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1 Ministero della Salute DIREZIONE GENERALE DELLA SANITA’ ANIMALE E DEI FARMACI VETERINARI Ufficio VIII DGSAF-Coordinamento PIF-UVAC GUIDANCE DOCUMENT ON IMPLEMENTATION OF REGULATION (EU) 2015/329 DEROGATING FROM UNION PROVISIONS ON ANIMAL AND PUBLIC HEALTH AS REGARDS THE INTRODUCTION INTO THE EUROPEAN UNION OF FOOD OF ANIMAL ORIGIN DESTINED FOR EXPO MILANO 2015 IN MILAN (ITALY) Introduction ........................................................................................................................................................................ 2 Scope of the guidance..................................................................................................................................................... 2 Legal Basis ........................................................................................................................................................................... 2 Duration of provisions of Regulation (EU) 2015/329 .................................................................................. 2 Subject matter .................................................................................................................................................................... 2 Requirements for the introduction INTO EU of NON-conforming products intended for EXPO Milano 2015 ........................................................................................................................................................... 3 Health certification.......................................................................................................................................................... 3 Procedures of introduction of non conforming food of animal origin intended for EXPO Milano 2015 ........................................................................................................................................................................ 4 Remainders of consignments or parts thereof not used for EXPO purposes.................................... 4 Obligations of the exhibitors of EXPO Milano 2015 ...................................................................................... 5 Information to the visitors and staff of EXPO Milano 2015 ....................................................................... 5 Annex...................................................................................................................................................................................... 6

Ministero della Salute · ministero della salute direzione generale della sanita’ animale e dei farmaci veterinari ufficio viii dgsaf-coordinamento pif-uvac guidance document on

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Ministero della Salute

DIREZIONE GENERALE DELLA SANITA’ ANIMALE E DEI FARMACI VETERINARI

Ufficio VIII DGSAF-Coordinamento PIF-UVAC

GUIDANCE DOCUMENT

ON IMPLEMENTATION OF REGULATION (EU) 2015/329 DEROGATING FROM UNION PROVISIONS ON ANIMAL AND PUBLIC HEALTH AS

REGARDS TH E INTRODUCTION INTO THE EUROPEAN UNION OF FOOD OF ANIMAL ORIGIN DESTINED FOR EXPO MILANO 2015 IN MILAN (ITALY)

Introduction ........................................................................................................................................................................ 2

Scope of the guidance..................................................................................................................................................... 2

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

Duration of provisions of Regulation (EU) 2015/329 .................................................................................. 2

Subject matter .................................................................................................................................................................... 2

Requirements for the introduction INTO EU of NON-conforming products intended for EXPO Milano 2015 ........................................................................................................................................................... 3

Health certification .......................................................................................................................................................... 3

Procedures of introduction of non conforming food of animal origin intended for EXPO Milano 2015 ........................................................................................................................................................................ 4

Remainders of consignments or parts thereof not used for EXPO purposes.................................... 4

Obligations of the exhibitors of EXPO Milano 2015 ...................................................................................... 5

Information to the visitors and staff of EXPO Milano 2015 ....................................................................... 5

Annex ...................................................................................................................................................................................... 6

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INTRODUCTION

Italy will host the universal exhibition “EXPO Milano 2015” which will be held in Milan from the 1st May to 31st October 2015. The theme of the event is "Feeding the Planet - Energy for Life" and many third countries that will participate in the event are not allowed to export products of animal origin to the Union. Therefore, certain transitory derogations to the current import health requirements have been established by European Commission in order to authorise the introduction of certain products exclusively for the purpose of their use in “EXPO Milano 2015”. However in order to protect the animal health status of the EU, only products of animal origin which fulfill the Union animal health import or transit requirements shall be authorised to enter the Union for the purpose of their use in “EXPO Milano 2015”. Such non-conforming products shall undergo to strict control measures of traceability in all stages of transport, storage, delivery and disposal of their remainder or waste.

SCOPE OF THE GUIDANCE Provide Third country and exhibitors participating to the event EXPO Milano 2015 with a proper assistance on the implementation of Regulation (EU) 2015/329 of 2 March 2015 derogating from Union provisions on animal and public health as regards the introduction into the European Union of food of animal origin destined for EXPO Milano 2015 in Milan (Italy).

