신청 방법 매뉴얼

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신청 방법 매뉴얼

Manual on Import Tolerances Application

식품의약품안전처

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What is an Import tolerance(IT)?

Step-by-step guide to apply on website Petition Type 1 Petition Type 2 Petition Type 3 Petition Type 4 How to pay service fees

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목 차

수입식품 잔류허용기준 (Import tolerance)이란?

단계별 신청 순서 신청유형 1 신청유형 2 신청유형 3 신청유형 4 수수료 결제 방법

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국내 잔류허용기준이 설정되어 있지 않으나 수출국에서 농약을 합법적으로 사용한 식품에 대해 안전성을 평가하고, 인체 건강에 위해 우려가 없는 경우 농약 잔류허용기준을 설정하는 제도

수입식품 잔류허용기준(Import tolerance)이란?

An IT is a Maximum residue limit(MRL) for a pesticide for which there is no MRL set in Korea but it is legally allowed to be used in or on food in exporting countries. An import tolerance is set when results of safety assessment on the food for which the pesticide was used indicate that there is no concern for risk to human health.

What is an Import tolerance(IT)?

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6 7 Manual on Import Tolerances Application

Relevant laws and regulations

· Article 7-3 of the Food Sanitation Act (Request for establishment of MRLs of pesticides, etc. in food)

· Article 5-2 of the Enforcement Regulation of the food Sanitation Act (Establishment of MRLs of pesticides or veterinary drugs in food) and Article 5-3 of the same regulation (Revision of MRLs, etc.)

· Korean Food Code (Attachment 6): Guidelines on the establishment of MRLs of pesticides and veterinary drugs in food

•식품위생법 제7조의3(농약 등의 잔류허용기준 설정 요청)

• 식품위생법 시행규칙 제5조의2(농약 또는 동물용의약품 잔류허용기준의 설정), 제5조의3 (잔류허용기준의 변경 등)

•식품공전[별표6] 식품 중 농약 및 동물용의약품 잔류허용기준 설정 지침

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① 식품에 잔류하는 「농약관리법」에 따른 농약, 「약사법」에 따른 동물용 의약품의 잔류허용기준 설정이 필요한 자는 식품의약품안전처장에게 신청하여야 한다.

② 수입식품에 대한 농약 및 동물용 의약품의 잔류허용기준 설정을 원하는 자는 식품의약품안전처장에게 관련 자료를 제출하여 기준 설정을 요청할 수 있다.

③ 식품의약품안전처장은 제1항의 신청에 따라 잔류허용기준을 설정하는 경우 관계 행정기관의 장에게 자료제공 등의 협조를 요청할 수 있다. 이 경우 요청을 받은 관계 행정기관의 장은 특별한 사유가 없으면 이에 따라야 한다.

④ 제1항 및 제2항에 따른 신청 절차·방법 및 자료제출의 범위 등 세부사항은 총리령으로 정한다.

제7조의3(농약 등의 잔류허용기준 설정 요청 등) Article 7-3 : Request for establishment of MRLs of pesticides, etc. in food

① Any person who needs the establishment of residue limit standards of pesticides under the Pesticide Control Act that remain on or in food, or veterinary drugs under the Pharmaceutical Affairs Act shall file an application with the Minister of Food and Drug Safety.

② Any person who intends to establish residue limit standards of pesticides on imported food and veterinary drugs may request the Minister of Food and Drug Safety to establish such standards by submitting related data.

③ Where the Minister of Food and Drug Safety establishes residue limit standards in accordance with a request under paragraph (1), he/she may request the heads of related administrative agencies to provide cooperation, such as the provision of data. In such cases, the heads of related administrative agencies who have received a request shall comply therewith unless extenuating circumstances exist.

④ Detailed matters concerning procedures and methods for filing an application, the scope of data to be submitted, etc. under paragraphs (1) and (2) shall be prescribed by Ordinance of the Prime Minister.

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10 11 Manual on Import Tolerances Application

① Those applying for the establishment of maximum residue limits (hereinafter "MRLs") in food according to paragraph 1, article 7-3 of the act should submit the attached application form 1 (electronic application form included) to the Minister of Food and Drug Safety.

