In response to information provided by the competent authority, any factual error noted in the draft report has been corrected; any clarification appears in the form of a footnote.

EUROPEAN COMMISSIONDIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Health and food audits and analysis

DG(SANTE) 2019-6640

FINAL REPORT OF AN AUDIT

CARRIED OUT IN

ITALY

FROM 26 NOVEMBER TO 6 DECEMBER 2019

IN ORDER TO

EVALUATE THE SYSTEM OF OFFICIAL CONTROLS ON IMPORTS OF ANIMALS AND GOODS

Ref. Ares(2020)1737794 - 24/03/2020

I

Executive Summary

The report describes the overall outcome of an audit carried out in Italy from 26 November to 6 December 2019 as part of the European Commission’s Directorate-General for Health and Food Safety's planned work programme.

The objective of the audit was to evaluate the implementation of official controls on the importation of commercial consignments of live animals and on products of animal and non-animal origin (goods), and to determine whether the system in place fulfils the requirements laid down in relevant European Union (EU) legislation and is capable of ensuring that only compliant consignments can be introduced into the territory of the EU. In addition, the audit evaluated the compliance of facilities and equipment of six border inspection posts (BIPs) visited, including the facilities of one new proposed inspection centre at Rome-Fiumicino airport BIP, and two designated points of entry (DPE) visited.

The Italian authorities have established a comprehensive framework for official controls on imported animals and goods, supported by guidance documents and information technology systems. Communication and cooperation between the authorities at the border control posts is, with the exception of the port authorities of Civitavecchia Port, largely effective and supports the implementation of import controls.

Implementation of official controls on imported animals and products of animal origin as well as controls on personal consignments is generally in line with relevant EU requirements. However, weaknesses in the control system were identified in relation to (a) documentary checks on food of non-animal origin subject to special import conditions, as the competent authority accepts copies of relevant documents and is not in a position to ascertain their authenticity; and (b) the hygiene and suitability of designated points of entry and import.

In relation to the BIPs visited, all facilities, bar one, did not meet expected operational hygiene standards. Whilst some facilities are being reconstructed to comply with Regulations (EU) 2017/625 and (EU) 2019/1014 there is, however, no plan to upgrade the substandard facilities and equipment at Civitavecchia Port BIP.

The report makes recommendations to the Italian competent authorities, aimed at rectifying the identified shortcomings and enhancing the implementation of the control measures in place.

II

Table of Contents

1 Introduction ....................................................................................................................................1

2 Objectives and scope......................................................................................................................1

3 Legal Basis .....................................................................................................................................2

4 Background ....................................................................................................................................2

5 Findings and Conclusions ..............................................................................................................4

5.1 STRUCTURE OF THE SYSTEM FOR IMPORT CONTROLS ...........................................................4

5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON IMPORTED GOODS .......................................9

5.3 PROCEDURES IN PLACE TO VERIFY THAT OFFICIAL CONTROLS ON IMPORTS OF ANIMALS

AND GOODS ARE EFFECTIVE AND APPROPRIATE .............................................................................15

5.4 SUITABILITY OF FACILITIES AND EQUIPMENT FOR IMPORT CONTROLS..............................16

6 Overall Conclusions .....................................................................................................................18

7 Closing Meeting ...........................................................................................................................19

III

ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT

Abbreviation Explanation

AIDA Automazione Integrata Dogane Accise, the information system of the Customs and Monopolies Agency

Approval categories of BIPs

Categories of animals and products of animal origin for the receipt of which BIPs in Italy are approved, and listed in Commission Decision 2009/821/EC:HC: all products for human consumption NHC: other productsNT: no temperature requirements(2): packed products onlyT(CH): chilled productsFR: frozen productsE: registered Equidae as defined in Council Directive 90/426/EEC O: other animals (including zoo animals)U: ungulates: cattle, pigs, sheep, goats, wild and domestic solipeds

BIP Border Inspection Post

CED Common Entry Document

CITES Convention on International Trade of Endangered Species

CN-code The goods nomenclature code as laid down by Annex 1 to Council Regulation (EC) No 2658/87 (i.e. the Combined Nomenclature)

Customs Agency The Customs and Monopolies Agency

CVED Common Veterinary Entry Document

DGISAN The Directorate General for Hygiene, Food Safety and Nutrition of the Ministry of Health

DGSAF The Directorate-General for Animal Health and Veterinary Medicine of the Ministry of Health

DPE Designated point of entry

DPI Designated point of import

EU European Union

NATO/US North Atlantic Treaty Organisation/United States of America

TRACES Trade Control and Expert System

USMAF-SASN The Port, Airport and Border Health Offices Services for Healthcare for seafarers and aircrew of the Ministry of Health

1

1 INTRODUCTION

This audit took place in Italy from 26 November to 6 December 2019 – in parallel with audit DG(SANTE)/2019-6627 - as part of the Directorate-General for Health and Food Safety's work programme. The audit team comprised two auditors.

The audit team was accompanied during the entire audit by at least one representative of the central competent authority, the Directorate-General for Animal Health and Veterinary Medicine (DGSAF) of the Ministry of Health (Ministry della Salute). In addition, the availability of representatives of other local, regional or central authorities involved in the implementation of the controls under the scope of the audit was ensured during the part of the audit relevant to them.

An opening meeting was held on 26 November 2019 between the audit team and the representatives from DGSAF, the Directorate General for Hygiene, Food Safety and Nutrition (DGISAN) of the Ministry of Health, and the Directorate Fraud and Controls of the Customs and Monopolies Agency (hereafter referred to as the Customs Agency), during which the objectives, itinerary and the reporting procedures were confirmed.

2 OBJECTIVES AND SCOPE

The objective of the audit was to evaluate the implementation of official controls on the importation of commercial consignments of animals and products of animal and non-animal origin (goods), and to determine whether the system in place fulfils the requirements laid down in relevant European Union (EU) legislation and is capable of ensuring that only compliant consignments can be introduced into the territory of the EU.

Particular attention was paid to whether:

official controls are implemented in compliance with the applicable legislation and planned arrangements;

for products of non-animal origin, that controls are implemented at the designated points of entry (DPE) and designated points of import (DPI), as laid down in Commission Regulation (EC) No 669/2009, Commission Implementing Regulation (EU) No 884/2014 and other relevant legislation;

the system fulfils the objectives laid down in the relevant EU legislation to prevent the spread of contagious or infectious diseases, and;

the implementation of official controls is effective and suitable in ensuring that only compliant consignments can be introduced into the territory of the EU.

In addition, to the main objective, the audit evaluated the compliance of facilities, equipment and the hygiene conditions of the three border inspection posts (BIPs) visited against the requirements of Council Directive 91/496/EEC, Council Directive 97/78/EC and Commission Decision 2001/812/EC.

2

Controls on non-commercial consignments of animals were not covered during the audit. Controls on livestock vehicles entering the Union were covered during audit DG(SANTE)/2019-6627, which was carried out in parallel.

