Approval of food enzymes in Denmark
Denmark have regulation on the approval of enzymes according to the Danish Order no. 1247/2018 on additions to food. The rules concerning the enzymes are in section 8 and annex 2. This order is only in Danish language. See link below under "Legislation"
The requirement for approval concerns food enzymes marketed in Denmark and/or used in food processes in Denmark.
Food business operators who produce or import enzymes for sale to food business operators in Denmark must have an approval for the enzymes and the processes for which the enzymes are marketed.
It also requires that the food business operators that buy and use the enzymes in the food processes e.g. baking, dairy, brewery etc. upon request from the authorities are able to document that the enzyme, they use is approved by the Danish Veterinary and Food Administration (DVFA).
This means that food enzymes that are active e.g. in a baking mix marketed in Denmark must be approved by the DVFA. For enzymes that have legally been used in a food production in another country and no longer have a function (activity) in the food product - that food can be imported and marketed in Denmark without an approval of the enzyme used. The requirements for approval concerns food enzymes, that are actively used in food production in Denmark or still is an active ingredient.
Process for approval
The process for approval of enzymes in Denmark is the following:
The applicant must send an application for approval of an enzyme directly to the DVFA (
29@fvst.dk).
There is a fee for approval. The fee for a full application is currently 32.100 DKK.
Procedure for approval of enzymes for the Danish market
- Application from company (manufacturer of enzyme, importer of enzyme or manufacturer of food)
- Risk assessment
- Risk management
- Approval of a specific enzyme for specific processes
- The approval is based on the documentation on safety, production methods etc. provided by the company
Requirements for application – according to SCF or EFSA guidelines:
- Administrative data
- Technical data
- active components
- source materials
- manufacturing process
- carriers and other additives/ingredients
- usage
- stability and fate in food
- General requirements and specifications
- Documentation for safety in use
- basic toxicological requirements
- exemptions from the basic toxicological requirements
- Evaluation of the safety in use
Guidances
See links to guidance on the dossier:
The SCF guidelines can be found via this link, page 20-29 As the Danish Order (Bek no. 1247 from 30/10/2018) also accept applications following the EFSA guidelines for risk assessment of food enzymes perhaps the EFSA guidance, see link:
Scientific Guidance for the submission of dossiers on Food Enzymes
Approvals
Approvals of enzymes are issued to the company applying for approval. There is no public available list with approved enzymes.
Approval via mutual recognition
Denmark and France have an agreement about mutual recognition of food enzymes that have been approved in one of the countries. The agreement on mutual recognition between the French and the Danish authorities concerning the approval of enzymes means that an enzyme, which is approved in one of the countries based on a SCF or EFSA guidance on evaluation of safety can be easily approved in the other country.
For this approval by mutual recognition the applicant need to provide a copy of the original approval and a statement from the authority declaring that they have approved this enzyme for the actual uses.
For an enzyme approved in France, the applicant would need to provide the statement from the French authorities declaring that they have indeed approved the enzyme in question for the actual uses.
