Committee Advice on the safety of cannabidiol (CBD) isolate as a novel food for use in food supplements - RP225

Reference number RP225

Advisory Committee on Novel Foods and Processes (ACNFP)

Regulated Product Dossier Assessment

Assessment finalised: September 2025

Summary

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2021 from Eusphera Nutraceuticals. (“the applicant”) for the authorisation of cannabidiol (CBD) isolate as a novel food.

The novel food is a CBD isolate which is intended to be used as a food ingredient in food supplements for adults (excluding pregnant and lactating women and other specifically identified vulnerable groups such as those taking medication and the immunosuppressed).

The novel food was assessed based on the data provided. This review indicated it was appropriate for the provisional ADI for 98% or greater purity CBD to form part of the evidence for this assessment. For CBD a provisional acceptable daily intake (ADI) of 10 mg/day for a healthy 70 kg adult has been published by the FSA and was considered in assessing this novel food. The provisional ADI (section 2.7) was recommended, subject to the existing advice to consumers that pregnant and breastfeeding women and people taking any prescription medication should avoid the consumption of CBD. Consumers on regular medications should seek advice from a medical professional before using any type of CBD food product. In addition, children and prospective parents trying for a baby are advised against consumption of CBD, as are those who are immunosuppressed, due to remaining data gaps and residual uncertainties concerning the safety of CBD for these groups of consumers. These contraindications would also apply to this novel food.

To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. The Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the food is safe and does not put consumers at a nutritional disadvantage.

The Committee concluded that the applicant had provided sufficient information to assure the novel food, which is an isolated CBD as detailed in application RP 225, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in foods and food supplements was not considered to be nutritionally disadvantageous.

1. Introduction

1. The ACNFP assessed the food safety risks of CBD isolated from hemp (Cannabis sativa) and its production under the proposed uses in line with Article 7 of assimilated Commission Implementing Regulation (EU) 2017/2469. The regulatory framework and the retained technical guidance put in place by the European Food Safety Authority (EFSA) for full novel food applications is applicable and formed the basis and structure for the assessment (EFSA NDA Panel, 2016). 

2. An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2021 from Eusphera Nutraceuticals. (“the applicant”) for the authorisation of isolated cannabidiol (CBD) as described in RP 225, as a novel food. The novel food is a ≥98% pure, hemp-derived (Cannabis sativa) CBD isolate, which is intended to be used as an ingredient in food supplements for adults excluding pregnant and lactating women and other specifically identified vulnerable groups including those taking medication and the immunosuppressed.

3. Advice on the quality of the toxicological evidence submitted in support of the application was sought from the joint Subgroup of the ACNFP and the Committee on Toxicity (COT) which has been considering the safety of CBD and hemp derived products containing 98% or more CBD (ACNFP and COT, 2023). The Subgroup’s advice, together with wider evidence available in the public domain, was considered in reviewing the toxicological evidence for this application.

4. Following the review by the ACNFP at the 173^rd meeting, final recommendations were presented, allowing the Committee Advice to be concluded.

5. This document outlines the conclusions of the ACNFP on the safety of isolated cannabidiol (CBD) as detailed in application RP 225, as a novel food.

2. Assessment

2.1 Identity of novel food

6. The novel food is a Cannabidiol (CBD) isolate in the form of a white to off white crystalline powder of purity equal to or greater than 98%. Information to support this characterisation was provided for five batches of the novel food.

7. CBD is characterised by the chemical formula: C21H30O2; molecular mass: 314.46 g/mol; CAS number: 13956-29-1; IUPAC name: 2-[(1R,6R)-3-methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol.

8. Confirmation of its identity and purity was provided by Liquid Chromatography coupled with Mass Spectrometry (LC/MS).

2.2 Production Process

9. The CBD isolate is manufactured using a multi-step process under controlled conditions.

10. Certificates of analysis for raw starting materials used in the extraction process were provided to demonstrate the effectiveness of the controls at this point in the process. The details of the commercially sensitive extraction process were shared with and reviewed by the ACNFP.

11. The novel food is extracted from the Cannabis Sativa. L. plant via ultrasound extraction process and further distillation and crystallisation steps. This process extracts CBD, producing an >98% Isolate which can be blended with food grade oils to produce tinctures/oils and capsules.

12. The ACNFP considered whether the use of solvents as processing aids resulted in residues that require highlighting to risk managers. To assess the safety of the solvent residues that remain in the novel food, comparison was made to residue limits for other consumed products as detailed in Table 1.

Table 1. Comparison of information on permitted residue levels for solvents used in the novel foods production compared to the proposed specification.

