EC Directive 853/2004 on Food of Animal Origin Lecture 4 PDF

EC Directive 853/2004 on specific hygiene rules required for foods of animal origin Lecturer: Michael King Module Learning Outcomes The Learning Outcomes for this modules are 1: Describe the quality management systems for ingredients and components. 2: Identify the relevant EU regulatory,...

EC Directive 853/2004 on specific hygiene rules required for foods of animal origin Lecturer: Michael King Module Learning Outcomes The Learning Outcomes for this modules are 1: Describe the quality management systems for ingredients and components. 2: Identify the relevant EU regulatory, industrial and retailer standards in the food industry. 3: Define the legal implications of non- conformance 4: Describe the QC testing pathway in food manufacturing industry. 5: Comply with Food Hygiene standards Level 1 and Level 2 ©2020, Innopharma Labs Ltd and King Quality Solutions 2 Learning Outcomes – Lecture 1 After Tonight's Lecture 1. Describe the quality management systems for ingredients and components. 2: Identify the relevant EU regulatory, industrial and retailer standards in the food industry. 3: Define the legal implications of non- conformance ©2020, Innopharma Labs Ltd and King Quality Solutions 3 EC Directive 853/2004 This directive lays down the specific hygiene rules that are required for place food or food products of animal origin. Once approved a food business operator can place any quantity of food on the market and sell it anywhere within the European Union. ©2020, Innopharma Labs Ltd and King Quality Solutions 4 EC Directive 853/2004 This directive is broken down into a number of relevant articles Article 3 – General obligations Article 4 – Registration and approval of establishments – companies should not produce without this approval Article 5 – Health and identification marking – typically the “rugby ball mark” Article 6 – Products of animal origin from outside the community Article 7 – Documents – permits the use of commercial of electronic documents Article 8 – Special guarantees (Sweden and Denmark) ©2020, Innopharma Labs Ltd and King Quality Solutions 5 EC Directive 853/2004 Article 9 – Final provisions Article 10 – Amendments and adaption of Annex II and III – makes provision for updates based on scientific advances and development of other guidelines. Also allow countries to make specific rules to account for geological constrained products. Other countries have been given the right to object Article 11 – Specific Decisions – Allows for country specific rules on transport of meat and handling of shellfish Article 12 – Committee Procedure Article 13 – Consultation with the European Food Safety Authority Article 14 - Report to EC Council & Parliament ©2020, Innopharma Labs Ltd and King Quality Solutions 6 EC Directive 853/2004 – Article 4 – Registration and Approval of Establishments 1. Food business operators shall place products of animal origin manufactured in the Community on the market only if they have been prepared and handled exclusively in establishments: – (a) that meet the relevant requirements of Regulation (EC) No /2004 * , those of Annexes II and III of this Regulation and other relevant requirements of food law; and – (b) that the competent authority has registered or, where required in accordance with paragraph 2, approved. ©2020, Innopharma Labs Ltd and King Quality Solutions 7 EC Directive 853/2004 – Article 4 – Registration and Approval of Establishments 2. Without prejudice to Article 6(3) of Regulation (EC) No /2004 * , establishments handling those products of animal origin for which Annex III to this Regulation lays down requirements shall not operate unless the competent authority has approved them in accordance with paragraph 3 of this Article, with the exception of establishments carrying out only: ©2020, Innopharma Labs Ltd and King Quality Solutions 8 EC Directive 853/2004 – Article 4 – Registration and Approval of Establishments (a) primary production; (b) transport operations; (c) the storage of products not requiring temperature-controlled storage conditions; or (d) retail operations other than those to which this Regulation applies pursuant to Article 1(5)(b). ©2020, Innopharma Labs Ltd and King Quality Solutions 9 EC Directive 853/2004 – Article 4 – Registration and Approval of Establishments 3. An establishment subject to approval in accordance with paragraph 2 shall not operate unless the competent authority has, in accordance with Regulation (EC) No 854 /2004 of the European Parliament and of the Council of.......... laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption * : (a) granted the establishment approval to operate following an on-site visit; or (b) provided the establishment with conditional approval. ©2020, Innopharma Labs Ltd and King Quality Solutions 10 EC Directive 853/2004 – Article 4 – Registration and Approval of Establishments 4. Food business operators shall cooperate with the competent authorities in accordance with Regulation (EC) No 854/2004 *. In particular, food business operators shall ensure that an establishment ceases to operate if the competent authority withdraws its approval or, in the case of conditional approval, fails to prolong it or to grant full approval. ©2020, Innopharma Labs Ltd and King Quality Solutions 11 EC Directive 853/2004 – Article 4 – Registration and Approval of Establishments 5. This Article shall not prevent an establishment from placing food on the market between the date of application of this Regulation and the first subsequent inspection by the competent authority, if the establishment: (a) is subject to approval in accordance with paragraph 2 and placed products of animal origin on the market in accordance with Community legislation immediately prior to the application of this Regulation; or (b) is of a type in respect of which there was no requirement for approval before the application of this Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 12 EC Directive 853/2004 – Article 4 – Registration and Approval of Establishments Refer to Annex II – ©2020, Innopharma Labs Ltd and King Quality Solutions 13 EC Directive 853/2004 – Article 5 – Health Marking 1. Food business operators shall not place on the market a product of animal origin handled in an establishment subject to approval in accordance with Article 4(2) unless it has either: (a) a health mark applied in accordance with Regulation (EC) No 854/2004 * ; or (b) when that Regulation does not provide for the application of a health mark, an identification mark applied in accordance with Annex II, Section I, of this Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 14 EC Directive 853/2004 – Article 5 – Health Marking 2. Food business operators may apply an identification mark to a product of animal origin only if the product has been manufactured in accordance with this Regulation in establishments meeting the requirements of Article 4. 3. Food business operators may not remove a health mark applied in accordance with Regulation (EC) No /2004 * from meat unless they cut or process it or work upon it in another manner. ©2020, Innopharma Labs Ltd and King Quality Solutions 15 EC Directive 853/2004 The annexes to the directive lay out requirements for the following categories of food Annex I – Definitions for terms used in other annexes Annex II - REQUIREMENTS CONCERNING SEVERAL PRODUCTS OF ANIMAL ORIGIN – Section I – Identification marking – Section II – Objectives of HACCP based procedures – Section III – Food chain information – Section IV – Requirements for frozen food of animal origin ©2020, Innopharma Labs Ltd and King Quality Solutions 16 EC Directive 853/2004 - Annex II Section 1 IDENTIFICATION MARKING Food business operators must ensure that products of animal origin have an identification mark applied in compliance with the following provisions. 1. The identification mark must be applied before the product leaves the establishment of production. 2. When a product's packaging and/or wrapping is removed or it is further processed in another establishment, a new mark must be applied to the product. In such cases, the new mark must indicate the approval number of the establishment where these operations take place. ©2020, Innopharma Labs Ltd and King Quality Solutions 17 EC Directive 853/2004 - Annex II Section 1 3. An identification mark is not necessary on packs of eggs when a packing centre code is applied in accordance with Part A of Annex XIV to Council Regulation (EC) No 1234/2007 ( 1 ). 4. Food business operators must, in accordance with Article 18 of Regulation (EC) No 178/2002, have in place systems and procedures to identify food business operators from whom they have received and to whom they have delivered products of animal origin. -TRACEABILITY SYSTEM – one step back and one step forward ©2020, Innopharma Labs Ltd and King Quality Solutions 18 EC Directive 853/2004 - Annex II Section 1 5. The mark must be legible and indelible, and the characters easily decipherable. It must be clearly displayed for the competent authorities. 