10/02 26 June 2002

FINAL ASSESSMENT REPORT (INQUIRY - SECTION s.24)

PROPOSAL P154

REGULATORY REQUIREMENTS FOR FOODS COMPRISING OR CONTAINING ROYAL JELLY, BEE

POLLEN AND PROPOLIS, INCLUDING THE NEED FOR LABEL WARNING STATEMENTS

THE AUSTRALIA NEW ZEALAND FOOD AUTHORITY The Australia New Zealand Food Authority’s (ANZFA) is a partnership between the Commonwealth Government, Australian State and Territory governments and the New Zealand Government. ANZFA is a bi-national, statutory body whose role, in association with others, is to protect the health and safety of people in Australia and New Zealand through the maintenance of a safe food supply. ANZFA seeks to achieve this goal by developing, varying and reviewing standards for food available for sale in Australia and New Zealand and through a range of other functions including national food surveillance and recall systems, conducting research, assessing policies about imported food and developing codes of practice with industry.

In developing and reviewing food standards for both Australia and New Zealand, ANZFA makes recommendations to change the food standards to the Australia New Zealand Food Standards Council, a Ministerial Council made up of Commonwealth, State and Territory and New Zealand Health Ministers. If the Council approves the recommendations made by ANZFA, the food standards are automatically adopted as regulations into the food laws of the Australian States and Territories and New Zealand.

STEPS IN DEVELOPING AND REVIEWING FOOD STANDARDS

The process for amending the Australia New Zealand Food Standards Code is prescribed in the Australia New Zealand Food Authority Act 1991 (ANZFA Act). The diagram below represents the different stages in the process including when periods of public consultation occur. This process varies for matters that are urgent or minor in significance or complexity.

tified nced

�� Those who have provided submissions are notified of the Board’s recommendation to the Ministerial Council which will appear on the ANZFA website

�� The decision of the Ministerial Council is gazetted in Australia and New Zealand and made available on the Food Regulation Secretariat’s website in Health

�� Comments received on DA report are analysed and amendments made to the report and the draft regulations as required

�� The ANZFA Board considers the final report and its recommendations before forwarding the report to the Ministerial Council for approval

�� Public submission collated and analysed �� Applicant pays fees if applicable. A Draft

Assessment (DA) report is prepared using information provided by the applicant, stakeholders and other sources

�� A scientific risk assessment is prepared as well as other scientific studies are completed using the best scientific evidence available

�� Risk analysis is completed and a risk management plan is developed together with a communication plan

�� Impact analysis is used to identify costs and benefits to all parties

�� An appropriate regulatory response is identified and a draft change to the Food Standards Code is prepared

�� A WTO notification is prepared if necessary �� DA Report considered by ANZFA Board � DA Report released for public comment

�� Applicant pays fees (if applicable) to commence Initial Assessment (IA) or is nowhen assessment has comme

�� An IA report is prepared with an outline of issues and possible options; affected parties are identified and questions for stakeholders are included

�� IA report accepted by General Manager or Proposals approved by ANZFA Board

IA Report released for public comment

�� Comment on scientific risk assessment; proposed regulatory decision and justification and wording of draft standard

�� Comment on costs and benefits and assessment of regulatory impacts

�� Comment on scope, possible options and direction of regulatory framework

�� Provide information and answer questions raised in Initial Assessment report

�� Identify other groups or individuals who might be affected and how – whether financially or in some other way

Public Consultation

Public Consultation

Ministerial Council

Final Assessment

Draft Assessment

Initial Assessment

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TABLE OF CONTENTS

EXECUTIVE SUMMARY...................................................................................................... 4 1. BACKGROUND ............................................................................................................. 5 2. REVISED SCOPE OF THIS PROPOSAL...................................................................... 5 3. SUMMARY OF SUBMISSIONS RECEIVED............................................................... 6 4. ASSESSMENT OF ALL ISSUES................................................................................... 6

4.1 Need for and Text of Warning Statement in Relation to Royal Jelly ...................... 6 4.2 Reference to Royal Jelly in Food Form ................................................................... 9 4.3 No Requirement for Warning Statement in Relation to Bee Pollen and Propolis ... 9 4.4 Relevance to Honey of Royal Jelly Warning Statement or Mandatory Declaration of Royal Jelly, Bee Pollen or Propolis.................................................................................... 10 4.5 New Zealand Only Issues in relation to Labelling Bee Products........................... 11 4.6 Removal of food forms of royal jelly from the market .......................................... 12 4.7 Transition Arrangements........................................................................................ 12 4.8 Regulatory Impact Statement ................................................................................. 13

5. SUMMARY CHANGES THAT APPLY TO VOLUME 2 OF THE FOOD STANDARDS CODE.............................................................................................................. 20

5.1 Standard 1.2.3, clause 1 ......................................................................................... 20 5.2 Standard 1.2.3, Table to clause 3 ........................................................................... 20 5.3 Standard 1.2.3, Table to clause 4 ........................................................................... 20

6. WORLD TRADE ORGANIZATION (WTO) NOTIFICATION.................................. 21 7. CONCLUSIONS............................................................................................................ 21 ATTACHMENT 1 – DRAFT VARIATIONS TO THE CODE............................................ 23 ATTACHMENT 2 – STATEMENT OF REASONS............................................................ 24 ATTACHMENT 3 – ADVICE FROM TGA ........................................................................ 26 ATTACHMENT 4 – SUMMARY OF ISSUES RAISED AT PRELIMINARY INQUIRY. 40 ATTACHMENT 5 – SUMMARY OF ISSUES RAISED AT DRAFT FINAL ASSESS. ... 45 ATTACHMENT 6 – EXECUTIVE SUMMARY FROM PRELIMINARY INQUIRY....... 46

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EXECUTIVE SUMMARY The Preliminary Inquiry to Proposal P154, circulated for public comment in 2000, assessed the regulatory requirements for food forms of royal jelly, bee pollen and propolis following action taken in 1997 to strengthen the then warning statement for food forms of royal jelly as a matter of urgency under section 37 of the Australia New Zealand Food Authority Act 1991 (ANZFA Act). This Final Assessment [Inquiry s.24] Report was deferred pending a review by the Australian Therapeutic Goods Administration (TGA) during December 2000 – July 2001 of the evidence implicating royal jelly in case events recorded on TGA’s Adverse Drug Reaction Database. The Review re-examined the 24 Australian reports of suspected adverse reactions to products containing royal jelly. Three of these reactions resulted in fatalities and 21 of the cases required serious medical intervention including two who required intensive care. On the basis of the re-assessed risk to public health, a warning statement in the label of a food comprising or containing royal jelly remains justified because of the considerable potential for royal jelly to cause severe adverse reactions, including life threatening and fatal reactions. Such a warning statement is necessary in order to inform susceptible people of the full extent of the risk of consumption of royal jelly in food form because these foods are not common and are promoted as health foods. The text of the statement, which includes reference to ‘fatalities’, is proposed to be maintained consistent with the re-assessed risk and as currently required in Volumes 1 and 2 of the Food Standards Code, part of the New Zealand Food Standard 2001 (Attachment 7), and with TGA requirements. The format of the statement, currently required in food regulation in UPPER CASE, has been changed to lower case. The proposed statement is: This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers The approach to risk assessment for food products containing bee pollen or propolis proposed at Preliminary Inquiry i.e. discontinuation of the pollen warning statement and non-introduction of a propolis warning statement is maintained in the light of no new developments and submitter support for this approach. Because of the potential for some therapeutic-type bee products to be inadvertently classified and regulated as foods by virtue of the Therapeutic Goods Act 1989, the definitions for royal jelly, bee pollen, pollen and propolis are proposed to be deleted from Volume 2 of the Food Standards Code and included in the User Guide to Standard 1.2.3. No definitions for these substances were previously given in the New Zealand Food Standard 2001. Once this Proposal P154 is extinguished, the draft amendments to Volume 2 gazetted and the transition arrangements expired, TGA is urged to consider the need to finalise its draft proposal issued in 1998 under section 7 of the Therapeutic Goods Act 1989 to declare royal jelly presented in capsule, phial or powder form to be a therapeutic good. This Final Assessment [Inquiry s.24] Report is also referred to the New Zealand Ministry of Health (NZMOH) for amendments to the New Zealand Food Standard 2001 that would be necessary to maintain a harmonised approach to food regulation.

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1. BACKGROUND The Preliminary Inquiry to Proposal 154, circulated for public comment in 2000, assessed the regulatory requirements for food forms of royal jelly, bee pollen and propolis, and their food products following action taken in 1997 in relation to royal jelly as a matter of urgency under section 37 of the Australia New Zealand Food Authority Act 1991 (ANZFA Act). The action involved strengthening the then existing warning statement on royal jelly or food containing royal jelly to:

THIS PRODUCT CONTAINS ROYAL JELLY WHICH HAS BEEN REPORTED TO CAUSE SEVERE ALLERGIC REACTIONS AND IN RARE CASES, FATALITIES, ESPECIALLY IN ASTHMA AND ALLERGY SUFFERERS.

Further detail on the background to the Proposal is given in the Preliminary Inquiry Report Executive Summary at Attachment 6. The Preliminary Inquiry Report proposed the following revised warning statement on food comprising or containing royal jelly: ROYAL JELLY MAY CAUSE VERY SERIOUS ALLERGIC REACTIONS. ASTHMA SUFFERERS ARE MOST AT RISK. The Preliminary Inquiry Report also proposed to delete the requirement for a warning statement on pollen products. The Report proposed that the prescribed provisions would apply to both Volumes 1 and 2 of the Food Standards Code. A related Proposal P161 – Specific Labelling Statements, now extinguished, inserted new definitions for bee pollen and propolis and required the presence as an ingredient or other added forms of royal jelly, bee pollen or propolis to be declared in the label of foods containing these substances, regardless of their final concentration. Because of developments in Australia relating to royal jelly as a therapeutic good that would delay finalisation of Proposal P154 beyond the end of the entire Review of Trans-Tasman food regulation, Proposal P227 was prepared in October 2000 under section 37 of the ANZFA Act inter alia to cross reference the requirement for the royal jelly warning statement contained in Volume 1 to Standard 1.1.3 - Temporary and Transitional Standards of Volume 2 of the Food Standards Code until the conclusion of this Proposal. 2. REVISED SCOPE OF THIS PROPOSAL Now that Proposal P161 has resulted in the aforementioned definitions and mandatory declaration requirements for royal jelly and related substances being included in Volume 2, and that the transition period to Volume 2 is likely to conclude in or around December 2002, the subject of the proposed drafting for this Proposal is now limited to the need for the four definitions of bee products in clause 1, and in relation to the need for warning statements on foods comprising or containing royal jelly, bee pollen or propolis in clauses 3 and 4 of Standard 1.2.3 – Mandatory Warning and Advisory Statements and Declarations. Clause 3 focuses on the text of proposed warning statements and the description of the foods to which such statements would apply whereas clause 4, which requires the mandatory declaration of allergens, may need to be amended to remove any duplication resulting from their reference in clause 3.