Solvent used	Available data on safe maximum level of consumption	Level in specification for the novel food
Ethanol	Guidance on residues in pharmaceutical products states it to be a class 3 solvent which should be limited by GMP or other quality-based requirements. A permissible daily exposure of up to 50 mg would be acceptable without justification (footnote)	≤ 50 mg/kg CBD (50 ppm)

13. The evidence presented (see Table 2 below) on composition indicates compliance with the specification for residues of solvents. When considered at the level of consumption the evidence suggests the levels of solvent residues in the novel food are below those which would represent a safety concern.

14. A HACCP statement was provided along with further details of the process and how it operates. The production process has characterised the potential hazards and detailed the corresponding control measures sufficiently.

2.3 Compositional Information

15. Results from analysis of five independent batches of the novel food demonstrated that the CBD content is produced consistently. The data is presented within Tables 2 to 7 below.

16. The data presented in Table 2 indicates CBD content is consistently above 98% purity with negligible amounts of starting materials detected across the five representative batches.

17. It is recognised that the detection and characterisation of cannabinoids in a range of food matrices is an evolving area and there are yet to be internationally recognised methods. The limitations of analytical methodology available have been subject to discussion in the Joint ACNFP and COT CBD Subgroup and remain a source of uncertainty in the assessment.

Table 2. Cannabinoid analysis as % weight for weight of five independent representative batches of cannabidiol (CBD) isolate.

Parameter	LOQ (%)	Batch 1	Batch 2	Batch 3	Batch 4	Batch 5
CBD (% w/w)	0.001	99.83	99.78	99.80	99.90	99.96
CBDA (% w/w)	0.001	< LOQ	< LOQ	< LOQ	< LOQ	< LOQ
CBN (% w/w)	0.001	< LOQ	< LOQ	< LOQ	< LOQ	< LOQ
Δ9-THC (% w/w)	0.001	< LOQ	< LOQ	< LOQ	< LOQ	< LOQ
THCA (% w/w)	0.001	< LOQ	< LOQ	< LOQ	< LOQ	< LOQ
Total Cannabinoids (% w/w)	-------	99.83	99.78	99.80	99.90	99.96
Total THC (THC + (THCA x 0.877))	-------	< LOQ	< LOQ	< LOQ	< LOQ	< LOQ
Total CBD (CBD + (CBDA x 0.877))	-------	99.83	99.78	99.80	99.90	99.96

Method of analysis: LC-MS (Liquid Chromatography coupled with Mass Spectrometry); LOQ = Limit of quantitation

18. Analytical data concerning the microbiological content from five independent batches of the novel food were reported in Table 3. The process in manufacturing this novel food uses extreme high and low temperatures and alcohol solvents, which may mitigate the levels of microbes present within the final product.

Table 3. The microbiological analysis of the novel food.

Parameter	Method	Batch 1	Batch 2	Batch 3	Batch 4	Batch 5
Microorganisms at 30°C / CFU/g	UNI EN ISO 4833-1:2013	< 10	< 10	< 10	< 10	< 10
Escherichia coli / CFU/g	AFNOR BIO 12/19-12/06	< 10	< 10	< 10	< 10	< 10
Yeasts and Moulds / CFU/g	ISO 21527-2: 2018	< 10	< 10	< 10	< 10	< 10
Pseudomonas aeruginosa / CFU/g	Met_Int_MC02	< 10	< 10	< 10	< 10	< 10
Staphylococcus aureus / CFU/g	UNI EN ISO 6888-2:2004	< 10	< 10	< 10	< 10	< 10
Salmonella species / absence in 25 g	AFNOR BRD 07/11-12/05	Absent	Absent	Absent	Absent	Absent

CFU = colony forming unit; UNI EN ISO = Italian Standards Body; AFNOR = Standards created by the French Association Française de Normalisation

19. The microbiological data presented confirm that the novel food does not raise a safety concern and consistently meets the proposed microbial specification levels.

20. Results from the mycotoxin analysis for five independent representative batches of isolated CBD are presented in Table 4. The data show that the isolated CBD consistently complies with the specifications set for mycotoxins within the final product.

Table 4. Mycotoxin analysis of five independent representative batches of cannabidiol (CBD) isolate.                                    

Parameter	LOQ / Action Level (ppb)	Batch 1	Batch 2	Batch 3	Batch 4	Batch 5
Aflatoxin B1	6 / 20	< 0.5	< 0.5	< 0.5	< 0.5	< 0.5
Aflatoxin Total	6 / 20	< 1.0	< 1.0	< 1.0	< 1.0	< 1.0
Ochratoxins	12 / 20	< 1.0	< 1.0	< 1.0	< 1.0	< 1.0

Method of analysis = LCMS/MS (Liquid Chromatography-Tandem Mass Spectrometry)

21. It is expected that novel food products comply with the legal requirements for heavy metal contaminants in food. Analytical data, presented for five independent batches of the novel food, demonstrated that heavy metals were present in low quantities and below established EU limits where applicable (applicable for arsenic, cadmium, mercury and lead) (Table 5).

