The Cabinet Office, government of Japan ＞ Top page of OTO ＞ Reorganization of the Office of the Trade and Investment Ombudsman
(Provisional Translation)
Policy Actions on Market Access Issues as concerns Standards, Certification and others (March 28, 1995)
March 28, 1995
Office of Market Access
Respecting the "Recommendation on Market Opening Measures as concerns Standards. Certification and others" (the 2nd Report of the Market Access Ombudsman Council, March 14, 1995) to the furthest extent possible, the following measures will be taken for further improvement of market access.
1. Animals and plants food
1-(1) Improvement of the plant quarantine system and others relating to the import of cut flowers
(1) The Food and Agriculture Organization of the United Nations is currently working toward establishing international standards for Pest Risk Analysis (PRA) by 1997. A study of measures to ensure rapid response by Japan will be undertaken, including a study of risk analysis measures for pests, for the purpose of classifying the pests which are not subject to quarantine.
Methods of proving that pests are of the same strain or bio type as those distributing in Japan will be developed. After the method is developed, bilateral negotiations will be held one by one as soon as possible in order to acquire the understanding of the countries where the pests occur.
Further study of sampling methods to reduce the burden on applicants , while keeping inspection efficiency, is being undertaken, in consultation with experts.
(2) When the increase of the number of quarantine officers is considered, the possibility of re-hiring retired quarantine officers on a non-regular basis, or of contracting with private sector technicians, will be considered as soon as possible.
(3) Necessary measures will be taken to interface the computer system for plant quarantine offices with the customs clearance system of Customs at an early date after FY1997.
(4) Regarding cut flowers examined under the prior quarantine arrangement, reasons why infringements have occurred will be clarified through discussions with experts. Based on the conclusions reached, bilateral consultations will be held to discuss the possibility of random checks for inspection.
(5) Space for international cargo sheds at Narita Airport will be expanded with the completion of a Cargo Building N0.4 during FY1995. In order to have the specific layout reflect users' needs, the parties concerned will be urged to provide opportunities for users to state their opinions, which will include the demand for the improvement of refrigeration facilities, in the near future. Based on the outcome of these meetings, the necessary improvements to warehousing and sorting areas will be made respectively. Areas covered with roof will also be provided for leaving samples awaiting inspection.
(6) Regarding fumigation fees at Narita Airport, users and fumigation companies will be encouraged to hold discussions and consider how to improve the situation. Regarding the improvement of international cargo sheds, the parties concerned will be urged to provide more space for fumigation warehouses.
1-(2) Review of heat processing standards relating to the import of meat of cloven-hoofed animals
Clarification of prospected time for revising standards and technical meetings with the countries concerned will follow the presentation of scientific testing data on the effects of deep-frying in oil in killing pathogenic organisms causing malignant animal infections diseases without delay.
1-(3) Acceptance of foreign test results and others relating to the import of mineral water
(1) To promote further acceptance of foreign test results, efforts to publicize the Foreign Official Laboratory System and the Pre-certification System for Imported Food, etc. will be continued. Regarding the Pre-certification System for Imported Food, etc. in particular, meetings will be held soon with individual countries so that their products may be registered at an early date.
(2) Based on an agreement between Japan and the EU, the forms to be presented at the time of import concerning testing for microorganisms have been simplified for the mineral water imported from the EU countries. This measure will be publicized and if other countries request similar simplification, their microorganism standards will be verified and agreements with countries whose standards are largely compatible with those of Japan will be promoted.
(3) Quarantine offices throughout the country will be directed once again with a written directive in April 1 995 to post a list of the forms which must be presented to quarantine offices in locations visible to importers, and to distribute such a list if requested.
2. Pharmaceuticals
2-(1) Simplification of approval procedures for in-vitro diagnostics
(1) Based on the opinions of parties involved, gradual preparation of standards for in-vitro diagnostics and the establishment of a range for in-vitro diagnostics not requiring approval and other measures will be considered so that these measures will be implemented at an early date under the condition that necessary function of in-vitro diagnostics is made sure. Research and study on the systems in Europe and the United States will be undertaken to contribute to this study.
(2) The following steps will be taken immediately for further simplification of procedures and requirements for approval and license under the current system:
* For categories subject to deliberation or consultation by the Central Pharmaceutical Affairs Council and categories for the commission of testing to the National Institute of Health, the categories will be further clarified and the products in the categories in question will be listed and posted as far as possible during FY1995.