The itinerary of the audit included the following visits and meetings:

VISITS CommentsCentral √ Opening and closing meetingCompetent

authorities Regional/Local √ BIPs, DPEs/DPIs, Customs

BIP Venezia Port √ HC, NHC

BIP Milano-Malpensa Airport √ HC(2), NHC(2), U, E, O

BIP Palermo Port √ HC

BIP Gioia Tauro Port √ HC, NHC-NT

BIP Civitavecchia Port √ HC(2), NHC(2)

BIP Rome-Fiumicino Airport √ Proposed inspection centre "Xpress" for categories HC-T(F)(2) and HC-T(CH)(2)

DPEs and/or DPIs 2 DPE/DPI Palermo Port and Venezia Port

Customs warehouses 1 Approved according to Articles 12 and 13 of Directive 97/78/EC

Postal/parcel distribution centre 1 Milano-Malpensa Airport

3 LEGAL BASIS

The audit was carried out under the general provisions of the EU legislation and, in particular, Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council.

4 BACKGROUND

Properly functioning border controls are a key factor to ensure that animals and food and feed (especially of animal origin) entering the EU are safe and meet specific import requirements laid down in the Union legislation.

The general rules on official controls on feed and food, both of animal and non-animal origin are laid down in Regulation (EC) No 882/2004. Specific requirements for veterinary checks of feed and food of animal origin are set out in Council Directive 97/78/EC and, for live animals, in Council Directive 91/496/EEC. Moreover, Union legislation lays down special conditions for import controls of feed and food for which there may be an increased risk to

3

human health, animal health or to the environment (e.g. Commission Regulation (EC) No 669/2009, Commission Implementing Regulation (EU) No 884/2014, etc.).

Commission Regulation (EC) No 206/2009 lays down measures with regard to imports of certain products for personal consumption. Pursuant to that Regulation, meat and meat products and milk and milk products cannot be introduced into the Union by travellers unless such products fully comply with the Union's commercial import rules. In practice, this means that meat, milk and their products, when carried by passengers, should be presented for veterinary checks provided for by Directive 97/78/EC at the border, and their introduction will be prohibited. To discourage such movements of goods, Member States may impose penalties as necessary, including the costs of disposal of the products, on persons held liable for a breach of the rules on the introduction into the EU of products of animal origin.

The Commission carries out regular audits on the implementation of import controls in the EU Member States. The most recent audit on this subject was carried out in Italy in November 2016 DG(SANTE)2016-8874.

The Commission maintains country profiles for EU Member States. These provide an overview of how each country’s official control systems are organised, based on information supplied by the respective competent authorities. The country profile for Italy is available at the following link:

http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=IT

There are 26 BIPs in Italy, listed in Commission Decision 2009/821/EC.

There are 24 DPEs and DPIs for feed of non-animal origin and 22 DPEs for food of non-animal origin listed according to Article 5 of Regulation (EC) No 669/2009 and Article 8 of Regulation (EU) No 884/2014 and are available on the European Commission website.

The following data have been provided by DGSAF:

2016 2017

Year/Commodity Number of consignments

imported

Number of consignments

imported

Animals 3 051 2 887

Products of animal origin intended for human consumption

39 536 40 840

Products of animal origin not intended for human consumption

5 820 5 504

Food of non-animal origin

4

Year/Commodity

2016 2017

Number of consignments

imported

Number of consignments

imported

Regulation (EC) No 669/2009

Regulation (EU) No 884/2014

Regulation (EU) No 885/2014

Regulation (EU) 2015/175

Regulation (EU) 2016/6

2 616

5 312

202

18

3

2 324

5 249

97

28

1

Feed of non-animal origin *

Regulation (EC) No 669/2009

Regulation (EU) No 884/2014

0

0

0

0

* Due to the absence of any imports of consignments of feed of non-animal origin which are subject to special import conditions, the audit team could not verify the competent authorities' implementation of import controls on such consignments.

5 FINDINGS AND CONCLUSIONS

Legal acts quoted in this report are provided in Annex I and refer, where applicable, to the last amended version. Relevant provisions of those legal acts that are audited against in the chapters of this report are specified in the appendix.

5.1 STRUCTURE OF THE SYSTEM FOR IMPORT CONTROLS

5.1.1 Competent authorities involved

1. The country profile for Italy describes the organisation and responsibilities for import controls and the competent authorities designated in accordance with Article 4(1) of Regulation (EC) No 882/2004 (see section 4 - background). DGSAF stated that changes to the organisation and responsibilities of the competent authorities are expected in 2020. Pending amendments to national legislation, it is foreseen that BIP staff will carry out the import controls on animals, goods of animal origin, goods of non-animal origin subject to special import conditions and food contact materials. It is estimated that this transfer of responsibilities will take place in June 2020.

2. DGSAF is the central competent authority for import controls on animals and goods of animal origin and feed of non-animal origin subject to special import conditions. Within DGSAF, Office 8 is responsible for import controls of animals and goods of animal origin and feed of non-animal origin subject to special import conditions and coordinates the BIP staff. The BIP staff are directly employed by the Ministry of Health

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and implement the import controls for animals and goods of animal origin and feed of non-animal origin subject to special import conditions.

3. DGISAN is the central competent authority for official controls of food of plant origin and food hygiene. Within DGISAN, Office 2 is responsible for import controls of food of non-animal origin, including products subject to special import conditions and food contact materials and coordinates the DPE/DPI staff i.e. USMAF-SASN (Port, Airport and Border Health Offices Services for Healthcare for seafarers and aircrew) of the Ministry of Health. USMAF-SASN implements the import controls for such products.

4. Customs are responsible for controls of passenger's luggage, including postal parcels. The Controls Office of the Directorate Fraud and Controls of the Customs Agency coordinate the Customs Offices. In addition, Customs can only release consignments for imports with a valid Common (Veterinary) Entry Document (CVED/CED).

5. The area of competences of the authorities dealing with import controls is summarised in the following table:

Areas of competence DGSAF/BIP staff Customs DGISAN/USMAF-SASNs

Animals X X

Food for human consumption of animal origin

X X

Food for human consumption of non-animal origin

X X

Goods of animal origin not intended for human consumption

X X

Feed of non-animal origin X X

Passengers’ luggage, including (postal) parcels

X

5.1.2 Communication and cooperation between competent authorities

6. The communication and cooperation between services involved in import controls occurs on a regular basis between the BIP/USMAF-SASN staff and their respective coordination Office 8 of DGSAF and Office 2 of DGISAN. Communication takes place through letters, e-mails, meetings and video conferences in order to give information, instructions, clarifications, etc. These mechanisms are also used for communication and cooperation with other Offices of the Ministry of Health and if necessary with the relevant national reference laboratories.

7. Similar mechanisms are in place for the intense collaboration with other Authorities involved in import controls such as the Customs Agency, Ministry of Agriculture,

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Ministry of Environment, Ministry of Transport, Ministry of Economic Development, etc. In addition several meetings have been held covering topics such as the Convention on International Trade of Endangered Species (CITES), the Customs' Single Window system, Trade Facilitation, requirements laid down in Regulation (EU) 2017/625, among others.

