Lecture 3- Directive 852-2004 Food Hygiene PDF

EC Directive 852/2004 on the hygiene of foodstuffs Lecturer: Michael King Module Learning Outcomes – This lecture The Learning Outcomes for this modules are 1: Identify the relevant EU regulatory, industrial and retailer standards in the food industry. – Introduction to key EC Directive 8...

EC Directive 852/2004 on the hygiene of foodstuffs Lecturer: Michael King Module Learning Outcomes – This lecture The Learning Outcomes for this modules are 1: Identify the relevant EU regulatory, industrial and retailer standards in the food industry. – Introduction to key EC Directive 852/2004 on the hygiene of food stuffs 2: Define the legal implications of non- conformance – Implications of failure to meet these minimum requirements ©2020, Innopharma Labs Ltd and King Quality Solutions 2 Assessment of this Module Final Exam in Jan 2024 accounts for 60% of the available marks available for this module The remaining 40% the marks available for this module are awarded for the one continuous assessment for the module. The continuous assessment is based on the requirement for Food Safety Level 1 and Food Safety Level 2 from the FSAI. This assessment will be – A closed book assessment – Will be carried out as part of the Saturday tutorials. – Will consist of 15 multiple choice questions that must be completed within 30 minutes. ©2016, Innopharma Labs Ltd 3 History of Food Laws in Ireland Food law in Ireland dates back to the early 1800’s and has been continually augmented and amended over the years. Today, most if not all of our national food legislation derives from Ireland’s membership of the European Union. The negotiation of these laws and the responsibility to give legal effect to the decisions, directives and regulations agreed in Brussels rests with several Government Departments. The Food Safety Authority of Ireland is the single, regulatory authority with responsibility for the enforcement of food safety legislation in Ireland. This responsibility for enforcement is managed through a series of service contracts with official agencies. Ireland’s food code is considerable in volume and ever evolving and consists of the various acts, regulations and orders made at national level as well as those directives and regulations made at EU level. (FSAI). 4 Administration of Food Safety Laws in Ireland Food Safety Authority Health Director of Department of County Department of Marine Services Consumer Agriculture Councils the Marine Institute Executive Affairs Sea Fisheries Trading Environmental Veterinary Veterinary Technical Protection Standards Health Officers Officers Officers Officials Agency Officials Verify Food Exercise controls in Exercises Control and control over Verify food - Retail control over inspect shellfish, fish Enforce food controls in - Catering foods of animal - small and fishery labelling aquaculture - origin. Focus on abattoirs - products. regulations , farms and Manufacturing – small meat Focus on minimum shellfish premises (non primary manufacturing - weights and production food origin). producers plants that primary quid (%) areas. Provide food - food plants supply the producers declarations safety manufacturing domestic - training. products of market. despatch and Investigate & animal origin purification control food for the export centres. poisoning market - and/or manufacturing infectious premises diseases outbreaks. 5 EC Directive 852/2004 on the hygiene of food stuffs All food business operators must apply to the local HSE (Environmental Health) or County Councils. Production volumes are restricted to 250Kg/week Product can only be distributed within 100 km radius of the production facility 6 EC Directive 852/2004 on the hygiene of food stuffs – Article 1 The foundation EC Legislation is; EC Directive 852/2004 on the control of foodstuffs - Basic Principal – The Food Business Operator (Owner/Manager) has the following responsibilities (a)Primary responsibility for food safety (b)It is necessary to exercise control throughout the food chain from primary production 7 EC Directive 852/2004 on the hygiene of food stuffs c) maintain a cold chain for products that cannot be stored at ambient (d) procedures based on HACCP and Good Hygiene Practice should be in place (e) follow guides to good practice (f) follow established guidelines for microbiological criteria and temperature control (g) it is necessary to ensure that imported foods are of the same standard as those produced in the EU 8 EC Directive 852/2004 – Article 1 This Regulation shall not apply to: (a) primary production for private domestic use; (b) the domestic preparation, handling or storage of food for private domestic consumption; (c) the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer; 9 EC Directive 852/2004 – Article 3 Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation. 10 EC Directive 852/2004 – Article 4 1. Food business operators carrying out primary production and those associated operations listed in Annex I shall comply with the general hygiene provisions laid down in Part A of Annex I and any specific requirements provided for in Regulation (EC) No....../2004 *. –Primary Production/Farming 2. Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) 11 EC Directive 852/2004 – Article 4 Food business operators shall, as appropriate, adopt the following specific hygiene measures: (a) compliance with microbiological criteria for foodstuffs; (b) procedures necessary to meet targets set to achieve the objectives of this Regulation; (c) compliance with temperature control requirements for foodstuffs; (d) maintenance of the cold chain; (e) sampling and analysis. 