* Regarding the requirement to have a supervisor at each manufacturing plant (import business office) for in-vitro diagnostics, during FY1995 this requirement will be simplified taking the nature of in-vitro diagnostics into consideration, so that one pharmacist may assume the duties of supervisor for both biological and non-biological products.
* Regarding the established period of validity for in-vitro diagnostics, in order to clarify that approval will be granted even for periods of under six months if rational reasons are shown, the notification on the rule will be amended during FY1995. When doing so the meaning of "rational reasons" will be clarified as much as possible.
* The clerical process for approval will be improved, by enabling applications on floppy disk from FY1995, by establishing an on-line system with each prefecture and Ministry of Health and Welfare, and by other measures so that the clerical processing for approval can be made within the standard processing periods, i.e. six months.
2-(2) Review of the definition of the pharmaceuticals
As the daily diet has diversified and the use of herbal products as medication has changed, ordinary consumers' recognition for pharmaceuticals have changed. Based on these changes and taking differences in systems among countries into full consideration as well, the classification list of substances indicating whether to be treated as pharmaceuticals or not will be reviewed in turn.
2-(3) Simplification of approval and licensing procedures for proprietary drugs
With due reference to systems in various countries, approval and licensing procedures for manufacture and import will be simplified and speeded up as much as possible. The following measures will be taken in FY1995.
* New approval standards will be set for external hemorrhoid preparations, and the approval authority will be delegated to the governors.
* With the exception of manufacturing of vaccine, etc., the authority to grant licenses for manufacture and import/sale will be delegated to the prefectural governors.
* An application and examination system using floppy disks will be introduced.
* Standardization of ingredient specification will be promoted to simplify forms required for approval.
3. Manufacturing and related areas
3-(1) Acceptance of country of origin certificates by intermediary exporting countries relating to the import of silk fabrics
The necessary measures will be taken within this fiscal year to ensure customs entry silk fabrics produced in the EU accompanied by certificates of origin issued by official organizations of non-producing countries within the EU.
3-(2) Establishment of classification standards for industrial- use X-ray film
Regarding international standards on classification standards for industrial-use X-ray film, Japan is actively participating in discussion of the TC135 (technical committee on non-destructive tests) of the International Standardization Organization (ISO). Once a draft of international standards is made, classification standards harmonized with the draft of international standards will be made in JIS at that stage, without waiting for formal adoption of the international standards.
3-(3) Improvement of approval procedures for electric and electronic products and others
(1) Japan Electrical Products Testing Laboratory, with the cooperation of Japan External Trade Organization (JETRO), will be encouraged to continue with the translation into English of the technical standards under the Electrical Appliance and Material Control Law. (Translation for 340 of the 498 product items has been completed.)
(2) Regarding seminars on the Electrical Appliance and Material Control Law organized by foreign testing organizations, if the organizers make requests for an extension of the seminar period, etc., Japan Electrical Products Testing Laboratory, which dispatches seminar lecturers, will be encouraged to cooperate.
(3) Given increasing internationalization, recognition of the role of English as an international language, etc., and in order to reduce the burden on foreign businesses, the possibility of permitting the use of English in application procedures for registration and model approval will be considered.
(4) During FY1995, 117 items in Type A electrical products will be transferred to Type B, and the reporting forms for Type B electrical products will be rationalized.
Over the next five years. Electrical Appliance and Material Control Law specifications will be made more harmonized with those of the International Electric commission.
4. Transport and traffic
4-(1) Acceptance of the test data from EU testing institutes not located in the country where the cars were produced
Since a unified EU approval system is in the process of being established, the test data from designated testing institutes not located in the country where the cars were produced within the EU will be accepted from May 1995.
4-(2) Relaxation of weight restrictions when ship containers are transported by road
To promote integrated sea-land transport of ship containers and to make distribution more efficient, the following measures will be adopted:
(1) Roads of important distribution routes will be improved within the period of the 11th 5-Year Road Improvement Program (until the end of FY1997), so that the passage of semi-trailers carrying fully-loaded ISO standard 40-ft containers will be enabled under the condition of acquiring the transit permits by road authorities.
If a certain network of roads can be established, by securing detour roads and so on, passage of the fully-loaded containers will be permitted on these roads even before the end of the 11th 5-Year Road Improvement Program.