② Those requesting for the establishment of MRLs in imported food according to Paragraph 2, Article 7-3 of the act should submit the attached request form 1-2 (electronic application form included) along with the following materials (electronic documents included) to the Minister of Food and Drug Safety.

1. Data on the toxicity of pesticide(s) or veterinary drug(s) and summary of the data 2. Data on the residues of pesticide(s) or veterinary drug(s) in food and summary of the data 3. Reference materials on MRLs set by the Codex Alimentarius Commission and their establishment 4. Reference materials on MRLs in exporting countries and their establishment

5. Reference standards of pesticides or veterinary drugs in exporting countries

③ The Minister of Food and Drug Safety may establish MRLs when the application or request in the above paragraphs 1 or 2 is deemed appropriate, and should notify the applicant or requesting party as soon as a decision is made regarding the establishment of MRLs using the attached form 1-3

Article 5-2 : Establishment of MRLs of pesticides or veterinary drugs in food

① 식품에 대하여 법 제7조의3제1항에 따라 농약 또는 동물용 의약품 잔류허용기준(이하 “잔류허용기준”이라 한다)의 설정을 신청하려는 자는 별지 제1호 서식의 설정 신청서(전자문서로 된 신청서를 포함한다)를 식품의약품안전처장에게 제출하여야 한다.

② 법 제7조의3제2항에 따라 수입식품에 대한 잔류허용기준의 설정을 요청하려는 자는 별지 제1호의2서식의 설정 요청서(전자문서로 된 요청서를 포함한다)에 다음 각 호의 자료(전자문서를 포함한다)를 첨부하여 식품의약품안전처장에게 제출하여야 한다.

1. 농약 또는 동물용 의약품의 독성에 관한 자료와 그 요약서 2. 농약 또는 동물용 의약품의 식품 잔류에 관한 자료와 그 요약서

3. 국제식품규격위원회의 잔류허용기준에 관한 자료와 잔류허용기준의 설정에 관한 자료 4. 수출국의 잔류허용기준에 관한 자료와 잔류허용기준의 설정에 관한 자료

5. 수출국의 농약 또는 동물용 의약품의 표준품

③ 식품의약품안전처장은 제1항에 따른 신청이나 제2항에 따른 요청 내용이 타당한 경우에는 잔류허용기준을 설정할 수 있으며, 잔류허용기준 설정 여부가 결정되면 지체 없이 그 사실을 별지 제1호의3서식에 따라 신청인 또는 요청인에게 통보하여야 한다.

제5조의2(농약 또는 동물용 의약품 잔류허용기준의 설정)

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Article 5-3 : Revision of MRLs, etc.

① In the case those granted with MRLs according to Paragraph 1or 2, article 5-2, need a revision, they should submit the attached application form 1 or request form 1-2 to the Minister of Food and Drug safety.

② Those who wanting to receive confirmation on the lack of necessity to establish MRLs, instead of applying or requesting for establishment of MRLs according to Paragraph 1 or 2, article 5-2, should submit the application form 1 or request form 1-2 for exemption for the establishment of MRLs to the Minister of Food and Drug Safety.

③ Paragraph 3, article 5-2 shall be complied with regarding the revision of MRLs, exemption from establishment of MRLs and relevant notifications.

※ For guidelines on the establishment of MRLs of pesticides and veterinary drugs in food in the Korean Food Code (Attachment 6), please refer to the English version of the Korean Food Code.

① 제5조의2제1항 또는 제2항에 따라 잔류허용기준의 설정을 받은 자가 그 기준을 변경할 필요가 있는 경우에는 별지 제1호서식의 변경 신청서 또는 별지 제1호의2서식의 변경 요청서를 식품의약품안전처장에게 제출하여야 한다.

② 제5조의2제1항 또는 제2항에 따라 잔류허용기준 설정을 신청 또는 요청하는 대신 잔류허용기준을 설정할 필요가 없음을 확인 받으려는 자는 별지 제1호서식의 설정면제 신청서 또는 별지 제1호의2서식의 설정면제요청서를 식품의약품안전처장에게 제출하여야 한다.

③ 잔류허용기준의 변경·설정면제 및 통보에 관하여는 제5조의2제3항을 준용한다.

