EU-Zulassung von Lebensmittelbetrieben Zulassung

Regulation (EU) 2017/625 - Art. 148
Regulation (EC) 852/2004 - Art. 6 and Annex II
Regulation (EC) 853/2004 - Art. 4 and Annex III
Regulation (EC) No 210/2013
§6 and 9 of the Animal Food Hygiene Ordinance (Tier-LMHV)

If you process food of animal origin or sprouts, you will need a licence before you start your work.

According to EU food law regulations, certain companies that process and market food of animal origin and sprouts require approval. These include, for example, slaughterhouses and companies that process milk, fish, meat and eggs and place these products on the market not only at the place of production. Commercial kitchens may also be subject to approval requirements.
If you run a business that belongs to the following categories (not exhaustive), you will need a licence for the corresponding activity:

• Meat processing:
  • Slaughterhouses
  • Cutting plants
  • Establishment producing minced meat, meat preparations or meat products
  • Mechanically separated meat manufacturer
  • Meat processing plants
  • Game processing plants
• Live mussels:
  • Shipping centers
  • Cleaning centers
• Fishery products:
  • Freezer and factory ships
  • Shrimp boat
  • Establishments producing fishery products
• Milk and milk products:
  • Establishments that produce heat-treated milk and milk products from raw milk
  • Establishments that produce dairy products from already processed dairy products (for example, butter from pasteurised cream, cheese from pasteurised milk or milk powder)
  • Milk collection points
• Egg products
  • Egg pretreatment plants
  • Egg breaking plants
  • Egg processing plant
  • Egg cooking companies
  • Egg packing stations
• Frog legs and snails
  • Establishments that prepare and/or process frog legs and snails
• Rendered animal fats and greaves
  • Companies that collect, store or process the raw materials
• Stomach and bladder
  • Companies that treat bladders, intestines and stomachs
• gelatin
  • Companies that produce edible gelatin
• Collagen
  • Companies that produce collagen
• Sprouts
  • Companies that produce sprouts
• Cold storage facilities that store food of animal origin cool or frozen
• Kitchens and canteens that do not supply food directly to the final consumer
• Establishments in which the above products are re-wrapped, regardless of whether this activity is carried out in conjunction with other activities such as cutting or cutting
• Wholesale markets that produce products of animal origin
• Cash & Carry markets, provided the food is not sold directly to the final consumer

If your business only carries out primary production, transport activities, stores products (which do not require temperature control) or carries out certain retail activities, you do NOT need a licence as a food business. This also applies if you fall under the retail definition and the sale of food of animal origin is a secondary activity (a maximum of one third of the production volume is sold to other retailers) at local level. If in doubt, contact the responsible authority in Hamburg. After an individual case-specific assessment, they will inform you whether a licence is required. It is your legal duty to clarify whether you need a licence or not.

• Company profile (general part and specific part for the respective activity)
• Confirmation of business registration
• Information from the Federal Central Register (certificate of good conduct of the food business operator) for submission to an authority (document type O), not older than three months
• extract from the central Register of trade and commerce
• Current floor plan of your business premises, taking into account all rooms. This includes a clear identification of all rooms on the plan and their use (by numbers or keywords), for example by means of a legend and the marking of the respective doors or gates
• Machine layout plan as well as routing of personnel and description of the production flow (integration into the floor plan is possible here)
• Brief description of the production processes taking into account the production categories and numbered rooms
• If applicable, organizational chart or list of responsibilities
• Proof of drinking water quality (microbiological and physical-chemical tests according to the Drinking Water Ordinance) by an approved drinking water testing laboratory
• Water supply and wastewater disposal plan (coloured differentiation) with floor drains taking into account the water taps (consecutive numbering so that the respective tap number can be taken into account on the corresponding water extraction or test reports) and the installed hand washing and disinfection facilities or the blind connections that exist or are planned in this regard
• Cleaning and disinfection plans with evidence of success control
• Pest control plan with description of control points, details of control agents and evidence of type and results of the measures
• Staff training (with current staff overview)
• Evidence of hygiene training in accordance with Article 4 paragraphs 2 and 6 in conjunction with Article 8 and Annex II Chapter XII of Regulation (EC) No. 852/2004 in conjunction with Section 4 of the Regulation on hygiene requirements for the production, handling and placing on the market of foodstuffs (Food Hygiene Regulation - LMHV) and evidence of instructions in accordance with Section 43 paragraphs 1 to 3 of the Infection Protection Act. Note: Both taken up in DIN 10514 (Food hygiene - hygiene training)
• detailed HACCP concept Article 5 of Regulation (EC) No 852/2004
• Information on temperature registration taking into account the connected rooms / equipment with details of the intended temperatures
• Traceability system with a register for the entry of food of animal origin and the exit of products
• Information on the incoming and outgoing goods register
• Emergency concept (elimination of faults, recall management)
• Proof of disposal of animal by-products (Regulation (EC) No 1069/2009)
• Information on self-control (sampling, test parameters and test results), in particular in accordance with Article 4 of Regulation (EC) No 2073/2005
• Information on maintenance measures of the company including maintenance plans for equipment, machines and furnishings

• Registration of the business
• If necessary, register as a food business with your local veterinary office
• Proof of reliability and expertise

Fees for the approval procedure and the necessary approval checks in the company are charged based on the time spent per quarter of an hour or part thereof in accordance with the fee schedule for public consumer protection.

To start the authorisation procedure, send an informal application describing the activities you want to carry out in the future. This application letter should at least state:

• Company name and responsible person
• Name of the establishment, street, postcode, city
• List of the activities requested (e.g. cooking eggs, cutting meat, storing frozen food, etc.)
• Signature
• We will review your application and may contact you if we require additional documentation.
• The company is then inspected by the competent authority in cooperation with the district authorities responsible for the subsequent monitoring of its operations.
• If no further deficiencies are found during the operational inspection, a temporary approval is usually granted for three months.
• If serious deficiencies are found in the inspected business, you will not be approved. However, you will usually be given the opportunity to remedy the deficiencies.
• If you have received a temporary permit, another inspection will be carried out shortly before the end of the three months. If all the food law requirements are met, you will receive a permanent permit.
• If deficiencies are still found, a final approval may be granted for a period of three months.
• After a further operational inspection, the application is either rejected (deficiencies still exist) or a permanent approval notice is issued.

Once the complete application documents have been received, the admission check is usually carried out at short notice after consultation with the applicant. If application documents are not submitted or are not submitted in full and have to be requested later, the processing time will be extended accordingly.

You need a license to operate as a food business before you can start your business. You may only carry out your business once you have received the license.

You are only permitted to start the intended activity after the permit has been issued. It is your duty to inform yourself.

If admission is refused, an objection can be filed.

• Apply for authorisation of food establishments
• EU approval for food establishments according to Art. 4 para. VO (EC) No.853/2004 Grant
• Companies wishing to place food of animal origin on the market may require authorisation.
• These include slaughterhouses, meat, milk, egg and fish processing plants, as well as sprout producing plants.

Justice and Consumer Protection Authority