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(Provisional Translation)

Policy Action on Market Access Issues as concerns Standards, Certification and others (March 25,1997)

March 25,1997
Office of Market Access

The following actions will be taken to further improve market access, based as much as possible on the "Recommendations on Market Opening Issues Relating to Standards, Certifications, etc. (dated March 17, 1997, the 4th report of the March Access Ombudsman Council).


1. Animal, Plants and Food

1-(1) Consolidation of Ministry of Agriculture, Forestry and Fisheries and Ministry of Health and Welfare quarantine procedures

(1) The concerned ministries have been actively cooperating in promoting consolidation of the quarantine certificates for animals and animal products issued by the MAFF and the sanitary certificates issued by the MHW, and have explained Japanese standards concerning these certificates in bilateral consultations with the countries concerned. They will work to ensure that the particulars to be included on the certificates meet the standards of both ministries, to avoid inconveniencing the applicants.

(2) To avoid incomplete information on sanitary certificates, the ministry concerned will inform the exporting countries thoroughly concerning the particulars needed.

(3) Among the particulars required on sanitary certificates, when the date of slaughter is known, in the case of processed meat, the matter of dropping the requirement for the date of slaughter will be studied at an early date. Further, a conclusion on study regarding further simplification of the particulars required will be reached by the end of FY 1997 and implemented without delay.

1-(2) Simplification of food inspection procedures

The matter of testing for aflatoxins in raw pistachio nuts at the time of import, including whether, like cashew nuts, they can be excluded from testing entirely, depending on storage and preservation during processing and test results, will be studied during FY 1997.


2. Pharmaceuticals, Medical Equipment and Cosmetics

2-(1) Relaxing import procedures for medical equipment in categories not yet approved

(1) Since regulations on medical devices differ from each other between Japan, USA and EU efforts will be made to harmonize them including the scope of equipment for which approval is required.

The requirements which must be met in order for medical equipment not to require approval will be made public. The reasons why a decision was made that the medical equipment in question no longer requires approval will also be explained.

(2) The matter of no longer requiring approval for massage apparatus and magnetic energy health equipment for home use will be studied and a conclusion reached by the end of FY 1997.

(3) The department which parties wishing to have their equipment exempted from approval can consult will be made clear, and procedures for not requiring approval will be established.

2-(2) Deregulation on cosmetics

(1) Regarding companies facilities required in terms of quality assurance of quasi-drugs, the ministry concerned will study and expand the scope of use of facilities which are not owned by the company itself in FY 1997. During the study and expansion work, with regard to cosmetics as well, it will study the use of the facilities of affiliated group companies.

(2) Approved ingredients for which it is no longer necessary to require approval are reviewed annually. Based on specification establishment, they are added to the Comprehensive Licensing Standards Cosmetics by Category (CLS), thus made public .For the other ingredients not included in the CLS, but which are in previous examples of formulation, the introduction of a system to make these public will be studied in consideration of intellectual property right protection.

(3) A guidebook has been published, which includes examples of false, exaggerated or misleading product names in terms of. Of caution. The ministry will work in close coordination with the prefectures to avoid divergence in the guidance at a prefecture level. The ministry will inform additional example to be included in the guidebook on the basis of a prefecture surveillance conducted in FY 1996.


3. Industry

3-(1) Deregulation relating to internal combustion

(1) Technical standards based on the Electricity Utilities Industry Law will be harmonized with ISO and other international standards by the end of March 1997.

(2) The ministry concerned will actively publicize the fact that the approval system for private power generating facilities set out by the Japan Association for Internal Combustion Power Generating Facilities are unrelated to the above-mentioned law or government approved standards. The ministry will also request the Association to correct the contents of its pamphlet by June 1997 and will instruct the Association to avoid giving the impression that products require by law the approval of the Association. If the business practice of requiring Association's approval hinders the import of foreign products, the ministry will endeavor not to aggravate it.

3-(2) Deregulation of sales restrictions for illegal measurement units

(1) The ministry concerned will continue efforts to standardize measurement units with SI international units, and given that other countries are standardizing their measurement units with SI units, the Measurement Law will be applied flexibly to avoid any negative impact on import activities and consumer purchases.

(2) If the law is applied flexibly, this will be publicized in a timely fashion, and local officials, including weights and measures officials at the prefectural level, will be well informed. Once a certain amount of experience in application is acquired, the matter of whether this comes under the sales restrictions of the Measurement Law will be studied when the study of establishing standards to avoid any negative impact on import activities and consumer purchases is undertaken. If such standards are adopted, this will be publicized in a timely fashion and all officials, including weights and measures officials at the prefectural level, will be informed.

3-(3) Deregulation on refrigeration facilities

Taking into consideration maintenance performance so far, a committee composed of the prefectural staff in charge and persons in related businesses will study how to streamline the selection process of qualified persons for refrigeration facilities other than those specified. They will reach a conclusion as soon as possible, and when measures are necessary on the basis of their decisions, the related legal statutes will be amended during FY 1997.

3-(4) Deregulation on attached freezing

Taking into consideration facilities maintenance performance so far, a committee composed of the prefectural staff in charge and persons in related businesses will study the need to retain regulations on attached freezing facilities. They will reach a conclusion as soon as possible, and all procedures necessary on the basis of their decisions will be implemented in FY 1997.

3-(5) Relaxation of container re-testing period

Based on the recommendations of the security advisory council on pressurized gases and explosives (January 1996), a committee of members, including persons in related businesses, is currently studying the entire re-testing system for containers, including the testing cycle. They will reach a conclusion as soon as possible, and based on the results of their study, will produce results in FY 1997.