12 EC Directive 852/2004 – Article 5 Deals with the requirements for the implementation of HACCP systems and is covered in a separate module. 13 EC Directive 852/2004 – Article 6 1. Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law. 2. In particular, every food business operator shall notify the appropriate competent authority, in the manner that the latter requires, of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of eachsuch establishment. Food business operators shall also ensure that the competent authority always has up-to-date information on establishments, including by notifying any significant change in activities and any closure of an existing establishment. 14 EC Directive 852/2004 – Article 6 3. However, food business operators shall ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required: (a) under the national law of the Member State in which the establishment is located; (b) under Regulation (EC) No....../2004 *; or (c) by a decision adopted in accordance with the procedure referred to in Article 14(2). 15 EC Directive 852/2004 – Article 6 Any Member State requiring the approval of certain establishments located on its territory under national law, as provided for in subparagraph (a), shall inform the Commission and other Member States of the relevant national rules. 16 EC Directive 852/2004 – Article 10 Imports As regards the hygiene of imported food, the relevant requirements of food law referred to in Article 11 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation. 17 EC Directive 852/2004 – Article 11 Exports As regards the hygiene of exported or re-exported food, the relevant requirements of food law referred to in Article 12 of Regulation (EC) No 178/2002 shall include the requirements laid down in Articles 3 to 6 of this Regulation. 18 EC Directive 852/2004 – Article 13 1. Annexes I and II may be adapted or updated in accordance with the procedure referred to in Article 14(2), taking into account: (a) the need to revise the recommendations set out in Annex I, Part B, paragraph 2; (b) the experience gained from the implementation of HACCP- based systems pursuant to Article 5; (c) technological developments and their practical consequences and consumer expectations with regard to food composition; 19 EC Directive 852/2004 – Article 13 (d) scientific advice, particularly new risk assessments; (e) microbiological and temperature criteria for foodstuffs. 2. Derogations from Annexes I and II may be granted, in particular in order to facilitate the implementation of Article 5 for small businesses, in accordance with the procedure referred to in Article 14(2), taking into account the relevant risk factors, provided that such derogations do not affect the achievement of the objectives of this Regulation. 20 EC Directive 852/2004 – Article 13 3. Member States may, without compromising achievement of the objectives of this Regulation, adopt, in accordance with paragraphs 4 to 7 of this Article, national measures adapting the requirements laid down in Annex II. 21 EC Directive 852/2004 – Article 13 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 geographical constraints. (b) In other cases, they shall apply only to the construction, layout and equipment of establishments. (Strict criteria have been laid down to cover these provisions) 22 EC Directive 852/2004 – Annex Details Annex I – Deals with the requirements for primary production (farming) Annex II – Deals with requirements for all food production facilities. This annex is broken down into 13 chapters 23 EC Directive 852/2004 – Annex II GENERAL HYGIENE REQUIREMENTS FOR ALL FOOD BUSINESS OPERATORS (EXCEPT WHEN ANNEX I APPLIES) 24 852/2004 – Annex II Chapter 1 – General Requirements for food business other the stalls and temporary facilities 1. Food premises are to be kept clean and maintained in good repair and condition. 2. The layout, design, construction, siting and size of food premises are to: (a) permit adequate maintenance, cleaning and/or disinfection, avoid or minimise air-borne contamination, and provide adequate working space to allow for the hygienic performance of all operations; (b) be such as to protect against the accumulation of dirt, contact with toxic materials, the shedding of particles into food and the formation of condensation or undesirable mould on surfaces; (c) permit good food hygiene practices, including protection against contamination and, in particular, pest control; 25 852/2004 – Annex II Chapter 1 – General Requirements for food business other the stalls and temporary facilities (d) where necessary, provide suitable temperature- controlled handling and storage conditions of sufficient capacity for maintaining foodstuffs at appropriate temperatures and designed to allow those temperatures to be monitored and, where necessary, recorded. 3. An adequate number of flush lavatories are to be available and connected to an effective drainage system. Lavatories are not to open directly into rooms in which food is handled. 26 852/2004 – Annex II Chapter 1 – General Requirements for food business other the stalls and temporary facilities 4. An adequate number of washbasins is to be available, suitably located and designated for cleaning hands. Washbasins for cleaning hands are to be provided with hot and cold running water, materials for cleaning hands and for hygienic drying. Where necessary, the facilities for washing food are to be separate from the hand-washing facility. 