6. The mark must indicate the name of the country in which the estab­lishment is located, which may be written out in full or shown as a two- letter code in accordance with the relevant ISO standard. IE is the donation for Ireland ©2020, Innopharma Labs Ltd and King Quality Solutions 19 EC Directive 853/2004 - Annex II Section 1 7. The mark must indicate the approval number of the establishment. If an establishment manufactures both food to which this Regulation applies and food to which it does not, the food business operator may apply the same identification mark to both types of food. 8. When applied in an establishment located within the Community, the mark must be oval in shape and include the abbreviation such as EC – EC 717 IE. ©2020, Innopharma Labs Ltd and King Quality Solutions 20 EC Directive 853/2004 - Annex II Section 1 ©2020, Innopharma Labs Ltd and King Quality Solutions 21 EC Directive 853/2004 – Article 6 - Products of animal origin from outside the Community 1. Food business operators importing products of animal origin from third countries shall ensure that importation takes place only if: (a) the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of third countries from which imports of that product are permitted; (b) (i) the establishment from which that product was dispatched, and in which it was obtained or prepared, appears on a list, drawn up in accordance with Article 12 of Regulation (EC) No 854/2004, of establishments from which imports of that product are permitted, when applicable, ©2020, Innopharma Labs Ltd and King Quality Solutions 22 EC Directive 853/2004 – Article 6 - Products of animal origin from outside the Community 1. Food business operators importing products of animal origin from third countries shall ensure that importation takes place only if: (a) the third country of dispatch appears on a list, drawn up in accordance with Article 11 of Regulation (EC) No 854/2004, of third countries from which imports of that product are permitted; (b) (i) the establishment from which that product was dispatched, and in which it was obtained or prepared, appears on a list, drawn up in accordance with Article 12 of Regulation (EC) No 854/2004, of establishments from which imports of that product are permitted, when applicable, ©2020, Innopharma Labs Ltd and King Quality Solutions 23 EC Directive 853/2004 – Article 6 - Products of animal origin from outside the Community (ii) in the case of fresh meat, minced meat, meat preparations, meat products and MSM, the product was manufactured from meat obtained in slaughterhouses and cutting plants appearing on lists drawn up and updated in accordance with Article 12 of Regulation (EC) No [* ]/2004 or in approved Community establishments, and (iii) in the case of live bivalve molluscs, echinoderms, tunicates and marine gastropods, the production area appears on a list drawn up in accordance with Article 13 of that Regulation, when applicable; ©2020, Innopharma Labs Ltd and King Quality Solutions 24 EC Directive 853/2004 – Article 6 - Products of animal origin from outside the Community (c) the product satisfies: (i) the requirements of this Regulation, including the requirements of Article 5 on health and identification marking; (ii) the requirements of Regulation (EC) No [* ]/2004; and (iii) any import conditions laid down in accordance with Community legislation governing import controls for products of animal origin, and (d) the requirements of Article 14 of Regulation (EC) No [**]/2004 concerning certificates and documents are satisfied, when applicable. ©2020, Innopharma Labs Ltd and King Quality Solutions 25 EC Directive 853/2004 – Article 6 - Products of animal origin from outside the Community 2. By way of derogation from paragraph 1, the importation of fishery products may also take place in accordance with the special provisions laid down in Article 15 of Regulation (EC) No [**]/2004. 3. Food business operators importing products of animal origin shall ensure that: (a) products are made available for control upon importation in accordance with Directive 97/78/EC * ©2020, Innopharma Labs Ltd and King Quality Solutions 26 EC Directive 853/2004 – Article 6 - Products of animal origin from outside the Community 4. Food business operators importing food containing both products of plant origin and processed products of animal origin shall ensure that the processed products of animal origin contained in such food satisfy the requirements of paragraphs 1 to 3. They must be able to demonstrate that they have done so (for example, through appropriate documentation or certification, which need not be in the format specified in paragraph 1(d)). ©2020, Innopharma Labs Ltd and King Quality Solutions 27 EC Directive 853/2004 – Article 7 - Documents 1. When required in accordance with Annex II or III, food business operators shall ensure that certificates or other documents accompany consignments of products of animal origin. 