Ref. Ares(2017)2559418 - 19/05/2017 TABLE OF CONTENTS
INTRODUCTION ...... 3 SUMMARY OF THE PROGRESS MADE BY THE MEMBER STATE IN THE IMPLEMENTATION OF RECOMMENDATIONS MADE BY DG HEALTH AND FOOD SAFETY...... 4 1. MAIN ISSUES ...... 5 2. FOLLOW UP STATUS OF RECOMMENDATIONS...... 6 2.A HORIZONTAL RECOMMENDATIONS ...... 7 2.B SECTORAL RECOMMENDATIONS ...... 7 2.B.1 Animal Health ...... 7 2.B.2 Food of animal origin...... 21 2.B.3 Imports of animals and food of animal origin...... 32 2.B.4 Feedingstuffs and animal nutrition...... 41 2.B.5 TSE\ABP...... 41 2.B.6 Veterinary medicines and residues...... 46 2.B.7 Foodstuffs and food hygiene...... 48 2.B.8 Imports of food of plant origin...... 49 2.B.9 Plant protection products...... 50 2.B.10 Animal welfare...... 50 2.B.11 Plant health...... 50 2.B.12 Quality Labelling ...... 52 3. OVERVIEW OF MORE RECENT AUDITS ...... 58 ANNEX I – ACRONYMS, ABBREVIATIONS, SPECIAL TERMS...... 60
2 DG(SANTE)/2016-8985 Final Version date May 2017 INTRODUCTION
The Directorate-General for Health and Food Safety of the European Commission, works to assure effective control systems for food and feed safety, animal health, animal welfare, plant health and food quality labelling and to evaluate compliance with EU standards. It does this mainly by carrying out audits in Member States and third countries.
It makes recommendations to Member States to deal with any shortcomings revealed during its audits. Member States are requested to present action plans on how they intend to address these shortcomings. Article 45 (5) (a) of Regulation (EC) No 882/2004 requires that Member States take appropriate follow-up action in the light of recommendations resulting from EU controls.
DG Health and Food Safety evaluates these action plans and systematically monitors their implementation through a number of follow-up activities. Verification of the completion and effectiveness of corrective action is an integral part of this activity.
The instrument of general follow-up audits to review progress on the implementation of recommendations made was introduced in 2005. This process follows the Commission services' "package meeting" approach whereby these audits provide an opportunity to discuss open issues with the competent national authorities. In the intervening period, Member States may provide additional information on progress and, following assessment by the Commission, this may result in an update of the follow-up status of recommendations.
This part of the country profile gives the current status of actions undertaken by the Member State in response to recommendations. The aim is to provide a summary of progress by Lithuania on the implementation of DG Health and Food Safety's recommendations.
The information in this part of the country profile has been compiled on the basis of a administrative follow-up which was carried out by our services in September 2016 and on information received since then from the authorities in Lithuania in response to the country profile issued in September 2016.
Administrative follow-up and general follow-up audits are regularly conducted in order to monitor progress in relation to open recommendations. This part of the country profile will be updated at regular intervals based on the results of future DG Health and Food Safety audits and other relevant information received by Commission services from the authorities in Lithuania.
3 DG(SANTE)/2016-8985 Final Version date May 2017 SUMMARY OF THE PROGRESS MADE BY THE MEMBER STATE IN THE IMPLEMENTATION OF RECOMMENDATIONS MADE BY DG HEALTH AND FOOD SAFETY
The following table gives an overview of DG Health and Food Safety's audits in Lithuania and shows the Commission services' assessment of actions taken in response to the recommendations contained in the reports of those audits.
This assessment is based on information and documentation received from the competent authorities and reviewed in the course of the 2016 administrative follow-up and on subsequent information provided by the authorities in Lithuania.
The basis for the assessment of actions in relation to individual recommendations is presented in Sections 2.A and 2.B.1 to 2.B.12. Recent finalised audit reports that are not yet ready for follow-up are listed in Section 3.
Overview of DG Health and Food Safety's audits in Lithuania 2009-2015
Total number of Control system Recommendations 2009-2015 finalised audits
Action Closed for In Action still Total taken other reasons progress required
Horizontal 1 8 8 0 0 0 Animal Health 3 21 18 0 3 0 Food of animal origin 6 40 36 4 0 0 Import controls 7 27 24 3 0 0 Feedingstuffs and 1 13 13 0 0 0 animal nutrition TSE/ABP 2 8 7 0 1 0 Veterinary medicinal 3 13 13 0 0 0 products and Residues Foodstuffs and Food 1 8 7 1 0 0 hygiene Imports of food of plant 1 8 8 0 0 0 origin Plant Protection Products (PPP) and 0 0 0 0 0 0 residues Animal welfare 3 16 16 0 0 0 Plant health 1 13 12 1 0 0 Quality labelling 1 5 5 0 0 0 Totals 30 180 167 9 4 0
General follow-up 3 audits
4 DG(SANTE)/2016-8985 Final Version date May 2017 1. MAIN ISSUES
There are no major issues that have been identified in Lithuania through DG Health and Food Safety's audits that still need to be addressed by the authorities.
5 DG(SANTE)/2016-8985 Final Version date May 2017 2. FOLLOW UP STATUS OF RECOMMENDATIONS
This part of the country profile gives the current status of actions undertaken in response to DG Health and Food Safety's recommendations. The aim is to provide a summary of progress by Lithuania on the implementation of our recommendations.
For the purpose of assessment, the terms: "Action taken," "In progress", "Closed for other reasons" and "Action still required" are defined as follows:
"Action taken": Appropriate measures to address the recommendation have been implemented by the competent authority. The recommendation is therefore closed.
"In progress": Appropriate measures to address the recommendation have been initiated by the competent authority but not all of the measures have been implemented. The recommendation therefore remains open.
"Closed for other reasons": For administrative, technical or legal reasons, follow-up of the recommendation is no longer appropriate. The recommendation is therefore closed.
"Action still required": Appropriate measures to address the recommendation have not been initiated by the competent authorities. The recommendation therefore remains open.
Given the nature and scope of the administrative follow-up, no verification through audit on-the-spot was carried out. The assessment undertaken through the administrative follow-up is considered complementary to other follow-up actions and verifications that may be necessary and carried out as part of future sectoral audits by our services. Recommendations classified as “In progress" or "Action still required" are not considered to require any immediate specific legal or administrative action on the part of Commission services. These recommendations will remain the subject of monitoring by Commission services to assess progress. If as a result of this monitoring the Commission services consider the situation in regard to any of these recommendations warrants additional action on its part, it will take the appropriate measures.
It should be noted that the number of recommendations in this overview does not represent, of itself, a measurement of the degree of responsiveness by the competent authorities or of the seriousness of problems. Some recommendations may be related to minor technical aspects while others may refer to more problematic, systemic, issues.
Acronyms are used throughout the following chapters for the sake of brevity. A list of acronyms, abbreviations and special terms is given in Annex I as a guide for the reader.
6 DG(SANTE)/2016-8985 Final Version date May 2017 2.A HORIZONTAL RECOMMENDATIONS
There are no recommendations currently open for follow-up.
2.B SECTORAL RECOMMENDATIONS
2.B.1 Animal Health
Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status 2014-7295-1 This recommendation was based on the findings in section 5.3 of the audit report that, due to Closed due to action a miscommunication from the CA, hunters believed that the objective was a 100% reduction in taken To communicate to the hunters the the wild boar population in the infected zone and a 90% reduction elsewhere. The associated current wild boar population conclusion in the the report was that the significant reduction in the wild boar population management policy to ensure that it is understood correctly and within the infected area has the potential of triggering future movements of infected animals implemented effectively as from surrounding areas. recommended by EFSA report: CA Response: "All hunting clubs should be repeatedly instructed by the State Food and EFSA-Q-2014-00149 (EFSA Journal Veterinary Service (SFVS) territorial branches till 15 September 2014 (Order of the Director 2014; 12(3):3616). of 19 August 2014 No B1-727)."
Updated CA action plan of 9 January, 2015: "Communication to the hunters was performed through territorial State Food and Veterinary Services (SFVS) and through representatives of Hunters and Fishermen associations sharing the newest information about African swine fever and wild boar population management strategy. By the Order No B1-727 of the Director of SFVS “On organisation of training” adopted on 19/08/2014 territorial SFVS were instructed
7 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status to organize till 15 September 2014 specified training on African swine fever for pig keepers, hunters, municipality, parishes, environment protection service workers, and animal supervisors".
"In all 51 territorial SFVS training was organised. Decision No. B1-875 of the Director of SFVS-Head of State Emergency Situation “On organisation of hunting” was adopted on 10/10/2014 in accordance with the recommendations of EFSA report (EFSA-Q-2014-00149 (EFSA Journal 2014; 12(3):3616) and CVET. This decision was circulated to territorial SFVS, which has organised the meeting with hunting organisations and informed them about the current wild boar population management policy. Ministry of Environment and Hunter and Fishermen association have been informed about this decision during the meeting held on 13 November."
Assessment: The Order B1-727 provides for a rather generic plan to train relevant stakeholders, including hunters. Wild boar population management is not specifically mentioned in the order. Further information on the completion of this action is needed, in particular to confirm that the specific issue of wild boar population management has been communicated and what exactly was the target group.
In the context of the Administrative Follow-Up of October 2016 the CA provided the following updated response: " Communication with the hunters was performed through territorial SFVS and through hunting organizations sharing the newest information about African swine fever and wild boar population management strategy. All hunters and interested organizations were informed about Decision No. B1-917 of the Director of SFVS - Head of State Emergency Situation 'For wild boar population control measures in the Republic of Lithuania' adopted on 05/10/2016 and the Order of the Director of 9 February 2016 No B1- 108 'For the payment procedure of approval description of the benefits for wild boar carcasses' and the Order of the Director of 13 November 2015 No B1- 1028 'For the procedure of
8 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status approval description of the calculation and benefits for 2015-2016 wild boar hunted female' which are published on SFVS website.
SFVS from the first case of ASF in Lithuania informs public and interested organizations, groups, etc. by publishing each ASF case in wild boar, about the current wild boar population management, about current ASF situation, and about all new decisions and implemented measures related to ASF on SFVS website:
http://vmvt.lt/naujienos/informacija-apie-afrikini-kiauliu-mara-0
http://vmvt.lt/naujienos/pristatytos-rekomendacijos-kaip-kovoti-su-akm
http://vmvt.lt/naujienos/uz-sumedziotas-sernu-pateles-ismokos-medziotojams
http://vmvt.lt/naujienos/medziotojai-ipareigojami-tikrinti-teritorijas-aplink-kiauliu-laikymo- vietas
http://vmvt.lt/naujienos/afrikinis-kiauliu-maras-2015-m-faktai-ir-skaiciai
http://vmvt.lt/naujienos/uz-surastas-sernu-gaisenas-bus-mokamos-ismokos"
The CA provided the Commission services with a table showing the wild boar population and the numbers of wild boars hunted, in respect of the years 2014, 2015 and in the year 2016 up to October. The CA also said that the population data for all wild animals can be found on the Lithuanian Ministry of Environment 's website http://www.am.lt/VI/index.php#r/966 .
