""

Voluntary Report - public distribution

**Date:** 12/16/2003

**GAIN Report Number:** JA3071

JA3071

**Japan**

**Sanitary/Phytosanitary/Food Safety**

**First draft of provisional MRL\'s for agricultural chemicals in
foods**

**2003**

**Approved by:**

![](media/image1.wmf)Kevin Latner

#### U. S. Embassy

**Prepared by:**

Tetsuo Hamamoto

**Report Highlights:**

Japan announced the first draft of provisional maximum residue limits
(MRLs) for agricultural chemicals in foods as a part of introduction of
a positive list system; a system to prohibit the distribution of foods
that contain agricultural chemicals above a certain level of MRLs has
not been established.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Tokyo \[JA1\]

\[JA\]

The Ministry of Labor, Health and Welfare (MHLW) invited foreign
Embassies in Tokyo today to comment on the proposal of the first draft
of provisional maximum residue limits (MRLs) for agricultural chemicals
in foods as a part of introduction of a positive list system; a system
to prohibit the distribution of foods that contain agricultural
chemicals above a certain level of MRLs have not been established.
Foreign governments have until January 27, 2004 to comment. MHLW will
open the proposal to comments to a wider audience and notify the WTO SPS
Committee before final review and adoption.

The draft provisional MRLs are listed by chemicals in English at:

<http://www.mhlw.go.jp/english/topics/mrls/index.html>

The MRLs are listed as pdf files written in English, but you may need to
download the Asian Language Package to read the file.

All interested parties are encouraged to send their comments well before
the deadline for consideration by Foreign Agricultural Service, USDA.
The office responsible for the comments is as follows:

Food Safety and Technical Services

International Trade Policy division

USDA Foreign Agricultural Service

Fax: 202-690-0677

Email: [fstsd@fas.usda.gov](mailto:Freeser@fas.usda.gov)

The following are the document distributed by MHLW.

(Begin document)

> 28 October 2003

Standards and Evaluation Division

Department of Food safety

Ministry of Health, Labour and Welfare

Request for Comments on

the First Draft of Provisional Maximum Residue Limits for

Agricultural Chemicals in Foods

The Ministry of Health, Labour and Welfare (MHLW) invites your comments
on draft provisional maximum residue limits (MRLs) for agricultural
chemicals in foods.

The MHLW is going to implement a so-called "positive list system"- 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,
veterinary drugs and feed additives. This activity is based on the
revised Food Sanitation Law published in May 2003. The system will take
effect within three years after the publication of the revised law.

The first draft provisional MRLs are based upon the opinion from the
Subcommittee on Pesticide and Veterinary Drugs of the Food Sanitation
Committee under the Pharmaceutical Affairs and Food Sanitation Council,
an advisory scientific expert group to the Minister. The list of [draft
provisional MRLs]{.underline} is attached to this document (this
document can be found at:
http://www.mhlw.go.jp/english/topics/foodsafety/index.html).

We are asking for your comments on the draft MRLs in order to facilitate
the implementation of the positive list system. Please send your
comments to us, according to the instruction given below. Please note
that the MHLW will not respond individually to each comment.

[Instruction for submission of comments]{.underline}

Comment Period: From 28 October 2003 to 27 January 2004

Necessary information

>  Please send your comments, accompanied by rationales including
> underlying documents, to the mailing address or e-mail address given
> below. Comments are preferably in Japanese.
>
>  Make sure to include the specific title: "Comments on the first
> draft of provisional MRLs." Submissions by phone will not be
> acceptable.
>
>  Please identify yourself by including your name, address, and
> occupation. In the case of a legal person (company or other
> organization), indicate the name and address of the legal person.
> Please note that submitted information, excluding your identity, may
> be made public.

Address

Mail: Standards and Evaluation Division

> Department of Food Safety
>
> Ministry of Health, Labour and Welfare
>
> 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo
>
> 100-8916, JAPAN
>
> E-mail: positivelist@mhlw.go.jp

Outlines of subcommittee sessions on the implementation of the positive
list system and accompanying documents are accessible at the MHLW web
site. The English versions are not available.

