MRL re-evaluation_&_guidelines_on_mrls_of_pesticides_and_veterinary_drugs_in_food

MRLs ReMRLs Re--evaluation & Guidelines on MRLs evaluation & Guidelines on MRLs

of Pesticides and Veterinary Drugs in Food of Pesticides and Veterinary Drugs in Food

Korea Food & Drug Administration

2011.10.28

Food Standards Division

Perspectives on Food Safety RiskCONTENTSCONTENTS

Guidelines on MRLs of Pesticides and Veterinary Guidelines on MRLs of Pesticides and Veterinary Drugs in Food Drugs in Food 2

Maximum Residue Limits(MRLs) ReMaximum Residue Limits(MRLs) Re--evaluation evaluation and the Managementand the Management11

Guidelines on MRLs of Pesticides and Veterinary Guidelines on MRLs of Pesticides and Veterinary Drugs in Food Drugs in Food 2

Revision and Establishment of Pesticides MRLs Revision and Establishment of Pesticides MRLs 3

Questions and Answers for the GuidelinesQuestions and Answers for the Guidelines4

MRLs Re-evaluation and the Management

• Pesticides that are not registered domestically

• Agricultural products that are not registered forregistered pesticides

• Re-evaluation• Deletion ofpesticides

• Deletion of MRLs

Collection of comments

• Pesticides that are not registered domestically

• Agricultural products that are not registered forregistered pesticides

Deletion ofpesticides that are notregistered domestically

Deletion ofpesticides that are notregistered domestically

Deletion ofagricultural products that are not registered

Deletion ofagricultural products that are not registered

Adoption of MRLs for imported

food

Adoption of MRLs for imported

food

exemptionlists

exemptionlists

<Positive List System (2014)>

Notice No. 2010-294 of the KFDA(December 31, 2010)- SPS 383

• Re-evaluation of pesticides MRLs for individualagricultural products of adopted pesticides withoutscientific evidence in the past

• Pesticides not to be detected because they are notused or registered domestically

MRLs Re-evaluation and the Management

• Re-evaluation of pesticides MRLs for individualagricultural products of adopted pesticides withoutscientific evidence in the past

• Pesticides not to be detected because they are notused or registered domestically

There are pesticides and MRLs to be deleted forforeign countries to prepare for a period of time (inthe attachment 1).

Guidelines on MRLs of Pesticides and Veterinary Drugs in Food Notice No. 2011-159 of the KFDA(August 19, 2011)

Attachment to Foods Import Report

To clarify procedures of establishmentstablishment ofof MRLs, and

to improve scientific transparency and predictability

in establishmentstablishment ofof MRLs to related companies.

(attachment 2) (SPS- 396)


To clarify procedures of establishmentstablishment ofof MRLs, and

to improve scientific transparency and predictability

in establishmentstablishment ofof MRLs to related companies.

(attachment 2) (SPS- 396)


Clarification for Scope of for the Establishment of MRLs

of Pesticides and Veterinary Drugs

Procedures and Methods for the Establishment of MRLs

Expert Review Panel and its Operation

Scope of Materials Submitted for the Establishment of MRLs

- Stipulation in Toxicity and Residue Data for the

Establishment of MRLs

Methods for the Establishment of MRLs at Each Step

Various forms for the Establishment of MRLs


Clarification for Scope of for the Establishment of MRLs

of Pesticides and Veterinary Drugs

Procedures and Methods for the Establishment of MRLs

Expert Review Panel and its Operation

Scope of Materials Submitted for the Establishment of MRLs

- Stipulation in Toxicity and Residue Data for the

Establishment of MRLs

Methods for the Establishment of MRLs at Each Step

Various forms for the Establishment of MRLs


Article 1 Purpose

Article 2 Definition

Article 3 Scope of Application

Article 4 Applications to Establish, Amend or Exemption of MRLs

Article 5 Review to Establish, Amend or Exemption of MRLs

Article 6 Expert Review Panel and its OperationArticle 6 Expert Review Panel and its Operation

Article 7 Matters for Consideration in Submitting document

Article 8 Supplementary Data, etc.

Article 9 Announcement and Notification

Article 10 Scope of Documents Submitted for the Establishment of MRLs of Pesticides

Article 11 Scope of Materials Submitted for the Establishment of MRLs of Veterinary Drugs

Revision and Establishment of Pesticides MRLs

Notice No. 2011-159 of the KFDA(August 19, 2011)

- Establishment of new Group MRLs of stone fruits and

pome fruits for Acetamiprid or etc.

- Establishment of new MRLs for imported food(orange, lemon,

grapefruit) for Azoxystrobin and Fludioxonil

- Establishment of new MRLs of agricultural products for 31

types of registered pesticides

- Establishment of new MRLs for a newly registered pesticide :

Ametoctradin, Imicyafos (attachment 2)

Notice No. 2011-159 of the KFDA(August 19, 2011)

- Establishment of new Group MRLs of stone fruits and

pome fruits for Acetamiprid or etc.

