body weights of the people surveyed forthe whole population and the three subgroups (infants and young children, pregnant
women, and the elderly) separately, based on data from the National Nutrition Survey.
9.

The factor is based on exposure to pesticides only from crops by deducting exposure

from pathways other than target crops, such as other foods, water, and air. Usually,
0.8 (80%) is used.

Diagram: TMDI method←Safety level (ADI)※

Increase in the intake of pesticides

Intake derived from rice

← TMDI〔MRL on rice (ppm)×intake of rice (g)〕Intake derived from wheat〔MRL on wheat(ppm)×Intake of wheat (g)〕Intake derived from carrots〔MRL on carrots (ppm)×intake of carrots (g)〕Intake derived from oranges

MRLs are established,so that the TMDI does
not exceed the safetylevel (ADI).

〔MRL on oranges (ppm)×intake of oranges (g)〕Intake derived from other products〔sum of the intakes of the remaining
products, obtained in the same manner〕＊

In order to determine the acceptance daily intake (ADI) of each pesticide, first acertain amount (maximum no observed adverse effect level), at which the pesticide
administered does not induce any effect on experimental animals, is obtained on thebasis of animal experiments. Then, the amount is multiplied by a safety factor. This is
to provide an adequate safety margin. The order of 100 as safety margin is widely used.

Annex 5.

The guidelines for designation of food additives, and for revision ofstandards for use of food additives (Excerpt)
Ⅰ Purpose
These guidelines are designed to provide the procedures required to apply fordesignation of substance intended to be used as food additives pursuant to Article 6 of
the Food Sanitation Law and to apply for establishment of use standards for foodadditives pursuant to Article 7, Paragraph 1 of the same law. Also, these guidelines
provide the scope of accompanying documentation for these applications and therecommended methods for safety studies that are required to prepare thedocumentation.
Ⅱ

Principles for designation and revision of standards for use of food additives
Food additives must pose no hazards to human health and be effective. Also, theuse of them must benefit consumers. In designating food additives and revising use
standards, the points given below must be scientifically confirmed. Scientificevaluations will be conducted by the Pharmaceutical Affairs and Food Sanitation
Council from the view of the public health. In these evaluations, standards of the Joint
FAO/WHO Codex Alimentarius Commission and conditions of Japanese food intake
will be considered.
1.

SafetyThe safety of the targeted food additive should be proven or confirmed in theintended methods of use.
2.

EffectivenessIt should be proven or confirmed that the use of the food additive comes under

one or more of the purposes set out in (1) to (4) below. However, where the
manufacturing or processing method for a target food can be improved or modified atcomparatively low cost, and the improved or modified method does not require the foodadditive for the manufacture or processing of the food, the use of the food additive is
not justified.

(1)To preserve the nutritional quality of the food.

An intentional reduction in the nutritional quality of a food would be justified in
the circumstances dealt with in section (2) below and also in other circumstanceswhere the food does not constitute a significant item in a normal diet.
(2) To provide necessary ingredients or constituents for food manufactured forgroups of consumers having special dietary need, provided that the food additive
is not intended to provide medical effects, such as prevention or treatments ofcertain diseases.
(3) To enhance the keeping quality or stability of a food or to improve its
organoleptic properties, provided that this does not so change the nature,
substance, or quality of the food as to deceive the consumer.
(4) To provide aids in the manufacture, processing, preparation, treatment,
packing, transport, or storage of food, provided that the food additive is not used
to disguise the effects of the use of faulty raw materials or of undesirable(including unhygienic) practices or techniques during the course of any of these
activities.

Ⅲ Procedures for designation and revision of standards for use of food additives
1.

Application
Those who wish to apply for designation of a food additive or to apply for revisionof standards for use of an food additive may submit an application to the Minister of
Health, Labour, and Welfare. The application should be accompanied by any required
documentation on draft specifications and use standards, and the safety of the foodadditive.
2.

