Re q u i rem e nts f o r S i l u r i f o r me s F ish and Fish Prod u cts 1 Presentation adapted from slides provided by FSIS Re q ui r e d F e a tu r es ID: 693575
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Slide1
USDA FSIS
Lab
e
l
ing Requirements for Siluriformes Fish and Fish Products
1
Presentation adapted from slides provided by FSISSlide2
Re
quired
Features
L
a
bels
ha
v
e
up
to nine (9) required features (9 CFR 541.7, cross-referencing 9 CFR 317.2; 9 CFR 557.14 cross-referencing 9 CFR 327.14)Regulations specify where the required features must be located on the immediate container:Principal Display Panel (PDP)(9 CFR 541.7, cross-referencing 317.2(c) and (d))Information Panel (IP)(9 CFR 541.7, cross-referencing 317.2 (m))
2Slide3
P
rincipal Display Pa
nel (PDP) and
Information Panel (IP)PDP is the
part of the label most likely to be displayed, presented…when offered f
or sale
u
n
der
cu
s
t
omary conditionsIP is any portion of a label not on the PDP thatdisplays certain mandatory featuresPDPInformation Panel3Slide4
Re
quired
Features: Principal
Display PanelFSIS requiremen
ts:Name of ProductNet Quantity of Contents
*(3
)
“
P
r
o
d
uct of (country of origin)” on Imported product only*(4) Official Inspection Legend*(5) Handling Statement(perishable product)*Feature unique to FSISFDA requirements:Name of ProductNet Quantity of Contents6Slide5
P
r
oduct Name
“C
atfish” may only be used
on products
fro
m
fis
h
in
the Ictaluridae familyNon-Ictaluridae fish must be labeled according to their common or usual name (e.g., Basa, Swai, Giant Pangasius)5Slide6
O
fficial Ins
pection Legend
NOTE: The USDA legend only applies to product inspected in the United States. 6Inspection legend ma
y be any size but must be legible(9 CFR 541.2, 312.2(
b)(1))
Siluri
f
or
m
es
Inspection Legend = Meat Inspection LegendSlide7
F
or
perishable
products that need special handl
ing to maintain their wholesomeness(9 CFR 541.7, 317.2 (k))Keep
Re
fri
g
e
r
a
t
edKeep FrozenKeep Refrigerated or FrozenPreviously Handled Frozen For Your Protection - Refreezeor Keep RefrigeratedHandling Statement10Slide8
Requi
r
ed F
eatures: Information Panel
FSIS requirements:(6) Name and place of business of manufact
urer/pa
c
k
er/di
s
t
r
ibutor(7) Ingredients statement(8) Nutrition labeling*(9) Safe Handling Instructions if the product is not ready-to-eat (may be located on any panel)*Feature unique to FSISFDA requirements:(3) Name and place of business ofmanufacturer/packer/distributor(4) Ingredients statement(5) Nutrition labelingThe remaining features may be
lo
c
at
e
d
on
t
h
e
PD
P
or
I
P
:
11Slide9
Requi
r
ed F
eatures: Information Panel
FSIS requirements:(6) Name and place of business of manufact
urer/pa
c
k
er/di
s
t
r
ibutor(7) Ingredients statement(8) Nutrition labeling*(9) Safe Handling Instructions if the product is not ready-to-eat (may be located on any panel)*Feature unique to FSISFDA requirements:(3) Name and place of business ofmanufacturer/packer/distributor(4) Ingredients statement(5) Nutrition labelingThe remaining features may be
lo
c
at
e
d
on
t
h
e
PD
P
or
I
P
:
11Slide10
S
a
f
e Handling Instructions
Must be on any product that is NOT ready
-to-e
a
t
R
equ
i
r
ed if destined for retail, hotels, restaurants and institutionsNot required on products shipped for further processing at an official establishment (USDA-inspected)“Meat and/or poultry” replaced with “fish” on labels for Siluriformes fish and fish products to minimize customer confusion
10Slide11
S
a
f
e Handling Instructions
Must be on any product that is NOT ready
-to
-e
a
t
R
equ
i
red if destined for retail, hotels, restaurants and institutionsNot required on products shipped for further processing at an official establishment (USDA-inspected)“Meat and/or poultry” replaced with “fish” on labels for Siluriformes fish and fish products to minimize customer confusion
11Slide12Slide13
P
r
oduct Nam
e - Descriptive Designation
for Added Solutions
Labels
on
r
a
w Siluriformes
fish products containing added solutions must include a descriptive designation (e.g., “Contains 10% added solution of water, salt, phosphates….”)Product name and descriptive designation must be in one easy- to-read type style, in one color, on a single color contrasting background (also 1/3 height requirement, ¼ until 1/1/18)Statement must list all ingredients by common or usual name in descending order of predominanceMulti-ingredient components (e.g. purchased soy sauce, seasoning blend)
not
require
d to
su
b
list
a
ll
ing
r
edient
s
in des
criptiv
e
designation;
ingredients
statement
m
ust
list
a
l
l individual
ingredients
•
9
CF
R
3
1
7
.