Regarding whether the hunting levels had been in line with EFSA recommendations, the CA said that " SFVS according to EFSA recommendations released decisions of Director of SFVS - Head of State Emergency Situation, which contribute to the wild boar population
9 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status management and control measures."
Assessment: the Lithuanian authorities have taken action to address the recommendation.
2014-7295-2 This recommendation was based on the findings in section 5..2.2.3 of the audit report that In Progress Post only 10 domestic pigs which had died on farm in the infected area had been sampled for GFA To improve passive surveillance in laboratory analysis, and that three out of the six territorial units in the infected area had no domestic pigs by increasing the samples from dead domestic pigs sent to laboratory. The associated conclusion in the report number of laboratory analysis carried out on pigs that have died on was that the passive surveillance of domestic pigs remains relatively weak and, as such, is not farm in order to ensure effective effective in providing a sufficient level of confidence that ASF is being continuously ruled out as a potential cause of pig mortality. implementation of the section “surveillance in domestic pigs” in CA Response the ASF guideline (SANCO/7138/2013). "All measures for passive surveillance in domestic pigs are set up by the Order of the Director of SFVS of 17 February 2014 “On African swine fever monitoring and control measures” with the last amendments on 6 August 2014 (https://www.e- tar.lt/portal/legalAct.html?documentId=eda46460987b11e3bdd0a9c9ad8ce1bf). Updated action plan: Order of the Director of SFVS No B1-620 issued on 16 July 2014, which amended Order No B1-114 of 17 February 2014 “On African swine fever control and surveillance measures”, improved passive surveillance in domestic pigs by increasing the number of laboratory analysis carried out on pigs that have died on farm and obliged pig keepers to inform and veterinary practitioner to inspect and to take a samples from different age group pigs. Enhanced passive surveillance of ASF is based on epidemiological investigations and tracing, based on the information received from pig owner or during the inspection / control in case of suspicion of ASF or in case of lesions similar to ASF, by
10 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status increased mortality or morbidity of pigs kept and from the pigs with increased fever. Regular inspections to pig holdings (both commercial and back yards) will be carried out by official or authorized veterinarians in order to check health status of pigs in holdings. In case of detection of clinical signs, similar to ASF, increased morbidity and mortality, sampling will be performed for virological testing. Blood and in case of death - tissues (organs) samples will be investigated for presence of virus (from blood and organs). From sick domestic pigs blood samples will be taken and analysed by RT-PCR. From dead pigs, pigs from the ASF risk area slaughtered in slaughterhouses and for own consumption tissues will be taken and analysed by RT-PCR for ASF virus determination.From wild boars blood samples and tissues will be taken. Blood samples will be analysed for antibodies determination. Tissues from the same wild boar will be analysed using RT-PCR for presence of ASF virus.Blood samples from domestic pigs will be collected by authorized veterinarians and from wild boars blood and tissue samples will be collected by authorized veterinarians and / or hunters."
Assessment: As the amendment to B1-114 (i.e. B1-667) referred to above does not provide any amendments to passive surveillance as outlined in B1-114 and the implementation of the un-amended B1-114 during the time of the mission was deemed to be not effective - we need further clarification on how the passive surveillance has been improved.
In the context of the Administrative Follow-Up of October 2016 the CA provided the following updated response: " The sampling schemes for wild boars in the free areas of Lithuania (which are not included into the Annex to the Commission Implementing Decision 2014/709/EU)are designed to allow the detection of 5% prevalence with 95 % confidence(active surveillance) in combination with the enhanced passive surveillance. In Lithuania all dead wild boars (found dead or killed in road incidents) and all hunted wild boars within infected area (Part III and Part II ) have to be tested for ASF using PCR and upon availability of the blood sample (in case of hunted wild boars) – by ELISA. For confirmation
11 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status of ELISA positive results additionally IPT is test.
In the domestic pig sector sampling in pig holdings for laboratory investigations are based mainly on passive surveillance in the entire country, active surveillance in the free areas and active surveillance due to official inspections according to Commission Decision 2014/709/EU.
Combining the passive surveillance and active surveillance the sampling scheme for wild boar has been designed to allow detection of 5% prevalence with 95 % confidence (59 hunted wild boars in each district municipality) following the epidemiological investigation of the last ASF outbreaks, when ASF has been detected in hunted wild boars firstly. In the infected area all hunted wild boars are obliged for the laboratory test. In the entire country of Lithuania passive surveillance is enforced and every found dead or killed in road incident wild boar is subjected to laboratory investigation for ASF and samples are taken only by official veterinarian (organ samples or whole cadaver) and delivered in the framework of national ASF programme to National Reference laboratory.
All hunted and found dead wild boars will be sampled and tested for the presence of ASF genome using RT-PCR. The samples of positive for ASF wild boars will be retested using ELISA for ASF antibodies detection."
The CA provided the following data:
"ASF Passive surveillance data in the infected area:
District 2015 2016 Alytus 6 4 Anykščiai 16 55
12 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status Biržai 3 4 Elektrėnai 11 9 Jonava 2 10 Kaišiadorys 10 82 Kaunas 8 11 Kėdainiai 8 32 Kupiškis 5 - Lazdijai 7 6 Molėtai 20 8 Prienai 1 2 Šalčininkai 43 33 Širvintai 3 3 Trakai 22 1 Ukmergė 7 - Utena 41 34 Vilnius - 1
ASF Passive surveillance data in the free ASF area:
2015 –58 samples
2016 – 93 samples"
Assessment: The recommendation relates to passive surveillance in domestic pigs whereas the latest response from the CA relates to passive surveillance in wild boars. A clear response/data related to domestic pigs is needed.
13 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status Additional CA response of 16 March 2017:
"The latest Order of the Director of State Food and Veterinary Service (dated on 30 March 2016) No B1-265 (https://www.e- tar.lt/portal/lt/legalAct/43f022a0f66c11e58a059f41f96fc264/cyRSIkLzHF) amended several Orders and clearly stated, that passive surveillance should be enhanced and samples should be taken:
from every sick or suspected to be sick pig – samples should be taken and tested by ELISA and PCR;
from pigs, that died on the way to slaughterhouse;
from slaughterhouse – if any suspicion has been observed;
every dead mother sow and boars should be tested for African Swine Fever (ASF);
in the holding where more than 5 pigs died or if they have lesions similar to ASF – samples should be taken from the last 5 pigs died, older than 60 days.
In 2016 through passive surveillance samples from 415 dead pigs have been taken and tested and 39 out of them have been proven to be positive for ASF virus."
Assessment: The CA made an Order in 2016 on measures to improve passive surveillance and sampling for domestic and wild pigs. The CA has provided the number of passive surveillance samples taken from dead pigs in 2016, together with the number of samples which proved positive for ASF.
Further verification of the implementation of passive surveillance in domestic pigs will take
14 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status place on the spot during the next audit on ASF (audit 2017-6116, planned for November 2017).
2014-7295-4 This recommendation was based on the findings in section 5.1.4 of the audit report that Closed due to action incomplete movement notifications which are flagged in the database provide an opportunity taken To improve the use of data in the pig to find the holdings for which pig declarations are not made. However, the CA has not yet database to identify holdings, which used this possibility to target on-farm inspections. The associated conclusion in the report was may have introduced animals without notifying them – in order to that the pig data-base has not been used to its full extent for targeting controls – leaving a give effect to the requirement of possibility for some keepers to escape controls while they could be easily detected . Article 15 (b) of Directive CA Response 2002/60/EC on carrying out and up- dating a census of all categories of "By the Decision of the SFVS Director – State Level Emergency Manager on 21 August 2014 pigs. No B1-746 all pig keepers should till 15 September 2014 renew data about pigs kept and to register all places without any sanctions which are not registered yet and to notify about any movement of pigs kept or introduced to the holding."
In the context of the Administrative Follow-Up of October 2016, and in relation to the impact of Decision B1-746 mentioned above, the CA provided the data in the table below. The table shows the decrease in the number of holdings, and pigs, between January 2014 and October 2016.
Date No of holdings No of pigs 2014-01-01 till 2014-12-31 40261 708861 2015-01-01 till 2015-12-31 28049 642883
15 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status 2016-01-01 till 2016-10-01 22328 623861
Assessment: the Lithuanian authorities have taken action to address the recommendation.
2014-7295-5 This recommendation was based on the findings in section 5.4 of the audit report which state In Progress Post that the audit team could not obtain, in either of the territorial units visited, a comprehensive GFA To ensure that Heads of territorial and unambiguous overview of the current delivery of the control programme or of the units are monitoring and verifying effectiveness of official controls carried out at territorial units. The associated conclusion in the effectiveness of controls as specified in the SFVS Quality the report was that the lack of regular verification and evaluation activities by senior Management System in order to give managers and scientific experts allows potential weaknesses in ASF controls to remain undetected. effect to the requirement in Article 8(3) of Regulation 882/2004. CA Response: "For the year 2015 it is foreseen to verify all territorial SFVS within the administrative units where African swine fever has been detected."
In the context of the Administrative Follow-Up of October 2016 the CA provided the following update: "ASF outbreaks in 2015 were detected in Jonava district municipality (one outbreak in backyard farm), in Trakaidistrict municipality (11 outbreaks in backyard farms) and in Kupiškis district municipality (1 outbreak in backyard farm). SFVS actively participated in the outbreaks eradication works. After positive results received according to contingency plan specialist group starts its activities. Organised meetings with territorial SFVS to discuss an action plan. In 2016 – in total 18 outbreaks in backyard farms (in Anykščiai, Elektrėnai, Jonava, Kaišiadorys and Kėdainiai district municipalities). Specialists from other local authorities were involved to perform epidemiological investigation. All information was delivered to central authority. Local contingency plans were reviewed and
16 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status updated. All contacts from other institutions were updated too. Local authorities share information about local contingency plans with colleagues from municipalities, police, fire fighters. Also real time exercise was performed in close communication with other institutions. In 2016 special group was established to ensure help for local authorities.
