Skip to main content

Full text of "Service and regulatory announcements"

See other formats


Historic, Archive Document 

Do not assume content reflects current scientific 
knowledge, policies, or practices 



S. R. A., F. D. No. 3 



Issued October, 1927 



United States Department of Agriculture 



FOOD, DRUG, AND INSECTICIDE ADMINISTRATION 



SERVICE AND REGULATORY ANNOUNCEMENTS 

Food and Drug No. 3 



CERTIFICATION OF COAL-TAR FOOD COLORS 



CONTENTS 



Page 



Introduction 

Purpose of certification and use of cer- 
tified dyes 

When a certified dve becomes uncerti- 
fied 

The permitted dyes 

Definition of terms 

Statement of dye content on primary 
dyes and repacks 



Page 

Certification requested 4 

Certification granted 5 

Lot number (\ 

Certification of subsequent batches G 

Recertification of repacked dyes 7 

Certification of mixtures . 8 

General labeling requirements 10 

Admission of additional dyes 10 



INTRODUCTION 

The procedure for the certification of coal-tar food colors outlined in this 
announcement supersedes that previously followed by the Department of Agri- 
culture as published in Miscellaneous Circular No. 52. 

The Food, Drug, and Insecticide Administration is hereby authorized to 
certify coal-tar food colors which meet the accompanying requirements. 

C. F. Marvin, 
Acting Secretary of Agriculture. 

Washington, D. C, August 22, 1927. 



PURPOSE OF CERTIFICATION AND USE OF CERTIFIED DYES 

As ordinarily manufactured for textile or other industrial purposes, dyes 
often contain impurities, some of which are harmless, whereas others are 
toxic. These impurities may not detract from the value of the dye* for in- 
dustrial use, but they would be highly objectionable in a substance designed 
for human consumption. Practically all dyes at one stage or another of 
their manufacture are treated with sulfuric or nitric acid, both of which are 
frequently contaminated with arsenic. The vessels in which the dyes are 
made may also contain arsenic. Unless special precautions are taken the 
dyes may therefore be seriously contaminated with arsenic compounds. If the 
manufacturing processes are carried on in vessels of lead or copper, appreciable 
quantities of these metals may be dissolved and contaminate the dye. Harmful 
intermediates and organic compounds are present in most industrial dyes. Un- 
combined intermediates and other organic compounds produced by side reac- 
tions during manufacture, even though comparatively harmless, are objectionable 
in food dyes, except in very small proportions. The standards of purity set for 
certified dyes necessitate special precautions in their manufacture and purifica- 
62528—27 1 



2 



SEKVICE AND BEGTJLATORY ANNOUNCEMENTS [S. R. A. 



tion, in order that appreciable quantities of objectionable substances may not 
be present in tbe finished dyes. Certification by the Food, Drug, and Insecticide 
Administration implies not only that the dye itself is harmless, but that it is 
uncontaminated by poisonous substances. 

The procedure of certification has been devised for the purpose of affording 
manufacturers of food colors and manufacturers of food products, as well 
as other consumers of food colors, a means of determining the suitability of 
these products for food use in so far as their purity and harmlessness are 
concerned. The use of color of any kind to conceal damage or inferiority in a 
food product is defined by the Federal food and drugs act as an adulteration 
and, when damage or inferiority is concealed, the employment of artificial 
color is not permissible, even though certified colors are used and their presence 
is declared on the label. In general, where colors are legitimately used in 
foods and beverages a statement on the label of the presence of artificial color 
is required. 

As unpermitted coal-tar dyes or permitted dyes which have not been certified 
are likely to be harmful in themselves or to contain harmful impurities, 
manufacturers who sell them for food purposes or who use them in coloring 
food products may render themselves liable to prosecution and the dyes or the 
foods colored with them liable to seizure under the Federal food and drugs act. 
The same objections apply to the use of mineral or inorganic coloring matters. 
Manufacturers who use organic coloring matters of natural origin, such as 
vegetable colors, should assure themselves that such substances are harmless 
in themselves and free from harmful impurities. 