8. A written agreement between the Ministry of Health and the Ministry of Finance was established on 22 March 2007. Although a reorganisation took place in 2010, creating the Customs Agency, the Customs Agency and DGSAF stated this agreement is still in force. The agreement aims to prevent illegal traffic and to enhance the control system of the goods and covers the following:

Exchange of information at central level in order to categorise the risks posed by goods;

To select consignments subject to controls based on risk in addition to the mandatory import controls;

The establishment of a permanent working group the Combined Nomenclature (CN) codes of goods subject to sanitary import checks;

Interoperability for exchange of information between the authorities' systems (note that this Agreement was in place prior to the establishment of the Customs' Single Window System);

To schedule joint physical checks on goods; and Preparation of guidelines for the activities that require co-operation between both

administrations.

9. The Ministry of Health has designated, in line with the requirements of Article 12 of Regulation (EC) No 882/2004 a laboratory network (the Istituti zooprofilattici sperimentali, IZS and the Agenzia Regionale per la Protezione dell'Ambiente, ARPA and their local branches) to carry out laboratory testing of official samples. These laboratories are accredited to ISO/IEC 17025 by the Italian Accreditation Body. The BIP/DPE/DPI staff have access to the respectively laboratory websites to obtain sampling test results.

10. The Interministerial Decree of the Ministry of Health and the Ministry of Finance of 10 March 2004 sets out the checks on passengers as regards imports of certain products for personal consumption, including postal parcels. Several additional instructions for controls as well as notes for informing passengers have been established by both the Ministry of Health and by the Customs Agency. The information for passengers is published on their websites.

11. The Customs Agency informed the audit team that joint operations are organised between Customs, the Ministry of Health and the Ministry of Agriculture. These actions are carried out at selected entry points under special names e.g. “Retriever” during one week in a sensitive period (e.g. before Christmas) to step up checks on specific product

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groups such as products of animal origin, medication, protected species (CITES) and may involve the use of sniffer dogs.

12. In order to prevent the release of consignments in the absence of import checks, the Customs information system (Automazione Integrata Dogane Accise, AIDA) flags consignments subject to import controls. On the basis of national law (DPCM No 242 of 4 November 2010) the information system Customs’ Single Window has been established. This system is being implemented and is interoperable between the information systems used by competent authorities involved in the import sector e.g. the system of DGSAF (NSIS-SINTESIS import) and the Customs system AIDA. The DGSAF system downloads from Trade Control and Expert System (TRACES) in real time the status of the consignments mentioned in the CVEDs. The Customs’ Single Window system for goods in transit is expected to be in place in 2023.

13. The audit team noted, in general good cooperation between the local inspection units, chief veterinarian and the port and airport authorities with the exception at Civitavecchia port (see related finding point 79).

14. The communication and cooperation between competent authorities is in line with Article 24 of Regulation (EC) No 882/2004.

5.1.3 Resources and training of staff

15. Staff at the BIPs, DPEs/DPIs and Customs offices visited have been appropriately trained in line with Article 6 of Regulation (EC) No 882/2004.

16. The central authorities provided information on training delivered for its staff in the period 2017-2019, which included e-learning modules. Training covered general aspects of official controls and control methods for the control staff, but also more specific topics for BIP/DPE staff such as the use of TRACES in order to familiarise themselves with the modifications of TRACES-New Technology and preparedness for the new entry into force of the Official Control Regulation (EU) 2017/625.

5.1.4 Legislative and administrative provisions for the implementation of EU rules and planning

17. In accordance with Article 8(1) of Regulation (EC) No 882/2004, the competent authorities have established documented control procedures such as guidelines and instructions.

18. The instructions on official import controls of animals, products of animal origin and feed of non-animal origin issued by DGSAF are included in the Operative Guidelines for BIPs “Linee Guida operative PIF” published on the website of the Ministry of Health. These guidelines describe each control step and the action to be taken when non-compliance is identified. Guidelines on the application of the re-enforced checks and sampling in case of suspicion have been issued as well as letters to official control staff on more specific topics such as for example checks on Nile perch related to super-

8

chilling. Separate instructions for non-harmonised products of animal origin and animals are also established and published.

19. In 2007 DGISAN Office 2 issued a standard operating procedure (Procedura Operative Standard 11/2007) as amended aimed at ensuring uniform official controls carried out by USMAF-SASNs staff. Controls are performed pursuant to Regulation (EC) No 882/2004. The procedure has since been updated. Whereas this procedure does contain general provisions for sampling, it does not give detailed instructions on sampling contrary to the requirements of Article 4(c) of Regulation (EC) No 669/2009.

20. The audit team noted in one BIP visited that the “Linee Guida operative PIF” has been adapted to the local situation and includes also instructions for controls on passengers’ luggage. One administrative region had in addition antifraud provisions in its guidance for official staff.

21. DGSAF and DGISAN have the legal authority to enforce EU import legislation and have provisions for sanctions in place, in line with Articles 54 and 55 of Regulation (EC) No 882/8004. DGISAN stated these measures are limited to the seizure, rejection, destruction of goods not complying with import legislation. In contrast, DGSAF stated that in line with Article 28 of Decree 80/2000 of 7 April 2000, attempted importation of goods constituted a criminal activity, DGSAF could refer the case to the police leading to severe sanctions and court proceedings. Such sanctions have recently been applied at the BIP Trapani where the importer had not presented goods subject to import controls to the authorities. DGSAF could also levy sanctions.

22. The Customs Agency seizes undeclared products in passengers’ luggage, and those arriving via the postal services, which are thereafter destroyed. At the airport BIP visited, the Customs information system AIDA is used to monitor repeat offenders and to take further measures if needed.

23. A well-developed information technology system is in place ensuring that the frequency of physical checks, including sampling on consignments of goods of animal origin for which import requirements are harmonised at EU level, are carried out in line with the requirements laid down in Articles 2, 3 and 4 of Commission Decision 94/360/EEC and on consignments of goods subject to special import conditions in line with Article 8(2) of Regulation (EC) No 669/2009 and Article 9(5) of Regulation (EU) No 884/2014. There was however no system in place at the DPEs visited to avoid repeated sampling of goods presented by the same importer, which is a legal requirement.

24. DGSAF, Office 8 has developed an annual monitoring plan for categories of goods of animal origin intended for import and related potential hazards, in line with Article 1(2) of Commission Regulation (EC) No 136/2004 and point 1 of Annex II to Commission Regulation (EC) No 136/2004. The plan comprises test parameters such as residues, microorganisms/their toxins and metabolites, and other substances dangerous to animal or public health. A further plan includes feed of non-animal origin subject to special

9

import conditions. The implementation of these plans have been subject to a previous Commission audit (reference DG(SANTE)2015/7441).

25. DGISAN has also established a sampling frequency of 5% for food of non-animal origin in addition to the frequency rate for food subject to special import conditions, laid down in relevant Union legislation.

26. No monitoring plan has been established by DGSAF for animals intended for import, although the instructions require a sampling rate of 3% of ungulates. The number of imported eligible ungulates other than registered Equidae in recent years is low.

Conclusions on structure of the system for import controls

27. The responsibilities of the competent authorities for the official import controls are clearly defined. Communication and cooperation between the authorities at the border control posts is, with the exception of the port authorities of Civitavecchia Port, largely effective and supports the implementation of official import controls.

