1. A. Mancuso – Belgrade, 5 February 2013 1 EU LEGAL FRAMEWORK: TRACEABILITY Alberto Mancuso Belgrade, 5 th February 2013 TAIEX - Expert mission on on Traceability of food and feed AGR 51085

2. CONTENTS Traceability in food and feed EU Legal framework Beef traceability Withdrawal and recall Guidelines concerning traceability and recalls

3. Ability to trace and follow a food, feed, food- producing animal or substance intended to be, or expected to be incorporated into a food or feed, through all stages of production, processing and distribution WHAT IS TRACEABILITY?

4. Past food incidents have demonstrated that being able to trace food and feed throughout the food chain is of prime importance for the protection of public health and consumers’ interests TRACEABILITY: WHY?

5. Facilitate targeted withdrawal and recall of food, thereby avoiding unnecessary disruption of trade Enable consumers to be provided with accurate information concerning implicated products, thereby helping to maintain consumer confidence Facilitate risk assessment by control authorities Traceability records help to

6. Traceability is a way of responding to potential risks that can arise in food and feed It is vital that when national authorities or food businesses identify a risk they can trace it back to its source in order to swiftly isolate the problem and prevent contaminated products from reaching consumers TRACEABILITY: WHY?

7. accurate withdrawals can be undertaken or information given to consumers or control officials, thereby avoiding the potential for unnecessary wider disruption in the event of food safety problems TRACEABILITY: GOAL

8. TRACEABILITY Traceability does not itself make food safe It is a risk management tool to be used in order to assist in containing a food safety problem Traceability has different objectives such as food safety, fair trading between operators and reliability of the information provided to consumers

9. EU LEGAL FRAMEWORK Regulation (EC) 178/2002, art 18 Commission Implementing Regulation (EU) No 931/2011 establishes the general principles of traceability of food lays down rules for the specific sector of food of animal origin to ensure the correct application of the requirements set out in art. 18 guidance on the implementation of Reg. 178/2002 EU Guidelines 26 January 2010

10. EU LEGAL FRAMEWORK makes traceability compulsory for all food and feed businesses: all stages of production, processing and distribution

11. REGULATION 178/02 Article 18 The traceability of food and feed, food-producing animals, and any other substances intended to be, or expected to be, incorporated into a food or feed shall be established at all stages of production, processing and distribution

12. 1.all food and feed operators must implement traceability systems 2.they must be able to identify where their products have come from and where they are going 3.this information is to be made available to the competent authorities upon demand REQUIREMENTS REGULATION 178/02

13. Food or feed which is placed on the market in the Community shall be adequately labelled or identified to facilitate its traceability REGULATION 178/02

14. Article 18 is worded in terms of its goal and intended result, rather than in terms of prescribing how that result is to be achieved REGULATION 178/02

15. Types of information to be kept Name, address of supplier, and identification of products supplied Name, address of customer, and identification of products delivered Date of transaction / delivery Volume, where appropriate, or quantity REGULATION 178/02

16. Food crises in the past have shown that tracing the commercial flow of a product by keeping invoices was not sufficient to follow the physical flow of the products, as food/feed could be, for example, sent for storage Therefore, it is essential that the traceability system of each food / feed business operator is designed to follow the physical flow of the products TRACEABILITY: REMARKS

17. SUPPLIERCUSTOMER FBO one step back”-“one step forward” approach TRACEABILITY

18. FBOs shall have in place a system enabling them to identify the immediate supplier(s) and immediate customer(s) of their products A link “supplier-product” shall be established (which products supplied from which suppliers) A link “customer-product” shall be established (which products supplied to which customers) one step back”-“one step forward” approach TRACEABILITY FBOs do not have to identify the immediate customers when they are final consumers

19. Tracking (track down) capability to follow the path of a specified unit of a product and/or batch through the supply chain as it moves between organizations towards the final point-of-sale or point-of-service Tracing (trace back) capability to identify the origin of a particular unit and/or batch of product located within the supply chain by reference to records held upstream TRACKING AND TRACING