27 852/2004 – Annex II Chapter 1 – General Requirements for food business other the stalls and temporary facilities 5. There is to be suitable and sufficient means of natural or mechanical ventilation. Mechanical airflow from a contaminated area to a clean area is to be avoided. Ventilation systems are to be so constructed as to enable filters and other parts requiring cleaning or replacement to be readily accessible. 6. Sanitary conveniences are to have adequate natural or mechanical ventilation. 28 852/2004 – Annex II Chapter 1 – General Requirements for food business other the stalls and temporary facilities 7. Food premises are to have adequate natural and/or artificial lighting. 8. Drainage facilities are to be adequate for the purpose intended. They are to be designed and constructed to avoid the risk of contamination. Where drainage channels are fully or partially open, they are to be so designed as to ensure that waste does not flow from a contaminated area towards or into a clean area, in particular an area where foods likely to present a high risk to the final consumer are handled 29 852/2004 – Annex II Chapter 1 – General Requirements for food business other the stalls and temporary facilities 9. Where necessary, adequate changing facilities for personnel are to be provided. 10. Cleaning agents and disinfectants are not to be stored in areas where food is handled. 30 852/2004 Annex II Chapter II Specific requirements in rooms where foodstuffs are prepared, treated or processed 1. Design and layout are to permit good food hygiene practices, including protection against contamination between and during operations. In particular: (a) floor surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials unless food business operators can satisfy the competent authority that other materials used are appropriate. Where appropriate, floors are to allow adequate surface drainage; 31 852/2004 Annex II Chapter II Specific requirements in rooms where foodstuffs are prepared, treated or processed (b) wall surfaces are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of impervious, non-absorbent, washable and non-toxic materials and require a smooth surface up to a height appropriate for the operations unless food business operators can satisfy the competent authority that other materials used are appropriate (c) ceilings (or, where there are no ceilings, the interior surface of the roof) and overhead fixtures are to be constructed and finished so as to prevent the accumulation of dirt and to reduce condensation, the growth of undesirable mould and the shedding of particles; 32 852/2004 Annex II Chapter II Specific requirements in rooms where foodstuffs are prepared, treated or processed (d) windows and other openings are to be constructed to prevent the accumulation of dirt. Those which can be opened to the outside environment are, where necessary, to be fitted with insect-proof screens which can be easily removed for cleaning. Where open windows would result in contamination, windows are to remain closed and fixed during production 33 852/2004 Annex II Chapter II Specific requirements in rooms where foodstuffs are prepared, treated or processed (d) windows and other openings are to be constructed to prevent the accumulation of dirt. Those which can be opened to the outside environment are, where necessary, to be fitted with insect-proof screens which can be easily removed for cleaning. Where open windows would result in contamination, windows are to remain closed and fixed during production (e) doors are to be easy to clean and, where necessary, to disinfect. This will require the use of smooth and non- absorbent surfaces unless food business operators can satisfy the competent authority that other materials used are appropriate; 34 852/2004 Annex II Chapter II Specific requirements in rooms where foodstuffs are prepared, treated or processed (f) surfaces (including surfaces of equipment) in areas where foods are handled and in particular those in contact with food are to be maintained in a sound condition and be easy to clean and, where necessary, to disinfect. This will require the use of smooth, washable corrosion- resistant and non-toxic materials, unless food business operators can satisfy the competent authority that other materials used are appropriate. 35 What happens when thing go wrong 36 852/2004 Annex II Chapter II Specific requirements in rooms where foodstuffs are prepared, treated or processed 2. Adequate facilities are to be provided, where necessary, for the cleaning, disinfecting and storage of working utensils and equipment. These facilities are to be constructed of corrosion- resistant materials, be easy to clean and have an adequate supply of hot and cold water. 3. Adequate provision is to be made, where necessary, for washing food. Every sink or other such facility provided for the washing of food is to have an adequate supply of hot and/or cold potable water consistent with the requirements of Chapter VII and be kept clean and, where necessary, disinfected. 