Food businesses; application for EU approval when handling products of animal origin

The activity requiring authorization may only be commenced after authorization has been granted. The procedure is subject to an application. A site inspection is carried out to check whether the requirements under food law have been met.

There are some complicated exceptions to the licensing requirement (e.g. primary production, retail in certain cases). It is therefore advisable to check with the responsible licensing authority or the district administrative authority.

The approval decision does not affect any other permits that may be required, such as planning permission, immission control permits, etc. This depends on the specific individual case and should be requested from the responsible licensing authority - usually the district administrative authority (district office or independent city).

The following food businesses require EU approval, regardless of whether they only operate within the country or also within the EU:

Meat plants/poultry meat plants

• All companies with their own slaughtering
• Companies that sell more than a third of their production volume to other companies

Dairy farms

All farms that treat or process milk from other farms require an approval and an approval number:

• Milk collection points
• Standardization bodies
• Milk processing plants

Other companies

Other businesses that handle products of animal origin, such as direct marketers.

Approval number

With the approval, the establishment also receives the approval number required for intra-Community trade.

With the exception of the health mark for carcasses, a so-called identification mark must be affixed to treated products of animal origin in approved food businesses since January 1, 2006. The identification mark consists of two letters for the member state and country code (e.g. DE) and the approval number for the respective company as well as the abbreviation for the European Economic Community (EC) or European Union (EU). The identification mark is an important prerequisite for the traceability of products.

The following exceptions to the authorization requirement exist:

There are some complicated exceptions to the licensing requirement:

• Primary production and the sale of small quantities of primary products to end consumers or local retailers do not require authorization.
• Approval is also not required for the supply of small quantities of meat from poultry and lagomorphs by the producer or for the supply of small quantities of game or game meat by the hunter to end consumers and local retailers.
• Businesses that handle, process and store food of animal origin at the point of sale or delivery to the final consumer (retail) and do not sell more than one third of their products of animal origin to other local retail businesses do not require approval. Retail businesses also include pubs and restaurants.

In this context, stores are to be seen as independent retail companies.

It is advisable to ask the responsible licensing authority or the district administrative authority.

Self-slaughtering butchers and self-slaughtering restaurants require a license for slaughtering in any case.

The regulations allow for flexible implementation, so that approval does not represent an insurmountable hurdle for the companies concerned.

Establishments are approved in accordance with Art. 6 Para. 3 of Regulation (EC) No. 852/2004. Art. 4 (1) and (2) of Regulation (EC) No. 853/2004 in conjunction with Annexes II and III list the requirements of EU law to be complied with by the individual establishments with regard to the structural equipment and furnishings of the establishment. Furthermore, occupational health and safety regulations must not prevent approval. The business owner or the responsible person appointed by the business owner must have the necessary reliability to run the business.

No activity requiring a license may be commenced without a license.

• Annex to the application - General information
• Attachment to the application - self-disclosure
• Application for approval of a food business
• Supplement to the company report - egg products
• Supplement to the farm report - Fishery products
• Supplement to the farm report - Meat
• Supplement to the company report - Gelatine and collagen
• Supplement to the company report - Commercial kitchen
• Supplement to the operating summary - Cold storage
• Supplement to the farm report - Milk
• Confirmation of the transfer of food law responsibility to the responsible food business operator
• Declaration by the food business operator on the withdrawal of the authorization
• Additional supplementary sheet for slaughterhouses
• Change request/notification for the approval of food businesses

• Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs

  Version from 24.03.2021

• Regulation (EC) No 853/2004 of the European Parliament and of the Council laying down specific hygiene rules for food of animal origin

  Version from 26.07.2019

• Regulation (EU) No 2017/625 on official controls

  Version dated 15.03.2017 in the currently valid version

• § Section 9 Ordinance on Hygiene Requirements for the Manufacture, Treatment and Placing on the Market of Certain Foodstuffs of Animal Origin (Animal Food Hygiene Ordinance - Tier-LMHV)

• Approval manual

Authorization procedure

The approval procedure begins with the submission of the documents to the government (competent authority) or to the Bavarian Food Safety and Veterinary Control Authority (KBLV).

After the application has been submitted and a preliminary assessment has been carried out, a site inspection is carried out by the government or the KBLV. During this inspection, it is checked whether the relevant requirements of food law are met in each individual case. The competent authority must consult veterinary experts when assessing the approval requirements of a business. The involvement of other, non-veterinary experts is possible. The administrative procedure is concluded by issuing an approval notice.

With the approval, the establishment also receives the approval number required for intra-Community trade.

• Food business operators; notification of establishments for registration
• Slaughter on the holding of origin; application for approval
• Food businesses; application for EU approval for sprout-producing businesses