Compliance Policy Guide
Compliance Policy Guidance for FDA StaffCHAPTER - 5
SUB CHAPTER - 510
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 concerning 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 Field
Programs/Division of Enforcement and Programs (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:
1. 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
2. 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)).
Issued: 10/22/2001
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.
Page created: tc October 25, 2001 |