New Korean Regulation for Foods & Supplements dated 13th March 2018 by Nikolaas Tilkin-Franssens

From March 2019, the sales person who labels and advertises the foods should prove the contents of the labels and advertisement. In addition, regulations on the labeling and advertising of foods distributed in the Food Sanitation Act, the Health Functional Food Act, and the Livestock Sanitation Management Act are integrated into one.

The government has promulgated the "Food and Other Labels and Advertisements Act" on March 13th enacted on March 14th, 2019.

The Act defines the main contents of foods, food additives, utensils, containers and packaging that are designated by the Food and Drug Safety Directorate as notifiable by law to be related to food, health functional foods, livestock products, and the key content of labeling and advertising regulations.

In addition, the salesperson who displays and advertises the foods shall be able to substantiate the facts related to the facts of the label and advertisement made by them, and the MFDS (Ministry of Food and Drug safety) shall, when it is deemed necessary to substantiate as unjustified labeling and advertisement, ask the salesperson to submit proofs of the substantiations.

At the same time, it is important to promote public morality and social ethics by encouraging the use of labels and advertising types such as foods prohibited by the Health Functional Food Act, the Food Sanitation Act, and the Livestock Sanitation Act, added infringing labels and advertisements.

Meantime, current preliminary deliberation system under the Health Functional Food Act and the Food Sanitation Act is abolished, and the group under the Article 28 of the Korean Food Industry Association and the Health Functional Food Act under the Food Sanitation Act, which operates the organization to prevent unwarranted labeling and advertising, has enrolled its operating facts to the MFDS.

For more detail, please visit, showing the detail regulation framework and its policy.

Source: SEAH bio

Easy to understand the banned foreign direct sales items by Nikolaas Tilkin-Franssens

The Korea Ministry of Food & Drug Safety(MFDS) has announced that it will reorganize its 'Direct Foreign Purchase Information Room' ( to make it easier for foreign direct purchasers.

In order to check whether direct foreign purchase was prohibited in foreign direct purchasing information centers, it was necessary to input the alphabet of the product name accurately. However, in the future, it is prohibited in the list provided in Korean (alphabetical order) and English (ABC order) Increased convenience to make it easier to find the product. It also plans to open up the items for which consumers want to be inspected every minute, and to open the results to the 'Foreign Direct Purchase Food Information Room'.

In addition, to enhance communication with consumers, an overseas direct purchase inquiry response window will be newly established, and promotional materials related to product safety will be posted periodically in the 'foreign direct food information room'. The KFDA said it will continue to make efforts to ensure that the public enjoys healthy food choices, including not only promptly blocking direct foreign purchases but also ensuring the convenience of accessing food safety information.

On the other hand, the pharmacy office plans to share relevant information in real time so that the KCS can quickly identify the products containing the hazardous ingredients and block them at the customs clearance stage through monitoring to enhance the safety of direct foreign purchased products.

Source: SEAH bio

Re-evaluation of 16 functional raw materials including xylitol and glucosamine, Korea by Nikolaas Tilkin-Franssens

Korea Ministry of Food and Drug Safety said yesterday that it will re-evaluate 16 functional ingredients such as xylitol and glucosamine.

Nine products, including xylitol, green lipped mussel extracted oil complex, policosanol, and sugarcane wax alcohol, are subject to periodic revaluation. Seven products, including glucosamine, vitamin D and sorghum fruit extract, the re-evaluation results will be announced in December.

The periodic revaluation target (9 products) is a combination of sardine peptide SP100N, green lipped mussel extracted oil complex, policosanol-sugar cane wax alcohol, mixed extract such as HemoHIM Angelica, xylitol, CJ Hibiscus, Pycnogenol- , Olive leaf extract (EFLA943), and regularly reevaluated (7 species) were glucosamine, vitamin D, soap palmetto fruit extract, fructooligosaccharide, EPA and DHA containing preservatives, to be.

The re-evaluation of health functional foods is divided into periodic re-evaluation of raw materials that have passed 10 years after the functional raw material recognition and regular re-evaluation which is confirmed by confirming new hazard information so that safe and excellent health functional foods can be supplied to consumers.

The data to be reviewed when reevaluating are the data submitted by the salesperson, the production results, the report on the manufacture of the items, the abnormal cases.Last year, 9 kinds of functional ingredients such as Garcinia cambogia extract and probiotics were reevaluated. △ change of manufacturing standard (1 kind), specification change (2 kinds), change of daily intake (2 kinds) was announced.