WHEN A CERTIFIED DYE BECOMES UNCERTIFIED 

When a container of a certified dye is opened, the guaranty of its purity 
can no longer apply, inasmuch as no one other than the person or firm breaking 
the package can further assume responsibility for its purity and identity. 
Certified dyes that have been repacked, either without mixing or with the 
admixture of other certified dyes or suitable diluents or both, therefore can 
not properly be marketed as certified dyes or mixtures, unless they are re- 
certified in the proper manner (p. 7). Dealers, mixers, and repackers of 
dyes should be particularly careful to observe this fact. The use of the word 
" certified " or the use of batch numbers, lot numbers, and the like on repacked 
dyes or color mixtures that have not been recertified creates a misleading 
impression, constituting a violation of the Federal food and drugs act if the 
products are brought within its jurisdiction. 

This provision applies only to the resale of dyes and mixtures. It does not 
prevent the use of such expressions as " colored with a certified dye " in 
advertising or labeling food products artificially colored with certified dyes or 
mixtures. 

THE PERMITTED DYES 

The following coal-tar dyes are accepted for certification as described on 
pages 4 to 6. (The first number in each line is that of the dve as listed in 
the Colour Index of 1924, published by the Society of Dyers and Colourists 
of England; the second number, in parentheses, is that appearing in former 
department announcements and is the identifying number of the dye given in 
Green's 'j Systematic Survey of the Organic Coloring Matters," 1904 edition. ) 

Red shades : 

80 (56) Ponceau 3R. 

184 (107) Amaranth. 

773 (517) Erythrosme. 
Orange shade : 

150 (85) Orange I. 
Yellow shades : 

10 (4) Naphthol yellow S. 

640 (94) Tartrazine. 

22 Yellow A B. 

61 Yellow O B. 
Green shades : 

666 (433) Guinea green B. 

670 (435) Light green S F yellowish. 

Fa ^ t /? re ^ n T F xT C F (p-hydroxy derivative of the sodium salt of alpbazurine 
r \jc. C I. .No. 671). 
Blue shade : 

1180 (692) Tndigotine. 



F. D. No. 3] 



CERTIFICATION" OF COAL-TAR FOOD COLORS 



3 



Yellow A B and Yellow O B are known as oil-soluble dyes, because they are 
soluble in edible oils but insoluble in water. The other ten dyes are soluble 
in water but insoluble in oils. 

The original list of seven permitted dyes was selected after a critical study 
of the reports of pharmacological tests on the more important dyestuffs. 1 
The other five dyes were added to the list after appropriate pharmacological 
and toxicological tests had proved them to be harmless. 

DEFINITION OF TERMS 

When used in these regulations, 

Manufacturer means the person or firm responsible for the identity and 
purity of the product, or the accredited selling agent in the United States of 
such person or firm which is not resident within the jurisdiction of this Gov- 
ernment. Such accredited agent must assume for his foreign principal all 
responsibilities which devolve upon the manufacturer resident within the 
United States. 

Batch means that quantity of the dye which has received as a unit such 
treatment in the same manner and at the same time and place as shall render 
the product uniform in composition throughout its entire mass. The maximum 
size of a batch is limited only by the capacity of the equipment used to pro- 
duce uniformity of composition. 

Batch number is the number assigned by the manufacturer to the batch with 
his request for certification. It provides a convenient way of designating the 
various batches while they are undergoing examination in the Food, Drug, and 
Insecticide Administration. The batch number must appear on all affidavits 
and agreements submitted for that batch and on the label of the sample sub- 
mitted for examination. 

Lot number is the number assigned to the batch by the Food, Drug, and In- 
secticide Administration upon certification and shall appear upon the labels of 
all packages of that batch. The use of original lot numbers in the resale of 
certified colors under distributors' labels is permitted, provided the original 
package is unbroken and the words " packed for " or " distributed by " pre- 
cede any name on the label other than that of the manufacturer. 