37 852/2004 Annex II Chapter III REQUIREMENTS FOR MOVABLE AND/OR TEMPORARY PREMISES (SUCH AS MARQUEES, MARKET STALLS, MOBILE SALES VEHICLES), PREMISES USED PRIMARILY AS A PRIVATE DWELLING HOUSE BUT WHERE FOODS ARE REGULARLY PREPARED FOR PLACING ON THE MARKET, AND VENDING MACHINES 38 852/2004 Annex II Chapter IV - Transport 1. Conveyances and/or containers used for transporting foodstuffs are to be kept clean and maintained in good repair and condition to protect foodstuffs from contamination and are, where necessary, to be designed and constructed to permit adequate cleaning and/or disinfection. 2. Receptacles in vehicles and/or containers are not to be used for transporting anything other than foodstuffs where this may result in contamination. 39 852/2004 Annex II Chapter IV - Transport 3. Where conveyances and/or containers are used for transporting anything in addition to foodstuffs or for transporting different foodstuffs at the same time, there is, where necessary, to be effective separation of products. 4. Bulk foodstuffs in liquid, granulate or powder form are to be transported in receptacles and/or containers/tankers reserved for the transport of foodstuffs. Such containers are to be marked in a clearly visible and indelible fashion, in one or more Community languages, to show that they are used for the transport of foodstuffs, or are to be marked ‘for foodstuffs only’. 40 852/2004 Annex II Chapter IV - Transport 5. Where conveyances and/or containers have been used for transporting anything other than foodstuffs or for transporting different foodstuffs, there is to be effective cleaning between loads to avoid the risk of contamination. 6. Foodstuffs in conveyances and/or containers are to be so placed and protected as to minimise the risk of contamination. 7. Where necessary, conveyances and/or containers used for transporting food- stuffs are to be capable of maintaining foodstuffs at appropriate temperatures and allow those temperatures to be monitored. 41 852/2004 Annex II Chapter V - Equipment Requirements 1. All articles, fittings and equipment with which food comes into contact are to: (a) be effectively cleaned and, where necessary, disinfected. Cleaning and disinfection are to take place at a frequency sufficient to avoid any risk of contamination; (b) be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination; 42 852/2004 Annex II Chapter V - Equipment Requirements (c) with the exception of non-returnable containers and packaging, be so constructed, be of such materials and be kept in such good order, repair and condition as to enable them to be kept clean and, where necessary, to be disinfected; (d) be installed in such a manner as to allow adequate cleaning of the equipment and the surrounding area. 43 852/2004 Annex II Chapter V - Equipment Requirements 2. Where necessary, equipment is to be fitted with any appropriate control device to guarantee fulfilment of this Regulation's objectives. 3. Where chemical additives have to be used to prevent corrosion of equipment and containers, they are to be used in accordance with good practice. 44 852/2004 Annex II Chapter VI - Food Waste 1. Food waste, non-edible by-products and other refuse are to be removed from rooms where food is present as quickly as possible, so as to avoid their accumulation. 2. Food waste, non-edible by-products and other refuse are to be deposited in closable containers, unless food business operators can demonstrate to the competent authority that other types of containers or evacuation systems used are appropriate. These containers are to be of an appropriate construction, kept in sound condition, be easy to clean and, where necessary, to disinfect. 45 852/2004 Annex II Chapter VI - Food Waste 3. Adequate provision is to be made for the storage and disposal of food waste, non-edible by-products and other refuse. Refuse stores are to be designed and managed in such a way as to enable them to be kept clean and, where necessary, free of animals and pests. 4. All waste is to be eliminated in a hygienic and environmentally friendly way in accordance with Community legislation applicable to that effect, and is not to constitute a direct or indirect source of contamination. 46 852/2004 Annex II Chapter VI - Water Supply 1 (a) There is to be an adequate supply of potable water, which is to be used whenever necessary to ensure that foodstuffs are not contaminated; (b) Clean water may be used with whole fishery products. Clean seawater may be used with live bivalve molluscs, echinoderms, tunicates and marine gastropods; clean water may also be used for external washing. When clean water is used, adequate facilities and procedures are to be available for its supply to ensure that such use is not a source of contamination for the foodstuff. 47 852/2004 Annex II Chapter VI - Water Supply 2. Where non-potable water is used, for example for fire control, steam production, refrigeration and other similar purposes, it is to circulate in a separate duly identified system. Non-potable water is not to connect with, or allow reflux into, potable water systems. 3. Recycled water used in processing or as an ingredient is not to present a risk of contamination. It is to be of the same standard as potable water, unless the competent authority is satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form. 48 852/2004 Annex II Chapter VI - Water Supply 4. Ice which comes into contact with food or which may contaminate food is to be made from potable water or, when used to chill whole fishery products, clean water. It is to be made, handled and stored under conditions that protect it from contamination. 