Import Alert 12-12

(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 # 12-12
Published Date: 02/09/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Cheeses Containing Nitrates"

Reason for Alert:

Reason for Alert:





Label review of an entry of pasteurized, part skim, Spiced Cheese, found the label to declare "Conserveringsmiddel (E251)" (Preservative E251). Label review of a second entry of Spanish Cured, Sheep Milk Cheese, found the label to declare "conservante (E252)." Currently the European system of naming food additives lists E251 as sodium nitrate and E252 as potassium nitrate.





There are no regulations that provide for the use of these or other salts of nitrates in dairy products including cheeses. In addition, FDA believes that these ingredients are not "generally recognized as safe" for their intended uses in cheese.

Guidance:

Districts may detain, without physical examination, the specified products manufactured by the firms identified in the Red List of this import alert.





***When Districts encounter violative shipments of product containing non-permitted additives, a recommendation for detention without physical examination and accompanying information, including product labels, should be forwarded to Division of Import Operation (DIO), Import Operations and Maintenance Branch (IOMB). DIO, in turn, will coordinate with Center for Food Safety and Applied Nutrition (CFSAN).





Districts do not need to analyze products for nitrates if this non-permitted additive is declared on the label. Products which list a nitrates additive on the label may be detained without physical examination. Recommendations for detention without physical examination should be forwarded to DIO/IOMB, along with the product label and invoice.





Products which contain non-permitted additives are adulterated and cannot be reconditioned.





In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis, which verifies the product does not contain nitrates.





In order to remove a firm from detention without physical examination, information should be provided which enables the Agency to assess whether the firm has identified the source of the problem, and has taken the appropriate steps to correct and prevent future occurrences. FDA recommends a firm requesting removal from detention without physical examination provide the following information:





1. Results of the firm's investigation(s) into the problem (i.e. failure to meet label declarations)


2. Documentation showing corrective action(s) taken in response to the findings of this investigation. This should include, at a minimum:


a. A description of current manufacturing processes; and


b. Labeling, analytical results, and supporting records, charts, and/or chromatograms for 3 production batches.


3. Documentation confirming a minimum of five (5) consecutive import entries have been released by FDA based on private laboratory analyses and corrected product labels of shipments.





For additional guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination (DWPE)."





If a firm, shipper or importer wishes to request removal from detention without physical examination, they should forward information supporting their request to FDA at the following address:





Food and Drug Administration


Division of Import Operations and Policy


12420 Parklawn Drive, ELEM-3109


Rockville, MD 20857





Or





Via email: Importalerts2@fda.hhs.gov





Requests for removal from detention without physical examination will be reviewed by DIO and then referred to CFSAN for additional evaluation.***





For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at (301) 796-6600.





***For questions or issues concerning import operations, contact DIO, Import Operations and Maintenance Branch at (301) 796-0356.





Other questions may be directed to CFSAN, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch (HFS-607) at (240) 402-1750.***

Product Description:

Cheese (see attachment)





Product Codes:





12[][][][][]

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a food additive which is unsafe within the meaning of Section 409. [Adulteration, Section 402(a)(2)(c)]





OASIS charge code - UNSAFE ADD

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


BELGIUM


Kempico C.V.
Date Published : 08/17/2012
Melkerijstraat 1 , Gierle, Antwerp BELGIUM
12 A - - 52 Cheese, Semisoft
Date Published: 08/17/2012

Desc:Fontal Fiorella Cheese
Problems: SODIUM NITRITE CFR-172.175/177 (PRE);


EGYPT


Four M Export & Import
Date Published : 11/15/2010
11 morkus bechara street-shoubra-cairo , 5 ahmad sadek street - shoubra - cairo , Cairo, EG-C EGYPT
12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 11/15/2010

Desc:Roomy Cheese (hard Buffalo
Notes:NOTE: Products from Four M Export & Import are subject to DWPE unless shown to not be Roomy Cheese manufactured by Halayeb For Dairy Product & Juice S.A.E

