RMP EGG-2005/Page 1 of 1

TRADE NOTICE: APEDA/QMC/GEN/046 DATED: 10.3.2005

RESIDUE MONITORING PLAN FOR 2005

FOR DRUGS AND PESTICIDES

FOR EXPORT OF EGG PRODUCTS

TO THE EUROPEAN UNION

Agricultural and Processed Food Products Export Development Authority

(Ministry of Commerce & Industry, Government of India) 3rd Floor, NCUI Building, 3 Siri Institutional Area,

August Kranti Marg, Hauz Khas New Delhi 110 016. Tel: 26534175, 26513219 Fax: 26519259 E-mail: qmc@apeda.com

RMP EGG-2005/Page 2 of 2

TRADE NOTICE: APEDA/QMC/GEN/046 DATED: 10th MARCH 2005

RESIDUE MONITORING PLAN FOR 2005 FOR DRUGS AND PESTICIDES FOR EXPORT OF EGG PRODUCTS TO THE EUROPEAN UNION

Background

Residue levels of drugs and pesticides in food commodities are becoming a major concern for food regulators all over the world. Since the residue levels cannot be changed drastically through various production techniques and because it is necessary to provide safe food to the consumers, it is essential that adequate monitoring should be in place to eliminate the possibility of the presence of the residues in food commodities in excess of the prescribed levels.

Keeping this in view, some importing countries, for instance, the European Union have desired that a residue-monitoring plan for egg products be in place right from the farm level covering water, compounded feed, animal tissues, excreta, body fluids, eggs meant for processing and finished egg products. This will ensure an overall monitoring along with controls at each stage of the production chain. The structure of this plan has been modified to monitor residues of drugs and pesticides as follows: a) Water b) Compounded feed c) Animal tissues [kidney, liver, adipose tissue (fat)] d) Body fluids (Blood and sera) e) Excreta f) Eggs g) Finished egg products

The Government of India, Department of Commerce (Ministry of Commerce and Industry), vide order dated 19th December, 2003 issued under the EIC Act and published in the Gazette of India has authorised APEDA to monitor the residues under a RMP implemented through a Trade Notice, notifying the procedure given in the following paragraphs:

RMP EGG-2005/Page 3 of 3

1 Objective 1.1 To establish a system for monitoring residues of drugs and pesticides at the feed mill, egg laying farms and eggs at the processing establishments.

1.2 To establish a system for corrective action in the event of detection of residue levels higher than those established through this RMP.

1.3 To establish a system for corrective action in the event of issuance of an Internal Alert Information.

1.4 To ensure that egg products exported from India to the European Union do not test for residues of drugs and pesticides in excess of the prescribed levels.

2 Scope 2.1 All egg processing units intending to process eggs for export, their affiliated feed mills, layer farms, recognized laboratories and their pre-requisites would get covered under these guidelines.

3 Definitions 3.0 In this part, unless the contexts otherwise requires, the following definitions shall be applicable:

3.1 AOAC - Association of Official Analytical Chemists.

3.2 APEDA - Agricultural and Processed Food Products Export Development Authority.

3.3 Confirmatory methods are methods that provide full or complementary information enabling the analyte to be identified unique vocally at the level of interest. These methods are aimed at preventing false positive results as well as having an acceptable low probability of false negative results.

RMP EGG-2005/Page 4 of 4

3.4 Consignment means a quantity of egg products for a single delivery to one destination for further processing by the food industry or intended for direct human consumption.

3.5 Country of Destination means the country to which egg products are dispatched from India.

3.6 Country of Despatch means the country from where the egg products are exported.

3.7 DGFT - Directorate General of Foreign Trade, Government of India.

3.8 Egg Products means products obtained after processing of eggs, their various components or mixtures there of after removal of shell membranes, intended for human consumption. They may be partially supplemented by other foodstuffs or additives. They may be liquid, concentrated, dried, crystallized, frozen, and quick frozen or coagulated.

3.9 EIA – Export Inspection Agencies established by the Government of India at Delhi, Mumbai, Chennai, Kolkata and Cochin, under Section 7 of the Export (Quality Control and Inspection) Act 1963.

3.10 EIC - Export Inspection Council of India, New De lhi.

3.11 Farm of Production means farms supplying eggs intended for manufacture of egg products.

3.12 Limits of Detection (LoD) are the smallest measured content that it is possible to detect the presence of the analyte with reasonable statistical certainty (at least 95% certainty).

RMP EGG-2005/Page 5 of 5

3.13 Maximum Residue Limit (MRL) - Official permissible limits of residues and contaminants so as not to pose a risk to human health.

3.14 MRPL - “Minimum required performance limit” means minimum content of an analyte in a sample, which at least has to be detected and confirmed. It is intended to harmonize the analytical performance of methods for substances for which no permitted limit has been established.

3.15 NRL – National Referral Laboratory Central Food Technological Research Institute, [CFTRI]

3.16 Nominated Laboratory shall mean a laboratory approved by APEDA for the purpose of examining an official sample in order to detect the presence of residues.