28. The competent authorities have put suitable arrangements in place to ensure staff are trained and are kept up-to-date in their area of competence. Staff have been provided with relevant legal acts, documented procedures and instructions to support their work. There is a monitoring plan in place which supports officials in identifying suitable consignments of goods for testing. The administrative framework, therefore, contributes to ensuring that the official import controls are largely carried out to a consistent standard.

5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON IMPORTED GOODS

5.2.1 Notification prior to arrival and systems to ensure the presentation of consignments for import controls

29. The importers or their representatives notify the arrival of consignments of animals and product of animal origin prior to arrival in TRACES. Food of non-animal origin subject to special import conditions is notified by the operator to the DPE staff either by email or by submitting the CED in the national database NSIS.

30. Several examples of notification prior to arrival of animals and goods were checked by the audit team and found to be in line with relevant legislation (Article 3(3) of Directive 97/78/EC, Article 2 of Regulation (EC) No 136/2004, Article 3(a) of Directive 96/496/EEC and Article 1 of Regulation (EC) No 282/2004). It was noted by the audit team that food of non-animal origin subject to special import conditions, was in several cases not notified prior to arrival. This is not in line with relevant legislation (Article 6 of Regulation (EC) No 669/2009 and Article 7 of Regulation (EU) No 884/2014). DGISAN staff stated that the late notifications had no adverse impact on the organisation of official controls and that importers not pre-notifying on time are not sanctioned.

10

31. In two BIPs visited, DGSAF staff stated that they obtain on a daily basis from airline/shipping line operators manifests which allow them to cross-check whether all consignments which should be presented for import controls are notified as required by Article 6 of Regulation (EC) No 136/2004 and Article 5 of Regulation (EC) No 282/2004. In the cases examined by the audit team, the BIP staff clarified that the consignments which were not notified were mainly of a non-commercial nature and the importer could provide either the mandatory documentation or the consignments were destroyed or sent back to the country of origin.

32. DGISAN and DPE staff stated that they did not carry out manifest checks, which is not an obligation under current legislation.

33. In addition to the manifest checks, the Customs information system AIDA and the information system Customs’ Single Window support the prevention of release of consignments which are subject to import controls without a valid CVED or CED.

5.2.2 Transhipment procedures

34. DGSAF stated that the transhipment of animals is rare in the airports. The few cases concerned mainly non-commercial consignments of animals. With the exception of transhipment of goods in a limited number of ports, with reference to Article 9(1) of Directive 97/78/EC, Italian ports are often the Member State of destination for transhipment taking place in other BIPs.

35. At one port BIP visited, where transhipment takes place, a procedure is in place and is implemented accordingly to verify if consignments intended for Member States or third countries for transhipment to another vessel are notified prior to arrival in this entry port and leave the port within given deadlines, in line with Articles 9 and 11 of Directive 97/78/EC and Articles 1, 2 and 3 of Decision 2011/215/EU.

36. In cases where the minimum time period of seven days for conduct of veterinary checks laid down in Article 2 of Decision 2015/215/EU had elapsed, the BIP staff did not check the original certificates, but accepted copies. The BIP staff had stamped and signed these copies as conforming to the original, which is neither in line with the Linee Guida operative PIF nor with Article 7(4) of Directive 97/78/EC. The BIP staff stated that they obtained from the staff of the BIP of destination, a scanned copy of the original certificate by email. However in a few cases selected for examination by the audit team, these emails were not archived. No cases were reported by the BIP staff of delays in excess of 30 days(1).

5.2.3 Transit and ship supply procedures

37. DGSAF stated that transit of consignments did take place from 2017 to date, but the number of consignments in transit to third countries is low. Consignments of goods in

(1) In its response to the draft report the competent authority noted that currently the provisions of Regulation (EU) 2019/2124 are applied and where the minimum times exceed, documentary checks are carried out on the original certificates.

11

transit take place to ship suppliers, North Atlantic Treaty Organisation/United States of America (NATO/US) army bases and/or direct supply of cross border means of sea transport (ship supply). The customs warehouses are approved in line with Article 12(4) of Directive 97/78/EC and the operators who directly supply cross-border means of sea transports are authorised by the competent authority. All consignments of products of animal origin in transit are subject to documentary and identity checks at the entry BIP, which is in line with Articles 11(2)(b) and 12(2) of Directive 97/78/EC.

38. At one BIP visited, the BIP staff demonstrated their controls on the entry, exit and storage of consignments at one customs warehouse visited, approved to store products not conforming to EU requirements in line with Articles 12(5) and 13(1) of Directive 97/78/EC.

39. Regarding records of supplies of goods from the customs warehouse to cross border means of sea transport checked by the audit team, the certificate referred to in Article 1(3) of Decision 2000/571/EC (the model certificate being laid down in the Annex thereto) was issued by the BIP staff. However, the audit team noted that in a few cases, operators had not provided the BIP staff with the completed certificate confirming the delivery of goods on board the vessel within the deadline of 30 days, which is not in line with Article 2 of that Decision.

40. The BIP staff issued a similar document for delivery of goods from the warehouse to NATO/US army bases, and validated thereafter the CVEDs in TRACES. The proportion of cases where confirmation of arrival at NATO/US army bases within the deadline of 30 days varies significantly between bases, ranging from 99,6% to as little as 13.4 % confirmed. DGSAF stated that further action is still needed to ensure that this legal obligation is satisfied in all cases.

5.2.4 Documentary, identity and physical checks

5.2.4.1 Checks on animals

41. At the airport BIP visited, most of the consignments of animals checked by the audit team had been subjected to a documentary, identity and physical check (including animal welfare) and the controls were in general implemented in line with the procedures in place. Where applicable, the BIP staff verified if consignments reached their destination. This is in line with relevant import requirements for animals laid down in Articles 2, 3, 4 and 5 of Decision 97/794/EC.

42. For six consignments checked by the audit team containing animals (non-harmonised) or germinal products (a rejected consignment), minor errors were found in relation to the documentary, identity and physical checks. These errors had little impact on the health condition of the animals and included the following:

The documentary checks for a few consignments were recorded as satisfactory, but the number of animals declared on the CVED compared with the number on

12

the accompanying documents/certificates did not match and one certificate contained non-official alterations.

The identification and/or physical checks were reported as satisfactory in a few cases, but information was missing regarding the number of animals (insects) or certificate was absent (germinal products).

5.2.4.2 Checks on goods of animal origin

43. The controls on goods of animal origin intended for import were in general implemented in line with the procedures in place. The consignments of goods intended for import checked by the audit team had all been subjected to a documentary and identity check by the BIP staff. If applicable, the physical checks were carried out at a reduced frequency and official samples were taken and sent to the designated laboratories for analysis in line with the monitoring plan in place for goods of animal origin. The results of the laboratory tests were available in all of the cases checked by the audit team and the turnaround times were acceptable.

44. In one port, the BIP staff carried out the identity checks of containerised frozen and chilled goods at the terminal where the packages selected for physical checks were also collected and not at the BIP facilities. This procedure is not in line with Article 4 of Directive 97/78/EC(2).

