Additional copies are available from:
Division of Compliance Policy HFC-230
Office of Enforcement
Office of Regulatory Affairs
Food and Drug Administration
5600 Fishers Lane
Rockville, MD� 20857
(Tel) 240-632-6860
http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg540-700.html
You may submit written or electronic comments regarding this guidance at any time.� Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.� Submit electronic comments to http://www.regulations.gov.� All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
U.S. Department of Health and Human
Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulatory Affairs (ORA)
November 2008
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic.� It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.� You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. �If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. �If you cannot identify the appropriate FDA staff, call the appropriate telephone number listed on the title page of this guidance.
The purpose of this document is to provide guidance for FDA staff on the proper labeling for processed and/or blended seafood products. �
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. �Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. �The use of the word should in Agency guidances means that something is suggested or recommended, but not required.*
*Surimi is a fish protein consisting primarily of the myofibrillar protein
fraction from one or more fish species.� Surimi is an intermediate processed
seafood product used in the formulation and fabrication of a variety of products
that are made to resemble, and be promoted as substitutes for, crabmeat, shrimp,
lobster, scallops, and other seafood.
Surimi is made from minced fish meat (usually pollock), which has been washed
to remove fat and undesirable matter (such as blood, pigments, and odorous
substances), and then mixed with cryoprotectants (such as sugar or sorbitol)
to improve its frozen shelf life.� In formulating finished seafood products,
surimi is thawed and blended with other ingredients such as the seafood being
imitated, seafood flavoring, salt, water, and starch or egg white.� This mixture
is then heat processed and extruded to make fibrous, flake, chunk, and composite-molded
consumer products.� The finished processed seafood products are marketed frozen
or unfrozen and may be breaded.
The following guidance is in response to inquiries FDA has received regarding the proper labeling for processed seafood products and current regulations to permit the use of "and/or" labeling for various fish species used in the production of surimi and processed seafood products (21 CFR 101.4(b)(23); 64 FR 50445, 9/17/99).*
III. Policy:
*Material between asterisks is new or revised.*
Issued:� 6/3/85
Reissued:� 10/30/89
Revised:�� 11/2008