4 Designated Ingredients | Pueraria mirifica, Black cohosh, Coleus forskohlii and Greater celandine
- Source: MHLW, Japan
- Mar 27, 2020
- 2 min read
The Ministry of Health, Labour and Welfare (MHLW) announced on 27 March, 4 designated ingredients or substances which require specific caution from the viewpoint of preventing the occurrence of health hazards based on the provisions of Article 8, Paragraph 1 of the Food Sanitation Act (MHLW Notification No. 119 of 2020).
In addition, the business operators handling (manufacturing, importing, selling, and otherwise handling) foods containing such ingredients/substances etc. shall report to MHLW through the prefecture or municipality under the jurisdiction when the operator concerned obtains information that their products are causing or likely to cause human health hazards. Good Manufacturing Practice (GMP) for the foods containing the designated ingredients etc. will be also introduced as ensuring uniformity of the designated ingredients etc. in products is paramount to prevent the occurrence of healthhazards.
Good Manufacturing Practice (GMP):
The following items are to be required as the standards for the manufacturing or processing:
Assignment of managing supervisor
Preparation of product standards
Preparation of procedure manuals
Manufacturing and quality management of the ingredients
Products manufacturing management
Product quality management
Product shipping management
Validation of the managing methods for manufacturing and quality
Management of changes in manufacturing methods
Management of deviations in manufacturing methods
Management of quality information and handling of defective products
Self-inspection
Management of documents and records
Overview of 4 Designated Ingredients:
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