Zootechnical Registration

Zootechnical registration of phytogenics

Did you know that in the European Union, every phytogenic product must pass the authorization process as zootechnical feed additive, if efficacy claims are used?

“A zootechnical feed additive is any additive used to affect favourably the performance of animals in good health or used to affect favourably the environment. “

Article 6 of Regulation (EC) No. 1831/2003 on additives for use in animal nutrition

Delacon was the first company obtaining zootechnical authorisation for phytogenic products . A complex authorization process is required to independently evaluate the efficacy and safety of a phytogenic additive:

The first step towards registering a phytogenic additive as a zootechnical feed additive is to apply for the evaluation of a dossier, which must be submitted to the European commission (EC). This dossier must contain complete, comprehensive and validated data on the safety, quality and efficiency of the feed additive.

The preparation of the dossier often takes years, since there is need to provide data of a vast number of safety and efficacy trials, basing on different methods and conducted in different (European) countries.

In the next step, the EU Commission mandates the European Reference Laboratory (EURL) and the European Food Safety Authority (EFSA) to evaluate the dossier in detail.  The EURL analyses and evaluates relevant parameters of the samples, methods and traceability of the additive in the feed chain (additive-premixture-feed). The full assessment report has to be submitted to the EFSA.

Following an order from the European Commission, EFSA must now provide the European Commission, the Member States and the applicant with a scientific opinion on the safety and efficacy of the additive. This opinion demonstrates whether the feed additive has the potential to meet the stated claims and whether it is safe for the target animals, workers, consumers and the environment.

Following this intensive evaluation, EFSA formulates a scientific opinion which serves as the basis for the final decision and approval by the European Commission in concordance with the Member States.

Did you know?

At Delacon, we develop and manufacture complex plant-based phytogenic feed solutions consisting of several single compounds. During risk assessment, EFSA is looking into the detailed composition of each ingredient, the constituents of essential oils, as well as all herbs & spices, and its safety for the target animal species, the consumer and the environment.

Scientific gold standard – at Delacon ­and in the industry

Delacon currently has two zootechnical authorisations in poultry.

  • Biostrongâ„¢ 510 EC: potential to be efficacious in improving performance of chickens for fattening, reared for laying and minor avian species for fattening and reared for laying.
  • Biostrongâ„¢ All Natural: potential to be efficacious in improving performance of all poultry for fattening.