20. Raw material Supplier 2 Producer Wholesaler Retail Raw material Supplier 3 Raw material Supplier 1 Retail Upstream: Tracing Downstream: Tracking Consumers WholesaleWholesaler TRACEABILITY: UPSTREAM AND DOWNSTREAM

21. This requirement covers all stages of production, processing and distribution in the EU, namely from the EU importer up to retail level Exporters in trading partner countries cannot be legally required to fulfil the traceability requirement imposed within the EU The EU importer must be able to identify from whom the product was exported in the third country TRACEABILITY AND IMPORT The traceability provisions of the Regulation do not apply outside the EU

22. should not be interpreted as the mere physical delivery of the food/feed or food producing animal this term refers more to the transfer of ownership of the food/feed or food producing animal brokers must be considered as a form of supplier in the case of trade between a retailer such as a supermarket and a restaurant, the traceability requirement still applies transporters are food businesses and they should also keep traceability records THE TERM “SUPPLY”

23. An internal traceability system will benefit the operator by contributing to more targeted and accurate withdrawals INTERNAL TRACEABILITY ‘Internal traceability’ is not a legal requirement the Regulation does not compel operators to establish a link between incoming and outgoing products

24. INTERNAL TRACEABILITY FBOs should be encouraged to develop internal traceability systems - the level of detail should be left to FBO commensurate with nature and size of business

25. No detail in the regulation Can be different: “on paper” – data system Business operators must include traceability in their HACCP-system Systematic recordkeeping is required TRACEABILITY SYSTEMS?

26. EU LEGAL FRAMEWORK COMMISSION IMPLEMENTING REGULATION (EU) No 931/2011 of 19 September 2011 on the traceability requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of animal origin

27. Food crises in the past have revealed that documentary records were not always sufficient to allow full traceability of suspect foods REGULATION 931/2011 in particular in the sector of food of animal origin

28. food business operators do not generally possess the information needed to ensure that their systems identifying the handling or storage of foods is adequate, in particular in the sector of food of animal origin. This has resulted to unnecessarily high economic losses due to the lack of quick and full traceability of the food REGULATION 931/2011

29. 1. Regulation shall apply to unprocessed and processed products ( Art. 2(1), Reg. 852/04) 2. Regulation shall not apply to food containing both products of plant origin and processed products of animal origin REGULATION 931/2011 Article 2 : Scope

30. 1. FBOs shall made available to the FBO to whom the food is supplied and, upon request, to the competent authority the following information: (a) an accurate description of the food (b) the volume or quantity of the food (c) the name and address of the FBO from which the food has been dispatched (d) the name and address of the consignor (owner) if different from the FBO from which the food has been dispatched Article 3 : Traceability requirements REGULATION 931/2011

31. (e) the name and address of the FBO to whom the food is dispatched (f) the name and address of the consignee (owner), if different from the FBO to whom the food is dispatched (g) a reference identifying the lot, batch or consignment (h) the date of dispatch REGULATION 931/2011 Article 3 : Traceability requirements

32. Additional information on: Specific rules: food of animal origin REGULATION 931/2011 the volume or quantity of the food of animal origin a reference identifying the lot, batch or consignment a detailed description of the food the date of dispatch

33. 3. The information shall be updated on a daily basis and kept at least available until it can be reasonably assumed that the food has been consumed When requested by the competent authority, the FBO shall provide the information without undue delay form in which the information must be made available: up to the choice of the supplier of the food information shall be clearly and unequivocally available to and retrievable by the business operator to whom the food is supplied REGULATION 931/2011

34. …shall apply from 1 July 2012 … shall be binding in its entirety … directly applicable in all Member States REGULATION 931/2011

35. 5 years General rule, and products without a specified durability date 6 month after manufacturing/delivering highly perishable products with a use-by date less than 3 months or without a specified date destined directly to final consumer Shelf-life plus 6 months products with a "best before" date TIME OF RECORD KEEPING Article 18 does not specify a minimum period of time for keeping records, and therefore it is for the businesses to decide