LEGAL BASIS COMMISSION IMPLEMENTING REGULATION (EU) 2015/329 of 2 March 2015 derogating from Union provisions on animal and public health as regards the introduction into the European Union of food of animal origin destined for EXPO Milano 2015 in Milan (Italy) http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1429179584490&uri=CELEX:32015R0329

DURATION OF PROVISIONS OF REGULATION (EU) 2015/329 Provisions established in Regulation (EU) 2015/329 are transitory. They shall apply from 1 March 2015 to 31 October 2015, however the procedures for disposal or re-exportation continue to apply until 31 December 2015.

SUBJECT MATTER Products of animal origin (or food containing those products) coming from third countries or establishments from which imports of those products (or food containing those products) to the EU is not authorized by EU public health legislation. However such products must:

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fulfil animal health requirements of EU legislation and therefore they are authorised for transiting through the Union

be fit for human consumption in the third country of origin be introduced only for the purpose of their use in the exhibition site of EXPO Milano 2015.

No derogation is granted in the case of:

bivalve molluscs (or food derived from these animals) considering the important public health risks linked to such products. Therefore they shall be allowed for EXPO Milano 2015 only if they fulfill the EU public health import requirements

products of animal origin/third countries subject the safeguard measures adopted in accordance with Article 22 of Directive 97/78/EC and in force during the period of application of this Regulation.

REQUIREMENTS FOR THE INTRODUCTION INTO EU OF NON-CONFORMING PRODUCTS

INTENDED FOR EXPO MILANO 2015 The third country of origin of the products takes officially part in the EXPO Milano 2015 and has an exhibition stand in the site of EXPO Milano 2015; The products are packaged in sealed containers or packages that do not allow any leakage of the content and are marked with the words ‘for exclusive destination EXPO Milano 2015’ in red and white and in a readable size proportionate to the dimension of those containers or packages. At the exibithion site EXPO Milano 2015 non conforming food will be used exclusively for display and tasting on the spot. Marketing and consumption are allowed only within the exhibition site and for no reason these products may be brought outsite.

HEALTH CERTIFICATION Two health certification systems shall be applied depending on the type of non conforming products. a) For non conforming products belonging to the following categories: Meat Meat preparation Meat products Milk and dairy products Composite products Eggs, egg products Fishery products of aquaculture origin two certificates shall be issued by the Competent Authority of third country of origin:

1. certificate model for transit included in the relevant EU legislation (annex II of Regulation (EU) 2015/329 and annex of this guidance)

2. certificate model of Annex III of Regulation (EU) 2015/329 which includes a public health attestation by official veterinarian or official inspector).

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b) For other non conforming products (not included in the above reported list) e.g. fishery

product, honey, frog legs, gastropods only the certificate model of Annex III of Regulation (EU) 2015/329 which includes a public health attestation by official veterinarian or official inspector shall be issued by the Competent Authority of third country of origin

PROCEDURES OF INTRODUCTION OF NON CONFORMING FOOD OF ANIMAL ORIGIN FOR EXPO MILANO 2015

Non conforming products are introduced in the European Union for EXPO Milan 2015 purposes through a Border inspection post listed in Annex I to Decision 2009/821/EC or in any relevant agreement between the Union and third countries http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009D0821-20141010&qid=1426849395712&from=EN Contact details of european Border inspection posts may be find at the following web site http://ec.europa.eu/food/animal/bips/bips_contact_en.htm The arrival of such products shall be notified to the Border inspection post of entry at least two working days before. The border inspection post of entry carries out a documentary and identy check and issues a Common Veterinary Entry Document (CVED) with the results of controls. If results of controls are favourable the consigments are shipped:

- directly to the exhibition site of EXPO Milano 2015 or

- to an authorized custom wharehouse (point 2 of Annex I of Regulation (EU) 2015/329) and subsequently to the exhibition site of EXPO Milano 2015. A list of authorized customs wharahouse for EXPO purposes is available at web site of Ministry of Health: http://www.salute.gov.it/imgs/C_17_pagineAree_1250_listaFile_itemName_2_file.pdf

REMAINDERS OF CONSIGNMENTS OR PARTS THEREOF NOT USED FOR EXPO

PURPOSES At the exibithion site EXPO Milano 2015 or at the Customs wharehouse (point 2 of Annex I of Regulation (EU) 2015/329) all remaining consignments or parts thereof not used for EXPO purposes are collected and disposed of as category 1 material in accordance with points (a) to (c) of Article 12 of Regulation (EC) No 1069/2009 or re- exported to a third country not later than 31 December 2015. The containers containing the above mentioned consignments or parts thereof may leave the exhibition site of EXPO Milano 2015 only if they are hermetically sealed and destined to a place of destination where the material will be disposed disposed of according points (a) to (c) of Article 12 to Regulation (EC) No 1069/2009 or re-exported to a third country not later than 31 December 2015 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R1069-20140101&qid=1426853612361&from=EN

