The food additive, gamma-linolenic acid safflower oil, may be safely used in animal food as a source of gamma-linolenic acid and other omega-6 fatty acids in accordance with the following conditions:

The additive is the oil obtained from whole seeds and/or partially dehulled seeds of a Carthamus tinctorius L. safflower Centennial variety genetically engineered to express the delta-6-desaturase gene from Saprolegnia diclina Humphrey. The 453 amino acid, delta-6-desaturase enzyme converts the fatty acid linoleic acid to gamma-linolenic acid (all-cis-6,9,12-octadecatrienoic acid) during seed development.

The additive obtained from the seeds of the genetically engineered safflower Centennial variety may be blended with oil obtained from seeds of non-engineered oleic acid safflower varieties in order to meet the specifications required for the additive or the blend in paragraph (a)(2) of this section.

The additive or a safflower oil blend containing the additive for use in animal food meets the following specifications:

Crude fat content of the additive or the safflower oil blend is not less than 99.5 percent.

Gamma-linolenic acid content is between 350 and 450 milligrams (mg) gamma-linolenic acid per gram of the additive or the safflower oil blend.

Total content of stearidonic acid and cis, cis-6,9-octadecadienoic acid in the additive or the safflower oil blend must not exceed a total of 0.3 percent.

Addition of the additive, or the safflower oil blend, to complete dry adult maintenance dog food must meet the following:

Addition of the additive or the safflower oil blend cannot provide more than 36 mg gamma-linolenic acid per kilogram body weight of the dog per day in more than 86 mg of the additive or the safflower oil blend. This maximum addition rate of the additive, or the safflower oil blend, is 0.3 percent of a complete dry adult maintenance dog food containing 3,600 kilocalories of metabolizable energy per kilogram of food as-fed.

Adjustments must be made for differing concentrations of gamma-linolenic acid and for dog food formulas of different caloric density and/or that are fed to specific weights, breeds, or dogs of different activity levels to meet the requirements of this paragraph.

Addition of the additive, or the safflower oil blend, to complete dry adult maintenance cat food must meet the following:

Addition of the additive or the safflower oil blend cannot provide more than 33 mg gamma-linolenic acid per kilogram body weight of the cat per day in more than 79 mg of the additive or the safflower oil blend. This maximum addition rate of the additive, or the safflower oil blend, is 0.5 percent of a complete dry adult maintenance cat food containing 4,000 kilocalories of metabolizable energy per kilogram of food as-fed.

Adjustments must be made for differing concentrations of gamma-linolenic acid and for cat food formulas of different caloric density and/or that are fed to specific weights, breeds, or cats of different activity levels to meet the requirements of this paragraph.

To assure safe use of the additive, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling of the additive shall bear the following:

The name of the additive, gamma-linolenic acid safflower oil, or GLA safflower oil;

A guarantee for the minimum content of gamma-linolenic acid; and

Adequate directions for use such that the finished animal food complies with the provisions of paragraphs (b) and (c) of this section.