Table 5. Heavy metal analysis of five independent representative batches cannabidiol (CBD) isolate.

Parameter	Action Level (ppm)	Batch 1	Batch 2	Batch 3	Batch 4	Batch 5
Arsenic (ppm)	0.1	<0.05	<0.05	<0.05	<0.05	<0.05
Cadmium (ppm)	1.0	0.05	0.04	0.05	0.05	0.06
Lead (ppm)	0.1	<0.01	<0.01	<0.01	<0.01	<0.01
Mercury (ppm)	0.1	0.09	0.07	0.05	0.06	0.08

Method of analysis = ICP-MS (Inductively Coupled Plasma Mass Spectrometry)

22. Results from the residual solvent analysis for five independent representative batches of isolated CBD are presented in Table 6. The data show that the isolated CBD is able to consistently comply with the specifications set for residual solvents within the final product.

Table 6. Residual solvent analysis of five independent representative batches of cannabidiol (CBD) isolate.

Parameter	LOD	Batch 1	Batch 2	Batch 3	Batch 4	Batch 5
Ethanol (Present/Absence)	0.01 %	Absence	Absence	Absence	Absence	Absence
Pentane (Present/Absence)	0.01 %	Absence	Absence	Absence	Absence	Absence

Method of analysis = GC/GCMS (Gas Chromatography Mass Spectrometry)

23. Additional analyses were presented to the Committee, covering fatty acids, alkaloids, polyaromatic hydrocarbons, and pesticides. No concerns were raised regarding the additional analyses and the results demonstrated consistency in production of the novel food.

THC as a potential contaminant in the novel food

24. The extraction process may result in cannabinoids other than CBD remaining in the product as contaminants. In particular, delta-9-tetrahydrocannabinol (Δ9-THC), and its precursor acid, delta-9-tetrahydrocannabinolic acid (Δ9-THCA), were analysed due to the potential for toxic effects resulting from their consumption and the status of Δ9-THC as a controlled drug within the UK (Table 2). Along with Δ9-THC, other minor cannabinoids which occur at contaminant levels also have the potential to play a role in the toxicity of CBD-containing novel food products; these require due consideration and monitoring to ensure the novel foods remain safe. The robustness, accuracy, and precision of the methods used were considered in interpreting the data on Δ9-THC and other potential contaminants and judged appropriate, in this case other minor cannabinoids which occur at contaminant levels also have the potential to play a role in the toxicity of CBD-containing novel food products; these require due consideration and monitoring to ensure the novel foods remain safe. The robustness, accuracy, and precision of the methods used were considered in interpreting the data on Δ9-THC and other potential contaminants and judged appropriate in this case

25. To understand the impact on food safety of trace levels of contamination with Δ9-THC, the Joint ACNFP and COT Subgroup on CBD reviewed the relevant scientific literature and considered both the Advisory Council on the Misuse of Drugs (UK ACMD) advice on THC in consumer products and the 2015 European Food Safety Authority (EFSA) Panel on Contaminants in the Food Chain’s (CONTAM Panel) scientific opinion on the risks for human health from the presence of THC in milk and other products of animal origin. This resulted in a joint statement of the ACNFP and COT on Δ9-THC as a contaminant in CBD and hemp derived products. This identifies a safe upper level of THC contamination of 1 µg /kg bw/day or 70 µg/day for a healthy adult below which adverse effects are not expected to occur.

26. This resulted in a joint statement of the ACNFP and COT on Δ9-THC as a contaminant in CBD and hemp derived products. This identifies a safe upper level of THC contamination of 1 µg /kg bw/day or 70 µg/day for a healthy adult below which adverse effects are not expected to occur.  

27. The analysis for Δ9-THC as a potential contaminant in the novel food was declared as [not detected] in any of the five batches tested (Table 2), with a limit of quantification of 0.05% (w/w).

28. Once adjusted to reflect the proposed use of CBD at a total dose of 10 mg per day, the levels of Δ9-THC detected in the novel food were below the safe upper intake level of 1 µg /kg bw/day or 70 µg/day for a healthy adult. This level does not present a concern in terms of consumer safety for the novel food under the proposed conditions of use.

29. To ensure Δ9-THC levels remain consistently low in the production of CBD, THC and its precursor acid combined should be a standard substance included in the specification as relevant to all batches produced.

30. The data presented did not indicate any additional hazards for inclusion in the specification. 

2.4 Stability

31. The stability of the novel food was assessed in an accelerated study (40 +/-2°C, relative humidity 75%) in five batches for 8 months. Results showed that the novel food meets the specification criteria for CBD and other cannabinoid content, and microbiological stability over these time periods. The Δ9-THC content was also tested and no significant changes in the levels of Δ9-THC were observed.