The MFDS reaffirms that it will distribute only safe and functional products to the market so that consumers will be able to enjoy an environment that they can safely consume. The re-evaluation plan for health functional foods in 2018 can be found on the homepage ( → Remarks → Notice.

Source: SEAH bio

Implementation of full list of agricultural chemical pesticide list management system (PLS) from next year by Nikolaas Tilkin-Franssens

The PLS (Positive List System) will be implemented for all agricultural products to strengthen the safety management of agricultural products since 2019.

The Ministry of Health, Welfare and Family Affairs (Ministry of Health, Labor and Welfare) announced on August 22 that it revised the standards and standards for foodstuffs. The introduction of this PLS was carried out to enhance the safety of agricultural products and to promote the use of correct pesticides. Pesticides for which no residue tolerance criteria are set are strictly controlled at the level of not detected (less than 0.01 ppm).

From Dec. 31, 2016, PLS, which is applied to nuts and seeds (coffee, almonds) and tropical and first-class (banana, mango, etc.), will be expanded to all agricultural products from January 1st next year. Until now, even if there is no pesticide residue tolerance standard, it has been recognized the CODEX standard, the minimum standard of similar agricultural products, and other agricultural products standards. PLS is being implemented in Japan ('06), European Union ('08), Taiwan ('08), etc., and the US, Australia, and Canada apply the non-detection criteria when there is no standard.

The Ministry of Agriculture, Forestry, Livestock and Livestock, and the Rural Development Administration will continue to educate and promote the food service center until the implementation of the pesticide PLS, and producers and importers of agricultural products are thoroughly prepared for the full implementation. Farmers must confirm the label (label) of the product before spraying the pesticide, check whether it is registered with the crop to be used by the pesticide, and apply the pesticide according to the safe use standard.The importer should confirm whether the pesticide used in the agricultural products to be imported is the pesticide which is set as the residual tolerance standard in Korea and apply for the imported tolerance standard (IT) if there is no standard in Korea.

In order to provide safe food to the people, the Food and Drug Administration announced that it plans to expand the PLS (List of Controlled Substances) for agricultural products as well as fish and shellfish products.

Source: SEAH bio

Revision notice of "Standard and Specification of Health Functional Foods" by Nikolaas Tilkin-Franssens

1. Reason for Establishment

In order to clarify the ingredients that can be used as a preservative for enteric capsules, granules, and tablets, we will delete the relevant regulations as it is obligatory to apply the "Good health functional food manufacturing standards" in the "Health Functional Food Act".

In order to prevent the confusion of the related workers by revising the labeling rules of the standard value to the range (a~b)

To be able to apply lead and cadmium standards to functional raw materials for which heavy metal standards have not been established, and to set the standards for acid value and peroxide value for EPA and DHA containing fats to contribute to the safety of health functional foods

We would like to contribute to expanding the selection range of consumers and promoting the industry through the production and distribution of various products by informing individual recognized functional raw materials that meet the requirements for additional listing of functional raw materials among "standards and specifications for health functional foods"

We have revised the Ginsenoside test method and established the test method of threonic acid to improve the efficiency and reliability of analysis.


2. Main contents

a. Deleted the recommendation to manufacture in accordance with the "Good Health Functional Food Manufacturing Standards"

Deleted the recommended regulations as required by the「Health Functional Food Act」to comply with the 「Standards for Manufacturing Superior Health Functional Food」 (Article 22 of the Seasonal Act, 18.12.1.)

b. Enables clarification of the basis of substances that can be used in capsule capsules, granules and tablets.

"To use the one that is suitable for the notification under the" Pharmaceutical Affairs Law "and" the product for the drug-use, notification and examination of drugs "[Attached Table 7]

c. Establishment of lead and cadmium standards for functional raw materials without heavy metal standard

Revised to apply lead and cadmium standards for functional raw materials that do not have individual heavy metal specifications

d. Amendment of the appraisal rule in which the standard value is set in the range (a ~ b)

'a ~ b' is defined as 'a or more and b or less'

e. Setting the acid value and peroxide value of EPA and DHA-containing oils

Establishment of standard of acid value and peroxide value to manage oxidation and rancidity of oil

f. Revised raw material name of lutein

Revised the ingredient name of lutein to "marigold flower extract"

g. Product-specific health functional food switch into Listed health functional food and New standard and specification add the relevant functional (assay) component

Establishment of standard and specification for extracts of Sophora japonica and its extraction

h. Amendment and new test method

1) Specify a detailed pretreatment procedure for cases where the sample contains a large amount of excipients in the ginsenoside test method.