STATEMENT OF DYE CONTENT ON PACKAGES OF PRIMARY DYES 

AND REPACKS 

The manufacturer shall state plainly and conspicuously on the label of each 
package of a primary dye or a repack the percentage of pure coal-tar color 
present in the product as determined by the Food, Drug, and Insecticide Ad- 
ministration, provided, however, that in the case of a dye of a pure color con- 
tent, as determined by .the Food, Drug, and Insecticide Administration, equaling 
or exceeding the percentage specified in Table 1, he may, if he desires, declare 
on the label that the product contains not less than the percentage of pure 
coal-tar color specified for that dye in Table 1. No tolerance below the stated 
percentage will be allowed when the declaration is in terms of such minimum 
percentage. 

Table 1. — Tolerances for minimum percentage declarations 



Coal-tar dye 


Tolerance 


Coal-tar dye 


Tolerance 


Ponceau 3R 


Per cent 
85 
86 




Per cent 

86 
82 


Amaranth 


Guinea green B 


Erythrosine 


85 
88 


Light green SFY 


82 


Orange I 




86 


Naphthol yellow S 


88 1 


Yellow A B 


99 
99 


Fast green FCF 


82 


Yellow OB 









The right is reserved to change the limits given in Table 1 after due notice 
to the trade, whenever it seems desirable to do so. 



1 Hesse. Coal-tar colors used in food products. U. S. Dept. Agr., Chem. Bui. 147 
(1912). 



4 



SERVICE AND REGULATORY ANNOUNCEMENTS 



[S. R. A. 



CERTIFICATION REQUESTED 

When a manufacturer has prepared his first batch of a permitted dye for the 
purpose of requesting certification, a representative sample of the batch should 
be analyzed by the methods prescribed by the Food, Drug, and Insecticide 
Administration. If the analysis shows that the dye complies with the specifi- 
cations of purity for that particular dye, he should execute a manufacturer's 
affidavit and agreement and have the examining chemist execute a foundation 
affidavit. The nature of the affidavits and agreement required is indicated 
in the following approved forms : 

MANUFACTURER'S AFFIDAVIT 



Before me, a , personally appeared 

(Title of officer administering oath.) 
the undersigned, in the county and State aforesaid, who, being first duly sworn, deposes 

and says : I, 

(Name.) 

am 

(State official title if officer of corporation ; if member of partnership, so state; if 

sole owner, so state.) 

of 

(Name of corporation or partnership or name under which sole owner conducts business.) 

of ; the material known as 

(Address.) (Name of dye.) 

hereto attached was manufactured by ; 

(Me or name of corporation or partnership.) 

the material corresponds to the coloring matter numbered in Colour 

Index (1924), published by the Society of Dyers and Colourists of England; the accom- 
panying affidavit, signed by , contains the 

(Name of examining chemist.) 

report of an analysis of a fair, average sample drawn from batch number ; the 

total weight of said batch is pounds ; and the material hereto attached is a 

fair, average sample of said batch. 



(Signature.) 

Subscribed and sworn to before me, at , this 

day of , 19__. 

[seal.] 

(Signature of officer administering oath.) 



(Title of officer administering oath.) 
MANUFACTURER'S AGREEMENT 2 



If the batch mentioned in the foregoing affidavit is certified by the Food, Drug, and 
Insecticide Administration, the undersigned agrees to place plainly and conspicuously on 

the label, which shall in every instance be attached to the package put up by 

and containing any of the material 

(Me or name of corporation or partnership.) 
from said batch, the lot number assigned by the Food, Drug, and Insecticide Administration 
and the following statement : 3 

This certified dye contained when 
packed per cent pure coal- 
tar dye. 

OR 

This certified dye contained when 

packed not less than per 

cent pure coal-tar dye. 