Draft specifications and standards for use(1)

An application for designation of a food additive should be basically accompanied

by draft specifications of the food additive. Draft standards are required only whentarget foods, in which the food additive is used, the amount of its use, and the way ofusing are restricted.
(2)

An application for revision of standards for use for a food additive should beaccompanied by a list in tabular form contrasting the existing standards and the
proposed standards.
3.

Process of examination of application
Documentation submitted by an applicant will first be examined by thesecretariat office. When the Minister determines it appropriate to hear opinions fromthe Pharmaceutical Affairs and Food Sanitation Council, then the Ministry of Health,Labour, and Welfare will start the processing required to consult the Council about theapplication.
The Council may ask for additional documents from the applicant if necessary.
When the Council determines the designation or revision to be appropriate after due
discussion, it will make an affirmative report to the Minister of Health, Labour, andWelfare.

In response to the report from the Council, the Ministry of Health, Labour,and Welfare will follow appropriate formalities, including the revision of the
Enforcement Regulations of the Food Sanitation Law. (See the attached diagram)
4.

Processing period
The standard period of time required for processing, from the receipt of theapplication by the Ministry of Health, Labour, and Welfare to the designation orrevision of standards for use, is one year. However, this period does not include any
time required for completion of incomplete applications or documents submitted, or any
time needed for replies to inquiries by the Council.
Ⅳ.

Documentation required for designation of food additives and revision ofstandards for use of food additives
1.

Scope of accompanying documentation(1)

Applications for designation of a food additive and for revision of use standards fora food additive, as a rule, require the documentation given in the Table. However, some

documents may be exempted from submission, provided that adequate reasons for the
exemption are stated.
(2)

The applicant should submit any data that would raise doubts about the quality,

safety, or effectiveness of the food additive, without regard to the reliability of thesubmitted documentation.
2.
(1)

General considerations for preparation of documentation
In preparing the required documentation for application, applicants should

assume full responsibility for the reliability of the information.
(2)

Basically, all documentation should be submitted in Japanese. However, thedocuments other than the summary (see Table 1) may be submitted in English.
(3)

Studies necessary to prepare the required documentation should be conducted inlaboratories that have adequate facilities, equipment, and personnel to ensure thereliability of test data, and that are recognized as adequately managed.
3.

Specific considerations for documentation required to apply fordesignation offood additives(1)

Summary of documentation① The summary should concisely describe the documentation categories.
② If any of the documents listed in Table is exempted from submission, thereasons for that exemption should be stated.

(2)

Documentation on origin or details of development and overseas conditions on use①

Origin or details of development
The history of the food additive should include a chronology of development

and use. Its use in other countries should be described.
② Condition on use in foreign countries

Overseas conditions (including approval status of the food additive, target foodsin which the food additive is used, standards for use, and specifications) should be
described.

Also, safety evaluation, standards for use, and specifications for thesame additive of international organizations should be described.
(3)

Documentation on physicochemical characteristics and specifications
The documentation should be prepared based on results of appropriate tests

conducted in accordance with the sections entitled“General Notice”and“General Tests”
in the official compilation of food additives (Japan’s Specifications and Standards for

Food Additives, former The Japanese Standards for Food Additives).
①

Name
The generic name and chemical name (International Union of Pure andApplied Chemistry Name) should be given.
②

Structural formula or rational formulaThis formula should be described by referring to the description of that of a

substance with a similar structure appearing in The Japanese Standards for Food
Additives.
③

Molecular formula and formula weight
These should

be describedbased onthe section entitle“General Notice”

in Japan’s Specifications and Standards for Food.
④

Assay
Assay requirements for the food additive should be established to ensure

constant quality in safety and effectiveness based on the manufacturing process,assay error, and stability.
⑤

Methods of manufacturing
Methods of manufacturing should be clearly stated because types andamounts of impurities produced or intermixed during the manufacturing process
vary with the⑥methods for the food additive.

Description

Information necessary to identify or handle the food additive should be stated.
Usually, the information includes taste, odor, color, and form.
⑦

Identification tests
Identification tests are required to identify whether the substance is thetarget food additive, based on its characteristics.