36. sector-specific legislation applies to certain categories of food products (fruit and vegetables, beef, fish, honey, olive oil) so that consumers can identify their origin special traceability rules for GMOs: accurate labelling to ensure that the GM content of a product can be traced, so that consumers can make an informed choice The traceability of food packaging materials has been covered by Regulation 1935/2004 SPECIFIC REQUIREMENTS

37. detailed rules for the application of Regulation(EC) No 1760/2000 BEEF TRACEABILITY LEGAL FRAMEWORK Regulation 1760/200 Regulation 1825/2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef amending Regulation (EC) No 1825/2000 Regulation 275/2007

38. Three key pillars: registering the premises (the holding) identifying the animals (individual or batch identification) recording their movements (database - individual or group) TRACEABILITY IN THE MEAT SECTOR The tools used (ear tags, passports, bar codes) may vary from one country to another but must carry the same information

39. double eartags with individual code computerised national database for individual animals cattle passport holding register TRACEABILITY: BOVINE

40. TRACEABILITY: CATTLE Ear tag

41. A. Mancuso – Belgrade, 6 June 2011 41 TRACEABILITY: CATTLE passport

42. TRACEABILITY: BEEF Regulation 1760/2000 compulsory beef labelling system The compulsory labelling system shall ensure a link between, on the one hand, the identification of the carcass, quarter or pieces of meat and, on the other hand, the individual animal or the group of animals concerned

43. TRACEABILITY: BEEF 1.A reference number or code 2.The name of the MS/non EC country in which the animal or group of animals were born 3.The name of the Member State or non EC country in which the animal or group of animals were raised 4.‘Slaughtered in: [name of MS/non-EC country]’ 5.Licence number of slaughterhouse 6.‘Cut in: [name of MS/non-EC country]’ 7.Licence number(s) of cutting plant(s) Compulsory Indications on the labels

44. TRACEABILITY: BEEF 1. reference number or code traceability reference number or code which ensures the link between the meat and the animal or group of animals from which it is derived

45. Identification number or other number relating to the individual animal Carcases should be individually identifiable (i.e. by the kill number) Where carcase batches are created in a slaughterhouse, the individual animal’s identity must remain with the carcase and also with the parts of the carcase after it has been cut reference number or code: SLAUGHTERHOUSE TRACEABILITY: BEEF

46. reference number or code: CUTTING Number or code relating to the animal from which the cut meat is derived It could be a batch number A batch may comprise at most one day’s production A batch may only be formed from beef which has been slaughtered in the same slaughterhouse Derogation (Reg. 275/07): operators can constitute batches from meat of animals slaughtered at a maximum of three different slaughterhouses and from carcases cut up at a maximum of three different cutting plants TRACEABILITY: BEEF

47. any reference number or code enabling traceability can be used there shall be a link between register/ documentation and the reference number or code It could be a batch number TRACEABILITY: BEEF reference number or code: RETAIL Meat of animals born and/or raised and/or slaughtered in different countries shall be clearly separated when displayed for sale

48. WITHDRAWAL AND RECALL Alberto Mancuso Belgrade, 5 th February 2013 TAIEX - Expert mission on on Traceability of food and feed AGR 51085

49. Withdrawal: The removal of an unsafe food from the market before it has reached the consumer Recall: The removal of an unsafe food from the market when it may have reached the consumer and the notification of the consumer WITHDRAWAL AND RECALL

50. A FBO shall immediately inform the competent authorities if it considers or has reason to believe that a food which it has placed on the market may be injurious to human health ROLES AND RESPONSIBILITIES Operators shall inform the competent authorities of the action taken to prevent risks to the consumer

51. If a FBO has reason to believe that a food (imported, produced, processed, manufactured or distributed) is not in compliance with the food safety requirements, it shall immediately initiate procedures to withdraw the food from the market where the food has left the immediate control of that initial FBO and inform the competent authorities WITHDRAWAL AND RECALL

52. Where the product may have reached the consumer, the operator shall effectively and accurately inform the consumers of the reason for its withdrawal, and if necessary, recall from consumers products already supplied to them when other measures are not sufficient to achieve a high level of health protection WITHDRAWAL AND RECALL

