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(Provisional Translation)

Policy Actions on Market Access Issues as concerns Standards, Certifications and others (March 26, 1996)

March 26, 1996
Office of Market Access

Respecting the "Recommendation on Market Access Issues as concerns Standards, Certifications and others" (the 3rd Report of the Market Access Ombudsman Council, March 18, 1996) to the furthest extent possible, the following measures will be taken for further improvement of market access.


1. Animals and Plants, Foods

1-(1) Dispatching Plant Quarantine Inspectors to Control the Vapor Heat Treatment of Fresh Fruits before Being Shipped to Japan

Besides assigning a sufficient number of Japanese side quarantine inspectors when the Thai side increases mango disinfestation facilities in the future, the following actions will be taken.

(1) First, as for the vapor heat treatment (VHT, hereafter), the problems which are claimed to have occurred in the field will be confirmed. At the same time, Thai and Japanese sides will promptly discuss the feasibility of abolishing a Japanese plant quarantine inspector's checking the VHT and the conditions therefor (e.g. appropriate facilities and a trained technician).

(2) As for the problem of expenses, even if a decision should be made to continue to assign an inspector, Thai and Japanese sides will promptly discuss the feasibility and measures for reducing the burden on Thai side by simplifying the procedure, such as by shortening the overall duration of the inspector's stay in Thailand.

1-(2) Partial Revision of JAS concerning Imported Fruit Juices

(1) A specific proposal will be developed within fiscal year 1996 on the revision of JAS for fruit juices whose deliberation began in November 1995. For this reform, the ministry concerned will consider the actual situation of imported fruit juices, and develop more general standards (not standards according to place of origin). The ministry concerned will also fully consider international standards and imported products. In deliberating the revision, the ministry concerned will take the initiative in collecting a broad range of overseas data instead of merely taking specific requests into accounts and waiting for samples and data to be submitted.

(2) Since the acidity for orange juice and amino nitrogen and ash content for grape juice are not stipulated by international standards, in deliberating the revision, an effort will be made to reach a conclusion on the necessity of stipulation these items in JAS for fruit juices as early as possible.

1-(3) Review of Designation System for Animal Feed Additives

As for the simplification of domestic tests b accepting foreign data, paying enough attention to ensuring safety of feed additives, the results of the deliberations at the Agricultural Materials Council should be compiled within fiscal year 1996, and then action will be taken based thereon.

1-(4) International Harmonization for Veterinary Drug Residue Standards in Edible Meats

(1) The deliberation schedule at the Food Safety Council for MRLs (maximum residue levels), for which international standards have been already established, will be clarified and the standards will be brought in line with the international standards as soon as possible. In this case, the ministry concerned will clarify and announce what veterinary drugs it plans to set MRLs for and when these standards will be established. In addition, when the standard setting work at the international institution reaches a certain stage, preparations for establishing MRLs for veterinary drugs will be undertaken and the standards will be established as soon as possible.

(2) As for veterinary drugs for which no international standards have been set, the ministry concerned will collect data, consult the Food Safety Council, including on the feasibility of accepting the standard levels of the United States, EU, etc., and advance the establishment of domestic MRLs at an early date.
In addition, for substances for which there is a great need to establish MRLs, contributions will be made to the establishment of international standards by submitting to the international institution data on safety and other means.

(3) The deliberation by the Food Safety Council on the establishment of MRLs for veterinary drugs in food products will be further expedited.

(4) In establishing MRL for each veterinary drug, a priority list will be prepared based on requests from within Japan and abroad and will be announced during fiscal year 1996 together with the standard establishment schedule.


2. Drugs, Medical Devices, Cosmetics

2-(1) Clarifying the Definition of "Dietary Supplements" and Deregulating Their Restrictions

As for the classification of drugs and food products, in the mid- to long-term, deregulation of the restrictions on food product raw materials and ingredients and establishment of a new category for dietary supplements will be considered.

