Fla. Admin. Code Ann. R. 5K-10.006 - Hemp Extract

(1) Products. Milk, Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption are subject to the requirements of Chapter 502, F.S., Section 581.217, F.S., and Chapter 5K-10, F.A.C., in addition to the requirements of this rule. Grade "A" milk and milk products to which Hemp or Hemp Extract for Human Consumption has been added shall be considered "Substitute Milk" or "Substitute Milk Products" as defined in Chapter 502, F.S. In addition to the requirements in Section 502.165, F.S., Substitute Milk and Substitute Milk Products containing Hemp or Hemp Extract for Human Consumption are subject to the requirements of Chapter 5K-10, F.A.C.

(2) Definitions. The definitions provided in Sections 502.012 and 581.217, F.S., and the following shall apply to this rule:

(a) "Approved Source" for the purposes of this rule means Hemp Frozen Dessert Plant, Hemp Substitute Milk Manufacturer, or Hemp Substitute Milk Product Manufacturer manufacturing, processing, packing, holding, or preparing or selling Substitute Milk, Substitute Milk Products, or Frozen Desserts at wholesale or retail that meet the requirements of Section 581.217(7)(a)1.d., F.S.

(b) "Attractive to Children" is defined in Section 581.217(3)(a), F.S.

(c) "Batch" or "Lot" means the Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption produced during a period of time under similar conditions and identified by a specific code that allows traceability.

(d) "Color Additive" is as defined in s. 500.03(1)(g), F.S. Food additives which contribute their own natural color when mixed with foods or other food ingredients are not regarded as color additives, except when used for the purpose of adding color to a food product.

(e) "Expiration Date" means the month and year as determined by the processor, plant, manufacturer, packer, or distributor based on tests or other information showing that the product, until that date, under the conditions of handling, storage, preparation, and use per label directions, will when consumed, contain not less than the quantity of each ingredient as set forth on its label.

(f) "Hemp" is defined in Section 581.217(3)(e), F.S.

(g) "Hemp Extract" is defined in Section 581.217(3)(f), F.S.

(h) "Hemp Frozen Dessert Plant" means a Frozen Dessert Plant who manufactures, processes, converts, partially freezes, or freezes any mix or frozen dessert containing Hemp or Hemp Extract for Human Consumption for distribution or sale.

(i) "Hemp Substitute Milk Manufacturer" means any place, premises, or establishment where Substitute Milk containing H Hemp or Hemp Extract for Human Consumption is collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, condensed, dried, packaged, bottled, or prepared for distribution at wholesale.

(j) "Hemp Substitute Milk Product Manufacturer" means any place, premises, or establishment where Substitute Milk Products containing Hemp or Hemp Extract for Human Consumption is collected, handled, processed, stored, pasteurized, ultra-pasteurized, aseptically processed and packaged, retort processed after packaging, condensed, dried, packaged, bottled, or prepared for distribution at wholesale.

(k) "Human Consumption" includes products intended for human Ingestion and/or human Inhalation but does not include topical applications.

(l) "Ingestion" means the process of consuming Hemp or Hemp Extract through the mouth whether by swallowing into the gastrointestinal or through tissue absorption.

(m) "Total delta-9 tetrahydrocannabinol concentration" means [delta-9 tetrahydrocannabinol] + (0.877 x [delta-9 tetrahydrocannabinolic acid]).

(3) Permits and Fees. Hemp Substitute Milk, Hemp Substitute Milk Products, and Hemp Frozen Dessert Manufacturers shall obtain a permit and pay the applicable fee required in Rule 5K-10.002, F.A.C.

(4) Requirements.

(a) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must originate from an Approved Source. The Hemp Frozen Dessert Plant, Hemp Substitute Milk Manufacturer, or Hemp Substitute Milk Product Manufacturer shall provide to the department, upon request, a valid dairy or food safety license/permit and the most recent dairy or food safety inspection report from the Approved Source.

(b) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must be stored and transported in accordance with Chapter 5K-10, F.A.C. Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must be packaged in containers minimizing the exposure to light to prevent degradation of the Cannabinoids.

(c) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption shall not contain a Total delta-9 tetrahydrocannabinol concentration of more than 0.3%.

(5) Contaminants. In addition to the requirements listed in Chapter 502, F.S., and Rule 5K-10.004, Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption shall be considered adulterated pursuant to Section 502.181(2), F.S., if contaminants are detected at levels greater than those listed in this rule.

(a) Pesticide Limits. The following list of contaminants does not constitute authorization to use or apply any of the following during Hemp cultivation or processing.