SFVS yearly approves Control program of infectious animal diseases by the order of the State Food and Veterinary Service director (SFVS Director order No. B1-17, 2015 January 9, with last amendments for the year 2015 and SFVS Director Order No B1-8, with last amendments, 2016 January 12 for the year 2016). National Food and Veterinary Risk Assessment Institute sends by e-mail monthly reports about performed tests. Also daily sends information about ASF test results. All territorial SFVS are controlled according to Control program of infectious animal diseases. SFVS analyses the data of taken samples. Also territorial SFVS data are inspected on the spot. On the circumstances the data of the samples are checked on the National Food and Veterinary Risk Assessment Institute.
From 2016, territorial SFVS monthly sends information to SFVS about bio-security inspections of the backyard farms in their territory.
According quality programs, territorial SFVS are verified annually."
Assessment: The recommendation relates to the monitoring and verification actions of the Heads of Territorial Units whereas the CA's update relates to the activities of the central level of the CA. An updated response is needed in relation to the monitoring and verification actions of the Heads of Territorial Units.
Additional CA response of 16 March 2017: The CA provided a copy of Order of Director of the State Food and Veterinary Service No. B1-100 of 27 February 2017 on the Approval of
17 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status the Verification Plan of Official Food and Veterinary Control for 2017.
Assessment: The document provided by the CA gives little further information in relation to the verification and monitoring activities of the Heads of Territorial Units in relation to ASF. No results of these activities have been provided.
This issue will be further assessed on the spot in the next audit on ASF (audit 2017-6116, planned for November 2017).
2014-7295-6 This recommendation was based on the findings in section 5.4 of the audit report that the In Progress Post independent expert group had provided relatively limited input to the eradication activities, in GFA To ensure that the expert group particular in relation to the verifying the effectiveness of eradication measures. The provides assistance in all areas associated conclusion in the report was that the lack of regular verification and evaluation covered by the sub-indents of Article 15.2(a) of Directive 2002/60/EC and activities by senior managers and scientific experts allows potential weaknesses in ASF in particular, in the verification of controls to remain undetected. effectiveness of eradication CA Response: "The expert group meeting was held on 19 May 2014. During the meeting measures, as required by the last current situation on ASF was presented together with the last draft of ASF eradication plan, sub-indent. which was intended to be sent for approval to the European Commission after expert group opinion. The plan was sent to each member and all the remarks have been taken into account before the submission."
"Updated action plan of 9 January, 2015: SFVS asked expert group for assistance in all areas covered by the sub-indents of Article 15.2(a) of Directive 2002/60/EC and in particular, in the verification of effectiveness of eradication measures, as required by the last sub-indent in 2014 and received negative reply, so for the year 2015 SFVS has an intention to form new
18 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status independent expert group from the biologist, scientist and environment specialists."
In the context of the Administrative Follow-Up of October 2016 the CA provided the following update: "In the ASF and CSF contingency plan, which was updated in 2016 and approved by the SFVS director Order No B1-357 on 3 May 2016, the expert group is established. The contacts and their activities are described. Expert group includes veterinarians, biologist, epidemiologists and environment specialist. The contacts were updated.
After ASF outbreaks in 2014, SFVS asked National Food and Veterinary Risk Assessment Institute specialist which are in the expert group to prepare an ASF risk assessment and scientific advice. On 2015 April 30 it was sent to SFVS by the letter No 3A-297.
During the ASF outbreaks experts of the group help SFVS to study the epidemiological situation and defining an infected area. SFVS organise meetings with experts and always ask for opinion and help during the outbreaks. SFVS service regularly organized trainings for local authorities’ specialists and performed trainings how to detect ASF, what are the clinical signs, what are measures in suspicion and outbreak period. Also we share experience from other countries."
Assessment: It is not clear from the latest response whether the expert group has provided assistance in the verification of the effectiveness of disease eradication measures, as requested in the recommendation.
Additional CA response of 16 March 2017:
"By the Order of the Director of State Food and Veterinary Service on 3 May 2016 No B1-357 an updated Contingency Plan on Classical and African Swine fever has been approved,
19 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status including the new Expert group. Former Expert group consisted from 7 members and current – from 10. The majority of the experts belongs to the National Food and Veterinary Risk Assessment Institute (5 members), Lithuanian University of Health Science, Veterinary Academy (3 members) and Nature Research Institute (2 members). The physical meeting with all members of the Expert group since the group has been established has never been conducted, but on regular basis information exchange is performed with the Expert group members from National Food and Veterinary Risk Assessment Institute and based on their recommendations / suggestions sampling plans in wild boar and domestic pigs has been modified - samples from wild boar are taken from every hunted wild boar (blood and organs) in the infected area (Part II and III of the Annex of Commission Implementing Decision 2014/709/EU) and tested using RT-PCR and ELISA and additionally for confirmation of positive or doubtful ELISA results samples are tested by IPT (imunoperoxidase technique).
Since the establishment of the Expert group it has been never provided assistance in the verification of the effectiveness of the disease eradication measures and also no view on why new outbreaks have occurred has been provided.
State Food and Veterinary Service eradication measures for ASF are strictly based on the EU legislation – Directive 2002/60/EC, Commission Implementing Decision 2014/709/EU and Documents SANTE/7113/2015 and SANCO/7138/2013. The current legislation clearly defines all principles of surveillance, control and eradication. Post-outbreak epidemiological investigation is carried out in accordance with National Contingency Plan by the epidemiological investigation group."
The CA provided a copy of the risk assessment and scientific advice from the National Food and Veterinary Risk Assessment Institute (letter No 3A-297 of 30 April 2015).
Assessment: The CA stated that the Expert Group does provide recommendations/
20 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7295 of 14 April 2014 in order to evaluate the implementation of animal health controls in relation to African swine fever Recommendation Basis for assessment Current Status suggestions on sampling plans but that it does not provide assistance in the verification of the effectiveness of the disease eradication measures. The CA has provided a copy of the risk assessment completed by the National Food and Veterinary Risk Assessment Institute. The CA also stated that Post-outbreak epidemiological investigation is carried out in accordance with National Contingency Plan by the epidemiological investigation group.
These matters will be further discussed and the issue assessed on the spot in the next audit on ASF (audit 2017-6116, planned for November 2017).
2.B.2 Food of animal origin
Audit 2012-6357 of 31 January 2012 in order to evaluate the follow-up action taken by the competent authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products Recommendation Basis for assessment Current Status 2012-6357-2 This recommendation was based on the findings in section 5.4 of the audit report which stated Closed due to action that there had been poor results in the proficiency tests for laboratories performing analyses taken To ensure that Trichinella for Trichinella, and that only the National Food and Veterinary Risk Assessment Institute and examinations are only performed in two of its four territorial sections were accredited for Trichinella testing. laboratories that have demonstrated the ability to carry out these CA Response examinations in full compliance with the requirements of Regulation (EC) "An evaluation of the capability of testing Trichinella was foreseen to be carried out in the last
21 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2012-6357 of 31 January 2012 in order to evaluate the follow-up action taken by the competent authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products Recommendation Basis for assessment Current Status No 2075/2005. quarter of 2012. It has been postponed to 2014. by Director Order B1-67 of 30 January 2014, the CCA instructed the National Food and Veterinary Risk Assessment Institute (NFVRAI) to carry out evaluation of the capability of testing Trichinella in all the existing Trichinella laboratories located in establishments throughout Lithuania, to select the ones which have demonstrated the capability to carry out these examinations in full compliance with the requirements of Regulation (EC) No 2075/2005, and to prohibit those activities in other ones". The CCA indicated that the results of evaluation (October 2014) and actions plans (November 2014) are expected be completed in the last quarter of 2014.
"In order to organise another round of PTs, two LT laboratory experts attended a 2-day Trichinella spiking course (October 2013, NRL-Estonian Veterinary and Food Laboratory, Tartu). Specific training has not been provided yet and the NFVRAI indicated that it will be organised after the exercise above, if it is needed."
In the context of the Administrative Follow-Up of October 2016 the CA provided the update below, together with supporting documentary evidence:
"By SFVS Director Order No. B1-67 of 30 January 2014, the CCA instructed the National Food and Veterinary Risk Assessment Institute (NFVRAI) to carry out evaluation of the capability of testing Trichinella in all the existing Trichinella laboratories located in slaughterhouses throughout Lithuania, to select the ones which have demonstrated the capability to carry out these examinations in full compliance with the requirements of Regulation (EC) No 2075/2005, and to prohibit those activities in other ones.
Till 15/09/2014, NFVRAI audited 53 laboratories at slaughterhouses, which perform the analysis of Trichinella larvae in accordance with Commission Regulation (EC) No 2075/2005 by the reference method of detection, and presented a detailed inspection and assessment
22 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2012-6357 of 31 January 2012 in order to evaluate the follow-up action taken by the competent authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products Recommendation Basis for assessment Current Status report. During the audits, it was established that 92.5 % of employees of the audited laboratories were competent to perform Trichinella detection analyses in accordance with Commission Regulation (EC) No 2075/2005 (by the reference method of detection). The laboratories rectified the irregularities and presented justifying documents.
On 30/10/2014, NFVRAI organised training for the staff of official laboratories available at slaughterhouses on the topics 'Detection of Trichinella larvae by the digestion method (EC 2075/2005 reference method of detection)' and 'Requirements for ensuring the quality of the method'. 40 veterinarians from 37 territorial SFVSs of the SFVS attended the training.
On 03/14-11-2014, NFVRAI, in accordance with the standard working procedure SOP 5.4.4.M.19:2014, organised inter-laboratory comparative tests for the detection of Trichinella larvae in meat in accordance with Chapter I, Annex I to Commission Regulation (EC) No 2075/2005 (reference method of detection). 45 official laboratories available at slaughterhouses, which received three encoded control samples of pig diaphragm each, participated in these analyses. 80% of the laboratories received positive assessment whereas 20% – negative. (NFVRAI Standard operating procedure SOP 5.4.4.M.19:2014 'Organisation of checks of qualification for the analysis of Trichinellosis by the reference method of detection and preparation of control samples').
The SFVS, after having analysed the report on the participation of official laboratories available at slaughterhouses at the inter-laboratory comparative tests provided by NFVRAI,instructed (SFVS Letter No No B6-(1.11)-933 of 14-04-2015) to organise follow-up proficiency tests for the performance of analysis for detection of Trichinella larvae for official laboratories available at slaughterhouses (20% of the laboratories, which received negative assessment after corrective actions) and to assess the results of this examination.
23 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2012-6357 of 31 January 2012 in order to evaluate the follow-up action taken by the competent authorities with regard to official controls related to the safety of food of animal origin, in particular meat, milk and their products Recommendation Basis for assessment Current Status On 11/19-05-2015, NFVRAI organised inter-laboratory comparative tests for the indicated laboratories, the results of which were assessed as 100 % positive.