5. Steam used directly in contact with food is not to contain any substance that presents a hazard to health or is likely to contaminate the food. 6. Where heat treatment is applied to foodstuffs in hermetically sealed containers it is to be ensured that water used to cool the containers after heat treatment is not a source of contamination for the foodstuff. 49 852/2004 Annex II Chapter VIII - Personal Hygiene 1. Every person working in a food-handling area is to maintain a high degree of personal cleanliness and is to wear suitable, clean and, where necessary, protective clothing. 2. No person suffering from, or being a carrier of a disease likely to be trans- mitted through food or afflicted, for example, with infected wounds, skin infections, sores or diarrhoea is to be permitted to handle food or enter any food-handling area in any capacity if there is any likelihood of direct or indirect contamination. Any person so affected and employed in a food business and who is likely to come into contact with food is to report immediately the illness or symptoms, and if possible their causes, to the food business operator. 50 852/2004 Annex II Chapter IX – Provisions Applicable to Foodstuffs 1. A food business operator is not to accept raw materials or ingredients, other than live animals, or any other material used in processing products, if they are known to be, or might reasonably be expected to be, contaminated with parasites, pathogenic microorganisms or toxic, decomposed or foreign substances to such an extent that, even after the food business operator had hygienically applied normal sorting and/or preparatory or processing procedures, the final product would be unfit for human consumption. 2. Raw materials and all ingredients stored in a food business are to be kept in appropriate conditions designed to prevent harmful deterioration and protect them from contamination 51 852/2004 Annex II Chapter IX – Provisions Applicable to Foodstuffs 3. At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state. 4. Adequate procedures are to be in place to control pests. Adequate procedures are also to be in place to prevent domestic animals from having access to places where food is prepared, handled or stored (or, where the competent authority so permits in special cases, to prevent such access from resulting in contamination). 52 852/2004 Annex II Chapter IX – Provisions Applicable to Foodstuffs 5. Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro- organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient separate refrigerated storage. 53 852/2004 Annex II Chapter IX – Provisions Applicable to Foodstuffs 6. Where foodstuffs are to be held or served at chilled temperatures they are to be cooled as quickly as possible following the heat-processing stage, or final preparation stage if no heat process is applied, to a temperature which does not result in a risk to health 7. The thawing of foodstuffs is to be undertaken in such a way as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins in the foods. During thawing, foods are to be subjected to temperatures that would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health it is to be adequately drained. Following thawing, food is to be handled in such a manner as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins. 8. Hazardous and/or inedible substances, including animal feed, are to be adequately labelled and stored in separate and secure containers 54 852/2004 Annex II Chapter X Provisions Applicable to Wrapping and Packaging of Foodstuffs 1. Material used for wrapping and packaging are not to be a source of contamination. 2. Wrapping materials are to be stored in such a manner that they are not exposed to a risk of contamination. 3. Wrapping and packaging operations are to be carried out so as to avoid contamination of the products. Where appropriate and in particular in the case of cans and glass jars, the integrity of the container's construction and its cleanliness is to be assured. 4. Wrapping and packaging material re-used for foodstuffs is to be easy to clean and, where necessary, to disinfect. 55 852/2004 Annex II Chapter XI - Heat Treatment The following requirements apply only to food placed on the market in hermetically sealed containers: 1. any heat treatment process used to process an unprocessed product or to process further a processed product is: (a) to raise every party of the product treated to a given temperature for a given period of time; (b) to prevent the product from becoming contaminated during the process; 56 852/2004 Annex II Chapter XI - Heat Treatment 2. to ensure that the process employed achieves the desired objectives, food business operators are to check regularly the main relevant parameters (particularly temperature, pressure, sealing and microbiology), including by the use of automatic devices; 3. the process used should conform to an internationally recognised standard (for example, pasteurisation, ultra high temperature or sterilisation). 57 852/2004 Annex II Chapter XII - Training Food business operators are to ensure: 1. that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity; 2. that those responsible for the development and maintenance of the procedure referred to in Article 5(1) of this Regulation or for the operation of relevant guides have received adequate training in the application of the HACCP principles; 3. compliance with any requirements of national law concerning training programmes for persons working in certain food sectors 58