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Food and Drugs Administration
1. Draft Regulations Governing Information that Must be Kept by Food Enterprises for Imported Foods and Foods Raw Materials
On August 20, 2014, The Ministry of Health and Welfare (MOHW) under authorization of the Act Governing Food Safety and Sanitation (AGFSS), Article 32, paragraph 3, announced the draft Regulations Governing Information that Must be Kept by Food Enterprises for Imported Foods and Foods Raw Materials. According to the draft Regulations and the AGFSS, the following information must be kept for five years:
(1) Product information including Chinese and English names, raw materials, storage and transportation conditions, obligatory inspection applicant, weight, volume, quantity, etc., expiration date or date of manufacture and shelf life, batch number, and number of the permission notice issued by an inspection authority.
(2) Vendor information including exporter or manufacturer’s name, address, contact information, and code issued by the exporting country, and country of origin of the raw materials as required by the central competent authority.
(3) Copies of import declaration forms.
Reported by: Jolene Wang / Crick Liang
2. Draft Regulations Governing Scope of Health Care Effects under Health Food Control Act
The MOHW announced on August 20, 2014 the draft Regulations Governing the Scope of Health Care Effects under the Health Food Control Act, stipulating that “health care effects” under the Health Food Control Act (HFCA) include liver protection, fatigue resistance, blood lipids regulation, blood sugar regulation, immunomodulation, bone healthcare, dental healthcare, delaying aging, iron absorption promotion, gastrointestinal function improvement, assistance in blood pressure regulation, reduction of body fat formation, assistance in allergic constitution modulation, and an effect described using a similar expression thereof. Foods not registered as health food under the HFCA are prohibited from claiming the above-mentioned health benefits.
Reported by: Jolene Wang / Crick Liang
3. Regulations Governing Food Enterprises Subject to Obligatory Inspection of Food Raw Materials, Semi-finished Food Products, or Finished Food Products, Minimum Inspection Cycle, and Other Related Matters
On August 21, 2014, the MOHW under authorization of the AGFSS, Article 7, paragraph 4, announced the Regulations Governing Food Enterprises Subject to Obligatory Inspection of Foods Raw Materials, Semi-finished Food Products, or Finished Food Products, Minimum Inspection Cycle, and Other Related Matters. We summarize the key points below:
(1) Food enterprises subject to obligatory inspection:
a. Aquatic food enterprises, meat processing enterprises, and dairy processing enterprises that have factory registration and must as announced by the central competent authority comply with the Regulations on Food Safety Control Systems.
b. Food enterprises dealing in the manufacture and import of food additives.
c. Registered Special nutritional food enterprises.
(2) Aquatic food enterprises, meat processing enterprises, and dairy processing enterprises must inspect relevant raw materials for veterinary drug residues at least quarterly or per batch.
(3) Food enterprises dealing in the manufacture and import of food additives must inspect single food additives and compound food additives for heavy metals and other impurities at least quarterly or per batch.
(4) Registered special nutritional food enterprises must inspect their products for microbial and nutrient content at least quarterly or per batch.
Reported by: Jolene Wang / Crick Liang
Insurance
4. FSC intends to propose amendments to "Insurance Act" to Executive Yuan for review
The proposed amendments to the Insurance Act are listed below:
(1) Banks to be permitted to apply to concurrently engage in insurance agent and insurance surveyor business (Article 8-1 and 163);
(2) Deletion of the wording regarding "similar to insurance" to avoid misunderstanding (Article 136 and 167);
(3) Regulator may adopt relevant supervisory methods and execute exit mechanism for an insurance company according to the capital adequacy ratio of the company (Article 143-4, 143-5, 143-6, 149 and 178);
(4) Insurance companies shall hire external auditors (Article 144 and 171);
(5) Insurance companies may act as directors and supervisors of an invested company when an insurance company invests in public and social welfare enterprises; and
(6) Penalty fines will be increased for insurance enterprises that fail to establish or execute internal control or audit systems
Reported by: David Tsai / Angela Chang
5. FSC announces "Guidelines for Insurance Enterprises to Engage in Business regarding Buying Insurance Online"
The FSC announced the "Guidelines for Insurance Enterprises to Engage in Business regarding Buying Insurance Online"(the "Guidelines"). We summarize the points below:
(1) Insurance enterprises engaging in business regarding the purchase of insurance on line (the "Business") shall establish specific areas or exclusive websites. Agents of insurance enterprises cannot establish websites (Article 3);
(2) The Business means that the proposer fills in the relevant information for the insurance policy online to execute the insurance agreement with the insurance company directly after registration and authentication of identity (Article 4) ;
(3) An insurance company shall back-up the electric records of the proposer's election or agreement and save them for at least 5 years ; (Article 14)
(4) Insurance companies shall include the contents of the Guidelines in their internal control systems or audit systems. (Article 17)
Reported by: David Tsai / Angela Chang
6. FSC amends "Regulations Governing Permission of Insurance Business Transactions and Investment Between the Taiwan Area and the Mainland Area"
The points are below:
(1) A Taiwan-area insurance enterprise and its offshore branches may engage in business regarding claim adjusting, consultation for avoiding losses and other relevant business approved by the competent authority with Mainland-area insurance enterprises and their overseas branches. This also applies to branches, subsidiaries or affiliated enterprises of Taiwan-area insurance enterprises established in the Mainland Area and branches of foreign insurance enterprises in the Mainland Area. Reinsurance business shall be subject to prior approval to avoid applications on a case by case basis. (Article 9 and 12)
(2) A Taiwan-area insurance enterprise may invest in shares of insurance enterprises invested by foreign insurance in the Mainland Area. The application requirements are also amended.