2. In accordance with the procedure referred to in Article 12(2): (a) model documents may be established; and (b) provision may be made for the use of electronic documents. ©2020, Innopharma Labs Ltd and King Quality Solutions 28 EC Directive 853/2004 – Article 10 – Amendment and Adaption of Annex II and Annex III Annexes II and III may be adapted or updated in accordance with the procedure referred to in Article 12(2), taking into account: (a) the development of guides to good practice; (b) the experience gained from the implementation of HACCP-based systems pursuant to Article 5 of Regulation (EC) No 852/2004* ; (c) the technological developments and their practical consequences and consumer expectations with regard to food composition; ©2020, Innopharma Labs Ltd and King Quality Solutions 29 EC Directive 853/2004 – Article 10 – Amendment and Adaption of Annex II and Annex III (d) scientific advice, particularly new risk assessments; (e) microbiological and temperature criteria for foodstuffs; (f) changes in patterns of consumption. 2. Exemptions from Annex II and III may be granted in accordance with the procedure referred to in Article 12(2), provided that they do not affect the achievement of the objectives of this Regulation. ©2020, Innopharma Labs Ltd and King Quality Solutions 30 EC Directive 853/2004 – Article 10 – Amendment and Adaption of Annex II and Annex III 3. Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 8, national measures adapting the requirements laid down in Annex III. ©2020, Innopharma Labs Ltd and King Quality Solutions 31 EC Directive 853/2004 – Article 10 – Amendment and Adaption of Annex II and Annex III 4. (a) The national measures referred to in paragraph 3 shall have the aim of: (i) enabling the continued use of traditional methods at any of the stages of production, processing or distribution of food; or (ii) accommodating the needs of food businesses situated in regions that are subject to special geographic constraints. (b) In other cases, they shall apply only to the construction, layout and equipment of establishments. ©2020, Innopharma Labs Ltd and King Quality Solutions 32 EC Directive 853/2004 – Article 10 – Amendment and Adaption of Annex II and Annex III 5. Any Member State wishing to adopt national measures as referred to in paragraph 3 shall notify the Commission and other Member States. Each notification shall: (a) provide a detailed description of the requirements that that Member State considers need to be adapted and the nature of the adaptation sought; (b) describe the foodstuffs and establishments concerned; ©2020, Innopharma Labs Ltd and King Quality Solutions 33 EC Directive 853/2004 – Article 10 – Amendment and Adaption of Annex II and Annex III Examples of Geologically Constrained Products Champagne for France Feta Cheese from Greece – Soft Greek Style Cheese Strained Greek Yogurt – Greek Style Yogurt Cornish Pasties Blah from Waterford ©2020, Innopharma Labs Ltd and King Quality Solutions 34 EC Directive 853/2004 - Annex II Section 2 HACCP Based Procedures 1. Food business operators operating slaughterhouses must ensure that the procedures that they have put in place in accordance with the general requirements of Article 5 of Regulation (EC) No 852/2004 meet the requirements that the hazard analysis shows to be necessary and the specific requirements listed in point 2. 2. The procedures must guarantee that each animal or, where appropriate, each lot of animals accepted onto the slaughterhouse premises: ©2020, Innopharma Labs Ltd and King Quality Solutions 35 EC Directive 853/2004 - Annex II Section 2 (a) is properly identified; (b) is accompanied by the relevant information from the holding of provenance referred to in Section III; (c) does not come from a holding or an area subject to a movement prohibition or other restriction for reasons of animal or public health, except when the competent authority so permits; (d) is clean; (e) is healthy, as far as the food business operator can judge; (f) is in a satisfactory state as regards welfare on arrival at the slaughter­house. ©2020, Innopharma Labs Ltd and King Quality Solutions 36 EC Directive 853/2004 - Annex II Section 2 3. In the event of failure to comply with any of the requirements listed under point 2, the food business operator must notify the official veterinarian and take appropriate measures. ©2020, Innopharma Labs Ltd and King Quality Solutions 37 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information Food business operators operating slaughterhouses must, as appropriate, request, receive, check and act upon food chain information as set out in this Section in respect of all animals, other than wild game, sent or intended to be sent to the slaughterhouse. 1. Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested, and been provided with, relevant food chain information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004. ©2020, Innopharma Labs Ltd and King Quality Solutions 38 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information Food business operators operating slaughterhouses must, as appropriate, request, receive, check and act upon food chain information as set out in this Section in respect of all animals, other than wild game, sent or intended to be sent to the slaughterhouse. 1. Slaughterhouse operators must not accept animals onto the slaughterhouse premises unless they have requested, and been provided with, relevant food chain information contained in the records kept at the holding of provenance in accordance with Regulation (EC) No 852/2004. ©2020, Innopharma Labs Ltd and King Quality Solutions 39 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information 2. Slaughterhouse operators must be provided with the information no less than 24 hours before the arrival of animals at the slaughterhouse, except in the circumstances mentioned in point 7. 3. The relevant food chain information referred to in point 1 is to cover, in particular: (a) the status of the holding of provenance or the regional animal health status; (b) the animals' health status; (c) veterinary medicinal products or other treatments administered to the animals within a relevant period and with a withdrawal period greater than zero, together with their dates of administration and withdrawal periods; ©2020, Innopharma Labs Ltd and King Quality Solutions 40 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information (d) the occurrence of diseases that may affect the safety of meat; (e) the results, if they are relevant to the protection of public health, of any analysis carried out on samples taken from the animals or other samples taken to diagnose diseases that may affect the safety of meat, including samples taken in the framework of the monitoring and control of zoonosis and residues; (f) relevant reports about previous ante- and post-mortem inspections of animals from the same holding of provenance including, in particular, reports from the official veterinarian; ©2020, Innopharma Labs Ltd and King Quality Solutions 41 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information (g) production data, when this might indicate the presence of disease; (h) the name and address of the private veterinarian normally attending the holding of provenance. 4. (a) However, it is not necessary for the slaughterhouse operator to be provided with: (i) the information referred to in point 3(a), (b), (f) and (h), if the operator is already aware of this information (for example, through a standing arrangement or a quality assurance scheme); - Bord Bia Quality Assurance (ii) the information referred to in point 3(a), (b), (f) and (g), if the producer declares that there is no relevant information to report. ©2020, Innopharma Labs Ltd and King Quality Solutions 42 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information (b) The information need not be provided as a verbatim extract from the records of the holding of provenance. It may be provided through electronic data exchange or in the form of a standardised declaration signed by the producer. ©2020, Innopharma Labs Ltd and King Quality Solutions 43 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information 5. Food business operators deciding to accept animals onto the slaughterhouse premises after evaluating the relevant food chain information must make it available to the official veterinarian without delay and, except in the circum­stances mentioned in point 7, no less than 24 hours before the arrival of the animal or lot. The food business operator must notify the official veterinarian of any information that gives rise to health concerns before ante-mortem inspection of the animal concerned. 