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No variations to Volume 1 are now proposed. NZMOH is responsible for any variations to the New Zealand Food Standard 2001. Transition arrangements contained in clause 4, Standard 1.1.3 – Transitional and Temporary Standards are also considered in this Final Assessment [Inquiry s.24] Report. 3. SUMMARY OF SUBMISSIONS RECEIVED The Preliminary Inquiry Report was advertised for public comment in August 2000. Thirteen submissions were received in response from industry, community and Australian and New Zealand government stakeholders. A summary of all comments made in submissions is given at Attachment 4. The draft Final Assessment [Inquiry s.24] Report proposed to revise (strengthen) the statement proposed at Preliminary Inquiry back to the currently required statement. It was therefore considered important that submitters be advised of this and be given the opportunity to comment. Eight submissions were received in response to a targeted consultation in May 2002. A summary of comments is at Attachment 5. Now that Proposal P161 has been extinguished, only those issues relevant to Proposal P154 are considered this Final Assessment [Inquiry s.24]. 4. ASSESSMENT OF ALL ISSUES 4.1 Need for and Text of Warning Statement in Relation to Royal Jelly 4.1.1 TGA Review of Evidence of Adverse Reactions to Royal Jelly This Final Assessment [Inquiry s.24] Report was deferred pending a review by the Australian Therapeutic Goods Administration (TGA) during December 2000 – July 2001 of the evidence implicating royal jelly in case events recorded on TGA’s Adverse Drug Reaction Database. The Review re-examined the 24 Australian reports of suspected adverse reactions to products containing royal jelly. Three of these reactions resulted in fatalities and 19 of the cases required serious medical intervention including two who required intensive care. The review was conducted under the auspices of the Adverse Drug Reaction Advisory Committee (ADRAC) and ADRAC’s Report (at Attachment 3) found that

…the role of the royal jelly product in each of the three cases is sufficiently documented as to warrant retention of the Committee’s causality grading of “possible”. This acknowledges that an alternative explanation may exist. In none of the three cases, however, did ADRAC find an alternative cause of comparable plausibility to that of the royal jelly product. The association between the reaction and the royal jelly product was assessed according to the Committee’s criteria as “certain” in three cases, “probable” in three instances and “possible” in the remaining 18 cases. The Committee is at pains to make clear that it, in common with other drug safety bodies, routinely makes judgements about the significance of the totality of evidence in addition to causality assessments of individual case reports.

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The ADRAC Report concluded that:

the totality of the clinical experience contained in the Australian reports indicates very strongly that products containing royal jelly that have been available in Australia have caused life-threatening reactions in sensitive patients and that the products were the most likely cause of three Australian reactions which had a fatal outcome.

The TGA accepted the recommendation of its Complementary Medicines Evaluation Committee (CMEC) that, on the basis of the ADRAC review, TGA should maintain the current wording on the warning statements on royal jelly regulated as therapeutic goods, which refers to ‘fatalities’. 4.1.2 Comments from Submissions at Preliminary Inquiry Support 12 Oppose 0 No comment 1 Twelve submissions were in favour of the requirement for a mandatory warning statement on royal jelly and food products containing royal jelly. However, there was some difference in opinion on the wording of the proposed statement. Use of the term ‘very’ Three submissions commented that the use of the term ‘very’ was superfluous to the requirements of the warning statement. Comvita commented that according to World Health Organization definitions, the term ‘serious’ refers to life-threatening situations, thus ‘very’ is not warranted. One submission considered the use of ‘very’ to be insufficient. Removal of the term ‘fatalities’ Three submissions supported the removal of the term ‘fatalities’ from the statement currently required in Australia and one option in New Zealand. The general reason for this was the belief that the term is extreme and alarmist and not in line with warning statements for other allergens. Four submissions opposed the removal of the term ‘fatalities’. The main reason was that the warning statement should alert consumers to the full extent of the risks. 4.1.3 Comments from Submissions at (draft) Final Assessment [Inquiry s.24] Support 4 Oppose 4 Two submissions from jurisdictions (including NZMOH) supported retention of the current warning statement and one other was opposed. Health professionals supported also supported retention of the statement. Two submissions from industry (New Zealand only) were strongly opposed and instead supported the statement proposed by the New Zealand Independent Scientific Ministerial Review “Royal jelly may cause serious allergic reactions. Most reports have been in asthma sufferers” and the remaining two submissions supported the statement proposed at Preliminary Inquiry and one did not suggest another option.

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4.1.4 ANZFA Assessment ANZFA discussed the results of the ADRAC Report with the TGA and the NZMOH who are responsible for the regulation of royal jelly as complementary medicines in Australia or dietary supplements in New Zealand respectively. These discussions focused on the potential for common agreement on the text after acknowledging the need for a warning statement on all forms of royal jelly and products containing royal jelly because the risk from all forms of royal jelly was the same, irrespective of source. All parties agreed that, without appropriate labelling, the target group, particularly allergy and asthma sufferers, would be unlikely to be informed about the full extent of those risks. In proposing a less stringent text for the warning statement that omitted reference to ‘fatalities’, ANZFA had given considerable weight to the New Zealand Report on the Findings of the Bee Products Warning Review Working Group, August 1999 (Attachment 6, P154 Preliminary Inquiry Report) that had excluded 2 of the 3 Australian deaths from the analysis because of what the Group believed to be a lack of rigorous supporting data. Following ADRAC’s meticulous review of the data which confirmed that the most likely explanation for the 3 deaths was from ingestion of royal jelly, and TGA’s acceptance of the ADRAC Report, ANZFA accepts this finding and therefore proposes that the text of the warning statement for food forms of royal jelly as currently given in Volume 1 of the Food Standards Code and as one of the options in the New Zealand Food Standard 2001 should be maintained, and moreover, that the format of the statement should be in lower case, consistent with other warning statements given in Volume 2 of the Food Standards Code: This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers This is a stronger approach than that required for other common food allergens (mandatory label declaration of presence), which is predicated on experience that knowledge of allergenicity is not ascertained unless exposure occurs, which for most food allergens, is early in life after trial introduction. Royal jelly is not a common food ingredient, and is promoted for its beneficial properties. It is therefore important that consumers, particularly those at higher risk, are also alerted to the risks of consumption given that they are unlikely to be aware of their potential allergenicity from previous experience. ANZFA believes that the prescription of a warning statement in lower case does not preclude that warning statement from being written in upper case. The definition of ‘warning statement’ in Standard 1.1.1 prescribes only the text of the statement and not the text's appearance. The only qualification to this is in Standard 1.2.9 which requires warning statements (except for small packages) to be in a size of type no less than 3 mm. The warning statement is also consistent with that required on therapeutic forms of royal jelly sold in Australia and with one option for food and dietary supplements given in the New Zealand Food Standard 2001. The reference to royal jelly in the prescribed warning statement now fulfils the requirement of clause 4 of Standard 1.2.3 for mandatory label declaration. Because royal jelly in the Table to clause 4 is now redundant, reference to royal jelly will be removed.

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4.2 Reference to Royal Jelly in Food Form The TGA pointed out that in the light of the (Australian) Therapeutic Goods Act 1989, the description of royal jelly products in Volume 1 (also cross referenced in Standard 1.1.3 of Volume 2) required to bear the warning statement may inadvertently regulate as foods some royal jelly products that should otherwise be regulated as therapeutic goods such as capsules, phials, and powders. This is exacerbated through the inclusion of a definition of royal jelly in both volumes of the Food Standards Code, and use of the term ‘package containing royal jelly’ in clause 8 of Standard K2 of Volume 1. In Australia, it is important to clearly differentiate between royal jelly presented as a food and as a therapeutic good, particularly as the TGA had previously signalled its intention to declare under section 7 of the Therapeutic Goods Act 1989 goods containing royal jelly presented in the form of capsules, phials or powders to be therapeutic goods. If sufficient clarity can be introduced by revised drafting in food regulation, this may negate the need for TGA to progress its draft section 7 declaration. NZMOH’s concerns about TGA’s proposed section 7 declaration in relation to restriction of trade have been referred to TGA. 4.2.1 Comments from Submissions at (draft) Final Assessment [Inquiry s.24] Support (qualified) 1 One jurisdiction gave qualified support to the removal of the four definitions provided it can be demonstrated that there are sufficient means within the Food Standards Code or associated mechanisms to provide surety on their definition if required for enforcement purposes. 4.2.2 ANZFA Assessment To address the problem, it is proposed to delete the definition of royal jelly and to describe the terms used for foods required to bear the warning statement listed in column 1 of the Table to clause 3 of Standard 1.2.3 be amended to indicate that only food forms of royal jelly are the subject of the requirement. Although the existing context of clause 3 clearly indicates that the subject of the requirement is limited to ‘food’, it is proposed that the terms be revised to: ‘royal jelly when presented as a food’ and ‘food containing royal jelly’ to categorically emphasise that the warning applies to foods only. TGA has advised that, should the draft section 7 declaration be progressed, it would not have direct application to New Zealand dietary supplements. Given the Trans Tasman Mutual Recognition Arrangement that exempts therapeutic goods, a section 7 declaration for the proposed forms of royal jelly would classify them as therapeutic goods and thus prevent New Zealand royal jelly dietary supplements in those forms from importation into Australia. The definition of royal jelly will be inserted into the User Guide to Standard 1.2.3. 4.3 No Requirement for Warning Statement in Relation to Bee Pollen and Propolis 4.3.1 Comments from Submissions at Preliminary Inquiry Support 6 Oppose 3 No comment 4

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Six submitters supported the proposed labelling changes for mandatory warning statements including a removal of the warning statements on products containing bee pollen and propolis. Reasons, where given, were that these two ingredients posed a lower threat to the consumer than royal jelly and it was sufficient that statement of their presence be mandated. Three submitters were opposed to the removal of the warning statement on products containing bee pollen and/or propolis given the small risk of these substances to cause allergic reactions, and that the mandatory ingredient declarations may not be sufficiently prominent on the label. 4.3.2 Comments from Submissions at (draft) Final Assessment [Inquiry s.24] Support 3 Oppose 0 Industry supported this approach. 4.3.3 ANZFA Assessment Most comments supported the proposed removal from regulation of the warning statement on food products containing bee pollen, and for the proposal not to introduce into Volume 2 a warning statement on food products containing propolis on the basis of an assessed smaller risk of serious adverse health effects from consumption of these substances. The TGA pointed out that in the light of the Therapeutic Goods Act 1989, the inclusion of definitions for pollen and propolis in Volumes 1 and 2, and bee pollen in Volume 2 of the Food Standards Code may inadvertently regulate some therapeutic-type products containing these substances as foods. Because no action is contemplated in relation to Volume 1, nor is any warning statement relevant to pollen or propolis contemplated for Volume 2, it is proposed to limit ANZFA’s response to deletion of the aforementioned three definitions. However because of their usefulness, these definitions will be inserted into the User Guide to Standard 1.2.3. This approach is inconsistent with that taken by TGA which requires warning statements on therapeutic goods containing bee pollen or propolis. Because the New Zealand Food Standard 2001 mandates warning statements for foods and dietary supplements containing bee pollen and propolis, this anticipated outcome will also be referred to NZMOH for their attention. 4.4 Relevance to Honey of Royal Jelly Warning Statement or Mandatory

Declaration of Royal Jelly, Bee Pollen or Propolis 4.4.1 Comments from Submissions at Preliminary Inquiry Two jurisdictions pointed out inconsistencies between the drafting and ANZFA’s declared intent that bee products naturally present in honey would not trigger the relevant mandatory labelling requirements. 4.4.2 Comments from Submissions at (draft) Final Assessment [Inquiry s.24] Support 0 Oppose 1

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Nutrition professionals raised concerns about the potential for foods which could be contaminated by royal jelly not being required to bear a label stating that the food ‘may contain royal jelly’. 4.4.3 ANZFA Assessment Honey, while potentially containing traces of royal jelly, does not contain royal jelly in the form of an ingredient, or other added substance, which is the necessary precondition for mandatory declaration in the label as defined by clause 4, Standard 1.2.3. Although the term ‘ingredient’ is used in Standard 1.2.3, it is clear from the definition of ‘ingredient’ in Standard 1.2.4 – Labelling of Ingredients, that the term does not cover incidental contamination such as from royal jelly in honey. To clarify this point, ‘food containing royal jelly’ discussed under point 2 above will be qualified to instances when royal jelly is deliberately added to the food i.e. ‘food containing royal jelly as an ingredient as defined in Standard 1.2.4’. The issue of unintended contamination and the use of a ‘may contain’ statement is being addressed by ANZFA more generally. 4.5 New Zealand Only Issues in relation to Labelling Bee Products 4.5.1 Comments from Submissions at Preliminary Inquiry A) Consistent Treatment of Foods and Dietary Supplements in New Zealand Support 4 Oppose 0 No comment 9 P154 suggested that the proposals for mandatory warning statements could be harmonised for use in both Australia and New Zealand across all forms of royal jelly to ensure a consistent approach to the regulation of consumable products containing royal jelly. Four submitters agreed with this suggestion stating that all forms may pose the same risk. One of these although opposed to the treatment of foods and dietary supplements more generally, supported the same approach to products that pose the same risk. Additional comments were made as to the desirability of the same requirements applying in Australia and New Zealand. B) Revision of mandatory requirements in New Zealand Food Standard 2001 consistent with Volume 2 Support 5 Oppose 0 No comment 8 All submitters who commented supported maintaining a labelling requirement in New Zealand while the New Zealand Food Regulations were in effect.