Therefore, the tests should bespecific to characteristics based on the chemical structure of the food additive.
⑧

Specific properties
Specific properties are expressed as values measured using physical orchemical means. They include absorbance, optical rotation, pH, and melting point.
Parameters necessary for quality assurance of the food additive should be
described.
⑨

Purity tests
Purity tests are required to determine levels of impurities in the food additive,

and specify the purity of the food additive as well as assays.
⑩

Loss on drying, loss on ignition, or water content
A test for“loss on drying”is usually required to measure substances that ispresent in the food additive and can be lost by drying.

The substances include freewater, all or part of the crystalline water, and volatile substances.

A test for“losson ignition”is usually required on an inorganic substance that can lose a part of its
components or admixed substances by igniting.

Water determination is usuallyrequired to determine the water content in the food additive.
⑪

Residues on ignition
This test is generally required to measure the total amount of inorganic

impurities present in an organic compound.

In some cases, this test may be

conducted to measure the amount of inorganic substances present in an organic
compound as its components or the amount of impurities present in an inorganic
compound that can volatilize by heating.
⑫

Method of assay
An assay method is intended to determine the content of an effective

component of the food additive using physical, chemical, or biological means.

When a relative analytical method is established, specifications for the reference
standard used in the analysis should be established.
⑬

Stability of food additives
The stability of the food additive including breakdown products should be

evaluated.
⑭

Also, the stability of decomposition products should be evaluated.

Analytical methods for food additives in food
Basically, analytical methods should be established for foods in which the foodadditive is likely to be used at high possibility.

They should be

methods toidentify the addition of the food additive quantitatively and qualitatively bychemically analyzing target foods.
If other additives with similar purposes are used together with the food additive,
the target additive should be separated from the additives used with and analyzed.
⑮

Principles to establish draft specificationsa) Specifications should be required to secure a constant quality concerning
safety and effectiveness.
b) A list contrasting the proposed specifications and international and othermajor countries' specifications(4)should be attached.

Documentation on effectiveness① Studies concerning effectiveness should be conducted to establish that the
food additive has expected effects, according to its purposes.
② Comparisons in effects with a widely used food additive, which has alreadybeen approved for the same use, are desirable.
③ Studies on the stability of the food additive in foods should be conducted.
For unstable food additives, breakdown products should be examined on kinds andextent.
④ Effects of the food additive on main nutrients in foods should be examined.

(5)Documentation on safety① Documentation on toxicitya) In order to ensure the reliability of animal toxicity study data, toxicity studies
should be conducted in accordance with appropriate good laboratory practice (GLP),
such as standards for the conduct of safety studies on drugs.
b) Generally used methods for each toxicity study are given in Chapter Ⅴ of the
Guidelines to help with adequate evaluation concerning the safety of food additives.
It is not reasonable to apply uniform methods to all food additives.

New

methods may be developed, keeping pace with the advance in scientific technology.
If obtained findings can enable scientific safety evaluation of the food additive,
examiners may not necessarily adhere to the methods specified in Chapter Ⅴ.
Studies complying with OECD (the Organization for Economic Cooperation andDevelopment) guidelines or USFDA (the US Food and Drug Administration)
guidelines are basically acceptable.
② Documentation on metabolism and pharmacokinetic studya) A metabolism and pharmacokinetic study is usually required to estimate
systems of absorption, distribution, metabolism, and excretion of the food additivein the living body when that additive is consumed by humans.

The documentation

should include not only animal test findings but discussions concerning
extrapolation to humans of metabolism and pharmacokinetics and possible harmful
effects.
b) General methods of metabolism and pharmacokinetic study are described in
Chapter Ⅴ.

The conduct of this study should follow the basic concept given in ①b) in this chapter.
③ Documentation on daily intake of the food additivea) The daily intake of the food additive is estimated by using data on the daily
intake of target foods and the amount of the food additive used in each food.

