IA #12-12 REVISION - 4/17/01 SUBJ: IMPORT ALERT #12-12, "Detention Without Physical Examination of Cheeses Containing Nitrates." (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or product(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). TYPE OF ALERT: Detention without Physical Examination PRODUCT: Cheese PRODUCT CODE: See Attachment PROBLEM: Nitrates PAF: FAD (Food Additive) PAC FOR COLLECTION: 09006A COUNTRY: See Attachment MANUFACTURERS/ SHIPPER/FEI #: See Attachment 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 RECOMMENDING OFFICE: NYK-DO (HFR-NE152) 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 from the firm's identified on the attachment for this alert. For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 443-3320 or 3007. PRIORITIZATION GUIDANCE: I FOI: No purging is necessary KEYWORDS: Cheese, nitrates, additives PREPARED BY: Stella Notzon, Division of Import Operations and Policy, HFC-170, 301-443-6553 DATE LOADED INTO FIARS: April 17, 2001 Attachment to Import Alert # 12-12 (Firms/products that may be subject to DWPE) NORWAY (NO) Firm Name and Address: Product/PC Date of DWPE: Norwegian Dairies Association Part-Skim Spiced 4/17/01 P.O. Box 9051 Vaterland Cheese Oslo 1, Norway "Nokkel Skorpefri" FEI # 1000181201 Nokelost Brand 12A- -19 SPAIN (ES) Hijos de Salvador Rodriguez, S.A. Cured Sheep Milk Cheese 4/17/01 Ctra. de Mozar, Km. 1 El Pastor de Santa Cristina Brand 49620 Sta. Cristina de la Polvorosa "Queso Zamorano" Zamora, Spain 12A- - 52 FEI # 3002973879