The Regulations are enacted pursuant to the provisions of Article 21 Paragraph 6 of the Act Governing Food Safety and Sanitation.
The competent Central Authoritymay appoint other organizations (hereinafter referred to as the “service provider”) to carry out the examination and registration of food and related products pursuant to Article 21 Paragraph 1 of the Act Governing Food Safety and Sanitation. When it elects to do so, the authority shall comply with the Regulations.
The outsourced scope of services covers the issuance of a new permit, the replacement, re-issuance, extension, transfer or revocation of an existing permit, as well as the change of registration information.
In outsourcing the matters stated in the preceding paragraph, the Central Authority shall appoint the service providers through an open selection process.
The service providers shall be limited to food-related government agencies, corporations or research institutions that meet one of the following criteria: 1) have at least three years of experience in researching the management of food sanitation and the research accomplishments have been adopted by the government agencies, or 2) have at least three years of experience in food product accreditation and certification.
The facility of aservice provider shall have a work environment appropriate for the tasks it performs, established operating procedures appropriate for the outsourced contracts, and a quality assurance plan. The professional examiners employed by the service provider shall be available in sufficient numbers.
The professional examiners as referred to in the preceding article shall have at least one year of experience working in examination and registration of food and related products or in accreditation and certification, as well as possess one of the following qualifications:
1. A bachelor’s degree in food sanitation of a domestic or foreign college or university duly recognized by the Ministry of Education;
2. Qualified in a general civil service examination or a professional or technical licensure examination or other higher examination levels on food products and received an official certificate or license to practice, or
3. Previously held a position ranked grade 5 or higher at a government agency.
The service provider and competent Central Authority shall sign and execute a written service contract according to which the service provider provides services pertaining to the examination and registration of food and related products.
A service provider shall properly manage its resources and competence to effectively carry out the contracted services. The service providers are prohibited from subcontracting the services to third-party organizations and bodies.
Any change or addition of the service provider’s professional examiners shall be reported to the competent Central Authority for filing at least one month prior to the expected change or addition.
The names, addresses, types of services and contract period of the service providers shall be subject to the official announcement of the competent Central Authority.
The service providers shall ensure that the examination and registration processes are in full compliance with the laws and regulations governing the management of food sanitation, examination procedure flowchart (see the attached document), contract period, as well as the competent Central Authority’s document processing procedures.
To apply for examination and registration, a food business operator submits the application to the competent Central Authority and pays the examination fee. The competent Central Authority acknowledges the receipt of the application and forwards the information to the service provider for processing.
The examination and registration services provided by a service provider are deemed to be an examination performed by the competent Central Authority. The food business operators shall accept the examination and cooperate accordingly. The service provider assigned to the application may request the applicant to supplement information or clarify matters, as appropriate, by contacting the applicant directly.
Upon completion of the examination of an application, the service provider shall submit the result of the examination along with all document material provided by the food business operator to the competent Central Authority. The competent Central Authority proceeds to review the application and awards the certification or dismisses the application accordingly.
The service provider shall record the examination and registration files in order through an appropriate approach. The records shall be signed by different levels of personnel at all parties participating in the examination and registration process, and compiled into a monthly report for submission to the competent Central Authority. The service provider shall maintain the records in file for at least three years for future reference.
The competent Central Authority may provide related information, as required and appropriate for the purpose of facilitating the registration and examination processes, to the service providers.
The outsourced service provider are bound by confidentiality and good management responsibilities for the related information received from the competent Central Authority as well as the documents and personnel information provided by the food business operator.
The service providers are liable for any error or violation, loss or disclosure of document material, unauthorized disclosure of classified information obtained through its position, or infringement of third-party rights.
The service providers are prohibited from announcing or publishing any news or information relating to the examination and registration processes without the prior consent of the competent Central Authority.
The service providers are prohibited from delaying the examination and registrationprocesses in any way without a just cause.
The competent Central Authority may from time to time audit the examination and registration services performed by the service providers and perform regular performance evaluation. The service providers shall cooperate accordingly. Evasion, obstruction or rejection of such monitoring measures is prohibited.
Should any deficiencies be identified through any of the monitoring measures provided in the preceding paragraph, the competent Central Authority may provide guidance and prescribe a period in which the service provider rectifies the said deficiencies.
The professional examiners employed by the service providers are obligated to attend the training programs offered by the competent Central Authority.
The service contract period is three years. Upon expiration of the contract, the competent Central Authority may review the past performance of the service provider and elect to give priority to the same provider for renewal of the contract.
If the contract is to be renewed, both parties shall negotiate the terms and conditions two months prior to the expiration of the existing contract. A contract may be renewed only once.
Any failure or delay that materially affects the performance of the service provider’s obligations under the service contract for reasons beyond the reasonable control of or not attributable to the service provider shall be reported immediately to the competent Central Authority. Both parties may negotiate to adjust the terms of the service contract to reflect the changes.
The competent Central Authority may terminate the service contract upon the occurrence of any of the following events:
1. The service provider is in violation of the qualification requirements of Article 4 Paragraph 2, Article 5, or Article 7 Paragraph 1 or provisions of Article 8, Article 11 Paragraph 3, Article 12, Article 15, Article 16, Article 17 Paragraph 1, or Article 17 Paragraph 3, and the service provider fails to rectify the violation within the prescribed period.
2. The service provider is in violation of the provisions of Article 7 Paragraph 2, Article 10, or Article 13 Paragraph 2;
3. One of the eventswhich bring about termination of the contract as prescribed in the service contract occurs.
The competent Central Authority, in terminating the service contract, shall take appropriate measures to ensure the availability of the examination and registration services.
The Regulations take effect from the date of promulgation.