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Differential Registration Scheme for Foreign Food Facility in South Korea: Acceptable Doc & FAQs

MFDS introduces differential registration scheme for overseas facilities of the risky imported food. This article introduces the scope of allowable foreign certificates and FAQs about the new facility registration system.

South Korea adopts mandatory registration of overseas food factories. However, South Korea requires only the basic information about the facility for registration. The continuous increase in import amounts and the high incidence of nonconformities of certain items have necessitated a change in the management system for imported foods. Therefore, as revealed by the Ministry of Food and Drug Safety (MFDS) on February 28, 2023, a new differential registration scheme1 (해외제조업소 차등 등록제) for foreign food facilities manufacturing foods with potential risks was newly introduced. The importers are required to submit safety certificates such as HACCP, GMP, ISO22000, etc., when registering the foreign food facilities. This new scheme aims to intensify the safety control of imported foods throughout the entire manufacturing procedure. 

1. Imported foods whose facility needs to be differentially registered

Overseas facilities of health functional food are firstly designated to follow the new registration scheme. The trial period will be from April 1 to October 31, 2023. The authority plans to compulsorily implement the differential registration to facilities of health functional food facility in 2024, and to facilities of processed agricultural food and seasoning foods in 2025.    

2. Scope of allowable certificates

MFDS introduced 7 kinds of safety certificates in the guideline2 of differential registration for foreign food facility. The scope of allowable certificates covers ISO 22000, HACCP, GMP, FSSC 22000, BRC Food, SQF, and IFS Food.

2.1 ISO 22000

Name

ISO 22000

Mark

1-iso-22000.jpg

Organization

ISO (International Organization for   Standardization)

Period of validity

3 years

Website

www.iso.org

ISO 22000 adopts all 7 principles and 12 procedures of HACCP based on ISO 9001 (Quality Management System) to ensure food safety throughout the food supply chain. ISO 22000 sets out the requirements for a food safety management system. Enterprises intending to obtain the ISO 22000 certificate shall apply with ISO and have the facility certified to ISO requirements.

Examples of ISO 22000 certifications:

1examples-of-iso-22000-certifications.jpg

India                                           China                                               Italy                                      Thailand

2.2 HACCP

Name

HACCP CERTIFICATE

Mark

Depending on the regulation in each   country

Organization

Depending on the   regulation in each country

Period of validity

Depending on the regulation in each   country

Hazard Analysis Critical Control Points (HACCP) ensures food safety by identifying and evaluating the hazards in the processes of food manufacturing, processing, cooking, portioning, and distribution to prevent the mixing of hazardous substances and/or contamination into foods.

HACCP is mandatory for fishery foods, canned foods, and some other specific foods in some country. In China, HACCP is conducted by organizations designated by Certification and Accreditation Administration of China (CNCA). There are also countries adopting HACCP as a voluntary certificate.

Examples of HACCP certifications:

2-examples-of-haccp-certifications.jpg

      China                                      Vietnam                                         Italy                                         Paraguay

2.3 GMP

Name

GMP certificate

Mark

Depending on the regulation in each   country

Organization

Depending on the regulation in each   country

Period of validity

Depending on the regulation in each   country

Good Manufacturing Practice (GMP) is a certification that ensures the safety and efficacy of food and drugs. In most countries, foods of specific categories such as health supplements are subject to GMP compulsorily. In the United States and Japan, food containing specified ingredients need to go through an inspection via private organizations. 

Examples of HACCP certifications:

3-examples-of-haccp-certifications.jpg

         India                                      the United States                                  German                                   Japan       

2.4. FSSC

Name

FSSC 22000 Certificate

Mark

4-fssc.jpg

Organization

Foundation for FSSC

Period of validity

3 years

Website

www.fssc22000.com

The FSSC (Food Safety System Certification) 22000 scheme contains a complete certification scheme for food safety management systems, using international and independent standards such as ISO 22000, ISO 9001, ISO/TS 22003, and technical specifications for sector-specific Pre-Requisite Programs (PRPs), including ISO/TS 22002-1.