2(e)
(
2),
5
4
1
.
7
(
a
)
13Slide14Slide15
P
r
oduct Nam
e - Descriptive Designation
for Added Solutions
USDA uses a
“weight-in, weight-out” or yield method
.
The
formula is based on knowing the weight of the product prior to treatment and the weight of the product after treatment. It does not depend on knowing a baseline moisture or an end moisture.
X%
added solution = weight of added solution/weight of product prior to treatment. Example: if the weight of the product was 100 pounds prior to treatment and the weight of the added solution is 20 pounds, the % solution added is: X% solution added = 20lb/100lbX% solution added = 20% 15Slide16
P
r
oduct Nam
e - Descriptive Designation
for Added Solutions
An
alternative calculation is based on knowing the weight of the product prior to and after treatment as follows:
X%
solution added
= (weight of finished product – weight of product prior to treatment)/weight of product prior to treatment.
Example: if the weight of the product was 100 pounds prior to treatment and the weight of the treated product is 120 pounds, the % solution added is: X% water added = (120lb-100lb)/100lbX% water added = 20%Source: 9 CFR 317.2(e)(2)(i) andFSIS Directive 7620.3 – Processing Inspectors’ Calculations Handbook16Slide17
Retained Water Statements
The USDA regulation for retained water (9 CFR 441.10) requires firms to:
1) limit
the amount of water pick-up in the raw product due to processing steps necessary for food safety purposes (such as washing or chilling),
2) indicate
the amount of retained water on the label to inform the consumer, and
3) develop
a protocol for gathering water retention data to support the label statement.
9
CF
R
441.10, 541.7(e)17Slide18
Retained Water Statements
Applies only
to products that have no other added ingredients.
The
retained water is not considered an ingredient because it is incidental to the process and not purposely added.
The
statement, such as “up to X% retained water” would appear on the principal display panel of the label, but would not need to be part of the product name.
Calculations based on the change in weight due to water
18Slide19Slide20
Ice Glazed Products – Labeling Policy
The
net weight of the product may not include the weight of the water or ice.
Label approval forms must indicate ice glazing.
A
prominent and conspicuous statement must appear on the principal display panel adjacent to the product name, describing that the product is protected with
ice
glaze (e.g., “Product Protected with Ice Glaze”).
20Slide21
Net Weight
FSIS follows the testing procedures in NIST Handbook 133.
Note that there are specific tables in Handbook 133 with FSIS specific sampling plans and MAVs.
FSIS considers any liquid (other than ice glaze) that purges from fresh or thawed product to be part of the product. The purged liquid will be included as part of the product weight when product is tested for net weight.
21Slide22
Label
Appro
val
Est
a
blishm
en
t
s
m
ust obtain FSIS prior approval for labels of Siluriformes fish products before products may be marketed.Label approval is granted one of two ways:Sketch approval by the Labeling and Program Delivery Staff (LPDS)Generic approval by being in compliance with applicable regulations22Slide23
Label
Appro
val
Onl
y
cer
t
a
i
n
types of labeling require submission for evaluation by the Labeling and Program Delivery Staff (9 CFR 541.7(g), 412.1):labels for temporary approval (e.g., change in product formula ingredients listed are no longer in descending order of predominance)labels for products for export with labeling deviations (e.g., nutrition fac
t
s
pa
n
el
i
n
a
f
orm
a
t
no
t
p
erm
i
tt
ed
o
n d
ome
s
t
ic
l
ab
el
s
)
l
ab
el
s
w
i
th
s
p
ec
i
al
s
t
a
t
em
e
n
ts
and
c
l
aims
(e
.
g
.
