In the United States, the Food and Drug Administration (FDA) regulates the quality, safety, and labeling requirements of fresh produce (including sprouts) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and its subsequent amending statutes including the Produce Safety Rule and Preventative Controls for Human Foods of the Food Safety Modernization Act (FSMA). Sellers must be registered as food business operators, maintain all applicable permits, and adhere to specific guidance, as required by local laws and regulations. All fresh produce sellers supplying to the US market must adhere to good agricultural and good manufacturing practices under 21 CFR 110, 112, and 117.
Sellers are required to submit documentation to Amazon through Azzule Systems, which reflects compliance with applicable regulations or standard requirements, including but not limited to the below:
|Products||Regulation or standard requirements|
MyGFSI.com recognized audit schemes
A valid, for example, not expired, third-party food safety audit certificate at growing, harvesting, cooling, storing, packing, and processing levels. Compliance documentation must be kept updated annually, or at the beginning of a new growing season. Accepted audit schemes are:
For high-risk (Appendix A: definition) raw agricultural commodity produce (Appendix B: product list): only GFSI-recognized audit schemes will be accepted (including GFSI Technical Equivalence). Amazon will not accept group or multi-site certification for high-risk products.
For all remaining raw agricultural commodity and rarely consumed as raw produce (Appendix C: product list): the accepted audit schemes are GFSI-recognized audits (including GFSI Technical Equivalence), Primus Standard Audit (GMP or GAP), and USDA Harmonized Audit (GMP or GAP). Additional audit schemes may be acceptable upon request.
Amazon leverages Azzule Systems to collect and review compliance requirements. The Azzule Supply Chain Program (SCP) facilitates the transmission and analysis of food safety documentation for real-time compliance. Sellers are required to provide food safety compliance documentation that includes the final audit results, certificates, and corrective actions through the Azzule SCP Portal. This ensures timely verification of food safety information. If your organization is contacted by Azzule Systems for compliance documents, complete the following steps to submit the requested information by logging into Azzule SCP portal.
If you do not provide the required information by the applicable deadline, Amazon may:
We reserve the right to take any further actions that may be necessary in our sole discretion.
Appendix A: High-risk fresh produce definition
Fresh produce that are unprocessed or minimally processed (raw) form has an inherent food safety risk due to the nature of the commodity exposing to microbial hazards and good agricultural and management practices common to the growing, harvesting, washing, sorting, packing, and transporting. It has resulted in a number of outbreaks and recalls in recent years therefore Amazon is taking an initiative to improve the safety of fresh produce as it moves from farm to the table with the focus on the production and packing operations.
Appendix B: High-risk raw agricultural commodity produce
|Fresh veg whole||Artichoke-globe type, avocado, Belgian endive, broad bean, broccoli, Brussel sprout, cabbage, Chinese cabbage (bok choy, mustard, and napa), carrot, cauliflower, celery, cress (garden), cucumber, curly endive, dandelion leave, fennel (Florence), green bean, herb (basil, chive, cilantro, oregano, parsley), kale, kohlrabi, leek, lettuce, mushroom (whole), mustard green, onion (whole), parsnip, pea (regular, pigeon), pepper, scallions (whole), snow pea, spinach, summer squash (patty pan, yellow and zucchini), Swiss chard, tomato, and watercress|
|Fresh fruit whole||Apple, apricot, aprium, Asian pear, babaco, banana, blackberry, blueberry, boysenberry, cantaloupe, carambola, chayote fruit, cherry (sweet), currant, gooseberry, grape, honeydew, Kiwi fruit, jujube, melon (Canary, Crenshaw, Persian), mulberry, nectarines, peach, pear, pineapple, plantain, plum, plumcot, quince, raspberry, soursop, sweetsop, strawberry, and watermelon|
|Fresh tropical tree fruits whole||Guava, jackfruit, lychee, mamey, mango, papaya, passion fruit, and starfruit|
|Fresh cut or refrigerated||Apple (slices), avocado chunk, bean-green, string, carrots (shredded or cut), herbs (cut), leafy green: single and mixed greens, mango (cut), melon (cut), micro greens, mixed fruit salad, mushroom (sliced), onions (diced or sliced), packaged single fruit, pineapple (cut), squash or butternut (cut or diced), tomatoes (cut), watermelon (cut), and wheat grass (cut)|
|Sprouts||Alfalfa sprout, bean sprout (garbanzo, mung, soy), broccoli sprout, clover sprout, daikon, green pea, lentil, radish, sunflower, and wheat|
Appendix C: All remaining raw agricultural commodity and rarely consumed as raw produce
|Fresh veg whole: roots||Burdock root, celeriac (celery root), chicory (roots pr tops), garlic, Jerusalem artichoke, rutabaga, turnip (roots or tops), taro, turmeric, radish (roots), and shallots (whole)|
|Fresh fruit whole citrus||Citrus (clementine, grapefruit, lemons, limes, orange, tangerine, tangor, and uniq fruit, genip, and kumquat)|
|RAC: Rarely consumed raw||Asparagus, beet, black bean, cashew, chickpea, cocoa bean, coffee bean, collard, corn, cranberry, date, dill (seed and weed), eggplant, fig, garden (roots and tops), ginger, Great Northern, hazelnut, horseradish, kidney bean, lentil, lima bean, okra, navy bean, pinto bean, sour cherry, peanut, pecan, peppermint, potato, pumpkin, sweet potato, water chestnut, and winter squash|
*Examples are provided but not meant to be an exhaustive list and subject to change.
Updated on [05-06-2021]