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Approving Businesses according to the new EU Hygiene Regulation

The new EU hygiene regulation also changes the regulations regarding the approval of businesses. In certain cases, small businesses must also be approved.


Approval and registration

Do not confuse this special approval of businesses with the general obligation to register businesses that handle food. The aim of registering a business is to disclose to food safety authorities that a business exists. Registration is a relatively simple procedure and involves informing the responsible authorities of the address of the business and the activity that business performs. Your business registration with the city or local authority is usually sufficient.

There are special hygiene regulations for food present a specific risk to health, which is why companies that produce such products require approval. Approval is only granted once the conditions have been met, in other words, when the company has taken all steps to ensure the food is safe.


Which businesses require approval?

According to Regulation (EC) no. 853/20041), laying down specific hygiene rules for food of animal origin applies to all businesses handling food of animal origin, in other words, businesses that produce, process or distribute these products. The following businesses do not need approval:

  • Primary production (e.g. farmers, hunters, apiarists and fishermen)
Example:
Meat from slaughtered animals is not a primary product, as it is obtained following slaughtering. Agricultural slaughtering operations are subject to approval with the following exception: Direct transfer of small quantities of poultry and rabbit (up to 10,000 pieces/year), which the farmer delivers directly to the consumer or local dealers.
  • Transport (e.g. carrier)
  • Storage without the need of temperature control
  • Retail (see example)

If in doubt, contact the relevant food safety authorities to determine whether and under what circumstances your business must be approved.


Definitions and examples of businesses requiring approval

1. Retail
Retail is the handling and/or processing of foods and their storage at the place of sale or their transfer to the final consumer. It comprises loading points, catering businesses, company cafeterias, canteen kitchens, restaurants, shops, supermarkets, supermarket distribution centres and wholesale sales outlets as well as small butcher shops without their own slaughtering operations.
Example 1: A butcher shop without its own slaughtering operation that processes fresh meat and produces a standard range of sausages itself, then sells these products at the same site, is considered a retail business and therefore does not require approval.

2. Secondary activities at the local level with a limited scope
    • When food of animal origin makes up no more than one-third of the total amount of food production of the retail operation and
    • distribution is limited to a radius of < 100 km.
Example 2: A butchery purchases a branch shop. The butchery then covers another retail operation's demand for food of animal origin. The production operation must therefore be approved unless the amount of food of animal origin distributed is no more than one-third of the production quantity of the distributing butchery and the branch office is located fewer than 100 km away.


General oblications and requirements for approval

For general hygienic obligations, such as those for sanitary equipment (toilets, sinks), processing, storage and changing room design, and also cleaning measures, see Annex II of EC Regulation 852/20042) on food hygiene. Approved meat-handling businesses must also comply with additional hygienic requirements, which are outlined in Annex III of EC Regulation 853/20041). The requirements refer to, for instance, slaughtering and butchering hygiene, storing and transporting meat, and the production of minced meat and meat preparations.


1) Regulation (EC) no. 853/2004 of the European Parliament and of the Council of 29 April 2004 with specific hygiene rules for food of animal origin (OJ L 226 of 25 June 2004, p. 22)
2) Regulation (EC) no. 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139 of 30 April 2004)