2) Establishment of a test method for analyzing threonic acid of calcium ascorbate containing threonic acid (not more than 2% of threonic acid)

3. References

a. Related Laws: "Act on Health Functional Foods"

b. Budget Action: No action required

c. Agreement: Not applicable

d. Etc.

1) Administrative notice

a) Announcement No. 2017-134 (from March 20, 2017 to March 21, 2017)

b) Announcement No. 2017-379 (October 13, 2017 to December 31, 2017)

c) Announcement No. 2017-436 (2017. 11.30 ~ 201. 201. 2017)

2) Deliberation by the Health Functional Food Deliberation Committee

- Functional raw materials • Component recognition and standards • Standards division (, 2.19)

Source: SEAH bio

Daily Intake of vitamin D to double, Korea by Nikolaas Tilkin-Franssens

In the future, the minimum daily intake of vitamin D is increased from 1.5 ug to 3 ug, and chromium is lowered from the current 0.015mg to 0.009 mg. 

According to the Korea Ministry of Food and Drug Safety (MFDS; ex-KFDA) on August 28, the Ministry of Health, Labor and Welfare (MHLW) announced that it would be possible to apply the standards of major advanced foreign countries such as the Codex Alimentarius Commission to the nutritional ingredients such as vitamins and minerals, The Ministry of Health, Labor and Welfare has prepared the revised bill of the standard and the standard of the functional food of the same contents by the October 23 administration.

The main contents of the amendment are as follows: △ Expansion of nutritional ingredients △ Amendment of minimum daily intake standard for vitamin D and chromium △ Addition of nutritional ingredients that can be used for folic acid and iron production △ Precautions for ingestion of gamma linolenic acid- Improvement. The amendment has made it possible to apply major advanced foreign standards and specifications, such as CODEX regulations, to nutritional ingredients such as vitamins and minerals that are not specified as food and food additives.

In particular, it was revised that the minimum content standard of daily intake of vitamin D and chrome to reflect the revised daily nutritional standard. Vitamin D has been increased from 1.5 ug to 3 ug, while chromium has been lowered from the current 0.015 to 0.009 mg.

Methyltetrahydrofolic acid glucosamine ((6S) -5-Methyltetrahydrofolic acid, Glucosaming Salt) was added to folic acid and sodium ferrous citrate to iron.In addition, MFDS clarified that the precautions to be taken when ingesting gamma-linolenic acid-containing fats having functionalities such as improvement of blood cholesterol and blood circulation can be applied only to 'improve the skin condition due to immunosensitive reaction.In addition, to improve the efficiency and reliability of test analysis, 12 test methods for health functional foods such as iodine, beta-glucan and catechin were revised.

Source: SEAH bio

Controversy about side effects Re-evaluation of raw materials for functional foods, Korea by Nikolaas Tilkin-Franssens

Ingredients of health functional foods which are controversial about efficacy and side effects are going to be reassessed at the food safety authorities. As a result of the reevaluation, if it appears to be harmful to the human body or to have insufficient efficacy evidence, it may be restricted or at worst pushed into an exit crisis. The Korea Ministry of Food and Drug Safety (MFDS; ex-KFDA) said on June 15 that it plans to re-evaluate the ingredients of health functional foods that have raised social controversy over its efficacy and safety. 

The functional ingredients put on the re-evaluation priority review subject are ▲ probiotics ▲ Garcinia cambogia extract ▲ green tea extract ▲ green tea extract / theanine mixture ▲ aloe whole leaf ▲ green mate extract ▲ combination of Hwanggi extract ▲ wild mango seed extract

MFDS will open a health functional food review committee composed of internal and external experts and select two or three raw materials for official reevaluation based on the urgency and severity out of the nine raw materials and announce them and reevaluate them. Also MFDS said it is considering reimbursement as a top priority for extracts of probiotics and Garcinia cambogia, which had a major controversy last year.

Probiotics refers to live lactic acid bacteria that enter the human body and exert a beneficial effect on health. It makes the intestinal environment acidic and suppresses harmful bacteria. Lactobacillus, Bifidobacterium, Enterococcus, and Streptococcus are among the representative probiotics. In addition to digestion and bowel movements, it is known to be effective for immunological diseases such as atopy and allergies. As a result, the market has grown to 150 billion Korean won as well as pharmaceutical companies as well as food companies.