45. The audit team checked the implementation of the procedures for re-imported consignments of four consignments. All were destined for the establishment of origin and the local veterinary units agreed to their return. Whilst the procedures to carry out documentary checks are in line with the requirements laid down in Article 15 1(a) of Directive 97/78/EC, they were not correctly implemented e.g. the absence of a non-manipulation documents or original certificate/authenticated copy had not been identified in the cases examined.

46. In line with Article 24 of Directive 97/78/EC, more stringent checks were carried out on consignments under the re-enforced check regime. In one port BIP visited, the audit team noted that consignments subjected to re-enforced checks or which were considered suspect had been sampled for microbiological chemical analysis and detained until the laboratory test results were available.

5.2.4.3 Implementation of special import conditions

47. The controls on food of non-animal origin subject to special import conditions were not implemented in line with EU rules in several cases below.

48. At Venice port, documentary checks on food of non-animal origin subject to special import conditions took place at the local USMAF-SASN office instead of in the port of

(2) In its response to the draft report the competent authority noted that the BIP staff of Civitavecchia carry out the identity checks of the containerised frozen and chilled goods and collect the packages selected for physical checks at the BCP facilities.

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entry where physical facilities are in place (see related finding point 82). This arrangement is not in line with the requirements laid down in Article 8(1)(a) of Regulation (EC) No 669/2009, Article 9(2) of Regulation (EU) No 884/2014 and Article 8(1) of Regulation (EU) 2015/175.

49. USMAF-SASN staff carry out documentary controls based on copies of original certificates and/or laboratory test results. This hinders the verification of the authenticity of the health certificates, declarations and the laboratory results due to the reliance on copies. This procedure is not in line with the requirements laid down in Articles 4, 5 and 9(2) of Regulation (EU) No 884/2014 and Articles 4, 5 and 8(1) of Regulation (EU) 2015/175.

50. In addition, in one port visited, DPE/DPI staff could not provide copies of the certificates and laboratory test results for one out of three consignments of peanuts from Egypt and one consignment of guar gum from India verified in order to demonstrate that the requirements laid down in Articles 4 and 5 of Regulations (EU) No 884/2014 and (EU) 2015/175 respectively were met.

51. The official samples, taken by DPE/DPI staff are sent to the designated laboratories for analyses. The consignments were detained awaiting results. The results of the laboratory tests were available in all cases verified, but in one case there was no link between the sampling and the consignment due to absence of the lot/batch number.

5.2.5 Decision on consignment and its follow-up

52. After completion of the checks, the BIP/DPE staff complete the CVED or CED in line with the provisions laid down in relevant EU legislation.

53. For rejected consignments of animal origin which were re-dispatched, the BIP staff could provide documented evidence of return within the given deadline of 60 days in line with their procedures and with Union legislation, in particular Article 21 of Regulation (EC) No 882/2004. For several consignments of goods which had been sent for destruction, BIP/DPE staff provided evidence of destruction. Customs provided evidence of destruction for consignments intended for personal use which were seized as a result of their controls. Where relevant, unfavourable laboratory results triggered Rapid Alert System for Feed and Food (RASFF) notifications in line with Article 50 of Regulation (EC) No 178/2002.

54. The audit team carried out a desk review of 50 consignments of animal origin which were allowed entry and must be channelled to their destination in line with the requirements of Articles 8(4), 12(1) or 15(1) of Directive 97/78/EC. DGSAF and BIP staff provided evidence that the local veterinary units had been informed of the dispatch and had reported the arrival of such consignments at destination. However, local veterinary units did not enter in TRACES the completion of part III of the CVEDs in 16 of the cases, but used instead other means to report the arrival e.g. by email. This is not in line with the requirements laid down in article 3(2) of Decision 2004/292/EC.

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Furthermore, audit report DG(SANCO)/2013-6899 had made a recommendation on this subject to which DGSAF had provided a satisfactory action plan.

5.2.6 Use of TRACES and other databases in relation to import controls and transit

55. For a number consignments selected by the audit team, the BIP staff had ensured that the data related to animals and products of animal origin intended for import were entered in TRACES in line with DGSAF documented procedures and the requirements laid down in Article 3 of Decision 2004/292/EC with the exception mentioned in the related finding 54.

56. For a number consignments selected by the audit team, the USMAF-SASN had entered the data related to import of food of non-animal origin in the database NSIS, which is interoperable with the Customs’ Single Window System.

57. BIP staff have restricted access to Customs’ databases, or they can obtain information upon request. The audit team saw evidence of this cooperation.

58. Both, the Ministry of Health and Customs Agency have their own internet sites on which the guidelines, instructions and references to applicable import legislation can be found. Some of this information is also available to the public.

59. BIP and DPE staff have access to the websites of the designated laboratories.

5.2.7 Controls on the presence of goods of animal origin in travellers' personal luggage, including postal parcels

60. The audit team examined the arrangements in place at one airport and one port BIP in relation to control on travellers’ personal luggage. Procedures are in place and posters in several languages advising passengers of the rules are available in the baggage reclaim area. This is in line with Article 3 of Commission Regulation (EC) No 206/2009.

61. At both BIPs, Customs and BIP staff cooperate closely on passenger luggage controls and through regular meetings. A veterinarian is required to co-sign the report on seizures drawn up by the Customs officials.

62. At the airport BIP, Customs have a risk-profiling system in place and stated that arrivals of third country flights are routinely targeted, as are passengers with non-EU luggage tags arriving via major transport hubs. Some passenger luggage is screened via an X-ray machine and is investigated further if anything suspicious is flagged, whilst some passengers are simply questioned and others are invited to open their luggage immediately. These arrangements are in line with Article 5 of Regulation (EC) No 206/2009. At the port BIP, the passengers' luggage is routinely checked.

63. When Customs at the airport BIP find prohibited products of animal origin, these are seized, weighed and stored in a dedicated freezer for seized animal by-products. At the port BIP, Customs estimate the weight of the seized products. In both cases the passenger is required to sign a destruction order detailing what has been seized, the

15

weight and the date. This is in line with Article 6 of Regulation (EC) No 206/2009. This destruction order is kept by Customs, who use the information for annual reporting purposes to the European Commission. The airport/port authority is responsible for sending the seized products for incineration. The audit team saw evidence of the destruction by incineration of the goods seized.

64. Customs at the main post office hub for parcels at the airport visited stated that postal parcels must be cleared by Customs before release. This is done based on the Customs' declaration accompanying the consignment which gives a description of the contents. Such parcels are also scanned by X-ray machines. Parcels containing products of animal origin - or where there is doubt - are sent by the post office to the inspection centre at the airport BIP using the T1-Customs' procedure. If the BIP staff confirm that the parcel contains products of animal origin, the post office informs the recipient that they have to pay for the import controls by BIP staff. Once payment is received, BIP staff can issue a formal decision (in the vast majority of cases, rejection). Those recipients who do not respond to the request for payment have their parcels returned to sender or destroyed.

65. The audit team saw evidence of good cooperation between Customs, Post Office officials and BIP staff to ensure the procedures described are followed.

Conclusions on implementation of official controls on imported goods

66. The implementation of import controls on animals and goods was, with few exceptions in line with EU legislation and could ensure that only compliant consignments are introduced into the territory of the EU.