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4.5.2 ANZFA Assessment New Zealand Food Standard 2001 contains mandatory requirements for warning statements on the package of a food, including a dietary supplement, comprising or containing royal jelly. The Standard prescribes alternate forms of statement, one of which replicates the text of the current requirement in Volume 1. Given NZMOH is responsible for the New Zealand Food Standard 2001, the outcomes anticipated by this Final Assessment [Inquiry s.24] Report have been referred to NZMOH for their attention. Since the release of the Preliminary Inquiry Report, ANZFA has prepared Proposal P235 – Food Type Dietary Supplements, which aims to regulate all food-type dietary supplements. It is understood that the NZMOH will soon be releasing a discussion paper for public comment on the future of the New Zealand Dietary Supplement Regulations. 4.6 Removal of food forms of royal jelly from the market One submitter contended that royal jelly should not be permitted to be sold at all. ANZFA does not believe that the risk to public health as recorded in the relatively small number of cases on the ADRAC and New Zealand Centre for Adverse Reactions Monitoring (CARM) databases is sufficient to warrant food forms of royal jelly being removed from the market or prohibited from sale. However, as discussed in this Final Assessment [Inquiry s.24] Report, appropriate risk management requires that consumers be informed of the full extent of the risks of product consumption. This is consistent with the approach taken by the other regulatory bodies regulating royal jelly in Australia and New Zealand. 4.7 Transition Arrangements Because of the elapse of time between public submissions and consideration at Final Assessment [Inquiry s.24], the issue of transition arrangements has evolved considerably such that comments made in submissions are no longer pertinent. Clause 4 of Standard 1.1.3 – Transition and Temporary Standards, sets out the requirements for the warning statement on labels of food forms of royal jelly until Proposal P154 is finalised. It is proposed that the draft provisions contained in this Report, once adopted, will commence on gazettal but that the cross reference to Volume 1 effected through clause 4 of Standard 1.1.3 will remain as a transition arrangement until that entire standard is repealed on or around 20 December 2002. Proposal P252 –Transitional Arrangements for the Repeal of Volume 1 of the Food Standards Code before the Ministerial Council, proposes the creation of individual transitional periods including for matters considered under P154, for two years after gazettal. The gazettal of the outcomes of Proposal P154 may have implications for some foods and food-type dietary supplements comprising or containing royal jelly sold in New Zealand. Given NZMOH’s stated preference that the labelling statements adopted for food also would be made mandatory for dietary supplements, since foods and dietary supplements that pose the same risks should be managed so as to achieve the same outcome, these anticipated outcomes will also be referred to NZMOH for their attention. Expiry of the transition period should also permit TGA to complete its processes in relation to section 7 declarations for therapeutic forms of royal jelly, should the agency choose to do so.

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4.8 Regulatory Impact Statement 4.8.1 Introduction In Australia currently, royal jelly, propolis and bee pollen may be regulated as foods or therapeutic goods depending on their intended purpose. In New Zealand, bee products may be sold either as foods or as dietary supplements depending on their intended purpose. ANZFA actively sought information from industry on the size of the food and therapeutic markets for these products, sales trends and the volume of trade between Australia and New Zealand. However, this data was not available. Most royal jelly, bee pollen and propolis products sold in Australia are regulated as therapeutic goods under the Therapeutic Goods Act 1989, and in New Zealand as dietary supplements, which themselves are regulated as foods under the Food Act 1981. Warning statements for products containing royal jelly (refers to ‘fatalities’) and propolis, and an advisory statement for products containing bee pollen are required on Australian therapeutic goods. Volume 1 of the Food Standards Code prescribed as warning statements, the same text for royal jelly and pollen products as required on equivalent therapeutic goods. In New Zealand, the New Zealand Food Standard 2001 mandates the current Australian (Volume 1) as well as alternative text (without ‘fatalities’) for the label warning statement on royal jelly foods and dietary supplements. It also mandates warning statements for foods and dietary supplements containing bee pollen or propolis. Standard 1.2.3 – Mandatory Warning and Advisory Statements of Volume 2 of the Food Standards Code does not (yet) contain prescribed label warning or advisory statements for royal jelly, bee pollen or propolis food products, although it requires the mandatory declaration in the ingredient list of the presence of any of these three substances, regardless of amount. However, transitional arrangements for royal jelly products only are in place such that Standard 1.1.3 references the warning statement for royal jelly products required by Volume 1. The full regulatory impact of the proposed changes to Volume 2 of the Food Standards Code will not be in effect until the New Zealand Food Standard 2001 as it applies to foods is amended consistent with Volume 2. For this reason, the impact analysis focuses on Australia but anticipates similar changes subject to the New Zealand government amending The New Zealand Food Standard 2001. Since Preliminary Inquiry, TGA undertook further examination of the evidence of the safety of royal jelly. ANZFA re-assessed the risks to the Australian and New Zealand populations, including vulnerable at-risk subpopulations of consumption of food-type royal jelly products on the basis of the TGA report and has revised (strengthened) the warning statement proposed at Preliminary Inquiry to that currently in effect since December 1997. 4.8.2 Problem Products comprising or containing royal jelly, bee pollen and propolis are potentially available to Australian and New Zealand consumers as foods. Nearly all products containing bee-derived ingredients on the market are regulated as therapeutic goods or dietary supplements. The current differences in prescribed text for warning statements that apply to royal jelly food products and in the labelling requirements for bee pollen and propolis food products are problematic in the light of the objective of harmonised Trans Tasman food standards. Aggregate data on the size of the industry, in particular, the food-related industry, or amount traded, are not available.

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Consumers generally are not as familiar with the potential health effects of these ingredients compared to regular foods. Moreover, because foods containing these bee products are particularly marketed as health products, consumers, particularly allergy and asthma sufferers, are not likely to be aware of the potential health risks. Case reports in Australia, New Zealand and throughout the world indicate that asthma and allergy sufferers are at risk of experiencing more frequent and severe adverse health events from the ingestion of royal jelly than the other bee products. Royal jelly has been strongly implicated as the cause of 3 deaths and 21 other cases of severe adverse reaction in Australia, whereas there are no records of mortality attributed to pollen or propolis in either Australia or New Zealand and fewer records of morbidity. The Australian Therapeutic Goods Administration has advised that under the Therapeutic Goods Act 1989, the current inclusion of definitions in the Food Standards Code for all four products (royal jelly, bee pollen, and propolis and pollen) may cause some products containing them to be inadvertently and inappropriately regulated as foods rather than as therapeutic goods, irrespective of the purpose of the product. 4.8.3 Objective for this Proposal To reduce the risks to public health of food products comprising or containing royal jelly, to apply the appropriate level of regulation for food products containing bee pollen and propolis commensurate with the assessed level of risk; and to ensure the risks to consumers are minimized through the application of appropriate regulation to products containing any of the three bee products at the food/therapeutic good interface. A further objective is to achieve consistency between Australia and New Zealand in the regulation of food products containing royal jelly, bee pollen and propolis. 4.8.4 Options for regulation Depending upon their presentation, royal jelly, bee pollen and propolis products would be classed as foods or therapeutic goods in Australia and as foods or dietary supplements in New Zealand. The following options relate to such products only as foods. Option 1 - Retain the status quo Do not introduce a warning statement on royal jelly, nor delete definitions of royal jelly, pollen, bee pollen and propolis in Standard 1.2.3 of Volume 2 of the Food Standards Code. Let requirements of Volume 1 in relation to these bee products (definitions, warning statements on royal jelly foods) lapse with the repeal of Volume 1 of the Food Standards Code, expected on or about December 2002. Rely on the repeal of Volume 1 to delete the requirement of a warning statement on foods containing bee pollen. Do not introduce a warning statement on foods containing propolis.

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Option 2 - Regulations consistent with re-assessed level of risk Maintain current warning statement in relation to royal jelly foods. Do not continue warning statement for foods containing bee pollen; do not introduce warning statement for foods containing propolis. Delete definitions of royal jelly, pollen, bee pollen and propolis to clarify Australian food/therapeutic good interface and ensure appropriate regulation of products containing these substances. Option 3 – non-regulatory approach to develop an industry Code of Practice Option 3 considers a non-regulatory approach to the development of a Code of Practice on the labelling aspects of Option 2 that would need to be subsequently supported and administered by industry. Such a Code of Practice would be expected to achieve the same public health and information outcomes as regulation including the widespread use of an appropriate voluntary advisory statement on royal jelly products. 4.8.5 Impact Analysis Affected parties: Consumers of royal jelly including at-risk population groups, manufacturers and importers of foods comprising or containing royal jelly and foods containing bee pollen, government, particularly health and regulatory authorities.

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Option 1 - Retain status quo Affected party Costs Benefits

Consumers

Potential for some therapeutic type bee products to be inappropriately regulated as foods in Australia thus exposing consumers to increased risk. Before repeal of Volume 1: Consumers not at risk unnecessarily deterred from purchasing of bee pollen containing foods because of labelling containing a warning statement pitched in excess of the assessed level of risk. After repeal of Volume 1: Consumers, particularly vulnerable groups, ignorant of potential health risks of royal jelly foods and thus exposed to increased risk of potentially serious adverse health events.

Before repeal of Volume 1: Present good level of protection of at-risk consumers through informative and appropriate labelling of royal jelly foods. After repeal of Volume 1: Consumers not at risk no longer potentially deterred from purchasing bee pollen containing foods.

Manufacturers /Importers

Ongoing cost of labelling and compliance with the regulations. Uncertainty in Australia about regulatory status as a food or therapeutic good that could adversely impact on business and bilateral trade. Before repeal of Volume 1: Potential for unnecessarily low sales of royal jelly-containing foods due to possible avoidance of the product by consumers not at risk in response to the qualified warning statement. Unnecessarily low pollen product sales for the same reason. After repeal of Volume 1: Based on experiences in the 1990s resulting from negative publicity, it is expected that any such publicity related to a future adverse health incident that implicated royal jelly foods would reduce sales and diminish the credibility of the retailers and distributors of royal jelly products and most likely, the health products industry in general. Increased risk of legal action over royal jelly foods.

Before repeal of Volume 1: Lower risk of complaints and legal action from consumers in the event of an adverse reaction to royal jelly or bee pollen. After repeal of Volume 1: Initial prospective growth in sales of royal jelly foods, whose maintenance would depend on the absence of relevant negative publicity. Possible increase in bee pollen foods sales after being labelled in accordance with assessed low level of risk.

Government

Some minor cost of enforcement resulting from uncertainty at the food/therapeutic good interface in Australia, and different regulatory requirements in Australia and New Zealand. Before repeal of Volume 1: Greater enforcement costs. After repeal of Volume 1: Additional health care costs for victims of severe adverse reactions to royal jelly.

Before repeal of Volume 1: Present level of health protection, whether through labelling changes, adverse publicity or chance has not recorded any deaths attributable to royal jelly consumption since 1997. No sales data available to explore this further. After repeal of Volume 1: Nil

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Option 2 - Regulations consistent with assessed level of risk Affected party Costs Benefits

Consumers

No foreseeable additional costs. Appropriate regulation of bee product foods and therapeutic goods in Australia thus minimising risk to consumers. High protection of at-risk consumers through the advice contained in the strong warning statement consistently applied between royal jelly foods and therapeutic goods in Australia. Appropriate lower level protection commensurate with lower risk for bee pollen food products.

Manufacturers /Importers

On-going cost of labelling and compliance with the regulations. Increased costs of compliance if the regulations are not ultimately harmonised between Australia and New Zealand.

Appropriate regulation of bee product foods and therapeutic goods in Australia thus providing clarity of regulatory requirements and certainty to industry. Lower risk of complaints and legal action from consumers in the event of an adverse reaction to royal jelly or bee pollen.

