Patulin Code Practice

Dr. Terry Troxell
Office of Plant and Dairy Foods and Beverages
Center for Food Safety and Applied Nutrition
Food and Drug Administration
200 C Street, SW
Washington, DC 20204

RE: Proposed Draft Code of Practice for the Prevention of Patulin Contamination in Apple Juice and Apple Juice Ingredients in Other Beverages.

Dear Dr. Troxell:

NFPA has reviewed the proposed Code of Practice referenced above with its members and offers the following comments.

First the Draft Code appears to be more a “Code of Practice for the Production of Apple Juice” rather than a Code specifically targeted to the prevention or limitation of patulin in apple juice. Indeed the Acknowledgements section notes that the draft document is developed from the British Soft Drinks Association “Code of Practice for the Production of Apple Juice.”

We suggest that items not specifically targeted to the prevention or limitation of patulin be deleted from the code. We request that the following paragraphs be deleted from the draft Code of Practice unless specific information can be put forward to demonstrate how the paragraph relates directly to control of patulin in apple juice: 50, 51, 52, 53, 54, 59, 60, 61, 62, 63, 64, and 68.

We further suggest that the title be amended to read “draft Code of Practice for the Prevention or Limitation of Patulin Contamination in Apple Juice.” Even the best controls will not assure complete prevention of patulin. The key is the quality of the fruit used to produce the juice.

We offer the following comments on selected sections of the draft Code of Practice referenced above:


4. We recommend an additional sentence be added at the end of this paragraph as follows: “In light of the JECFA determination the Codex Alimentarius Commission has established a maximum level of 50mg/kg for patulin in single strength apple juice.”

5. The reference (9) listed in Para 5 is a personal communication from IFU. References listed in a draft Code of Practice should be readily available in the literature for easy access to all affected parties. We recommend an appropriate journal reference be cited for this information.

Recommended Practices Based on GAP

12. The first sentence states “Consignments of apples…which do not meet the recommended mineral compositional standards…should be excluded from long-term storage…”

What is the recommended mineral composition of the apples and how does this contribute to the likelihood of patulin contamination? If this is a controlling factor the limits should be contained in the document with supporting references. The last sentence in this paragraph refers to apples having low acidity. Is this the mineral composition to which they refer? If so, this should be stated with the acidity range included in the paragraph (e.g., “Apples having a pH greater than ___ are more susceptible to patulin contamination”).

13. “Where levels of minerals … are outside optimum ranges…”

The calcium and phosphorus levels and calcium/phosphorous ratios should be included in the paragraph if they can influence the tendency for rot (and thereby patulin production) during storage. The cited reference (10) is from 1980. Does the data presented therein represent current apple juice authenticity data bases and include apple juice sourced worldwide? There are several new sources of apple juice concentrate in international trade, which were not available in 1980.

23. Second sentence “Boxes and bins should be cleaned, ideally by hosing with water or preferably by scrubbing with soap and water. Boxes and bins should be adequately dried prior to use.”

The water should be of appropriate sanitary quality to prevent contamination of the boxes or bins. Use of inappropriate water sources can be counterproductive. Suggest the following insertion (…by hosing with suitable clean water or…”

If the boxes and bins are to be washed, they must be dried prior to use. If wooden boxes are not completely dry when put into cold storage, mold can grow on the wood surface and contaminate the fruit.

29. If you provide for mechanical harvesting onto the ground for subsequent recovery (Para 18) how can you avoid contact with the soil? Is there a section missing in Para 18 concerning covering the ground with a suitable drop cloth to prevent direct contact with the soil?

35. The last sentence states: “The prediction is based on the chemical composition of the fruit at or just prior to harvest and the storage conditions available.”

There is no corresponding “chemical composition” provided to make the prediction. Recommend the last sentence be deleted or appropriate guidelines provided in the document.

36. Controlled Atmosphere (CA) storage conditions should be achieved within 24 hours using latest CA technology. Controlled Atmosphere storage conditions will vary according to variety and new technology.

Recommended Practices Based on GMP

Further Treatment and Transportation of Bulk Juice

Although this section contains generic advice that is useful in reducing the risk of microbial degradation or cross-contamination it does not seem meaningful with respect to the purpose of the guideline ” Prevention of Patulin Contamination.” Patulin prevention is controlled by selection of the initial fruit for processing. Later contamination with microorganisms combined with improper storage temperatures will provide an opportunity for quality deterioration and spoilage but it is unlikely that there will be an increase in patulin content. The key spoilage organism, yeast, will ferment the product.

47. The third sentence refers to analysis being conducted “…and other quality measures by appropriate methods in an accredited laboratory.”

There is no need to include the reference to “other quality measures” unless they are items that specifically address the potential for patulin contamination in which case they should be listed. The reference to “accredited” should be deleted from the laboratory reference. Most governments do not “accredit” food laboratories especially food industry laboratories that may be responsible for the testing of their products to confirm the product meets company specifications. If appropriate control measures are in place to assure the removal of susceptible fruit there is no need to test every production lot. Spot-checking of random lots will determine whether the fruit selection process is under control and appropriately limiting patulin levels.

49. There is no need to require a positive release basis provided that appropriate fruit selection has been done. In any case the packer is responsible for the finished product.

51. The packer should only accept product for packing if it complies with a predetermined compositional specification.

What does this have to do with prevention of patulin contamination? Although it is recommended that the packer assure that the product he is receiving is actually 100% apple juice. We suggest the following language be substituted in Para 51.

“The packer should have appropriate controls in place to ensure that patulin levels are within appropriate regulatory and/or company limits.”

55. Suggest the paragraph be modified as follows: “Specifications for the purchase of apple juice concentrates should include an appropriate limit for patulin subject to confirmation by the recipient.”

56. See Para 55. Delete Para 56 as redundant. There is no need to require the testing of every lot. Company experience with the supplier coupled with spot-checking of random lots will confirm continued compliance with company patulin limits.

57. Do we have any evidence of patulin production during transportation and storage of juice or juice concentrate?

58. Same question as Para 57. Yeast fermentation is more likely to occur during improper storage and handling of the product prior to packaging.

65. Suggest a minor rewording “Specifications for the purchase of apple juice or apple juice concentrates should include a maximum limit for patulin based on an appropriate method of analysis.”

Thank you for providing an opportunity to review the proposed Draft Code of Practice for the Prevention of Patulin Contamination in Apple Juice and Apple Juice Ingredients in Other Beverages.


Allen Matthys, Ph. D.
Vice President
Federal and State Regulations