Regulation of antioxidants in Animal Nutrition

One of the main barriers facing producers today is to grant antioxidants the name of feed additives or veterinary drugs. This classification is important since, if veterinary medicines are considered, more exhaustive controls should be passed than in the case of additives.

According to Regulation (EC) No 1831/2003, antioxidants in animal nutrition will be considered “technological additives” defining antioxidants as: “substances that prolong the shelf life of feed and feed materials, protecting them against spoilage caused by oxidation. ”
The same regulation establishes the comunity procedure for the authorization of the commercialization and use of additives for animal feed introduces the rules of surveillance and labeling of additives and premixtures for animal feed. It therefore establishes the basis to guarantee a high level of protection of human health, animal health and welfare, and the environment, as well as the interests of users and consumers, on additives intended for animal feed.

The Regulation establishes the difference between “food additive” which is basically considered as the substance that helps to promote good health of the animal and therefore have a good performance, compared to “veterinary products” that serve more as a treatment of certain specific disorders.

It is worth highlighting the importance that currently exists for many antioxidants, such as vitamins, but these are not based on any law that regulates or investigates the use of antioxidants, and the problem that could lead to excessive use is known of these antioxidants, leading to a prooxidation, with an opposite effect to the desired one.

An additive for animal feed is considered to be any substance, micro-organism and preparation other than feed materials and premixtures, which are added intentionally to feed or water, in order to carry out in particular one or more of the following functions:

  • positively influence the characteristics of the feed;
  • positively influence the characteristics of animal products;
  • favorably influence the color of ornamental birds and fish;
  • satisfy the nutritional needs of the animals;
  • positively influence the environmental impact of animal production;
  • positively influence the production, activity or welfare of the animals, especially acting on the  gastrointestinal flora or the digestibility of the feed, or have a coccidiostatic or histomonostatic effect.

As stated in Regulation (EC) 1831/2003 of the European Union on the use of additives in animal feed, livestock production has an important place in the agriculture of the Community, and part of the benefits of this livestock production are due to the use of safe and good quality feed, a good feeding of the animals, which will ultimately affect the health of the citizens.

Therefore, to increase the protection of human health, animal health and the environment, the additives that will be used in animal feed must follow a series of safety assessments according to what the European Union procedure indicates, prior to marketing, use or transformation.

In this way, only authorized additives as established in this regulation may be used or transformed for use in animal feed. In addition, the categories of the additives must be defined in order to be able to evaluate their authorization of use more adequately.

The rules that refer to the request for this authorization of additives for animal feed must take into account a series of requirements:

  • Food-producing animals
  • Other types of animals

Together with this standard, the evaluation of the European Food Safety Authority (Regulation n° 178/2002) will have to be considered, since in these evaluations the waste presented by the food will be valued (Maximum Residue Limit, or MRL).

But this risk assessment cannot offer all the information necessary for risk management and the subsequent authorization to use an additive. In addition, other factors of a sociological, economic and environmental nature must be taken into account, as well as the viability of the controls and the benefit to the animals.

The Commission responsible for the authorization of feed additives and their conditions of use must inform about their maintenance and must publish a register of authorized additives. In addition, the holder of said authorization will have to follow a surveillance plan in accordance with the traceability requirements dictated by food legislation, after the product is marketed, to assess any effect that mixing these additives in the feed may cause on human health, animal health or environment.

The authorization will be for a limited time and in this way a periodic review of the additives will be favored.

A record of authorized feed additives should be established, including specific information on the products, in addition to their detection method.

A detailed labeling of the products allows the end user to choose with full knowledge of the cause and also reduces the obstacles to its commercialization, as well as facilitating the fairness of the transactions.

How to request the authorization of an additive

The application must be submitted to the Commission in charge of its management, for the use of additives for animal feed. This Commission shall inform the Member States thereof and transfer it to the European Food Safety Authority.

This request must be presented with the following information and documentation:

  1. The name and address of the applicant
  2. The identification of the feed additive, a proposal to classify it by category and group, and its specific data, including, the degree of purity when applicable.
  3. A description of the method of production and manufacturing and the expected uses of the additive for animal feed, the method of analysis of the feed additive according to its intended use, and, where appropriate, the method of analysis used to determine the level of the residues of the feed additive, or its metabolites, in food
  4. A copy of the studies carried out and any other material available to demonstrate that the feed additive meets the established criteria
  5. The proposed conditions for the marketing of the feed additive, including labeling requirements and, where applicable, specific conditions of use and handling (including known incompatibilities), levels of use in supplementary feed and animal species and categories to which the feed additive is intended
  6. A written declaration stating that the applicant has sent three samples directly to the aforementioned Community reference laboratory according to a set of established requirements.
  7. A proposal for follow-up to the commercialization
  8. A summary of the file that includes the information provided
  9. Information on any authorization granted under the applicable legislation, for additives falling within the scope of Community legislation on the marketing of products that consist of, contain or are produced from GMOs.

After submitting the application, the Authority will issue an opinion in a period of approximately six months, in which they will have reviewed and verified the information and documentation presented, and will verify the report in the reference laboratory.