Competent Authorities response received on 23 June 2010...

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Response of the Cttttipeteni Authorities of Bulgaria to the recommea dations of Mission Report ref. DG(SANCO)/2fllO-8436-MR carried out from 23 to 29 March 2010 in order to evaluate the «afrol of residues and contaminants and the ūse of veterinary medicinal producís in food producing animals

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Ίο amend the MANCP such that a description of lhe organisational relationships between the different Units involved in residues and veterinary medicinal product controls is included in Ene with the requirements of Article 42 (e) of Regulation (EC) No 882/2004.

Order No. ĀD (¡9-147/26.02.2010 (of 26.02.201 Ü) issued hy Ле Minister of Agriculture and Food has established an inter-instìMionaì working group to draft а new and properly updated MANCP with a deadline of 30'September 2010.

To ensure that the national residue control plan complies with requirements laid down in Articles 3 and 5 of Council Directive 96723/EC particularly to in relation to addressing the deficiencies observed in relation to the geographical distribution of sampling and coverage throughout the full year. Planning should take into accenni al! relevant data and be based on risk as required by Article 3 (1) of Commission Regulation (БС) No 882/2004.

To ensure that food business operators are not informed in advance of the scope of testing under the national residue control plan (i.e. by ml publishing the scope of testing, regions and

The following text has been added in Annex I, Item M(b) to (he 20 JO National Monitoring Plan for Contro! of Residues (NMPCR): "When doing sample-selection there should be an approach lo eliminate multiple sampliag of one and the same manufacturer and/or geographic region ". This text is intended to be taken in consideration by the NVS officials responsible for the implementation of the said plan /programme/

There is an Order (of ref. No. RD 11-420 of S1.O5.2O10) issued by WS Director-General to ensure that when performing sample-selection and sampling pursuant to NMPCR, the live animals or products concerned are to be selected on a random basis and from regions countrywide, in order to guarantee that the whole territory of the country v/oulâ be covered appropriately.

Alter been finalized and approved, the 201 ϋ NMPCR of VMPs or pollutants of environmental origin in live animais and products of environmental origin, the latter was promulgated on the web-page of NVS

Date; 10 May 2010

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Competent Authorities response received on 23 June 2010

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o S EespoBse of the Competent Authorities of Bulgaria to the reconnendadom of Mtafon Report ref. DG(SATCO)/2M0-8436~MR carried out

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months of sampling m advance) in orderio ensure that lhe element of surprise in checks is eomtmtly maintained, in accordance with the requirements of Annex Ш to Council Directive 96/23/BC

To easure that sampling for residues is carried out in accordance with, all of the requirements laid down in the Annex to Commission Decision 98/179/BC, and that testing is implemented in accordance with planned arrangements, if necessary taking appropriate corrective action to ensure this outcome as required by Article S (3) b of Regulation (EC) No Ш/2004.

To ensure the provision of adequate laboratory capacity for residue analysis as required by Article 4 (2) c of Regulation (EC)

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īn contrast to the one of 2009, the 2QÎÛNMPCR does not contain In its web-versl<m any regional plans for sampling distribution, i.e. page 166 of Annex, Vīte missing in the web publication.

The 2010 regional plans for control of residues have bee» forwarded only to the Regional Veterinary Service 's (RVS) officies responsible for their implementation, in order to ensure that respective FBÓs would not be notified in advance about any forthcoming sampling and would not be aware anyhow about any sampling (under theNMPCR) that is going to happen in their plants or farms.

The aforementioned Order (of ref No. RD 11-420 of 3105.2010} issued by NVS Director-General provides also for strict respecting ¡he sampling rides laïddovminÂnnexIto20IÙ NMPCR.

All the necessary actions have been taken to supply the needed laboratory reagents, consumables and equipment that are to be duty delivered in the laboratory concerned (CL VSEE), in order to ensure the proper performance of ali tests and analyses provided for in NMPC& (see also the text in the net item 5, herein under).

In response to tL· SANCO letter (cfref No. SÁNCO/EWMz (2010) 55Ô081) signed by Ms Paola Testori-Coggi), urgent measures have been

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Response of the Competent Aut&orities «f Bulgaria to the recommendations af Mission Repart ref. DG(SANCO)/2Oi0-8436-MR carried out from 23 to 29 Marc 201Ö in order to evaluate the control of residues and contaratīiatrts aud the use of veterinary medicinal products in food producing animate σι

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No 882/2004. taken to ensure ihe necessary level of laboratory capacity for control of residues. One of these steps involve the already started, public procurement (fender) procedure for "Delivery of Laboratory Reagents, Consumables and Equipment ", its deadline of public notification been 28.d5.2Uia

Early Odober of 2010 is the final deadline for resioraUan ofthefiiU laboratory capacity to perform all types of analyses currently suspended due to lack of resources and performing these appropriately.

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To ensure that appropriate quaüiy control measures are puţ in place in the laboratory in line with Article 5 of Commission Decision 2002/657/EC.