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OBLIGATIONS OF THE EXHIBITORS OF EXPO MILANO 2015

The exhibitors of EXPO Milano 2015 shall: a) give logistical support to the Competent Authorities with respect to the storage of non

conforming products; b) ensure that the use of the non conforming products is limited to display or tasting on the spot; c) provide upon request and under the supervision of the competent authorities separated

spaces and appropriate means dedicated to the storage of non conforming products not used for display or tasting on the spot;

d) inform the competent authorities of any non-compliance or any possibly imminent non-compliance arising with respect to the implementation of the measures provided for in the regulation (EU) 2015/329;

e) ensure that any non conformimg product not used for display or tasting on the spot is recorded, collected and disposed of as category 1 material in accordance with points (a) to (c) of Article 12 of Regulation (EC) No 1069/2009 or re- exported to a third country not later than 31 December 2015.

INFORMATION TO THE VISITORS AND STAFF OF EXPO MILANO 2015

In the locations of EXPO Milano 2015 where the non conforming products of animal origin are given to the public or are used to prepare food to be given to the public the following information is displayed to visitors and staff of the EXPO Milano 2015”

“This food contains products of animal origin coming from countries outside the EU and complies only with the standards of public health of those countries. The consumption and distribution of such products are prohibited outside the exhibition site of EXPO Milano 2015”.

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ANNEX

Description of products1

Union legal acts including the requirements for transit to be applied and the relevant veterinary certificate models to be used

Meat Commission Regulation (EU) No 206/20102 including the veterinary certificate model set out in Annex III thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02010R0206-20141204&qid=1426843545845&from=EN Commission Regulation (EC) No 798/20083 including the veterinary certificate model set out in Annex XI thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0798-20141003&qid=1426843697432&from=EN Commission Regulation (EC) No 119/20094 including the veterinary certificate model set out in Annex III thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02009R0119-20130326&qid=1426843895398&from=EN

Meat preparations Commission Decision 2000/572/EC5 including the veterinary certificate model set out in Annex III thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02000D0572-20130326&qid=1426843966994&from=EN

Meat products Commission Decision 2007/777/EC6 including the veterinary certificate model set out in Annex IV thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02007D0777-20141031&qid=1426844042599&from=EN

Milk and dairy products Commission Regulation (EU) No 605/20107 including the veterinary certificate model set out in Part 3 of Annex II thereto

1 The products referred to in the first column of the table fall within the scope of the corresponding Union acts listed in the second column. 2 Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorized for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements (OJ L 73, 20.3.2010, p. 1). 3 Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1). 4 Commission Regulation (EC) No 119/2009 of 9 February 2009 laying down a list of third countries or parts thereof, for imports into, or transit through, the Community of meat of wild leporidae, of certain wild land mammals and of farmed rabbits and the veterinary certification requirements (OJ L 39, 10.2.2009, p. 12). 5 Commission Decision 2000/572/EC of 8 September 2000 laying down the animal and public health and veterinary certification conditions for imports of meat preparations into the Community from third countries (OJ L 240, 23.9.2000, p. 19). 6 Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC (OJ L 312, 30.11.2007, p. 49). 7 Commission Regulation (EU) No 605/2010 of 2 July 2010 laying down animal and public health and veterinary certification conditions for the introduction into the European Union of raw milk, dairy products, colostrum and colostrum-based products intended for human consumption (OJ L 175, 10.7.2010, p. 1).

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http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02010R0605-20140326&qid=1426844133347&from=EN

Composite products Commission Regulation (EU) No 28/20128 including the veterinary certificate model set out in Annex II thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02012R0028-20130701&qid=1426844423404&from=EN

Eggs, egg products Regulation (EC) No 798/2008 including the veterinary certificate model set out in Annex XI thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0798-20141003&qid=1426843697432&from=EN

Fishery products of aquaculture origin

Commission Regulation (EC) No 2074/20059 including the veterinary import certificate model set out in Appendix IV to Annex VI thereto http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02005R2074-20140601&qid=1426844719616&from=EN

8 Commission Regulation (EU) No 28/2012 of 11 January 2012 laying down requirements for the certification for imports into and transit through the Union of certain composite products and amending Decision 2007/275/EC and Regulation (EC) No 1162/2009 (OJ L 12, 14.1.2012, p. 1). 9 Commission Regulation (EC) No 2074/2005 of 5 December 2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004 (OJ L 338, 22.12.2005, p. 27).