※ 식품공전 [별표 6] 식품 중 농약 및 동물용의약품 잔류허용기준 설정 지침은 식품공전 영문 번역본 참고

제5조의3(잔류허용기준의 변경 등)

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Step-by-step guide to apply on website

단계별 신청순서

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Step 1.식품안전정보포탈 홈페이지(www.foodsafetykorea.go.kr)

접속후[통합민원상담서비스]선택

(*로그인계정필요)

“통합민원상담서비스”클릭 로그인

Integrated Civil Service

Data Service Company Safety Management Service

Corperate Membership

Individual Membership

Step 1. Access the homepage of Food Safety Korea

(www.foodsafetykorea.go.kr) and click [Integrated Civil Service]

(*Log-in required.)

Click “Integrated Civil Service” Log-in

Integrated Civil Service

Data Service Company Safety Management Service

Corperate Membership Individual Membership

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18 19 Manual on Import Tolerances Application

User Guide

Step 2.통합민원상담서비스창에서[전자민원]선택

① “전자민원” 클릭 ② “전자 민원 신청” 클릭

❶

❷

Consultation Center Adulterated Food Report Report on Side Effects of Health Functional Foods

Step 2. Click [E-Civil Service] on the Integrated Civil Service Window

① Click “E-Civil Service” ② Click “E-Civil Service Request”

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❷

Consultation Center Adulterated Food Report Report on Side Effects of Health Functional Foods User Guide

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Step 3.전자민원신청에서민원검색창에“농약”을입력후검색버튼을클릭

❶

^농약

❷

^{“검색” 클릭}

Step 3. Click 'Search' after entering 'Pesticides' into the Civil Petition Section in 'E-Civil Service Request'.

❶

Pesticides

❷

Click 'Search'

E-Civil Request

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22 23 Manual on Import Tolerances Application

Step 4.검색결과,“농약”에관련된민원중에,원하는유형의민원을선택

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❷

❸

❹

Step 4 . Select one out of the given pesticide related civil petitions.

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❷

❸

❹

Request for the establishment of import tolerances (toxicity data review) Request for the establishment of import tolerances (residue data review)

Request for the revision of or exemption from the requirements of import tolerances(toxicity data review) Request for the revision of or exemption from the requirements of import tolerances(pesticide residue data review)

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Check point !!

① Request for the establishment of import tolerances (toxicity data review) Service fee: ₩ 30,000,000(Processing time: 12 months)

② Request for the establishment of import tolerances (residue data review) Service fee: ₩ 5,000,000(Processing time: 12 months)

③ Request for the revision of or exemption from the requirements of import tolerances (toxicity data review)

Service fee: ₩ 10,000,000(Processing time: 7 months)

④ Request for the revision of or exemption from the requirements of import tolerances (pesticide residue data review)

Service fee: ₩ 5,000,000(Processing time: 7 months)

[Type of petition]

확인해주세요!!

[신청유형]

① 수입식품 중 농약 및 동물용의약품의 잔류허용기준 설정 요청(독성자료 검토) 수수료: 30,000,000원 (처리기간 : 12개월)

② 수입식품 중 농약 및 동물용의약품의 잔류허용기준 설정 요청(잔류자료 검토) 수수료: 5,000,000원 (처리기간 : 12개월)

③ 수입식품 중 농약 및 동물용의약품의 잔류허용기준 변경 또는 설정면제 요청 (독성자료검토)

수수료: 10,000,000원 (처리기간 : 7개월)

④ 수입식품 중 농약 및 동물용의약품의 잔류허용기준 변경 또는 설정면제 요청 (농약잔류자료 검토)

수수료: 5,000,000원 (처리기간 : 7개월)

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Petition Type 1

Request for the Establishment of Import tolerances

(Toxicity data review)

신청유형 1

수입식품 중 농약 및 동물용의약품의 잔류허용기준 설정 요청

(독성자료 검토)

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Step 5. 수입식품 중 농약 및 동물용의약품의 잔류허용기준설정 요청

(독성자료 검토) 선택 후

“확인”선택

1 2

3

- 유해물질기준과 선택 후 신청 - 확인 팝업이 뜨면, 확인 클릭

Step 5. After selecting ‘Request for the establishment of import tolerances (toxicity data review)’

- Make a request after choosing ‘Residues and Contaminants standard Division’

- Click [ok]

① Select ‘Residues and Contaminants Standard Division’

② Then, click [Request]

③ Click [OK]

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3

Request for the establishment of import tolerances (toxicity data review)

(Residues and Contaminants standard Division, Food Standard Planning Office, Food Policy Bureau,

Ministry of Food and Drug Safety) Request

E-Civil Service Request List

Will you make an E-Civil Service Request to selected division?