,
(
“
all
n
a
tu
r
al” or “no a
n
t
i
bio
t
i
c
s
ad
m
ini
s
t
e
r
e
d”)
ALL
O
THE
R
l
a
bels
do
not
r
eq
u
i
r
e
s
u
b
mi
s
sion
t
o
LP
D
S
f
or
app
r
o
v
al
Ma
n
y
fi
s
h labels can be generically approved and do not need to be submitted to LPDShttp://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/labeling/Labeling-Policies#Generic
23Slide24
Label
Approv
alEstablishments may
submit labels to LPDS during the 18-month transitional
period
O
n
Se
pt
ember
1, 2017 all labels requiring LPDS approval must have a label approval on file24Slide25
H
o
w to
Submit Labels
Web-based: Label Submission and Approval System (LSAS)Paper: express mail, mail, courier, or consul
tant
F
a
x
a
p
plications are typically illegible and willnot be accepted.LPDS cannot accept labels via e-mail25Slide26
F
o
od Sa
fety and Inspection Serv
ice:Authentication (Level 2) is required to use Label Submission
and
App
r
o
v
al
System (LSAS)Persons conducting business with governmentManaged by the Department of AgricultureWebsite: www.eauth.egov.usda.govHelpdesk: www.eauthhelpdesk@ftc.usda.govHelpdesk telephone: 800-457-3642Label Submission: LSAS26Slide27
Lab
e
l Submiss
ion: LSAS27Web-
based software applicationRequires Level 2 eAuthentication
In
t
eg
r
at
es
and implements a secure electronic label application process for establishments to submit label applications and appealsApplication processing via LSAS is faster than paperEnrollment and use instructions at:http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory- compliance/labeling/labeling-procedures/label-submission-and-approval-system/lsasSlide28
Lab
e
l Submiss
ion: PaperUse FSIS F
orm 7234-1, available at: https://www.fsis.usda.gov/wps/portal/fsis/forms
C
heck
“
M
eat”
for Siluriformes fish and fish products20Slide29Slide30
Lab
e
l Submiss
ion: PaperSubmit
two copies of the application and two copies of the labelApp
lica
tion
is
th
r
ee pages (includes product formula page and processing procedures page)Address and additional information at:http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/ labeling/labeling-procedures/label-application-guidance30Slide31
Lab
e
l Submiss
ion: Paper31All la
bels submitted via paper application will bescanned
int
o
L
S
AS
by the labeling staffSince they must be scanned into LSAS, paper applications will take longer to review than those submitted electronicallyEstablishments strongly encouraged to submit labelapplications electronicallyAddress and additional information at:http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory- compliance/l
a
bel
i
ng/
l
abel
i
ng
-
p
r
o
c
ed
u
re
s
/lsa
s
-
i
n
t
egrationSlide32
P
r
essur
e Sensitive Stickers
Alternative to reprinting labels which require changes or added i
nfor
m
a
tion
M
a
y
cover inaccurate and/or misleading labeling information with corrected textMay be used to add information such as the USDA legend and Establishmentnumber or a handling statementMust destroy the underlying label or package if removed, or be self- destructiveTemporary label approval is not required when the entire label including the pressure sensitive sticker is truthful,
no
t
m
i
s
l
e
adin
g
,
and
the
p
r
od
u
ct
is
not
m
i
sb
r
anded
Labelin
g
bearin
g
p
r
es
s
u
r
e
sens
i
ti
v
e
s
tic
k
e
r
s
f
al
l
s
u
n
de
r
the
p
r
o
v
i
s
i
on
s
o
f
the
g
ene
r
i
c
a
l
ly
app
r
o
v
ed
l
a
bel
i
n
g
r
egul
a
ti
o
n
s 9
C
F
R
41
2
.2
32Slide33
Lab
e
ling
Record33Establishme
nts are required to keep records of all labeling (9
CFR
55
0
.1
,
32
0
.1(b)(11) and 9 CFR 541.7(g), 412.1)Labeling record must include:Final label applied to productProduct formulation and processing proceduresSupporting documentation for statements and/or claims on the label, including prior sketch approval from LPDS (if applicable). For example:Support for the use of state-approved agricultural l
o
g
os
such
as
“
Go
T
e
x
an”
or “
K
e
n
tuc
k
y
P
r
oud”
Sup
p
o
r
t
f
o
r
t
h
e
s
t
at
e
m
e
n
t
“Ce
r
t
i
f
i
ed
Glu
t
en
F
r
e
e
”
Docum
en
t
a
t
i
on
suppo
r
t
i
ng
the
c
l
a
i
m
“Fish
n
ev
er
admin
i
s
t
e
r
ed
a
n
t
i
biot
i
cs”
Labeling
r
e
c
o
r
d
k
e
p
t
i
n
-hou
s
e,
mu
s
t
b
e
p
r
ese
nt
ed
t
o
F
SIS personnel on requestSlide34
F
o
od Sa
fety and Inspection Serv
ice:During
the tr
ansit
i
ona
l
period
, FSIS will find noncompliance if one or more of the following scenarios occur:There is no label on the productAn undeclared “Big 8” allergen is present in the productThe “Big 8” allergens are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, soy and wheatThe product is labeled as “Catfish” but does not contain fish fromthe family IctaluridaeThe net weight is over-declaredFor all othe
r
labe
l
ing
d
e
ficien
c
i
e
s
,
F
SI
S
w
i
ll
w
or
k
w
i
th
e
s
t
abli
s
hme
n
ts
t
o
br
i
n
g
the
i
r
l
a
bel
s
i
n
t
o
c
o
m
pl
i
ance
w
ith
F
SI
S
r
equi
r
e
m
e
n
ts
b
y
the end
o
f
the
t
r
ansit
i
ona
l
period
(
S
e
p
t
e
m
be
r
1,
2
0
1
7
)
Lab
e
li
n
g
En
f
o
r
cement
34Slide35
www.fsis.usda.govSlide36