3.17 Official Sample shall mean a sample taken by the competent authority or his authorized nominee.

3.18 Permitted limit means maximum residue limit, maximum level or other maximum tolerance for substances.

3.19 Qualitative method means an analytical method, which identifies a substance on the basis of its chemical, biological or physical properties.

3.20 Quantitative method means an analytical method that determines the amount or mass fraction of a substance so that it may be expressed as a numerical value of appropriate units.

RMP EGG-2005/Page 6 of 6

3.21 Recovery means the percentage of the true concentration of a substance recovered during the analytical procedure. It is determined during validation.

3.22 Reference material means a material of which one or several properties have been confirmed by a validated method, so that it can be used to calibrate an apparatus or to verify a method of measurement.

3.23 Residue shall mean a residue of substances having pharmacological action, or their metabolites and of other substances transmitted to animal products and likely to be harmful to human health.

3.24 Recovery test: All methods should be checked by the addition of a known quantity of analyte to a blank sample so that the recovery of analyte when the fortified sample is put through the analytical procedure can be computed.

3.25 RMP – Residue Monitoring Plan for 2005.

3.26 Screening method means methods that are used to detect the presence of a substance or class of substances at the level of interest. These methods have the capability for a high sample throughput and are used to sift large numbers of samples for potential non-compliant results. They are specifically designed to avoid false compliant results.

3.27 Unauthorized substances or products shall mean substances or products the administering of which to animals is prohibited.

RMP EGG-2005/Page 7 of 7

3.28 Validation means the confirmation by examination and the provision of effective evidence that the particular requirements of a specific intended use are fulfilled.

4 Monitoring Plan and Surveillance

4.1 APEDA shall revise the RMP so as to meet requirements of importing countries like EU through a Committee consisting of representatives of exporters association, designated laboratories under the leadership of NRL.

4.2 It shall be the primary responsibility of the processors to ensure that egg products meant for export are subjected to residue monitoring at all stages from farm to products.

4.3 APEDA shall ensure that all processors comply with the implementation of residue monitoring plan, and shall be assisted by the NRL and nominated laboratories for effective supervision and control.

4.4 APEDA will decide on the nominated laboratories that will be responsible for the implementation of the RMP for each processor.

4.5 APEDA will compile and forward to EIC residue analysis results on a quarterly basis for evaluation and further suggestions on the implementation of control measures suggested by the designated laboratories and NRL.

4.6 APEDA will assess the work carried out by the NRL with respect to the responsibilities as laid down in these guidelines.

RMP EGG-2005/Page 8 of 8

4.7 APEDA will regularly monitor the functioning of each nominated laboratory to ensure implementation of the procedures laid down in these guidelines based on its testing capacity for pesticide residue analysis.

4.8 APEDA will nominate a Committee consisting of representatives of exporters/association and designated laboratories under the leadership of National Referral Laboratory.

4.9 To ensure implementation of control measures suggested by NRL.

5. Procedure for sampling and inspection

5.1 Name and address of the nominated laboratories and NRL is given at Annexure-1.

5.2 The procedure to be followed by the nominated laboratories for sampling and testing is given at Annexure-2.

5.3 Method of sampling for determining levels of residues of pesticides and drugs is given at Annexure-3.

5.4 Sampling should be targeted so as to test particular compounds or group of compounds.

5.5 A sample slip to be provided by egg processor/exporter, feed mill, egg laying farm, etc to the designated laboratories is given at Annexure-4.

5.6 A list of maximum residue limits of pesticides and drugs in egg, liquid frozen or dried egg products is given at Annexure-5.

RMP EGG-2005/Page 9 of 9

6. Accreditation/Recognition requirements and responsibilities of Nominated Laboratories

6.1 All the nominated laboratories shall be accredited to the National Accreditation Board for Testing and Calibration Laboratories (NABL) and/or accreditation to ISO/IEC-17025.

6.2 All the nominated laboratories shall have APEDA recognition under its scheme for laboratory recognition.

6.3 The nominated laboratories shall test for residue levels of the drugs and pesticides (listed in Annexure-4) to be monitored for exports as per the method of analysis given in AOAC/Codex.

6.4 The test reports shall be issued within a week of drawl of the samples by the laboratory and sent to the processors, EIC and NRL.

6.5 The nominated laboratories shall issue test certificates as per Annexure-6.

6.6 Nominated laboratories shall submit monthly statement of samples tested to APEDA, NRL and EIC as per Annexure-7 by the 15th day of the following month .

6.7 The designated laboratories shall participate in the training/proficiency inter-laboratory testing programmes organized by NRL.

6.8 The recognized laboratories shall nominate its representative for drawing samples as per the procedure given in Annexure-3.

6.9 The nominated laboratories are under an obligation to provide access, on demand, to their

RMP EGG-2005/Page 10 of 10

analysis records (including chromatograms) to authorized officials of APEDA, EIC and National Referral Laboratory.

6.10 The nominated laboratories shall communicate the details of the samples drawn for analysis to the NRL immediately so that the NRL can draw 5% samples as per procedure given in para 4.2 of Annexure-3.

7. (a)

Responsibilities of the National Referral Laboratory (NRL)

7.1 The NRL, Central Food Technological Research Institute (CFTRI), Mysore will monitor the work of nominated laboratories by conducting surveillance audit to ascertain that they are following the criteria laid down under this monitoring system.