OK Cancel

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Step 6-1. 신청인정보 입력

- 신청자 휴대전호 및 e메일로 결과를 통보할 예정임

신청자 정보 입력

성명

신청자 메모

핸드폰 전화번호

E-mail

SNS 사용여부 수수료 확인

※ 신청 수에 따라 자동변경

결과통보방법

30,000,000

Step 6-1. Registrant Information Entry

- Notification of results will be made through mobile phones or e-mail.

Registrant Information Entry

Name

Registrant’s memo

Mobile phone E-mail

Use of SMS : Yes or No Service fees

※ These are expected to automatically change, depending on the number of requests.

How to send results (Via web; visit; mail) Civil petition receipt and registration

Registrant information

Manual on Import Tolerances Application

30,000,000

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Step 6-2. 기본정보 입력

^{농약/동물용의약품}

선택

회사명

주소1

농약 성분명 식품명

주소2

①

②

신청 대상

화합물명/식품명입력 식품 수 입력

※신청 수에 따라 수수료 자동 변경 주소입력

동물용의약품

Step 6-2. Enter basic data

Select ①’pesticide’ or

②’veterinary drug’

Pesticide and veterinary drug residue tolerance setting and management

Company Name

Address 1

Chemical Commodities

Address 2

①

② ^{동물용의약품}

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Step 7. 첨부서류 확인 및 파일첨부 후 [신청] 버튼 클릭

1

^{“첨부서류”클릭} ^{“신청”클릭}

※ 업로드한 구비서류 다운 시 파일명을 더블클릭

※ 해당 구비서류 선택 후 파일첨부

Required documents

2 3

“파일첨부”클릭

Step 7. Click [Request] after checking documents and attaching files

1

Click “Attached Documents”

1. Data on the toxicity of pesticides or veterinary drugs their summary(2 copies)

2. Data on the residues of pesticides or veterinary drugs in food and their summary(2 copies) 3. Data on the Codex Alimentarius Commission’s tolerances and their establishment

4. Data on the exporter’s tolerances and their establishment 5. Standards pesticide or veterinary drugs in exporting countries

※ Please select the required document and then attach the file.

※ Please double-click the file name when downloading uploaded documents.

Required documents

2

Click “Attach the file”

Click “Request”

3 Manual on Import Tolerances Application

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Would you like to complete?

“확인”클릭

그 외 모든 자료를 CD등 전자매체와 2부의 복사본으로 유해물질기준과에 보내주세요. 그 후 “수수료 결제”창에서 수수료를 결제해 주세요

Click [OK]

Please send the other data (via e-media such as CD) with two copies to the Residues and Contaminants Standard Division.

You may then move to ‘service fee payment’.

You must pay the fee ( 30,000,000) of this Civil Service Request.

(Request for the establishment of import tolerances (toxicity data review)) Then your application will be finally completed.

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Petition Type 2

Request for the Establishment of Import tolerances

(Residue data review)

신청유형 2

수입식품 중 농약 및 동물용의약품의 잔류허용기준 설정 요청

(잔류자료 검토)

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Step 5. 수입식품 중 농약 및 동물용의약품의 잔류허용기준설정 요청

(잔류자료 검토) 선택 후

“확인”선택

1 2

3

(잔류자료검토)

Step 5. After selecting ‘Request for the establishment of import tolerances (residue data review)’

- Make a request after choosing ‘Residues and Contaminants standard Division’

- Click [ok]

① Select ‘Residues and Contaminants Standard Division’

② Then, click [Request]

③ Click [OK]

1 2

3

Request for the establishment of import tolerances (residue data review)

E-Civil Service Request List

OK Cancel

(잔류자료검토)

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Step 6-1. 신청인정보 입력

신청자 정보 입력

성명

신청자 메모

E-mail

결과통보방법

Step 6-1. Registrant Information Entry

- Notification of results will be made through mobile phones or e-mail.