The undersigned further agrees to keep available to representatives of the Food, Drug, 
and Insecticide Administration at all reasonable hours for two years from date of certifi- 
cation complete records of the disposition of said batch and each and every part of 
it, including dates of and number of pounds in each delivery or shipment, or other 
disposition, and names and addresses of the persons or firms receiving the dye from 

(Me or name of corporation or partnership.) 

(Signature.) 



2 If more convenient to the person or firm requesting certification, the acknowledgment 
by officer may be replaced by the signature of a responsible person as witness. 

3 The form of labeling used and the percentage of dye declared shall agree with the 
requirements of " Statement of dye content on packages," as given on page 3. 



F. D. No. 3] CERTIFICATION OF COAL-TAR FOOD COLORS 



, ss* 

I hereby certify that on this day of , 19 — , before me, 

a , , 

(Title of officer.) (Name of person signing agreement.) 

, of 

(Sole owner, partner, or official title of officer of corporation.) 

(Name of corporation or partnership or name under which sole owner conducts business.) 

who is personally known to me and who is known by me to be 

, of 

(Sole owner, partner, or official title of officer of corporation.) 

, 

(Name of corporation or partnership or name under which sole owner conducts business.) 
personally appeared and did acknowledge that he signed the above agreement. 

[seal.] 

(Signature of officer taking acknowledgment.) 



(Title of officer taking acknowledgment.) 
FOUNDATION AFFIDAVIT 



Before me, a , personally appeared the 

(Title of officer administering oath.) 
undersigned, in the county and State aforesaid, who, being first duly sworn, deposes 

and says : I, , residing at , 

(Name.) (Street address.) 

in the city of . county of , 

State of , have personally examined and tested for 

, of the 

(Full name of firm covered by manufacturer's affidavit.) 

city of , county of , State of , 

the sample described in the attached manufacturer" s affidavit ; the sample corresponds 

to the coloring matter numbered in Colour Index (1924), published by 

the Society of Dyers and Colourists of England ; said sample consists of 

only ; it is free from harmful constituents ; it 

(Name of color.) 

contains no contamination due to imperfect or incomplete manufacture ; and the fol- 
lowing is a complete and accurate report of my chemical analysis and my interpretation 
of results-: (Here insert a complete statement of all tests applied to determine the 
identity of the dye, the absence of harmful mineral, metallic, or organic constituents and 
the absence of contamination due to improper or incomplete manufacture. There should 
be set forth the quantity or volume of each material and reagent employed, its strength 
or concentration, temperature, duration of treatment, limits of delicacy of tests employed, 
and all other information necessary to enable other chemists to repeat accurately all work 
herein reported. For each test performed the conclusions drawn and the reason for 
these conclusions should be stated. This should be followed by a brief summary of 
the results obtained, preferably in a table of two columns of figures, one showing the 
percentages of the substances actually found and the other the ratio of each of these 
percentages to the percentage of dye. The methods of analysis used should be those 
described in Department of Agriculture Bulletin 1390, with such additions or revisions as 
may be made from time to time, or those known to and approved by the Food, Drug, and 
Insecticide Administration.) 



(Signature.) 

Subscribed and sworn to before me, at . , this 

day of , 19— 

[seal.] 

(Signature of officer administering oath.) 



(Title of officer administering oath.) 

These affidavits and agreement, attached to a 1-pound representative sample 
of the batch in the case of water-soluble dyes or a half-pound sample in the 
case of oil-soluble dyes, are sent to the Food, Drug, and Insecticide Administra- 
tion. The samples submitted should be packed in suitable containers and labeled 
conspicuously with the name and address of the manufacturer, the name of 
the dye, the batch number, and the total weight in pounds of the batch. For 
convenience, most manufacturers label their batches of each permitted dye in 
a consecutive series. The label should be securely attached to the container. 