- Establishment of new MRLs for imported food(orange, lemon,

grapefruit) for Azoxystrobin and Fludioxonil



- Establishment of new MRLs for a newly registered pesticide :

Ametoctradin, Imicyafos (attachment 2)

WTO (SPS- 396)

Notice No. 2011-189 of the KFDA(September 30, 2011)

- Establishment of new Group MRLs of pome fruits for

Difenoconazole and Fenarimol

- Establishment of new MRLs for imported food(cherry) for

Fenpropathrin



- Revision of MRLs for 10 types including Bifenthrin

(attachment 3)

Revision and Establishment of Pesticides MRLs

Notice No. 2011-189 of the KFDA(September 30, 2011)

- Establishment of new Group MRLs of pome fruits for

Difenoconazole and Fenarimol

- Establishment of new MRLs for imported food(cherry) for

Fenpropathrin



- Revision of MRLs for 10 types including Bifenthrin

(attachment 3)

WTO (SPS- 397)

Q&A for the Guidelines

You do not have to submit any data to KFDA if you havesubmitted toxicity and residue data to RDA to register newpesticides or additional crops. Accordingly, there is nodifference from the existing method.However, please note that the time to review the establishmentof MRLs of pesticides can be shortened if you submit data toboth RDA and KFDA at the same time when you considersubmitting data to RDA.

Q: Do we have to submit data to both Rural DevelopmentAdministration(RDA) and Food and Drug Administration toestablish MRLs of pesticides?

You do not have to submit any data to KFDA if you havesubmitted toxicity and residue data to RDA to register newpesticides or additional crops. Accordingly, there is nodifference from the existing method.However, please note that the time to review the establishmentof MRLs of pesticides can be shortened if you submit data toboth RDA and KFDA at the same time when you considersubmitting data to RDA.

-> attachment 4

If you want to change the MRLs for the currently registeredpesticides, the establishment, change and/or exemption ofthe MRLs can be done when you submit the related data toKFDA and those data are recognized as valid.If you want to change the MRLs for usage and production,the establishment, change and/or exemption of the MRLscan be done if it is considered as valid when you submit therelated data to KFDA which will discuss it with RDA.


Q: Is it possible for a company to apply for the establish-ment, change and/or exemption of standards individually

to KFDA without going through RDA?

If you want to change the MRLs for the currently registeredpesticides, the establishment, change and/or exemption ofthe MRLs can be done when you submit the related data toKFDA and those data are recognized as valid.If you want to change the MRLs for usage and production,the establishment, change and/or exemption of the MRLscan be done if it is considered as valid when you submit therelated data to KFDA which will discuss it with RDA.

-> attachment 4


Q: It is necessary to clarify data to be submitted andstandards for exemptions in case of toxicity becausethe respiratory toxicity, nervous toxicity and repetitivetoxicity among others belong to certain types of pesti-cides.

The submission of data can be omitted if you submit thevalid reasons when it is recognized as unnecessary tosubmit data considering foreign regulations and examplesamong others.

-> attachment 4

Information about impurities shall be submitted if there isany concern of harm to health due to the remainingimpurities in any food because some pesticides include theundesired impurities during the manufacturing of crudematerials.Example) Dioxin as the impurity during the manufacturingprocess of 2, 4, 5-T.


Q: What does information about impurities in the productmean?

Information about impurities shall be submitted if there isany concern of harm to health due to the remainingimpurities in any food because some pesticides include theundesired impurities during the manufacturing of crudematerials.Example) Dioxin as the impurity during the manufacturingprocess of 2, 4, 5-T.

-> attachment 4

We are planning to ensure that the announcement of data can bedone generally within 180 days for the additional registration ofcrops, alleviation of standards and/or exemptions, and that thedata review and administrative procedures can be completedwithin 210 days if the time has to be extended because anyopinion is submitted due to the preliminary administrationannouncement. However, it is difficult to shorten the time toestablish the standards because it takes a long time to develop thetesting methods for the applicable pesticides in case of any newpesticides.


Q: Could the time to establish the MRLs be shortenedas an enormous deal of economic damages to thecompany might be caused if the review time takeslonger?

We are planning to ensure that the announcement of data can bedone generally within 180 days for the additional registration ofcrops, alleviation of standards and/or exemptions, and that thedata review and administrative procedures can be completedwithin 210 days if the time has to be extended because anyopinion is submitted due to the preliminary administrationannouncement. However, it is difficult to shorten the time toestablish the standards because it takes a long time to develop thetesting methods for the applicable pesticides in case of any newpesticides. -> attachment 4

We will make efforts to minimize the number of copies necessaryfor the review when the related regulations are established andenforced, although the number of copies necessary for the reviewshould be submitted by the company due to no regulation on therelated charges as of now. Korea KFDA will ensure no leakage ofany data due to CD and/or DVD which any company submit to usunder our responsibility.


Q: It is necessary to improve the submission methodbecause two copies of toxic data and five copies ofresidue data seem to be not only too many to besubmitted, but also vulnerable in security in case ofCD and/or DVD.

We will make efforts to minimize the number of copies necessaryfor the review when the related regulations are established andenforced, although the number of copies necessary for the reviewshould be submitted by the company due to no regulation on therelated charges as of now. Korea KFDA will ensure no leakage ofany data due to CD and/or DVD which any company submit to usunder our responsibility.

-> attachment 4

Thank you!

Food Standards Division Korea Food & Drug Administration

HP: www.kfda.go.kr☎ 043-719-2416, E-mail: [email protected]

Thank you!

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MRL re-evaluation_&_guidelines_on_mrls_of_pesticides_and_veterinary_drugs_in_food