Registrant Information Entry

Name

Registrant’s memo

Mobile phone E-mail

Manual on Import Tolerances Application

42 42 43

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Step 6-2. 기본정보 입력

선택

회사명

주소1

주소2

①

②

신청 대상

동물용의약품

Step 6-2. Enter basic data

Select ①’pesticide’ or

②’veterinary drug’

Company Name

Address 1

Address 2

①

② ^{동물용의약품}

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Step 7. 첨부서류 확인 및 파일첨부 후 [신청] 버튼 클릭

1

“첨부서류”클릭 “신청”클릭

Required documents

2 3

Manual on Import Tolerances Application

Step 7. Click [Request] after checking documents and attaching files

1 1. Data on the toxicity of pesticides or veterinary drugs their summary(2 copies)

2. Data on the residues of pesticides or veterinary drugs in food and their summary(2 copies) 3. Data on the Codex Alimentarius Commission’s tolerances and their establishment

4. Data on the exporter’s tolerances and their establishment 5. Standards pesticide or veterinary drugs in exporting countries

Required documents

2

Click “Request”

3

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“확인”클릭

Click [OK]

(Request for the establishment of import tolerances (residue data review)) Then your application will be finally completed.

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Petition Type 3

Request for the Revision of or

Exemption from the Requirements of Import tolerances

(Toxicity data review)

신청유형 3

수입식품 중 농약 및 동물용의약품의 잔류

허용기준 변경 또는 설정면제 요청

(27)

Step 5. 수입식품 중 농약 및 동물용의약품의 잔류허용기준설정

변경 또는 설정면제 요청(독성자료 검토) 선택 후

“확인”선택

1 2

3

변경 또는 설정 면제 요청(독성자료검토)

Step 5. After selecting ‘Request for the revision of or exemption from the requirements of import tolerances(toxicity data review)

- Make a request after choosing ‘Residues and Contaminants standard Division’

- Click [ok]

① Select ‘Residues and Contaminants Standard Division’

② Then, click [Request]

③ Click [OK]

1 2

3 E-Civil Service Request List

OK Cancel

변경 또는 설정 면제 요청(독성자료검토)

52

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Step 6-1. 신청인정보 입력

신청자 정보 입력

성명

신청자 메모

E-mail

결과통보방법

10,000,000

Step 6-1. Registrant Information Entry

- Notification of results will be made through mobile phones or e-mail.

Registrant Information Entry

Name

Registrant’s memo

Mobile phone E-mail

Manual on Import Tolerances Application

10,000,000

54 54 55

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Step 6-2. 기본정보 입력

선택

회사명

주소1

주소2

①

②

①

②

변경/면제 선택

신청 대상

동물용의약품

Step 6-2. Enter basic data

Select ‘①pesticide’ or

‘②veterinary drug’

Select ①'revision’ or Select

Enter the name of the

target chemical / commodities (food)

Enter the number of food items

※ Depending on the number of food items, service fees will automatically change.

Enter ’address’

Company Name

Address 1

Address 2

①

②

①

②

동물용의약품

56

(30)

Step 7. 첨부서류 확인 및 파일첨부 후 [신청] 버튼 클릭

1

Required documents

2 3

Manual on Import Tolerances Application

Step 7. Click [Request] after checking documents and attaching files

1 1. Data on the toxicity of pesticides or veterinary drugs their summary(2 copies)

2. Data on the residues of pesticides or veterinary drugs in food and their summary(2 copies) 3. Data on the Codex Alimentarius Commission’s tolerances and their establishment

4. Data on the exporter’s tolerances and their establishment 5. Standards pesticide or veterinary drugs in exporting countries

Required documents

2

Click “Request”

3

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“확인”클릭

Click [OK]

Request for the revision of or exemption from the requirements of import tolerances (toxicity data review)) Then your application will be finally completed.

60

(32)

Petition Type 4

Request for the Revision of or

Exemption from the Requirements of Import tolerances

(Pesticide residue data review)

신청유형 4

수입식품 중 농약 및 동물용의약품의 잔류 허용기준 변경 또는 설정면제 요청

(농약잔류자료 검토)

(33)

Step 5. 수입식품 중 농약 및 동물용의약품의 잔류허용기준 변경 또는

설정면제 요청(농약잔류자료검토) 선택 후

“확인”선택

1 2

3

변경 또는 설정 면제 요청(농약잔류자료검토)

변경 또는 요청하는 민원사무입니다.