The regulation on shape (dosage form) will be abolished or substantially eased if appropriate indication as a food product (a dietary supplement) is established so that consumers can make correct choices without getting mixed up.

As for the restriction on labeling, relaxation will be made to allow labeling on ingesting method, dietary supplement claim, precautions, etc., which will enable consumers to appropriately select the product they require.

Products distributed and sold normally abroad as food products will not be regulated as drugs but be allowed into the market as food products. For this purpose, the current regulations on shape (dosage form) and labeling will be relaxed as much as possible for vitamins in fiscal year 1996 and for herb in fiscal year 1997; and the measures will be advanced consecutively to products other than vitamin and herb, beginning with minerals in fiscal year 1998.

2-(2) Deregulation and Simplification of Cosmetic Regulations

The entire structure of cosmetics regulations will be reviewed, from various viewpoints including international harmonization, during the fiscal year 1996. In this review, the required measures will be taken for the following points.

(1) Modification of the comprehensive licensing standards of cosmetics by category (CLS, hereafter), from the viewpoint of international harmonization, will be promoted. As a result, ingredients which are used in the United States, EU countries, etc., will be incorporated into CLS, referring to the regulations in the United States and EU. Furthermore, to make approval unnecessary upon import of a cosmetic whose ingredients are the same as those of an approved cosmetic, the specifications of the ingredients outside CLS will be established based on the data submitted upon approval procedure and be promptly included in CLS.

(2) The system of licensing an importer for each office will be reviewed during fiscal year 1996, including the necessity of employing a responsible engineer and installing testing facilities, then the required improvement measures will be taken promptly.

(3) As for the import product notice submitted when actually importing a product, the notice will be reviewed during fiscal year 1996 to reduce the burden, and then the required improvement measures will be taken promptly.


3. Manufacturing

3-(1) Simplification of Prior Confirmation Procedure for Fabrics of Silk and Other Fiber

Applications for prior confirmation of fabrics of silk and other fiber, silk bed linens, etc., which have been accepted only at the headquarters of the ministry concerned will also be accepted via its regional bureaus in April 1996. As for simplification of the information required in the application form for prior confirmation, the procedure will be carried out flexibly on a case-by-case basis and this will be notified to relevant parties. Continual review will also be conducted to simplify other application procedures.

3-(2) International Harmonization of Approval for High-Pressure Containers

To simplify the procedure for changing high-pressure gas types, by the end of fiscal year 1996, gas types will be added to those that the ministry concerned allows for storage in the same container. In addition, grouping gas types to enable the storage of several gas types without a special filling permission will be implemented successively in three or four years after studying the safety factors.

3-(3) Mutual Recognition of Electric Machines with Explosion-Proof Construction

In the interest of international harmonization of standards and certifications, the review will be advanced as follows.

(1) A product that has been certified by a foreign government or an institution authorized by a foreign government as meeting the IEC standards or foreign standards aligned with the IEC standards will be handled as having passed the type inspection, after confirming the necessary information with the certifying institutions. At the same time, if the details or interpretation of the standards are different between Japan and overseas, they will be standardized as soon as possible.

(2) As for products that have not been certified as mentioned above, the designated foreign inspection institution system will be publicized. The acceptance of foreign inspection data will be actively promoted by active designation those institutions which many importers have requested for designation.

(3) Investigation and deliberation will be actively perform to successively take the necessary measures, in about five years from now, towards mutual certification of standards other than IEC standards as well.


4. Transportation and Traffic

4-(1) Facilitating Imports of Camping Trailers and Motorhomes

Camping trailers used for camping at camping at camping grounds will not be subject to the Building Standard Law, and those concerned will be informed of this decision. The Ministry of Transport, the Ministry of Construction, and other relevant ministries (the relevant ministries, hereafter) will study and conclude within one year on how to prepare new specifications and standards for camping trailers, i.e. whether the new specifications and standards should be established within the current legal framework or a new law (including amendment of existing laws) should be enacted. To this end, the relevant ministries will promptly study the specifications and U.S. regulations submitted by the complainant and compare them with the current laws of Japan.