67. The guarantees in response to recommendation 1 of a previous audit report in relation to entering required data into TRACES by the local veterinary units, confirming the arrival of consignments at destination have not been effectively implemented.

68. USMAF-SASN do not check the originals of certificates or other relevant documents and therefore are not in a position to ascertain their authenticity. Furthermore, the way in which the system for documentary checks on consignments of food of non-animal origin subject to special import conditions has been set up at the designated point of entry in Venice Port (checks are being carried out at local office level instead of at the entry point at the border) is contrary to EU requirements.

69. The competent authorities effectively control passenger luggage and postal parcels to prevent the introduction into the EU of contagious animal diseases in the EU.

5.3 PROCEDURES IN PLACE TO VERIFY THAT OFFICIAL CONTROLS ON IMPORTS OF ANIMALS AND GOODS ARE EFFECTIVE AND APPROPRIATE

70. Audits at BIPs and DPE/DPIs are included in the Audit system of Ministry of Health coordinated by Office 3 of Directorate-General for Hygiene, Food Safety and Nutrition.

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Audits are scheduled each year based on some factors and the risk (e.g. previous non-compliance, number of consignments, etc.).

71. All of the BIPs visited had been audited within the last 5-year cycle, with the exception of the airport BIP, which was last audited in 2010. The reason for the exclusion was that this BIP had been audited by the European Commission in 2016. Office 3 of the Ministry of Health has developed a detailed checklist to guide these audits and has made pertinent findings which have led to improvements in the import control system. This is in line with the requirements of Article 4(6) of Regulation (EC) 882/2004.

72. In addition, the central competent authority has set objectives to be achieved and indicators for measuring the performance of BIPs, for example a minimum percentage of consignments to be sampled and a minimum percentage of compliance checks on CVEDs issued by BIP staff. Various other monitoring systems are in place which the central competent authority verifies regularly via TRACES reporting.

73. BIPs are supervised at local level by the head of the BIP, who carries out the aforesaid compliance checks. Any recurring problems are discussed at meetings, which are minuted. The audit team saw an example of such minutes at several BIPs. Procedures are in place to check the BIP facilities on a regular basis (every 1-3 months depending on the BIP). Whilst the checks on the whole lead to corrective action eventually, the request for corrective action is not well-documented and deadlines for its completion are not set, resulting in some non-compliances persisting much longer than they should (e.g. the leaking roof in the facilities for import controls of animals category Equidae and Ungulates (E and U) at one airport BIP). The supervision/verification of BIPs is generally in line with Article 8(3) of Regulation (EC) No 882/2004 but there are weaknesses in following up non-compliances identified.

74. The DPE/DPIs visited in both ports of entry were audited in 2014 and 2016 respectively. These audits are carried out on the basis of a checklist. The audit of one DPE/DPI visited did not identify the major shortcomings identified by the audit team, namely, the fact that the documentary check is being carried out inland rather than at the DPE and often on the basis of scanned or copies of certificates, and the fact that the identity and physical checks are taking place in non-authorised warehouses instead of at the DPI. There was no evidence of any local supervision in both DPE/DPIs.

5.4 SUITABILITY OF FACILITIES AND EQUIPMENT FOR IMPORT CONTROLS

75. The facilities and equipment at the port BIP Venezia are in compliance with the requirements for approval.

76. At Palermo Port, new border control facilities are under construction. The audit team inspected the construction site and noted that works were progressing in line with the construction plan. It is foreseen that the new border control facilities will be operational before 2020.

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77. At Milano-Malpensa Airport BIP, the facilities for animals (categories U and E) were visited only. In response to a recommendation of a previous audit report (DG(SANTE)/2016-8874), the facilities have been adapted to accommodate ungulates (category U). However, the facilities lacked maintenance, in particular the roof was leaking at different places. This was identified during recent internal verification visits, but BIP staff could not provide evidence that corrective action was underway (see related finding point 73). In addition, BIP staff did not identify damaged floor surfaces and the absence of restraining equipment for animals, categories U and E. Furthermore, the housing facilities for these categories of animals were not appropriately cleaned. The facilities for animals, categories U and E do not meet the minimum requirements laid down in Annex A to Directive 91/496/EEC.

78. The facilities at Gioia Tauro Port BIP will be replaced by new border control facilities in 2020. The plans have been approved, but construction has not yet begun. The current facilities have not been well-maintained and the non-compliances identified by the audit team were described in the DGSAF audit report (e.g. partly damaged floors and walls). Moreover, the facilities and equipment were not appropriately cleaned. The facilities and equipment are not in line with the requirements laid down in the Annex to Decision 2001/812/EC.

79. The facilities and equipment for HC and NHC products at Civitavecchia Port BIP did not meet the standards for approval, which are laid down in Article 4 and Annex to Decision 2001/812/EC. This was also concluded in the internal DGSAF 2018 audit report (e.g. damaged floors, walls and ceiling). In addition, the audit team identified damaged entry doors, one could not be opened and there was a big gap under the second door, non-functioning cooling systems in the storage rooms and rusty equipment. Moreover the facilities and equipment were not appropriately cleaned. Despite the fact that the port authorities, who own the facilities have been informed about the shortcomings identified by DGSAF and BIP staff, no action has been undertaken by the port authorities to remedy the situation.

80. The new inspection centre "XPRESS" at Rome-Fiumicino airport BIP was built in line with the plans for the categories HC-T(CH)(2) and HC-T(FR)(2) (packed products to be kept under temperature conditions) and the necessary equipment was in place. However, the facilities were not appropriately cleaned and the walls in both storage rooms need some repair. The facilities were therefore not in line with the requirements laid down in the Annex to Decision 2001/812/EC.

81. The DPEs/DPIs for feed of non-animal origin are shared with the BIP facilities for non-human consumption and the DPEs/DPIs for food of non-animal origin are separate facilities.

82. DGISAN has not made available to the public a list of points of entry with suitable designated DPE/DPI facilities for food of non-animal origin. The list with DPEs erroneously refers to local offices of DGISAN, which are not all located in ports and

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airports of entry e.g. DPE Venice and the published list has not been updated since 2016. Furthermore, DPE Palermo is not listed, which is not in line with Article 4 of Regulation (EC) No 669/2009. DGISAN has not designated any DPIs, but stated that the DPEs also carry out the duties of DPIs. DGISAN consequently did not maintain publicly available an up-to-date list of DPEs and DPIs, which is not in line with Article 5 of Regulation (EC) No 669/2009 and Article 8 of Regulation (EU) No 884/2014. In addition, This is contrary to an earlier commitment given, which is mentioned in point 11 of audit report DG(SANTE) 2016-8874.

83. In case consignments are selected for official sampling, the consignments are forwarded to the inspection facilities for food of non-animal origin, which are located in the port of entry. In Venice port, physical checks and sampling takes also place in customs warehouses, which are not designated by DGISAN as DPIs. Carrying out physical checks at these warehouses is not in line with Article 9(2) of Regulation EC) No 669/2009, Article 8(1)(b) of Regulation (EU) No 884/2014 and Article 8(2) of Regulation (EU) 2015/175.