CERTIFICATION GRANTED 



Upon receipt of the sample and properly executed affidavits and agreement 
by the Food, Drug, and Insecticide Administration, the sample is examined 
chemically if the foundation affidavit indicates that the dye is of proper iden- 
tity and purity. If the results obtained substantiate the claimed identity of the 



6 SERVICE AND REGULATORY ANNOUNCEMENTS [S. R. A. 

dye and its compliance with the standards of purity, a certificate assigning a lot 
number to the batch and reporting the dye content as determined by the admin- 
istration is issued by the administration to the manufacturer. If the adminis- 
tration's examination shows that the product does not conform to the require- 
ments for certification, the batch is rejected for use in foods. The chemical 
examination and the certification or rejection of the batch usually take approxi- 
mately two weeks. 

LOT NUMBER 

The lot number assigned on certification applies only to that particular batch 
of dye and to no other batch of the same or another dye. It is to be used by the 
manufacturer on each container in which the batch is packed for commerce. 
It is the manufacturer's guaranty that the dye has been certified and as such 
can apply only to those containers in which it was originally packed by him. 

CERTIFICATION OF SUBSEQUENT BATCHES 

The certification of subsequent batches of the same dye is accomplished in 
exactly the same way as the certification of the first batch, except that a supple- 
mental aflidavit is submitted instead of a foundation aflidavit and a smaller 
sample is required. The facts necessary in the supplemental aflidavit are indi- 
cated in the following approved form: 

SUPPLEMENTAL AFFIDAVIT 



Before me, a , personally appeared 

(Title of officer administering oath.) 
the undersigned, in the county and State aforesaid, who, being first duly sworn, deposes 

and says : I, , residing at , 

(Name.) (Street address.) 

in the city of , county of , , 

State of , have personally examined and tested for 

, of the city of 

(Full name of firm covered by manufacturer's affidavit.) 

, county of , State 

of , the sample described in the attached manufac- 
turer's affidavit ; the sample corresponds to the coloring matter numbered 

in Colour Index (1924), published by the Society of Dyers and Colourists of England; 

said sample consists of only ; it is free from harmful 

(Name of color.) 

constituents ; it contains no contamination due to imperfect or incomplete manufacture ; 
and the following is a complete and accurate report of my chemical analysis, conducted in 
strict accordance with the detailed scheme of examination fully set forth in the founda- 
tion affidavit covering , sworn to by 

(Name of dye.) (Me, or, if 

, on , 19__: 

another chemist, give name.) (Date.) 
(Here insert a brief summary of the results obtained, preferably in the form of a table 
of two columns of figures, one showing the percentages of the substances actually found 
and the other the ratio of each of these percentages to the percentage of dye.) 



(Signature.) 

Subscribed and sworn to before me at , this 

day of , 19__. 

[seal.] 

(Signature of officer administering oath.) 



(Title of officer administering oath.) 



The manufacturer's affidavit and agreement are identical in form with those 
required for original certification. 

Only a half-pound sample of the water-soluble dyes or a one-fourth pound 
sample of the oil-soluble dyes need be submitted with the manufacturer's afli- 
davit and agreement and the supplemental affidavit. The general procedure in 
labeling and packing the sample and in issuing a certificate assigning a lot 
number or in rejecting the batch is the same as that for the certification of the 
first batch. The lot number assigned applies only to the particular batch for 
which it is issued and to no other batch of the same or another dye or mixture. 
The time necessary for certification or rejection of subsequent batches is usually 
shorter than that for original batches, ordinarily only about one week being 
required. 



F». D. No. 3] 



CEKTIFICATION OF COAL-TAR FOOD COLORS 



7 



RECERTIFICATION OF REPACKED DYES 

When a certified dye is repacked it should be recertified by submitting to the 
Food, Drug, and Insecticide Administration a secondary affidavit and agree- 
ment, with a one-fourth pound sample, packed and labeled as required for 
original certification. The facts required in the secondary affidavit and agree- 
ment are indicated in the following approved forms : 

SECONDARY AFFIDAVIT (FOR REPACKS) 



Before me, a , personally appeared 

(Title of officer administering oath.) 
the undersigned, in the county and State aforesaid, who, being first duly sworn, deposes 

and says : I, , 

(Name.) 

am 

(State official title if officer of corporation; if member of partnership, so state; if 

sole owner, so state.) 

of ; 

(Name and address of corporation or partnership or name under which sole owner con- 
ducts business.) 

the material known as hereto attached is a fair, aver- 

(Name of dye.) 

age sample of batch number ; said batch was made by repacking 

pounds of certified , lot number , 

(Name of dye.) 

obtained from ; said 

(Name and address of person or firm from whom obtained.) 
batch was not otherwise mixed or treated in any way or manner. 



