[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: 21CFR570.20]

[Page 488-489]
 
                        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 B--Food Additive Safety
 
Sec.  570.20  General principles for evaluating the safety of food additives.


    (a) In reaching a decision on any petition filed under section 409 
of the act, the Commissioner will give full consideration to the 
specific biological properties of the compound and the adequacy of the 
methods employed to demonstrate safety for the proposed use, and the 
Commissioner will be guided by the principles and procedures for 
establishing the safety of food additives stated in current publications 
of the National Academy of Sciences-National Research Council. A 
petition will not be denied, however, by reason of the petitioner's 
having followed procedures other than those outlined in the publications 
of the National Academy of Sciences-National Research Council if, from 
available evidence, the Commissioner finds that the procedures used give 
results as reliable as, or more reliable than, those reasonably to be 
expected from the use of the outlined procedures. In reaching a 
decision, the Commissioner will give due weight to the anticipated 
levels and patterns of consumption of the additive specified or 
reasonably inferable. For the purposes of this section, the principles 
for evaluating safety of additives set forth in the above-mentioned 
publications will apply to any substance that may properly be classified 
as a food additive as defined in section 201(s) of the act.
    (b) Upon written request describing the proposed use of an additive 
and the proposed experiments to determine its safety, the Commissioner 
will advise a person who wishes to establish the

[[Page 489]]

safety of a food additive whether he believes the experiments planned 
will yield data adequate for an evaluation of the safety of the 
additive.