4. Transport and Traffic

4-(1) Clarification of the formula used to calculate output for fishing vessel propelling apparatus

(1) The formula for calculating output for fishing vessel propelling apparatus, including where it is necessary to regulate output, will be reviewed during FY 1997.

(2) During FY 1997, the systems in use in other countries will be studied thoroughly, and in particular, regulations will be harmonized with international standards, by using objective criteria for total engine displacement.

(3) A broad range of parties, not only fisheries groups and fishing vessel associations, but also other concerned parties, will be given opportunities to present their views, as this matter includes engineering issues, and new criteria will be established taking those views into account.

4-(2) Reducing the number of documents required concerning construction of high-speed ferries and ensuring their confidentiality

When vessels jointly owned by the Maritime Credit Corporation are built, the necessary measures will be taken to harmonize practical and technical matters relating to the reduction of documents needed and ensuring confidentiality with international business practices. When its standard contract form is amended, the Corporation will refer to the opinions of domestic shipyards as well as foreign ship builders. When the contract is translated into English, the Corporation will seek to offer convenience to foreign shipyards, making active use of examples from other government organizations involved in similar operations.

4-(3) Deregulation in order to lower harbor fees

(1) Policies will be changed to abolish control on supply-demand adjustments after establishing measure to ensure the smooth operation of ports and harbors, and price regulation will be reviewed as well. To carry this out, the Administrative Reforming committee will have deliberations concerning the abolishment of control on supply demand adjustments in FY 1997.

(2) While this is being studied, the system of fees, including further development of discount fee system will be approved more flexibly, in order to diversify fares and charges and reduce the burden on operators.

(3) In addition, when specific deregulatory measures are taken, these will be adequately known in public in order to avoid misunderstanding of system.


5. Information and Telecommunications

5-(1) Deregulation of preservation of documents on microfilm

Regarding books and records which must be preserved to meet tax law requirements, conditions for the preservation on microfilm will be studied in order to ensure fairness in taxation. Consideration should also be given to the institutional purposes of preserving books and records, the cost benefits to the economy as a whole, and the requirements for records retention in electronic form. Measures are expected to be taken to allow preservation on microfilm for the entire period required. All procedures necessary to allow this are expected to be taken in FY 1997.


6. Import Procedures

6-(1) Simplification of presentation of documents using electronic systems

The requirement to submit invoices to the Ministry of International Trade and Industry for post-import inspection and for statistics-keeping purposes will be reviewed in order to reduce the burden on companies. The review will include reducing the number of particulars required, and the use of NACCS (Nippon Automated Cargo Clearance System), and discussions will be undertaken with the aim of reaching a conclusion in FY 1997.

6-(2) One stop service for legal procedures for imported cargo

(1) The concerned parties will be thoroughly informed regarding specific procedures which can be simplified as a result of networking between the MHW system, the MAFF systems and the NACCS system used by Customs.

(2) The ministry concerned shall endeavor to publicize import-related system network prior to implementation, by providing information to foreign embassies in Japan.

(3) The ministries concerned with import procedures shall improve their mutual cooperation and support system and work closely together to further simplify and speed up import procedures. The ministries concerned shall use liaison meetings effectively for this purpose.

(4) When improvements are made to existing ports or new ports are opened, positive measures shall be taken to enable legal procedures for imported cargo to be handled in one centralized location.

6-(3) Simplification of procedures for extension of payment date for Customs duties and consumption tax on imported cargo

Sea-NACCS (Nippon Automated Cargo Clearance System) and Air-NACCS (Nippon Automated Cargo Clearance System), which currently operate separately, are expected to be modified to permit setting of collateral for extension of payment date for Customs duties and consumption tax on imported cargo on both, when Sea-NACCS will be replaced during FY 1999.

6-(4) Elimination of document preservation requirement for import applications kept by Customs brokers

Taking into account factors such as ability to ensure genuineness, readability of data, ease of preservation, and legal validity, the problems related to allowing Customs brokers to preserve documents by means of electronic media will be studied and all procedures necessary to implement this are expected to take place in FY 1997.

6-(5) Permission for Customs clearance and unloading of sea cargo on holidays

To speed up unloading of sea cargo on holidays, active measures will be taken regarding government import procedures. The concerned ministries shall work closely together, particularly on the following:

(1) Customs personnel shall be assigned outside of regular duty hours at sea ports other than Shimonoseki where there is sufficient administrative demand, and taking into account administrative efficiency.

(2) MHW quarantine stations at sea ports shall be staffed adequately to meet users' needs and in accordance with food imports there, on a level similar to that of major airports.


7. Other

7-(1) Review of landing examination criteria

(1) Regarding the application and the examination criteria for the status of residence, further clarification and transparency will be achieved by the explicit stating of the interpretation and application of the contents of the status of residence and its examination criteria in order to facilitate the entry and stay in Japan of persons engaged in legitimate business.

(2) Regarding the maximum term of stay of five years for Intra-company Transferee, the results of the consideration of this matter shall be given as early as possible in FY 1997, to extend this term for persons concerned in order to facilitate the conduct of their legitimate business.

(3) Regarding the status of residence for Investor/Business Manager, the rules will be applied flexibly, in cases where this involves a change of status from Intra-company Transferee, to permit a change of status when the applicant proves his business to be in a healthy state, in addition to the present formulaic requirements such as the number of employees or the size of office.