Q. What is
the new final rule that eliminated the standards of identity
for pizza with meat or sausage products?
A.
The
final rule published on July 31, 2003, in the
Federal Register and was effective October 22, 2003. It
eliminated the standards for pizza products, i.e., the
standards in
9 CFR 319.600, which required a minimum meat content
and required components of a traditional pizza. The standards
were eliminated to allow for more innovation in pizza manufacturing.
To inform consumers of the changes in pizza products, 9
CFR 317.8 (b)(40)and
381.129 (f) require a percentage statement regarding
the meat/poultry component to be placed contiguous to the
ingredients statement for a time period of approximately
3 years.
Requirements for Labeling the Percentage
of a Meat/Poultry Component on Pizza Products
1. Q. When is the percentage
labeling no longer required?
A.
The percentage labeling requirement expires October
30, 2006. The date of October 24, 2006, placed in the
"Date" section of the final rule in the July 31, 2003,
Federal Register is an error in printing.
2. Q. Is there a minimum type size requirement
for the percentage labeling of the meat/poultry component?
A. No, however, consistent with rules on
all required labeling features, the information must
be prominent and conspicuous, e.g., navy blue print
on a black background is not considered to be prominent
and conspicuous.
3. Q. Can a company declare the exact percentage of
the meat/poultry component on the label if the formula
lists the amount to the hundredth or thousandth decimal
place?
A. We suggest the required percentage
listing be limited to one place past the decimal point,
e.g., 5.2% would be acceptable.
4. Q. Can the required percentage declaration of the
meat/poultry component be rounded up to the nearest
whole number or tenths?
A. No, the percentage
cannot be over-declared. Consistent with the Agency´s
current labeling policies, rounded numbers have to
be rounded down, e.g., 5.26% could be rounded to "5%"
or "5.2%."
5. Q. Can the required percentage declaration of the
meat/poultry component be rounded up to the nearest
whole number or tenths?
A. No, the percentage
cannot be over-declared. Consistent with the Agency´s
current labeling policies, rounded numbers have to
be rounded down, e.g., 5.26% could be rounded to "5%"
or "5.2%."
6. Q. If the ingredients statement and signature line
fill the space of the side panel on the product packaging,
can the percent declaration of meat/poultry component
be moved to the next panel to the right?
A. No. The percentage is required to appear on the same
panel, and contiguous to, the ingredients statement.
It may appear above, below, or to the right or left
of the ingredients statement.
7. Q. Can the percent declaration be placed contiguous
to the ingredients statement by a means other than
reprinting the label or using a pressure-sensitive
sticker?
A. Yes, the percentage information
can be ink jetted on the label, hand stamped with indelible
ink, or imprinted on the label, provided it is in the
required location and is prominent and conspicuous.
For Child Nutrition (CN)-labeled products, see the
section entitled "Child Nutrition (CN)-Labeled Products."
8. Q. For a pizza topped with meat components, e.g.,
sausage and pepperoni, can the two meat percentages
be combined and declared as a total meat percentage
contiguous to the ingredients statement?
A. The regulation states that pizza products that "list
a meat component as part of the product name must bear
a parenthetical statement contiguous to the ingredients
statement that conveys the percent of the cooked, cured,
or dried meat component." Thus, if two meat components
are declared, e.g., sausage and pepperoni, in the product
name, companies should list the percentage of each
contiguous to the ingredients statement. However, the
Agency will also view other percentage listings as
being in compliance with the intent of the regulation.
There is no objection to listing a combination of the
labeled meat/poultry components, and the total percentage
of meat/poultry food products or a declaration of the
percentage of meat/poultry in the components, provided
that the percentage of meat/poultry present in the
finished meat/poultry food products is known.
Examples below show acceptable declarations based
on meat/poultry components:
Percentage Of Ingredients In Product Formula
Examples Of Acceptable Labeling Of Percentages
To Meet Requirement In Final Rule
"4% meat food product,"
"4% Ham and Water Product"
6%
Turkey Ham and Water product
"6% Turkey Ham
and Water Product"
5%
Uncooked Sausage
"5% Uncooked Sausage"
5%
Fat-Reduced Pepperoni
"5% Fat-Reduced
Pepperoni"
9. Q. If a product is named "Sausage Pizza" but the
product is topped with 20% "meat pizza topping" (e.g.,
12% sausage/8% textured soy protein), is it acceptable
to declare the required meat content simply as "20%
meat food product?"