On 30-11-2015, SFVS, in view of the results of both inter-laboratory comparative tests organised by NFVRAI, drew up Order No B1-1059 of Director of SFVS of 30-11-2015 'On the approval of the list of laboratories carrying out analyses for the detection of Trichinella under official meat control' with the list of 58 laboratories (including the accredited NFVRAI with its territorial units), which carry out analyses for the detection of Trichinella under official meat control."
The CA also commented that "... Regulation 882/2004 is going to be amended and the amendments will come into force very soon and the new version of Article 39 of the new Official control regulation is: 'Derogations from the condition for the mandatory [...] accreditation for certain official laboratories', i. e. by derogation from point (e) of Article 36(4), competent authorities may designate the following as official laboratories irrespective of whether they fulfill the condition provided for in that point: iv) participate regularly and have satisfactory performance in the inter-laboratory comparative tests or proficiency tests organised by the national reference laboratories for the methods they use for the detection of Trichinella."
Assessment: the Lithuanian authorities have taken action to address the recommendation.
24 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2013-6671 of 29 May 2013 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products Recommendation Basis for assessment Current Status 2013-6671-1 This recommendation was based on the finding in section 5.1 of the audit report that national Closed due to action provisions regarding the direct supply of “small quantities” to final consumer or the retail taken The CA should notify to the level had not been communicated to the European Commission and Member States. This is European Commission and Member contrary to the requirements of Directive 98/34/EC, States their national legislation regarding the direct supply, by the The national legislation regarding the direct supply by the producer of small quantities of producer, of small quantities of primary products to the final consumer / local retail establishments was reviewed by the primary products to the final CCA. The Commission and Member States were notified of the draft legislation on consumer or to local retail 21/07/2015 by means of TRIS Notification Number 2015/400/LT. establishments directly supplying the final consumer in line with Directive Assessment: the Lithuanian authorities have taken action to address the recommendation. 98/34/EC.
2013-6671-2 This recommendation was based on the findings in section 5.2 of the audit report which stated Closed due to action that the CA had granted conditional approval to an establishment even though all taken The CA should ensure that only infrastructural requirements had not been met, and that the CA had not visited the establishments which fully comply establishment to evaluate progress within three months following the granting of conditional with the requirements foreseen in Regulations (EC) Nos 852/2004 and approval, as set out in legislation. 853/2004 are approved in CA Response: accordance with Article 3 of Regulation (EC) No 854/2004. 02/09/2013 - "In the second half of 2013 (25/10/2013), training for inspectors of territorial SFVSs on official veterinary control of fishery products with the focus on control issues related to the enforcement of requirements for the veterinary approval of fishery
25 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2013-6671 of 29 May 2013 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products Recommendation Basis for assessment Current Status establishments is planned.By the end of 2013, on the order of the director of the State Food and Veterinary Service in order to increase the effectiveness of control, 10 co-ordination centres (territorial SFVSs) will be appointed one of their functions being the assignment of veterinary approval numbers and conduct of HACCP audits with the most experienced inspectors involved in those tasks."
Assessment following the GFA of May 2014:
A one day training course was organised in October 2013 for staff performing controls on the fish and fishery products and involved in the approval of the establishments. In total 156 participants were trained: 1-2 officers for each territorial SFVS.
In order to increase the effectiveness of the approval procedure the SFVS anticipated, in the original action plan sent to the Commission, the appointment of 10 co-ordination centres (territorial SFVSs). At the time of the GFA the project was still under discussion. Work on developing this new project was on-going and new legal arrangements were needed. No timetable was provided by the CCA.
In the context of the Administrative Follow-Up of October 2016 the CA provided the update below, together with supporting documentary evidence: "In order to rectify the irregularities related to infrastructure that were revealed in the establishment, on 04/06/2013, the activity of the establishment was suspended, and the permission for the activities was resumed after the establishment has rectified the irregularities and additional on-the-spot checks were conducted.
In order to prevent similar violations SFVS entrusts control of certain operators to officers from other territorial SFVSs who have higher qualification. For this purpose 18 inspections
26 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2013-6671 of 29 May 2013 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products Recommendation Basis for assessment Current Status have been conducted at fishery establishments in 2016 (risk assessment of business operators of territorial units of SFVS was carried out, inspections of activities of business operators of territorial units of SFVS that are subject to control were organised, if necessary, instructions were given to territorial SFVSs that are subject to control on adjustment of produced documents, sanctions for identified irregularities were applied to business operators of territorial SFVSs, etc.).
Seeking the implementation of this recommendation Order No B1-114 of Director of the State Food and Veterinary Service of 10 February 2016 'On internal control procedures at territorial units of the State Food and Veterinary Service' was adopted, the 'List of controlling territorial units of the State Food and Veterinary Service and territorial units of the State Food and Veterinary Service subject to control' was approved. 7 controlling SFVSs (i. e. coordination centres) were appointed and included in the list, which were entrusted to control the activities of the territorial units assigned to them (i. e. to perform HACCP control of business operators of territorial units of SFVS, to control the approval of operators and withdrawal of the approval,to organise inspections of activities of business operators, to participate in investigations into complaints or other reports, if necessary, to give required instructions to territorial units of SFVS that are subject to control on enforcement of orders, apply sanctions to business operators of territorial units of SFVS that are subject to control for identified irregularities).
Seeking the implementation of this recommendation and to ensure that establishments that are not in conformity with infrastructure requirements are not presented for approval and that the deadlines for the validity of conditional approvals are observed, evaluation of the effectiveness of control of fishery product handling establishments is carried out both through available information systems and by going to the fishery product handling establishments to make an on-the-spot assessment of the control carried out, if inspectors had duly assessed the
27 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2013-6671 of 29 May 2013 in order to evaluate the food safety control systems in place governing the production and placing on the market of fishery products Recommendation Basis for assessment Current Status compliance of the establishment with structural, hygiene and safety requirements, documents are completed, corrective actions are applied and if they are adequately understood by officers.
In 2014–2016, 21 evaluations of the effectiveness of control of fishery product handling establishments were carried out, during which irregularities in infrastructure of the establishments and in approval conditions were identified. The effectiveness of control was evaluated as: 13% in 2014, 14% in 2015 and 17% in 2016 of the total number of approved fishery product handling establishments."
Assessment: the Lithuanian authorities have taken action to address the recommendation.
Audit 2014-7106 of 09 September 2014 in order to evaluate the operation of official controls over the post-slaughter traceability of meat, meat productsand preparations, composite products Recommendation Basis for assessment Current Status 2014-7106-2 This recommendation was based on the findings in section 5.2.2.2 of the audit report which Closed due to action states that the audit team had noted, in several instances, that the identification mark on taken The CCA should ensure that packages destined for the final consumer had not been applied in the establishments of identification marks are applied in production. compliance with Article 5 and in addition with paragraph 1, Part A, CA Response Section I of Annex II to Regulation (EC) No 853/2004, before product in "On 02/12/2014, training was conducted for inspectors of territorial SFVSs during which they
28 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7106 of 09 September 2014 in order to evaluate the operation of official controls over the post-slaughter traceability of meat, meat productsand preparations, composite products Recommendation Basis for assessment Current Status a package destined for direct supply were presented the labeling infringements detected during the FVO audit, requirements for the to the final consumer leaves the application of identification marks were explained with the special emphasis on the establishment of production. requirement that the marking of products intended for the final consumer with the identification mark has to be endured before they leave the establishment. The territorial SFVSs where the infringement had been detected in establishments under their control have delivered evidence on actions taken in the establishments to rectify the infringement."
In the context of the Administrative Follow-Up of October 2016 the CA provided the update below on the training given to official control staff, and on the correction of deficiencies identified in the report. The CA provided supporting documentary evidence.
"On 2 December 2014, the SFVS conducted training for food and veterinary control specialists of territorial units. The training programme included the topic: Overview of irregularities identified during audit conducted by the Food and Veterinary Office (FVO) of the European Commission on the traceability of meat and meat products after slaughter, which took place on 9–19 September 2014, and implementation of recommendations provided in the report. The training materials are available on the intranet site of the SFVS.
SFVS confirms that the non-compliances in the companies where the irregularity concerning the marking of the final product with the identification mark was revealed during audit, were corrected. The labels of products, with which the products are sent from the establishment to distributing storages, are presented, identification marks are indicated on the labels."
Assessment: the Lithuanian authorities have taken action to address the recommendation.
(See also recommendation 2014-7106-3, below).
29 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7106 of 09 September 2014 in order to evaluate the operation of official controls over the post-slaughter traceability of meat, meat productsand preparations, composite products Recommendation Basis for assessment Current Status
2014-7106-3 This recommendation was based on the findings in section 5.2.2.2 of the audit report which Closed due to action states that the audit team had noted incorrect, incomplete or misleading information on taken The CCA should ensure that the consignments of food of animal origin, such as the erroneous labeling of ABP containers, FBOs comply with the requirements missing batch numbers, and various different terms being used on commercial documents to of Article 3 of Regulation (EU) No 931/2011 regarding the availability describe MSM. This incorrect information misleads FBOs using these products as raw and content of the information material as a result of which the correct labelling of the final product cannot be ensured. concerning consignments of food of CA Response animal origin in particular where different establishments share "On 02/12/2014, training was conducted for inspectors of territorial SFVSs. Inspectors were facilities under the same roof. presented the infringement related to insufficient information in case of moving a product from one establishment to another establishment; requirements for the transfer of information on products set out in Article 3 of Regulation (EU) No 931/2011 were explained.The territorial SFVSs where the infringement had been detected in establishments under their control have delivered evidence on actions taken in the establishments to rectify the infringement and on the implementation of the procedure for the delivery of information on products when they are moved from one establishment to another."
In the context of the Administrative Follow-Up of October 2016 the CA provided the update below on the training given to official control staff, and on to the correction of deficiencies in the establishments concerned. The CA provided supporting documentary evidence.
"On 2 December 2014, the SFVS conducted training for food and veterinary control specialists of territorial units. The training programme included the topic:Overview of
30 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7106 of 09 September 2014 in order to evaluate the operation of official controls over the post-slaughter traceability of meat, meat productsand preparations, composite products Recommendation Basis for assessment Current Status irregularities identified during audit conducted by the Food and Veterinary Office (FVO) of the European Commission on the traceability of meat and meat products after slaughter, which took place on 9–19 September 2014, and implementation of recommendations provided in the report. The training materials are available on the intranet site of the SFVS.
Corrective actions were taken at the establishment concerning the labelling of category 3 animal by-products at the labelling terminal of the establishment and the oval-shaped identification mark is no longer used for the labelling of category 3 animal by-products that are not intended for human consumption.