Indetermining the daily intake of the target foods in Japan, data on the food intake

obtained based on the National Nutrition Survey or other related surveys areuseful.
b) Safety evaluation should be performed by comparing the daily intake of thefood additive with the acceptable daily intake determined by toxicity studies.
When the food additive is consumed with other similar additives, its safety should
also be evaluated.
Attention should, if necessary, be given to overintake of the food additive andeffect on the balance of electrolytes in the living body, in the light of conditions ofJapanese food intake.
(6)

Documentation on draft standards for use①

When the applicant determines that standards for use of the food additive arenecessary to restrict the target foods and the amount of use, as a result ofcomprehensive evaluation of the safety and effectiveness of the food additive, he or
she should clarify the evidence supporting the necessity of standards for use, basedon the documents given in (2) through (5) above.

Standards for use should beestablished, according to those already established for other food additives.
②

When the applicant determines that standards for use of the food additive are

not necessary, he or she should clarify the evidence supporting that determination,
based on the documents given in (2) through (5).

4.

Specific considerations for documentation required to apply for revision ofstandards for use
The applicant should follow the specific considerations given in section 3, Chapter
Ⅳ. The documentation should include evidence supporting the necessity of the revisionof standard(s) for use of the food additive, including the addition of target foods and thechange of amount of use.

TableDocumentation required to apply for designation of food additives
and for revision of their standards for use

Document Category

Approval

Revision

1. Summary○○

2. Chronology on origin or development and overseas use conditions(1) Details of origin or development(2) Overseas use conditions

○
○

△
○

3. Physiochemical characteristics and specifications(1) Name(2) Structural formula and rational formula(3) Molecule formula and formula weight(4) Assay(5) Methods of manufacturing(6) Description(7) Identification tests(8) Specific properties(9) Purity tests(10) Loss on drying, loss on ignition, or water(11) Residues on ignition(12) Method of assay(13) Stability(14) Analytical method for the food additives in foods(15) Principles to establish proposed specifications

○
○
○
○
○
○
○
○
○
○
○
○
○
○
○

△
△
△
△
△
△
△
△
△
△
△
△
△
△
△

4. Effectiveness(1) Effectiveness and comparison in effect with other similar food additives(2) Stability in foods(3) Effects on nutrients of foods

○
○
○

○
△
△

5. Safety evaluation(1) Toxicity studies
1) 28-day toxicity study2) 90-day toxicity study3) One-year toxicity study4) Reproduction study5) Teratogenicity study6) Carcinogenicity study7) Combined chronical toxicity/carcinogenicity study8) Antigenicity study9) Mutagenicity study10) General pharmacological study(2) Metabolism and pharmacokinetic studies(3) Daily intake of food additives

○
○
○
○
○
○
○
○
○
○
○
○

△
△
△
△
△
△
△
△
△
△
△
○

6. Proposed standards for use

○

○

Note:
Documents marked with the symbol, "○,"are basically required.
Documents marked with the symbol, "△,"should be submitted, only when considered as necessary:e.g., where new information is obtained.

Process of the Designation of Food Additives
Diagram

Ministry of Health,
Labor and Welfare

Food Safety Commission

Confirmation of Application

Risk Assessment
Chronic toxicity study
Carcinogenicity study
Teratogenicity study

Hearing of opinions
Food Safety Basic Law

RequestObtainment of Documents*

Council （Subcommittee）
Public Comments（Discussion on draft standards）
Repot/Recommendation

Establishment of ADIWTO Notification
Public comments* Documents on effectiveness and compositional
standards

Council (Food Sanitation Committee)
ReportRevision of regulations
Regulations will be enforced on the date ofannouncement or a few months after that date.

Enforcement

3－4 months

Annex 6.
Change in the Number of Designated Food Additives
400

353 351
346 350350

Number of Food Additives

300

337 336 333 334 334 336

353
347 347 347 347 350 348 349 351 352

345
338 340352 357

360

291

250

247
208

200

150

100

106

50

0

'56

'58

'60

'62

'64

'66

'68

'70

'72

'74

'76

'78

'80

'82

'84

'86

Year

'88

'90

'92

'94

'96

'98

'99

'00

'01

'02

'03

'04

'05

'06