7.2 The NRL shall draw 2% of the samples mentioned in this RMP directly from the registered feed mills and egg suppliers/ producers to ascertain that the limits established in this RMP for antibiotics, drugs and pesticides are adhered to. The NRL shall analyze these samples and report as per the format given in Annexure-5.

7.3 During the year, the NRL shall also evaluate 5% of the tested samples (finished egg products) analyzed by the nominated laboratories pertaining to the batches tested by the nominated laboratories of the finished products as a measure of conformity.

7.4 The NRL shall, without delay and in any case within 24 hours, issue Internal Alert Information pertaining to raw products in case of detection of higher residues. A format of Internal Alert Information is given in

RMP EGG-2005/Page 11 of 11

Information is given in Annexure-8(A). The alert information will be sent to all those mentioned in the format.

7.5 The NRL shall, without delay, issue Internal Alert Information pertaining to finished egg products in case of detection and confirmation of higher residues or major elements than the limits prescribed in this document as amended from time to time. A format of Internal Alert Information is given in Annexure-8(B). The alert information will be sent to all those mentioned in the format and also provide advice on the control measures required to be taken.

7.6 It will submit to APEDA and EIC, a quarterly statement of consolidated test reports as received from the nominated laboratories alongwith an analysis of its findings and recommendations. The NRL shall prepare the statement in Annexure-9 and use it for preparation of the RMP for the following year.

7.7 The NRL shall organize training programmes for testing of each residue or groups of residues for the nominated laboratories as well as the processors.

7.8 The NRL shall also initiate proficiency/inter-laboratory testing prorammes for the designated laboratories.

7.9 NRL will ensure that the designated laboratories are using validated methods for sampling and analysis.

RMP EGG-2005/Page 12 of 12

7.10 The NRL shall regularly update itself on the amendments pertaining to the residue levels implemented by the importing countries, especially the EU with the help of the industry. It will verify this information from EIC and disseminate it to APEDA and the nominated laboratories.

7. (b)

Powers of NRL 7.11 The NRL shall have the right to draw samples from egg processing units, their affiliated feed mills, laying farms and nominated laboratories.

7.12 The NRL shall have right to verify analysis data corresponding to the samples drawn and/or tested by the designated laboratories.

7.13 The NRL shall have authority to recommend to APEDA and/or NABL, derecognition of nominated laboratories in the event of non-compliance with the procedure for drawl of samples, testing of water, compounded feed, animal tissues, body fluids, excreta, eggs and finished egg products, etc.

8. Responsibilities of Egg Processors, laying farms & Feed Mills

8.1 The egg processor/exporters shall be registered with APEDA for the export of egg products.

8.2 The feed mills and farms supplying eggs to the processor shall be registered with the egg processor. The egg processor shall maintain records of feed mills and egg supplying farms as per Annexure-10 and Annexure-11, respectively, and shall make available a copy of these records to nominated laboratories at the time of drawl of samples, APEDA, EIC and NRL.

RMP EGG-2005/Page 13 of 13

8.3 The egg products processor / exporters shall submit a list detailing the names and address of the registered feed mills, egg suppliers to APEDA. Any addition or deletion o f suppliers will have to be notified immediately to APEDA, EIC and NRL.

9. Responsibilities of EIC

9.1 EIC shall obtain the following when positive results are obtained:

i) Full details of the

examination & the result. ii) The reason for the presence

of residues. iii) Advise the processor on the

corrective action to be implemented.

iv) Make periodical inspection

and tests until the residue levels are below the MRL.

9.2 The authorized person of the

EIC/EIA shall make official random checks with an element of surprise at the feed mill, farm, and the processing plant with a view to detect fraudulent usage of prohibited substances and in general for compliance of the RMP.

9.3 If the above checks reveals:

(i) Suspicion or usage of unauthorized substances

(ii) The test results exceeds the

MRL specified in the RMP The authorized person of the EIC shall carry out an investigation and will submit a report under intimation to APEDA.

RMP EGG-2005/Page 14 of 14

9.4 In case of repeated offence, approval/ registration shall be withdrawn by the EIC, which will also notify the same to APEDA.

9.5 To evaluate and send residue monitoring data to the European Commission.

9.6 To evaluate the bimonthly and

quarterly statements submitted by the nominated laboratories and NRL, respectively and suggest measures to all concerned on a regular basis.

9.7 To keep APEDA and NRL informed of any information on excessive residues brought to their notice from any quarter.

9.8 To keep APEDA and NRL informed of any Government of India notifications on use of drugs and pesticides and the prescribed residue levels.

9.9 To keep APEDA and NRL informed of any EU notifications or changes in the MRLs of residues of drugs and pesticides.

9.10 Establish corrective measures in consultation with APEDA and NRL.

10 Penal provisions 10.1 In the event of breach of this monitoring plan of pesticides and drugs residues in egg products, APEDA may initiate action as per the provisions of section 19(3), Chapter-V of the APEDA Act, 1985 (Extract from APEDA Act is given in Annexure-12), in addition to the following:

a) Cancellation of Registration-cum-Membership Certificate of exporters

RMP EGG-2005/Page 15 of 15

b) Notifying to DGFT for cancellation of Import-Export Code number allocated to such exporters.

c) Any other action as deemed

fit

Date: 10th March 2005 (K S MONEY) Place: New Delhi CHAIRMAN, APEDA

RMP EGG-2005/Page 16 of 16

ANNEXURE-1

LIST OF NOMINATED LABORATORIES

Sl. No.