The control of incoming raw materials was strengthened at the establishment, while, as regards the unduly performed documentary control, warnings were issued for the responsible persons of the establishment. Raw materials arrive at the establishment with duly and fully completed international freight waybills CMR. One CMR is completed for one consignment of raw materials.
On 25/11/2014, the procedure for the production and packaging process was changed at the establishment including clear specification of the provision of required information at the moment of transfer of the product from one establishment to another with the indication of the name of the product, date,batch number and identification mark. The other poultry meat establishment with identified non-compliances of information about the product has ceased its activities."
Assessment: the Lithuanian authorities have taken action to address the recommendation.
(See also recommendation 2014-7106-2, above).
31 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7106 of 09 September 2014 in order to evaluate the operation of official controls over the post-slaughter traceability of meat, meat productsand preparations, composite products Recommendation Basis for assessment Current Status
2.B.3 Imports of animals and food of animal origin
Audit 2011-8925 of 11 April 2011 in order to evaluate the follow-up action taken by the Competent Authorities with regard to the import/transit control system and border inspection posts Recommendation Basis for assessment Current Status 2011-8925-4 This recommendation was based on the findings of section 5.7.2 of the audit report which Closed due to action stated that the non-compliances identified in previous audit 2009-8079 in relation to the taken To correct the structural deficiencies storage of products for non-human consumption had not yet been addressed by the CA. at the BIP Pilies in order to comply with the requirements of Directive CA Response 97/78/EC and Decision 2001/812/EC. "Information received on 19/7/2011: The State Food and Veterinary Service has sent the letter No. B6-(1.20)-1129 of 21 June 2011 with the proposals on the rectification of deficiencies noted for the Pilies BIP, to Food and Veterinary Office."
Assessment in the context of the October 2016 desk review of the progress of follow-up actions:
This issue was followed up with the CA during the audit 2015-7433 on the official controls on consignments in transit. The Lead Auditor reported that the CA had addressed the issues satisfactorily and that the CA had provided photos of the refurbishment of BIP Pilies.
32 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2013-7116 of 18 October 2013 in order to evaluate the implementation of border controls against African swine fever Recommendation Basis for assessment Current Status 2013-7116-1 This recommendation was based on the finding 26 in the audit report which stated that Closed due to action passengers at the border with Belarus who were detected with products of animal origin, and taken To ensure the uniform who did not abandon the products, were allowed to return to the third country of origin. The implementation of the requirement associated conclusion was that this reduces the effectiveness of the controls in deterring of Article 6(1)(b) of Regulation (EC) No 206/2009 in order to seize and further attempts to illegally import products of animal origin. destroy all prohibited products of CA Response animal origin detected at the designated entry points. "Pursuant to point 5 of the trilateral order No B1-196/ 1B-244/ 4-314 of the Director of the State Food and Veterinary Service, Director General of the Customs Department under the Ministry of Finance of the Republic of Lithuania and Commander of the State Border Protection Service under the Ministry of Interior of the Republic of Lithuania of 29 April 2009 on the approval of procedure for the official control of animal products imported from third countries for personal use (Official Gazette, 2009-05-05, No 50-2026), the official control of consignments of animal products brought from third countries, which are not accompanied by veterinary documents, shall be performed by the Customs Department under the Ministry of Finance of the Republic of Lithuania and the State Border Protection Service under the Ministry of Interior of the Republic of Lithuania (https://www.e- tar.lt/portal/forms/legalAct.html?documentId=TAR.0450F2A88EF9)The Customs Department under the Ministry of Finance of the Republic of Lithuania has informed that they had studied the European Commission Audit Report and had no comments on it. In view of Article 6(b) of the Commission Regulation (EC) No 206/2009 of 5 March 2009 the Customs Department under the Ministry of Finance of the Republic of Lithuania confiscates and destroys the products of animal origin imported from third countries for personal use the entry of which is banned.The State Border Protection Service under the Ministry of Interior (hereinafter – SBPS) in view of the finding No 26 of the FVO Draft Audit Report informs that the SBPS officers working at the border control posts of local traffic with the Republic of Belarus will
33 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2013-7116 of 18 October 2013 in order to evaluate the implementation of border controls against African swine fever Recommendation Basis for assessment Current Status be additionally informed by means of official notifications, which will include descriptions of inspection results. During inspections, the overall performance of border control posts of local traffic is assessed while the control of products of animal origin is not separately performed. In view of the draft FVO recommendations the SBPS is going to conduct separate audits for the control of products of animal origin carried in private luggage."
Assessment
This recommendation was followed-up during the course of audit 2015-7433 to evaluate the official control system implemented by the competent authorities on consignments transiting the EU (February 2015). The Lead Auditor reported that the CA had put further measures in place to ensure that controls at the borders are effective. The CA has conducted separate inspections for the control of products of animal origin carried in private luggage. As a proof the CA provided evidence of written communications to the SBS officers and also reports of the confiscation and destruction of personal consignments.
Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status 2015-7433-1 This recommendation is based on findings 3, 11 and 15 of the audit report establishing that Closed due to action the CA had not implemented specific requirements for communication, cooperation and taken To develop procedures, in line with training in regard to the transit of live animals (following a 2013 similar recommendation) requirements laid down in Article 8 and in controls on external transits (which are not included in the planning of controls). In of Regulation (EC) No 882/2004. addition, lack of clear instructions on resealing of consignments subject to full identity checks Recommendation based on
34 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status conclusion 7. at BIPs could lead to inconsistencies among BIPs.
Associated findings: 3, 11 and 15. CA Response:
"By Order No. B1-406 of SFVS Director of 7 May 2015, were approved:
1) Standard operating procedure of the quality system KT-6-10 'On veterinary checks of live animals in transit',
2) Work instruction KT-6-10-D1 'Veterinary checks at a border inspection post (hereinafter – BIP) of entry of live animals in transit', and
3) Work instruction KT-6-10-D2 'Veterinary checks at a BIP of exit of live animals in transit'.
The border veterinary control procedure for EU consignments that have transited via third countries and re-entered the EU territory via a BIP will be drawn up and is envisaged to be approved by the 2nd quarter of 2016."
In the context of the Administrative Follow-Up of October 2016 the CA provided the update below, together with supporting documentary evidence:
"Standard operating procedure of the quality system KT-6-12 'On veterinary checks of animal origin products transported from EU countries via third country' (hereinafter – SOP KT-6-12) was approved by Order No B1-802 of SFVS Director of 12 October 2016.
Considering to SOP KT-6-12,veterinary inspector of BIP should carry out documentary and seal checks on EU animal origin consignments re-entering EU territory after transiting via third countries. In case of suspicion, full identity and physical checks could be performed.
35 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status Veterinary inspector of BIP have to verify if consignment was transported via third country from which import of that category product is allowed as it is established in appropriate EU legislations.
After veterinary check, the register (Annex I of SOP KT-6-12) and check list (Annex II of SOP KT-6-12) should be filled. In case the irregularities are established during veterinary check, consignment should be rejected or sent for destruction."
Assessment: The CA has addressed the recommendation. SOP KT-6-12, regarding veterinary checks on 'Products of animal origin transported from EU countries via a third country', which regulates the checking of consignments transiting EU territory, has been updated. Veterinary controls on external transit of consignments of products of animal origin will be carried out by official veterinarians at BIPs.
The verification of category and seal checks have been included in the SOP, under section § 5 - documentary checks.
In cases of suspicion, conformity checks are foreseen under paragraph § 6 of the SOP. Measures following checks comprise rejection and destruction (paragraph § 7).
2015-7433-2 This recommendation is based in conclusion 37 (Official Controls implemented on specific Closed due to action transits; derogations for consignments from Russia [Kaliningrad] and destined to Russia). taken To ensure that, when identity checks Identity checks on consignments of products of animal origin in transit between Russian are implemented, they ensure that territories via EU territory are limited to the boxes accessible through access doors (tail the veterinary certificate(s) or veterinary document(s) or other checks); this does not ensure that they are subjected to full identity checks.
36 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status document(s) provided for by CA Response: veterinary legislation tally with the product itself as specified in Article "Order No B1-312 of SFVS Director of 03-04-2015 'On veterinary checks of consignments of 2(2)(c) of Directive 97/78/EC. animal origin products coming in transit from the Russian Federation to the Russian Federation via the territory of the Republic of Lithuania' was approved to improve the Recommendation based on veterinary control of consignments shipped in transit via the territory of the Republic of conclusion 37. Lithuania between the Kaliningrad Region and the Russian Federation. Order No B1-312 Associated with findings: 16 and 35. establishes that a veterinary inspector after risk assessment of animal origin consignments, which are transported in transit from the Russian Federation to the Russian Federation, can only carry out the seal check, a partial identity check in case the means of transport are sealed by the seal of a veterinary inspector of the Russian competent veterinary authority. After the veterinary control only 'seal checks' is marked in box 27 of CVED. The training course for veterinary inspectors of BIPs will be organized in the 4th quarter of 2015, where the shortcomings detected during the inspections carried out by the FVO mission (2015) will be presented and discussed considering how to improve the veterinary control (including identity check) of animal origin consignments in transit."
In the context of the Administrative Follow-Up of October 2016 the CA provided the update below, together with supporting documentary evidence:
"The training for veterinary inspectors of BIPs was carried out on 17 September 2015 which was organized by Order No B4-713 of SFVS director of 14 September 2015.
The presentation 'Discussion of FVO recommendations and the improvement of shortcomings' was presented for veterinary inspectors of BIPs."
Assessment: The recommendation has been addressed. SFVS Director's Order No. B1-312 of 03-04-2015 “On veterinary checks of consignments of products of animal origin coming in
37 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status transit from the Russian Federation to the Russian Federation via the territory of the Republic of Lithuania" includes provisions on checks on consignments which has been sealed by officials of the Federal Veterinary and Phytosanitary Service of the Russian Federation.
Veterinary inspection procedures on consignments in transit will be carried out in accordance with Quality System Programme KT-6-2 “On veterinary checks of products of animal origin transported from EU countries via third country".
Training documentation addressing the shortcomings as regards identity checks has been provided.
2015-7433-3 This recommendation is based on conclusion 19 in section 5.2.1.1 [Controls at the entry Closed due to action Border Inspection Posts - Pre-notification] of the audit report, according to which the high taken To ensure that persons responsible percentage of late notifications found during the audit visit (contrary to what article 2(1) of for the load forward information to Regulation No 136/2004/EC requires) undermines the effectiveness of TRACES pre- the competent authority in advance of the transit consignments before notification system. The CA should ensure that pre-notifications are delivered to BIP on time the physical arrival on EU territory before consignments arrival (Part I of Common Veterinary Entrance Document- CVED). as required by Article 3(3) of CA Response: Directive 97/78/EC. Recommendation based on "To ensure that Part I of a Common Veterinary Entrance Document (hereinafter – CVED) is conclusion 19. presented to the BIP before arrival of the consignment and the information it is fully in conformity with the arriving consignment, letter of SFVS No. B6-(1.9)-1816 of 21 July 2015 Associated with finding: 9. was sent to Lithuanian Customs Brokerage Association. The letter informed that the customs broker (operator) should deliver Part I of the CVED before the consignment is presented to the BIP for veterinary control and explained how Part I of the CVED should be filled in. A
38 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status training course for custom brokers is planned to be organized in the 4th quarter of 2015 by specialists of the State Food and Veterinary Service, where information concerning the delivery of Part I of the CVED to a BIP and data entry in the Traces information system will be presented."
