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Scheduling delegate's final decisions, March 2017

23 March 2017

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2.5 Fennel Oil

Part A - Final decisions on matters referred to an expert advisory committee

Joint Advisory Committee on Chemicals and Medicines Scheduling (ACCS-ACMS #14)

2.5 Fennel Oil

Referred scheduling proposal

The TGA has proposed that a new Schedule 5 entry be created for fennel oil (active component of fennel oil - methyl chavicol), with consideration of the appropriateness of low volume containers with a restricted flow insert, Medicines Advisory Statements, such as 'keep out of reach of children'; or exemption cut-off of 5 per cent or less of methyl chavicol.

Scheduling application

This was a general application. The applicant's proposed amendments to the Poisons Standard are as follows:

Schedule 5 - New Entry

FENNEL OIL except:

  1. in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Medicines Advisory Statements Specification;
  2. in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

    KEEP OUT OF REACH OF CHILDREN; or

  3. in preparations containing 5 per cent or less of methyl chavicol.

The applicant's reasons for the request are:

  • Fennel oil should be included in Schedule 5 with the same restrictions as basil oil.
  • Fennel oil, as with basil oil, may contain methyl chavicol (estragole) (see Substance Summary).
  • The reasons are identical to those for basil oil, which was added to Schedule 5 in February 2000 on the basis of the potential for basil oil to contain methyl chavicol (estragole), which has acute oral toxicity in rats and which can be metabolised to a carcinogenic metabolite (1'-hydroxyestragole).
  • In March 2016, the CMES of the TGA undertook a safety evaluation of fennel oil to ensure that the ingredient is appropriate for the low-risk listed complementary medicines. The safety evaluation of fennel oil incorporated information from international regulatory agencies, including the National Toxicology Program and academic literature.
Current scheduling status and relevant scheduling history

Fennel oil is not specifically scheduled in the Poisons Standard however basil oil (which also may contain methyl chavicol) is included in Schedule 5 and Appendix E as follows:

Schedule 5

BASIL OIL - except:

  1. in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Medicines Advisory Statements Specification;
  2. in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

    KEEP OUT OF REACH OF CHILDREN; or

  3. in preparations containing 5 per cent or less of methyl chavicol.

Appendix E, Part 2 - BASIL OIL

Warning statements: A [For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once)], G3 (If swallowed, do NOT induce vomiting).

Basil Oil is also included in Part 2.4 with a container nominal capacity limit of 200 mL or less for CRCs.

Australian and international regulatory information

The ARTG contains multiple entries for listed medicines containing fennel oil. It is currently used as an excipient in 17 listed medicines and as an active in eleven listed medicines.

Fennel oil is listed in the Therapeutic Goods (Permissible Ingredients) Determination No. 1 of 2017 as an active, excipient and homoeopathic preparation ingredient. There are no specific requirements applying to the ingredient.

Fennel oil is unclassified in New Zealand and the USA with brief searches for drug products or medicines containing fennel oil, methyl chavicol, chavicol, or estragole on the FDA or Medsafe databases returning no information.

Substance summary

Fennel oil is extracted from the seeds of Foeniculum vulgare Mill. (Apiaceae; International Plant Names Index: kew-2813604).

Table 2.5: Chemical information
Property Fennel oil
CAS No. 8006-84-6.
Australian Approved Name (AAN) Fennel oil (53603)
Structure of major volatile components of fennel oil Chemical structure of fennel oil

There are two varieties of fennel in use - sweet fennel (Foeniculum vulgare Mill. subsp. vulgare var. dulce (Mill.) Batt.) and bitter fennel (Foeniculum vulgare Mill. subsp. vulgare var. vulgare). The oils extracted from the two varieties differ slightly in their chemical composition. Sweet and bitter fennel oils contain several components of which trans-anethole (50-80%) and estragole (methyl chavicol, 5-20%) are of concern due to their toxic effects.

The safety report concluded that on the basis of the unequivocal evidence of carcinogenicity for estragole, in combination with the current Schedule 5 entry for basil oil (containing a similar content of estragole), suggests that fennel oil should also be scheduled with the similar restrictions.