Laboratory Regions

1.

Central Food Technological Research Institute (CFTRI), Mysore 570 013 Tel: 0821-514972, Fax: 0821-517233 e-mail: aqcl@cscftri.ren.nic.in Contact Person : Dr.K.N. Gurudutt, Head, Food Safety & Analytical Quality Control Laboratory

National Referral Laboratory

2. Shriram Institute for Industrial Research (SIIR) Plot 14 & 15 Sadarmangla, Industrial Area, White Field Road, Bangalore – 560 048 Tel : 080-8410189Fax : 080-8410189 e-mail: srisbr@vsnl.net.in Contact Person : Dr. A Radha Krishna, Joint Director

1. Ovobel Foods Limited, Bangalore.

2. Indo-Dutch

Proteins Limited, Hyderabad.

3. Vimta Labs Ltd 142, I.D.A. Cheralapally Hyderabad – 500 051 Tel : 040-7124141, Fax : 040-7123657 e-mail : crm@vimta.com Contact Person : Dr. S P Vasireddi, Chairman & Managing Director

Venkateshwara Hatcheries Ltd., Hyderabad.

4. SGS India limited, 304 – 305, Ist Floor, Anna Salai, Teynampet, Chennai – 600 018 Phone : 044 – 24470184, 24473929, Fax : 044 – 24470317 E-mail: vakkalanka_meenakumari@sgs.com Contact Person : Mr. V.K. Gupta Lab Manager

SKM Egg Products Export (India) Ltd., Erode.

RMP EGG-2005/Page 17 of 17

ANNEXURE-2

PROCEDURE FOR SAMPLING AND TESTING OF EGG PRODUCTS FOR RAW AND PROCESSED EGG PRODUCTS

(TO BE FOLLOWED BY NOMINATED LABORATORIES & NRL)

1. The laboratory shall follow the criteria laid-down in APEDA’s scheme for laboratory recognition.

2. Sampling 2.1 Sampling of compounded feed, water, excreta, animal tissues, eggs

and egg powder shall be carried out by an authorized person of nominated laboratory at the feed mill, commercial layer farms and processing plant or place of storage, in such a manner that the element of surprise is constantly maintained.

2.2 Method of Sampling 2.2.1 For the purpose of testing of residue of antibiotics, drugs, pesticide,

etc. in egg products intended for exports the method of sampling as given in Annexure-3 shall be followed. If there is a departure from the recommended sampling procedure, records accompanying the samples should fully describe procedure actually followed.

3. Method of Analysis

The method of analysis used for antibiotics, drugs, and pesticide residues analysis shall be determined by their MRLs established in this RMP. Following criteria when selecting the analytical method shall be used:

(a) Published in books and manuals internationally accepted as the

validated method for example AOAC. (b) Capability of determining more than one residue for example

multi-residue method (c) Suitable for the commodity and at or below the specified MRLs (d) Preference should be given to the method of analysis being

prescribed by Codex Alimentarius Commission

In the event of dispute of test results, test methods, etc. the recommendation of National Referral Laboratory determined by validated analytical methods shall be final for the methods to be followed by nominated laboratories.

RMP EGG-2005/Page 18 of 18

ANNEXURE-3

METHOD OF SAMPLING FOR CHECKING THE RESIDUE LEVELS OF PESTICIDE AND DRUGS IN RAW AND PROCESSED EGG PRODUCTS

(TO BE FOLLOWED BY NOMINATED LABORATORIES & NRL) 1. PURPOSE AND SCOPE

Samples intended for checking of the levels of residues of pesticides and drugs in compounded feed, water, excreta, animal tissues, eggs and egg powder shall be taken according to the methods described below.

2. DEFINITIONS

Analytical Portion: A representative quantity of material removed from the analytical sample, of proper size for measurement of the residue concentration.

Analytical Sample: The material prepared for analysis from laboratory sample, by separation of the portion of the product to be analysed.

Bulk Sample: The combined & well-mixed aggregate of the primary samples taken from a lot.

Laboratory Sample: The sample sent to, or received by, the laboratory (a representative quantity of the material removed from the bulk sample).

Lot: A quantity of a food material delivered at one time and known or presumed to have uniform characteristics such as origin, variety, producer, type of packing, marking, packer, consignor etc.

Batch: A quantity of compounded feed, water, excreta, animal tissues, eggs and egg powder, which have been prepared under the same conditions and in particular treated in single continuous operation.

Primary Sample: One or more units taken from one position in a lot.

Unit: A smallest discrete portion in a lot, which should be withdrawn to form a whole or a part of a primary sample.

3. GENERAL PROVISIONS 3.1 Personnel

Sampling shall be performed by an authorized person of the nominated laboratory.