32. The data provided supports the stability of CBD isolate for a period of at least 36 months.

2.5 Specification

33. The applicant’s specification parameters reported in Table 7 were assessed using internationally recognised methods or determined using internally developed and validated methods. The results of the analysis are detailed in Tables 2 to 6 and indicate the novel food can be produced consistently to the specification.

Table 7. Specification of the novel food.

Parameter	Specification	Method
Appearance	White, crystalline powder free of particulates	Visual inspection
CBD (%)	98 (+/-2%)	HPLC-UV/LCMS
CBDA (%)	< 0.02	HPLC-UV/LCMS
CBN (%)	≤ 0.1	HPLC-UV/LCMS
Delta-9-THCA (%)	≤ 0.005	HPLC-UV/LCMS
Delta-9-THC (%)	≤ 0.005	HPLC-UV/LCMS
Total Related Cannabinoid Content (%)	Report	HPLC-UV/LCMS

Residual solvents

Parameter	Specification	Method
Ethanol (ppm)	≤ 1000	GCMS
Pentane (ppm)	≤ 1000	GCMS

Elemental Impurities

Parameter	Specification	Method
Arsenic (mg/kg)	< 0.1	ICP-MS
Cadmium (mg/kg)	< 1.0	ICP-MS
Lead (mg/kg)	< 0.1	ICP-MS
Mercury (mg/kg)	< 0.1	ICP-MS

Pesticides

Parameter	Specification	Method
Individual Pesticide Content (mg/kg)	Individual Pesticide Limit	GC-MS/MS: validated in house method

Mycotoxins

Parameter	Specification	Method
Aflatoxin (ppb)	≤ 20.0	LCMS/MS
Ochratoxin A (ppb)	≤ 20.0	LCMS/MS

Microbiological

Parameter	Specification	Method
Microorganisms at 30°C / CFU/g	< 100	Ph.Eur.5.1.4
Escherichia coli / CFU/g	< 20	Ph.Eur.5.1.4
Yeasts and Moulds / CFU/g	< 100	Ph.Eur.5.1.4
Pseudomonas aeruginosa / CFU/g	< 20	Ph.Eur.5.1.4
Staphylococcus aureus / CFU/g	< 20	Ph.Eur.5.1.4
Salmonella species / absence in 25 g	Absent	Ph.Eur.5.1.4

HPLC = high-performance liquid chromatography; LC-MS = liquid chromatography-mass spectrometry; ICP-MS = inductively coupled plasma mass spectrometry; GC-MS/MS = gas chromatography tandem mass spectrometry; Ph.Eur = European Pharmacopoeia 

34. The ACNFP concluded the information provided is sufficient for the specification of CBD and appropriately characterises the novel food seeking authorisation.

2.6 History of Use

35. Hemp has been widely consumed in the UK and EU as a seed oil, in tea and as an alternative to hops in beer. Extracts of hemp including CBD and synthetic CBD have not been widely consumed and are considered novel foods. While CBD products are widely available on the UK high street, indicating some consumption of CBD as a food, at the time of publication, no previous applications for CBD have yet received authorisation as a novel food.

36. As detailed in the COT review of the literature there has been use of both hemp derived and synthetic forms of CBD for medicinal purposes. These provide an indication of the toxicological effects that should be explored in the testing regime – primarily effects on liver, thyroid and potential impacts on reproductive organs. Also reported are behavioural effects such as somnolence (sleepiness) (COT, 2020).

37. As reported in the COT review of the publicly available data on CBD and summary data on a medicinal product, signs of adverse effects on the liver were observed at doses of CBD as low as 5 mg/kg bw/day in patients and healthy human volunteers; this dose is equivalent to 350 mg in a 70 kg adult. The data in the literature also suggested that humans might be more sensitive to the adverse effects of CBD in the liver than laboratory animals.

38. Somnolence effects were noted at doses ≤10 mg/kg bw/day in human studies. Inhibitory drug-drug interactions have also been observed with some medications when CBD is co-administered at doses of 1 mg/kg bw/day (equivalent to 70 mg in a 70 kg adult); the likelihood of effects at lower doses has not been determined (COT, 2020). Based on the COT assessment, therefore, the FSA concluded in February 2020 that 1 mg/kg bw/day, or 70 mg in a 70 kg adult, was a pragmatic upper level of intake above which there would be clear concerns about safety.

39. It is noted that the doses used for medicinal purposes are higher than those proposed for food use. The purpose of an assessment for medicines authorisation is different to that for food and this is reflected in the data requirements. Unlike medicines, there is no risk-benefit context in foods with the requirement instead being that the products are safe.

