Throughout the EU food hygiene is governed by three central regulations:
Regulation (EC) 852/2004 on the hygiene of foodstuffs.
Regulation (EC) 853/2004 laying down specific hygiene rules for food of animal origin.
Regulation (EC) 854/2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption.
The Food Safety and Hygiene (England) Regulations 20131 provide the domestic framework within which the EU legislation is enforced.
This documents sets out the overall approach taken by Regulation (EC) 852/2004.
2. Scope and General Obligations
Regulation (EC) 852/2004 lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:2
Primary responsibility for food safety rests with the food business operator.
Food safety throughout the food chain, starting with primary production, must be ensured.
The importance, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain.
The general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility.
The Regulation does not apply to:
Primary production for private domestic use.
The domestic preparation, handling or storage of food for private domestic consumption.
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.3
It is for Member States to establish under domestic law the rules governing direct supply but these must ensure the achievement of the objectives of the Regulation. The principal objective of which is to ensure a high level of consumer protection with regard to food safety.4
The European Commission has issued some guidance5 on the meaning of ‘small quantities’ of primary products which states that, in general terms, the notion ‘small quantities’ should be broad enough, amongst other things, to allow:
Farmers to sell primary products (vegetables, fruits, eggs, raw milk6 etc.) directly to the final consumer e.g. farm gate sales or sales at local markets, to local retail shops for direct sale to the final consumer and to local restaurants.
Individuals who collect products in the wild such as mushrooms and berries to deliver their yield directly to the final consumer or to local retail shops for direct sale to the final consumer and to local restaurants.
The guidance states that it is up to Member States to further refine the notion of small quantities depending on the local situation, and to lay down under national law the rules necessary to ensure that the safety of the food is guaranteed. In general, national rules should allow current practices to continue to apply, provided they ensure achievement of the objectives of Regulation (EC) 852/2004.
A meaningful interpretation of what constitutes a small quantity of various primary products will vary enormously from product to product. The following interpretations are offered for certain types of primary product.
- For wild game a small quantity is currently set at under 10,000 small wild game and under 300 large wild game per year. …
- In relation to small quantities of primary fishery products and live bivalve molluscs (LBMs) it is suggested that it will be appropriate to maintain the approach of the outgoing legislation. This would mean that ‘small quantities’ would be interpreted as up to 25 tonnes of fish and/or LBMs together in any calendar year.
The guidance goes on to provide additional interpretations and in relation to ‘local’ states:
It has been decided that “local” and “localised” be interpreted as ‘sales within the supplying establishment’s own county plus the greater of either the neighbouring county or counties or 30 miles/50 kilometres from the boundary of the supplying establishment’s county’. “County” is interpreted here as meaning metropolitan or non-metropolitan counties in England and Wales as defined in the Local Government Act 1972 and London Government Act 196314 (e.g. Greater London, North Yorkshire, Leicestershire, Powys), …
The direct supply by the producer of small quantities of meat from poultry or lagomorphs (rabbits, hares and rodents) slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer are required to carry a label or other marking clearly indicating the name and address of the farm where the animal from which it is derived was slaughtered. The producer must:
Keep a record to show the number of birds and lagomorphs received into, and the amounts of fresh meat despatched from, her/his premises during each week.
Retain the record for one year.
Make the record available to an authorised officer on request.
A producer who fails to comply with any of these requirements is guilty of an offence.
The exempt activities of direct supply are still covered by the general requirements concerning the placing of unsafe food on the market under Regulation (EC) 178/2002,8 in particular Articles 14 and 19 of Regulation (EC) No 178/2002, as implemented by the General Food Regulations 2004. 9
2.2 General Obligations
Food business operators must ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements.10
‘Primary production’ is defined as “the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products.”11
Food business operators carrying out primary production and associated storage, transport and handling operations12 must comply with the general hygiene provisions13 and any specific requirements provided for in Regulation (EC) 853/2004. The general hygiene provisions include:
A general duty, so far as possible, to protect against contamination, having regard to any processing primary products will subsequently undergo.
Compliance with appropriate EU and national legislation relating to the control of hazards in primary production and associated operations, including measures to control contamination arising from the air, soil, water, feed, fertilisers, veterinary medicinal products, plant protection products and biocides and the storage, handling and disposal of waste; and measures relating to animal health and welfare and plant health that have implications for human health, including programmes for the monitoring and control of zoonoses and zoonotic agents.