However, the side effects of probiotics were little known in Korea. Premature infants with poor immunity, the elderly, and those with severe illness can experience bacteremia by the probiotics intake. Bacteremia is the risk of organ damage and sepsis leading to bacterial infections in the bloodstream and worsening symptoms of circulation throughout the body. According to the MFDS, consumers often complained of abdominal pain, tickling, diarrhea after taking probiotics.

Garcinia cambogia is a tropical plant native to the southwestern part of India. The body contains a functional ingredient (HCA: hydroxycitric acid) that inhibits fat production and induces weight loss or increases secretion of serotonin in the brain. The Department of Medicine recognizes the body fat reduction function (grade 1 of physiological activity) of Garcinia cambogia bark extract and allows using a certain amount within the standard. As of 2015, 74 companies have launched 335 Garcinia cambogia extracts, with production of 27.6 billion Korean won in 2015. However, Garcinia cambogia extracts are known to cause liver damage.

The National Health and Medical Research Institute (NECA) analyzed 80 domestic and overseas research documents (42 clinical trials, post-war comparative studies, 38 case reports) to confirm the safety and efficacy of Garcinia cambogia extracts. According to the analysis, a total of 16 people, including one in Korea in 2004 and 2015, suffered from liver damage such as acute hepatitis, hepatic insufficiency, and heart disease such as acute myocarditis and cardiac tachycardia by eating a single product or a compound ingredient.

Source: SEAH bio

Ministry of Food and Drug Safety to Establish Food Type of 'Fish Oil' by Nikolaas Tilkin-Franssens

The Korea Ministry of Food and Drug Safety (MFDS) announced on the 29th that it will announce an amendment to the 'Food Specifications and Standards', which will include the establishment of food types and standards. 

MFDS has revised it to manage fish oil, which is increasingly circulated and consumed internationally.

The main contents are: △ new type of fish oil type, △ addition of 6 kinds of marine products and 4 kinds of microorganisms to the list of food ingredients △ new condition of use of large mockery (Baeksuo, Cynanchum wilfordii) △ improvement of preservation and distribution standards for fish meat products, Standards revision, and so on.

We have newly established a food type of 'fish oil', which is increasing in international circulation, and have established manufacturing and processing standards, acid value and peroxide value standards suitable for its characteristics. In July, the International Food Standards Committee (CODEX) has become a standard for fish oil, which is in accordance with international trends.

Six species of marine products such as hooked white squid and four kinds of microorganisms such as Acetobacter aceti have been added to the list of food ingredients.

As a result of the evaluation of the safety of the water extract as a result of the evaluation of the large mockery (Baeksuo, Cynanchum wilfordii) the standard was established to use only the water extract as the food raw material, and the bake or frying fish paste processed in the form of apron or snack has low moisture content, So that it can be circulated at room temperature.

Also, beverages, carbonated drinks and mixed drinks distributed at room temperature or in cold storage were allowed to be frozen and sold.

Reflecting the reality that it is difficult for consumers to comply with freezing temperatures (below -18 ° C) when delivering frozen food by courier, frozen products delivered by courier have been revised to preserve and preserve foodstuffs to keep them frozen.

In addition, the KFDA will introduce or amend the 75-species pesticide residues used for domestic use, such as delta-metrin, and the residual permissible standards for imported agricultural products, and apply the 6 pesticides, including chlorpyrifos, Residual acceptance criteria were newly established.

"We will continue to improve food safety in the future, and we will improve food standards in the direction of eliminating unnecessary regulations that are not related to safety."

Source: SEAH bio

Notice from Authority - "Cosmetics Act" Partial revision law (draft) Notice of legislation” by Nikolaas Tilkin-Franssens

In the amendment of the "Cosmetics Act", the public will be informed of the purpose and contents of the revision in accordance with Article 41 of the Administrative Procedure Act.

1. Reason for revision
The purpose of this amendment shall be to provide a basis for establishing the risk level and standards of the cosmetics to be recovered (hereinafter referred to as "Harmful Cosmetics") in violation of safety standards, and to provide cosmetics manufacturers and manufacturers and sellers (hereinafter referred to as "Business party" ), And to expand the scope of the government's recovery order, and to strengthen administrative efficiency and consumer protection by complementing and improving the lack of operations. 