84. In Venice port, the lay-out of the inspection facilities for food of non-animal origin, the maintenance of equipment and its cleansing did not ensure hygienic operations, which is not in line with Article 16(3) of Regulation (EC) No 882/2004. The entrance from outside to administrative and changing offices, including toilets and hand-wash facilities is through the inspection room. The storage facilities for ambient temperature contained samples, mainly household items (food contact materials) taken since 2012.

Conclusions on suitability of facilities and equipment

85. All facilities visited with the exception of the BIP facilities at Venezia Port, did not meet the operational hygiene standards resulting from either lack of maintenance and/or inappropriate cleansing and disinfection. Whilst some facilities are being reconstructed to comply with Regulations (EU) 2017/625 and (EU) 2019/1014 there is, however, no plan to upgrade the substandard facilities and equipment at Civitavecchia Port BIP.

86. In relation to import controls on food of non-animal origin, DGISAN has not made available to the public a list of points of entry with suitable designated DPE/DPI facilities. The list of DPEs only erroneously refers to local offices of DGISAN and the published list has not been updated since 2016. DGISAN does not ensure that documentary checks are done at the DPE and that physical checks, including sampling, are carried out at the DPE/DPIs.

6 OVERALL CONCLUSIONS

The responsibilities of the competent authorities for the official import controls are clearly defined. The Italian authorities have established a comprehensive framework for official controls on imported animals and goods, supported by guidance documents and

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information technology systems. Communication and cooperation between the authorities at the border control posts is, with the exception of the port authorities of Civitavecchia Port, largely effective and supports the implementation of import controls.

Implementation of official controls on imported animals and products of animal origin as well as controls on personal consignments is generally in line with relevant EU requirements. However, weaknesses in the control system were identified in relation to (a) documentary checks on food of non-animal origin subject to special import conditions, as the competent authority accepts copies of relevant documents and is not in a position to ascertain their authenticity; and (b) the hygiene and suitability of designated points of entry and import.

In relation to the BIPs visited, all facilities, bar one, did not meet expected operational hygiene standards. Whilst some facilities are being reconstructed to comply with Regulations (EU) 2017/625 and (EU) 2019/1014 there is, however, no plan to upgrade the substandard facilities and equipment at Civitavecchia Port BIP.

7 CLOSING MEETING

A closing meeting was held on 6 December 2019 with the representatives of the central authorities, DGSAF and DGISAN of the Ministry of Health and Customs Agency. At this meeting, the main findings and preliminary conclusions of the audit were presented by the audit team. The central competent authority did not express disagreement with the findings and conclusions presented.

8 RECOMMENDATIONS

No. Recommendation

1. To ensure that a) the facilities and equipment to carry out official controls on imports of animals, products of animal origin, and products of non-animal origin subject to special import conditions comply with the requirements laid down in Article 6(3) and Annex A to Directive 91/496/EC (animals), Article 4 and Annex to Decision 2001/812/EC (products of animal origin) and Article 4 of Regulation (EC) 669/2009 and Article 8 of Regulation (EU) 884/2014 (food of non-animal origin subject to special import conditions), and b) that an updated list of designated points of entry and imports is made publicly available in line with Article 5 of Regulation (EC) 669/2009 and Article 8 of Regulation (EU) 884/2014.

Recommendation based on conclusions: 85 and 86

Associated findings: 77 – 80, 82, and 84

2. To ensure that official controls on food of non-animal origin subject to special import conditions are performed at appropriate facilities (designated points of entry and/or designated points of import) in line with the requirements laid down in Articles 8(1)(a)

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and 8(1)(b) of Regulation (EC) 669/2009, Articles 9(1) and 9(2) of Regulation (EU) 884/2014 and Articles 8(1) and 8(2) of Regulation (EU) 2015/175.

Recommendation based on conclusions: 68 and 86

Associated findings: 47 - 51 and 83

3. To ensure that official control staff enter the required data into TRACES on consignments which require confirmation of receipt at destination, in particular related to transit, supplying sea transport and re-importation of products of animal origin in line with the requirements laid down in Article 3(2) of Decision 2004/292/EC.

Recommendation based on conclusion:67

Associated findings: 39, 40 and 54

The competent authority's response to the recommendations can be found at:

http://ec.europa.eu/food/audits-analysis/rep_details_en.cfm?rep_inspection_ref=2019-6640

ANNEX 1 – LEGAL REFERENCES

Legal Reference Official Journal TitleReg. 178/2002 OJ L 31, 1.2.2002, p.

1-24 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Reg. 282/2004 OJ L 49, 19.2.2004, p. 11-24

Commission Regulation (EC) No 282/2004 of 18 February 2004 introducing a document for the declaration of, and veterinary checks on, animals from third countries entering the Community

Reg. 882/2004 OJ L 165, 30.4.2004, p. 1, Corrected and re-published in OJ L 191, 28.5.2004, p. 1

Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Reg. 136/2004 OJ L 21, 28.1.2004, p. 11-23

Commission Regulation (EC) No 136/2004 of 22 January 2004 laying down procedures for veterinary checks at Community border inspection posts on products imported from third countries

Reg. 206/2009 OJ L 77, 24.3.2009, p. 1-19

Commission Regulation (EC) No 206/2009 of 5 March 2009 on the introduction into the Community of personal consignments of products of animal origin and amending Regulation (EC) No 136/2004

Reg. 669/2009 OJ L 194, 25.7.2009, p. 11-21

Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC

Reg. 884/2014 OJ L 242, 14.08.2014, p. 4-19

Commission Implementing Regulation (EU) No 884/2014 of 13 August 2014 imposing special conditions governing the import of certain feed and food from certain third countries due to contamination risk by aflatoxins and repealing Regulation (EC) No 1152/2009

Reg. 885/2014 OJ L 242, 14.08.2014, p. 20-26

Commission Implementing Regulation (EU) No 885/2014 of 13 August 2014 laying down specific conditions applicable to the import of okra and curry leaves from India and repealing Implementing Regulation (EU) No 91/2013

Reg. 2015/175 OJ L 30, 6.2.2015, p. 10–15

Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins

Reg. 2016/6 OJ L 3, 6.1.2016, p. 5–15

Commission Implementing Regulation (EU) 2016/6 of 5 January 2016 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station and repealing Implementing Regulation (EU) No 322/2014

Dir. 91/496/EEC OJ L 268, 24.9.1991, p. 56-68

Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC

Dir. 97/78/EC OJ L 24, 30.1.1998, p. 9-30

Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries

Dec. 94/360/EC OJ L 158, 25.6.1994, p. 41-45

94/360/EC: Commission Decision of 20 May 1994 on the reduced frequency of physical checks of consignments of certain products to be implemented from third countries, under Council Directive 90/675/EEC

Dec. 97/794/EC OJ L 323, 26.11.1997, p. 31-36

97/794/EC: Commission Decision of 12 November 1997 laying down certain detailed rules for the application of Council Directive 91/496/EEC as regards veterinary checks on live animals to be imported from third countries