40. Within the literature, further human studies utilising chemically derived CBD provides further evidence of a history of synthetic CBD use (Izegelov et al., 2010; Stereo Biotechs Ltd., 2020; Klotz et al., 2019; Wheless et al., 2019). A review by Heuestis et al., 2019 of cannabidiol adverse effects and toxicity notes that CBD is not risk-free. At doses higher than those recommended for human pharmacotherapies, such as those prescribed to treat forms of epilepsy severe adverse events occur.

41. The data on previous consumption of CBD suggest areas for careful consideration in the toxicological review to understand potential effects at the lower doses used in foods.

2.7 Proposed Use and Anticipated Intake

42. The intended use is food supplements as defined The Food Supplements (England, Scotland and Wales) Regulations 2003 in a range of forms.

43. The applicant initially proposed a use level of 70 mg/day CBD for the novel food in adults, excluding pregnant or lactating women. The proposed uses have been updated to reflect the provisional acceptable daily intake (ADI) for the use of ≥98% pure form CBD established at 10 mg per day (ACNFP and COT, 2023) as detailed in section 2.10. The proposed maximum use levels for the novel food are outlined in Table 9.

Table 9. Amended proposed uses and maximum use levels for the novel food.

Food category	Maximum use level per day (mg CBD/day)
Food Supplements (for adults) as defined in the Food Supplements (England) Regulations 2003 and other equivalent legislation in the other nations of the UK as capsules, chewable forms, liquid or drops in dose form intended for those 18 years of age or over. Excluding pregnant and lactating women and other specifically identified vulnerable groups.	10

44. It is noted that consumers may be exposed to CBD from a range of food categories. The standard methodology for calculating exposure for a novel food would explore intake from a range of sources and ensure that exposure via the proposed uses would not exceed any safety level identified when consumption of the food category was analysed. It is noted that for CBD there are already many products available. The assessment has been made on the basis of identification of a maximum level of CBD that can be consumed per day. As such proposed uses will only be considered safe within the assessment when at a maximum consumption of 10mg of CBD per day from all sources (as concluded in section 2.10 of this assessment).

45. Concerns were raised by the Committee regarding the potential for foreseeable misuse of CBD if consumed in multiple formats on a single day. This is because of the increased risk of consuming CBD above the provisional acceptable daily intake (ADI). The scope of the assessment is restricted to the uses proposed and any further uses or additional food categories would be subject to the change in conditions of use process.

46. Risk managers must consider whether consumers would benefit from information on the CBD content of foods in order to ensure their consumption does not exceed the maximum intake of 10mg per day for a healthy adult.

47. As recommended in the ACNFP and COT statement on CBD of 98% purity, “The provisional ADI is recommended, subject to the existing advice to consumers that pregnant and breastfeeding women and people taking any prescription medication should avoid the consumption of CBD if possible. Consumers on regular medications should seek advice from a medical professional before using any type of CBD food product. In addition, children and prospective parents trying for a baby are advised against consumption of CBD, as are those who are immunosuppressed, due to remaining data gaps and residual uncertainties concerning the safety of CBD for these groups of consumers.” (ACNFP and COT, 2023).

48. The ACNFP explored the potential for foreseeable misuse of the novel food. It was noted that the availability of multiple formats of the novel food could create conditions where exposure estimates are exceeded. It is highlighted to risk managers that they may wish to consider whether risk management measures are needed beyond those in the food supplements regulation to ensure consumers are aware of the provisional ADI of 10 mg CBD/day for the product, a dose at which it is considered that no adverse effects would be expected.

49. It is also strongly recommended that risk managers consider how consumers can be supported to manage their intake appropriately within the safe limits identified and appreciate the nature of the potential risks at higher doses, for uses that are not in dosed forms.

50. The food supplement products are to be labelled in accordance with the labelling requirements of Food Supplements (England) Regulations 2003 and the equivalent legislation in the nations of GB. The ACNFP recommended that the applicants proposed warning labelling be updated to include information on not exceeding the safe limit of 10 mg/day for a 70 kg healthy adult and that the product is not suitable for use under the age of 18 or for use during pregnancy or breastfeeding. As well as information on its suitability if the consumer is taking medication or has existing health conditions.

2.8 Absorption, Distribution, Metabolism and Excretion (ADME)

51. The Absorption, Distribution, Metabolism and Excretion (ADME) of CBD are known to be complicated by the food matrix and are currently still being defined by professional bodies. 

52. The oral bioavailability of CBD is low, indicating that it is not absorbed to any notable extent following ingestion (Mechoulam et al., 2002). Published works report the bioavailability of CBD to be between 13 and 19% (Grotenhermen., (2003) or 6% (Hawksworth and McArdle., 2004). The low systemic availability was demonstrated by Martin-Santos et al., 2012 and further supported by a literature search which identified the pharmacokinetics of CBD in humans (Miller et al., 2018).  The COT statement on CBD of 2020 noted that although CBD has low fasting bioavailability (<10%), consumption with food could increase CBD uptake, by, for example, up to 5-fold if eaten with a high fat meal. As such the potential for matrix effects that impact bioavailability cannot be ruled out.  

