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16 Bus. Law. 107 (1960-1961)
Safe Food Additives and Additives Generally Recognized as Safe - There is a Difference

handle is hein.journals/busl16 and id is 109 raw text is: November 1960

On March 6, 1961 the enforcement provisions of the Food Addi-
tives Amendment of 1958 become fully effective. Food additives that
have not been proved safe will then become food adulterants.
Before next March, the food and chemical industries must com-
plete the tremendous task of gathering and presenting sound scientific
data to support the needed food additive regulations. And the FDA
must shoulder its responsibility for reviewing this data and issuing
regulations under which food additives can be safely used.
Most of our efforts thus far have been devoted to the immediate
problems of the transitional period; the problems coverage of the
amendment, of exemption, and of obtaining time extensions. This
transitional period is near the end, so we need not be seriously con-
cerned with the existing extensions. They are important only as they
provide advance notice of the magnitude of the job that remains to be
But the basic questions of coverage and of exemption will grow in
importance as we approach the effective date of the legislation. Since
a great amount of energy is being exerted to have substances included
on the so-called GRAS list, and since valuable time is being lost in
obtaining action on food additive petitions for some substances that
cannot be cleared ultimately under this exemption, we welcomed the
opportunity to review this problem as a part of today's program.
You will recall that any substance which is generally recognized
among appropriately qualified experts as an article which has been
adequately shown to be safe for its intended use is not a food
additive. There is no need to prove such an article safe, when its
safety is generally recognized. General recognition of safety may be
based upon reported scientific studies, and in case of substances used
in food prior to January 1, 1958, it may be based on common experi-
ence with the article as an item of food.
The concept of general recognition of safety is an old one with
us. It originated in the New Drug provisions of the 1938 Act. The
idea was carried forward in the Pesticide Chemicals Amendment of
1954, and it was improved and made a part of the Food Additives
Amendment of 1958. In explaining the clause to the House Committee
on Interstate and Foreign Commerce, Mr. Larrick said that it was
*Assistant General Counsel for Food and Drugs, Department of Health,
Education, and Welfare. Address before the annual meeting of the Section's
Division of Food, Drug and Cosmetic Law, on August 31, 1960.

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