REPUBLIC OF SEPBIAMINISTRY OF AGRICTJLTURE

FORESTRY AND WATER MANAGEMENTVeterinary Directorate

Ref: 323-07- 9412020-05103

Date: January 14,2020

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

HEALTH AND FOOD AT]DITS AND AI\ALYSIS

Subject: AUDIT 2019 - 6684, Ref. tuts(2019)443Yy2-l0l07n00 on the controls over the production ofred meat and meat products and milk and dairy products intended for export to the european union

Dear Sir/Madame,

Based on Audit Draft report the controls over the production of red meat and meat products and milk and dairyproducts intended for export to the European union (audit reports DG(SANCO) 2010-8509 and DG(SANCO)2010-8505, held from 22 October to I November 2019, the Competent AuthorityA/eterinary Directorate provides

with followed:

the Action plan:

ANNEX I -SERBIA - CVO LETTER&FORMS FOR DELATION OF FOOD ESTs

ANNEX 2 - Directive on the manner of official controls on establishments producing food of animal originin the process of approval for export to the European Union/EU, as well as on the procedure for suspension

and withdrawal from the List of Third countries' establishments ("non-EU countries") approved for exporlto the EU

ANNEX 3 - TRAINING PLAN 2O2O

ANNEX 4 - TRICINELLA LABs CHECK LIST

Updated documents based on planned action measures, stipulated in Action plan, Veterinary Directorate

shall follow the Audit Health and food audits and analysis of DG SANTE.

Sincerely,

hief

ANNEX

Response ofthe competent authorities ofserbia to the r€commendations ofrcport ref. DC(SANTE) 2019-6684 ofthe audit canied out from 22 October 2019to 0l November 2019 in order to assess the implementation ofthe corective actions taken following the audits on the controls over the production of rcdmeat and meat products and milk and dairy prcducts intended for e4,ort to the European Union (audit rcpoits DG(SANCO) 2010-8509 aIId DG(SANCO)2010-850s)

IFo RecommertdationI The CCA should take further measures to ensure that:

only those establishments that comply with requirements of the EU areincluded in the list of establishments to be authorised for EU export, inline with Article l2 of Regulation (EC) No 854/2004;only establishments which continue to comply with these requirements,are maintained in that list;in order to fully address the relevant recommendations of the previousaudits.In particular, the CCA should fully implement the national measuresrelated to listing/delisting and suspending of establishments for EUexport and should reinforce the measures related to follow up ofdeficiencies and to the enforcement of their correction in all EU-listedestablishments.Recommendation based on conclusions Nos 16,53 and 54.Associated finding No 7, 12, 73,74,44,45,50 and 52.

The procedure for approval and suspension of the establishmentsapproved for export to the EU and the procedure for listing on DGSANT'E Third Countries establishments list. approved for exportto the EU, was adopted on 31.01.201 l. no. 323-07-1983 I l1-05.

1'his procedure provides that in the case that a food businessoperator ceases to operate in the establishment listed on the EUapproved list fcr economic reasons, for an economical reason orbecause it no longer fulfils the corrditions for export, The centralcompetent authorityiVeterinary Directorate shall carry out theprocedure provided for in Article 77 of the Law on VeterinaryMatters (Official Gazette of the RS" No. 9112005, 3012010,93i2012), i.e., an inspection tearn shall be formed to determine theoperational status of the establishment and assess the level ofcompliance with the EU relevant general arrd specific hygierrerequirements.

