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Labeling and Establishment Responsibilities
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Since July 1, 1996, the Labeling and Consumer Protection
Staff (LCPS) of FSIS only grants temporary approvals and
sketch approvals. Before submitting label applications for
sketch approval, establishments should ensure that the print
is legible and that all required features (i.e., inspection
legend, ingredients statement, handling statement, product
name, signature line, and safe handling instructions, net
weight, and nutrition facts, when required) are present and
in compliance with requirements.
The generic approval labeling regulations (9
CFR 317.5 and
381.133 provide for use of final labeling without
further authorization from FSIS. It is the establishment's
responsibility to prepare final labeling in accordance with
applicable regulations/policies, and to create and maintain
records of final labeling, otherwise known as generic
approvals.
Establishment Responsibility
- Create a record of final labeling for labeling previously approved
as a sketch by the Labeling Compliance Team.
- Modifications (per sketch approval) are made to label before
final printing
- Create a record of final labeling for amenable
single ingredient products or amenable standardized
multi-ingredient products that bears no special
claims, guarantees, foreign language
- Create a record of final labeling when minor changes occur to
labeling as permitted by generically approved labeling regulations
9 CFR 317.5(b)(9) and 381.133(b)(9), e.g., changes to net weight,
vignette, serving instructions, etc.
- Create a record for any other final labeling as indicated by
9 CFR 317.5(b) and 381.133(b), e.g., shipping containers, animal food,
legends, etc.
- Maintain labeling records
- Temporary approvals
- Final labeling (generic approvals)
Generic Label Record (Final Labeling)
Each generic label record consists of:
- The actual product's label
- The product formulation
- Processing procedure
- Sketch approvals, if appropriate
Establishments should also refer to FSIS's labeling approval regulations in
9 CFR 317.4 and
381.132
and required recordkeeping regulations for labeling in
9 CFR 320.1(b)(11) and
381.175(b)(6).
For additional information, please contact the LCPS at (202) 205-0279 regarding policy issues and
the LCT, at (202) 205-0623 regarding label applications and procedural guidance.
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