Apply for EU approval when handling products of animal origin
What do I need to know?
Service description
You may not begin the activity requiring a license until the license has been granted. The process is application-based. We will conduct an on-site inspection to verify that the requirements under food safety regulations have been met.
There are some complex exceptions to the licensing requirement (e.g., primary production, retail trade in certain cases). It is therefore advisable to inquire with the competent municipal or district administrative authority.
The licensing decision does not affect any other necessary permits, such as building permits, environmental protection permits, etc. This depends on the specific individual case. Please inquire with the relevant authority.
The following food businesses require EU approval, regardless of whether they operate only domestically or also within the EU:
Meat establishments/poultry meat establishments
- All establishments with their own slaughter facilities
- Establishments that supply more than one-third of their production volume to other establishments
Dairy operations
- Milk collection centers
- Standardization centers
- Milk processing and dairy processing facilities
Other establishments handling products of animal origin, e.g., direct marketing
Approval number
Upon approval, the facility also receives the approval number required for intra-Community trade.
Since January 1, 2006, approved food establishments have been required to affix a so-called identification mark to treated products of animal origin. An exception is the health mark on carcasses. The identification mark consists of two letters for the member state and country code (e.g., DE), the approval number for the respective establishment, and the abbreviation for the European Economic Community (EC). The identification mark is an important prerequisite for the traceability of products.
The following exceptions to the licensing requirement apply:
- Primary production, as well as the sale of small quantities of primary products to end customers or local retail businesses, does not require authorization.
- You do not need a license if, as a producer or hunter, you sell small quantities of meat, poultry, and lagomorphs or game and game meat to end customers and local retail businesses.
- Businesses that handle, process, and store food of animal origin at the point of sale or delivery to end customers (retail) and do not supply more than one-third of their products of animal origin to other local retail businesses do not require a license. Retail businesses also include eateries and restaurants.
In this context, branches are to be regarded as independent retail businesses. It is advisable to check with the competent authority. Butchers’ shops and restaurants that slaughter their own animals require a slaughter license in all cases. The regulations allow for flexible implementation, so that obtaining a license does not pose an insurmountable hurdle for the businesses concerned.
Prerequisites
Establishments are approved in accordance with Article 6(3) of Regulation (EC) No. 852/2004. Article 4(1) and (2) of Regulation (EC) No. 853/2004, in conjunction with Annexes II and III, lists the requirements of EU law that individual establishments must comply with in terms of the structural design and equipment of the establishment. Furthermore, occupational health and safety regulations must not prevent approval. Business owners or appointed responsible persons must have the necessary reliability to manage the business.
Procedure
The approval process begins with the submission of documents to the local competent authority, which conducts a preliminary review and forwards the application to the Ministry of Climate, Environment, Energy, and Mobility (MKUEM).
After the application has been submitted and the preliminary review has been carried out, the authority and the MKUEM will conduct an on-site inspection. This inspection will verify whether the relevant food law requirements have been met in each individual case. When assessing the approval requirements for a facility, the competent authority must consult veterinary experts. It is possible to consult other non-veterinary experts. The administrative procedure is concluded with the issuance of an approval notice.
With the approval, the establishment also receives the approval number required for intra-Community trade.
Legal basis
- Regulation (EC) No. 852/2004 of the European Parliament and of the Council on the hygiene of
foodstuffs, version dated April 29, 2004, as amended - Regulation (EC) No. 853/2004 of the European Parliament and of the Council of April 29, 2004, laying down specific hygiene rules for food of animal origin,
version dated July 26, 2019 - Regulation (EU) No. 2017/625 on official controls,
version dated March 15, 2017, as amended - Section 9 of the Regulation on hygiene requirements for the production, handling, and placing on the market of certain foods of animal origin (Animal Food Hygiene Regulation - Tier-LMHV)
What do I need to bring or submit?
- Company profile with supplementary sheets
- Detailed description Appendix 6 TierLMHV
- Documents designating the use of space
- If applicable, true-to-scale business plan with material and personnel flow as well as machine layout (depending on the size of the business and not for craft-based businesses)
- Proof of the food business's reliability
(certificate of good conduct, extract from the Central Trade Register, and self-disclosure)
Forms, information sheets, links
- Application for approval of a food business
- Appendix to the application – self-disclosure
- Appendix to the application – Company profile, general information
- Supplement to the company profile – egg products
- Supplement to the company profile – fishery products
- Supplement to the company profile – meat
- Supplement to the company profile – Gelatin and collagen
- Supplement to the company profile – commercial kitchen
- Supplement to the company profile – Cold storage
- Supplement to the company profile – Milk
- Additional supplementary sheet for slaughterhouses
- Declaration by the food business operator on the revocation of approval
- Confirmation of the transfer of food law responsibility to the responsible food business
- Application for amendment/notification of amendment to the approval of food businesses
Contact us
Address
Lebensmittelüberwachung und Verbraucherschutz
Stadthaus Kaiserstraße, Kreyßig-Flügel
Kaiserstraße 3
55116 Mainz
Postal address
55026 Mainz
Your way to us
Contact persons
| Mr. Michael BinderHead of department (Official veterinarian) | Amtlicher Tierarzt | Mr. Michael Binder |
Accessibility
Information on accessibility
- Barrier-free access is available
- The WC is barrier-free
Wheelchair-accessible WC available (5th floor Kreyßig wing, first floor Lauteren wing).