(Signature.) 

Subscribed and sworn to before me at , this. 

day of , 19—. 

[SEAL.] 

(Signature of officer administering oath.) 



(Title of officer administering oath.) 

SECONDARY AGREEMENT (FOR REPACKS) 4 

If the batch mentioned in the foregoing affidavit is certified by the Food, Drug, and 
Insecticide Administration, the undersigned agrees to place plainly and conspicuously 
on the label, which shall in every instance be attached to the package put up by 

, and containing any 

(Me or name of corporation or partnership.) 
of the material from said batch, the lot number assigned by the Food, Drug, and Insecti- 
cide Administration and the following statement : 5 

This certified dye contained when 

packed per cent pure 

coal-tar dye. 

OR 

This certified dye contained when 

packed not less than 

, per cent pure coal-tar dye. 

The undersigned further agrees to keep available to representatives of the Food, Drug, 
and Insecticide Administration at all reasonable hours for two years from date of 
certification complete records of the disposition of said batch and each and every part 
of it, including dates of and number of pounds in each delivery or shipment, or other 
disposition, and names and addresses of the persons or firms receiving the dye from 

, except that no rec- 

(Me or name of corporation or partnership.) 
ord will be kept of the names and addresses of persons or firms receiving containers of 
three ounces or less, but the total quantity of color distributed through such deliveries 
shall be recorded. 



(Signature.) 



* If more convenient to the person or firm requesting certification, the acknowledgment 
by officer may be replaced by the signature of a responsible person as witness. 

5 The form of labeling used and the percentage of dye declared shall agree with the 
requirements under " Statement of dye content on packages," as given on page 3. 



8 SERVICE AND REGULATORY ANNOUNCEMENTS I S. R. A ^ 



I hereby certify that on this day of , 19 , before me, a 

(Title of officer.) (Name of person signing agreement.)" 

(Sole owner, partner, or official title of officer of corporation.) 



(Name of corporation or partnership or name under which sole owner conducts business.) 
kft( 



of 

who is personally kSown to" me and who is known by me to be 

(Sole owner, partner, or official title of officer of corporation.) 

of , 

(Name of corporation or partnership or name under which sole owner conducts business.) 
personally appeared and did acknowledge that he signed the above agreement. 

[seal.] 

(Signature of officer taking acknowledgment.) 



(Title of officer taking acknowledgment.) 



The general procedure in issuing a certificate assigning a lot number or in 
rejecting the batch is the same as that for the previous certification. The new 
lot number assigned applies to the particular repacked batch for which it is 
issued and to no other batch of the same or any other dye or mixture. Affidavit, 
agreement, and sample must be submitted for each batch repacked. Certification 
or rejection of batches of repacked dyes requires ordinarily about one week. 



CERTIFICATION OF MIXTURES 



Color mixtures should be certified before sale. 

A mixture is a color which is made from two or more certified dyes without 
any other added substance, or a color made from one or more certified dyes 
mixed with a harmless diluent suitable for use in foods and not of itself a 
coloring matter. 

Adequate precautions must be taken to make sure that the mixture is homo- 
geneous throughout and that liquid mixtures are clear and free from sediment. 

The formula of a mixture is the quantitative statement of component dyes 
and mixtures, and the qualitative statement of diluents, etc., entering into the 
composition of the mixture. It includes the percentage of dye content claimed 
in the agreement regarding labeling. 