Take adequate measures, as appropriate, to:
Keep facilities used clean and, where necessary after cleaning, to disinfect them in an appropriate manner.
Keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels.
Ensure the cleanliness of animals going to slaughter and, where necessary, production animals.
Use potable water, or clean water, whenever necessary to prevent contamination.
Ensure that staff handling foodstuffs are in good health and undergo training on health risks.
Prevent animals and pests from causing contamination.
Store and handle waste and hazardous substances so as to prevent contamination.
Prevent the introduction and spread of contagious diseases transmissible to humans through food, including precautionary measures when introducing new animals and reporting suspected outbreaks of disease to the competent authority.
Use feed additives and veterinary medicinal products correctly and as required by the relevant legislation.
Take appropriate remedial action when informed of problems identified during official controls.
Keep and retain records relating to:
Measures put in place to control hazards in an appropriate manner and for an appropriate period commensurate with the nature and size of the food business, and make relevant information available to the competent authority and receiving food business operators on request.
Keep records on the nature and origin of feed fed to the animals; veterinary medicinal products or other treatments administered to the animals, dates of administration and withdrawal periods; the occurrence of diseases that may affect the safety of products of animal origin; the results of any analyses carried out on samples taken from animals or other samples taken for diagnostic purposes, that have importance for human health; and any relevant reports on checks carried out on animals or products of animal origin.
Assistance may be provided by other persons, including veterinarians, agronomists and farm technicians, with the keeping of records.
The general arrangements go on to set out recommendations in the development of guidance on good hygiene practice.
Food business operators carrying out any stage of subsequent production, processing and distribution of food must comply with a separate set of general hygiene requirements14 and any specific requirements provided for in Regulation (EC) No 853/2004. The general hygiene requirements, in summary, cover:
General requirements for food premises (except those in paragraph 3) below).
Premises must be kept clean and maintained in good repair and condition. The layout, design, construction, siting and size of food premises are to 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, 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, permit good food hygiene practices, including protection against contamination and, in particular, pest control, and, 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.
Provision is also made for 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. 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. There is to be suitable and sufficient means of natural or mechanical ventilation
Specific requirements in rooms where foodstuffs are prepared, treated or processed (except those in paragraph c) below).
In rooms where food is prepared, treated or processed (excluding dining areas and premises specified in paragraph c) below, but including rooms contained in means of transport) the design and layout are to permit good food hygiene practices, including protection against contamination between and during operations.
Provision is also made for the specification to be met by floor and wall surfaces, ceilings, windows, doors and surfaces where food is handled.
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.
Premises and vending machines are, so far as is reasonably practicable, to be so sited, designed, constructed and kept clean and maintained in good repair and condition as to avoid the risk of contamination, in particular by animals and pests.
Provision is also, where necessary, to be made for facilities to maintain adequate personal hygiene, surfaces in contact with food are to be in a sound condition and be easy to clean and, where necessary, to disinfect, adequate provision is to be made for the cleaning and, where necessary, disinfecting of working utensils and equipment.
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. Receptacles in vehicles and/or containers are not to be used for transporting anything other than foodstuffs where this may result in contamination.
All articles, fittings and equipment with which food comes into contact are to be effectively cleaned and, where necessary, disinfected, and be so constructed, be of such materials and be kept in such good order, repair and condition as to minimise any risk of contamination.
Food waste is to be removed from rooms where food is present as quickly as possible, deposited in closable containers of an appropriate construction, kept in sound condition, be easy to clean and, where necessary, to disinfect. All waste is to be eliminated in a hygienic and environmentally friendly way in accordance with Community legislation
There is to be an adequate supply of potable water, which is to be used whenever necessary to ensure that foodstuffs are not contaminated. 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. 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.
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. No person suffering from, or being a carrier of a disease likely to be transmitted 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.
Provisions applicable to foodstuffs.
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.
Provisions applicable to the wrapping and packaging of foodstuffs.
Material used for wrapping and packaging are not to be a source of contamination and is to be stored in such a manner that they are not exposed to a risk of contamination.
Where food is placed on the market in hermetically sealed containers which has been subject to any heat treatment process used to process an unprocessed product or to process further a processed product, such process is to raise every party of the product treated to a given temperature for a given period of time and prevent the product from becoming contaminated during the process;
Food business operators are to ensure that food handlers are supervised and instructed and/or trained in food hygiene matters commensurate with their work activity.