4-(2) Revision of Import Inspection System for Vessels, Vessel Engines and Propulsion Devices, etc.

The following actions will be taken pertaining to pleasure boats, small vessel engines, etc., while making sure not to impair the safety of human lives and preservation of environment.

(1) Contribution will be made to the development of the ISO standard for pleasure boats and when the standard is established, the domestic standard will be promptly harmonized with the ISO standard. Furthermore, while observing the situations in EU, the United States, and other major industrialized countries and, if there is no particular problem in the inspection standards in these countries, the ministry concerned will consider accepting their inspection standards and allowing the use of the pleasure boats in Japan only with the examination of documents such as certification conformance in the county of origin and a physical inspection of the boat, and reach a conclusion during fiscal year 1998.

(2) To further the acceptance of testing data from overseas public testing institutions at the Japan Craft Inspection Organization (JCI), the ministry concerned will hold constructive discussions on the inspection methods with institutions from which no testing data is currently accepted to reduce the burden on applicants. As for the testing data from principal classification societies, the ministry concerned will promptly consider accepting the data that would not hinder safety, and reach a conclusion by the end of 1998, confirming the effectiveness of the "Guideline for the authorization of organizations on behalf of the Administration" effective in January 1996.

(3) Through public relations to foreign companies, an effort will be made to promote the use of and improve the type approval system, the authorization system of factory, etc. For example, as for the authorization system of factory, measures such as promotion of certification by using ISO 9000 series will be examined and conclusion will be reached by the end of fiscal year 1997. In addition, a vigorous effort will be made to reduce the number of inspection items and simplify the inspection procedures paying attention the progress in technology.


5. Construction

5-(1) Relaxing Regulations of Imported Housing Materials

(1) The specifications that are generally approved for 2 x 4 construction housing materials will be incorporated into the Japanese system. In this process, the study and deliberation under way with the foreign specification/certification institutions will be concluded as soon as possible and materials of houses generally used abroad will be allowed into Japan as a package. The ministry concerned will actively solicit overseas institutions for request and will collect data on its own for materials that are in great demand. The building regulations of the structure of 2 x 4 construction method will be revised to performance-based regulations. The third-party certification system will be introduced to the certification of performance-based standards.

A measure will be studied soon and taken by the beginning of fiscal year 1997 to thoroughly inform those concerned that the structural standards of the Government Housing Loan Corporation's 2 x 4 construction common specifications are absolutely the same as the standards under the Building Standard Law. If the notification on 2 x 4 construction is revised to performance-based standard format, the specifications will also be accommodated to the revision from the fiscal year 1997 version.

Designating overseas testing laboratories will be promoted in order to facilitate the certification as noncombustible materials of exterior wall and roofing materials. At the same time, the requirement for the Government Housing Loan Corporation's loan will be abolished that the roofing materials be noncombustible.

Furthermore, the framework for the new building regulations will be established within fiscal year 1996 to change the building regulations to a performance-based regulations.

(2) As for regulations on plumbing fixtures, a partial amendment of the Waterworks Law will pass at the current session of the Diet including such steps as the creation of plumbing fixtures works chief technician system, elucidation of the designation requirements for plumbing fixtures contractors, etc.

The current type approval and inspection system for water supply equipment will be abolished, and the following measures will be taken. The preparations necessary for the measures will be made within fiscal year 1996 aiming at implementing the measures in fiscal year 1997.

* Elucidate Japanese standards for water supply equipment structure and materials, and employ performance-based standards.

* Eliminate the requirement that water supply equipment must undergo type approval and inspection before being used as well as elucidate Japanese standards, i.e. receiving a third-party certification is not an obligation.
* As for the inspection for the third-party certification, accept the self-inspection system. Also, allow a sampling inspection conducted by a third party institution. In essence, rationalize significantly the individual inspection required for the type approval under the current system.
* Promote mutual recognition with overseas certifying institutions to harmonize with overseas standards.
* Request water suppliers for necessary reviews such as abolishing redundant inspections of products that meet the country's standards.

