1) The document discusses guidelines for re-evaluating and managing maximum residue limits (MRLs) of pesticides and veterinary drugs in food in Korea. 2) It outlines the process for re-evaluating pesticides MRLs, deleting pesticides that are not registered domestically, and adopting MRLs for imported foods. 3) It also provides questions and answers to clarify the guidelines, such as the process for establishing new MRLs, data submission requirements, and timelines.

1. MRLs Re-evaluation & Guidelines on MRLs
Re-
of Pesticides and Veterinary Drugs in Food
2011.10.28
Food Standards Division
Korea Food & Drug Administration

2. CONTENTS
Perspectives on Food Safety Risk
Maximum Residue Limits(MRLs) Re-evaluation
Re-
1 and the Management
Guidelines on MRLs of Pesticides and Veterinary
2 Drugs in Food
3 Revision and Establishment of Pesticides MRLs
4 Questions and Answers for the Guidelines

3. MRLs Re-evaluation and the Management
• Pesticides that are not • Re-evaluation
Collection
registered domestically • Deletion of
of comments
• Agricultural products pesticides
that are not registered for • Deletion of MRLs
registered pesticides
Deletion of Deletion of
agricultural Adoption of MRLs
pesticides exemption
products for imported
that are not lists
that are not food
registered
domestically registered
<Positive List System (2014)>

4. MRLs Re-evaluation and the Management
Notice No. 2010-294 of the KFDA(December 31, 2010)- SPS 383
• Re-evaluation of pesticides MRLs for individual
agricultural products of adopted pesticides without
scientific evidence in the past
• Pesticides not to be detected because they are not
used or registered domestically
There are pesticides and MRLs to be deleted for
foreign countries to prepare for a period of time (in
the attachment 1).

5. Guidelines on MRLs of Pesticides and Veterinary
Drugs in Food
Notice No. 2011-159 of the KFDA(August 19, 2011)
To clarify procedures of establishment of MRLs, and
stablishment
Attachment to Foods Import Report
to improve scientific transparency and predictability
in establishment of MRLs to related companies.
stablishment
(attachment 2) (SPS- 396)

6. Clarification for Scope of for the Establishment of MRLs
of Pesticides and Veterinary Drugs
Procedures and Methods for the Establishment of MRLs
Expert Review Foods Import its Operation
Attachment to Panel and Report
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

7. Article 1 Purpose
Article 2 Definition
Article 3 Scope of Application
Article 4 Applications Import Report Amend or Exemption of MRLs
Attachment to Foods to Establish,
Article 5 Review to Establish, Amend or Exemption of MRLs
Article 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

8. 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)
WTO (SPS- 396)

9. 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
- Establishment of new MRLs of agricultural products for 16
types of registered pesticides
- Revision of MRLs for 10 types including Bifenthrin
(attachment 3)
WTO (SPS- 397)

10. Q&A for the Guidelines
Q: Do we have to submit data to both Rural Development
Administration(RDA) and Food and Drug Administration to
establish MRLs of pesticides?
You do not have to submit any data to KFDA if you have
submitted toxicity and residue data to RDA to register new
pesticides or additional crops. Accordingly, there is no
difference from the existing method.
However, please note that the time to review the establishment
of MRLs of pesticides can be shortened if you submit data to
both RDA and KFDA at the same time when you consider
submitting data to RDA.
-> attachment 4

11. Q&A for the Guidelines
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 registered
pesticides, the establishment, change and/or exemption of
the MRLs can be done when you submit the related data to
KFDA 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 MRLs
can be done if it is considered as valid when you submit the
related data to KFDA which will discuss it with RDA.
-> attachment 4

12. Q&A for the Guidelines
Q: It is necessary to clarify data to be submitted and
standards for exemptions in case of toxicity because
the respiratory toxicity, nervous toxicity and repetitive
toxicity among others belong to certain types of pesti-
cides.
The submission of data can be omitted if you submit the
valid reasons when it is recognized as unnecessary to
submit data considering foreign regulations and examples
among others.
-> attachment 4

13. Q&A for the Guidelines
Q: What does information about impurities in the product
mean?
Information about impurities shall be submitted if there is
any concern of harm to health due to the remaining
impurities in any food because some pesticides include the
undesired impurities during the manufacturing of crude
materials.
Example) Dioxin as the impurity during the manufacturing
process of 2, 4, 5-T.
-> attachment 4

14. Q&A for the Guidelines
Q: Could the time to establish the MRLs be shortened
as an enormous deal of economic damages to the
company might be caused if the review time takes
longer?
We are planning to ensure that the announcement of data can be
done generally within 180 days for the additional registration of
crops, alleviation of standards and/or exemptions, and that the
data review and administrative procedures can be completed
within 210 days if the time has to be extended because any
opinion is submitted due to the preliminary administration
announcement. However, it is difficult to shorten the time to
establish the standards because it takes a long time to develop the
testing methods for the applicable pesticides in case of any new
pesticides. -> attachment 4

15. Q&A for the Guidelines
Q: It is necessary to improve the submission method
because two copies of toxic data and five copies of
residue data seem to be not only too many to be
submitted, but also vulnerable in security in case of
CD and/or DVD.
We will make efforts to minimize the number of copies necessary
for the review when the related regulations are established and
enforced, although the number of copies necessary for the review
should be submitted by the company due to no regulation on the
related charges as of now. Korea KFDA will ensure no leakage of
any data due to CD and/or DVD which any company submit to us
under our responsibility.
-> attachment 4

16. Thank you!
Food Standards Division
Korea Food & Drug Administration
HP: www.kfda.go.kr
☎ 043-719-2416, E-mail: kfda4797@korea.kr