53. Following oral absorption, CBD is extensively metabolised in the liver. This rapid first pass metabolism contributes to the low oral bioavailability reported in the literature (Taylor et al., 2018; WHO, 2018). In vitro studies indicate that CYP3A4 and CYP2C19 are the primary hepatic enzymes responsible for first-pass metabolism of cannabidiol; however, several other hepatic cytochrome P450 isoforms (CYP1A1, CYP1A2, CYP2C9, CYP2D6, and CYP3A5) have also demonstrated a capability of metabolising cannabidiol (Jiang et al., 2011; Zendulka et al., 2016). 

54. The metabolism of CBD is thought to follow two separate pathways. One is P450-mediated, in which cannabidiol is metabolised into its major metabolite 7-COOH-CBD. This is followed by further metabolic reactions which yield the minor metabolites of CBD including 6-OH-CBD (Devinsky et al., 2018; Taylor et al., 2018;). The other involves decarboxylation (Kraemer et al., 2019). The resultant metabolites are predominantly excreted in faeces and urine (Hawksworth and McArdle, 2004; WHO, 2018). 

55. Multiple dosing with CBD is associated with a steady state concentration up to 2-fold accumulation of CBD in plasma when compared with a single dose (Taylor et al., 2018). Minimal evidence of plasma accumulation has been reported in dosing studies over 5–9 days (Millar et al., 2018; Sellers et al., 2013; Stott et al., 2013).

56. The pharmacokinetics of CBD have also been systematically reviewed by Millar et al., 2018 in 24 studies, most of which assessed the administration of CBD at doses of 5–20 mg/day. This correlates to a low dose application similar to this CBD novel food application. With oral administration, single doses of 5.4 and 10 mg CBD achieved peak serum concentrations (Cmax) of 0.9 and 2.5 ng/mL. The time to maximum concentration (Tmax) was approximately 1 hour, with a half-life between 1 to 3 hours. Given the intended use of this CBD, with an approximate half-life of one to three hours, with a total clearance of 6 hours, there are no significant concerns of accumulation. (Millar et al., 2018).   

57. The ADME data provides context for interpreting the toxicological data. It is noted that the bioavailability of CBD is typically low but can be affected by the matrix. It was noted that the potential for CBD to accumulate in the body has not been examined based on the data supplied. This also suggests the food context for CBD could impact whether the CBD present in the ingredient is more, or less, bioavailable. This has been taken into account when considering the additional uncertainty factors used for setting the provisional ADI.

2.9 Nutritional information

58. The ACNFP sought clarification of the potential for the presence of antinutritional factors from the preparation. It was noted that hemp can contain a range of substances that could impact the digestion and absorption of nutrients from the diet. These include phytic acid (which can negatively affect the bioavailability of some minerals), tannins (which can inhibit the absorption of iron), trypsin inhibitors (which can affect protein digestion), and saponins (which can cause gastric irritation and increase the permeability of the intestine).

59. The product is highly purified as indicated in the information on the composition. There is no presence of other components that would impact the digestion or absorption of nutrients from the diet.

60. The data on nutritional composition confirms that CBD has no caloric or nutritional value. The application is not intending that CBD replace another food in the diet. Consumption of the novel food at the proposed use levels is not expected to be nutritionally disadvantageous for consumers. 

2.10 Toxicological information

61. Toxicological studies on CBD were performed by the applicant to support the safety assessment of the novel food. The respective study reports are unpublished and claimed as confidential and proprietary data. They were considered essential in the assessment of the safety of the novel food and were reviewed by the ACNFP. The way in which data on systemic toxicity was managed and interpreted in the context of the provisional ADI is explained in the sub chronic toxicology section 2.10.2. below.

2.10.1 Genotoxicity

62. In vitro genotoxicity testing of CBD was conducted under Good Laboratory Practice (GLP) conditions and utilised the following OECD guidelines: in vitro bacterial reverse mutation test (OECD TG 471) and in vitro mammalian cell micronucleus test (OECD TG 487). The approach using these two genotoxicity tests in vitro is recommended by the UK Committee on Mutagenicity and is also the basis of guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283. 

63. The in vitro bacterial reverse mutation test (Palamur Bio study number 22833) demonstrates that this CBD ingredient is non-mutagenic, in the absence or presence of metabolic activation. In addition, the in vitro mammalian cell micronucleus test (Palamur Bio study number 22834) demonstrated that CBD was non-clastogenic and non-aneugenic in the absence and presence of metabolic activation.

