Updated: 2005-11-29
Sec. 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products -
Adulteration with Patulin This guidance document represents the Agency's current thinking
on its enforcement process bbconcerning the adulteration of apple juice,
apple juice
concentrates, and apple juice products with patulin. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
INTRODUCTION
This compliance guidance document is an update to the Compliance Policy
Guides Manual (August 2000 edition). It is a new CPG and will be included
in the next printing of the Compliance Policy Guides Manual. It is intended
for FDA personnel and is available electronically to the public.
BACKGROUND:
Patulin is a toxic substance produced by molds that may grow on apples.
In the past, patulin has been found to occur at high levels in some apple
juice products offered for sale in or import into the U.S.
REGULATORY ACTION GUIDANCE:
The following criteria should be considered in deciding whether to recommend
legal action or whether to recommend detention of imports to CFSAN/Office
of *Compliance/Division of Enforcement* (HFS-605):
The sample is analyzed in accordance with applicable methods of the current
Official Methods of Analysis of the Association of Official Analytical
Chemists1, and its supplements, and both of the following conditions are
met:
- Original and check analysis show patulin at or above 50 micrograms
per kilogram (50 parts per billion) as determined on single strength
apple
juice, reconstituted single strength apple juice (if the food is an
apple juice concentrate), or the single strength apple juice component
of the
food (if the food contains apple juice as an ingredient); (For the
purpose of this guidance, single strength juice is 100 percent juice
that is unconcentrated
(see 21 CFR 101.30(h)).)
and
- Identity of patulin is confirmed by gas chromatography/mass spectrometry.
SPECIMEN CHARGE:
For domestic goods:
The article (apple juice, apple juice concentrate, or apple juice
product) was adulterated when introduced into and while in interstate
commerce and
is adulterated while held for sale after shipment in interstate commerce
within the meaning of 21 U.S.C. 342 (a)(1), in that it bears or contains
an added poisonous or deleterious substance, patulin, which may render
the article of food injurious to health.
For imported goods:
The article (apple juice, apple juice concentrate, or apple juice
product) is subject to refusal of admission pursuant to 21 U.S.C.
381 (a)(3) in
that it appears to bear or contain an added poisonous or deleterious
substance, patulin, which may render the article injurious to health
(adulteration
under 21 U.S.C. 342 (a)(1)).
1 At the time of this issuance, the current method can be
found in the Seventeenth Edition, section 995.10 - Patulin in apple
juice, liquid chromatographic method, AOAC-IUPAC-IFJU Method. This method
was adopted by AOAC International in 1995. The method was published
in JAOAC 79(2):452-455, 1996.
*Material between asterisks is new or revised.*
Issued: 10/22/2001
Revised: 5/2005
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