Reported by: David Tsai / Angela Chang
7. FSC amends "Offshore Banking Act"
The main amendments are as follows:
(1) The addition of offshore insurance business (Article 1 and 2);
(2) Units of offshore insurance businesses (the "OIU") may engage in offshore insurance business (Article 12);
(3) The business scope for the OIU includes insurance business paid in foreign currencies, reinsurance business and other business approved by a competent authority (Article 22-13); and
(4) The OIU may not be restricted by the laws and requirements regarding the Foreign Exchange Regulation Act and Insurance Act (Article 22-15); and
(5) Tax benefit for OIU. (Article 22-17)
Reported by: David Tsai / Angela Chang
Electronic Stored Value Cards
8. Amendment to the Regulation Governing Review Criteria and Administration for Issuance of International Electronic Stored Value Cards or Cooperation with a Foreign Institution to Issue Electronic Stored Value Cards
On August 14, 2014, a draft amendment to the Regulation Governing Review Criteria and Administration for Issuance of International Electronic Stored Value Cards or Cooperation with a Foreign Institution to Issue Electronic Stored Value Cards was announced by the Financial Supervisory Commission. Regarding cooperation with a foreign institution to issue international electronic stored value cards, this amendment removes the requirement that the foreign institution shall have issued international electronic stored value cards for at least one year.
Reported by: Stacy Lo / Mark Chen
OSU
9. Draft amendments to "Regulations Governing the Scope of Business, Restrictions on Transfer of Beneficiary Rights, Risk Disclosure, Marketing and Conclusion of Contract by Trust Enterprises"("Regulations")
On August 19, 2014, the Financial Supervisory Commission ("FSC") issued a ruling (Ref. No.:Jin-Guan-Yin-Piao-Zi-10300178400) to announce the addition of Article 7-1 to the Regulations. This stipulate that restrictions on the scope of investment for trust assets, qualifications of professional investors, review/ approval/ report for effectiveness of products, and regulations for recommendation, advertisement and so forth shall not apply to Offshore Securities Branches ("OSU") when conducting assets allocation on behalf of an offshore customer by means of a trust.
Reported by: Jeffrey Liu / Judy Tai
SICE/OSU
10. Relevant Rulings Issued by FSC
On August 21, 2014 and August 25, 2014, the FSC issued rulings related to Securities Investment Consulting Enterprises ("SICE") and OSUs respectively. The key points are summarized below:
(1) On August 21, 2014, the FSC issued a ruling (Ref. No.:Jin-Guan-Zheng-Tou-Zi-1030028247) to allow a SICE to hold up to 30% of its net assets in foreign currency for purposes other than business operations.
(2) On August 25, 2014, the FSC issued two rulings (Ref. No.:Jin-Guan-Zheng-Quan-Zi-1030028654 and Jin-Guan-Zheng-Quan-Zi-10300286542) to provide that (i) certain legal restrictions shall not apply to OSU's businesses for offshore clients, provided that such restrictions shall still apply to businesses for domestic clients; and (ii) investment in international bonds denominated in foreign currency (including Formosa bonds) by offshore funds or securities investment trust funds distributed by an OSU can be excluded from the calculation of 30% investment limitation on domestic securities markets by these funds.
Reported by: Jeffrey Liu / Judy Tai
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2014-09-09