In order to ensure tke quality of analyses, the fallowing actions are foreseen:

® Elaborating and improving th e procedure for accepting or rejecting of samples, including the specification and establishing of written unambiguous criteria and precise tolerances;

® There is s new form (of ref. No. FK 504-6) entered into use in the residue laboratory (CL VSEE) io cover ihe processes of preparation and comparison of analytical standardized solutions;

• There is a procedure entered into use to ensure the proper identification and control of operational thermometers usedal cold-storage cab'mefs (refrigerators), freezers, incubators, drying cabinets (driers) and their regubr calibration against the

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Response of the Competent Authorities of Bulgaria to the recommendations of Mission Report ret DC3{SANCO}uí)10-843ťí"MR eanried out from 23 to 29 March 2010 in order to evaluate the control of residues and eontamtaanls and the use of veterinary medicinal products in food producing animals . . σι

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To ensure Ihat the requirements for on-řaím mediernes rerørtk, as laid down in Article 10 of Council Directive %/23/EC, are complied with.

control activities, including the usage of VMP(s) for animals and controls on residues and pollutants in food-

Artide 3$(2)(3) of the Law on Veterinary Activities (LVÁ) provides for that veterinarians exercising veterinary practice are obliged to record in th e holding logbook the following data; a) the date of usage (administering or other type of use) of a VMP to animal(s); b) name (brand), batch ftumber, best before date and withdrawal period of respective VMP used; c) this veterinarian shall also inform the owner of animat concerned about the health and legal consequences that might be result of miss-respect of withdrawal period of any VMP administered or medicated feeding stuff med.

According to Article 9(1) of Ordinance No. 42 (of 12.12 2008) on the requirements applicable to veterinary curative units (sites) and the type and scope of veterinary activities that may be performed therein, any veterinary clinic or ambulatory should keep its individual 'ambulatory' logbook, where veterinarians) operating therein shall record data on each professional action effected. The updated model form of this logbook will be approved and adopted under NVS DG 's order till the end of June 2010,

Date; 10 May 201Q

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Response of the Competetti Autboritíes of Balgaria to the recommeadattoiM ol Mission Report ref. BG(SA24CO)/2010-8436-MR carried out fFom 23 to 29 March 2010 in order to evaluate tie control of residues and cuatamtaants and the use of veterinary medicīnai products îo foed producing animals . . .

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50 BGN (aboul 25 Euro), while in case of repeated infringemeat this fine should he doubled (100 BGN);

2. Art. 452 (1) of the same law »ads "Anyone, who -violating Art. 374 (1), sell a VMP shall be penalized by a fine between 50 and 100 BGN, while in while in case of repeated infringement this fine should be between 200 BGN and 50» BGN.

3. Any person referred to in Ait. 355 (i.e. a VMP importer) who has committed a sale of a VMP So an owner of a /animal/ holding without been presented a recipe written and signed /issued/ by a veterinarian referred to in Art. 25(1) shall be penalized by a property sanction between 1000 BGN and 2000 BGN, while in case of repeated iafimgement this sanction mmst be between 2000 and 5000 BGN.

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To consider amending the format of food chain information in order to allow official veterinarian® in slaughterhouses ţo identify individual animals which may have been treated with veterinary medicinal producís and thus be targeted for residues testing in line with the requirements of Point 2.3 3.1. of the Annex to Cbimussion Decision 9&179ÆC.

The aforementioned Order (of ref Mo. W i 1-420 of 31.05 JOIO) issued by NVS Director-General provides also that any plant (FBO) dealing m primary treatment (slaughtering, processing etc. of primary products of animal origin) of live animals, raw materiāls andfor products thereof shall be extremky strict in requiring and checking the Déclarations provided for in Árt. 8(2) ofOrdmance IJ 9/21.12.2006, which documents shall be signed by respective animal owners and/or traders.

The aforementioned declaration should include the relevant data about

Date: 10 May 2010

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Response oř tne Competent Authorities of Bulgaria to the rscommendatio»s of Mission Report ref. DG<SANOO)/2010-8436-MR carried out from 23 to 29 March 2010 ín order to evaluate the control of residues and contaminants and the ase of veterinary medMna! products in food producing animals

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504/2008. After entering into full operation of the WS integrated information system (MS), the equidae module has been completely incorporated in iL Ås hy now NVS SS contains more than 1090 equidae, but entering such data is ongoing.

NVS have developed relevant texts to be adopted to amend appropriately Bulgarian Lavt on Veterinary Activities and the Tariff on fees and Charges to be collected by NVS. These texts are currently wider the procedure ofinter-instìtwtìonal agreement wider a NVS Letter of 28.04.2010 addressed to Ministry of Agriculture and Pood.

There is a NVS'DG Order (of ref П-320/15Ж2О10) to designate a working group to develop the appropriate amendments of the current version ofOrdhiance No. 61/9.Ů5.2006 on identification of animais and registration of animal holdings.

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To ensure thai horses without individual identification or aa equine passport or appropriate food сЬаш information do not eater the food chain in accordance with Commission Regulation (EC) No 504/2008.

There is an Order (of ref. No. RD Π-319/13.05.2010} issued by NVS Director General to expliátfy ban any reception into a slaughterhouse any equidae that are noi identified in accordance with the requirements of Regulation ßC) S04/2Ű0S.

12 To consider rationalising the current system for carrying out controls on veterinary medicinal producís to «enhance coordination and cooperation between official services in line with Article 4 (5) of Regulation (EC) No 882/2004.

There is a finalized version of a strategy document approved by the Council of Ministers and outlining the rules for establishing an "ExecUtve Agency for Food Safety and Center for Risk Assessment", its activities are to be focused on improving (he level of coordination and

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