RMP EGG-2005/Page 19 of 19

3.2 Material to be sampled

Each lot, which is to be examined, must be sampled separately in accordance with the specific provisions in clause 4.0 of this Annexure larger lots should be sub-divided into sub-lots to be sampled separately.

3.3 Precaution to be taken

In the course of sampling and preparation of the laboratory sample, precautions must be taken to avoid any contamination or changes in the sample, which would affect the residue, the analytical determination or make the laboratory sample not representative of the bulk or final sample. The primary sample shall be taken at various places distributed throughout the lot or sub-lot. Departure from the given sampling procedure must be recorded and provided on the label of the sample.

3.4 Collection of primary samples

The number of primary samples to be taken from compounded feed, water, excreta, animal tissues, eggs and egg powder should be arrived/ determined to represent the entire lot.

3.5 Preparation of bulk sample

The primary samples shall be combined and mixed well to form the bulk sample.

3.6 Preparation of laboratory sample

Where the bulk sample is larger than required it should be divided to provide a representative portion. Replicate laboratory sample should be withdrawn at this stage [Minimum of 3 samples, 1 each for Nominated Laboratory, National Re ferral Laboratory and Processor]. The size sample is determined by Table-1.

Table-1: Minimum size of laboratory sample

Sl. No.

Product Minimum Size of the sample to be drawn

1. Compounded feed 2 Kg 2. Water 1 Litre 3. Excreta 100 gms 4. Tissues 100 gms 5. Body fluid 100 gms 6. Shell egg 12 eggs 7. Egg powder 500 gms

RMP EGG-2005/Page 20 of 20

3.7 Sampling record

The sampling officer shall record the nature, and origin of the lot; the date and place of sampling and any other relevant information. Any departure from the recommended method must be recorded. A signed copy of the record shall accompany each replicate laboratory sample and a copy shall be retained by the sampling officer. A copy of the sampling record shall also be given to the exporters of the lot or its representative.

3.8 Packaging and transmission of laboratory sample

The laboratory sample must be placed in a clean, inert container, which provide secure protection from contamination, damage and leakage. The container shall be sealed securely, labeled and the sampling record shall be attached.

3.9 Preparation of analytical sample

The laboratory sample shall be given a unique identifier, which, together with the date of receipt and the sample size, should be added to the sample record. The part of the commodity to be analysed i.e. analytical sample shall be separated as soon as practicable. Where the residue level must be calculated to include parts, which are not analyzed, the weights of the separated parts must be recorded.

3.10 Preparation and the storage of the analytical portion

The analytical portion shall be mixed well to enable representative analytical portions to be withdrawn. The size of the analytical portion shall be determined by the analytical method and the efficiency of the mixing. Where appropriate, the analytical sample should be processed under such conditions, for example, sub-zero temperature to minimize adverse effects. Representative of sufficient analytical sample must be retained as required.

3.11 Criteria for determination of compliance

Analytical results derived from laboratory samples taken from the lot must be supported by acceptable quality control data (example for instrument calibration and pesticide recovery refer Codex Standards). Results should not be corrected for recovery where the residue is found to exceed MRLs. Its identity should be confirmed and its concentration must be verified by one or more additional analytical portions derived from the original laboratory sample.

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- The MRLs as detailed in Annexure – 5 determines the compliance of the bulk sample.

- The lot shall be considered in compliance where analytical

result does not exceed the MRL. - Where results for bulk sample exceed the MRL, before

conforming the non-compliance, the results obtained from one or more as applicable must be considered, in addition to the conformance of accuracy of analysis by supporting quality control data.

3.12 On the condition that the given lot is representative in nature, primary

samples shall be drawn as given in the Clause 3.4. 3.13 Each of the primary samples collected from a lot shall be combined

and mixed well to form a bulk sample as given in clause 3.5. 3.14 Laboratory sample shall be prepared from bulk samples as per clause

3.6. 3.15 Sample records shall be prepared as referred to in clause 3.7. On

receipt of sample at laboratory, analytical sample shall be separated while analytical portion is stored as per clause 3.9 and 3.10.

3.16 The remaining portion of the laboratory sample shall be stored for a

period of 2 months from the date of laboratory test report for the finished products.

3.17 The designated laboratories/egg processors shall also retain counter

samples for feed and finished egg products. 4. SAMPLING LEVELS AND FREQUENCY 4.1 For Nominated Laboratories 4.1.1 The nominated laboratories shall draw random samples from all the

batches. The number of samples to be taken by the nominated laboratories for analysis during 2005 from the finished egg powder batches in the egg processing units, their egg supplying farms and feed mills supplying feed to these farms shall be determined by the following table:

RMP EGG-2005/Page 22 of 22

Table-2 Samples to be taken by nominated laboratories

Sl. No.

Samples Sampling plan*

SKM* VHL** Ovobel***

Indo-Dutch

****

Total

1. Compounded feed

29 29 20 12 90

2. Water 29 29 20 12 90 3. Excreta,

Tissues and Body fluid

74 74 53 29 230

4. Shell egg 65 65 45 25 200 5. Egg products 29 29 20 12 90

Total 226 226 158 90 700 * M/s. SKM Egg Products Export (India) Limited, Erode ** M/s. Venkateshwara Hatcheries Limited, Hyderabad *** M/s. Ovobel Foods Limited, Bangalore **** M/s. Indo-Dutch Proteins Limited, Hyderabad 4.1.2 The designated laboratories shall follow following ratio for analysis of

the samples.

