Hygiene requirements for the primary production, production, processing and distribution of foods

All food business operators, including agricultural enterprises, are subject to the EU hygiene legislation. At all stages of production, processing and distribution, including primary production, they must ensure that the foodstuffs they place on the market are safe.

Food must not be placed on the market if it is unsafe. Reasons for foods being considered unsafe include if they are harmful to health or unfit for human consumption due to contamination or spoilage.

The underlying general and specific hygiene requirements for the production, processing and sale of foods, including on retail premises, are regulated by Regulation (EC) No. 852/2004 on the hygiene of foodstuffs and Regulation (EC) No. 853/2004 laying down specific hygiene rules for the hygiene of food of animal origin.

Legal provisions

The underlying hygiene requirements for the production, processing and sale of foods are regulated by Regulation (EC) No. 852/2004 on the hygiene of foodstuffs and Regulation (EC) No. 853/2004 laying down specific hygiene rules for the hygiene of food of animal origin. They also include the obligation to provide training on health risks and food hygiene issues for staff handling primary and finished products. These regulations serve the purpose of ensuring that the food is in perfect condition from when it is produced to when it is sold to the consumer.

Food business operators must comply with legislation complementing Community law, such as the national Food Hygiene Ordinance (LMHV) and the national Animal Food Hygiene Ordinance (Tier-LMHV), and with the relevant Community law enforcement system.

Food business operators producing primary products must comply with the general hygiene rules (good hygiene practice) laid down in Annex I to Regulation (EC) No 852/2004, which aim in particular to protect primary products from contamination and contaminant residues.

Food business operators involved in the production, processing and sale of foods are subject to the general hygiene rules laid down in Annex II to Regulation (EC) No 852/2004, such as requirements concerning premises, rooms, transport, water supply, personnel hygiene, etc.

Depending on the type, volume and supply route of food, food businesses are subject to mandatory registration or approval requirements. Establishments subject to approval have to submit an application for approval to the competent authority, accompanied by the following documents:

  • company profiles in accordance with the templates provided;
  • a true-to-scale draft operating plan that shows the flows of materials and personnel; and
  • proof of the food business operator's reliability, generally in the form of an official certificate of good conduct.

For establishments with a handicraft structure, it is sufficient to provide documents containing details of the envisaged activity on the respective premises instead of an operating plan.

Less stringent hygiene requirements are planned for the production of certain traditional foods.

The placing on the market of food of animal origin from non-approved establishments is limited to well-defined exceptional cases. The competent authority has discretionary powers with regard to the approval requirements, which can be used to take account of the individual circumstances of the establishment to be approved, in particular in the case of establishments with a handicraft structure, on a case by case basis.

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Responsibilities of food business operators

The core ideas of the EU food hygiene legislation, which is in force in all Member States, include the strengthening of the food business operators' own responsibility for food safety and the involvement of the entire food chain based on the "from farm to fork” principle.

Food business operators (with the exception of primary production) must fulfil this responsibility by carrying out their own checks in accordance with the HACCP principles (Hazard Analysis and Critical Control Points). Thanks to this instrument, businesses can identify any risks in relation to food and establish a clear structure to avoid any such risks arising.

Where food of animal origin is produced, processed or distributed, the specific hygiene requirements of Regulation (ЕC) 853/2004 also apply. Establishments producing food of animal origin, with the exception of retail establishments, are generally obliged under this Regulation to apply for approval. The approval is a prerequisite for allowing the food in question to be placed on the market.

Regulation (EC) No 852/2004 and Regulation (EC) No 853/2004 do not apply to the direct supply of small quantities of primary products by producers to final consumers or retail establishments which sell their products directly to final consumers. In respect of  directly supplying final consumers with small quantities of primary products, small quantities of meat from poultry or lagomorphs or small quantities of game or game meat, corresponding requirements are laid down in the national Food Hygiene Ordinance and the national Animal Food Hygiene Ordinance.

Requirements for direct marketing

Direct marketers are also food business operators within the meaning of food hygiene law and must ensure that the food they place on the market complies with the food law requirements applicable in each case.

Which hygiene regulations are important for direct marketers?

Depending on the type, volume and supply route of the foodstuffs placed on the market, food business operators must comply with the general and specific requirements of EU food hygiene law, the provisions of the national Food Hygiene Ordinance and of the national Animal Food Hygiene Ordinance.

Which direct marketing establishments are subject to the approval requirement?

Establishments producing food of animal origin are generally required to apply for approval on the basis of Regulation (EC) No 853/2004. The placing on the market of food of animal origin from non-approved establishments is limited to well-defined exceptional cases. Direct marketing establishments are also subject to approval unless they meet the definition of a retail establishment or if they - as a retail establishment -

  • process animal products (meat, poultry meat, hare meat, milk, eggs, fish, honey etc.) and sell more than one-third of their production volume to other retail establishments (including, for instance, large-scale kitchens, restaurants, catering facilities and other direct marketers). Sales outside the premises, e.g. at market stalls, are not counted towards this  third of production volume that is sold to other retailers. Approval is also required if these products are supplied to other establishments located outside a sales radius of 100 kilometres,
  • or if they slaughter read-meat animals (for example pigs or cattle) in holding slaughterhouses or slaughter rooms. Slaughterhouses for poultry and lagomorphs are exempt under certain conditions. Further information can be found in the "Basic statements on requirements for the approval of establishments" of the Working Group on Meat and Poultry Meat Hygiene and the specific questions on food of animal origin of the Länder Working Group on Consumer Health Protection (AFFL) of the Länder Working Group for Consumer Health Protection (LAV).