A. No, that name would be
misleading since the implication would be that the
product contained 20% sausage when in reality it contained
only 12%. Accurate, non-misleading percentage declarations
would include "12% sausage," "12% meat food product,"
and "X % meat," if the actual percentage of meat in
the pizza topping is known. The declaration of "20%
Pizza Topping" would be acceptable because it is a
name that conveys the presence of additives beyond
the sausage portion in the meat food product.
10. Q. Can the amount of meat or poultry topping in the
pizza be determined based on pre-cooked weight if the
percentage statement is qualified, e.g., "15% beef
(pre-cooked)"?
A. No. The amount of meat or
poultry must be determined according to the cooked,
cured, or dry weight of the topping as a percentage
of total weight according to the new final rule.
Exhausting the Inventory of Existing
Labels of Pizza Products
1. Q. What are the allowances for exhausting inventories
of existing labels before the declaration of meat/poultry
is needed?
A. In order to use existing label inventory, the product
would need to remain the same, i.e., a traditional
pizza. There are three situations that apply: (1) The
first is where there is no change to the product formulation,
label, order of predominance of ingredients, and nutrition
facts (outside of the 80/120 parameters) so no modification
to the label is necessary. In this case, we are extending
the effective date of the
final rule to July 31, 2004, for the provision
of adding the percentage of meat content to the labeling
of existing pizza products, provided that the percentage
declaration remains on each individual label for at
least three years from the date of first use. (2) The
second situation involves changes to the formulation
and, therefore, to the label. However, in this case,
the manufacturer decides to make the changes to the
existing label by use of pressure sensitive stickers,
ink jetting, indelible ink hand-stamps, etc. The product
labeling qualifies for generic label approval under
9 CFR 317.5(b)(1) and
9 CFR 381.133(b)(1)
which means that some changes
may be made to the existing labeling under the generic
provisions in
9 CFR 317.5(b) (9) or
381.133(b) (9), e.g., the order of predominance
of the ingredients statement can be corrected by use
of a pressure sensitive sticker covering the inaccurate
information. The label would bear the percent declaration
when the formula is changed to lower the amount of
meat/poultry or meat food product or poultry product
from that which was required in the traditional standardized
pizzas. In all cases, the labeling must prominently
bear all mandatory features and cannot be false or
misleading in any manner. (3) The third situation involves
changes to the formulation and label where a temporary
approval is sought by the company, and it meets the
conditions specified in
9 CFR 317.4(f)
and
381.132(f).
2. Q. If the pizza formula remains the same, is the
percentage of meat/poultry component required to be
added to the existing labels for them to be used up?
A. No, the existing labels can be used up without
adding the percentage, provided that the formulation
does not change. However, the percentage may be voluntarily
added by a sticker to existing stock under the generic
labeling provisions. (For Child Nutrition (CN) labeled
products, see the section entitled "Child Nutrition
Labeled Products.")
3. Q. If the supplier of a company´s pepperoni or crust
makes minor changes to the formula of the purchased
component, can the old labels continue to be used?
A. The company would need to submit such labels
to the Labeling and Consumer Protection Staff (LCPS)
with a request for a temporary approval. The conditions
for granting temporary approvals are listed on the
website.
Minor changes can be granted temporary approval, or
the company can change the existing label by use of
pressure sensitive stickers, ink jetting, indelible
ink hand-stamps, etc. Such labeling qualifies for generic
label approval (9
CFR 317.5(b)(1) and
9 CFR 381.133(b)(1)) and generic label modifications
(9
CFR 317.5(b) (9) and
381.133(b) (9)). (See the answer to "
2 Q." above, in this section.)
4. Q. If a company wants to reduce the percentage of
the meat/poultry component, can the old labels be used
by adding a sticker declaring the percent of meat/poultry
component without an LCPS temporary approval?
A. Yes, but only when there are no other changes
needed to the label, i.e., the order of predominance
in the ingredients statement does not change, the nutrition
information remains in compliance, and all other information
on the label remains accurate. If there are changes,
e.g., order of predominance, the company would need
to request a temporary approval that provides data
on the nutrient profile of the revised formula to ensure
that the nutrition facts information remain in compliance
with the regulations. Temporary approvals will be permitted
on a case-by-case basis. (For CN labeled products,
see the section entitled "Child Nutrition Labeled Products.")