> The Meeting of the Joint Subcommittee on Toxicology, Pesticide
> Residues and Animal Origin Foods of the Food Sanitation Committee, 27
> June 2003
>
> [http://www.mhlw.go.jp/shingi/2003/06/s0627-22.html]{.underline}
>
> The Meeting of the Subcommittee on Pesticides and Veterinary Drugs of
> the Committee on Food Sanitation, 1 August 2003
>
> [http://www.mhlw.go.jp/shingi/2003/08/s0801-8.html]{.underline}

[Future business]{.underline}

The Subcommittee on Pesticides and Veterinary Drugs will conduct further
discussion before the provisional MRLs are finalized, taking the
obtained comments into consideration. The MHLW will then notify the WTO
in accordance with the necessary formalities, and also seek public
comments on the final draft provisional MRLs.

Attachment

The First Draft of Provisional Maximum Residue Limits (MRLs) for

Agricultural Chemicals in Foods

Ⅰ. Background

The Ministry of Health, Labour and Welfare revised Food Sanitation Law
in May 2003. Based on the revised Food Sanitation Law, the MHLW is going
to implement the positive list system. The system is aimed at
prohibiting the distribution of foods that contain agricultural
chemicals above a certain level unless MRLs for the chemical on the food
are established. This system will go into effect within three years
after the publication of the revised Food Sanitation Law.

Provisional Translation of the Article 11, Paragraph 3, of the revised
Food Sanitation Law

(newly established provision)

Any food that contains, as a residue, an active ingredient of an
agricultural chemical defined in the Agricultural Chemical Control Law,
a feed additive defined in the Feed Additives Safety Control Law, or a
veterinary drug defined in the Pharmaceutical Affairs Law (including a
substance produced by a chemical change in the active ingredient and
excluding any substance specified by the Minister of Health, Labour and
Welfare as not posing any adverse health effects) at a level exceeding
the amount that is established by the Minister of Health, Labour and
Welfare as not posing any adverse health affects after hearing the
opinion of the Pharmaceutical Affairs and Food Safety Council, shall not
be produced, imported, processed, used, prepared, or stored for the
purpose of sale, or sold. However, this provision shall not be applied
in the case that the maximum residue limit is established for the
chemical on the food, in accordance with the provision of Paragraph 1 in
this article.

After the positive list system goes into effect, a food that contains an
agricultural chemical without MRLs will be prohibited from being
distributed if the chemical residue is over a certain level. The
introduction of this system in the current situation could result in
unnecessary disruption in international food trade, because the number
of chemicals with MRLs is small in Japan, compared with that of globally
distributed chemicals. Therefore, it is necessary to provisionally
establish MRLs before the implementation of the system. These
provisional MRLs will be established for chemicals that are domestically
authorized under the Agricultural Chemical Control Law, and chemicals
for which Codex MRLs or other MRLs are established based on scientific
evaluations.

The three related subcommittees under the Food Sanitation Committee have
agreed that provisional MRLs should be established according to the
following procedure, and that comments on the draft provisional MRLs be
invited from various experts.

Ⅱ. Establishment of the First Draft Provisional MRLs

1\. Drafting Provisional MRLs

> \(1\) Procedures
>
>  Take into account 1) the Codex MRL; 2) the registration withholding
> limits under the Agricultural Chemicals Law (for veterinary drugs,
> limits of quantification or determination (LOD) established at
> authorization under the Pharmaceutical Affairs Law; 3) the MRLs in
> foreign countries that have been based upon scientific toxicity
> evaluations required by the Joint FAO/WHO Meetings on Pesticide
> Residues (JMPR) and the Joint FAO/WHO Expert Committee on Food
> Additives (JECFA). Australia, Canada, New Zealand, the USA, and
> European Union have kindly offered their cooperation in response to
> our request to the foreign delegations at the Food Safety Group
> meeting on 11 April 2003.
>
>  Follow the decision tree given in Figure 1.
>
>  Take necessary measures to prevent excessive regulation of
> substances that can remain in food as agricultural chemical residues,
> and that can also remain as contaminants derived from the natural
> environment.
>
>  Do not establish provisional MRLs for substances that are
> agricultural chemicals already regulated as food additives.
>
>  In addition, consider the following points.