12 C - - 99 Cheese Products, Non-Standardized, N.E.C.
Date Published: 11/15/2010

Desc:Roomy Cheese (hard Buffalo
Notes:NOTE: Products from Four M Export & Import are subject to DWPE unless shown to not be Roomy Cheese manufactured by Halayeb For Dairy Product & Juice S.A.E

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 11/15/2010

Desc:Roomy Cheese (hard Buffalo & Cow's milk cheese)
Notes:NOTE: Products from Four M Export & Import are subject to DWPE unless shown to not be Roomy Cheese manufactured by Halayeb For Dairy Product & Juice S.A.E

Halayeb For Dairy Product & Juice S.a.e
Date Published : 11/15/2010
Industrial Zone , New Damietta, EGYPT
12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 11/15/2010

Desc:Roomy Cheese (hard Buffalo & Cow's Milk Cheese)
Notes:NOTE: Products from Four M Export & Import are subject to DWPE unless shown to not be Roomy Cheese manufactured by Halayeb For Dairy Product & Juice S.A.E

12 C - - 99 Cheese Products, Non-Standardized, N.E.C.
Date Published: 11/15/2010

Desc:Roomy Cheese (hard Buffalo
Notes:NOTE: Products from Four M Export & Import are subject to DWPE unless shown to not be Roomy Cheese manufactured by Halayeb For Dairy Product & Juice S.A.E

12 Y - - 99 Cheese And Cheese Products, Not Elsewhere Mentioned, N.E.C.
Date Published: 11/15/2010

Desc:Roomy Cheese (hard Buffalo & Cow's Milk Cheese)
Notes:NOTE: Products from Four M Export & Import are subject to DWPE unless shown to not be Roomy Cheese manufactured by Halayeb For Dairy Product & Juice S.A.E


LITHUANIA


AB Zemaitijos Pienas
Date Published : 12/18/2013
Sedos g. 35 , STREET , Telsiu r. sav., Telsiu LITHUANIA
12 A - - 12 Cheese, Edam
Date Published: 12/18/2013

Desc:Palanga Cheese
Problems: POTASSIUM NITRITE CFR-172.160 (PRE/ILL);


NETHERLANDS


A-ware Packaging B.V.
Date Published : 10/03/2013
Handelsweg 3 , Zeewolde, NL-FL NETHERLANDS
12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 10/03/2013

Desc:Maasdam Cheese
Notes:Problem; Sodium Nitrate

12 A - - 60 Cheese, Swiss, Emmentaler
Date Published: 10/03/2013

Desc:Maasdam Cheese
Notes:Problem; Sodium Nitrate

Drents-Overijsselse Coop. Kaas B.A.
Date Published : 10/03/2013
Alteveerstraat 70 , Hoogeveen, Drenthe NETHERLANDS
12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 10/03/2013

Desc:Maasdam Cheese
Notes:Problem; Sodium Nitrate

12 A - - 60 Cheese, Swiss, Emmentaler
Date Published: 10/03/2013

Desc:Maasdam Cheese
Notes:Problem; Sodium Nitrate

Visser Kaashandel BV
Date Published : 06/07/2010
Nijverheidsweg 20 , Huizen, Noord-holland NETHERLANDS
12 A - - 12 Cheese, Edam
Date Published: 06/07/2010

Desc:Edam Cheese


NORWAY


Norwegian Dairies Association
Date Published : 09/10/2009
P.O. Box 9051 Vaterland , Oslo 1, NORWAY
12 A - - 19 Cheese, Hard (Chesire,Esrum,Fortina,Fortine,Kasseni,Mozzarella,Montasio,Pecarino,Port Salut, Etc)
Date Published: 09/10/2009

Notes:Part-Skim Spiced Cheese "Nokkel Skorpefri" Nokelost Brand 4/17/2001


UKRAINE


Jsc Shostka Dairy Plant
Date Published : 09/10/2009
41103 , Shostka, UKRAINE
12 - - - -- Cheese/Cheese Prod
Date Published: 11/27/2009

Notes:3/29/2006