Generic Label Record (Final Labeling)
1. Q. If a company only adds a sticker that declares
the percentage of the meat/poultry component to previously
approved labeling, can the label be approved generically?
A. Yes, provided there are no other deficiencies
on the label (See answer to III. Q. 4
above). (For CN labeled products, see the section entitled
"Child Nutrition Labeled Products.")
2. Q. If a company changes their existing formula, can
label modifications be approved generically?
A. No, since there is no longer a standard of identity
for pizza with meat/sausage products, such products
are now classified as non-standardized products or
products guided by a common or usual name, "pizza."
The first time new or modified labels for such products
need to be approved, they must be sent to LCPS for
approval. Further modifications to the LCPS- approved
label may be handled generically if they fall under
the generic labeling modifications in
9 CFR 317.5(b)(9) or
381.133(b)(9) of the regulations.
Naming of "Traditional"
and Non-Traditional, Descriptively Labeled Pizza-Like
Products
1. Q. For the purposes of this regulation, what is a
traditional versus non-traditional pizza?
A.
A traditional pizza is a product formulated with the
components that were stipulated in the regulatory standard
that existed in
9 CFR 319.600, i.e., tomato sauce, cheese,
and meat topping on a bread-based crust. A non-traditional
pizza is a product missing one or more of these components,
e.g., instead of tomato sauce, it may include a white
sauce, and instead of a bread-based crust it may use
a corn tortilla.
2. Q. If a company renames their pizza-like product
with a descriptive name that does not include the term
"pizza," do they need to include a percent declaration
of the meat/poultry component?
A. No, if the
product is descriptively named, e.g., "sausage, cheese,
and sauce on a crust," and the term "pizza" does not
appear anywhere on the label (including the nutrition
facts panel, heating instructions, and romance copy),
percent declaration of the meat/poultry component is
not required.
3. Q. Does the order of ingredients/components in the
product name of descriptively labeled pizza-like products
have to follow the order of ingredients in the product
formula?
A. No, the Agency does not require
a specific order of predominance in the product name
of descriptively labeled products.
4. Q. In naming traditional pizzas or non-traditional
pizza-like products, if a company uses 1% Italian sausage,
1% pepperoni, and 1% bacon, can the product name list
all three meat components individually or collectively
as "meat?"
A. Even though the three meat components
are at levels of 1 percent, they can each be identified
in the product name since they could each characterize
the product. The general term "meat" could also be
used in the name, e.g., "Meat Pizza," for the traditional
pizza, and "Meat, Cheese, and Pesto Sauce on a Crust,"
for a non-traditional product.
5. Q. If a company formulates their product with a pizza
topping that contains textured vegetable (source) protein
(TVP), does the TVP need to be included in the product
name?
A. The final rule that eliminated the
pizza with meat or sausage standards did not affect
the Agency´s longstanding labeling policy on meat/poultry-to-TVP
ratios which was created to ensure that meat and poultry
products are identified in an accurate and non-misleading
way. The meat/poultry-to-TVP ratios are applicable
to the naming of all pizza products unless the pizza
is formulated with a meat food or poultry product the
policy for which provides for the use of TVP without
product name implications, e.g., "(species or kind)
Patty" or "(species or kind) Pizza Topping." In the
case of these two examples, TVP is an expected ingredient
in such products.
6. Q. Is the requirement in
9 CFR 317.8(b)(27) and
381.120 for qualifying the presence of calcium
propionate or sodium propionate in pizza crust in the
product name still in effect?
A.
Yes. The final rule only eliminated the standards of
identity for pizza with meat or sausage products; other
prevailing regulations, e.g., those dealing with ingredients
labeling, are not implicated.
7. Q. Is it acceptable for the pizza product name to
list some "characterizing" components that are at or
below two percent and not mention other ingredients
that are at a higher level but still below the two
percent or less characterizing amount?
A. Yes,
some components, e.g. anchovies, garlic, and jalapeno
peppers, are used at levels that are well below two
percent and low levels can significantly characterize
a product to the extent that they are included in the
product name. However, it is not necessary to list
all other components that are at a higher level, but
still below the two percent level, e.g., imitation
cheese.
8. Q. What guidance exists for naming substitute cheese
and real cheese on pizza-like products?