Government

Greater enforcement costs than if no royal jelly labelling statement was required.

Present level of health protection, which through labelling changes, adverse publicity or chance has not recorded any deaths attributable to royal jelly consumption since 1997. No sales data available to explore this further.

Option 3 – Non-regulatory approach to develop an industry Code of Practice The success of this approach is contingent on the industry and government reaching agreement on labelling and advertising that includes an appropriately pitched and relatively consistent advisory statement for royal jelly food products. It is also contingent upon industry’s effective administration of, and broad voluntary compliance with the Code. Such a Code would benefit from clarification of the regulatory status of these products in Australia which should be achieved through the deletions of the definitions from Volume 2. The costs and benefits of such a Code of practice for each of the affected parties entirely depend on the timeliness and level of success of implementation of the Code of Practice. New Zealand industry submitted that prior to the introduction of the mandatory requirement for a warning statement, roughly 85% of royal jelly products carried a warning statement. This leaves a significant minority of products associated with an increased risk to public health. Industry also conceded that the costs of development and administration of a narrowly based Code of Practice would be greater than compliance with a mandatory requirement. NZMOH was not in support of a Code of Practice because of less than complete coverage, and the potential for different statements to be devised.

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Affected party Costs Benefits Consumers

Depending on the success and timeliness of the Code, consumer confusion could increase if there is an inconsistent approach to labelling or provision of consumer information on the safety aspects of the product. Potential for an increase in consumer risk through non compliance with a Code of Practice.

Depending on the success and timeliness of the Code, benefits would be the same as Option 2 if highly successful and quickly implemented, but would reduce in parallel with the level of adherence to the Code of Practice and any delay in its implementation. However, over the longer term, a code of practice would provide greater flexibility in responding to changing circumstances.

Manufacturers/ Importers

Depending on the success and timeliness of the Code of Practice, costs of compliance might be the same as Option 2 or greater flexibility might incur greater design costs. However industry would be required to bear the additional cost of establishment and administration of the Code, which they are reluctant to do. Increased costs of compliance if a code of practice is not harmonised between Australia and New Zealand. Potential loss of consumer confidence in the product if the industry does not consistently label and inform about the safety aspects of the product.

Depending on the success and timeliness of the Code of Practice, benefits would be, at best, the same as Option 2 if highly successful and timely, but not be as great if the industry did not consistently adhere to the Code or implementation was delayed. However, over the longer term, a code of practice would provide greater flexibility in responding to changing circumstances. Greater or equal risk than Option 2 of complaints and legal action from consumers depending on success and timeliness of Code of Practice.

Government

Depending on the success and timeliness of the Code of Practice, costs would be less than Option 2 if successfully implemented because of reduced enforcement costs. Some costs in developing a non-regulatory approach and monitoring the overall success or otherwise of the Code.

Depending on the success of the Code of Practice, benefits would be the same as Option 2 if the Code was successfully implemented in a timely manner and any advisory statement was consistently formed and applied.

4.8.6 Assessment of options Until the repeal of Volume 1. Both Options 1 and 2 would ensure that consumers were provided with adequate information about royal jelly to make an informed choice about consumption of the product. In addition, fewer consumers would unnecessarily avoid bee pollen food products under Option 2 than Option 1. Both options provide the small number of high-risk individuals to bee pollen with label information to indicate the presence of this allergen, irrespective of concentration. Option 2 also ensures the risks to consumers are minimized through the application of appropriate regulation to products containing royal jelly, pollen or propolis at the food/therapeutic good interface. After the repeal of Volume 1, the balance of costs and benefits change significantly. Under Option 1, there may be short-term benefits for manufacturers and importers by increased sales and fewer costs, but this may in time drop markedly if a publicised adverse health outcome for a consumer were to eventuate. The risk to consumers, particularly vulnerable groups, would markedly increase because they would not be informed of the dangers of the product at the point of purchase. In contrast, Option 2 reduces the risks to consumers in terms of adequate labelling information and appropriate regulation of products at the interface.

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Options 1 and 2 would present some costs to government in the form of costs of enforcement and, in the case of Option 1 (after the repeal of Volume 1), costs associated with different requirements for royal jelly presented as foods and as therapeutic goods in Australia. Option 1 (after the repeal of Volume 1) may also increase the health costs to government from the medical treatment of a susceptible person, who otherwise might have been informed of the risks. Options 1 and 2 may present a barrier to trade and may breach the WTO agreement; however, this could be justified on the basis of protection of public health and safety. As most products containing royal jelly are therapeutic goods, the trade impact of Option 2 would be very small. Given the specific risks associated with bee product substances not commonly consumed in foods, Option 3, development of a non-regulatory Code of Practice, would carry an unacceptably high risk to public health and safety and therefore it does not satisfy the objectives of this Proposal. 4.8.7 Preferred option Option 2 is the preferred option because it: �� protects the public health and safety of consumers of royal jelly and other bee products

in the form of food, commensurate with the re-assessed risk; �� provides adequate information for consumers, particularly those at risk, to make an

informed choice; �� provides consistent information across royal jelly containing foods and therapeutic

goods in Australia to minimise consumer confusion; and �� clarifies the regulatory status in Australia of products containing bee-derived

ingredients. 4.8.8 Comments from Submissions at Preliminary Inquiry Option 1 Retain status quo i.e. do nothing, in both Australia and New Zealand, or

alternately, New Zealand adopt the present Australian requirements. 0

Option 2 Regulations consistent with re-assessed level of risk – maintain current warning statement for royal jelly; do not continue warning statement for foods containing bee pollen; do not introduce warning statement for foods containing propolis.

8*

Option 3 Non-regulatory approach to develop an industry Code of Practice – advisory statement for royal jelly only; mandatory declaration of royal jelly, bee pollen, and propolis

0

No comment 5 * Submitters varied as to which version of the warning statement was preferred i.e. proposed at Preliminary Inquiry, or current and proposed at Final Assessment [Inquiry s.24] (refer to sections 4.1.2 and 4.1.3).

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4.8.9 Implementation and Review It is proposed that the draft provisions contained in this Report, once adopted, will commence on gazettal but that the cross reference to Volume 1 effected through clause 4 of Standard 1.1.3 – Transition and Temporary Standards will remain as a transition arrangement until that entire standard is repealed on or around 20 December 2002. Proposal P252 – Transitional Arrangements for the Repeal of Volume 1 of the Food Standards Code before the Ministerial Council, proposes the creation of individual transitional periods including for matters considered under P154, for two years after gazettal. The gazettal of the outcomes of Proposal P154 may have implications for some foods and food-type dietary supplements comprising or containing royal jelly sold in New Zealand. The full regulatory impact of the proposed changes to Volume 2 of the Food Standards Code to achieve harmonisation of regulations will not come into effect until The New Zealand Food Standard 2001 as it applies to foods is amended consistent with Volume 2. Given NZMOH’s stated preference that the labelling statements adopted for food also would be made mandatory for dietary supplements, since foods and dietary supplements that pose the same risks should be managed so as to achieve the same outcome, these anticipated outcomes will also be referred to NZMOH for their attention. Expiry of the transition period should also permit TGA to complete its processes in relation to section 7 declarations for therapeutic forms of royal jelly, should the agency choose to do so. Given that it is expected that the same warning statement will appear on royal jelly products irrespective of whether they are regulated as therapeutic goods, foods or dietary supplements, any review of these regulations would aim to maintain a consistent approach. 5. SUMMARY CHANGES THAT APPLY TO VOLUME 2 OF THE

FOOD STANDARDS CODE 5.1 Standard 1.2.3, clause 1 1. Omit definitions for royal jelly, pollen, bee pollen, propolis 5.2 Standard 1.2.3, Table to clause 3 1. Revise the names of the foods in column 1 to ‘royal jelly when presented as a food’, and

‘food containing royal jelly as an ingredient as defined in Standard 1.2.4’. 2. Revise the text of the warning statement in column 2 (no longer case sensitive) to:

This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers.

3. Omit drafting note immediately following the Table to clause 3. 5.3 Standard 1.2.3, Table to clause 4 1. Omit ‘royal jelly as a food or royal jelly present in a food’ from the Table to clause 4.

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6. WORLD TRADE ORGANIZATION (WTO) NOTIFICATION Australia and New Zealand are members of the WTO and are bound as parties to WTO agreements. In Australia, an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory. Under the agreement between the Governments of Australia and New Zealand on Uniform Food Standards, ANZFA is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO. In certain circumstances Australia and New Zealand have an obligation to notify the WTO of changes to food standards to enable other member countries of the WTO to make comment. Notification is required in the case of any new or changed standards which may have a significant trade effect and which depart from the relevant international standard (or where no international standard exists). This matter was notified to the WTO by New Zealand because the TBT Agreement requires that proposed regulatory measures such as technical regulations, including labelling requirements, be notified to other WTO members whenever relevant international standards do not exist and where the proposed measure may have a significant effect on trade. The agency responsible for WTO Notifications in New Zealand determined that, in New Zealand’s circumstances, notification of the proposal was appropriate. ANZFA received no submissions in response. WTO will be renotified by New Zealand because of the proposed change to the original wording of the warning statement. There is no regulatory measure proposed for Australia as the recommended wording is the same as the existing requirements. 7. CONCLUSIONS Given the evolution of this matter since Preliminary Inquiry: This Final Assessment [Inquiry s.24] Report concludes that, on the basis of the re-assessed risk to public health, a warning statement in the label of a food comprising or containing royal jelly remains justified because of the considerable potential for royal jelly to cause severe adverse reactions, including life threatening and rarely fatal reactions, as assessed by TGA’s ADRAC Report and the recommendations of the Complementary Medicines Evaluation Committee. Such a warning statement is necessary in order to inform susceptible people of the full extent of the risk of consumption of royal jelly because these foods are not common and are promoted as health foods. The text of the statement, which includes reference to ‘fatalities’, is proposed to be maintained consistent with the re-assessed risk and as currently required in Volumes 1 and 2 of the Food Standards Code, part of the New Zealand Food Standard 2001, and with TGA requirements. The format of the statement, currently required in food regulation in UPPER CASE, has been changed to lower case. The proposed statement is: This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers

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The approach to risk assessment for food products containing bee pollen or propolis proposed at Preliminary Inquiry i.e. discontinuation of pollen warning statement and non introduction of propolis warning statement is maintained in the light of no new developments and submitter support for this approach. Mandatory declaration of these ingredients was implemented through Proposal P161. Because of the potential for some therapeutic-type bee products to be inadvertently classified and regulated as foods by virtue of the Therapeutic Goods Act 1989, the definitions for royal jelly, bee pollen, pollen and propolis have been deleted from Volume 2 of the Food Standards Code and will be included in the User Guide to Standard 1.2.3. No definitions for these substances were previously given in the New Zealand Food Standard 2001. Once this Proposal P154 is extinguished and the draft amendments to Volume 2 are gazetted and the transition arrangements expired, TGA is urged to consider the need to finalise its draft proposal issued in 1998 under section 7 of the Therapeutic Goods Act 1989 to declare royal jelly presented in capsule, phial or powder form to be a therapeutic good. This Final Assessment [Inquiry s.24] Report is referred to the NZMOH for amendments to the New Zealand Food Standard 2001 that would be necessary to maintain a harmonised approach to food regulation. ATTACHMENTS 1. Proposed Draft Variations as amended 2. Statement of Reasons 3 CMEC/ADRAC Report 4 Summary of Submissions to Preliminary Inquiry Report 5 Summary of Submissions to draft Final Assessment [Inquiry s.24] Report 6 Executive Summary from Preliminary Inquiry Report 7 The New Zealand Food Standard 2001

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ATTACHMENT 1

DRAFT VARIATIONS TO THE FOOD STANDARDS CODE

P154 – Royal Jelly Warning Statement

To commence: on gazettal [1] Standard 1.2.3 of Volume 2 of the Food Standards Code is varied by – [1.1] omitting clause 1, substituting – 1 Deleted [1.2] inserting in Columns 1 and 2 respectively in the Table to clause 3 – Royal jelly when presented as a food; or Food containing royal jelly as an ingredient as

defined in Standard 1.2.4

This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers

[1.3] omitting from the Table to clause 4 – Royal jelly presented as a food or royal jelly present in a food

[1.4] omitting the Drafting note immediately following the Table to clause 3.