1. Abamectin, 300 parts per billion.

2. Acephate, 3,000 parts per billion.

3. Acequinocyl, 2,000 parts per billion.

4. Acetamiprid, 3,000 parts per billion.

5. Aldicarb, 100 parts per billion.

6. Azoxystrobin, 3,000 parts per billion.

7. Bifenazate, 3,000 parts per billion.

8. Bifenthrin, 500 parts per billion.

9. Boscalid, 3,000 parts per billion.

10. Captan, 3,000 parts per billion.

11. Carbaryl, 500 parts per billion.

12. Carbofuran, 100 parts per billion.

13. Chlorantraniliprole, 3,000 parts per billion.

14. Chlordane, 100 parts per billion.

15. Chlorfenapyr, 100 parts per billion.

16. Chlormequat chloride, 3,000 parts per billion

17. Chlorpyrifos, 100 parts per billion.

18. Clofentezine, 500 parts per billion.

19. Coumaphos, 100 parts per billion.

20. Cyfluthrin, 1,000 parts per billion.

21. Cypermethrin, 1,000 parts per billion.

22. Daminozide, 100 parts per billion.

23. DDVP (Dichlorvos), 100 parts per billion.

24. Diazinon, 200 parts per billion.

25. Dimethoate, 100 parts per billion.

26. Dimethomorph, 3,000 parts per billion.

27. Ethoprop(hos), 100 parts per billion.

28. Etofenprox, 100 parts per billion.

29. Etoxazole, 1,500 parts per billion.

30. Fenhexamid, 3,000 parts per billion.

31. Fenoxycarb, 100 parts per billion.

32. Fenpyroximate, 2,000 parts per billion.

33. Fipronil, 100 parts per billion.

34. Flonicamid, 2,000 parts per billion.

35. Fludioxonil, 3,000 parts per billion.

36. Hexythiazox, 2,000 parts per billion.

37. Imazalil, 100 parts per billion.

38. Imidacloprid, 3,000 parts per billion.

39. Kresoxim-methyl, 1,000 parts per billion.

40. Malathion, 2,000 parts per billion.

41. Metalaxyl, 3,000 parts per billion.

42. Methiocarb, 100 parts per billion.

43. Methomyl, 100 parts per billion.

44. Methyl parathion, 100 parts per billion.

45. Mevinphos, 100 parts per billion.

46. Myclobutanil, 3,000 parts per billion.

47. Naled, 500 parts per billion.

48. Oxamyl, 500 parts per billion.

49. Paclobutrazol, 100 parts per billion.

50. Pentachloronitrobenzene, 200 parts per billion.

51. Permethrin, 1,000 parts per billion.

52. Phosmet, 200 parts per billion.

53. Piperonyl butoxide, 3,000 parts per billion.

54. Prallethrin, 400 parts per billion.

55. Propiconazole, 1,000 parts per billion.

56. Propoxur, 100 parts per billion.

57. Pyrethrins, 1,000 parts per billion.

58. Pyridaben, 3,000 parts per billion.

59. Spinetoram, 3,000 parts per billion.

60. Spinosad A & D, 3,000 parts per billion.

61. Spiromesifen, 3,000 parts per billion.

62. Spirotetramat, 3,000 parts per billion.

63. Spiroxamine, 100 parts per billion.

64. Tebuconazole, 1,000 parts per billion.

65. Thiacloprid, 100 parts per billion.

66. Thiamethoxam, 1,000 parts per billion.

67. Trifloxystrobin, 3,000 parts per billion.

(b) Residual Solvent Limits.

1. 1,2-Dichloroethene, 5 parts per million

2. 1,1-Dichloroethene, 8 parts per million

3. Acetone, 5,000 parts per million

4. Acetonitrile, 410 parts per million

5. Benzene, 2 parts per million

6. Butane, 2,000 parts per million

7. Chloroform, 60 parts per million

8. Ethanol, 5,000 parts per million

9. Ethyl Acetate, 5,000 parts per million

10. Ethyl Ether, 5,000 parts per million

11. Ethylene Oxide, 5 parts per million

12. Heptane, 5,000 parts per million

13. Hexane, 290 parts per million

14. Isopropyl Alcohol, 500 parts per million

15. Methanol, 3,000 parts per million

16. Methylene Chloride, 600 parts per million

17. Pentane, 5,000 parts per million

18. Propane, 2,100 parts per million

19. Toluene, 890 parts per million

20. Trichloroethylene (1,1,2-Trichloroethene), 80 parts per million

21. Xylenes, Total (ortho-, meta-, para-), 2170 parts per million

(c) Metals Limits.

1. Cadmium, 0.5 micrograms/gram.

2. Lead, 0.5 micrograms/gram.

3. Arsenic, 1.5 micrograms/gram.

4. Mercury, 3.0 micrograms/gram.

(d) Biological Limits.

1. Shiga toxin-producing Escherichia coli (STEC E. coli) and other pathogenic E. coli, none present.

2. Listeria monocytogenes, none present.

3. Salmonella, none present.

(e) Mycotoxin Limits.

1. Total Aflatoxin (B1, B2, G1, G2), 20 parts per billion.

2. Ochratoxin, 20 parts per billion.

(f) Cannabinoid Limits. Total delta-9 tetrahydrocannabinol concentration shall not exceed 0.3%.