• 100% samples shall be analysed for banned drugs, Group A6. • 30% samples shall be analysed for Group B1. • 30% samples shall be analysed for Group B2. • 10% samples shall be analysed for Group B3. • 30% samples shall be analysed on the basis of previous data, if

required or as directed by the NRL. 4.2 For NRL 4.2.1 5% of the samples drawn by the nominated laboratories will be

sampled and tested by the NRL. The batch number will be indicated by the NRL to the units for the samples to be verified directly by the NRL with reference to reports submitted by the designated laboratories to the NRL.

4.2.2 2% of the samples drawn by the NRL directly from the registered feed

mills and egg suppliers / producers to ascertain that the limits established at Annexure -5 for antibiotics, drugs and pesticides are adhered to. The NRL shall analyze these samples and report as per the format given in Annexure-6, for the purpose of consolidation of data.

RMP EGG-2005/Page 23 of 23

ANNEXURE-4

SAMPLE SLIP

Sample Slip No.____________

1) Name & address of the exporter/

processor/feed mill/egg laying farm, etc

2) APEDA Registration No. of the exporter/egg processing unit

3) Registration No./Code No. of feed mill

4) Registration No./Code No. of egg laying farm

5) Details of samples (compounded feed, water, excreta, tissue, body fluid, shell egg, egg powder)

6) Location and address of the egg processors, feed mill and egg laying farm from where samples to be drawn

7) Quantity of the sample (in kgs.)

8) Drugs, pesticides, etc. required to be tested as prescribed in Annexure-5

9) Sample weight : a) compounded feed b) water c) excreta d) tissue e) body fluid f) shell eggs g) finished egg product

10) Date and time of drawl of sample

11) Names of drugs, pesticides, etc. along with concentration if any administered.

Date : Signature of Exporter Signature of Egg Supplier/ Place: (Name of Exporter) Feed Mill Owner/Egg Processing Unit (Name)

RMP EGG-2005/Page 24 of 24

DECLARATION ( Strike-out whichever is not applicable ) 1. I/We hereby declare that the shell eggs received from the above

mentioned supplier(s) only would be used for processing for exports to the European Union.

2. I/We hereby declare that the compounded feed, water, etc. having higher residues of pesticides and drugs will not be used for feeding to the birds, which are intended to produce shell eggs for processing for exports of egg powder to the European Union.

3. I/We also certify that in case the above samples contain residue of drugs or pesticides in excess of the prescribed levels, it would not be processed or used in any form for exports of eggs products to the European Union.

Date : Signature of Egg Supplier/Feed Mill Owner/ Place: Egg Processing Unit (Name)

CERTIFICATE

This is to certify that I have personally drawn this sample from the premises of the above mentioned egg processor, feed mill, egg laying farm, etc. from the batches of compounded feed, water, excreta, tissue, body fluid, shell eggs, egg powder by adopting the procedure given in Annexure-2 and method of sampling given in Annexure-3 of this Residue Monitoring Plan for exports of egg products to EU. I have also obtained a copy of Annexure -10 and Annexure-11 giving relevant records maintained for the feed mills and egg supplying farms. Date : Signature : Place : Name of authorized

representative of : Nominated Laboratory Official address :

Sample condition on arrival : at the laboratory Date : Signature of the person : Time : taking sample(s) in custody

RMP EGG-2005/Page 25 of 25

ANNEXURE-5

LIST OF PESTICIDES & DRUGS FOR MONITORING RESIDUES IN FINISHED EGGS PRODUCTS

(TO BE FOLLOWED BY NOMINATED LABORATORIES, NRL & EXPORTERS) Sl.No. Compounds MRLs Group

1. Antibiotics and growth promoters banned for use

1.1 Chloramphenicol* Absent 1.2 Dimetridazole Absent 1.3 Metronidazole Absent 1.4 Nitrofurans** Furazolidone (AOZ) Absent Furatadone (AMOZ) Absent Nitrofurantion (AHD) Absent Nitrofurazone (SEM) Absent

A6

2. Antibiotics 2.1 Spectinomycin 200 microgram/kg 2.2 Sulfonamides 50 microgram/kg 2.3 Quinolones Tiamulin 1000 microgram/kg Oxolinic acid Absent 2.4 Macrolides Erythromycin 150 microgram/kg Tylosin 200 microgram/kg Josamycin 200 microgram/kg 2.5 β Lactamase inhibition Colistin 300 microgram/kg 2.6 Lincosamide Lincomycin 50 microgram/kg 2.7 Aminoglycosides Neomycin 500 microgram/kg 2.8 Tetracyclines Chloro-tetracyline 200 microgram/kg Oxy-tetracycline 200 microgram/kg Tetracycline 200 microgram/kg