Pre-meeting public submissions

One (1) public submission was received. The submission did not indicate whether or not it supported the proposal. The main points were:

  • Assumes that the intent of the scheduling proposal for fennel oil is to create a new schedule entry for fennel oil in line with the existing schedule entry for basil oil.
  • The Schedule 5 proposal has the potential to impact on the use of fennel oil in non-medicinal uses and notes that the consideration of this scheduling proposal by the ACMS and related public notice may not have alerted those that may be impacted by the non-medicinal uses of fennel oil.
Summary of Joint ACCS-ACMS advice to the delegate

The committee advised that a new Schedule 5 entry be created for fennel oil as follows:

Schedule 5 - New entry

FENNEL OIL except:

  1. in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Medicines Advisory Statements Specification;
  2. in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

    KEEP OUT OF REACH OF CHILDREN; or

  3. in preparations containing 5 per cent or less of methyl chavicol.

Appendix E, Part 2 - New Entry

FENNEL OIL

Standard Statements: A (For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).), G3 (If swallowed, do NOT induce vomiting)

2.4 Child resistant closures - New Entry

Column 1
Name of the poison:
Fennel oil when included in Schedule 5

Column 2
Nominal capacity
: 200 millilitres or less

The ACCS/ACMS advised an implementation date of 1 June 2017

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (f) any other matters that the Secretary considers necessary to protect the public health.

The reasons for the advice comprised the following:

  • The substance remains available. It has no therapeutic benefit and is used primarily as a flavouring. There may be valid uses in aroma and flavour areas.
  • Acute toxicity and potential carcinogenicity of the component methyl chavicol.
  • There is potential for fennel oil containing methyl chavicol to result in human toxicity, as indicated by the acute oral toxicity in the rat and its carcinogenic metabolite.
  • The proposed controls will make the chemical available but ensure that accidental overexposure will be significantly reduced.
  • Smaller volumes and preparations containing methyl chavicol in concentrations less than 5% pose reduced risk and would be in line with basil oil scheduling.
Delegates' considerations

The delegate considered the following in regards to this application:

  • Scheduling proposal
  • Public submissions received
  • ACMS advice
  • Section 52E of the Therapeutic Goods Act 1989
  • Scheduling Policy Framework (SPF 2015)
  • Other relevant information.
Delegates' interim decision

The delegates' interim decision is that a new Schedule 5 entry be created for fennel oil.

The proposed wording for the schedule and appendix entries is as follows:

Schedule 5 - New Entry

FENNEL OIL except:

  1. in medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert and compliant with the requirements of the Medicines Advisory Statements Specification;
  2. in preparations other than medicines for human therapeutic use, when packed in containers having a nominal capacity of 25 mL or less fitted with a restricted flow insert, and labelled with the warning:

    KEEP OUT OF REACH OF CHILDREN; or

  3. in preparations containing 5 per cent or less of methyl chavicol.

Appendix E, Part 2 - New Entry

FENNEL OIL

Standard Statements: A (For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).), G3 (If swallowed, do NOT induce vomiting)

Part 2, Section 2.4 Child-resistant closures - New Entry

Column 1, Name of the poison: Fennel oil when included in Schedule 5.

Column 2, Nominal capacity: 200 millilitres or less.

The proposed implementation date is 1 June 2017.

The delegates considered the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989: (a) the risks and benefits of the use of a substance; (b) the purposes for which a substance is to be used and the extent of use of a substance; (c) the toxicity of a substance; (d) the dosage, formulation, labelling, packaging and presentation of a substance; (f) any other matters that the Secretary considers necessary to protect the public health.

The reasons for the interim decision are the following:

  • The delegates acknowledge and agree with the committee's advice.
  • There is potential for fennel oil containing methyl chavicol to result in human toxicity, as indicated by the acute oral toxicity in the rat and its carcinogenic metabolite.
  • The proposed controls will make the chemical available but ensure that accidental overexposure will be significantly reduced. The substance remains available. It has no therapeutic benefit and is used primarily as flavouring.
  • Smaller volumes and preparations containing methyl chavicol in concentrations less than 5% pose reduced risk and would be in line with basil oil scheduling.
Public submissions on the interim decision

One (1) submission was received, which opposed the delegate's interim decision. The main points were:

  • According to IFRA there is a significant difference in concentrations of estragole between basil and fennel oils. The submission questions the appropriateness of scheduling fennel oil with similar restrictions to those for basil oil.
Delegates' final decision

The delegates note the submission and have confirmed the interim decision and reasons for the decision as no evidence has been received to alter the interim decision. The delegates' final decision is that a new Schedule 5 entry be created for fennel oil with an implementation date of 1 June 2017.

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