[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR80.21]
[Page 427-430]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 80_COLOR ADDITIVE CERTIFICATION--Table of Contents
Subpart B_Certification Procedures
Sec. 80.21 Request for certification.
A request for certification of a batch of color additive shall:
(a) Be addressed to the Commissioner of Food and Drugs.
(b) Be prepared in the manner set forth in paragraph (j) of this
section.
(c) Be submitted in duplicate.
(d) Be signed by a responsible officer of the person requesting
certification of the batch. In the case of a foreign manufacturer, the
request for certification must be signed by a responsible officer of
such firm, and, by his agent who resides in the United States.
(e) Show the name and post office address of the actual manufacturer
in
[[Page 428]]
case such manufacturer is not the person requesting certification of the
batch.
(f) Be accompanied by the fee prescribed in Sec. 80.10 unless the
person has established with the Food and Drug Administration an advanced
deposit to be used for prepayment of such fees. In no case shall the
Commissioner consider a request for certification of a batch of color
additive if the fee accompanying such request is less than that required
by Sec. 80.10 or if such fee exceeds the amount held in the advance
deposit account of the manufacturer submitting such request for
certification.
(g) Be accompanied by the sample prescribed in Sec. 80.22
consisting of:
(1) Four ounces in the case of straight colors and lakes.
(2) Two ounces in the case of repacks and mixtures.
A sample accompanying a request for certification must be submitted
under separate cover and should be addressed to the Color Certification
Branch.
(h) The name of a color additive shall be given in the following
manner:
(1) The name of a straight color shall be the name of the color as
listed in parts 74 and 81 of this chapter.
(2) The name of a lake shall be the name derived in the manner
described in part 82 of this chapter.
(3) The name of a mixture shall be the name given to such mixture by
the person requesting certification.
(4) The name of a repack shall be the name described in paragraph
(h)(1), (2), or (3) of this section, whichever is applicable.
(i) The information and samples enumerated in paragraphs (a) to (h),
inclusive, of this section are the minimum required. Additional
information and samples shall be submitted at the request of the Food
and Drug Administration when such additional information and samples are
necessary to determine compliance with the requirements of Sec. 80.31
for the issuance of a certificate.
(j) The form for submission of the application shall be one of the
following, depending upon whether the color additive is a straight
color, a lake, a repack of a previously certified color additive, or a
color additive mixture.
(1) Request for certification of a batch of straight color additive.
Date --------
Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of straight color additive.
Name of color___________________________________________________________
(As listed in 21 CFR part 74)
Batch number____________________________________________________________
(Manufacturer's number)
Batch weighs ---- pounds
Batch manufactured by ------------ at ------------------ (Name and
address of actual manufacturer)
How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested of this color for use in________________________
________________________________________________________________________
________________________________________________________________________
(State proposed uses)
Required fee, $---- (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) --------------------
By --------------------
--------------------
(Title)
(2) Request for certification of a batch of color additive lake.
Date --------
Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of color additive lake.
Name of color___________________________________________________________
Batch number____________________________________________________________
(Manufacturer's number)
Batch weighs ---- pounds
Name of color used______________________________________________________
[[Page 429]]
________________________________________________________________________
Quantity ---- pounds
Lot number______________________________________________________________
(When certification of the lake
for use in foods is requested)
Precipitant used________________________________________________________
Substratum used_________________________________________________________
Quantity ---- pounds
Batch manufactured by ---------- at -------------- (Name and address of
actual manufacturer)
How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested of this color for use in________________________
________________________________________________________________________
________________________________________________________________________
(State proposed uses)
Required fee, $---- (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) --------------------
By --------------------
--------------------
(Title)
(3) Request for certification of a repack of a batch of certified
color additive.
Date ----------
Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of color additive repack.
Name of color___________________________________________________________
(As listed in regulations and as certified; or repacker's name, if a
mixture)
Original lot number_____________________________________________________
Certified color content_________________________________________________
This color obtained from________________________________________________
Batch number____________________________________________________________
Batch weighs ---- pounds
How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested for use in______________________________________
________________________________________________________________________
________________________________________________________________________
(State proposed uses)
Required fee, $---- (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) ------------------
By --------------------
--------------------
(Title)
(4) Request for certification of a batch of color additive mixture.
Date ----------
Office of Cosmetics and Colors (HFS-100),
Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
5100 Paint Branch Pkwy.,
College Park, MD 20740
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of color additive mixture.
Name of mixture_________________________________________________________
(Manufacturer's trade name)
Batch number____________________________________________________________
(Manufacturer's number)
Weight of batch ---- pounds
Volume of batch ---- (If liquid) gallons
Batch manufactured by___________________________________________________
Constituents of the mixture:
1. Color(s). (List separately each color and each lot number.)
Name of color
as certified Lot number
________________________________________________________________________
________________________________________________________________________
Quantity used
(in pounds) Obtained from
________________________________________________________________________
________________________________________________________________________
2. List of diluents. (List separately each diluent.)
Name of diluent
________________________________________________________________________
________________________________________________________________________
Quantity used
By volume
By weight (if liquid)
________________________________________________________________________
________________________________________________________________________
Batch mixed as follows__________________________________________________
(Describe in detail)
How stored pending certification________________________________________
________________________________________________________________________
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested for use in______________________________________
________________________________________________________________________
________________________________________________________________________
[[Page 430]]
(State proposed uses)
Required fee, $---- (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) --------------------
By ------------------
--------------------
(Title)
[42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979; 44 FR 22053,
Apr. 13, 1979, as amended at 54 FR 24890, June 12, 1989; 61 FR 14479,
Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001]
| File Type | application/msword |
| File Title | [Code of Federal Regulations] |
| Author | ATaylor |
| Last Modified By | Jonna Capezzuto |
| File Modified | 2007-11-16 |
| File Created | 2007-11-16 |