5-(2) Improvement of Procedures of Foreign Construction Materials Quality Assessment and Verification System

It will be studied whether there are those specifics of quality assessment and certification that are common to ISO certification in early part of fiscal year 1996 and any parts of the assessment will be omitted if possible. From fiscal year 1996, the term of validity of the certification will be prolonged from the current one year to approximately three years, and the charge for assessment will be discounted by the maximum of 40%.


6. Employment and Labour

6-(1) Review of Worker Dispatching Undertakings

(1) As for the kinds of designated works, 12 kinds of works will be added to the current 16 ones. The regulation will be reviewed if necessary, including the feasibility of employing the way to allow worker dispatching undertakings in all works but the inappropriate ones.

(2) As for permission, besides the simplification of procedures which is scheduled in the legislation draft, simplification of related documents will be promptly implemented.

In addition, constructive steps will be taken for the considerable relaxation of the regulation concerning running both worker dispatching undertakings and employment placement projects in the current deliberation of the Central Employment Deliberative Council, for the considerable relaxation of the regulation concerning office space in the succeeding deliberation on the worker dispatching undertakings, and for the considerable relaxation of the regulation on the ratio of the number of responsible persons to that of dispatched workers and the length of work experience in the deliberation by the Central Employment Deliberative Council in fiscal year 1996.

6-(2) Review of Employment Placement Projects

The renewal of the term of validity of the permission will be simplified as much as possible and the related documents required for permission will also be simplified within fiscal year 1995. And then effort will be continued to achieve further simplification.

Constructive steps will be taken in the studies concerning the fee-charge employment placement projects in progress at the Central Employment Deliberative Council, under the current ILO No.96 Convention, for increasing the kinds of designated works as many as possible, (including the feasibility of employing the way to allow fee-charge employment placement projects in all occupations but the inappropriate ones), and for considerable relaxation of the regulations concerning fees, permission for each office, running both worker dispatching undertakings and employment placement projects, office space, and the length of work experience on the occupations.

6-(3) Revision of the Criteria of the Examination for Landing in Japan and Other regulations

To make applicability to the status of residence and the criteria of the examination for landing more transparent for foreign nationals who enter or reside in Japan, the interpretation of the regulations will be elucidated. Furthermore, when a foreign national is attempting to open a new office in Japan based on a contract with a foreign company, for the purpose of engaging in sound economic activity, an improvement measure will be taken to allow him to get a status of residence (approve of its change) by reviewing practical operation of the current law and ordinances.


7. Import Procedures

7-(1) Introduction of the Nationwide Common Bond for the Release of Imported Goods before (Formal) Permit

By the end of fiscal year 1996, collateral for release of imported goods before (formal) permit (BP collateral) that is now placed with each customs office may be used nationwide with Customs entry processing system for sea cargo (Sea-NACCS) and Customs entry processing system for air cargo (Air-NACCS).

7-(2) Introduction of Pre-Filing System

Much attention will be paid to the operational aspects of "immediate release system of air cargo at the time of arrival report", which will be introduced for air cargo in April 1996, including the scope of its application and the procedures, in order to fully respond to users' needs for prompt customs clearance. For example, the specifics of confirmation of cargo's arrival will be examined and made as convenient as possible for the users. In essence, the system will be managed so that it deserves the name of "immediate release system". At the same time, it is necessary to inform all those concerned of the creation of this system.

Furthermore, observing how the system is utilized in air cargo, it is necessary to consider applying the system to sea cargo in order to expedite customs clearance.

7-(3) Simplification of Import Procedures concerning Generalized System of Preferences Certificate of Origin

The Temporary Tariff Measure Law Enforcement Ordinance was revised so that if a product is approved by the Director-General of Customs as clearly coming from the claimed origin due to its type or shape, the importer need not submit the preferential origin certificate.
Import procedure will continue to be simplified and expedited for users' convenience.