Import Alert 26-03
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 26-03
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Perchloroethylene (PCE) and Trichloroethylene (TCE) Residue in Olive Oil"
Reason for Alert:
On April 28, 1988, Import Operations Branch issued an Import Bulletin (26B-01) advising districts of reported findings of PCE or TCE in olive oil by the U.S.D.O.D. and the Government of the Federal Republic of Germany.
On May 2, 1988, ORA issued an assignment to sample shipments of all grades of olive oil. Approximately 160 samples of olive oil were sampled and examined. Levels reported ranged from none (<50 ppb) to 956 ppb with 37 samples containing detectable levels. Trichloroethylene (TCE) was also reported in 7 samples at levels up to 891 ppb. No PCE or TCE was found in three domestically produced olive oil samples tested.
Subsequent review of the findings by CFSAN toxicologists concluded that the levels found should not pose a hazard to the public health. However, in July, 1988, FDA received information from Italy, Spain, France, and Germany which suggests that the industrial solvents, PCE and TCE, are being used in a food additive context in one or more of those countries and that these uses are the source of these substances in the olive oil from those countries. Reported possible uses include putting PCE contaminated olives into the regular production, following extraction of those olives with PCE to test for oil content in the Foss-Let test and use as a solvent for degreasing and cleaning tanks, harvesting nets or other equipment in the plant. In view of this information, the agency is now viewing the PCE and TCE residues in olive oil as unsafe food additives.
Residues were found in the product from many countries. Much of the olive oil from other countries is reportedly produced in Spain, and the bulk of reported residues are in product manufactured in Spain. However, since these products are frequently transshipped, we have no basis for excluding product from any country from the alert. The substances are reportedly found in virgin or cold pressed grades of olive oil. Refining apparently removes the substances
On May 2, 1988, ORA issued an assignment to sample shipments of all grades of olive oil. Approximately 160 samples of olive oil were sampled and examined. Levels reported ranged from none (<50 ppb) to 956 ppb with 37 samples containing detectable levels. Trichloroethylene (TCE) was also reported in 7 samples at levels up to 891 ppb. No PCE or TCE was found in three domestically produced olive oil samples tested.
Subsequent review of the findings by CFSAN toxicologists concluded that the levels found should not pose a hazard to the public health. However, in July, 1988, FDA received information from Italy, Spain, France, and Germany which suggests that the industrial solvents, PCE and TCE, are being used in a food additive context in one or more of those countries and that these uses are the source of these substances in the olive oil from those countries. Reported possible uses include putting PCE contaminated olives into the regular production, following extraction of those olives with PCE to test for oil content in the Foss-Let test and use as a solvent for degreasing and cleaning tanks, harvesting nets or other equipment in the plant. In view of this information, the agency is now viewing the PCE and TCE residues in olive oil as unsafe food additives.
Residues were found in the product from many countries. Much of the olive oil from other countries is reportedly produced in Spain, and the bulk of reported residues are in product manufactured in Spain. However, since these products are frequently transshipped, we have no basis for excluding product from any country from the alert. The substances are reportedly found in virgin or cold pressed grades of olive oil. Refining apparently removes the substances
Guidance:
Districts may detain, without physicla examination, olive oil in import status found to contain over 50 ppb PCE or TCE.
Product Description:
Olive Oil, Virgin Grades or Cold Pressed Grades
Charge:
"The article is subject to refusal of admission pursuant to Section 801 (a)(3) because it appears to be adulterated under Section 402 (a)(2)(C) in that it contains the food additive, perchloroethylene (and/or trichloroethylene), which is unsafe within the meaning of section 409."
OASIS charge code -UNSAFE ADD
OASIS charge code -UNSAFE ADD
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(26 C - - 04) Olive Oil, Refined, Single Ingredient
Notes:olive oil contain over 50 ppb PCE or TCE
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