In the context of the Administrative Follow-Up of October 2016 the CA provided the update below, together with supporting documentary evidence:
" Order No B1-752 of SFVS Director of 05-08-2015 'On pre-notification data submission to border inspection posts' was approved to ensure that pre-notification data about import and transit consignments of live animals and animal origin products are presented to BIPs before consignment arrives to the BIP. From 1st of November 2015 person responsible for consignment should fill and present part I of CVED for live animals or CVED via Traces information system. In accordance with point 1.3 of Order No B1-752, persons responsible for consignments should apply to Information Systems Department of SFVS for the access to Traces information system.
By letter No 2015-10-20-1-1 of 20 October 2015 and by letter of 22 October 2015 Lithuanian Customs Brokerage Association asked SFVS to organize the training for customs brokers. Considering to the letters, two trainings for customs brokers were organized on 27 of October 2015 and 28 of October 2015. The topics of trainings were:
- Goods under control of State Food and Veterinary Service which should be subjected for border veterinary control.
- Traces information system and its practical use."
Assessment: The recommendation has been addressed. The SFVS Director's Order No B1-752
39 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status of 05-08-2015 “On pre-notification data submission to border inspection posts” includes provisions intended to ensure that pre-notification data is presented to BIPs before the arrival of a consignment.
In accordance with the provisions, preliminary information on the consignments will therefore be entered in the TRACES pre-notification system prior to arrival.
Specific training on the TRACES pre-notification information system has been provided to
customs brokers .
2015-7433-4 This recommendation is based on conclusion 11 in section 5.2.1.1 of the audit report Closed for other [Controls at the entry Border Inspection Posts- Pre-notification]. The CA shall ensure that reasons To gather and analyse relevant BIPs undergo appropriate procedures to detect consignments which are eligible for veterinary information to ensure that eligible checks and subject to pre-notification via TRACES, through the new Single Window transit consignments are subject to veterinary checks, as required by Information System. Articles 6 and 7 of Regulation (EC) CA Response: No 136/2004 and Articles 5 and 6 of Regulation (EC) No 282/2004. "In the last quarter of 2015 the new information system “Electronic service of electronic Recommendation based on submission of customs declarations on a single window basis” (hereinafter – single window conclusion 19. information system), which is based on a single window principle, will start operating. When it starts, customs officers will be able to complete a customs declaration in case the veterinary Associated with finding: 11. control procedure is performed for the consignment and the number of CVED should be entered into the customs declaration. The local customs office will receive all pre-notifications of consignments arriving at the border control post through this single window information
40 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7433 of 23 February 2015 in order to evaluate the official controls on consignments in transit Recommendation Basis for assessment Current Status system and in case the consignment should be subjected to veterinary control, the operator will automatically get a feedback notification that the pre-notification (CVED part I) should be sent via the Traces information system to the BIP. A list of animals and animal origin products with Customs Nomenclature Codes (CN) for which veterinary control should be performed is included in the single window information system."
In the context of the Administrative Follow-Up of October 2016 the CA provided the following update:
" The Single Window Information System is in test stage currently".
Assessment: This recommendation has been 'Closed for other reasons' as the Single Window Information System is under development at EU level.
2.B.4 Feedingstuffs and animal nutrition There are no recommendations currently open for follow-up.
2.B.5 TSE\ABP
Audit 2014-7063 of 17 June 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products Recommendation Basis for assessment Current Status 2014-7063-1 This recommendation is based on conclusion 20 of the audit report. The audit team found that In Progress Post
41 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7063 of 17 June 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products Recommendation Basis for assessment Current Status To ensure that all operators active some of transporters of Animal By-Products (ABM) operating in Lithuania are not registered GFA along the chain of ABP/DP, namely for such activity (finding 10, section 5.1.2- Registration and approval). In many cases, the transporters, are registered before official services were not aware of the situation or did not carrry out corrective actions. In commencing operations as required others, the owner of the transport and the transporter indicated in commercial documents by Article 23 of Regulation (EC) No were not identical. 1069/2009.Recommendation based on conclusion 20.Associated CA Response: findings: 10, 11 and 12. "On 29 September 2014, following Order No B4-629, a meeting was organised where the chiefs of the territorial SFVSs presented the irregularities identified during audit.
The Quality Management Programme KT-2-4-11 'Official Veterinary Control of Animal By- Product Handling Establishments' will be amended by the end of the 1st quarter of 2015 by adding a new chapter, which would ensure the actions to be performed by inspectors to ensure that all the transporters engaged in the activity were registered. A new traceability checklist were approved by Order No B1-506 of 09/06/2014.
Training will be organised for specialists of the territorial SFVSs by the end of the 1st quarter of 2015."
In the context of the Administrative Follow-Up of October 2016 the CA provided a copy of the amended Quality Management Programme document KT-2-4-11 and a copy of the new traceability checklists, together with evidence that the training mentioned above had been carried out.
Assessment: The QMS programme KT-2-4-11, such as amended, establishes that inspections on ABP transporter shall be carried out to assess whether the vehicles transporting ABP do not pose a risk for Animal and Public Health, that records of processed ABP have been
42 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7063 of 17 June 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products Recommendation Basis for assessment Current Status correctly filled in, to verify the correctness of ABP registers and other commercial documents and certificates, and to check the activity logs. Specific training addressing the relevant issues has been organised.
However, clear evidence on the measures intended to ensure that all ABP transporters are duly registered has not been provided.
CA update of 16 March 2017:
The CA provided a copy of Annexes 11 and 12 of the QMS programme KT-2-4-11, with certain provisions highlighted as relevant to ABP transporters being registered. The CA also said that "... In addition since 2017, the State Tax Inspection has implemented the electronic commercial document control programme. The programme is available for SFVS for the control purposes."
Assessment: It is not evident, from the controls highlighted in the latest documents/checklists provided by the CA , that there is a check on whether the transporter concerned is officially registered for the purposes of the transportation of ABP. Regarding the electronic commercial document control programme, the CA does not state how the programme can be used to check the transporter's registration, nor that the programme is being used for that purpose.
2014-7063-2 This recommendation is based on conclusion 35 and section 5.2.2 of the audit report Closed due to action (Operator's obligations regarding identification, transport and traceability). Inaccuracies and taken To ensure that ABP/DP are omissions on commercial documents accompanying consignments (i.e. traders identification), accompanied during transport by a prevent the adequate traceability of products. The transport of products traded by paper commercial document as required by traders should also be covered by original documents according to Annex VIII, Chapter III to
43 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7063 of 17 June 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products Recommendation Basis for assessment Current Status Article 21 of Regulation (EC) No Regulation (EU) No 142/2011. 1069/2009, which contain the information laid down in Annex CA Response: VIII, Chapter III to Regulation (EU) No 142/2011.Recommendation "On 29 September 2014, following Order No B4-629, a meeting was organised where the based on conclusion 35.Associated chiefs of the territorial SFVS were presented the irregularities identified during audit. findings: 28 and 29. The Quality Management Programme KT-2-4-11 'Official Veterinary Control of Animal By- Product Handling Establishments' will be amended by the end of the 1st quarter of 2015 by adding a new chapter with the procedure for checking the commercial document through checking all paper traders with the application of the new traceability checklist approved by Order No B1-506 of 09/06/2014.
Training will be organised for specialists of the territorial SFVSs by the end of the 1st quarter of 2015"
In the context of the Administrative Follow-Up of October 2016 the CA provided a copy of the amended Quality Management Programme document KT-2-4-11, and a copy of the new checklist relating to commercial documents of paper traders.
Assessment: the Lithuanian authorities have taken action to address the recommendation.
2014-7063-3 This recommendation is based in conclusion 35 and section 5.2.1 of the audit report (Imports, Closed due to action exports, and intra-EU trade). The channelling procedures in place for imported raw ABP taken To ensure that the channelling intended to pet food production is not fully in line with article 8(4) of Council Directive procedure followed for imports of 97/78/EC. Imported consignments are split in intermediate storage plants which are not raw ABP for the production of pet
44 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7063 of 17 June 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products Recommendation Basis for assessment Current Status food is fully in line with the authorised for those purposes, and sent separately to the pet food plants afterwards. requirements of Article 8(4) of Council Directive 97/78/EC, namely The channelling procedure also ends at these intermediate facilities before reaching the pet by maintaining the oversight on the food plant. products until these reach the pet food plant where processing takes CA Response: place. Recommendation based on conclusion 35.Associated findings: "On 29 September 2014, following Order No B4-629, a meeting was organised where the 22. chiefs of the territorial SFVSs were presented the irregularities identified during audit. The Quality Management Programme KT-2-4-11 'Official Veterinary Control of Animal By- Product Handling Establishments' will be amended by the end of the 1st quarter of 2015 by adding a new chapter concerning the strengthening of controls at the place of destination. At the moment, a storage where ABPs as well as products (raw materials) subject to controls carried out by an appointed veterinarian until they reach the place of destination arrive has been approved. Training will be organised for specialists of the territorial SFVSs by the end of the 1st quarter of 2015.
The work instruction KT-6-1-D4 on procedure after veterinary checks of products of animal origin imported from third countries will be amended by the 1st quarter of 2015 with the reference that imported channelled consignments could be sent from the BIP to an intermediate storage plant, which, is authorised for channelling procedures in accordance with Article 8 of Council Directive 97/78/EC and with the rules of traceability of channelled consignments movement from the intermediate storage plant to the pet food plant as provided in EU legislation."
In the context of the Administrative Follow-Up of October 2016 the CA provided a copy of the amended Quality Management Programme document KT-2-4-11 (paragraph 9 deals
45 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2014-7063 of 17 June 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products Recommendation Basis for assessment Current Status with the strengthening controls at the place of destination). Regarding the rules of traceability of channelled consignments the CA provided a copy of Working Procedure KT-6-1-D4 'Procedure following veterinary checks for animal origin products imported from third countries' (paragraph 2 deals with ' Special requirements for control of consignments of animal origin products subject to reinforced control'. The CA also provided a copy of their Quality Management Programme document KT-6-1 'Procedure for veterinary checks of animal origin products imported from third countries', referring especially to its Annex 5 which is entitled 'Accounting journal for consignments of imported animal origin products subject to reinforced control'.