B1

3. Anti-parasitic agents piperazine derivatives 3.1 Piperazine 2000 microgram/kg B2a 3.2 Nitroimidazole 1000 microgram/kg 3.3 Anti cocidials Amprolium Absent 4. Agents acting against endo-parasites 4.1 Benzimidazoles and Pro-

Benzimidazoles 4.2 Flubendazole

Absent

B2b

*Chloramphenicol MRPL 0,3 microgram/kg **Nitrofurans MRPL 1 microgram/kg for all

RMP EGG-2005/Page 26 of 26

Sl.No. Compounds MRLs Group

5. Pyrethroids 5.1 Cypermethrin 0.05 5.2 a-cypermethrin 0.05 5.3 Deltamethrin 0.05 5.4 Permethrin 0.05

B2c

6. Organochlorine compounds mg/kg 6.1 Aldrin 0.02 (combined limit) 6.2 Chlorthalonil 0.01 6.3 DDT (all isomers) 0.05 (combined limit) 6.4 Dicofol 0.05 6.5 Dieldrin 0.02 6.6 a - Endosulfan 6.7 Endosulfansulfate

0.1 (combined limit)

6.8 Endrin 0.005 6.9 HCH (all isomers) 0.03 (combined limit)

a0.02, b0.01 6.10 Lindane (g-HCH) 0.1 6.11 Methoxychlor 0.01

B3a

6.12 PCB 0.3

RMP EGG-2005/Page 27 of 27

ANNEXURE-6

FORMAT FOR THE TEST CERTIFICATE (TO BE FOLLOWED BY NOMINATED LABORATORIES & NRL)

Certificate No. __________

Date : _________________ 1) Name and Address of the Exporters 2) Address of the Unit 3) Place of Testing 4) Product 5) Batch No. 6) Quantity of the batch produced 7) Sampling

Ø Procedure Followed Ø Quantity of Sample Taken Ø Place of Sampling Ø Date of Sampling

8) Packing

Ø Description

9) Tests Ø Date of start of analysis ____________ completion of analysis _______

Drug or Pesticide Residue Name

Residue levels found in the sample

MRLs Limits of Detection (LoD)

Method of Testing

Recovery %age

Conformity

CERTIFICATE

1) This is to certify that the sample was drawn by our authorized representative

from farm/feed mill/egg processing units having Registration No. __________ and have been analysed by us. The sample was tested for the residues of the antibiotics and pesticides mentioned above and the residue content in the sample is as given in Column 3 of the table given above.

2) The APEDA recognition of this laboratory is valid as on date. 3) The sample collected from _____ meets the MRLs - YES/NO 4) If no, give reasons Name of Analyst & Authorized Signatory & Signature Seal of the Laboratory

RMP EGG-2005/Page 28 of 28

ANNEXURE-7

MONTHLY STATEMENT TO NATIONAL REFERRAL LABORATORY, APEDA & EIC

(TO BE FURNISHED BY NOMINATED LABORATORIES)

Date : Period of Testing :

Name of the unit/ Exporter Address

Date of Sampling

Batch No.

Nature of sample

Date of completion of Testing

Results (conformed or not conformed) as per requirements

Remarks, in case of non-conformance

Signature of Authorized Signatory of Nominated Laboratory

RMP EGG-2005/Page 29 of 29

ANNEXURE-8 (A)

INTERNAL ALERT INFORMATION FOR RAW EGG PRODUCTS (TO BE ISSUED BY NATIONAL REFERRAL LABORATORY)

Tel: 0821-514972, Fax: 0821-517233, e -mail: aqcl@cscftri.ren.nic.in

Page No__ of __Pages Sub: Detection of _____ drugs/pesticides beyond MRLs 1. Item tested :

a. Water : b. Compounded Feed : c. Animal tissues : d. Body fluids : e. Excreta : f. Eggs :

2. Affiliation (along with its Regn. No.) : to APEDA Registered exporter

3. Code/Batch Number of the : produce, if any

4. Date of sampling : 5. Place of sampling : Egg laying farm

Feed mill Egg processing unit

6. Date of analysis : 7. Findings of the analysis :

____________________________________________________________________________________________________________________________________

8. Recommendations of National Referral Laboratory

____________________________________________________________________________________________________________________________________

Date : Signature of the Authorized Place : Signatory of the National Referral

Laboratory along with seal Copies to : 1. Egg laying farm 2. Feed mill 3. All Exporter/Egg Processing Unit 4. Egg Processors Exporters’ Association 5. All nominated laboratories

Alert Information No…………

Original

RMP EGG-2005/Page 30 of 30

ANNEXURE-8 (B)

INTERNAL ALERT INFORMATION FOR FINISHED EGG PRODUCTS

(TO BE ISSUED BY NATIONAL REFERRAL LABORATORY) Tel: 0821-514972, Fax: 0821-517233, e -mail: aqcl@cscftri.ren.nic.in

Page No__ of __Pages Sub: Detection of _____ drugs/pesticides beyond MRLs

1. Finished egg products : 2. APEDA Registration No. of the exporter : 3. Code/Batch Number of the produce, if any : 4. Date of egg processing : 5. Date of sampling : 6. Egg processing unit :