A. Consistent
with the final rule, which stated that ingredients
above two percent are characterizing, non-standardized
products, such as pizza products, that highlight "cheese"
in the product name or on the principal display panel
(PDP) must contain above two percent real cheese to
be characterizing. In addition, imitation/substitute/fat-reduced
cheese, when used above two percent, also would be
included as part of the product name. For descriptively
named pizza products, cheese and imitation/substitute/fat-reduced
cheese at characterizing levels, i.e., above two percent,
would be included as part of the product name.
9. Q. The preamble to the final rule stated that once
the final rule became effective, other "pizza products
with standards specified in the Food Standards and
Labeling Policy Book will no longer be subject to the
requirements of
9 CFR section 319.600, including minimum meat requirements."
Which entries will be removed from the Policy Book?
A. Because the pizza product entries in the Policy
Book, viz., "Pizza with Meat," "Pizza with Sausage,"
"Pizza with Poultry," "Pizza with Bacon," "Pizza with
Chili and Beans," "Pizza with Meat Pattie Crumble,"
and "Pizza, Combination or Deluxe," were interpretations
of the now-deleted
9 CFR section 319.600, it would not make sense
to apply them. They will be removed shortly.
10. Q. What is the status of the entries in the Policy
Book that include "pizza" in the product description
that were not based on the previous pizza with meat/sausage
standard? Will they be retained?
A. At the present
time, the Agency will retain the entries for products
that include "pizza" that were not established as interpretations
of the previous standard in
9 CFR section 319.600. These entries include:
Pizza Burger
Pizza, Chicago Style
Pizza Dogs
Pizza, Pan Style
Pizza Pups
Pizza Roll
Pizza Sauce with Sausage
Pizza Sausage
Pizza, Sicilian Style
Pizza Topping Mix
White Pizza
Child Nutrition (CN) - Labeled Products
1. Q. Can CN-labeled products (i.e., products bearing
CN labeling features that are required by the Food
and Nutrition Service, FNS) get temporary approval
for formulation changes?
A. Temporary approvals
for minor changes not affecting crediting will be granted
by FNS.
2. Q. Can formulation changes to CN-labeled products
be handled by generic approval?
A. No. All formulation
changes to CN-labeled products must be resubmitted
to FNS for approval
3. Q. Can pressure-sensitive stickers be used to correct CN-labeled products?
A. No. Stickers cannot
be used on CN-labeled products for final or temporary
approval.
4. Q. Can CN-labeled products that do not meet CN requirements
be given a temporary approval by FSIS?
A. No.
5. Q. Can a label keep the same CN identification number
if the declaration of the percent of meat/meat food
product in the product is added voluntarily or as required
by FSIS?
A. Generally, FNS requires a new CN
identification number and approval for any changes
to the product name. However, if there are no other
changes to the label application, FNS will not object
to the generic approval of the addition of the declaration
of percent meat/meat food product. FNS requires one
copy of the generically approved label, along with
a statement that indicates what was changed, to be
sent to USDA, FNS, 3101 Park Center Drive, Rm. 632,
Alexandria, VA 22302 ("Attention CN Label Reviewer").
6. Q. Will CN product labels with changes need to be
resubmitted to FSIS, LCPS, for re-approval?
A. The answer depends on the circumstances:
Yes - for labels resubmitted for temporary approval
Yes - for labels submitted with new CN ID numbers
No - for labels resubmitted as required by FNS
that can be generically approved by FSIS. In this
situation, the FNS re-approval will retain the previous
FSIS approval number. (It is the company´s responsibility
to convey to FNS that the label change can be done
generically for FSIS so that the label is not forwarded
to FSIS after the FNS review.)
7. Q. How do I contact the FNS, CN labeling staff, if
I have other questions?
A. The FNS, CN labeling
staff can be reached at 703-305-2609.
Miscellaneous Issues
1. Q. How low can the level of meat/poultry be before the
product is no longer amenable to U.S. Department of Agriculture
(USDA) jurisdiction (i.e., to the FMIA or PPIA)?
A. In general, foods containing less than 3 percent
raw or less than 2 percent cooked livestock or poultry
ingredients are not defined as meat food or poultry products
and, thus, are under the jurisdiction of FDA.
2. Q. If a pizza-like product contains 1% cooked meat sausage
and 1% cooked poultry meat, is the product amenable?
A. Yes. The product would bear the inspection legend
of the meat or poultry component that is listed first in
the product name.