[Points for consideration in the establishment of provisional
MRLs]{.underline}

\- The current established MRLs will remain unchanged and continue to
apply.

\- When an ADI cannot be established due to carcinogenecity or other
reasons, the provisional MRLs should be established as "Not Detected
(ND)," according to the manner that has so far been used.

\- The current standards for antibiotics and synthetic antibacterials
should remain unchanged, but the scope of targeted foods should be
harmonized with global standards.

> The Food Sanitation Law stipulates that foods shall not contain
> antibiotics and that meat, poultry, eggs, fish, and shellfish shall
> not contain synthetic antibacterials.

\- When chemicals have different active ingredients but remain in food
in the form of the same metabolite or decomposed substance, provisional
MRLs for these chemicals should be set for the metabolite or decomposed
substance. Also, when chemicals have different active ingredients but
substances that can be determined for these chemicals are all the same,
provisional MRLs should be set for the substance targeted for
determination. Example: MCPB and MCPB methyl (Herbicide)

\- According to the FAO guideline, one significant figure should be
used. The figures should be rounded if necessary.

\- Adoption of foreign countries' MRLs

> \(i\) The mean value should be applied as the provisional MRL when
> MRLs from multiple countries are used for one crop

Example:

  --------- -------------- ------ ----- ----- ------- ------ ------ ---- ------ ----
  Food      PR- MRL        Ref.   MRL   WHL   Codex   US     AU     CA   EU     NZ

  Orange    3.3 rounded to FC                         1             6    3      
            3                                                                   

  Chinese   0.036 rounded  FC                         0.02   0.04        0.05   
  cabbage   to 0.04                                                             
  --------- -------------- ------ ----- ----- ------- ------ ------ ---- ------ ----

> \(ii\) When there is a big difference in MRLs used for one crop, the
> most appropriate value should be applied, taking the deviation into
> account. The simple mean value should not be used. However if there is
> a justifiable rational, it should be considered.
>
> \(iii\) When only EU or one of these four countries sets a numerical
> value that is the LOD as the MRL, a certain uniform level that does
> not pose any adverse health effect should be applied in the positive
> list system.

\- Individual limits should be harmonized among crops in the same food
category, such as cereal grains and cruciferous vegetables.

\(2\) Legal Status of Provisional MRLs

The provisional MRLs will be applied as the legal standards based on
Article 11 of the Food Sanitation Law, after the positive list system
goes into effect (within three years after publication of the revised
law, that is, not later than May 2006). The provisional MRLs will be
published without distinctions between agricultural chemicals,
veterinary drugs, and feed additives.

2\. Reference MRLs

> The following table shows information on MRLs that were referenced in
> the development of draft provisional MRLs.

  ------------------ ----------------------------------- -------------------
  **Source Country   **Category**                        **Number of
  (Organization)**                                       Substances**

  Japan              Agricultural Chemicals with         231 as of June 2003
                     Registration Withholding Limits     
                     under the Agricultural Chemical     
                     Control Law                         

                     Veterinary Drugs authorized under   133 as of June 2003
                     the Pharmaceutical Affairs Law (\*) 

  Codex              Agricultural Chemicals              129 as of June 2003
  Alimentarious                                          
  Commission                                             

                     Veterinary Drugs                    49 as of June 2003

  United States of   Agricultural Chemicals              326 as of April
  America                                                2003

                     Veterinary Drugs                    104 as of April
                                                         2002

  Canada             Agricultural Chemicals              151 as of June 2003

                     Veterinary Drugs                    65 as of May 2003

  European Union     Agricultural Chemicals              158 as of February
                                                         2003

                     Veterinary Drugs                    124 as of July 2003

  Australia          Agricultural Chemicals and          418 as March 2003
                     Veterinary Drugs (\*\*)             

  New Zealand        Agricultural Chemicals and          161 as of December
                     Veterinary Drugs (\*\*)             2003
  ------------------ ----------------------------------- -------------------

\* Limits of quantification or determination (LOD) provided by the MAFF
are referred because veterinary drugs are authorized under the
Pharmaceutical Affairs Law on the condition that no residue occurs in
animals at the final stage.