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ATTACHMENT 2

STATEMENT OF REASONS PROPOSAL P154 - REGULATORY REQUIREMENTS FOR FOODS COMPRISING OR CONTAINING ROYAL JELLY, BEE POLLEN AND PROPOLIS, INCLUDING THE NEED FOR LABEL WARNING STATEMENTS The Australia New Zealand Food Authority (ANZFA) has before it a Proposal to amend Volume 2 of the Food Standards Code to include provisions for labelling requirements for foods comprising or containing royal jelly, and to consider the need for such requirements in relation to bee pollen and propolis. ANZFA recommends the adoption of the draft variation to Standard 1.2.3, as amended, on the basis of recent and comprehensive risk assessments of royal jelly, bee pollen and propolis, and for the following reasons: 1 Royal jelly has been implicated in severe adverse reactions and in three deaths in

Australia. There is a continuing need to inform people with asthma and allergies, who are most at risk of very serious allergic reactions to royal jelly, and who may be unaware of that risk, that consumption of food comprising or containing royal jelly as a food ingredient may pose a risk to their health and wellbeing. It is proposed that the current warning statement (no longer case sensitive) continue to be mandated in the label of food comprising or containing royal jelly as a food ingredient:

This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers

This statement fulfils the requirements for the statement to:

�� apply to food comprising or containing royal jelly as an ingredient; �� refer to the at-risk target group, but also to others at risk; and �� describe an appropriate level of risk emphasising that risk particularly for the

target group. 2 The statement is also consistent with that required on royal jelly products regulated as a

therapeutic good in Australia and with one of the options contained in the New Zealand Food Standard 2001 that regulates foods and dietary supplements.

3 Bee pollen and propolis have been reported to be implicated in allergic reactions;

however, these reactions are rare and are not as serious as those caused by royal jelly. On the basis of ANZFA’s risk assessment, a warning statement is no longer warranted in relation to bee pollen nor warranted in relation to propolis.

The need to inform people who know they are allergic to bee pollen or propolis that a

food product contains these ingredients has been already addressed in Standard 1.2.3 of Volume 2 by requiring label declaration of these substances irrespective of their concentration in the food.

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4 The application of the warning statement recommended in this Proposal has been clarified to reflect the intent that it does not apply in cases where royal jelly is present naturally (in trace amounts) or due to unintentional contamination of products (eg. in honey).

5 Because of the potential for some therapeutic-type bee products to be inadvertently

classified and regulated as foods by virtue of the Therapeutic Goods Act 1989, the definitions for royal jelly, bee pollen, pollen and propolis have been deleted from Volume 2 of the Food Standards Code and included in the User Guide to Standard 1.2.3. No definitions for these substances were previously given in the New Zealand Food Standard 2001.

6 ANZFA recommends to the New Zealand Ministry of Health that the same labelling

approach as recommended by this Proposal, be adopted for royal jelly, bee pollen and propolis products regulated as foods under the New Zealand Food Standard 2001.

REGULATORY IMPACT ANZFA has undertaken a regulatory impact assessment process, which also fulfils the requirement in New Zealand for an assessment of compliance costs. That process concluded that amendment to Volume 2 of the Food Standards Code is necessary to assist in the protection of public health and safety; is cost effective; and is of benefit to producers, consumers and government. WORLD TRADE ORGANIZATION (WTO) NOTIFICATION Australia and New Zealand are members of the WTO and are bound as parties to WTO agreements. In Australia, an agreement developed by the Council of Australian Governments (COAG) requires States and Territories to be bound as parties to those WTO agreements to which the Commonwealth is a signatory. Under the agreement between the Governments of Australia and New Zealand on Uniform Food Standards, ANZFA is required to ensure that food standards are consistent with the obligations of both countries as members of the WTO. In certain circumstances Australia and New Zealand have an obligation to notify the WTO of changes to food standards to enable other member countries of the WTO to make comment. Notification is required in the case of any new or changed standards which may have a significant trade effect and which depart from the relevant international standard (or where no international standard exists). This matter was notified to the WTO by New Zealand because the TBT Agreement requires that proposed regulatory measures such as technical regulations, including labelling requirements, be notified to other WTO members whenever relevant international standards do not exist and where the proposed measure may have a significant effect on trade. The agency responsible for WTO Notifications in New Zealand determined that, in New Zealand’s circumstances, notification of the proposal was appropriate. ANZFA received no submissions in response. WTO will be renotified by New Zealand because of the proposed change to the original wording of the warning statement. There is no regulatory measure proposed for Australia as the recommended wording is the same as the existing requirements.

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ATTACHMENT 3

ADVICE FROM TGA FOLLOWING CMEC’S CONSIDERATION OF THE ADRAC REPORT

The Adverse Drug Reaction Advisory Committee (ADRAC) has completed a systematic review of the case narratives and the coding of the ADRAC case reports involving royal jelly. The Report of the review has been considered by the Complementary Medicines Evaluation Committee (CMEC) and, at its meeting on Friday, 27 July 2001, recommended to the TGA that therapeutic goods containing royal jelly should continue to carry the current warning statements. The statements currently required are: “This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases, fatalities, especially in asthma and allergy sufferers”. (in 3 mm type) OR “Not to be taken by asthma and allergy sufferers” (in 3 mm type), combined with “Royal jelly may cause severe allergic reactions and in rare cases, fatalities”. (in 1.5 mm type) In addition, the CMEC recommended that the ‘Report of the review by ADRAC of Australian reports of suspected adverse reactions to royal jelly’' be disseminated to stakeholders. A copy of the Report is attached at Appendix 1.

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Appendix 1

Report of Review by ADRAC of Australian Reports of Suspected Adverse Reactions to Royal Jelly Received up to March 2000

Conclusions of the Review Twenty four Australian reports of suspected adverse reactions to products containing royal jelly have been reviewed by a working party established by ADRAC. Fourteen reports which did not have death as an outcome and which had not been identified originally by ADRAC in published literature were found to have been largely recorded accurately and assessed appropriately. Some changes to the computer records have been requested but these related to fine detail and do not alter in any way the information or clinical lessons to be drawn from these reports. A further report (71716), not counted in these 14 reports, was both reported to ADRAC and also mentioned in published literature (see below). Limited details of five cases were published in the Medical Journal of Australia in 1993 by a group of doctors at the Alfred Hospital, Melbourne. Subsequently greater details about these five cases and another two cases were published. Duplicate publication in the journals has been acknowledged. One of the cases had been correctly identified by ADRAC as involving a patient for whom a record of the reaction already existed in the ADRAC database (report 71716). Six new records based on two publications (letter; journal paper) were created in the ADRAC database. With the assistance of Dr F Thien, Alfred Hospital, further information has been obtained. This information puts beyond doubt that there were seven patients, that the same seven patients were described in the two journal papers, that five of the seven were the cases described in the Medical Journal of Australia and that seven case records in the ADRAC computer database correspond to the seven cases described in the publications. The information also puts beyond doubt that there has not been duplication of these cases within the ADRAC database. Three other reports to ADRAC described reactions from which the outcome was death. It is worthwhile commenting on the issue of death as a consequence of an adverse reaction. It may seem trite but it is important to point out that rechallenge to confirm the causal role of the drug is not possible. Further, death from drug-induced allergy may occur unexpectedly and remote from initial medical observation and medical intervention. Fine clinical detail may not be documented well. That was to some extent the case with respect to each of the three cases with fatal outcomes recorded by ADRAC. In ADRAC’s view, the role of the royal jelly product in each of the three cases is sufficiently documented as to warrant retention of the Committee’s causality grading of “possible”. This acknowledges that an alternative explanation may exist. In none of the three cases, however, did ADRAC find an alternative cause of comparable plausibility to that of the royal jelly product.

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The association between the reaction and the royal jelly product was assessed according to the Committee’s criteria as “certain” in three cases, “probable” in three instances and “possible” in the remaining 18 cases. The Committee is at pains to make clear that it, in common with other drug safety bodies, routinely makes judgements about the significance of the totality of evidence in addition to causality assessments of individual case reports. Concerning the safety risk of royal jelly products, ADRAC believes that it is important to note that nineteen of the twenty one patients who did not have a fatal outcome are documented as having been given treatment with medications for their suspected reactions- often involving medical intervention which included intramuscular or intravenous injections. Of the nineteen, two are documented as having been admitted to an intensive care unit, another required intubation and ventilation for 24 hours and two others were treated with adrenaline injections. The use of adrenaline is significant because, although the most appropriate treatment for anaphylaxis, it is not given lightly because of concerns about accidental maladministration leading to an episode of hypertension. In ADRAC’s view, the totality of the clinical experience contained in the Australian reports indicates very strongly that products containing royal jelly that have been available in Australia have caused life-threatening reactions in sensitive patients and that the products were the most likely cause of three Australian reactions which had a fatal outcome. ADRAC has also accepted the recommendations about appropriate procedures set out in the body of this report. Detailed Report of the Review Background At the 243rd meeting in March 2000 (Item 10.2), the Committee reviewed the issue of royal jelly and other bee products. This review was in response to a letter to Senator Tambling, Parliamentary Secretary to the Minister for Health and Aged Care from the National Nutritional Foods Association of New Zealand (NNFA). This organisation had contested the regulations on bee products which had been introduced in New Zealand to bring that country into line with existing warning labels in Australia. The New Zealand Minister of Health established an expert scientific inquiry to investigate the scientific basis for the requirement of warning labels and other related matters. The report from the Scientific Review Working Group (SRWG) was provided for that meeting. The issue was reviewed again at the 245th meeting in June 2000 (Item 8) and the Committee endorsed its previous coding and interpretation of the reports involving royal jelly and agreed that the warning statement for products containing royal jelly should remain. At the 248th meeting in October 2000 (Item 14), members were informed that there had been a meeting on the issue involving representatives of the Complementary Healthcare Council, a consultant to the New Zealand National Nutritional Food Association and a representative of the Australian Self-Medication Industry (OTC industry body) and TGA representatives. The meeting arose following receipt of the report that was provided to the CHC from the 245th ADRAC meeting in June where a full narrative review of all the ADRAC cases was undertaken. This resulted in the CHC questioning further the reliability of ADRAC records of reactions to royal jelly. It was alleged that the ADRAC reports contained duplicate and triplicate recordings of cases and that the records were unreliable.

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The Committee agreed that the concerns of industry should be reviewed systematically. A working party comprising Dr Mathew, Dr Chow and Professor McNeil was established to review the case narratives and the coding of the ADRAC case reports involving royal jelly. It was decided that the review would best be handled by examining in turn three subsets of the ADRAC holdings of Australian reports. Part 1. Non-Fatal, Non-Published Reports The working group reviewed the fourteen reports that did not have a fatal outcome and did not involve reports published in the literature by a group at the Alfred Hospital, Melbourne. Copies of the original reports, the computer summaries and the narratives prepared by the ADRAC secretariat were reviewed. This first step was completed on 14 December 2000. Overall, the working group found the original assessments and the computer records to be in accordance with procedures and accurate. The working group recommended a number of minor amendments to further improve the accuracy of the records and these are highlighted in the document entitled “ADR Reports in Association with Royal Jelly (Version 2)”. Part 2. Three Reports with a Fatal Outcome There had been three cases with a fatal outcome, two of which had been the subject of coronial inquiry. The working group was provided with extensive documentation from the two coronial inquiries together with all the other documentation which could be located at TGA for the three reports. The working group discussed their findings by teleconference with the Secretariat on 21 March 2001. 2.1 The 11 Year Old Girl Report 88747 described the death of an 11 year old girl. The working group noted that the girl had previously had an illness for which she had taken antibiotics. It was agreed that this illness may have made her more sensitised to an asthma attack and that it adds to the possibility that she had an allergic response. The time course of the events was quite suggestive that the asthma attack was related to the ingestion of royal jelly in that it occurred within 20 minutes of the dose being taken. The event occurred late in the evening. A close review of the evidence and the statements presented to the coroner indicated that, apart from a short lived abdominal pain, the girl was healthy and well throughout the day. An acute exacerbation of the girl’s pre-existing asthma unrelated to medicines was a possibility. It was not until after the ingestion of royal jelly, however, that the clinical events began to occur. The working group noted that the systemic nature of the reaction (severe bronchospasm, diarrhoea, vomiting) was consistent with her having developed anaphylaxis. The group proposed some minor alterations to the narrative so that it was accurate with respect to the detail provided by the transcript. The coding of royal jelly as a possible cause was confirmed. The group also recommended that salbutamol and an unspecified antibiotic be added to the computer record but that these two drugs were not to be recorded as suspected drugs. Salbutamol had been used intermittently in the past, although not on the day of the reaction until after the onset of the reaction. An antibiotic had been taken in the days prior to the reaction but had been ceased about two days prior to the reaction.