Examples of FSSC 22000 certifications:

4-examples-of-fssc-22000-certifications.jpg  Argentina                                Turkey                                   England                                      Japan

2.5 BRC Food

Name

BRCGS   (previously known as BRC)

Mark  

5 BRC Food.jpg

Organization

BRCGS

Period   of validity

6   months/ 12 months

Website

www.brcgs.com

BRC Food, or BRC GS (Global Standards), refer to global standard food safety certifications for food safety, packaging materials, storage and distribution, consumer products, retail, gluten-free, plant-based and ethical trade, and more. The certifications are issued through the authorities approved by BRCGS in each country.

Examples of BRC Food certifications:

5-examples-of-brc-food-certifications-1.jpg

              Vietnam                                      Italy                                        Thailand      

2.6 SQF

Name

Safety quality food

Mark

6 SQF.jpg

Organization

SQFI

Period of validity

6 months/ 12months

Website

www.sqfi.com

Safe Quality Food (SQF) certifies the food quality risk and food safety management with a focus on HACCP. Enterprises can obtain the SQF certification through a certification body that is accredited to the international standard ISO/IEC 17065:2012 and recognized by the Safe Quality Food Institute. 

Examples of SQF certifications:

6examples-of-sqf-certifications.jpg

The United States                                         Australia       

2.7 IFS Food

Name

IFS certificate

Mark

7 IFS Food.jpg

Organization

IFS

Period of validity

1 year

Website

www.ifs-certification.com

The IFS (International Featured Standards) Food Standard reviews the products and production processes to evaluate food producer’s ability to produce safe, authentic, and high-quality products according to legal requirements and customer specifications.

Examples of IFS Food certifications:

7-examples-of-ifs-food-certifications.jpg

                  Portugal                                        Swiss                                              Italy                                    India                     

3. Certification Submission Methods

Enterprises whose products are subject to the differential registration scheme can submit the safety certificates via MFDS imported food portal (https://impfood.mfds.go.kr) following the below steps:

(1)    After logging in the website, applicant can click 전자민원(online service)” and “전자민원 바로가기(go to online service)” to access the registration webpage. mfds-imported-food-portal-1.jpg

(2)    Select the corresponding registration type to submit the certificate.

For un-registered facilities, choose “해외제조업등록신청(No. 1) (Application for registration of the foreign food facility)”. For registered facilities, choose “해외제조업변경등록신청(No. 2) (Application for changing registration of the foreign food facility)”. As for facilities whose registration expired applicant shall select “해외제조업갱신등록신청(No. 3) (Application for reviewing registration of the foreign food facility)”. 

mfds-imported-food-portal-2.jpg

(3) The safety certificates are submitted via “영업정보 business information column”. Select the relevant certificate type and update the certificate file.

mfds-imported-food-portal-3.jpg

mfds-imported-food-portal-3-1.jpg

(4) The application result can be confirmed by entering the “전자민원 진행상황 (confirmation of application)” under the “전자민원(online service)”

mfds-imported-food-portal-5.jpg

 4. Frequently Asked Questions

As published by MFDS in the guideline2, Frequently Asked Questions (FAQs) cover the new scheme, certificate submission methods, and the answers are as the follows.

Q1. Which product’s facility shall register under the new scheme?

A. The pilot will start with high-risk health functional foods, and will gradually mandate additional items.

Q2. What are the criteria for selecting potentially risky products?

A. Products with potential risk were selected by weighting non-compliance records in the Customs and distribution steps, global risk information (physical, chemical, and biological), and import volume from 2017 to 2021.

Q3. During the pilot period, can I register my overseas facility without submitting a certificate?

A. During the pilot period, it is possible to register as an overseas manufacturer without submitting a certificate. However, it’s worth noting that the differential registration scheme will be mandatory after the pilot program in 2024. At that time, no submission of safety certificate will lead to the failure of foreign food facility registration for the specific imported food items. 

Q4. Is OEM subject to new risk management scheme, too?

A. Regardless of product type, import conditions, etc., all overseas manufacturers of health functional foods are subject to the risky food safety management and shall submit the safety certificate.

Q5. If I have several certificates, do I need to submit them all?

A. The authority accepts the submission of more than one safety certificates. However, submitting the certificate with the longest remaining period of validity is recommended.

Q6. Is a registered health functional food facility subject to new registration scheme?

A. For a register facility without submitting the safety certificate, it is recommend to submit a food safety management certificate when applying for the change or renewal of the foreign food facility registration.

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