Change of formula is any change in a given mixture involving the percentage 
dye content claimed in the agreement regarding labeling, variation in the 
relation of the color components to one another, or change in the identity of the 
diluents. 

Formulas for mixtures are held confidential by the Food, Drug, and Insecti- 
cide Administration. 

Certified mixtures are ordinarily sold under trade names. The name chosen 
should be simple and in no way ambiguous or misleading. No firm or person 
should use for mixtures of different formulas names or designations of such 
resemblance that the products to which they are applied may be confused with 
one another, but if a change in formula of a certified mixture having an estab- 
lished trade name becomes justified, the mixer or responsible officer of the mix- 
ing firm may submit an affidavit setting forth the facts on which the change is 
based and stating that all the materials made under the old formula will be 
used before any made under the new formula are placed on the market. If the 
facts in the affidavit justify an alteration in the formula, approval for the 
change will be given. 

Certification of color mixtures is accomplished by submitting to the Food, 
Drug, and Insecticide Administration a secondary affidavit and agreement, with 
a one-fourth pound representative sample of the mixture, packed and labeled 
as required for original certification, except that the label may bear the trade 
name in lieu of the names of the dyes present. The facts required in the 
secondary affidavit and the agreement are indicated in the following approved 
forms : 



P. D. No. 3] CERTIFICATION OF COAL-TAR FOOD COLORS 
1 SECONDARY AFFIDAVIT (FOR MIXTURES) 



9 



, ss: 

Before me, a > personally appeared 

(Title of officer administering- oath.) 
the undersigned in the county and State aforesaid, who, being first duly sworn, deposes 

and says : I, -- 

CName.) 

am 

(State official title if officer or corporation; if member of partnership, so state; if 

sole owner, so state.) 

° Name "and "address "of "corporation or partnership or name under which sofe owner con- 
ducts business.) 

the material known as hereto attached is a fair, 

(Name of mixture.) 

average sample of batch number ; said batch was made by mixing 

pounds of certified ■ lot number , obtained 

(Name of dye or mixture.) 

from (repeat for 

(Name and address of person or firm from whom obtained.)' 

each dye or mixture used) and pounds of 

(Name of diluent. ) 

(repeat for each diluent used) ; said batch was made from these ingredients and none 
other ; the total weight of said batch is pounds ; said batch was thor- 
oughly mixed to insure uniformity. 



(Signature.) 

Subscribed and sworn to before me, at , this . 

day of , 19__ 

[seal.] . 

(Signature of officer administering oath.) 



(Title of officer administering oath.) 
SECONDARY AGREEMENT (FOR MIXTURES) 6 

If the batch mentioned in the foregoing affidavit is certified by the Food, Drug, and 
Insecticide Administration, the undersigned agrees to place plainly and conspicuously 
on the label, which shall in every instance be attached to the package put up by 

and containing any of the material 

(Me or name of corporation or partnership.) 
from said batch, the lot number assigned by the Food, Drug, and Insecticide Administra- 
tion, the designation under which the batch is certified, and the following statement : 

This certified dye contained when 

packed not less than per 

cent pure coal-tar dye. 

The undersigned further agrees to keep available to representatives of the Food, Drug, 
and Insecticide Administration at all reasonable hours for two years from date of cer- 
tification complete records of the disposition of said batch and each and every part of 
it, including dates of and number of pounds in each delivery or shipment, or other dis- 
position, and names and addresses of the persons or firms receiving the dye from 

, except that the names and ad- 

(Me or name of corporation or partnership.) 
dresses of persons or firms receiving quantities of three ounces or less shall not be 
recorded, but a record shall be made of the total quantity of color distributed through 
such deliveries. 



(Signature.) 



, ss: 

I hereby certify that on this day of , 19 , before me, a 



(Title of officer.) (Name of person signing agreement.) 



