City of Newton HEALTH AND HUMAN SERVICES DEPARTMENT 1000 Commonwealth Avenue Newton, MA 02459 Telephone 617.796.1420 Fax 617.552.7063 Ruthanne Fuller TDD/TTY 617.796.1089 Mayor APPLICATION FOR LICENSE TO MANUFACTURE FROZEN DESSERTS AND / OR ICE CREAM MIX In accordance with the provisions of Massachusetts General Law Chapter 94, Section 65H and 105 CMR 561.000 Frozen Desserts and Frozen Dessert Mixes, the undersigned hereby applies for a license for the wholesale / retail manufacture of frozen desserts and or ice cream mix. Please Print Legibly Date: Name of Establishment: Establishment Address: Newton, MA 024 Establishment Phone Number: ☐ New Establishment ☐ Existing Establishment ☐ Same as above If not the same as above, list the location of each establishment (plant) where product(s) will be manufacture: Applicant’s Name: Applicant’s Address: Phone Number: Applicant’s Email Address: Owner’s Name: Phone Number: Owner’s Address: Type of Business ☐ Retail Manufacturer ☐ Wholesale Manufacturer If Wholesale Manufacturer, brand and trade name(s) of products: Type of Product ☐ Custard ☐ Gelato ☐ Ice Cream ☐ Frozen Yogurt (not soft-serve) (not soft serve) ☐ Frozen Yogurt ☐ Soft-Serve Ice Cream ☐ Soft-Serve Frozen Yogurt ☐ Sherbet (not soft-serve) ☐ Sorbet (only if dairy-based) ☐ Other: If Frozen Yogurt is manufactured, will it contain “friendly” cultured bacteria (live cultures)? ☐ Yes ☐ No Page 1 of 5 Describe the following Source(s) of Ingredients: No milk or cream from a source outside of the United States, subject to the Federal Import Milk Act, 21 U.S.C §141 et seq., shall be used unless the importer has documentation to show that the exporter is in compliance with 21 CFR Part 1210. ☐ Yes – Type of Machine: ☐ No Will a Soft-Serve Machine(s) be used? How many machines? Submit the specification sheets for the machine(s) If No, describe how the product will be prepared and the storage of the final product: Will commercially pasteurized product(s) be used? ☐ Yes ☐ No If No, describe what will be used and how: Will the above final product be pasteurized? ☐ Yes ☐ No If Yes, describe the pasteurization process: How will the refrigerated and frozen product be delivered and transported? If transported, how will the product temperature be monitored? How often will the surfaces and equipment be cleaned and sanitized? What are the procedures for cleaning the equipment and surfaces and what product will be used? How will the equipment and surfaces be sanitized? Name and Type of Sanitizer: Page 2 of 5 Testing Requirements and Standards All manufactured frozen desserts produced shall have the following tests performed by a certified laboratory on its finished product monthly. Bacterial and other Standards shall not exceed the following standards Item Standard Plate Count (SPC) Coliform Finished Products Produced by means other than a Soft-Serve Machine 50,000/g 20/g Finished Products Produced in a Soft-Serve Machine 50,000/g 50/g ** If Frozen Yogurt contains “live cultures”, SPC laboratory testing is not required ** Copies of all test results for required tests shall be submitted directly to the Newton Health and Human Services by the certified laboratory within three (3) business days of the completion of the tests. SUBMIT THE FOLLOWING ☐ Completed Application for License to Manufacture Frozen Desserts and / or Ice Cream Mix ☐ Completed Food Establishment Plan Review and Food Establishment Application (for new food establishments only) including all of the required documents. Page 6 on the Plan Review Application contains the required documents. ☐ License fee of $5.00 Note: This can be included in the total fee for the Plan Review and Food Establishment Permit ☐ Equipment Specification sheets used in the process (i.e. Soft-Serve Machine(s) etc.) ☐ For existing food establishments, provide a sketch of the processing area and / or the placement of the Soft-Serve Machine(s) ALL APPLICATIONS MUST BE FILLED OUT COMPLETELY WITH A FEE PAYABLE TO THE “CITY OF NEWTON” CASH IS NOT ACCEPTED AT THIS TIME ALL FEES ARE NON-REFUNDABLE Please note that any missing information may cause a delay in the decision making process. STATEMENT: I, hereby certify that the above information is correct and I fully understand that any deviation from the above without prior permission from the Newton Health and Human Services Department may nullify final approval. Additionally, I certify I will manufacture such products only from pure and wholesome ingredients and only under sanitary conditions. Signature: Title: Print Name: FOR OFFICIAL USE ONLY Date Submitted: Fee Received: $ Check #: Updated 1/22/2018 Page 3 of 5 FROZEN DESSERTS AND FROZEN DESSERT MIXES GUIDELINES • What types of establishments are considered frozen dessert manufacturers? 