1. Reason for Amendment
In accordance with Article 15-2 of the "Health Functional Foods Act," the re-evaluation results of safety and functionality for eight functional ingredients, such as Garcinia Cambogia extract, are reflected in this amendment. Specifically, the Ganoderma lucidum fruit body extract is removed from the list of ingredients, four functional ingredients, including soybean isoflavones, have their daily intake amounts reset, the heavy metal (lead) standard for lecithin is strengthened, and the manufacturing standards for Garcinia Cambogia extract, lecithin, and mucopolysaccharides/proteins are modified. Additionally, precautionary measures for seven ingredients, including guava leaf extract, are added, the source materials for iron and zinc are expanded, the functionality of whey protein hydrolysates is added, and a standard for iodine starch reactions in aloe gel is included to prevent consumer deception by mixing low-cost starches. The goal is to establish proper standards and regulations for health functional foods.
2. Key Contents
a. Amendment of Safety, Manufacturing Standards, Specifications, and Daily Intake for Eight Functional Ingredients (Articles 3.2.2-10, 3.2.2-11, 3.2.2-15, 3.2.2-18, 3.2.2-25, 3.2.2-27, 3.2.2-32, 3.2.2-48, 3.2.2-64, 4.3.3-35)
1) According to Article 15-2 of the "Health Functional Foods Act," a re-evaluation of the safety and functionality of already recognized functional ingredients has been conducted based on the latest scientific standards.
2) Based on the re-evaluation results of safety and functionality for health functional ingredients, Ganoderma lucidum fruit body extract, which lacks functionality, is removed from the list of ingredients, and the daily intake amounts of soybean isoflavones, astaxanthin extract, lecithin, and mucopolysaccharides/proteins are adjusted. The heavy metal (lead) standard for lecithin is strengthened, and the manufacturing standards for Garcinia Cambogia extract, lecithin, and mucopolysaccharides/proteins are amended. Additionally, precautionary measures for seven ingredients, including guava leaf extract, are added or revised.
3) The latest scientific standards have been used to improve the criteria and specifications for functional ingredients, ensuring the provision of safe health functional foods to the public.
b. Addition of Source Materials for Nutrients (Articles 3.1.1-17, 3.1.1-18)
1) There are limited sources available for the manufacture of nutrients.
2) Add ferrous fumarate as a source for iron and zinc citrate as a source for zinc.
3) This expansion allows for the manufacture of a wider variety of iron and zinc products, contributing to the activation of related industries.
c. Expansion of Functional Content for Functional Ingredients (Article 3.2.2-64)
1) To activate the production of whey protein hydrolysates, it is necessary to include the newly recognized functional content in the official regulations.
2) The functionality of whey protein hydrolysates (helping improve sleep quality) is added to the official recognized ingredients.
3) The expansion of functional content for officially recognized ingredients is expected to stimulate product production.
d. Strengthening of Regulatory Standards for Functional Ingredients (Articles 3.2.2-47)
1) To eliminate fraudulent activities such as mixing low-cost starch with aloe gel, it is necessary to establish new standards.
2) A standard and testing method for iodine starch reactions have been introduced.
3) The establishment of quality management standards for aloe gel will prevent consumer deception and enhance the credibility of health functional foods.