(Sole owner, partner, or official title of officer of corporation.) 

of - , 

(Name of corporation or partnership or name under which sole owner conducts business.) 

who is personally known to me and who is known by me to be 

(Sole owner, partner, or official 
title of officer of corporation.) 

of 

(Name of corporation or partnership or name under which sole owner conducts business. ) 
personally appeared and did acknowledge that he signed the above agreement. 

[seal] 

( Signature of officer taking acknowledgment. ) 



(Title of officer taking acknowledgment.) 



6 If more convenient to the person or firm requesting certification, the acknowledgment 
by officer may be replaced by the signature of a responsible person as witness. 



10 



SERVICE AND REGULATORY ANNOUNCEMENTS 



[S. R. A, 



The general procedure in issuing a certificate assigning a lot number or in 
rejecting the batch is the same as for the original certification of the dyes. 
The lot number assigned applies only to that particular batch of the mixture 
for which it is issued and to no other batch of the same or other mixture or 
straight dye. Affidavit, agreement, and sample must be submitted for each 
batch of mixture made. 

Certification or rejection of batches of mixtures requires ordinarily about one 
week. 

A certified mixture may be repacked and recertified, or it may be used as a 
constituent of another mixture for which certification is requested. Samples of 
repacked mixtures submitted with requests for recertification should be packed 
and labeled in accordance with the procedure outlined for the original certifica- 
tion of mixtures, and the procedure otherwise is identical with that of orginal 
certification, except that the form of secondary affidavit and agreement required 
for recertification of repacked dyes is used, substituting the words " certified 
mixture for " certified dye." 

GENERAL LABELING REQUIREMENTS 

In addition to the labeling covered by the agreement submitted with samples 
for certification, the general provisions of the Federal food and drugs act 
regarding labels should be observed if the dye is distributed in interstate com- 
merce. These require that the containers bear a plain and conspicuous state- 
ment of the quantity of the contents and prohibit the use of statements, designs, 
or devices that are false, misleading, or deceptive. If, owing to the absorption 
of moisture or other cause, the dye content falls below the labeled declaration 
before interstate shipment, the product is in violation of the law, even if the 
declaration is the one reported by the Food, Drug, and Insecticide Administra- 
tion at the time of certification. 

ADMISSION OF ADDITIONAL DYES 

To be considered suitable for inclusion in the list of permitted coal-tar food 
colors, a dye must not be protected in any way by unexpired patents covering 
either the dye itself or the only known methods of preparing it or any of its 
intermediates. Its complete process of manufacture must have been described 
in some recognized scientific publication. Names chosen for new dyes to be 
certified should not be false or misleading in any particular and no element 
in them should tend to advertise the product of any particular manufacturer. 

Manufacturers wishing to have a dye added to the permitted list should 
prepare the dye in as pure a form as possible and submit to the Food, Drug, 
and Insecticide Administration a manufacturer's affidavit and agreement, a 
foundation affidavit, and a detailed report by one or more reputable pharma- 
cologists and toxicologists on the pharmacological and toxicological properties 
of the dye. When a knowledge of the process of manufacture is necessary to 
determine the identity of the dye, the submission in the manufacturer's af- 
fidavit of a complete description of certain steps or all steps in the manu- 
facturing procedure may be required. To these reports should be attached a 
5-pound sample of the dye taken from the same batch as that from which the 
sample used for analysis and pharmacological and toxicological investigations 
was obtained. If the data submitted indicate the suitability of the dye for 
food use, the Food, Drug, and Insecticide Administration proceeds with chem- 
ical, pharmacological, and toxicological examinations of the sample. If these 
investigations show that the dye is harmless and of suitable purity, it is 
added to the permitted list, provided need for a new dye can not be met by 
dyes already on the list, or other sufficient reason obtains. The time required 
for these investigations is necessarily long; in most cases about two years 
will probably be needed. 

The contemplated addition of a dye to the permitted list will be published 
by the Food, Drug, and Insecticide Administration at least two months before 
its admission. In the case of newly developed dyes, this announcement will 
not appear in advance of the description in a recognized scientific publication 
of the complete process of manufacture of the dye. 



o