(2) Regarding a road network capable of handling fully-loaded 40-ft containers, if axle weight restrictions are met, vehicles with a distance between foremost and rearmost axles of 10m will be permitted to transit carrying fully-loaded ISO standard 20-ft containers .
(3) Clarification of the conditions that vehicles should meet to be allowed to transit carrying fully-loaded ship containers will be provided as soon as possible, after taking enough account of the opinions of the related businesses.
(4) Regarding the improvement of roads to withstand passage of fully-loaded ship containers, priority will be given to routes which are necessary for the transportation of ship containers, and roads with frequent transportation of ship containers with transit permits will be used as references.
(5) Information on road networks where weight restrictions have been relaxed will be provided as soon as possible.
4-(3) Abolition of restrictions on transportation ships built for export
When permission to build coasting vessels (ships weighing 2,500 gross tons or more and less than 12,000 dead weight tons built for export) is granted, the foreign orderer of the ship is required to declare in a written manner not to load or unload cargo in Japan. From June 1995, such declaration will no longer be required, and overall restrictions will be abolished by the end of FY1996.
5. Construction
5-(1) Improvement of the inspection system for multi-story car parks, etc.
Regarding the safety of special devices from the technical viewpoint, the following measures will be taken regarding approval of off-road car parks by the Minister of Construction :
(1) The examination system will be improved during FY1995, such as making the Examination Committee of the Multi-story Car Park Industry Association be composed of neutral academic experts and so on.
(2) Dispatching of members of the Examination Committee of the Multi-story Car Park Industry Association abroad for on-site inspections, by request will be considered.
(3) The use of foreign inspection organizations will be considered at an early date, after ascertaining that the organizations in question have sufficient experience and ability and that there is concrete demand among foreign producers. Toward this end, an on-site study of the organizations in question will be undertaken at an early time in FY1995.
5-(2) Improvement of the certification system for wallpaper
(1) Active publicity will be undertaken to ensure that designation of foreign testing laboratories based on the Guidelines for Designating Testing Laboratories proceeds smoothly.
(2) Negotiations will be held actively with foreign countries such as France, the United States, Canada and the EU, and as soon as agreements have come into effect, a mutual recognition system will be introduced to enable mutual acceptance of performance evaluation obtained by certification organizations in the counterpart countries.
6. Tertiary industries and related area
6-(1) Liberalization on representation of parties by foreign lawyers in international arbitration
The Study Commission on the Representation of Parties in International Arbitration is studying for the liberalization, and the conclusion of the study is aimed to be drawn around October 1995, after which the necessary measures will be taken including adjustment of related laws in time for the next ordinary session of the Diet.
6-(2) Review of regulation on premium offers
The Fair Trade Commission is attempting to review regulation on premium offers, considering the conclusion of the study group concerning the review and clarification of regulation on premium offers consisting of academics at the end of March, 1995, as to abolish the notification of the Commission concerning premium offers by department stores(subsection 8 of the Specific Unfair Trade Practices in the Department Store Industry) and one concerning premium offers to entrepreneurs, and to increase the upper limit of premiums set up by notification concerning prize without connection with transactions, one concerning premiums offered by lotteries, and one concerning premiums offered to general consumers not by lotteries, as well as to clarify the regulation including the scope of regulation during FY1995. Then the Commission will also attempt to review, as appropriately, regulation on premium offers applied to specific industry by notifications or the fair competition codes.
6-(3) Horse owner registration for persons residing overseas by the Japan Racing Association (JRA)
JRA will be encouraged to review without delay the way how it can appropriately conduct the evaluation for registering persons residing overseas, as horse owners, as well as domestic residents, after it hears the opinions of various related foreign organizations etc. and studying the horse owner registration systems in various countries.
7. Import procedures
7-(1) Extension of work hours for Customs offices and other bodies relating to import processing procedures and others
(1) Hours when custom officers are on-duty at Nagoya and Fukuoka airports will be extended during 1995 based on the demand for the work outside of regular hours and staff availability.
Fees for overtime customs service will be reviewed appropriately, with due consideration for clerical processing conditions.
(2) Considering administrative efficiency the issue of increasing personnel and extending operating hours for testing at quarantine offices, animal quarantine offices and plant quarantine offices at major airports such as Narita, Nagoya and Fukuoka to enable the last international flight cargo of the day to be examined will be studied.
7-(2) Post-clearance examination of Consumption Tax on tax-free imports, etc.
The policy to require only necessary and indispensable documents from import declarer will continue to be kept in the future