Dec. 2000/571/EC OJ L 240, 23.9.2000, p. 14-18

2000/571/EC: Commission Decision of 8 September 2000 laying down the methods of veterinary checks for products from third countries destined for introduction into free zones, free warehouses, customs warehouses or operators supplying cross border means of sea transport

Dec. 2001/812/EC OJ L 306, 23.11.2001, p. 28-33

2001/812/EC: Commission Decision of 21 November 2001 laying down the requirements for the approval of border inspection posts responsible for veterinary checks on products introduced into the Community from third countries

Dec. 2004/292/EC OJ L 94, 31.3.2004, p. 63-64

2004/292/EC: Commission Decision of 30 March 2004 on the introduction of the Traces system and amending Decision 92/486/EEC

Dec. 2011/215/EU OJ L 90, 6.4.2011, p. 50-52

2011/215/EU: Commission Implementing Decision of 4 April 2011 implementing Council Directive 97/78/EC as regards transhipment at the border inspection post of introduction of consignments of products intended for import into the Union or for third countries

Dec. 2011/884/EU OJ L 343, 23.12.2011, p. 140-148

2011/884/EU: Commission Implementing Decision of 22 December 2011 on emergency measures regarding unauthorised genetically modified rice in rice products originating from China and repealing Decision 2008/289/EC

1

APPENDIX –LEGAL REQUIREMENTS REFERRED TO IN THE SPECIFIC CHAPTERS IN THE REPORT

REPORT CHAPTER

TITLE OF CHAPTER AND/OR SECTION

APPLICABLE LEGISLATION– LEGAL REQUIREMENTS CORRESPONDING TO THE SPECIFIC CHAPTERS AND/OR SECTIONS OF THE REPORT1

REG 882/2004 DIR. 97/78PAO2

REG. 136/2004PAO

DEC. 97/794ANIMALS

DIR. 91/496/ANIMALS

REG. 669/2009PNAO3

REG. 884/2014PNAO

OTHER RELEVANT LEGISLATION

5.1.1 COMPETENT AUTHORITIES INVOLVED

ART. 4

5.1.2 COMMUNICATION AND CO-OPERATION BETWEEN COMPETENT AUTHORITIES

ART. 4, 12 AND 24

ART. 6 REG. 282/2004, ART. 5

5.1.3 RESOURCES AND TRAINING OF STAFF

ART. 6 ART. 27 ART. 4(A) ART. 8(A)

5.1.4 LEGISLATIVE AND ADMINISTRATIVE PROVISIONS FOR THE IMPLEMENTATION OF EU RULES AND PLANNING

ART 8; 54 AND 55

ART. 1 AND ANNEX II

ART 4.1 ART. 4(C) AND 8(2)

ART. 9(5) DEC 94/360/EEC, ART. 2, 3 AND 4

5.2.1 NOTIFICATIONS PRIOR TO ARRIVAL AND SYSTEMS TO ENSURE THE PRESENTATION OF IMPORTED CONSIGNMENTS FOR IMPORT CONTROLS

ART. 17.1 ART. 3.3 ART. 2 AND 6 ART 3.1.A ART. 6 ART. 7 REG. 282/2004, ART 1.1 AND 5;

REG. 885/2014, ART. 7;

REG. 2015/175, ART 7;REG. 2016/6, ART 9;

DEC. 2011/884, ART. 3

5.2.2 TRANSHIPMENT ART. 7(4), 9 AND 11

DEC 2011/215/EU, ART. 1, 2 AND 3

5.2.3 TRANSIT PROCEDURES AND SHIP SUPPLY PROCEDURES

ART. 11, 12 AND 13

ART. 3.4 DEC. 2000/571/EC

5.2.4 DOCUMENTARY, IDENTITY AND PHYSICAL CHECKS

ART. 16 ART. 4; 7.2; 8.2; 9.1; 15; 20, 24 AND ANNEX III

ART. 1 AND ANNEXES I AND II

ART. 1; 2; 3; 4; 5 AND ANNEXES I AND II

ART. 4; 5; 8; 9 AND 11.1

ART. 8.1 AND ANNEX I

ART. 4, 5 AND 9

REG. 885/2014, ART 8;

REG. 2015/175, ART. 4, 5 AND 8;

REG. 2016/6, ART. 10;

DEC 2011/884, ART. 5

5.2.5 DECISION ON CONSIGNMENT AND ITS FOLLOW-UP

ART. 21 ART. 8(4), 12(1) , 15(1)

ART. 3, 4 AND 5

REG. 178/2002, ART. 50;REG. 282/2004, ART. 3 AND 4

1 Legal acts quoted in this appendix are provided in Annex 1 and refer, where applicable, to the last amended version.2 PAO: abbreviation for products of animal origin3 PNAO: abbreviation for products of non-animal origin

2

REPORT CHAPTER

TITLE OF CHAPTER AND/OR SECTION

APPLICABLE LEGISLATION– LEGAL REQUIREMENTS CORRESPONDING TO THE SPECIFIC CHAPTERS AND/OR SECTIONS OF THE REPORT1

REG 882/2004 DIR. 97/78PAO2

REG. 136/2004PAO

DEC. 97/794ANIMALS

DIR. 91/496/ANIMALS

REG. 669/2009PNAO3

REG. 884/2014PNAO

OTHER RELEVANT LEGISLATION

AND 17 DEC. 2004/292/EC, ART. 3

5.2.6 USE OF TRACES AND OTHER DATABASES

ART. 3.3 ART. 2, 7 AND 10

REG. 282/2004, ART. 3, 6 AND 7;DEC 2004/292, ART. 1, 2 AND 3

5.2.7 CONTROLS ON THE PRESENCE OF GOODS OF ANIMAL ORIGIN IN TRAVELLERS' PERSONAL LUGGAGE, INCLUDING POSTAL PARCELS

ART. 8 REG. 206/2009

5.3 PROCEDURES IN PLACE TO VERIFY THAT OFFICIAL CONTROLS ON IMPORTS OF ANIMALS AND GOODS ARE EFFECTIVE AND APPROPRIATE

ART. 4.6 AND 8.3

5.4 SUITABILITY OF FACILITIES AND EQUIPMENT FOR IMPORT CONTROLS

ART. 4.2 (D) ART. 6 AND ANNEX II

ART. 6 AND ANNEX A

ART. 4, 5 AND 9

ART. 8 DEC. 2001/812REG. 2015/175, ART. 8

FOR RELEVANT SECTIONS ABOVE, IF APPLICABLE

ENFORCEMENT MEASURES, DECISION ON CONSIGNMENTS AND FOLLOW-UP

ART 4.2(E); 15.5; 16.2; 19; 20; 21; 23.2 AND ART. 54, 55 AND 56

ART. 8; 10; 11.2(B); 15; 17; 22 AND 24

ART. 3 ART. 8.3; 11; 12; 16 AND 18

ART 1; 8.2; 10 AND 13

ART. 3; 9.3; 9.4; 11 AND 12

REG.178/2002, ART. 53;

DEC. 94/360;

REG. 885/2014 ART. 3; 10 AND 11REG. 2015/175, ART. 3; 10 AND 11

REG. 2016/6, ART. 3; 12 AND 13DEC. 2011/884, ART 4