In the case that the establishment does not meet the general and/orspecific structural corrditions. the EU approved establishmerrt shallbe suspended for export to the EU, for a period of up to sixmonths and the EU competent authoritv/Dc SANTE shall benotified ol'the suspension in question.

lf the establishment lails to fullil the reqtrired conditions forexport to the EU dtrring the suspensiorr period, the CentralCompetent Authority' shall undertake the activities for rvithdrawalof approval, including the lbnnal submission of a request to thecompetent authority of the relevant DG SANTE -Directorate F, to

Date: 14 January2020 Page: I

Actian Pro*osed'{tv the comoelefit ilalhoritv

ANNEX

Response ofthe comp€tent authorities of Serbia to th€ recommendations of report r€f. DG(SANTE) 2019-6684 ofthe audit carded out from 22 October 2019to 01 November 2019 in order to ass€ss the implementation ofthe corective actions tak€n following the audit on th€ conhols over the production ofredmeal and meat products and milk and dairy products intended for export to the Eurcpean Union (audit reports DG(SANCO) 2010-8509 and DG(SANCO)2010-8s0s)

oI ction Proposed b-y the fiftrlr€fefit ualharily

delisted the establishment flom the List o1'EU approved Thirdcountries establishments.

In the case of the two establishrnents that rvere first delegated tolre audit by side of the EU audit team, the slaughter activity wasnot carried out for a period longer thtrn 6 months" where thistnismatch rvas identilied shortly before the arrival of the EU audit.The Central Competent Authorilv, the Veterintuy Directorate.immediately after receiving the minutes flonr the con'lpetentinspection and request done by the food business operator to be

removed from the slaughter activity list, prepared the appropriatefonns and submitted a requests to the DG SANTE Directorate F,for deletion o1'these activities for targeted establishments.

Also. checking the other EU Iisted establishments that rvere notsub.iected to EU audit, it was found that several moreestablishments were no longer operational and VeterinaryDirectorate sent a request for its deletion from DG SANTE Lists.Please see Annex l.

In addition. in order to avoid such inconsistencies in the future,the Veterinary Directorate has adopted a nerv. irnproved Directiveon the nranner of approval and suspension of establishments forEU No. 323-07-9412020-05. from 8'l'January 2020.

Pleuse see Annex 2.

2 In order to support the statement of the animal welfare attestationcontained in the veterinary certificate for bovine meat in Regulation (EC)No 20612010, the CCA should ensure that official controls in relation to

The amendrnents on I-aw on animal welfare are in legalprocedure. Ihese alnendlnents shall provide legal basis foradoption of Rulebook harmonized with Regulation (EC) No.

Date: 14 January2020 Page: 2

ANNf,X

Respons€ ofthe competent aulhorities ofserbia to the rEcommendations ofreport rcl DC(SANTE) 2019-66E4 ofthe audit canied out from 22 October 2019to 01 Noyember 2019 in order to assess the implementation ofthe corrective aEtions taken following the audib on the contlols over the production ofr€dmeat and meat products a.nd milk aod dairy products intended for expo( to the European Union (Eudit reporb DC(SANCO) 2OlO-8509 and DC(SANCO)2010-8s05)

,lfo Recammendttion ,4ction Proposed hy the t'ompelcnt sulhoriry^the requirements of Regulation (EC) No 1099/2009 are systematicallyrecorded.Recommendation based on conclusions No 55.Associated findings No 38.

109912009, rvith clear provisions on an authority and technicalcompetence of animal welf'tue officer and the obligation forsetting out the standard operating procedtres of theslaughterhouse.

f'he Veterinary Directorate has also issued guidelines fbr thecontrol of animal rvellare during the slaughter, which contains therequirements stipulated in Regulation (EC) No. 109912009,including the frequency of official r.velfare controls at the lairageand slauglrter line.

Within the nevg Directive No. 323-07-941 2020-05, from 8'h

January 2020. durirrg the approval procedure of establishment as

well as auditing of conditions irr liU approved establishments. it ismandatory to use the checklist 06-Animal Welfare at slaughter.

ln cooperation with the Faculty of Veterinary Medicine, a trainingplan for veterinary inspection has been prepared and it isaddressed to the conditions of animal u,elfare in the lairage andon the slaughter line.

