QSAI Analysis and Research Center Co.,Ltd.

The Positive List System

THE POSITIVE LIST SYSTEM

PARTICIPATION IN EXTERNAL PROFICIENCY TESTING PROGRAMS


Overview of the Positive List System

 

The Positive List System
This is a system to prohibit the distribution of foods that contain agricultural chemicals above a certain level.

The system was implemented on May 29, 2006, following the revision of the Food Sanitation Law.
All agricultural chemicals, veterinary drugs and feed additives in all kinds of foods, including processed foods, are subject to regulation.¦
The distribution of foods which contain agricultural chemicals in excess of the determined residue limits is banned in principle.
¦Some specified substances are exempt from the regulation.

Overview of the Positive List System

INQUIRIES

The Uniform limit and Provisional Residue limits

 

1.The uniform limit
The uniform limit is set at 0.01 ppm,¦which was determined by the Ministry of Health, Labor and Welfare as a volume that is not likely to pose any adverse health effects.
¦0.01 ppm indicates a concentration that is roughly equivalent to the concentration of a 25 meter-swimming pool containing a few drops of a pesticide.

The uniform limit

2.Provisional residue limits
These are provisionally established limits, referring to Codex standards, among others.

Before the enforcement of the Positive List System
@ rice (unmilled rice) soybeans onion
agricultural chemicals A 0.5ppm 1.0ppm Exempted substances
agricultural chemicals B Exempted substances 0.05ppm Exempted substances
agricultural chemicals C Exempted substances Exempted substances 0.1ppm
After the enforcement of the Positive List System
@ rice (unmilled rice) soybeans onion
agricultural chemicals A 0.5ppm 1.0ppm 0.1ppm
Provisional residue limits
agricultural chemicals B 0.01ppm
uniform limit
0.05ppm 0.01ppm
uniform limit
agricultural chemicals C 1.5ppm
Provisional residue limits
0.01ppm
uniform limit
0.1ppm

INQUIRIES

Processed Food

 

1. Not only perishable, but also processed foods are subject to regulation.
When residue limits are not established, the uniform limit is applied in principle; however, when residual values of ingredients for processed foods comply with the limit.

2. As for processed foods such as dried foods, the probability of violation for ingredients according to the estimated value based on moisture content can be suggested.

Take fivefold concentrated fruit juice as an example. 0.04 ppm was detected, but the juice is diluted fivefold in drinking. So actually, the residal value is: 0.04 €5=0.08 ppm. As a result, this is not a violation of the uniform limit of 0.01 ppm.

INQUIRIES

Drifting of Agricultural chemicals

 

Consider a case in which there is an apple orchard next to the field where carrots are grown, and fenbuconazol used in the apple orchard drifted from the orchard to the carrot field.

Drifting of Agrochemicals

While the residue limit of fenbuconazole in apples is set at 1 ppm, the residue limit of the pesticide in question in carrots has not been determined. Therefore, the uniform limit is applied to corrots, and the limit becomes 0.01 ppm.

Drifting of Agrochemicals
INQUIRIES

Inspections Conducted by the National and Prefectural Governments

 

1. Inspections conducted by the nation (monitoring inspections, mandatory inspections, etc.)
Importers submit the gNotification Form for Importation of Foodsh to the Ministry of Health, Labor and Welfare via a quarantine station, and the food in question is screened to determine whether it is in conformity with the Food Sanitation Law by food sanitation inspectors from a quarantine station.


yMonitoring Inspectionsz
This is an inspection performed at a quarantine station for food with a low probability of violating the Food Sanitation Law. It is based on the annual plan, taking seriousness of problems into consideration such as volumes, number of violation cases, and violation rate by food type. This inspection aims at grasping the sanitary conditions of a wide variety of imported foods, along with promoting a smooth import and distribution process. Thus, importers can go through import procedures without waiting for the test results.


yAdministrative Inspections Other Than Monitoring Inspectionsz
Quarantine stations conduct inspections of first-time imported foods, confirmatory tests of food against the Food Sanitation Law, confirmatory inspections of damaged food in transit, etc.


yMandatory Inspectionsz
These are inspections performed by an importer by an order of the Ministry of Health, Labor and Welfare for food which is considered to have a high probability of violating the Food Sanitation Law, taking into account foreign exporterfs national circumstances, the properties of the food in question, and the previous cases in which a same type of food have not been approved. Naturally the inspection cost is born by the importer. Importers cannot begin import procedures until the food is proved to be in compliance with the law.