64. The results from these in vitro studies support the conclusion that the novel food (≥98% pure CBD) is not genotoxic. This is consistent with the view of the Committee on Mutagenicity in reviewing CBD generically as a substance from evidence available in the public domain (Committee on Mutagenicity; MUT/MIN/2020/1, 2020).

2.10.2 Sub-chronic toxicology study

65. The Joint Subgroup of the ACNFP and COT, formed to address questions in relation to the safety of CBD, cannabinoids and hemp-derived ingredients and considered the data submitted in support of this novel food application.

66. This applicant submitted a Repeated Dose 90-Day Oral Toxicity Study (Palamur Bio study number 22832) in rats, which was conducted under GLP conditions and to OECD Test Guideline 408. In this 90-day study, each group comprised 10 female and 10 male rats which were dosed with 0 (control – corn oil), 25, 75 or 150 mg/kg bw/day CBD once per day by oral gavage at a dose volume of 10 mL/kg bw/day. Satellite groups of 5 female and 5 male rats were treated with corn oil or CBD (150 mg/kg bw/day) in the same way as test animals during the treatment phase of the study and allowed 28 days’ untreated recovery after dosing was completed. The applicant concluded a NOAEL of 150 mg/kg bw/day based on effects seen in liver endpoints.

67. The Subgroup reviewed the data and requested further information from the applicant. The Subgroup required clarification on the doses administered in the study and queried the histological changes in the liver and the implications of these in order to confirm the study’s findings.

68. The Subgroup reviewed the additional information provided by the applicant and concluded the applicant has addressed the concerns on the effects seen in the liver. As such the Subgroup considered that the NOAEL for the study be 150 mg/kg bw/day. Review of the study by the Subgroup supported the conclusion that it was of sufficient quality to support the safety of the novel food.

69. In addition to the data submitted by the applicant there is a body of evidence on the effect of 98% or greater CBD. In order to take account of all pertinent data and to put the individual assessment in the context of the totality of relevant evidence for the active substance.  The data from this application was compared to the wider body of evidence.

70. A weight of evidence approach allowed the Subgroup to identify a provisional ADI for CBD ingredients of ≥98% purity of 0.15 mg/kg bw/day or 10 mg per day for a 70 kg healthy adult (Joint position paper from the ACNFP and COT; FSA consumer advice published in October 2023). This value was identified to be protective of the most sensitive known effects in the liver and thyroid parameters and included consideration of data gaps and uncertainties. The dataset includes several studies where highly purified CBD has been tested. Given the low level of contaminants, it is reasonable to consider that these represent the effect of CBD as a substance and are therefore relevant to other novel foods with similar compositions.

71. It was considered whether the wider data and therefore the provisional ADI for 98% or greater CBD was relevant to the review of the novel food. It was considered appropriate, on the basis that the test substance used in the study to support the novel food was ≥98% pure and the compositional data was consistent with a highly purified CBD. The contaminants present were not suggestive of a significant impact on the toxicology. The point of departure in the form of a NOAEL, from the study submitted to support this novel food, once corrected for CBD content is consistent with the range of the points of departure used to develop the provisional ADI (ACNFP and COT, 2023). The NOAEL was also based on the same effect - impacts on the liver. It was, therefore, considered scientifically appropriate to apply the provisional ADI of 0.15 mg/kg bw/day or 10 mg/day as identified in the joint statement of the ACNFP and COT on ≥98% pure forms of CBD to the novel food in this application.

2.11 Allergenicity

72. This CBD isolate comprises >98% CBD and the production process for CBD does not introduce any risk of allergenic potential. As a chemical entity the potential for IgE mediated food allergy is unlikely.

73. Given CBD as a substance is not considered allergenic, the allergenicity assessment considered whether the other 1% of the novel food’s composition was likely to be allergenic or elicit food allergic reactions. It was noted that none of the raw materials or processing aids used in the production process are derived from or contain any of the allergenic food ingredients specified under assimilated Regulation (EU) No 1169/2011 on the provision of food information to consumers. This suggests the potential to elicit reactions in those sensitive to those foods is unlikely.

74. The novel food is unlikely to trigger allergic reactions in the target population under the proposed conditions of use.

3. Discussion

75. The novel food is a CBD isolate ingredient from industrial hemp containing >98 % CBD produced using a multi-step manufacturing process.

76. This CBD isolate is intended to be used as a food ingredient in food supplements for adults excluding pregnant and lactating women and other specifically identified vulnerable groups at a defined intake for each product type of up to 10 mg CBD per day; it is not intended to replace any food.