Which direct marketing establishments are subject to compulsory registration?

Establishments with the following production processes require registration, but no approval:

  • establishments in primary production without direct marketing, provided they are food businesses;
  • establishments with on-farm processing of foods of plant origin (cereals, flour, potatoes, vegetables, etc.), also in conjunction with the processing of already processed foods of animal origin (dumplings filled with ham, etc.);
  • establishments engaged in on-farm processing of food of animal origin, if they sell their own goods to final consumers on the spot or supply a maximum of one third of their production volume to other retail establishments (including, for example, large-scale kitchens) as a 'marginal and localised activity', whereby 'localised' is generously defined as anywhere within 100 km of the establishment;
  • holdings, if they supply small quantities of meat from poultry and lagomorphs slaughtered on the farm directly to consumers or to local retailers (including, for example, large-scale kitchens). A small quantity of meat is defined as meat from no more than 10,000 head of poultry or lagomorphs per year.

The direct marketing establishments subject to registration but not to approval must comply with the general hygiene rules laid down in particular in the Annex to Regulation (EC) No 852/2004 on the hygiene of foodstuffs or in the national Food Hygiene Ordinance and the national Animal Food Hygiene Ordinance referred to above. The additional specific hygiene requirements of Regulation (EC) No 853/2004 applicable to approved establishments do not apply.

Which establishments are subject neither to compulsory approval nor to compulsory registration?

Neither approval nor registration is required for establishments which only supply small quantities of primary products directly to the final consumer or to local retailers (including, for example, large-scale kitchens).

The following products produced by the farm itself or caught or harvested by the establishment are considered to be "small quantities":

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    • plant-based primary products and foods of plant origin; exception: establishments producing sprouts falling within the scope of Regulation (EC) 852/2004 are subject to approval under Regulation (EU) 210/2013;
    • honey;
    • eggs coming from a farm's own production if the farm has fewer than 350 laying hens;
    • fishery products, whether live, fresh or prepared, if their general characteristics have not been substantially altered;
    • and fresh mussels/clams;

     

    if these products are directly supplied to consumers in normal household quantities, or if they are supplied to retail establishments (including, for example, large-scale kitchens) in quantities corresponding to a regular daily supply to consumers by the respective establishment.

The requirements of the national Food Hygiene Ordinance apply to the direct supply of small quantities of primary products; these requirements, and the requirements of the Animal Food Hygiene Ordinance apply to the supply of small quantities of fishery products, mussels/clams, eggs, fresh poultry meat, hare meat and bagged game.

More extensive information on the conditions in each individual case and the requirements can be requested from the competent food inspection authorities or veterinary offices.

Slaughterhouses: micro-enterprises also require approval

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All slaughtering establishments require official approval. This also applies to small butchers or direct marketers carrying out their own slaughtering. The approval requirements of EU food hygiene law do not stipulate any rigid and detailed rules, but are formulated in a sufficiently flexible way that the individual situation of even small and very small slaughterhouses can be adequately reflected. They give the approval authorities discretionary powers, which can be used to take account of the individual circumstances of the establishment that is to be approved, in particular in the case of establishments with a handicraft structure. The General Administrative Regulation concerning Food Hygiene (AVV LmH) also provides the approval authorities with explanatory guidance for the approval requirements in order to find case-by-case solutions taking due account of the specific situation of small and medium-sized farms.

Requirements for the sale of food by retailers

In the retail sector, food business operators are also responsible for ensuring that the food under their control meets the relevant hygiene requirements and is protected, inter alia, from contamination.

In the case of non-prepackaged food which is consumed without prior washing, peeling or heating, e.g. bakery products, this duty of care must be particularly observed. In this case, possible measures taken by the staff to avoid any adverse effect on food may include the wearing of gloves or headgear or the use of pastry tongs.

However, the legislator has deliberately not enacted any special individual legal provisions that would, for example, require sales personnel in retail stores to wear gloves or headgear. The adoption of such detailed rules would no longer be in line with the overall concept of the new EU food hygiene legislation, which is oriented towards the objective of food safety and largely refrains from imposing detailed provisions. The food control authorities responsible for the enforcement of food legislation have to decide in dialogue with the actors involved which specific action is appropriate in each individual case.

This applies mutatis mutandis to retail stores of all kinds, including, for example, the sale of lettuce or vegetables in supermarkets. With regard to the duty of care for businesses, and compliance with the legal obligation to protect food from contamination, it is crucial for to demonstrate an awareness of hygiene and to behave appropriately.

Particular attention must be paid to this in the case of fruit and vegetables, e.g. lettuce or other types of vegetables, which are eaten raw without prior peeling or heating.

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