\*\* MRLs in Australia and New Zealand are not distinguished between
agricultural chemicals and veterinary drugs.

3\. Food Categories for MRL setting

A food that has currently be categorized as "products other than
above-mentioned products" will be separated from that category and newly
categorized as a single food category when its consumption is
considerably large (above one gram per person per day) and Codex
standards are established for that food category. The new food
categories will be implemented at the enforcement of the positive list
system. The following are examples of separated categories:

[New Food Categories (daily consumption)]{.underline} [Current Category
(daily consumption)]{.underline}

*Qing-geng-cai* (1.37 grams) Other cruciferous vegetables

*("pak-choi"*-type Chinese cabbage*)* (3.7 grams to 2.3 grams)

*Nira* (Chinese chive) (1.74 grams) Other liliaceous vegetables

(2.5 grams to 0.8 grams)

Bamboo shoots (2.05 grams) Other vegetables

(13.3 grams to 11.3 grams)

4\. Provisional Maximum Residue Limits (MRLs) on Processed Foods

　

Provisional MRLs for processed foods will be established only when Codex
MRLs are established for them. Individual MRLs will not be established
for other processed foods; processed foods can be distributed as long as
they are made of ingredients that meet standards under the Food
Sanitation Law.

5\. Review of Provisional MRLs

**　**

The established provisional MRLs will be reviewed about every five
years, according to changes in the reference MRLs used in setting
provisional MRLs. In addition, the MRLs will be reviewed based upon the
risk assessments obtained from toxicity studies. The reviews will be
conducted in the order of priority based upon total diet studies.

6\. Others

\(1\) Any future changes in reference MRLs used in setting provisional
MRLs will be reflected in the final provisional MRLs if time permits in
administrative formalities (i.e., if changes occur before WTO
notification and the invitation of public comment). Changes include the
addition and withdrawal of chemicals and target crops.

\(2\) The MHLW will develop a system for establishing MRLs on certain
crops for agricultural chemicals that are not used at all in Japan or
are used only for limited crops, upon request from abroad. Around spring
2004, the MHLW will prepare a guideline describing procedures for
application from abroad.

\(3\) In light of comments obtained during the given period, formal MRLs
(MRLs established pursuant to regular formalities) might be established
before the enforcement of the positive list system.

**Figure 1.**

**Decision Tree on Provisional Maximum Residue Limits (MRLs)**

![](media/image2.png){width="5.633333333333334in"
height="7.544444444444444in"}

\* WHLs: Registration Withholding Limits under the Agricultural
Chemicals Control Laws.

\*\* Foreign Standards: Standards in foreign countries that have been
based upon scientific toxicity evaluations.

\*\*\* When no provisional MRLs are established, a certain level of
uniform limit that does not pose adverse health effects is applied.

**Type**

1\. Basically, the codex standard is applied, when both a Codex Standard
and an WHL exist

> 1-1.　The Codex Standard is applied.
>
> 1-2.　The WHL is applied when registration and domestic use need to be
> considered for an agricultural chemical.

2\. The Codex Standard is applied, when a Codex Standard exists but no
WHL exists.

3\. Basically, the WHL is applied, when both an WHL and one or more
foreign standards exist.

> 3-1. The WHL is applied.
>
> 3-2-1. The foreign standard (or the mean) is applied when the
> production/distribution of imported foods and use situation for an
> agricultural chemical in the exporting country need to be considered.
>
> 3-2-2. The appropriate foreign standard is applied with special
> consideration.

4.　The WHL is applied when an WHL exists but no foreign standards
exist.

5\. The foreign standard (or the mean) is applied when no WHL exists but
one or more foreign standards exist.

5-1.　The foreign standard (or the mean) is applied.

5-2. The appropriate foreign standard is applied with special
consideration.

6.　Harmonization within the food category is done.

(End document)