2. Main contents
a. (Article 5-2, Paragraph 4, Article 23. (3)).
In order to easily and accurately inform the consumers about the degree of danger in the collection of the cosmetics, we establish the basis for determining the risk level and the classification standard of the cosmetics in the Prime Ministerial Order.
b. Provide basis for punishment when the cosmetics collection duty of the business party is not fulfilled. (Article 24, Paragraph 1, Item 6, Item 2, Article 38, Paragraph 1, Item 2)
If the business party does not fulfill the recovery order, there will be grounds for penalty and administrative disposition but there will be no grounds for penalty and administrative disposition in the case of the number of salespersons who have the same obligation to fulfill the government collection.
c. Extending the scope of the order to withdraw or withdraw the government (Article 23. (1)
In order to efficiently respond to the various harmful cosmetics, the scope of the current government withdrawal and abolition order is extended to the case where there is a risk of causing or causing harm to the public health in violation of other cosmetic laws and ordinances
d. Reduction of penalties for penalties in violation of price marking obligation (Article 38 (2), Article 40 (1) 5, Item 2)
In consideration of the degree of violation of the seller's price indication obligation and the equity of other laws such as the "Law on the stabilization of the price of goods", the existing penalties are reduced to fines
e. Clarification of notification procedures such as whether or not the notification of the closure is made (Article 6 (2) and (3) of Article 6)
It is expressly stipulated to notify the complainant whether or not the notification of the closure of the cosmetics manufacturing company and the manufacturer is to be repaired.
f. Establishing the basis for international cooperation on cosmetic safety and quality (Article 33-2)
Clarification of the legal basis for international cooperation efforts, such as the conclusion of agreements with exporting and importing countries for the safety and quality control of cosmetics

3. Submit feedback
A corporation or individual who has an opinion on some amendments to this "Cosmetics Act" may file an opinion online through the integrated legislative notice system ( by December 12, 2017 , Please fill out the written statement with the following information and submit it to the Director of the Food and Drug Administration (Address: (28159) 187, Osong Life 2, Osong-eup, Heungduk-gu, Cheongju, Chungbuk) Refer to the website of the Korean Agency for Safety of Medicine ( → Laws and documents → Legislative / Administrative Notice or the Food and Drug Safety Department's Cosmetics Policy Division (Tel: 043-719-3409, Fax: 043-719-3400) Please contact us.

a. Opinion by item on the notice of the legislature
b. Name (in the case of a corporation or group, the name of the corporation or the name of the corporation and its representative), address and telephone number
c. References

Source: SEAH bio

Notice from Authority - "Preliminary safety management system registration and management standard of imported food, etc." Some revision notice (plan) administrative notice by Nikolaas Tilkin-Franssens

In revising the "Guidelines for the Registration and Management of Prior Safety Management Systems such as Imported Foods" (No. 2016-15 of the Food and Drug Administration Notice, February 5, 2016), the purpose, The main contents are announced in accordance with Article 46 of the Administrative Procedure Act as follows.
1. Reason for revision
We intend to increase the efficiency of safety management for superior salespersons by enhancing preferential measures for superior salespersons and adding more targets to enhance superior salespersons, strengthening follow-up management and clarifying compliance with salespersons. 

2. Main contents
a. Change the notification name to match the contents of the notification.
b. Expansion of simple processed products (heating, freezing, aging) to eligible exports / exports to overseas manufacturing companies to alleviate registration application requirements. (Article 3)
c. Provide a letter of authorization for application for registration of overseas excellent manufacturing company. (Article 5)
d. If the overseas manufacturing company for registration of excellent importers complies with the registration criteria as a result of local inspection within one year from the application date, it is possible to omit the due diligence and register the priority. (Article 5)
e. If the exporting country government confirms that it complies with the registration standard at the time of application for renewal of good importer / overseas excellent manufacturing establishment, it shall be improved so as to renew the registration first. (Article 7)
f. It clearly stipulates the reporting standards of the self sanitation inspection result report. In other words, it shall be defined as within 30 days from the date of registration every year (Article 8).
g. Provide a basis for discontinuing the preferential treatment if it is determined that the local inspection result is not satisfactory. (Article 9)
h. To improve the registration of excellent importers and overseas excellent manufacturing companies, the design should be improved to be able to display designs on product packaging. (Article 10, star)

3. Submit feedback
Any organization or individual who has comments on the revised Notification of Annexes of the "Pre-Safety Management System for Imported Foods, etc." shall submit a written statement to the Director of the Food and Drug Administration (Postal Code: 28162, Address: Ohsong-eup, Osong-eup, Cheongju-city, Chungcheongbuk-do, Korea 187 Osong Healthcare Administration Town Food and Drug Administration, please refer to: Local Affairs Department, Fax 043-719-6200, Tel 043-719-6210) For more information, please refer to the website of the Korea Food and Drug Administration [( → Acts and documents → Legislative / Administrative notice].

a. Comments on the notice (whether it is cold or not and why)
b. Name (in the case of a group, the name of the group and its representative), address and telephone number
c. References

Source: SEAH bio

Notice from Authority - Notification of revision of medical device reexamination regulations by Nikolaas Tilkin-Franssens

1. Reason for revision
To reduce the re-examination period for newly developed medical devices, to clarify the procedures for re-examination, and to revise the final annual report by re-examination. 