J In order to support the "Animal Health Attestations" contained in theveterinary certificates for dairy products (MILK-HTB and MILK-HTCpoint II.l(b) of Part 2 of Annex ll to Regulation (EU) No 605/2010), theCCA should ensure that official veterinarians participating in the EUcertification chain are aware of the relevant EU requirements, inparticular those related to the pasteurisation of milk (including therequirements related to alkaline phosphatase tests).Recommendation based on conclusions No 67.Associated findings Nos 64 and 65.

ln cooperation rvith the Faculty of Veterinary Medicine, theVeterinary Directortrte prepared the training plan for a veterinarianinspection relating to the following areas:

L Control on the operating system of pasteurization (tin're,temperattre. florv) * The work of the pasteurization device,rnonitoring of critical control points, flo,w calculation. correctivemeasures;

Date: 14 January 2020 Page: 3

ANNEX

Respons€ ofthe competeflt authoriti€s of Sorbia to the rc€ommendations ofreport rcf. DG(SANTE) 2019-6684 ofthe audit canied out ftom 22 October 2019to 01 November 2019 in order to assess the implementatiol ofthe corective actions taken following th€ audits on the controls over th€ Foduction ofredmeat and meat ploducts and milk and dairy products intended for export to the European Union (audit rcpofls DC(SANCO) 2010-8509 alld DG(SANCO)2010-8505)

2. Approval of the establishment and control of rarv milk systernirr accordance r+'ith EU requirements and milk processing fbcilitiesthat e.rpoft or intend to e.xpoft to the EU:

3. Certification requirernents fbr MILK-HTB and MILK-HTCbased on point IL I (b) of Part 2 of Annex II of (EtJ) No605/2A10);

,1. Alkaline fosfatasis - Test based on standard ISO I 1816-2:2016

Note: [n the check list of the approval o{'rnilk processingestablishment in accordance rvith the EU, it has been added apoint requiring the testing of the pasteurized rnilk - test alkalinephosphate is in accordance with tSO 11816-2:2016.

Please see Appendix 3. _- Education PIan for the year 2020.

Ihe time fi'ame for training is the first and second r of 2020.In order to support the attestation contained in point 11.2.3.1of the modelveterinary certificate for certain meat products of Annex III to theCommission Decision 20071777lEC, the CCA should ensure thatTrichinella detection laboratories meet the requirements of CommissionImplementing Regulation (EU) 2015/1375. In particular, thoselaboratories are designated and are subject to official controls by the CAand fully meet the requirements conceming the equipment used forexamination.Recommendation based on conclusion No 72.Associated findings No 70.

The Veterinary Directorate prepared a nerv rulebook. laying dorvnspecific rules on official controls for Trichinella in meat. inaccordance rvith the Regulation (EU) 201 5i1375.

With this rulebook, in addition to the transiton of EU regulation" itis errvisaged that all laboratories dealing Trichinella testing inmeat. als paft of the post-morlem inspection, shall be listed in theRegistry of official laboratory for the examination of the meat onthe presence of lrihinella in the Veterinary Directorate.

Based on the conditions fbreseen by the ner,v rulebook. veterinaryinspectiorrs rvill perfonn control of these laboratories in

Date: 14 lanuary 2020 Page: 4

NO Recommendalion Action Pronased l;t' the comoelent autharitt

4

ANNDX

Response ofthe competent authorilies of SerbiE to the recommendations ofrEport ref. DG(SANTE) 2019-6684 ofthe audit carried out fron 22 Octobcr 2019to 0l Novembff 2019 in order to assess the implementation ofthe corrective actions talcn following the aualits on the conhols over the production ofrcdmeat and meat products and milk and dairy products intended for export to the European Union (audit reports DG(SANCO) 2010-8509 aod DqSANCO)2010-8505)

accordarlce with the plan of official control and using theappropriate control list.

The deadline for adopting the rulebook and registratiori of thelaboratories is second quarter 2020.

Note: A special checklist that contains the conformity of meattesting on the presence of Trichinella in meat, btrsed on theprovisions from the Regulation (EU) 2015/1375, is prepared.

Pleuse refer to Annex ,4. Control List B

Date: 14 January2020 Page: 5

A$: Recommendation Actiott Pronued bv lhe tarr*t€t€nl aalharit,