2015 food and medicine safety system is changed
2017-05-22 13:48 | NS NEWS
□ Ministry of Food and Drug Safety (Commissioner: Seung Jeong) announced in 2015 that the system in the field of food, medicine, medical device and cosmetics will be changed as follows.
○ The 2015 system focuses on strengthening safety management, expanding consumer rights and rationalizing procedural regulations.
□ In the food area, ▲ the application of labeling standards for liquor products, ▲ the introduction of labeling systems for food apparatus, ▲ the mandatory labeling of limited edition hamburger and pizza, ▲ the reinforcement of penalties for violations of the livestock hygiene control act and, ▲ relief of business facility standard of livestock.
○ Since the standard for management of liquor products was changed, all raw materials which were not displayed in the liquor will be displayed from January to expand consumers’ right to know.
– This is because the indication management standard is changed from the “notice of mandate for the use of brand of liquor” to the “labeling standard of food.”
※ Reason: Notice of mandate for the use of brand of liquor → Labeling standard of food (While it was enacted from Jan. 1, 2014, one year of grace period is granted)
※ Display of raw materials: 3 kinds of raw materials (excluding water and some additives) → Display all raw materials (including water)
○ For food products, imported dishes and disposable gloves, labeling and marking of ‘food appliance’ shall be mandatory from January so that consumers can purchase and use them properly.
– Prioritized mandatory was implemented to metal tools such as knives and scissors in 2015 and the subjects will be expanded by 2018.
※ (15) Metal → (16) Rubber → (17) Synthetic resin → (18) Paper and 7 kinds
○ It becomes mandatory to indicate nutrients such as calorie from January to the limited edition products such as hamburgers and pizza, which are sold for less than 90 days per year as a specific day or plan marketing product.
○ A regulation to impose additional penalty to the maximum statutory amount according to the number of violation to the regulation violators in order to strengthen the safety of livestock food will be applied in January.
○ From January, it will be easier to establish small-scale slaughterhouses by easing the standards of slaughterhouses and it will be possible to report sales as egg collection and sales business using part of poultry facility in poultry farms.
□ The pharmaceutical area includes ▲ radiation medicine, medical high pressure gas pharmaceutical manufacturing and quality control standard (GMP) application ▲ human body import approval system and traceability requirement ▲ mandatory for herbal pharmaceutical manufacturing and quality management standard (GMP).
○ From July onwards, it will be mandatory to comply with the GMP of radiopharmaceuticals and medical high pressure gas manufacturers in the same way as the member countries (43 countries) of Pharmaceutical Inspection Co-operation Scheme in the United States, Japan, the EU and other countries.
※ The mandatory obligation will apply from July to new business operators, 1, 2015, and from July 1, 2017 for existing manufacturers.
○ From January onwards, the human tissue bank will operate traceability system to check history from donors to the recipient, and the medical history and administration history check will be mandatory through the health insurance screening institution when collecting human tissue from the donor.
– In addition, whenever human tissue is imported, import approval must be received including approval for change.
○ Herbal medicine GMP which was introduced to improve the quality reliability of herbal medicines and to enhance safety becomes full mandatory from January onwards. Thus, herbal materials produced from the GMP vendors can be supplied to the Korean pharmaceutical clinics, oriental pharmaceutical clinics and Chinese pharmacies.
□ Medical device area includes ▲ prohibition of distribution of medical device raw materials which are potentially risky and ▲ introduction of quality control standards for medical devices.
○ Manufacture, import and sale of mercury containing medical devices (except for dental purpose) and phthalate containing fluid sets are prohibited from January to prevent potential health hazards to people caused by medical devices in advance.
○ Companies engaged in selling or leasing medical devices are obliged to prepare facilities and equipment, designate the management staff and to perform document management and education from January onward for the medical device quality management.
□ Cosmetics and quasi-medicines area includes ▲ safety management with “wet tissue for human cleansing” cosmetics and ▲ expansion of eligibility for quasi-medicine manufacturing management.
○ “Wet tissue for cleaning human body” has been managed as an industrial product, but it will be managed by cosmetics in July to meet the safety management requirement of consumers.
○ From October onwards, the qualification of manufacturing manager for hygiene goods among quasi-medicines such as sanitary pad or bandages is extended from certain major fields such as chemistry and textile engineering to all departments of science and engineering.
– In addition, non-science and high school graduates can be a manufacturing manager by recognizing their experience in quasi-medicine manufacturing.
□ The MFDS announced that they will make every effort for people to enjoy safe and excellent food, medicines, medical devices and cosmetics through a newly introduced system.