Assessment: the Lithuanian authorities have taken action to address the recommendation.
2.B.6 Veterinary medicines and residues
Audit 2009-8131 of 09 June 2009 in order to evaluate the control of residues and contaminants and the use of veterinary medicinal products in food producing animals Recommendation Basis for assessment Current Status 2009-8131-8 This recommendation is based on section 5.1.2 of the audit report (Planning of the national Closed due to action residue control plan, indent 14) which states that many analytical methods used for the NRCP taken Ensure that all methods used for were not validated as required under Commission Decision 2002/657/EC; and on section analysis of samples for residues of 5.2.1 of the audit report (Laboratories- General description) related to specific methods used veterinary medicinal products under the NRCP, regardless of the for testing of samples within the NCRP which have not been validated e.g. confirmatory
46 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2009-8131 of 09 June 2009 in order to evaluate the control of residues and contaminants and the use of veterinary medicinal products in food producing animals Recommendation Basis for assessment Current Status laboratory in which they are method for tetracyclines in honey. performed, are validated in accordance with the requirements of CA Response Article 3 of Commission Decision 2002/657/EC. The CA sent the RMP 2013 to the Commission. By letter Ares (2013)3532813/21/11/2013, the Commission provided the LT CA with the assessment of 2013 residue monitoring plans (RMPs).
In addition the CCA indicated that the method for Amitraz in honey has been developed. Work on validation of the method was on-going. They indicated that it is expected to be completed before August 2014.
Assessment October 2016: According to Lithuania's '2016 Plan for monitoring of residues in live animals and animal origin products' (page 22) the confirmatory methods for honey have been validated in accordance with Decision 2002/657/EC.
47 DG(SANTE)/2016-8985 Final Version date May 2017 2.B.7 Foodstuffs and food hygiene
Audit 2009-8159 of 25 May 2009 in order to assess the official control systems in place for food hygiene (follow-up of the mission DG(SANCO)/2007- 7190), and for food additives and food contact materials Recommendation Basis for assessment Current Status 2009-8159-1 This recommendation was based on the finding in section 5.4 of the audit report that there is Closed for other no monitoring system for Food Additives as required by the relevant legislation. reasons Ensure that competent authorities establish a monitoring system for the Assessment in the Country Profile of May 2014: consumption of FA as required by European Parliament and Council The MH and NFVRAI agreed to develop a system to monitor food additives. Directives 94/35/EC (Article 8) on sweeteners for use in foodstuffs, In 2010 a programme was designed and implemented. Food consumption data was reviewed 94/36/EC (Article 6) on colours for to look at exposure of the Lithuanian population to additives and to determine what would be use in foodstuffs and 95/2/EC the maximum allowable limits. A pre-questionnaire was designed for FBO to give information (Article 7) on food additives other to the CCAs on which additives they are using and details of same. An online reporting system than colours and sweeteners. was to be set up with FBOs. The CCA indicated that the project was expected be completed in 2013.
In 2012 the CCA indicated they were making some progress with the project but it was difficult as it seems very few member states had put this type of monitoring system in place. The CCA were unclear how to proceed and tried to get advice from the Commission and EFSA but failed to get answers.
Consequently the CCA had started to devise their own system:
- the first phase is to work with retailers to assess what additives are in products and what products people are buying
48 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2009-8159 of 25 May 2009 in order to assess the official control systems in place for food hygiene (follow-up of the mission DG(SANCO)/2007- 7190), and for food additives and food contact materials Recommendation Basis for assessment Current Status - the second phase would be to work with food manufacturers regarding the production of foodstuffs and the use of additives ; the second phase is unlikely to start before 2013. The second phase may use an online reporting system but this had not been finalised. The latest food consumption study was done in 2007 and it was felt the data was out of date; the CCA expected to do another one, but it is not finalised or agreed.
In addition the CCAs indicated that the food additives monitoring project was restricted due to lack of resources. It was decided to research only two food additives groups: nitrates (in dairy products) and nitrites (in meat products).
During the 2014 GFA the CCAs indicated that agreement on the design of the monitoring has not been reached among the authorities and that they are looking forward for a harmonised approach at EU level.
Process on hold until European Commission elaborates the general rules for EU.
Assessment October 2016: t his recommendation has been closed pending the development, by the European Commission, of a common methodology for gathering information on the consumption and use of food additives and flavourings across the European Union.
2.B.8 Imports of food of plant origin There are no recommendations currently open for follow-up.
49 DG(SANTE)/2016-8985 Final Version date May 2017 2.B.9 Plant protection products There are no recommendations currently open for follow-up.
2.B.10 Animal welfare There are no recommendations currently open for follow-up.
2.B.11 Plant health
Audit 2009-8169 of 12 May 2009 in order to evaluate the import controls for plant health, the implementation of the plant passport system, the protected zone for Erwinia amylovora and the internal market controls of wood products of relevance for Bursaphelenchus xylophilus Recommendation Basis for assessment Current Status 2009-8169-5 This recommendation is based on the findings in section 5.2.8 of the audit report (Personal Closed for other Use concessions). Lithuania has established exemptions for small quantities of plant and plant reasons Review the amounts allowed for products for passengers based in Article 13b(3) of Directive 2000/29/EC. Notwithstanding import as personal concession and this, the allowed amounts for certain commodities, e.g. seeds for certain plant species, seemed ensure that they are indeed "small" as required in Article 13b(3) of to be quite high. Directive 2000/29/EC; and consider CA Response implementing Article 13b(5) of the same Directive for facilitating the "In the nearest future the amounts of plants, plant products foodstuffs for import as personal necessary, regular movement of concession will be reviewed." commodities by people in the border areas Assessment after the general follow up audit of 2014:
The CCA originally envisioned adopting the revised legislation by end of 2012. During 2014 GFA they indicated that the drafted document had not yet been adopted. They indicated that a new document - at Final Draft Stage - has been prepared by the Phytosanitary Division and includes also provisions for seeds and wood packaging material. The Customs and Border
50 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2009-8169 of 12 May 2009 in order to evaluate the import controls for plant health, the implementation of the plant passport system, the protected zone for Erwinia amylovora and the internal market controls of wood products of relevance for Bursaphelenchus xylophilus Recommendation Basis for assessment Current Status authorities have been involved in the drafting. The CA stated that it expects it to be in force by the end of 2014. A copy of the draft has been provided.
Concerning the protected zone status for Erwinia amylovora in LT (excluding Babtai and Kėdainiai municipalities) and the danger of spreading the harmful organisms, especially for wood and plants for planting from Belarus and Russian Federation, LT considered the derogation for regular movement of commodities by people in the border areas too high a risk of harmful organisms introduction to LT and EU. LT will not be implementing the derogation.
In the context of the Administrative Follow-Up of October 2016 the CA provided the following update:
"With respect to recommendations, the amounts of plant and plant products allowed for import as personal concession were drastically reduced. Phytosanitary Division prepared a draft of legal act, however it is still not adopted. Drafting and harmonisation of the document is delayed, whereas there is no confirmation at EU legal basis for indicated amounts"
Assessment: In the absence of a harmonised EU definition of the levels of plant and plant products allowed for import as personal concession this recommendation is 'closed for other reasons'.
51 DG(SANTE)/2016-8985 Final Version date May 2017 2.B.12 Quality Labelling
Audit 2015-7365 of 15 September 2015 in order to evaluate the control systems for organic production and labelling of organic products Recommendation Basis for assessment Current Status 2015-7365-2 According to section 5.2.3 (Planning and Prioritisation of Controls) of the audit report , the Closed due to action percentage of unannounced inspections on organic operators is lower than the threshold set taken To ensure that the additional up in Article 65(4) of Regulation (EC) No 889/2008 (at least,10% of total of organic inspections carried out by the operators) Control Authority are primarily unannounced, as required by Article CA Response: 65(4) of Regulation (EC) No 889/2008. "A draft procedure drawn up (scheduled for adoption by 31 March 2016), 'to amend the PR-10 Recommendation based on selection procedure for assessing risk management and random/additional testing', was conclusion 26. approved by Order No V-12 of the Director of VšĮ 'Ekoagros' of 23 March 2015." Associated finding 20. Additional information received from the CA on 13 April 2016:
"On 23 March 2016, by Order No V-11 of the Director of VšĮ 'Ekoagros', approval of: amendments to the PR-10, selection procedure for assessing risk management and random/additional checks. Paragraph 5 of the procedure states that 'all additional checks under this procedure at the premises of the economic operators selected shall be carried out unannounced, the annual checks for group I economic operators likewise being carried out unannounced' (Annex 3)."
In the context of the Administrative Follow-Up of October 2016 the CA stated that "according to the updated procedure 'PR-10 Risk Management and Evaluation of random / additional checks selection procedure' there would be altogether 3183 inspections of operators including 413 unannounced inspections for 2016 (12,98 %)".
52 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7365 of 15 September 2015 in order to evaluate the control systems for organic production and labelling of organic products Recommendation Basis for assessment Current Status The CA provided a list of the annual and planned inspections of operators for 2016.
Assessment: the CA has addressed the recommendation.
2015-7365-3 According to the findings in Section 5.2.7 (Exceptional production rules and other Closed due to action derogations) of the audit report, organic operators of small holdings are being authorised to taken To ensure that the derogation to tether animals irrespective of whether the specific constraints laid down in Article 22(2)(a) of tether animals is only granted to Regulation (EC) 834/2007 are being met (these constraints are that the derogation on small holdings that, in addition to satisfying the requirements of tethering of animals shall be restricted to small holdings that are confronted with climatic, Article 39 of Regulation (EC) No geographical or structural constraints). 889/2008, are confronted with CA Response: climatic, geographical or structural constraints, as required by "Amendments drafted (scheduled for adoption by 31 March 2016) to the organic farming rules Regulation (EC) No 22(2)(a) of approved by Order No 375 of 28 December 2000 of the Lithuanian Minister for Agriculture." Regulation (EC) No 834/2007. Recommendation based on Additional information received from the CA on 13 April 2016: conclusion 50. "Order No 3D-113, of 3 March 2016, introduces amendment of the Rules for organic farming Associated finding 49. approved by Order No 375 of the Minister for Agriculture of the Republic of Lithuania of 28 December 2000 approving the Rules for organic farming. http://old.zum.lt/index.php?1229382726. Paragraph 67 of these rules repeals competent authority authorisation for the tethering of bovine animals in all small cattle sheds on organic livestock holdings. Paragraphs 113-118 and subparagraphs 4.11, 118.14–118.14.1 set out detailed requirements about obtaining authorisation to tether bovine animals in cattle sheds on separate small organic livestock holdings. Further, on 21 March 2016 VšĮ Ekoagros included
53 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7365 of 15 September 2015 in order to evaluate the control systems for organic production and labelling of organic products Recommendation Basis for assessment Current Status in the establishment register form No F-143 'Application to tether in cattle sheds certified bovine animals kept on small organic holdings' http://www.ekoagros.lt/?mid=59&id=0".