7. Date of analysis : 8. Findings of the analysis :

____________________________________________________________________________________________________________________________________

9. Recommendations of National Referral Laboratory ____________________________________________________________________________________________________________________________________

Date : Signature of the Authorized Place : Signatory of the National Referral

Laboratory along with seal Copies to: 1. Concerned Exporter/Egg Processing Unit 2. APEDA, New Delhi 3. EIC 4. Concerned EIA

Alert Information No…………

Original

RMP EGG-2005/Page 31 of 31

ANNEXURE-9

QUARTERLY CONSOLIDATED STATEMENT OF TEST REPORTS (TO BE SUBMITTED BY NATIONAL REFERRAL LABORATORY TO

APEDA & EIC)

1) Report period 2) Name and address of the unit 3) Place of testing (Name of the laboratory) 4) Product:

a) compounded feed b) water c) excreta d) tissue e) body fluid f) shell eggs g) egg powder

5) Number of batch 6) Batch size 7) Number of samples tested 8) Sampling procedure followed

Sl.No

Name of drugs and pesticides

Residue levels found

MRLs Method of testing

Limits of Detection

Comp-liances

Non comp-liances

Remarks

Place: Signature of the Authority of Date : National Referral Laboratory

RMP EGG-2005/Page 32 of 32

ANNEXURE-10

REGISTRATION RECORD OF EGG SUPPLYING FARMS AND RECORD OF VETERINARY MEDICINE APPLICATION

(TO BE MAINTAINED AND PROVIDED BY THE EGG PROCESSORS TO APEDA AND NOMINATED LABORATORIES)

A. FARM RECORD

01. Registration No/Code No. of the : farm supplying eggs to the processor 02. Name and Address of the farm : 03. Flock Details : 04. Age of the flock : 05. Source of supply/purchase : 06. Date of supply/purchase : 07. Names of Medicines used : 08. Withdrawal period : From :

To :

09. No .of days of withdrawal period : 10. Likely production in the current year: 11. Targeted export destination Note: For Eggs the minimum withdrawal period is 7 days.

RMP EGG-2005/Page 33 of 33

B. VETERINARY MEDICINE APPLICATION RECORD (SEPARATE FOR E ACH FLOCK)

1. Name of the farm : 2. Registration Number : 3. Postal Address : 4. Phone : 5. Number of chicks : 6. Breed and source of supply : 7. Vaccination details :

A. At Hatchery

a) MDV : b) NDV : c) IBV :

B. Vaccination at Farm

a. NDV - Primary : - Secondary : - Booster

i) : ii) : iii) : b. IBV - Primary : - Secondary : c. Infectious Coryza - i) : - ii) : d. IBDV - Primary : - Booster : e. Any other vaccine :

8. Date of commencement of production : Date : Signature of Farm Signature of Egg Place : Owner Processor

RMP EGG-2005Page 34 of 34

ANNEXURE-11

REGISTRATION RECORD OF FEED MILLS (TO BE MAINTAINED AND PROVIDED BY THE EGG PROCESSORS TO

APEDA AND NOMINATED LABORATORIES) 01. Registration No./Code No. of the : feed mill supplying feed to the

egg laying farms 02. Name of the feed mill :

03. Postal Address : 04. Contact person : 05. Phone : 06. Name of Medicines etc. used : 07. Testing facility availability with the : feed mill 08. Source of supply/purchase of : raw material 09. Likely production in the current year: 10. Systems followed for feed : manufacturing 11. Means of storage : 12. Means of transport of feed to the :

egg laying farms Date : Signature of feed mill Signature of Egg Place : Owner Processor

RMP EGG-2005Page 35 of 35

ANNEXURE-12

EXTRACT FROM APEDA ACT REGISTERED No. D-(D)-72

The Gazette of India

EXTRAORDINARY PART II – Section 1

MINISTRY OF LAW AND JUSTICE (Legislative Department)

New Delhi, the 9th January, 1986/Pausa 19, 1907 (Saka) The following Act of Parliament received the assent of the President on

the 8th January, 1986, and is hereby published for general information :-

THE AGRICULTURAL AND PROCESSED FOOD PRODUCTS EXPORT DEVELOPMENT AUTHORITY ACT, 1985

No. 2 OF 1986

[8th January, 1986]

An Act to provide for the establishment of an Authority for the development and promotion of exports of certain agriculture and processed food products and for matters connected therewith.

CHAPTER-V

Power to prohibit or control imports and exports of Scheduled products

CONTROL BY THE CENTRAL GOVERNMENT

19 (1) The Central Government may, by order published in the Official Gazette, make provision for prohibiting, restricting or otherwise controlling the import or export of the Scheduled products, either generally or in specified classes of cases. (2) All Scheduled products to which any order under sub-section (1) applies, shall be deemed to be goods of which the export has been prohibited under section 11 of the Customs Act, 1962, and all the provisions of that Act shall have effect accordingly. (3) If any person contravenes any order made under sub-section (1), he shall, without prejudice to any confiscation or penalty to which he may be liable under the provisions of the Customs Act, 1962, as applied by sub-section (4), be punishable with imprisonment for a term which may extend to one year, or with fine, or with both.

* * * * * * *