(1) Reasons for Proposal

The Amendment increases the legislative level of the Regulations for Good Manufacturing Practice to ensure the Regulations are easily understood by the public, and prescribes grounds to assess compliance with the Regulations once a year or more if necessary, thereby aiming to strengthen consumer protection.

It imposes an administrative fine in cases where a report on manufacturing items has been filed with false product names or ingredient names, etc.; introduces a system where any “other food sales business” that sells health functional foods shall be construed as having filed a business report for general sale of health functional foods; and otherwise addresses and improves upon a number of weaknesses that have emerged from the operation of the current system.

(2) Major Provisions

A. Introduce a system where “other food sales businesses” shall be construed as having filed a business report for general sale of health functional foods (Article 6)

1) Current provisions stipulate that a person other than a pharmacy who intends to sell health functional foods shall file a report for a general sales business.

2) There has been a suggestion that non-pharmacy businesses of a certain size or larger that are capable of seller management should be construed as having filed a business report for general sale of health functional foods. Accordingly, the Amendment prescribes that “other food sales businesses” pursuant to the Food Sanitation Act shall be construed as having filed a business report for the general sale of health functional foods.

3) The increase in the number of health functional food distributors is expected to stimulate the market and improve consumer convenience.

B. Increase the legislative level of the Regulations for Good Manufacturing Practice (GMP); prescribe additional investigations/assessments; and provide incentives to exemplary businesses (Article 22)

1) The Amendment increases the legislative level of the GMP regulations, which are currently delegated to a Notice, in preparation for compulsory implementation in 2020. The current Act prescribes regular yearly assessment of GMP compliance, but the Amendment prescribes legal grounds to conduct additional investigations and assessments if necessary to address problematic businesses, such as those that have violated the law.

2) The Amendment allows exemplary businesses identified in regular assessments to be exempt from investigations and assessments, thereby aiming to encourage active GMP compliance.

C. Newly insert provisions to impose administrative fines for reports on manufacturing items that are filed in a fraudulent manner, and non-compliance with inspection orders (Article 47)

1) There are no penal provisions concerning reports on manufacturing items that are filed in a fraudulent manner, or non-compliance with inspection orders.

2) The Food Sanitation Act imposes an administrative fine on persons who file a report on manufacturing items in a fraudulent manner or fail to comply with an inspection order. To improve fairness, the Amendment newly inserts provisions to impose administrative fines.