In the context of the Administrative Follow-Up of October 2016 the CA provided a c opy of the Order No 3D-113 establishing the rules repealing competent authority authorisation for the tethering of bovine animals in all small cattle sheds on organic livestock holdings and setting up detailed requirements for new authorisations. The CA also provided copies of the Establishment register form No F-143, of VšĮ Ekoagros, for small organic production holdings with reference to Article 22(2)(a) of Council Regulation (EC) No 834/2007.
Assessment: The Lithuanian authorities has adopted amended rules addressing the recommendation in line with Article 22(2)(a) of Council Regulation (EC) No 834/2007.
2015-7365-4 This recommendation is based in conclusion 54 in section 5.2.8 (Imports of Products from Closed due to action Organic Production) of the audit report. The competent authority for completing the taken To ensure that official controls on certificate of inspection (Box 17) are the Custom services; nevertheless, the SFVS is the imports of organic products are designated authority according to the written procedures. carried out in accordance with documented procedures, as required CA Response: by Article 8(1) of Regulation (EC) No 889/2008. "Draft version on the description of the procedure for checking the documents accompanying Recommendation based on imported organic agricultural and food products, approved by Order No 3D-352 of 17 May conclusion 54. 2012 of the Lithuanian Minister for Agriculture approving a description of the procedure for checking the documents accompanying imported organic agricultural and food products Associated finding 52 and 53. (scheduled for approval by 31 March 2016)."
54 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7365 of 15 September 2015 in order to evaluate the control systems for organic production and labelling of organic products Recommendation Basis for assessment Current Status Additional information received from the CA on 13 April 2016:
"On 15 March 2016, amendments to the description of the procedure for documentary checks on imported organic agricultural products and foodstuffs were approved by Order No 3D-352 of 17 May 2012 approving the description of the procedure for documentary checks on imported organic agricultural products and foodstuffs http://old.zum.lt/index.php?-. The functions set out in paragraph 17 of this Description for approving box 17 of the certificate are transferred to customs (from the State Food and Veterinary Authority): After the State Plant Service has carried out a phytosanitary and/or quality check on an incoming consignment and/or the State Food and Veterinary Service has carried out an organic integrity and safety check, and after the State Food and Veterinary Service and/or the State Plant Service has duly completed box 16 of the original certificate of approval and the State Food and Veterinary Service or the State Plant Service has authorised the consignment to be placed in circulation as organic, the competent customs officials complete box 17 of the certificate of approval, giving the number and date of the customs declaration of release for free circulation, and approve the entries by means of a numbered customs institution stamp."
In the context of the Administrative Follow-Up of October 2016 the CA provided a copy of Order No 3D-352 setting out the procedures for completing the certificate of approval; and, in order to show that the Order is being complied with, they also provided examples of documents accompanying imported organic products which had been checked and completed in accordance with the Order.
The CA has transferred the competencies for fulfilling box 17 of the certificate to Customs services (from the State Food and Veterinary Authority) according to Chapter V, final provisions, section 21 of Order, No 3D-352 of 17 May 2012 'On approval of the procedure for documentary checks on imported organic agricultural products and foodstuffs' (Version of
55 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7365 of 15 September 2015 in order to evaluate the control systems for organic production and labelling of organic products Recommendation Basis for assessment Current Status 18 03 2016).
Assessment: the CA has addressed the recommendation.
2015-7365-5 This recommendation is based on conclusion 59 in section 5.2.9 (Measures in cases of Closed due to action irregularities and infringements) of the audit report. In some cases, the cumulative nature of taken To revise the sanctions catalogue in the non-compliances detected is not taken into account for the assessment of the severity of the order to ensure that enforcement infringements, resulting in enforcement measures being neither proportionate nor dissuasive. measures for accumulative non- compliances are proportionate and CA Response: "Draft procedure in preparation (scheduled for adoption by 31 March 2016) to dissuasive, as required by Articles amend then on-compliance assessment procedure PR-05 approved by Order No V-41 of 22 54(1) and 55(1) of Regulation (EC) June 2015 of the Director of VšĮ 'Ekoagros'." No 882/2004, in particular for primary production of organic Additional information received from the CA on 13 April 2016: "On 1st April 2016, products of animal origin. amendments to procedure PR-05 'Non-compliance assessment procedure, 12th edition' (Annex Recommendation based on 4 were approved by Order No V-27 of the Director of VšĮ 'Ekoagros', conclusion 59. http://www.ekoagros.lt/?mid=32&id=0)." Associated finding 57. In the context of the Administrative Follow-Up of October 2016 the CA provided examples of enforcement notices taken, in line with Order No V-27, against keepers of organic livestock where non-compliances were detected. They also provided Annex A and Annex B to the Compliance assessment procedure PR-05, used in assessing the severity of infringements: A) 'Non-compliance levels and effects of crop production, livestock production, honey production, wild collection and aquaculture areas'; and B) 'The levels and effects of measures for non-conformities management on holdings/enterprises'.
56 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2015-7365 of 15 September 2015 in order to evaluate the control systems for organic production and labelling of organic products Recommendation Basis for assessment Current Status Assessment: the CA has addressed the recommendation.
57 DG(SANTE)/2016-8985 Final Version date May 2017 3. OVERVIEW OF MORE RECENT AUDITS
In addition to the recommendations which are dealt with in chapters 2.B.1 to 2.B.12, the report of two further audits carried out by DG Health and Food Safety in Lithuania have now been published. The follow up of the recommendations in these reports will be published in future country profile updates. The overall conclusions of the audits are set out below.
Audit 2016-8835 of 2 February 2016 carried out in order to evaluate the official controls related to production and storage of milk and milk products The current system for milk supply in Lithuania comprises 27,000 dairy holdings (19,000 farms have 1 to 5 cows) which supply milk to 17 milk collection centres, 1,332 milk collection points and 35 milk processing establishments. Milk purchasing and testing rules are set centrally and regulated in detail by the state. Milk collection points are not approved but registered "for domestic trade". The current national regulation prevents them from supplying their milk directly to other EU member states. Nevertheless, they deliver milk to the approved establishments in Lithuania.
The system for official controls is well organised and it has the potential to fulfil most of the relevant EU requirements. The implementation of official controls is also largely satisfactory. Nevertheless, the effectiveness of the system is reduced by a number of weaknesses mainly at the level of milk collection points (approval and controls are not fully in line with EU requirements) and in other establishments by insufficient controls on HACCP based procedures and microbiological criteria. Some deficiencies identified by the audit team had not been identified by the competent authorities, or had been identified but not enforced, mostly at milk collection level. Other than for milk collection points, the procedures for approval were satisfactory and have been followed in all cases assessed.
All testing of raw milk in the country is done by a national agency Pieno Tyrimai. The testing system run by the agency is efficient. Official data indicates that 97 % of milk by volume is compliant with the relevant EU requirements. It was noted, however, that under national legislation, the agency applies a modified method in the calculation of raw milk quality parameters, which is not in line with EU legislation. This incorrectly lowers the threshold for raw milk to be considered compliant. Official monitoring of raw milk quality by the competent authorities is carried out on the basis of the data contained in the database of the agency. Separate samples are taken on suspicion. The National Reference Laboratory for milk and dairy products carries out its duties for dairy products but not for raw milk. Official testing of raw milk takes place in the accredited Pieno Tyrimai laboratory.
58 DG(SANTE)/2016-8985 Final Version date May 2017 Audit 2016-8782 of 10-14 October 2016 carried out in order to evaluate the system for authorisation of plant protection products The objective of the audit was to evaluate the control systems in place for plant protection products, in particular those rules laid down in Regulation (EC) No 1107/2009 which relate to their authorisation, and to identify good practices in the authorisation process.
The high level of compliance with EU legal deadlines when Lithuania acts as zonal Rapporteur Member State contributes to the proper functioning of this system. This also facilitates the processing of authorisations by other Member States within the northern zone.
When acting as concerned Member State, for handling applications for mutual recognition and for re-authorisation of existing products, delays led to consistent breaches of European Union legal deadlines. The policy of systematically re-assessing the evaluations conducted by other Member States and the need to satisfy the additional national requirement contribute to these delays. Consequently, access to the market for new products is restricted, while existing products remain on the market beyond legal deadlines.
The report identifies good practices and contains recommendations to Lithuania, to address the shortcomings identified.
59 DG(SANTE)/2016-8985 Final Version date May 2017 ANNEX I – ACRONYMS, ABBREVIATIONS, SPECIAL TERMS
ACRONYM DESCRIPTION ABP Animal By-Products ABP/DP Animal by-products and derived products ASF African Swine Fever BFVCD Border Food and Veterinary Control Department BIPs Border Inspection Posts BSE Bovine Spongiform Encephalopathy CA Competent Authority CCA Central Competent Authority CRL Community Reference Laboratory CSF Classical Swine Fever CtrlA(s) Control Authority(ies) CVED Common veterinary entry document EFSA European Food Safety Authority FMD Foot and Mouth Disease GMOs Genetically Modified Organisms FVO Food and Veterinary Office (Directorate F – Health and Food Audits and Analysis – of DG Health and Food Safety, with effect from 1 February 2016) HACCP Hazard Analysis and Critical Control Points IAD Internal Audit Department LVU Local veterinary unit MANCP Multi Annual National Control Plan NFVRAI National Food and Veterinary Risk Assessment Institute (Nacionalinis maisto ir veterinarijos rizikos vertinimo institutas) MRL Maximum Residue Level NRL National Reference Laboratory OF/SI Organic fertilizers and soil improvers PAP Processed animal proteins Paper Traders of ABP/DP which do not actually receive the products concerned traders PPP Plant Protection Products PD Phytosanitary Division (of the MoA) RASFF Rapid Alert System for Food and Feed RD Regional Division of the SPSMoA SEHC State Environmental Health Centre SFSVS State Food and Veterinary Service (Valstybinė maisto ir veterinarijos tarnyba) SOP Standard Operating Procedure SPHS State Public Health Service under the Ministry of Health SPSMoA State Plant Service under the Ministry of Agriculture SRM Specified Risk Materials TRACES Trade control and expert system TSEs Transmissible Spongiform Encephalopathies VMPs Veterinary Medical Products
60 Version date May 2017