6. If any animal arrives at the slaughterhouse without food chain information, the operator must immediately notify the official veterinarian. Slaughter of the animal may not take place until the official veterinarian so permits. ©2020, Innopharma Labs Ltd and King Quality Solutions 44 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information If the competent authority so permits and provided it does not jeopardise the objectives of this Regulation, food chain information may arrive less than 24 hours before the arrival of the animals of all species to which it relates at the slaughterhouse or accompany these animals to the slaughterhouse. However, any item of food chain information, knowledge of which may result in serious disruption of the slaughterhouse activity, is to be made available to the food business operator operating the slaughterhouse in sufficient time before the animals arrive at the slaughterhouse, in order for that food business operator to plan the slaughterhouse activity accordingly. ©2020, Innopharma Labs Ltd and King Quality Solutions 45 EC Directive 853/2004 - Annex II Section 3 Supply Chain Information The food business operator operating the slaughterhouse must evaluate the relevant information and must submit the food chain information received to the official veterinarian. The slaughter or dressing of the animals may not take place until the official veterinarian so permits. 8. Food business operators must check passports accompanying domestic solipeds (horse/donkeys) to ensure that the animal is intended for slaughter for human consumption. If they accept the animal for slaughter, they must give the passport to the official veterinarian. ©2020, Innopharma Labs Ltd and King Quality Solutions 46 EC Directive 853/2004 - Annex II Section 4 Requirements for Frozen Foods of Animal Origin Until the stage at which a food is labelled in accordance with Directive 2000/13/EC or used for further processing, food business operators must ensure that in the case of frozen food of animal origin intended for human consumption, the following information is made available to the food business operator to whom the food is supplied and, upon request, to the competent authority: (a) the date of production; and (b) the date of freezing, if different from the date of production. ©2020, Innopharma Labs Ltd and King Quality Solutions 47 EC Directive 853/2004 - Annex II Section 4 Requirements for Frozen Foods of Animal Origin Where a food is made from a batch of raw materials with different dates of production and of freezing, the oldest dates of production and/or of freezing, as appropriate, must be made available. 3. The appropriate form in which the information must be made available is up to the choice of the supplier of the frozen food, as long will be clearly and unequivocally available to and retrievable by the business operator to whom the food is supplied. ©2020, Innopharma Labs Ltd and King Quality Solutions 48 EC Directive 853/2004 - Annex III - Special Requirements Section I – Meat of Domestic Ungulates Section II – Meat from poultry and lagomorphs Section III – Meat of farmed game Section IV - Wild game meat Section V – Minced meat, meat preparations and MRM Section VI – Meat products Section VII - Live bivalve molluscs Section VIII – Fishery products ©2020, Innopharma Labs Ltd and King Quality Solutions 49 EC Directive 853/2004 - Annex III - Special Requirements Section IX – Raw milk, colostrum, dairy products and colostrum based products Section X – Egg and egg products Section XI – Frog’s legs and snails Section XII – Rendered Fats and greaves Section XIII – Treated stomachs, bladders and intestines Section XIV – Gelatine Section – XV – Collagen ©2020, Innopharma Labs Ltd and King Quality Solutions 50 EC Directive 853/2004 - Annex III - Special Requirements SECTION V: MINCED MEAT, AND MEAT PREPARATIONS ©2020, Innopharma Labs Ltd and King Quality Solutions 51 EC Directive 853/2004 - Annex III - Section V - CHAPTER I: REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS Food business operators operating establishments producing minced meat and meat preparations must ensure that they: 1. are constructed so as to avoid contamination of meat and products, in particular by: (a) allowing constant progress of the operations; or (b) ensuring separation between the different production batches ©2020, Innopharma Labs Ltd and King Quality Solutions 52 EC Directive 853/2004 - Annex III - Section V - CHAPTER I: REQUIREMENTS FOR PRODUCTION ESTABLISHMENTS 2. have rooms for the separate storage of packaged and exposed meat and products, unless stored at different times or in such a way that the packaging material and the manner of storage cannot be a source of contami­nation for the meat or products; 3. have rooms equipped to ensure compliance with the temperature requirements laid down in Chapter III; 4. have equipment for washing hands used by staff handling exposed meat and products with taps designed to prevent the spread of contamination; and 5. have facilities for disinfecting tools with hot water supplied at not less than 82 °C, or an alternative system having an equivalent effect. ©2020, Innopharma Labs Ltd and King Quality Solutions 53 EC Directive 853/2004 - Annex III - Section V - CHAPTER II – REQUIREMENTS FOR RAW MATERIALS Food business operators producing minced meat and meat preparations must ensure that the raw materials used satisfy the following requirements. 