PROPOSED TOLERANCES FOR USE OF THE COLOR ADDITIVE FD&C RED NO. 2

Proprietors of Distilled Spirits Plants, Manufacturers of Nonbeverage Products, and Others Concerned:

The purpose of this circular is to inform you of a Food and Drug Administration proposed rule making, published in the Federal Register of July 4, 1972, to amend the provisional regulations for color additives by establishing interim tolerances for FD&C Red No. 2 until December 31, 1972.

The Food and Drug Administration proposes to amend Section 8.501 and add new paragraph (d) to Section 8.503 to the Food and Drug Color Additives Regulations to provide, in part, that FD&C Red No. 2 may be safely used or intended for use during the transitional period, as a colorant in food (including alcoholic beverages) and ingested drugs, provided it is used only in amounts not exceeding 30 parts per million.

In view of the foregoing, formulas on Form 27-B Supplemental or 1678 calling for the use of this color agent in amounts exceeding 30 parts per million will not be approved by the Director, Bureau of Alcohol, Tobacco and Firearms. Moreover, proprietors should examine any previously approved formulas to determine whether the additive is among the manufacturing ingredients. New formulas on Form 1678, or amended formulas or riders to Form 27-B Supplemental, may be filed to provide that FD&C Red No. 2 will be used in amounts not exceeding 30 parts per million, or to substitute another approved coloring agent.

The Food and Drug Administration is engaged in a continuing effort to establish safety levels for the use of food and color additives. Proprietors who submit formulas for approval should be aware of the listing of currently approved ingredients and be guided accordingly. Approval of formulas under Treasury Department law and regulations does not authorize the use of materials or ingredients prohibited or restricted by other Federal laws or regulations.

Inquiries regarding this circular should refer to its number and be addressed to your Regional Director, Bureau of Alcohol, Tobacco and Firearms.

Rex D. Davis

Acting Director