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It was also noted that the stated date of onset of the reaction on the original report (18 April 1993) was incorrect and should be corrected to the day before. This error had apparently come about because the onset of the reaction was very late on 17 April 1993, and the girl died early in the morning of 18 April 1993. The group noted criticism that witnesses had recorded details some time after the event. The group noted that much of the coronial transcript was devoted to inquiry into the events later that night at the hospital but that was all after the initial reaction and not relevant to the group’s considerations. The group did not find any conflict of importance in the information about events prior to the girl’s arrival at hospital. Members also noted criticism of the fact that the letter to the MJA (which reported this event) had as a co-author the Secretary of ADRAC and was also signed by the mother of the girl but she had not identified her relationship to the patient. It was agreed that this was an unfortunate omission but it did not alter the facts of the case or ADRAC’s assessment. The group noted that the vial labelled as royal jelly which was ingested by the girl had not been analysed. This was apparently because there was no post-mortem conducted and the decision to refer the case to the coroner was made some months later. It was noted that a person who had given evidence to another coronial enquiry had claimed in other statements that vials of the same brand of royal jelly product were found to contain no royal jelly or protein. The Secretariat had not found any corroboration of this evidence and undertook to investigate further the origin of this statement. In 1991, testing of 500 mg, 1000 mg and 2000 mg presentations almost certainly of the brand taken by this girl was undertaken. The 500 mg strength was reported to not contain protein (a marker for royal jelly). The 1000 mg strength was reported as being under strength, while the 2000 mg was thought to have the labelled content. Further, ADRAC was informed that in 1996, testing of a 500 mg product, not to date clearly identified as being the brand taken by the girl, found that it did not contain 10-hydroxydecenoic acid (a marker for royal jelly). The information found suggests that from time to time royal jelly products on the Australian market did not contain royal jelly or contained less than the stated label amount of royal jelly. The results of the testing of the 1000 mg and 2000 mg vials of the same product support the proposition that the royal jelly content of the products was not reliable. The results are not sufficient, however, to support a claim that the product taken by the girl did not contain royal jelly. The revised case narrative is as follows with changes highlighted: ADRAC report no 88747 was a letter from a consultant initially followed by additional correspondence including a letter from the patient’s mother. These described an 11 year old female who, twenty minutes after ingesting Peking Royal Jelly Extra Strength 500 mg, developed diarrhoea, vomiting, severe bronchospasm and had a cardiac arrest. Resuscitation at hospital was attempted after some delay and the patient died approximately 30 minutes later. The patient had a recent history of tonsillitis treated with a course of antibiotics, which was completed some days before the event. The girl had also used additional salbutamol at this time. She had a short lived stomach pain on the morning of the episode (at least 10 hours prior to taking royal jelly) but was otherwise well.

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Over the past two years, the patient had taken short courses of royal jelly on three occasions and had experienced an asthma attack several minutes after the most recent previous dose, more than two years beforehand. That particular event resolved after treatment with salbutamol, beclomethasone and astemizole. The patient had a history of asthma, allergic rhinitis, allergies and elevated IgE and eosinophil levels.1 2.2 The 31 Year Old Male Report 91729 described a fatality involving a 31 year old male who developed an asthma attack after surfing and lost consciousness. Despite resuscitation he did not regain consciousness. After about three months of hospitalisation the patient died. The working group noted that the major weakness with this report was the anecdotal nature of the evidence that he had ingested royal jelly prior to the attack. Despite the anecdotal nature of this information, the group felt compelled to accept as factual the information which had been supplied. Some criticism of the interpretation of this case had arisen because of a statement made in the name of ADRAC. The group concluded that this statement that “it would not be fair, or scientifically defensible, to pin this death on the product. He was unlike the other cases we have seen in that he was a relatively severe, and poorly controlled, asthmatic” was incorrect. This situation had probably arisen because the reporter of the adverse reaction had contacted the Secretariat on two occasions and given conflicting information as to the severity of the asthma of the patient. The working group has relied on the written record from the hospital where the man was treated initially and has noted that the patient had a past history of mild asthma treated with salbutamol on an occasional basis with no hospital admissions and no inhaled or oral steroid use. The group was also unable to find evidence to support the comment that “he had been taking large amounts of royal jelly for years”. The part of the comment that “it would not be fair, or scientifically defensible, to pin this death on the product ” was not consistent with the Committee’s long-established practices for describing possible causal associations and could not be supported. The group also noted that the medical records indicated that at the time of hospital admission, the patient had extreme acidosis and elevated carbon dioxide and reviewed a claim that this was incompatible with a recent asthma attack. The group rejected this proposition and concluded that the medical records including the blood gases were consistent with a post cardiac arrest state with a metabolic acidosis secondary to cardiac standstill. It was not possible to infer anything about the events preceding cardiac arrest from these blood gas measurements. The group also noted that there was some discrepancy regarding the patient’s age. Careful review showed that the patient was aged 31 years at the time of the event but he had passed his thirty second birthday when he died three months later. 1 In this report, the medical officer in the Adverse Drug Reactions Unit who initially assessed the report regarded that only royal jelly was suspected of causing the adverse reaction. This was probably due to the close time correlation between ingestion and the onset of the reaction and is consistent with ADRAC causality guidelines. This coding has been reviewed and the causality rating with respect to royal jelly remains unchanged. ADRAC directed that salbutamol and an antibiotic (not otherwise specified) should be added to the computer record but they were not suspected drugs. It was also noted that the date of onset was 17 April 1993, not 18 April as indicated on the computer printout.

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The group agreed that the narrative of this case was accurate but that the footnote should be amended for completeness. Two minor amendments to the narrative have been made by the Secretariat. The causality should remain unchanged as “possible”. The narrative is shown below: ADRAC report no 91729 consisted of the documentation by an ADRAC Secretariat medical officer of a telephone report by a specialist who described a 31-year-old male who, after ingesting royal jelly, developed a severe acute asthma attack, and copies of the patient’s hospital summaries. The patient had a cardio-respiratory arrest and a subsequent brain scan showed cerebral oedema. The patient was initially treated with endotracheal intubation, adrenaline and hydrocortisone. The patient’s neurological condition deteriorated and a second brain scan showed cerebral ischaemia. He died approximately 3 months after the event. The patient had a past history of mild asthma treated with salbutamol on an occasional basis, and a recent mild exacerbation of asthma a few days prior to the event.2 2.3 The 23 Year Old Female Report 118195 described the death of a 23 year old female with an approximately ten year history of asthma. Her mother regarded her as a mild sufferer of asthma. She had been prescribed Ventolin for her asthma. She had required treatment at a hospital for an asthma attack about two years prior to her death and according to some evidence had attended hospital for asthma twice in the six months prior to her death. She was otherwise in good health. On 31 December 1995, she attended a barbeque with members of her family. She took a capsule of a product containing royal jelly and subsequently developed shortness of breath. The woman then used Ventolin inhaler frequently but without relief and then suffered an apparent cardiac arrest. Ambulances were called at 1438 hours and arrived at 1509 hours. At that time she was unconscious. Ambulance officers administered adrenaline and commenced CPR. After some CPR had been administered pieces of meat were removed from her larynx and she was then intubated. She was resuscitated but did not regain consciousness. She arrived at hospital at 1557 hours and was admitted to Intensive Care. At some time on 31 December 1995 after admission an “ante mortem” blood sample is believed to have been taken. It was not possible to ascertain accurately the timing of the antemortem sample in relation to the reaction. It may have been taken up to 6 to 8 hours after the onset of the episode. She died in the Intensive Care Unit at 1810 hours on 2 January 1996. A “post mortem“ blood sample was taken subsequently by the forensic pathologist. The group noted extensive documentation from the coronial inquest but some of the evidence was unclear. In particular, although it was clear that her boyfriend had given her a royal jelly capsule, he was unable to recall accurately the time she had taken it. Thus, the time course is unclear – a range between 45 minutes and two and a half hours has been suggested. Members

2 The statement made in the name of ADRAC in a letter dated 12 June 1997 that “he was a relatively severe, and poorly controlled, asthmatic” was incorrect. There is ample evidence to indicate that the patient had a past history of mild asthma treated with salbutamol on an occasional basis with no hospital admissions and no inhaled or oral steroid use. ADRAC was also unable to find evidence to support the comment that “he had been taking large amounts of royal jelly for years”. The Committee confirmed that this report would remain in the database with royal jelly as a possible cause. In addition, following the review of these reports, cardiorespiratory arrest has been added as a reaction term.

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noted, however, that an expert witness had indicated that an onset in this time range was compatible with anaphylaxis caused by foreign proteins. The finding of food in the larynx rendering intubation difficult was not thought to be an unusual finding in a patient who had been given CPR, including by relatives. In the Committee’s view, it did not suggest an alternative cause of the woman’s circulatory collapse or cardiac arrest. The group noted that there were some concerns over the fact that the results of both the ante-mortem and post-mortem tryptase tests were negative. It was not accepted by the working party that the test is an absolute “gold standard” for allergic reactions. Advice on the tryptase test was obtained from a specialist clinical immunologist who had no previous involvement in this matter. He advised that there has been a recent change in the method used for the measurement of serum tryptase. Until about 1999, a radioimmunoassay (RIACT Tryptase, Pharmacia) was used. Since then, a new fluoroimmunoassay (UniCAP Tryptase, Pharmacia and Upjohn) has been introduced. This latter method distinguishes between monomer (inactive) and tetramer (active) forms of two types of tryptase (alpha and beta tryptase). The new assay has improved sensitivity. It would seem certain that the older method was used for the assays of the ante-mortem and post-mortem sera of the 23 year old woman. The specialist’s advice was that a reaction to a systemic allergen challenge (eg by ingestion) may not always be generalised, but under some circumstances can be largely limited to one organ. In atopic asthma, there can be demonstrated increased numbers of mast cells in the airway mucosa and lung parenchyma due to local cytokine release driven by allergen exposure. Thus a subject with a respiratory mucosa and parenchyma “primed” by increased mast cell densities may respond to a systemic allergen challenge with bronchospasm alone without symptoms or detectable signs elsewhere, particularly with pre-exiting hyper-reactive airways. In this specialist’s opinion, an IgE-mediated allergic reaction could have occurred locally in the lung with fatal consequences; but not of a magnitude sufficient to elevate the circulating venous serum tryptase. A Medline search was conducted by the TGA Library, concentrating on review articles and copies of papers identified from the abstracts by the Secretariat were retrieved. From this limited search, five papers were reviewed by the working party.3,4,5,6,7 It was noted that these papers included a small proportion of cases of documented anaphylaxis in which the serum tryptase concentration was not elevated. These may be a reflection of inappropriate sampling or true negative results.