All food business operators must, as appropriate, adopt the following specific hygiene measures:15
Compliance with microbiological criteria for foodstuffs.
Procedures necessary to meet targets set to achieve the objectives of Regulation (EC) 852/2004.
Compliance with temperature control requirements for foodstuffs.
Maintenance of the cold chain.
Sampling and analysis.
The criteria, requirements and targets referred to above and associated sampling and analysis methods are set by the Commission.16 If Regulation (EC) 852/2004, Regulation (EC) No 853/2004 and any implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other EU or national legislation or, in the absence of such methods, methods that offer equivalent results to those obtained using the reference method, if they are scientifically validated in accordance with internationally recognised rules or protocols.
3 Hazard Analysis and Critical Control Points
Food business operators carrying out any stage of production, processing and distribution of food after primary production must17 put in place, implement and maintain a permanent procedure or procedures based on the Hazard Analysis and Critical Control Points (HACCP) principles as follows:
Identifying any hazards that must be prevented, eliminated or reduced to acceptable levels.
Identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels.
Establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards.
Establishing and implementing effective monitoring procedures at critical control points.
Establishing corrective actions when monitoring indicates that a critical control point is not under control.
Establishing procedures, which shall be carried out regularly, to verify that the measures outlined in paragraphs a) to e) above are working effectively.
Establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in paragraphs a) to f) above.
When any modification is made in the product, process, or any step, food business operators must review the procedure and make any necessary changes.
The use of HACCP is more fully explained in the document on Food Hygiene: General – Hazard Analysis and Critical Control Points.
4 Registration and Approval of Food Businesses
Food business operators must cooperate with the competent authorities and, in particular, every food business operator must notify the appropriate competent authority, in the manner required, 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 each such establishment.18
Food business operators must ensure 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 and must ensure that establishments are approved by the competent authority, following at least one on-site visit, when approval is required under the national law, Regulation (EC) No 853/2004 or a decision adopted by the Commission.19
The process of registration is more fully dealt with in the document on Food Hygiene: General - Registration and Approval of Food Businesses.
The Food Standards Agency or the food authority in whose area a food business operator carries on business is responsible for enforcement depending on the nature of the business.20
Sampling, where the analysis/examination is to be carried out by an official laboratory.
Other interventions include education, advice and coaching provided at a food establishment, information and intelligence gathering (including sampling where the analysis or examination is not to be carried out by an official laboratory). It is recognised that more than one type of intervention may be carried out during a single visit to a food business establishment.
Inspections are carried out at all stages of production, processing and distribution in order to establish whether legal requirements are being met.
Food establishments (not those engaged in primary production) are assessed and placed in one of five categories – Category A to E. The highest risk establishments (Category A) are subject to intervention at least every six months and Category E, low risk establishments, are subject to an alternative enforcement strategy at least once every three years.22
7 Microbiological Criteria for Food
Food business operators must adopt specific hygiene measures to ensure compliance with microbiological criteria for foodstuffs.23 Furthermore, foodstuffs should not contain micro-organisms or their toxins or metabolites in quantities that present an unacceptable risk for human health.24 Regulation (EC) 2073/2005 sets out the microbiological criteria for foodstuffs25 of which there are two types: ‘food safety criteria’ and ‘process hygiene criteria’.
A ‘food safety criterion’ means a criterion defining the acceptability of a product or a batch of foodstuff applicable to products placed on the market.26
A ‘process hygiene criterion’ means a criterion indicating the acceptable functioning of the production process. Such a criterion is not applicable to products placed on the market. It sets an indicative contamination value above which corrective actions are required in order to maintain the hygiene of the process in compliance with food law.27
When the results of testing against the criteria are unsatisfactory, the food business operator must take prescribed measures which include withdrawal and recall of the foodstuff28 together with other corrective actions defined in their HACCP-based procedures and other actions necessary to protect the health of consumers.29 In addition, measures must be taken to find the cause of the unsatisfactory results in order to prevent the recurrence of the unacceptable microbiological contamination. It is an offence not to deal with unsatisfactory results in the prescribed manner.30
Minimum requirements are established for bacteriological sampling in slaughterhouses and at premises producing minced meat, meat preparations, mechanically separated meat and fresh meats, and for food business operators producing sprouts.31
In the absence of more specific rules on sampling and preparation of test samples, the relevant standards of the ISO (International Organisation for Standardisation) and the guidelines of the Codex Alimentarius shall be used as reference methods.32
8 Temperature Controls
Food business operators shall, as appropriate, adopt hygiene measures to ensure compliance with temperature control requirements for foodstuffs and maintenance of the cold chain.33
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.34
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.