53. The obligation to withdraw from the market applies when the following two cumulative criteria are met: the food in question is considered by the operator as not being in compliance with the food safety requirements a food is on the market and has left the immediate control of the initial food business WITHDRAWAL AND RECALL

54. Two types of cases will need to be considered The food does not comply with the specific Community (or national) provisions governing its safety The food complies with the specific Community (or in their absence, national) provisions governing its safety but there are reasons to consider that it is unsafe WITHDRAWAL AND RECALL

55. ROLES AND RESPONSIBILITIES

56. GUIDELINES CONCERNING TRACEABILITY AND RECALLS Alberto Mancuso Belgrade, 5 th February 2013 TAIEX - Expert mission on on Traceability of food and feed AGR 51085

57. EC Guidance on the Implementation of Articles 11, 12, 14, 17, 18, 19 and 20 of Regulation 178/2002 - 26 January 2010 FAO/WHO Guide for developing and improving national food recall systems. Pre-Publication Copy (June 2012) Guidance Note: Product recall and traceability. (Revision 2). Food Safety Authority of Ireland, Dublin - 2010 GUIDELINES ON TRACEABILITY

58. EC Guidance on the Implementation of Regulation 178/2002 MAIN CHAPTERS i. article 14: food safety requirements ii. article 17: responsibilities iii. article 18: traceability iv. article 19: withdrawal, recall and notification by Food BOs v. article 20: withdrawal, recall and notification by Feed BOs vi. article 11: import of food and feed vii. article 12: export of food and feed

59. Internal traceability: the Regulation does not expressly compel operators to establish a link (so called internal traceability) between incoming and outgoing products. Nor is there any requirement for records to be kept identifying how batches are split and combined within a business to create particular products or new batches GUIDELINES ON TRACEABILITY EC Guidance on the Implementation of Regulation 178/2002

60. FAO/WHO Guide for developing and improving national food recall systems GUIDELINES ON TRACEABILITY Preliminary steps for developing and/or improving national food recall systems National food recall systems Setting up and operating a national food recall system Food recall management MAIN CHAPTERS

61. TRACEABILITY SYSTEM - KEY STEPS Step 1. Decide on the scope of the traceability system Step 2. Decide on the size of the optimal production unit for tracing purposes (e.g. lot, batch, consignment) Step 3. Identify the traceability information needed, including information on food ingredients, internal processes, packaging material and food products Step 4. Establish a system of record-keeping and retrieval Step 5. Establish procedures for review and testing of the traceability system Step 6. Document the traceability system FAO/WHO Guide for developing and improving national food recall systems – June 2012

62. SIZE OF THE OPTIMAL PRODUCTION UNIT Selecting larger production units can simplify tracing activities; however, it could mean that more food would have to be recalled should a food-related event occur FAO/WHO Guide for developing and improving national food recall systems – June 2012

63. Example of a recall action decision tree The actions may be conducted by the CA, the FBOs or both FAO/WHO Guide for developing and improving national food recall systems – June 2012

64. Essential to ensure timely, regular and effective communication between the CA and the recalling FBO Established procedures should include the necessary communication steps, so that appropriate monitoring can be conducted and appropriate measures taken to ensure the satisfactory progress and effectiveness of the recall Communication between the CA and the FBOs during a food recall is most effective when prior arrangements have been made that enable efficient communication in the case of an emergency FAO/WHO Guide for developing and improving national food recall systems – June 2012 Interaction between the CA and the recalling FBO

65. CA needs to receive detailed information from the recalling FBOs. The information may include: a list of the recalled products physical description of the products distribution details the nature of the health risk advice to consumers list of premises where the recalled food has been available amount of time the recalled food has been on the market actions taken/to be taken by the recalling FBO actions required by other FBOs contact details for the recall coordinator of the recalling FBO FAO/WHO Guide for developing and improving national food recall systems – June 2012 Effective communication by the FBO

66. Examples of recall activity flows Generic food recall activity flow for food business operators in collaboration with competent authority FAO/WHO Guide for developing and improving national food recall systems – June 2012