3 Schwartz LB, Metcalfe DD, Miller JS, Earl H, Sullivan T. Tryptase levels as an indicator of mast-cell activation in systemic anaphylaxis and mastocytosis. N Engl J Med 1987; 316:1622-6. 4 Pumphrey RSH ,Roberts ISD. Postmortem findings after fatal anaphylactic reactions. J Clin Pathol 2000; 53:273-276. 5 Fisher MM, Baldo BA. Mast cell tryptase in anaesthetic anaphylactoid reactions. Br J Anaesth 1998; 80:26-29. 6 Schwartz LB. Tryptase, a mediator of human mast cells (Review). J Allergy Clin Immunol 1990; 86:594-8. 7 Tanus T, Mines D et al. Serum tryptase in idiopathic anaphylaxis: A case report and review of the literature. Ann Emerg Med 1994;24:104-107.

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The group noted that the narrative for this case was generally accurate, but should be expanded to include more information. The computer entry had relied on the coroner’s summary and could be improved by the addition of the terms acute bronchospasm and anaphylactoid reaction. “Death” as a reaction term should be removed. Death should be recorded as an outcome, “possibly drug-related”. The causality of royal jelly in this report was confirmed as possible. The revised narrative is as follows: ADRAC report no 118195 was initially entered from an extract from the Coroner’s report. It described a 23-year-old female with an approximately ten year history of asthma. Her mother regarded her as a mild sufferer of asthma. She had been prescribed Ventolin for her asthma. She had required treatment at a hospital for an asthma attack about two years prior to her death and according to some evidence had attended hospital for asthma twice in the six months prior to her death. She was otherwise in good health. While attending a barbeque with members of her family, she took a capsule, containing royal jelly 2000 mg, originating from Nature’s Goodness Products Pty Ltd, and subsequently developed shortness of breath. This evolved into an acute asthma attack, which did not respond to self-administered salbutamol. She had a cardiac arrest and was treated by ambulance officers. She was resuscitated but did not regain consciousness. She was admitted to the Intensive Care Unit and died in hospital two days later.8 Part 3. Reports from the Alfred Hospital Background A group of doctors associated with the Allergy and Respiratory Immunology Unit, Department of Respiratory Medicine, Alfred Hospital, Melbourne published a brief letter in the Medical Journal of Australia, Volume 159, 1 November 1993, page 639. In this letter they reported five cases of royal jelly-induced asthma and anaphylaxis. Some limited details of the patients were provided. Subsequently, this group published two other more detailed papers. These papers were Leung R, Thien FCK, Baldo B and Czarny D. Royal jelly-induced asthma and anaphylaxis: clinical characteristics and immunologic correlations. Journal of Allergy and Clinical Immunology 1995; 96: 1004-7, and Thien FCK, Leung R, Baldo BA, Weiner JA, Plomley R and Czarny D. Asthma and anaphylaxis induced by royal jelly. Clinical and Experimental Allergy 1996; 26: 216-222. Both papers contained clinical details of seven cases of reactions induced by royal jelly. Subsequently, in 1997, the editors of both journals published notices drawing attention to duplicate publication in the two journals.

8 In this report, it was the opinion of the medical officer in the Adverse Drug Reactions Section who assessed the report that only royal jelly was suspected as causing the adverse reaction. This was the only medicinal substance ingested prior to the reaction. Alternative explanations including a food allergy, most probably to sausages, were considered by ADRAC to be less likely in view of the patient’s history. The negative finding in the tryptase test is not considered definitive. At the coronial inquest, the witness who gave her a royal jelly tablet was unable to recall the time she had taken it. Thus, the time course is unclear and the initial asthma attack may have occurred some hours after ingestion. ADRAC was of the opinion that an onset of some hours, although not usual, was compatible with anaphylaxis caused by foreign proteins. The causality remains as possible.

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Consistent with the practice of the Adverse Drug Reactions Advisory Committee and its secretariat concerning published details of cases of suspected adverse reactions which had occurred in Australia and which had been found during literature searches by the Secretariat, entries were made in the ADRAC computer database of five suspected adverse reactions to royal jelly in 15 November 1993. The ADRAC report numbers are 88953-57. The details entered about each case were limited, reflecting the limited information in the letter to the MJA. Subsequently, the ADRAC secretariat identified the publication of the Leung et al. paper in Journal of Allergy and Clinical Immunology. The secretariat assumed (correctly, it transpires) that five of the seven cases were identical to those in the Medical Journal of Australia letter and amended the existing five computer records to incorporate the additional details. The secretariat identified one of the other cases as corresponding to ADRAC report 71716. The secretariat created a new record in the computer database for the additional (seventh) case. The record number of this new case is 123415. Neither the staff of the secretariat nor the Committee were aware of the publication of the Thien et al. paper in Clinical and Experimental Allergy until early in 2000. The three publications have been subject to close scrutiny by a number of people with an interest in the safety of royal jelly. Differences in the information published in the letter and the two papers have been found and a number of questions have been raised. A major concern has been whether the seven patients described in the two papers are exactly the same patients and their exact relationship to the five patients described in the earlier letter. Nature and Conduct of the Review Dr McEwen wrote to Dr Frank Thien on 29 November 2000 explaining the various concerns and seeking information. Dr McEwen spoke with Dr Thien by phone on 12 December 2000. Dr Thien provided some information in response on 15 January 2001. Dr McEwen sent a further letter on 25 January 2001. Further information was provided by Dr Thien in a letter dated 21 February 2001. Dr McEwen then arranged to meet with Dr Thien in Melbourne. That meeting was held on Friday March 9 at the Alfred Hospital. Dr McEwen was able to examine all of the relevant documents currently in Dr Thien’s possession. Dr Thien has been given an opportunity to comment on this report and to respond to some further matters identified during the drafting of this report. Outcome – Identities of the Patients Dr Thien currently holds some information about each of the patients described in the letter and papers. The depth of detail held currently about each individual patient is different. To obtain the detailed individual clinical records of each patient would be a considerable task – two of the patients were existing patients of the Alfred Hospital, another was a patient at another Melbourne hospital (under the direct care of one of the authors) and another was the private patient of another of the authors. The other three patients attended the Allergy and Respiratory Immunology Unit for testing (one referred by yet another of the authors; one self-referred after the initial letter was publicised; the other – the patient described in ADRAC report 71716 -was referred after contact with the ADRAC secretariat) and were not registered as patients of the Alfred Hospital. In his correspondence, Dr Thien provided and subsequently expanded the tabulation attached to this document. This tabulation clearly identifies seven individual patients who are identified uniquely by initials and date of birth (four patients), initials and year of birth (one patient) or as the sole patient referred by one of the other authors (two patients).

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The ages of these two patients as stated by the referring doctors are known. Dr Thien has also linked the identities of these seven patients to the identifiers used in the two published papers. Concerning apparent discrepancies in the ages of the patients between the two published papers, Dr Thien has provided the following comment: “When matched up like this (i.e. in the tabulation) the reason for the apparent discrepancy becomes very clear. I had constructed the table in the JACI paper using the ages of the patients at the time of their reaction. However, the serum I had sent to Dr Baldo was labelled with their dates of birth. Obviously, when Dr Baldo wrote the CEA paper, he had inserted the patients’ ages at the time of the immunological analysis.” The sera had been batched and sent to Dr Baldo in April or May 1994 and the initial analyses are understood to have been performed in June/July 1994. �� Patient JL (DOB 24/08/1961) was 26 when she had her reaction on 8/1/1988. She was

32 when the serum was analysed in mid-1994. �� Patient TB (DOB 6/9/1968) was 23 when the reaction occurred in July 1992 and was 25

when the serum was analysed in mid-1994. �� Patient RW (DOB 19/2/1949) was 42 (and not 43 as stated in JACI) when the reaction

occurred in January 1992 (which was in fact just before the 43rd birthday) and was 45 (the CEA age) in mid-1994.

�� Patient SB (DOB 1/7/1960) was 30 when the reaction occurred on 30/6/1991 and was 33 when the serum was analysed in mid-1994.

�� Patient NJ was born in the latter part of 1973 and was 19 when the reaction occurred in October 1992 and was 20 (the CEA age) when the sera were analysed in mid-1994.

It is ADRAC’s opinion that this information answers the major criticisms. There were in fact seven patients. The same seven patients were the subjects in the two papers and reconciliation between the two identifying systems has been provided. Five of the seven patients were the subjects in the earlier letter to the Medical Journal of Australia. A plausible explanation has been provided for the discrepancies in ages between the two published papers. It has been noted that the age of one of the patients (RW) may have been wrongly stated (by one year) in the JACI paper but the ages of the patients as stated in the CEA paper are consistent with the explanation put forward by Dr Thien. Outcome – Other Criticisms of Clinical Matters Some other criticisms have been made of clinical aspects of the published papers and these have been discussed with Dr Thien. 1. In the paper by Thien et al. in Clinical and Experimental Allergy, the Summary states

“Asthma, together with, in some cases (plural), anaphylaxis …” In Table 1, which gives the clinical details, only one case of anaphylaxis is documented. In the Leung et al. paper in Journal of Allergy and Clinical Immunology also, only one subject, #5, a 66 year old male, was identified as having suffered anaphylaxis. DB (Dr Baldo) argued in court that all seven cases were anaphylaxis.

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In response, Dr Thien acknowledges that the table identifies explicitly only one case of anaphylaxis. Two of the other patients, however, had sufficiently severe reactions as to warrant use of either inhaled or intramuscular adrenaline (see Table 1 in JACI paper)– the appropriate treatment for incipient or actual anaphylaxis- and the distinction between whether these patients were or were not described as having anaphylaxis in Table 1 is rather academic. Comment was not sought from Dr Baldo, who was not involved in the clinical care or clinical assessment of the patients. 2. In the same paper, it is stated that sera were collected hours or a few days after reactions

and stored at - 20�C. (pg 217, Col 2). However the clinical details of subject 4291 in Table 1 state “Serum collected � 6 years after royal jelly reaction.”

Dr Thien acknowledged that the text of the paper is in error. The dates or approximate dates on which the sera were collected are set out in the attached tabulation. 3. In the paper by Leung at al. in Journal of Allergy and Clinical Immunology, it is stated

that there was “Single blind oral challenge with royal jelly capsules…” The criticism made was that the gold standard test is a double blind oral challenge as single blind oral challenges are open to researcher bias.

Dr Thien acknowledged the value of a double blind challenge but pointed out that in the clinical challenge of individual patients, as distinct from clinical trial subjects, single blind challenge is the customary practice as it enables the clinician to be alert for the onset of adverse reactions which need to be treated. Furthermore, the objective nature of the reactions (such as bronchospasm, hypotension or angioedema) exclude any patient or doctor biases of the sort that might influence reactions or observations that are purely subjective. 4. In the same paper, “Table 1 identifies subjects by number 1-7. Fig 2 identifies patients

by letters (? initials). By using two identification systems within the same paper it is impossible to relate the electrophoresis pattern in Fig 2 to the patient and clinical details in Table 1.”

The attached tabulation provided by Dr Thien reconciles initials with subject numbers. 5. It has been claimed that it is not possible to reconcile the letter to the Medical Journal

of Australia, which states that there were two subjects aged 19 years of age at the time of the reaction, and the Leung et al. paper which states that Patient 2 was 19 and patient 3 was 23 years of age.

Dr Thien acknowledged that there was an error in the letter to the Medical Journal of Australia. There was one patient aged 19 years and one patient aged 23 years at the time of their reactions. 6. There is a discrepancy between the Leung et al. paper (JACI) and the Thien et al. paper

(CEA), in their recordings of the numbers of subjects who had skin prick tests to royal jelly. Leung et al. states that all of 7; Thien at al. states 6/7, this being consistent with 4/5 in the Thien et al. letter to the MJA.

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Dr Thien explained that the 66 year old man, unlike the other six patients, was not skin tested by Dr Thien but was tested by Dr Leung at another hospital - something Dr Thien learnt only at a later date. This led Dr Thien to count this patient as not tested in both the letter to the MJA and the Thien et al. paper. Consistent with this explanation, this man was counted as having been tested in the paper written by Dr Leung. 7. The letter to the Medical Journal of Australia stated that four of five subjects had been

skin prick tested with bee venom and had been found negative. Both the Thien et al. paper in CEA and the Leung et al. paper in JACI stated that only three of seven subjects had been so tested.