2. Main contents
a. Reduction of re-examination period for newly developed medical devices (Article 3)
○ Track the re-examination period for newly developed medical devices Although the target medical devices are designated as 5 years, and the medical devices prescribed by the Food and Drug Safety Directorate are separately designated as 4 years, they are all reduced to 4 years to reduce the regulations.
b. Clarify related procedures such as application period, result notification, etc. (Article 4)
○ Clarify the procedure for re-examination by specifying the application period (within 3 months after the re-examination period) and the result notification procedure
○ Reasonable improvement of regulations by deleting unnecessary attachments when applying for re-examination
c. Improvement process of post-marketing surveillance plan data (Article 6)
○ If the post-marketing research institute does not comply with the relevant regulations, or if there is serious defects in the post-marketing survey plan, it is clear that the object of the supplement is subject to clearance.
d. Reasonable improvement of review method of annual report (Article 8)
○ The last annual report should be revised reasonably so that it will not be reported separately.
e. Survey on the status of post-marketing surveys adjustment of notification period (Article 9)
○ If additional seal is required for preparation of foreign source materials, the notification period will be adjusted so that the notification period can be extended (from 7 days to 14 days).
f. Clarification of preservation methods of documents and materials (Article 10)
○ The company clarified that the documents and materials related to the post marketing survey are stored in an electronic recording medium (CD, diskette, etc.) and can be kept.
g. Clarification of safety information reporting side effects (Article 11)
○ To clarify safety information such as adverse reactions that occur during post marketing surveillance, follow "Regulations on safety information management such as side effects of medical devices".

3. References
a. Relevant law: Article 8, Article 15, Article 6 of the "Medical Device Technique" and Article 18 (5), Article 34
b. Budget Action: No action required
c. Agreement: No agency
d. Others: (1) Administrative notice (from April 9, 2017 to May 25, 2017)
(2) Verification of regulatory examination target ('17 .8.4, not subject to regulatory examination)

Source: SEAH bio

Notice from Authority - Establishment of methods and standards for on-site inspection of overseas manufacturing facilities and overseas work sites by Nikolaas Tilkin-Franssens

1. Reason for Establishment
We intend to improve efficiency and equity by integrating and operating local inspection methods and standards that differentiate food and livestock products for the purpose of pre-safety management of imported food.

2. Main Contents
a. Establishment of hygiene standards for overseas manufactures and overseas workplaces (Article 4)
1) To ensure the safety of imported food, a detailed standard for each hygiene item is prepared.
b. Improvement of local inspection procedures (Article 5)
1) Specify the deadline for reply based on local action plan notification
c. Refine local survey methods and improve assessment items to meet hygiene standards (Article 6)
1) Identify the method of inspecting by local inspection (self, consignment / work place, etc.), and subdivide the evaluation items into sanitary standards
d. Establishment of measures based on criteria and results of assessment on site assessment (Articles 7 and 8)
1) Determine criteria for each score and prepare a method for determining important items
2) Identification of measures according to evaluation results
3) The time limit should be specified in detail if necessary to improve the results of on-site inspection
e. Other matters that require local inspection standards (Article 9 ~ Article 11)
1) Recognition of mutual consultation between countries on due diligence procedures, methods and evaluation
2) Sanitary inspection standards and cycle of OEMs
3) Specification of the submitted data when reporting the results of on-site inspection by the sanitary evaluation agency

3. References
a. Related Laws: Special Act on Imported Food Safety Management
b. Budget Action: No action required
c. Agreement: Not applicable
d. etc

(1) Administrative notice
Announcement No. 2017-340, September 18, 2017 (September 27, 2017 ~ December 20, 2017)
(2) Regulatory review
a) Whether or not the regulatory examination will be conducted by the Office of State Coordination: 2017-2705 (Regulation, September 29, 2017)
b) Self-regulatory review by the Food Ministry (Oct. 18, 2017)
c) Office of the State Planning and Regulatory Commission Regulatory Review: No. 2017-494 (Non-critical, October 30, 2017)

Source: SEAH bio