Changes in the number of residual agricultural chemicals inspection items in monitoring inspections for imported food, etc.

2.Inspections Performed by Prefectures (Random Sampling Inspections and On-Site Inspections)
As for domestically manufactured or sold food, public health centers and wholesale food market sanitary inspection stations collect the necessary amounts of foodstuffs concerned for inspection from production facilities or distribution outlets based on their annual plan. ¦When a violation is discovered, the foodstuffs concerned are discarded and/or recalled. When facilities for production, manufacturing, and processing are in locations separate from the inspected site, the inspectors in charge contact the prefectures and municipalities concerned and take necessary measures immediately, all working in tandem.
¦According to the publication, g2007 (FY) Fukuoka Prefecturefs Food Sanitation Monitoring Guidance Plan,h the prefecture plans to inspect approximately 100 samples for the year (200 residual agricultural chemicals).


yRandom Sampling Inspectionsz
These inspections are conducted by municipalities based on their monitoring guidance plan to confirm the safety of foodstuffs which are manufactured and distributed in the area under their jurisdiction.


yOn-Site Inspectionsz
These are inspections conducted for food-related business facilities based on an on-site inspection plan.
When agricultural chemicals or other substances are found in excess of the determined level, administrative penalties such as guidance for improvement, discontinuation of sales/shipments, and recall of the relevant lot are imposed on the facility concerned.

Inspections Conducted by the National and Prefectural Governments
yViolation Cases Discovered by Prefecturesz

  1. 0.44 ppm of fosthiazate (determined acceptable level: 0.05 ppm) remained in strawberries. The berries were voluntarily recalled and the shipment was discontinued.
  2. 0.07 ppm of heptachlor (determined acceptable level: 0.03 ppm) remained in pumpkins. The shipment was temporarily discontinued, and the in-stock pumpkins were all incinerated after being voluntarily recalled.

The number of violation cases after the implementation of the Positive List System (by the Ministry of Health, Labor and Welfarefs website)
yOur Perspectivez

Since the enforcement of the Positive List System enacted on May 29, 2006, there has been a sharp increase in violation cases.
The violation cases in FY 2006 totaled as many as 425, a figure which is 6.43 times higher than the last year. Violation of the uniform limit (0.01 ppm) in the system amounted to 205 cases, which accounts for approximately 48% of the total.
Therefore, we believe that producers and importers need to implement a more stringent quality control management system.


Measures for Complying with the Positive List System

 

In the Positive List System agricultural chemicals stipulated in the list are allowed to be remain within the determined level; however, chemicals which are not listed are prohibited from remaining in principle.¦
¦Residues are allowed up to 0.01 ppm of the uniform limit.

Therefore, we recommend analyzing as many residual agricultural chemicals as possible.

1.Testing many agricultural chemicals subject to regulation 2.Testing should be reliable. 3.Consideration of cost and promptness

Recommendation: our simultaneous analysis of 626 agricultural chemicals
  1. Analyzing 630 agricultural chemicals, including approximately 460 out of the approximately 800 whose residue limits are established in the Positive List System, again, the most comprehensive analysis of its kind available.
  2. For all agricultural chemicals to be tested, recovery tests are carried out in two different concentrations for verification, thus yielding high reliability.
  3. 262,500 yen, approximately 417 yen per chemical, and the test results are reported in as few as 6 business days at earlist, ¦which means reasonable cost and rapid results
    ¦Please be forewarned that some analyses may take longer than normal due to the presence of interfering substances.

INQUIRIES
Address to which test-samples are to be sent:
QSAI Analysis and Research Center Co., Ltd. Central Research Center
411-1 Ohmaru, Munakata City, Fukuoka Prefecture, 811-3422 Japan
TEL: +81-940-37-3988
FAX: +81-940-37-3911
Address for Inquiries:
QSAI Analysis and Research Center Co., Ltd. Head Office
1-7-16 Kusagae Chuo-ku, Fukuoka City, 810-8606 Japan
TEL: +81-92-751-5832
FAX: +81-92-724-0189