[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR570.3]

[Page 485-486]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 570--FOOD ADDITIVES--Table of Contents
 
                      Subpart A--General Provisions
 
Sec.  570.3  Definitions.


    (a) Secretary means the Secretary of Health and Human Services.
    (b) Department means the Department of Health and Human Services.
    (c) Commissioner means the Commissioner of Food and Drugs.
    (d) As used in this part, the term act means the Federal Food, Drug, 
and Cosmetic Act approved June 25, 1936 (52 Stat. 1040 et seq., as 
amended; 21 U.S.C. 301-392).
    (e) Food additives includes all substances not exempted by section 
201(s) of the act, the intended use of which results or may reasonably 
be expected to result, directly or indirectly, either in their becoming 
a component of food or otherwise affecting the characteristics of food. 
A material used in the production of containers and packages is subject 
to the definition if it may reasonably be expected to become a 
component, or to affect the characteristics, directly or indirectly, of 
food packed in the container. Affecting the characteristics of food does 
not include such physical effects, as protecting contents of packages, 
preserving shape, and preventing moisture loss. If there is no migration 
of a packaging component from the package to the food, it does not 
become a component of the food and thus is not a food additive. A 
substance that does not become a component of food, but that is used, 
for example, in preparing an ingredient of the food to give a different 
flavor, texture, or other characteristic in the food, may be a food 
additive.
    (f) Common use in food means a substantial history of consumption of 
a substance by a significant number of animals in the United States.
    (g) The word substance in the definition of the term food additive 
includes a food or feed or a component of a food or feed consisting of 
one or more ingredients.
    (h) Scientific procedures include those human, animal, analytical, 
and other scientific studies, whether published or unpublished, 
appropriate to establish the safety of a substance.
    (i) Safe or safety means that there is a reasonable certainty in the 
minds of competent scientists that the substance is not harmful under 
the intended conditions of use. It is impossible in the present state of 
scientific knowledge to establish with complete certainty the absolute 
harmlessness of the use of any substance. Safety may be determined by 
scientific procedures or by general recognition of safety. In 
determining safety, the following factors shall be considered:
    (1) The probable consumption of the substance and of any substance 
formed in or on food because of its use;
    (2) The cumulative effect of the substance in the diet, taking into 
account any chemically or pharmacologically related substance or 
substances in such diet;
    (3) Safety factors which, in the opinion of experts qualified by 
scientific training and experience to evaluate the

[[Page 486]]

safety of food and food ingredients, are generally recognized as 
appropriate.
    (j) The term nonperishable processed food means any processed food 
not subject to rapid decay or deterioration that would render it unfit 
for consumption. Not included are hermetically sealed foods and other 
processed foods requiring refrigeration.
    (k) General recognition of safety shall be determined in accordance 
with Sec.  570.30.
    (l) Prior sanction means an explicit approval granted with respect 
to use of a substance in food prior to September 6, 1958, by the Food 
Drug and Administration or the United States Department of Agriculture 
pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry 
Products Inspection Act, or the Meat Inspection Act.
    (m) Food includes human food, substances migrating to food from 
food-contact articles, pet food, and animal feed.

[41 FR 38644, Sept. 10, 1976, as amended at 42 FR 55206, Oct. 14, 1977]