Ausnahmegenehmigungen nach § 68 LFGB Erteilung

If you wish to produce, treat or market foodstuffs in Germany that deviate from national legislation, you can apply for a derogation from the Federal Office of Consumer Protection and Food Safety (BVL).

Does your foodstuff deviate from local legislation? Then you need a special permit to be able to produce, handle and market it in Germany.

You can apply to the Federal Office of Consumer Protection and Food Safety (BVL) for the exemption permit. The BVL decides on the exemptions in consultation with the Federal Office of Economics and Export Control.

You must enclose meaningful documents with your application to prove that your product is harmless to health. You can only obtain an exemption for such products. The BVL involves the Federal Institute for Risk Assessment and, if necessary, other authorities in the assessment.

A derogation has no general effect, but is only valid in individual cases. Therefore, a separate exemption must be applied for each product.

Once a derogation has been granted, the authorities of the federal state in which your company is based will monitor the production and distribution process. The labeling, proper production and compliance with the requirements, maximum quantities and formulation on which the exemption is based are checked.

As a rule, exemptions are granted for a maximum of 3 years. You can apply for an extension. You must also submit a corresponding application to extend or amend the exemption granted.

• exact recipe of the product with all ingredients and the corresponding quantities as well as the specification of the ingredients with exact chemical name
• Packaging designs for the German market
• Specification of complex ingredients and documents from which their safety can be derived
• when using flavorings, enzymes and additives: Confirmation or documentary evidence that the legal requirements for these substances have been met
• if the application is made by proxy: Power of attorney
• In the case of an application for a derogation for the irradiation of a foodstuff:
  • Device (manufacturer, device designation)
  • Companies involved
  • Wavelength over the application period (in nm)
  • Intensity of the radiation or irradiation time of the products
  • Distance between irradiation source and food
  • applied radiation dose
  • technical specification, evidence to ensure constant wavelengths over the application period and compliance with the regulations for the applied radiation dose for the specified device

• Your product is not expected to pose a health hazard.

You can apply for the exemption online via the federal portal, by e-mail or by post.

Apply for an exemption online via the federal portal:

• Call up the online application on the federal portal verwaltung.bund.de. This will guide you step by step through the necessary information, which you can enter electronically.
• Upload the required documents as a file and submit the application.
• You will receive confirmation that your application has been received.
• The BVL will check your details and documents and forward them to the other competent authorities.
• The BVL will contact you if further documents or information are required.
• You will receive a notification of the result of the review digitally via the feedback channel function of the federal portal or by post.
• You will also receive a separate notification of fees. You then pay the fees.

Apply for an exemption permit by e-mail or post:

• Call up the online application on the federal portal verwaltung.bund.de. Complete the application online and save it as a print preview.
• Attach all the necessary documents.
• Send your application to the BVL by e-mail. Alternatively, you can send the application and all necessary documents to the BVL by post.
• You will receive confirmation that your application has been received.
• The BVL will check your details and documents and forward them to the other competent authorities.
• The BVL will contact you if further documents or information are required.
• You will receive notification of the result of the examination by post.
• You will also receive a separate notification of fees. You then pay the fees.

• Appeal. Further information on how to lodge an appeal can be found in the information on legal remedies in the notification of your application.
• Appeal to the administrative court. You can find more information on how to lodge a complaint in the legal remedies information in the notice of objection.

• Exemptions according to § 68 LFGB Foodstuffs that deviate from national legislation can be produced, treated and placed on the market in Germany with an exemption permit
• Exemption must be applied for at the Federal Office of Consumer Protection and Food Safety
• Required documents:
  • in particular proof of the recipe of the product
• Fees for the
  • initial issue: EUR 630.00 to EUR 15,800.00
  • Renewal: EUR 610.00 to EUR 4,700.00
  • for the amendment: EUR 610.00 to EUR 6,000.00
  • for the extension: EUR 570.00 to EUR 4,800.00
• Processing time: usually 3 months to 12 months after submission of the complete application
• Applications can be submitted:
  • online via the federal portal
  • by e-mail or by post
• Exemption permits are generally limited in time and can be extended a maximum of 3 times
• A new application must be submitted for the extension, amendment and expansion of a previously issued exemption permit
• Responsible: Federal Office of Consumer Protection and Food Safety in agreement with the Federal Office of Economics and Export Control