1. The raw material used to prepare minced meat must meet the following requirements. (a) It must comply with the requirements for fresh meat; (b) It must derive from skeletal muscle, including adherent fatty tissues; (c) It must not derive from: (i) scrap cuttings and scrap trimmings (other than whole muscle cuttings); ©2020, Innopharma Labs Ltd and King Quality Solutions 54 EC Directive 853/2004 - Annex III - Section V - CHAPTER II – REQUIREMENTS FOR RAW MATERIALS (ii) MSM; (iii) meat containing bone fragments or skin; or (iv) meat of the head with the exception of the masseters, the non- muscular part of the linea alba, the region of the carpus and the tarsus, bone scrapings and the muscles of the diaphragm (unless the serosa has been removed). ©2020, Innopharma Labs Ltd and King Quality Solutions 55 EC Directive 853/2004 - Annex III - Section V - CHAPTER II – REQUIREMENTS FOR RAW MATERIALS 2. The following raw material may be used to prepare meat preparations: (a) fresh meat; (b) meat meeting the requirements of point 1; and c) if the meat preparation is clearly not intended to be consumed without first undergoing heat treatment: – (i) meat derived from the mincing or fragmentation of meat meeting the requirements of point 1 other than point 1(c)(i); ©2020, Innopharma Labs Ltd and King Quality Solutions 56 EC Directive 853/2004 - Annex III - Section V - CHAPTER III – HYGIENE DURING AND AFTER PRODUCTION Food business operators producing minced meat, meat preparations must ensure compliance with the following requirements. 1. The work on meat must be organised in such a way as to prevent or minimise contamination. To this end, food business operators must ensure in particular that the meat used is: (a) at a temperature of not more than 4 °C for poultry, 3 °C for offal and 7 °C for other meat; and (b) brought into the preparation room progressively as needed ©2020, Innopharma Labs Ltd and King Quality Solutions 57 EC Directive 853/2004 - Annex III - Section V - CHAPTER III – HYGIENE DURING AND AFTER PRODUCTION 2. The following requirements apply to the production of minced meat and meat preparations. (a) Unless the competent authority authorises boning immediately before mincing, frozen or deep-frozen meat used for the preparation of minced meat or meat preparations must be boned before freezing. It may be stored only for a limited period. (b) When prepared from chilled meat, minced meat must be prepared: (i) in the case of poultry, within no more than three days of their slaughter; (ii) in the case of animal other than poultry, within no more than six days of their slaughter; ©2020, Innopharma Labs Ltd and King Quality Solutions 58 EC Directive 853/2004 - Annex III - Section V - CHAPTER III – HYGIENE DURING AND AFTER PRODUCTION or (iii) within no more than 15 days from the slaughter of the animals in the case of boned, vacuum-packed beef and veal (c) Immediately after production, minced meat and meat preparations must be wrapped or packaged and be: (i) chilled to an internal temperature of not more than 2 °C for minced meat and 4 °C for meat preparations; or (ii) frozen to an internal temperature of not more than -18 °C. These temperature conditions must be maintained during storage and transport. ©2020, Innopharma Labs Ltd and King Quality Solutions 59 EC Directive 853/2004 - Annex III - Section V - CHAPTER IV- LABELLING 1. In addition to the requirements of Directive 2000/13/EC ( 1 ), food business operators must ensure compliance with the requirement of point 2 if, and to the extent that, national rules in the Member State in the territory of which the product is placed on the market so require. ©2020, Innopharma Labs Ltd and King Quality Solutions 60 EC Directive 853/2004 - Annex III - Section V - CHAPTER IV- LABELLING Packages intended for supply to the final consumer containing minced meat from poultry or solipeds or meat preparations containing MSM must bear a notice indicating that such products should be cooked before consumption. ©2020, Innopharma Labs Ltd and King Quality Solutions 61