67. Guidance Note: Product recall and traceability. (Revision 2). Food Safety Authority of Ireland, Dublin - 2010 GUIDELINES ON TRACEABILITY reference document for the food industry outlines the legal requirements for the traceability of food and recall/withdrawal of unsafe food covers food that is not unsafe but is nevertheless non-compliant outlines what is considered best practice for the development of traceability systems and management of food recalls or withdrawals

68. OBJECTIVES OF A FOOD TRACEABILITY SYSTEM Guidance Note: Product recall and traceability. Food Safety Authority of Ireland, Dublin - 2010 1.To identify uniquely, a batch of food and the raw material batches used in its production, in a way which allows tracking the physical flow of the food forwards through the food chain to the immediate customer and tracing of the physical flow of raw materials backwards to the immediate supplier 2.To create and maintain accurate traceability records that can be provided within a short time period for routine examination or investigation purposes at the demand of the competent authorities

69. KEY STEPS IN DEVELOPING FOOD TRACEABILITY SYSTEMS Guidance Note: Product recall and traceability. Food Safety Authority of Ireland, Dublin - 2010 Step 1. Define the scope of the traceability system Step 2. Decide on the optimal batch size Step 3. Identify the traceability information needed, including: Information that must accompany food ingredients used by the FBO Internal process information that is needed to maintain traceability through food processing or preparation where applicable Information that must accompany distribution of the food produced Step 4. Establish a system of record keeping and retrieval Step 5. Establish procedures for review and testing of the traceability system Step 6. Document the traceability system

70. SUPPLIER TRACEABILITY INFORMATION Guidance Note: Product recall and traceability. Food Safety Authority of Ireland, Dublin - 2010 Each incoming raw material should carry an identification code as a means of tracing its source of supply, e.g. batch code In situations where this is not possible, a business should apply its own identification code as soon as the raw material is received In the case of delivery of bulk ingredients (flour, milk) into bulk storage facilities, it may not be possible to prevent mixing of batches In addition to the supplier details, the delivery dates, identification of storage facility and weight/volume of the delivery may be the only way of identifying an ingredient

71. PROCESS TRACEABILITY INFORMATION Guidance Note: Product recall and traceability. Food Safety Authority of Ireland, Dublin - 2010 Each food manufacturer should be able to ensure that the ingredients used in foods produced on the premises are traceable back to their suppliers Manufacturers involved in re-wrapping products for the market should ensure that traceability of the food to the original supplier is maintained

72. Guidance Note: Product recall and traceability. Food Safety Authority of Ireland, Dublin - 2010 Identification of a product batch Application of a unique batch code identifier to: Each and every pack comprising the product batch unless the pack is too small to allow for a code to be applied The outer case, if any Internal process documentation associated with the product batch Generation of records of the traceability codes of ingredients and primary packaging, e.g. batch codes, lot codes etc, used in the production of the product batch PROCESS TRACEABILITY INFORMATION traceability information appropriate for process traceability

73. Generation of production and quality records with all the necessary information relating to ingredients, packaging and process times to allow traceability to the finished product batch Examples of relevant traceability information are: product name, product batch code, date of production, time of start and end of production, saleable unit size, number of packs per case, number of cases, a means of linking the product batch code to raw material batches used in its manufacture PROCESS TRACEABILITY INFORMATION Traceability information appropriate for process traceability Guidance Note: Product recall and traceability. Food Safety Authority of Ireland, Dublin - 2010

74. Reviewing and verifying traceability systems An audit should consist of a horizontal and vertical assessment of the system The horizontal check should consist of an audit of several batches at the same point in the process to ensure all identification marks and documentation is correct The vertical check should follow several batches from the customer to the supplier to ensure all identification marks and documentation is correct Guidance Note: Product recall and traceability. Food Safety Authority of Ireland, Dublin - 2010

75. We will buy in a large retail 1 package of fresh beef We will try to trace it back: seller, cutting plant, slaughterhouse, farm (or relevant countries) We will try to identify other recipients of the same lot We will try to identify all products manufactured with the batch in question CASE STUDY: PROPOSAL

76. E-mail HVALA NA PAŽNJI!! a.mancuso@izs.it