Where foodstuffs are held or served at chilled temperatures they must 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.35 The thawing of foodstuffs is to be undertaken in a way that minimises the risk of growth of pathogenic microorganisms or the formation of toxins in the food.36
More detailed guidance can be found in the FSA’s Guidance on Temperature Control Legislation in the United Kingdom.37 Examples are given of various food types which under normal conditions should kept under temperature control (chill and hot holding) so as not to pose a risk to health, including:
Smoked or cured fish which is not ambient shelf-stable.
Smoked or cured ready-to-eat meat which is not ambient shelf-stable.
Prepared ready-to-eat foods.
Uncooked or partly cooked pastry and dough products.
The enforcement of temperature controls is provided for in The Food Safety and Hygiene (England) Regulations 201338 but which does not apply to any food business operation to which Regulation (EC) 853/2004 applies. Any person who keeps any food which is likely to support the growth of pathogenic micro–organisms or the formation of toxins and, with respect to which any commercial operation is being carried out, at or in food premises at a temperature above 8°C is guilty of an offence.39
There are a number of exceptions, including one for food which, as part of a mail order transaction, is being conveyed to the final consumer. It should be noted that there is a specific prohibition on the supply by mail order of any food which is likely to support the growth of pathogenic micro-organisms or the formation of toxins and is conveyed by post or by a private or common carrier to the final consumer, at a temperature which has given rise to or is likely to give rise to a risk to health.
In the case of hot holding requirements, any person who in the course of the activities of a food business keeps at or in food premises at a temperature below 63°C any food which has been cooked or reheated, is for service or on display for sale and needs to be kept at or above 63°C in order to control the growth of pathogenic micro–organisms or the formation of toxins, is guilty of an offence.40
1 SI 2013/2996
2 Regulation (EC) 852/2004, Article 1
3 Ibid., Article 1(2)
4 Ibid., recital 7
5 European Commission, Guidance Document on the Implementation of Certain Provisions of Regulation (EC) No 852/2004, 2012, page 9, para 3.3
6 Subject to the domestic controls under the Food Safety and Hygiene (England) Regulations 2013 SI 2013/2996, Schedule 6 and see also the document on Traditional Foods: Dairy - Raw Drinking Milk
7 Food Standards Agency, FSA Guidance on the Requirements of Food Hygiene Legislation, Annex H
8 Article 14 and The General Food Regulations 2004 SI 2004/3279, r4
10 Regulation (EC) 852/2004, Article 3
12 Regulation (EC) 852/2004, Annex I, Part A, paragraph 1(1)
13 Ibid., Annex I, Part A
14 Ibid., Annex II
15 Ibid., Article 4(3)
16 Ibid., Article 4(4)
17 Ibid., Article 5
18 Ibid., Article 6
19 In accordance with the procedure set out under Regulation (EC) 852/2004, Article 14(3)
21 Food Standards Agency, Food Law Code of Practice (England), April 2014, p79, para 4.1.2
22 Ibid., Annex 5
23 Regulation (EC) 852/2005, Article 4(3)(a)
25 Ibid., Annex I
26 Ibid., Article 2(c) and Annex I, Chapter 1
27 Ibid., Article 2(d) and Annex I, Chapter 2
28 Regulation (EC) 178/2002, Article 19
29 Regulation (EC) 852/2004, Article 7(1)
31 Regulation (EC) 2073/2005, Annex I, Chapter 3
32 Ibid., Annex I, Chapter 3, para 3.1
33 Regulation (EC) 852/2004, Article 4(3)(c) and (d)
34 Ibid., Annex II, Chapter IX, point 5
35 Ibid., Annex II, Chapter IX, point 6
36 Ibid., Annex II, Chapter IX, point 7
37 September 2007
39 Ibid., Schedule 4, para 2(1)
40 Ibid., Schedule 4, para 6
41 Food Standards Agency, April 2014, Chapter 3.6