Step 5. After selecting ‘Request for the revision of or exemption import tolerances (pesticide residue data review)’

- Make a request after choosing ‘Residues and Contaminants standard Division’

- Click [ok]

① Select ‘Residues and Contaminants Standard Division’

② Then, click [Request]

③ Click [OK]

1 2

3 E-Civil Service Request List

OK Cancel

변경 또는 설정 면제 요청(농약잔류자료검토)

변경 또는 요청하는 민원사무입니다.

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Step 6-1. 신청인정보 입력

신청자 정보 입력

성명

신청자 메모

E-mail

결과통보방법

Manual on Import Tolerances Application

Step 6-1. Registrant Information Entry

- Notification of results will be made through mobile phones or e-mail.

Registrant Information Entry

Name

Registrant’s memo

Mobile phone E-mail

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Step 6-2. 기본정보 입력

선택

회사명

주소1

주소2

①

②

①

②

변경/면제 선택

신청 대상

동물용의약품

Step 6-2. Enter basic data

Select ①'pesticide‘ or

‘②veterinary drug‘

Select ①‘revision’ or Select

Enter the name of the

target chemical / commodities (food)

Enter the number of food items

※ Depending on the number of food items, service fees will automatically change.

Enter ’address’

Company Name

Address 1

Address 2

①

②

①

②

동물용의약품

68

(36)

Step 7. 첨부서류 확인 및 파일첨부 후 [신청] 버튼 클릭

1

Required documents

2 3

Manual on Import Tolerances Application

Step 7. Click [Request] after checking documents and attaching files

1 1. Data on the toxicity of pesticides or veterinary drugs their summary(2 copies)

2. Data on the residues of pesticides or veterinary drugs in food and their summary(2 copies) 3. Data on the Codex Alimentarius Commission’s tolerances and their establishment

4. Data on the exporter’s tolerances and their establishment 5. Standards pesticide or veterinary drugs in exporting countries

Required documents

2

Click “Request”

3

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“확인”클릭

변경 또는 설정면제 요청(잔류자료검토))은 수수료(5000000원)

Click [OK]

You must pay the fee ( 5,000,000) of this Civil Service Request. (Request for the revision of or exemption from the requirements of import tolerances (pesticide residue data review)) Then your application will be finally completed.

변경 또는 설정면제 요청(잔류자료검토))은 수수료(5000000원)

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How to pay service fees

수수료 결제 방법

(39)

1

2 Step 8. 수수료 결제

[전자민원] 페이지에서 [나의 민원] 탭 선택 후 민원을 골라서

[수수료결제] 버튼 클릭

Step 8. Service Fee Payment

Choose the requested petition after clicking [My Petition] or [E-Civil Service] and then click [service Fee Payment].

My Petition

Service Fee Payment In progress

Request for the establishment of import tolerances(residue data review) Residue s and Contaminants Standard Division, Food Standard planning Office, Food Safety Policy Bureau, Ministry of Food and Drug Safety

1

2

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내용확인후 [수수료납부] 버튼 클릭

결제수단 선택 후 [결제진행] 버튼 클릭

Civil Petition;

Credit Card; Account Transfer;

Regisirant; Request Date; Payment Amount(KRW) How to pay

Payment

1 2 3

Check details and click [service fee payment]

Select ‘how to pay’ and click [payment]

Payment number

Civil Petition;

Credit Card; Account Transfer;

Regisirant; Request Date; Payment Amount(KRW) How to pay

Payment

Payment Date Receiving Agency Payment Amount(KRW) How to pay

Service Fee Payment Classification

1 2 3

Manual on Import Tolerances Application

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신용카드 납부 Credit Card

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계좌이체

내용 입력 후 결제

수수료 지불은 은행을 통한 계좌이체로도 가능하며, 이 경우 담당부서로 연락하여 주세요.(유해물질기준과, ☎ 043-719-3867, eomjy1979@korea.kr)

Account Transfer

Enter necessary information and pay service fees

Payment of fees can also be made through bank account transfers. In this case, please contact the division in charge of relevant affairs.

(Residues and Contaminants Standard Division, ☎ 043-719-3867, eomjy1979@korea.kr)

Manual on Import Tolerances Application

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신청 방법 매뉴얼