(g) Color additives prohibited for Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Human Consumption:

1. FD&C Blue No. 1

2. FD&C Blue No. 2

3. FD&C Green No. 3

4. Orange B

5. Citrus Red No. 2

6. FD&C Red No. 3

7. FD&C Red No. 40 (Allura Red)

8. FD&C Yellow No. 5

9. FD&C Yellow No. 6

10. FD&C Red No. 3

11. Cochineal extract

12. Carmine

13. Mica-based pearlescent pigments

14. Quinoline Yellow (FD&C Yellow No. 10)

15. Yellow 2G

16. FD&C Green No. 1

17. FD&C Green No. 2

18. FD&C Red No. 1

19. FD&C Red No. 2, Amaranth

20. FD&C Red No. 4, Ponceau SX

21. FD&C Violet No. 1

22. Azorubine Carmoisine

23. Ponceau 4R, Ponceau Red, Cochineal Red A

24. Patent Blue V

25. Green S

26. Brilliant Black BN, Black PN

27. Brown FK

28. Brown HT, Chocolate Brown

29. Cuttlefish Black

30. Cuttle Black

31. Alkanet (Alkane)

32. Carbon Black, Vegetable Carbon

33. Charcoal-NF XI

34. Cudbear

35. Ferric Chloride

36. Ferrous Sulfate

37. Logwood, Chip & Extract

(h) The following substances are prohibited for use in Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption when used as a color additive:

1. Annatto extract

2. Dehydrated beets (beet powder)

3. Butterfly pea flower extract

4. Calcium carbonate

5. Canthaxanthin

6. Caramel

7. [BETA]-Apo-8'-carotenal

8. [BETA]-Carotene

9. Sodium copper chlorophyllin

10. Toasted partially defatted cooked cottonseed flour

11. Ferrous gluconate

12. Ferrous lactate

13. Grape color extract

14. Grape skin extract (enocianina)

15. Synthetic iron oxide

16. Fruit juice

17. Vegetable juice

18. Carrot oil

19. Paprika

20. Paprika oleoresin

21. Riboflavin

22. Saffron

23. Soy Leghemoglobin

24. Spirulina extract

25. Titanium dioxide

26. Tomato lycopene extract

27. Tomato lycopene concentrate

28. Tumeric

29. Tumeric oleoresin

(i) If a testing sample is found to contain levels of any pathogen, toxicant, residual solvent, metal, color additive, controlled substance, drug, or pesticide not enumerated in this rule or by Florida law the Substitute Milk, Substitute Milk Product, or Frozen Dessert containing Hemp or Hemp Extract for Human Consumption shall be considered adulterated.

(6) Product, Packaging, Labeling, and Advertisement. Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption must comply with and be packaged and labeled in accordance with Chapter 502, F.S., Section 581.217(7), F.S., Rule 5K-4.034, F.A.C., and 21 CFR 101 . The label must also contain the name and address of the manufacturer or plant. 21 CFR 101 (Revised April 1, 2019) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-11459 and by email request to the department at FoodSafety@FDACS.gov. Advertisements for Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption shall comply with Section 581.217, F.S., and Rule 5K-4.034, F.A.C.

(7) Disposal.

(a) Laboratory samples found to contain more than a Total delta-9 tetrahydrocannabinol concentration of 0.3% shall be disposed of in accordance with 21 CFR 1317 . 21 CFR 1317 (Revised April 1, 2019) is hereby incorporated by reference and available online at http://www.flrules.org/Gateway/reference.asp?No=Ref-11460 and by email request to the department at FoodSafety@FDACS.gov.

(b) Substitute Milk, Substitute Milk Products, or Frozen Desserts containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% shall be detained pursuant to Section 502.014, F.S. Substitute Milk, Substitute Milk Products, or Frozen Desserts containing a Total delta-9 tetrahydrocannabinol concentration that exceeds 0.3% which have been detained pursuant to Section 502.014, F.S., shall not be further subdivided or renumbered such that the integrity of the lot for identification is not maintained. The establishment shall not dispose of the Substitute Milk, Substitute Milk Products, or Frozen Desserts in any manner until written permission for removal, use, or disposal is given by the department or a court of competent jurisdiction.

(8) Penalties.

(a) Violations of this rule will be evaluated, and penalties imposed in accordance with Rule 5K-10.005, F.A.C.

(b) Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption sold in violation of this rule shall be considered adulterated pursuant to subsection 502.181(2), F.S.

(c) The sale of Substitute Milk, Substitute Milk Products, and Frozen Desserts containing Hemp or Hemp Extract for Human Consumption to persons under the age of 21 is punishable as provided in paragraph 581.217(7)(d), F.S., and shall result in an administrative fine of $5,000 per occurrence.

Notes

Fla. Admin. Code Ann. R. 5K-10.006

Rulemaking Authority 502.014, 502.053, 570.07(23), 581.217(12) FS. Law Implemented 502.012, 502.014, 502.032, 502.042, 502.053, 502.091, 502.121, 502.165, 502.231, 581.217(7) FS.

Adopted by Florida Register Volume 45, Number 243, December 17, 2019 effective 1/1/2020, Amended by Florida Register Volume 48, Number 091, May 10, 2022 effective 5/22/2022, Amended by Florida Register Volume 50, Number 253, December 31, 2024 effective 1/12/2025.

New 1-1-20, Amended 5-22-22.