77. In October 2023, the Joint ACNFP and COT Subgroup identified a provisional acceptable daily intake (ADI) of 10 mg per day (0.15 mg/kg bw/day) for CBD products containing 98% CBD or above, such as the novel food discussed in this assessment.  A weight of evidence approach was used to arrive at a provisional ADI of 10 mg/day (0.15 mg/kg bw/day). The most sensitive human health effects, which this provisional ADI protects against, are seen consistently in the liver and thyroid in a number of studies using ≥98% pure CBD. This value also takes account of the lack of human-based long-term evidence and evidence regarding potentially vulnerable groups.

78. Based on the dossier of evidence provided by the applicant, the safety of the novel food was reviewed and evidence to reach a conclusion on safety provided. The evidence presented by the applicant was then compared to the wider data set on CBD and is consistent with evidence presented to support the development of a provision ADI of 10 mg/day for CBD of 98% purity or above. As such the provisional ADI should be applied to this novel food.

79. This is subject to the existing advice to consumers that pregnant and breastfeeding women and people taking any prescription medication should avoid the consumption of CBD. Consumers on regular medications should seek advice from a medical professional before using any type of CBD food product. In addition, children and prospective parents trying for a baby are advised against consumption of CBD, as are those who are immunosuppressed, due to remaining data gaps and residual uncertainties concerning the safety of CBD for these groups of consumers. These contraindications would also apply to this novel food.

80. The maximum safe exposure for healthy adults of 70 kg as identified in the provisional ADI is 10 mg per day from all food sources. If the inclusion level of this CBD isolate leads to an intake per individual serving of each product type of 10 mg/day, multiple intakes of food products containing CBD on the same day should be avoided to support minimising exposure to below the provisional ADI.

4. Conclusions

81. The ACNFP has undertaken a review of this CBD isolate and concluded that the novel food is safe under the proposed conditions of use and does not pose a safety risk to human health. The proposed uses are not considered nutritionally disadvantageous.

82. These conclusions were supported by the information in the novel food dossier submitted by the applicant plus the supplementary information and could not have been reached without the following data claimed as proprietary by the applicant:

• in vitro bacterial reverse mutation test [(Palamur Bio study number 22833)]
• in vitro mammalian cell micronucleus test [(Palamur Bio study number 22834)]
• 90-day repeat dose gavage study [(Palamur Bio study number 22832)]

83. The members of the ACNFP during the course of the assessment who were;  Dr Camilla Alexander White, Dr Anton Alldrick, Alison Austin, Professor George Bassel, Dr Mark Berry, Professor Dimitris Charalampopoulos, Dr Meera Cush, Dr Catharina Edwards, Professor Susan Fairweather-Tait, Professor Sophie Foley, Professor Paul Frazer, Professor Andy Greenfield, Professor Wendy Harwood, Professor Huw D. Jones, Dr Ray Kemp, Dr Elizabeth Lund, , Dr Lynne McIntyre, Professor Clare Mills,  Dr Isabel Skypala, Professor Lesley Stanley, Professor Hans Verhagen, and Professor Bruce Whitelaw.

84. Additional advice was provided by Professor Shirley Price and Dr Cheryl Scudamore during the course of the assessment of the novel food.

To note, interests were received from members of the ACNFP, Dr Alldrick declared a potential interest relating to his previous employment and this was considered a potential conflict and as a result he was not present for discussions of CBD by the Committee.

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Abbreviatio

ACMD	Advisory Council on the Misuse of Drugs
ACNFP	Advisory Committee on Novel Foods and Processes
ADI	Acceptable Daily Intake
ADME	Absorption, Distribution, Metabolism and Excretion
AFNOR	Standards created by the French Association Française de Normalisation
AOAC	Association of Official Agricultural Chemists
bw	body weight
CAS	Chemical Abstracts Service
CBD	Cannabidiol
Cmax	Peak serum concentration
COT	Committee on Toxicity
CFU	Colony Forming Unit
DAD	Diode array detection
EC	European Commission
EFSA	European Food Safety Authority
EMA	European Medicines Agency
EU	European Union
FDA	Food and Drug Administration (USA)
FSA	Food Standards Agency
FSS	Food Standards Scotland
GC	Gas chromatography
GLP	Good Laboratory Practice
HACCP	Hazards Analysis and Critical Control Points
HPLC	High-performance liquid chromatography
ICP	Inductively coupled plasma
IR	Infra-red
LCMS	Liquid chromatography coupled with mass spectrometry
LOAEL	Lowest observable adverse effect level
LOD	Limit of detection
LOQ	Limit of quantification
NOAEL	No Observable Adverse Effect Level
NM	Not measured
OECD	Organisation for Economic Co-operation and Development
Ph.Eur	European Pharmacopoeia
THC	Tetrahydrocannabinol
Tmax	Time to maximum concentration
UHPLC	Ultra high-performance liquid chromatography
UNI EN ISO	Italian Standards Body
USP	United States Pharmacopeia
UV	ultra-violet