1.Wholesale manufacturing plants that pasteurize raw milk and cream; 2.Wholesale manufacturers who purchase a pasteurized mix and manufacture ice cream; 3.Retail manufacturers* who purchase a pasteurized mix and manufacture ice cream, soft-serve ice cream or frozen yogurt in a “frozen dessert freezing / dispensing machine.” *It is important that the term manufacturer be understood as it pertains to frozen desserts. The term manufacturer or frozen dessert manufacturer as it appears in the regulations includes any retail establishment operating a frozen dessert freezing/dispensing machine. A “frozen dessert freezing/dispensing machine” is any machine that freezes, mixes and dispenses frozen desserts. This includes soft serve machines frequently operated at the retail level. This means that all frozen dessert manufacturers, whether wholesale or retail, require licensing by the local board of health having jurisdiction. • What types of establishments are NOT considered frozen dessert manufacturers? 1.Stores and restaurants that purchase ice cream in bulk and scoop it, but do not make ice cream in a frozen dessert freezing/dispensing machine; 2.Retail stores that purchase ice cream or other frozen desserts in pre-packaged retail containers for re-sale to the public; 3.Vending machines that dispense packaged ice cream, novelties, etc.; and 4.“Dispensing only machines.” Dispensing only machines are machines that dispense a prepackaged ready-to-use frozen dessert. These machines do not mix or freeze a mixture. They merely dispense it. Therefore the machine is not considered a manufacturing machine. Testing and Testing Exemptions 105 CMR 561.007 states that all manufacturers must have their frozen dessert products tested monthly by an approved laboratory. Section 561.007(F) (2) (a) refers to seven categories of frozen dessert products. The intent is to require bacteriological testing for dairy-based frozen desserts only. Dairy-based frozen desserts such as ice cream, sherbet and frozen yogurt are frozen dessert products that contain dairy ingredients. Non-dairy frozen desserts no longer require bacteriological testing. Non-dairy frozen desserts, such as sorbet, water ices, Italian ice, slush and some frozen coffee beverages are frozen desserts that do not contain any dairy ingredients. These products do not pose the same potential for supporting pathogenic organisms as do frozen desserts that do contain dairy ingredients. Therefore, testing of non-dairy frozen desserts is no longer required. According to 105 CMR 561.007 all frozen dessert manufacturers (this includes soft serve dispensing machines and ice cream barrel freezers) shall have bacteriological tests performed on at least one dairy-based frozen dessert product per month by a certified laboratory. The laboratory must submit copies of the results to the board of health upon completion of the analysis. If the SPC is above the 50.000 limit, the Person-in-Charge (PIC) shall: 1. Review the cleaning and sanitization procedures for the machine. Check the machine’s specification sheets for additional instructions and cleaning protocols for the machine. 2. Evaluate the handling of the products / ingredients. 3. If SPC is above the limit for two (2) consecutive samplings, additional sampling will be required. If the Coliform Count is above the 20/g (produced other than from a soft-serve machine) or 50/g (products from a soft-serve machine), the PIC shall: 1.Review the cleaning and sanitization procedures for the machine. Check the machine’s specification sheets for additional instructions and cleaning protocols for the machine. 2. Evaluate the handling of the products / ingredients. 3. If one (1) sample is above the required standard, resampling will be required. The presence of coliform is an indicator of inadequate operational sanitation and controls somewhere in the process. Bacteria counts slightly above the standards should be a wake -up call. It should alert the machine operator that something might not be right with cleaning, temperature, storage or handling. If a high coliform count is found (coliform count is an indicator that pathogens might be present), further testing is necessary to confirm actual pathogens. Page 4 of 5 Helpful Recommendations • Check all pieces of the machines components for pitting, cuts, clean ability etc. Often worn parts can lead to bacteria problems even when cleaning and sanitizing are completed properly. • Be sure to follow the disassembling, cleaning, sanitizing and assembly of the frozen dessert machines are performed as indicated by manufacturers’ recommendation and at the required frequency. Verify the machine has been maintained properly. • Wear gloves when assembling the machine. Be sure to wash hands properly prior to glove use. Codes can be found at the following websites: City of Newton http://www.newtonma.gov/health Frozen Desserts & Frozen Dessert Mixes https://www.mass.gov/files/documents/2017/10/26/license-frozen-desserts.pdf MA State Sanitary Code Chapter X - Minimum Sanitation Standards for Food Establishments 105 CMR 590.000 https://www.mass.gov/files/documents/2018/10/09/105cmr590.pdf FDA 2013 Food Code http://www.fda.gov/downloads/food/guidanceregulation/retailfoodprotection/foodcode/ucm374510.pdf Page 5 of 5 .