Dr Thien explained that four patients had been tested with bee venom and had been negative. They were Patients JL, TB, SB and NJ. The information in the two published papers was wrong. Other Criticisms Other criticisms made of the papers relate to aspects of the published details of the laboratory analyses undertaken by Dr Baldo at the Kolling Institute of Medical Research, Royal North Shore Hospital of Sydney. These criticisms are less relevant to the consideration and recording of the clinical events on which the ADRAC records and judgements were based. These criticisms have not been followed up at this time. Conclusions from the Part 3 Review. The assistance given by Dr Thien, both in writing and face-to-face, has provided sufficient information to resolve the major criticisms. There can be no doubt that the authors of the papers collectively saw seven patients with adverse reactions to royal jelly, that the same seven patients were described in the two papers and that sufficient information has been provided to reconcile the identities of, and clinical information about, the patients described in the two papers. Further, the information provided permits reconciliation of the information in the earlier letter to the Medical Journal of Australia and the two published papers. A small number of factual errors in the publications have been found and acknowledged. While they are to be regretted, they do not bring into question the general veracity of the descriptions of the clinical events. Criticism has been made of the initial recording of the reactions in the database maintained by the Adverse Drug Reactions Advisory Committee (ADRAC). “The ADRS (Adverse Drug Reactions Section) appears to have entered the five adverse reaction reports appearing (in the MJA letter) onto the register from the paper. The five subjects have sequential report numbers (88953-88957). The five subjects were reported on the same date (1/11/93) which coincides with the date of publication of (the letter) in the MJA. The five subjects were added to the register on the same date (15/11/93). The five subjects were each recorded with the same set of clinical symptoms (bronchospasm, rhinitis, conjunctivitis, pruritus) which statistically is so remote that it questions the authenticity of the symptoms. Angioedema was mentioned in the letter to have been seen in three of the subjects, but as it couldn’t be identified which three these details were not entered onto the records.” This raises two matters.

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Concerning the reports of reactions to royal jelly described in the letter and the two papers, the criticism has been largely answered by the revision of the database records during the preparation of the narrative document titled “ADR Reports in Association with Royal Jelly.” The amendments to the database record were based on the clinical information in the Leung at al. paper – the ADRS at that time being unaware of the Thien at al. CEA paper. The ADRU should review the database records again in the light of the further information provided by Dr Thien and inform ADRAC of any changes made to the records. More generally, there are matters warranting consideration by ADRAC. It was agreed that it remains legitimate for ADRAC to extract the details of published reports of Australian suspected adverse reactions to drugs. As is nicely illustrated by the circumstances that led to the present review, clinicians may from time to time publish details of clinically important reactions but not report them to ADRAC. That is a reality. Identifying such reactions in the literature and recording them in the database gives a more comprehensive view. It must, however, be mandatory for the ADRU to make a careful search of the database to exclude duplication. In addition, the source of the report must be entered into the record. If several cases are described this information must be included in every case’s database record. The information must be recorded in such a way that it is included in the routine publicly available printout (currently the Type 16 report). These matters should be included in the written procedures of the ADRU. In all cases where the reactions described are clinically serious, severe or otherwise having a potential for some regulatory action, the clinical details in the published report should be reviewed carefully and where warranted further information sought from the author by the professional staff of the ADRU.

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ATTACHMENT 4

SUMMARY OF ISSUES RAISED IN SUBMISSIONS ON PRELIMINARY INQUIRY REPORT, September 2000 1. Need for and text of warning statement in relation to royal jelly Support 12 Oppose 0 No comment 1 Twelve submissions were in favour of the requirement for a mandatory warning statement on royal jelly and products containing royal jelly. However, there was some difference of opinion on the wording of such a statement. The proposed statement reads: ROYAL JELLY MAY CAUSE VERY SERIOUS ALLERGIC REACTIONS. ASTHMA SUFFERERS ARE MOST AT RISK Use of the term ‘very’ Three submissions commented that the use of the term ‘very’ was superfluous to the requirements of the warning statement. Comvita commented that according to WHO definitions, the term ‘serious’ refers to life-threatening situations, thus ‘very’ is not warranted. One submission considered the use of ‘very’ to be not sufficient. Removal of the term ‘fatalities’ Three submissions supported the removal of the term ‘fatalities’ from the statement currently required in Australia and one option in New Zealand. The general reason for this was the belief that the term is extreme and alarmist and not in line with warning statements for other allergens. Four submissions opposed the removal of the term ‘fatalities’. The main reason was that the warning statement should alert consumers to the full extent of the risks. 2. No Requirement for Warning Statements in relation to Bee Pollen and Propolis Support 6 Oppose 3 No comment 4 Six submitters were in support of the proposed labelling changes for mandatory warning statements including removal of the warning statements on products containing bee pollen and propolis. Reasons, where given, were that these two ingredients posed a lower threat to the consumer than royal jelly and it was sufficient that statement of their presence be mandatory. Three submitters were opposed to the removal of the warning statement on products containing bee pollen and/or propolis given the propensity for these substances to cause allergic reactions, and that the mandatory ingredient declarations may not be sufficiently prominent on the label.

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3. Mandatory declaration of Royal Jelly, Propolis and Bee Pollen Support 9 Oppose 0 No comment 4 There was no opposition to the proposal that declaration of the presence of royal jelly, bee pollen and propolis in any food product be mandatory. Nine submissions made specific comment in favour of this. 4. Labelling print size Under Proposal P142 – Review of Print Size and Quality, warning statements must appear in a print size of 3 mm, where the smallest letter must not be less than 3 mm. The working must also be prominent, legible and in English. Small packages are not exempt. The warning statement for Royal Jelly must meet these requirements. Support 1 Oppose 3 No comment 9 Three submissions made specific comments that would oppose this labelling requirement. However, all three showed concern about the size of the type for small packages. One suggested a size of 1.5 mm more appropriate for small packages and one suggested that this labelling could be in association with bulk packaging. All three did support the requirements for labelling to be clear and prominent. One submission made a comment that the warning statement should be in large print. Nine submissions made no comment specifically relating to print size and quality however many stated a general support of the proposed labelling requirements and this would include print size and quality along with mandatory declaration and warning statements. 5. Definitions Support 5 Oppose 1 No comment 8 Five submissions specifically outlined support of the proposed definitions for royal jelly, bee pollen and propolis and their inclusion in Standard K2 and Standard 1.2.3 No submitters were opposed to the inclusion of definitions for royal jelly, propolis and bee pollen in the food standards, however one submitter (Comvita) felt the definitions proposed were too prescriptive and gave evidence to support revised definitions. 6. New Zealand only issues in relation to labelling bee products A) Treatment of Foods and Dietary Supplements in New Zealand Support 4 Oppose 0 No comment 9

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P154 suggested that the proposals for mandatory warning statements could be harmonised for use in both Australia and New Zealand across all forms of royal jelly to ensure a consistent approach to the regulation of consumable products containing royal jelly. Four submitters agreed with this suggestion stating that all forms may pose the same risk. One of these although opposed to the treatment of foods and dietary supplements more generally, supported the same approach to products that pose the same risk. Additional comments were made as to the desirability of the same requirements applying in Australia and New Zealand. B) Revision of mandatory requirement in New Zealand Food Standard 2001 consistent with Volume 2 Support 5 Oppose 0 No comment 8 All submitters who commented supported maintaining a labelling requirement in New Zealand while the New Zealand Food Regulations were in effect. 7. Regulatory Impact Statement Option 1 0 Option 2 8 Option 3 0 No comment 5 Of those that gave a preference, all submitters were in favour of Regulatory Impact Statement Option 2: Change regulations consistent with assessed level of risk. No submitters choose Option 1. However submitters were divided as to which version of the warning statement they preferred. One submitter, who gave no preference, felt that further clarification is required on the different levels of regulation between ANZFA and TGA. 8. Other comments �� Two jurisdictions pointed out inconsistencies between the drafting and ANZFA’s

declared intent that bee products naturally present in honey would not trigger the relevant mandatory labelling requirements.

�� New Zealand products should be treated the same as Australian counterparts. �� Support for changes in Volume 1 being mandatory and at the same time, the warning

statement requirements contained in New Zealand Food Regulation 2001 should be repealed.

�� The NZ Ministry of Foreign and Trade (through the submission by the NZMOH) has recommended that the WTO notification statement be amended.

�� One submitter requested the removal of royal jelly products from the market in the interests of public health.

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Submitter Submission 1 Dr John Birkbeck

InforMed Systems Supports Option 2 of the Regulatory Impact Statement for revised Standard K2 (and Standard 1.2.3 to replace New Zealand Food Standard 1996 Amendment 11). Supports proposed approach to labelling of royal jelly, pollen and propolis products.

2 Mr Eric Johnson Public & Environment Health Service, Tasmania

Supports a warning statement for royal jelly only, but does not comment on wording. Supports the recommendation to require the presence of royal jelly, bee pollen and propolis to have mandatory declaration by manufacturers. Need to highlight the difference between naturally-occurring and unintentional contamination of royal jelly, bee pollen and propolis in foods such as honey.

3 Dr Paul Psaila-Savona Western Australian Food Advisory Committee

Supports drafted warning statement for royal jelly only, suggesting that ‘fatalities’ is extreme and alarmist and not consistent with approach taken for other allergens. Supports mandatory declaration of royal jelly, pollen and propolis as ingredients. Labelling should be prominent or be displayed in conjunction with unpackaged forms.

4 Ms Elaine Conroy Food Technology Association Victoria

New Zealand products should be treated the same as Australian counterparts. Foods and dietary supplements should be treated in the same way. Supports mandatory warning statement for royal jelly and ingredient listing for royal jelly, propolis and bee pollen.

5 Mr Graeme Boyd, Chief Executive Officer, Comvita NZ Ltd

Offers qualified support for P154. Warning statement for royal jelly only. Opposes the use of ‘very’ in the statement to emphasise serious allergic reactions. According to WHO definitions, the term ‘serious’ refers to life-threatening situations, thus ‘very’ is not warranted. Supports not requiring bee pollen and propolis products to be labelled with warning statement, instead always list as ingredients. Type size should be 1.5 mm not 3 mm due to package sizes. Need to clarify definitions and specific terms for this standard. This includes the definition of honey, propolis, and royal jelly, the composition of honey. New Zealand issues: food and dietary supplements should not be treated in the same way; food and dietary supplements that pose the same risk be managed so as to achieve the same outcome; food standard should mandate warning statement and ingredient listing. Changes in AFSC should be made mandatory and at the same time, the warning statement requirements contained in NZFR 1996 Amendment 11 should be repealed. Submitted evidence to suggest that a code of practice could operate successfully, but given the scope of the matter, preferred Option 2 of the Regulatory Impact Statement as a more cost effective measure for industry. Provided information in support of a revised definition of honey, propolis and royal jelly.

6 Mrs Elaine Attwood & Ms Gracia Baylor National Council of Women of Australia

Believe the current warning statement does not convey sufficient warning about risk of fatality and suggests the following: “THIS PRODUCT CONTAINS ROYAL JELLY WHICH MAY CAUSE SERIOUS ALLERGIC REACTIONS, AND IN RARE CASES, FATALITIES. ASTHMA SUFFERERS ARE MOST AT RISK”. Oppose removal of warning statement for bee pollen. Support quick implementation of revised Standard K2 and 1.2.3 and consistent approach between Australia and New Zealand Support inclusions of definitions for Royal Jelly, Bee Pollen, Pollen and Propolis. Ideally prefer Option 1b of the Regulatory Impact Statement but in recognition of its limitations, support Option 2 providing the stronger warning statement is adopted.

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7 Dr Bob Boyd

New Zealand Ministry of Health

Supports the findings of the expert advice and the proposals for labelling except for the use of ‘very’ which are believed to be superfluous. Supports Option 2 in the regulatory impact statement. Supports the opinion that compositional requirements are unnecessary. Supports that royal jelly, bee pollen and propolis statements are not required when naturally present in foods (eg honey). 3 mm type is not realistic due to small size packaging, rather warning statements should be clear and prominent. The Ministry of Foreign Affairs and Trade have recommended that the WTO Notification statement be amended

8 Ms Rae Frampton Orakei Auckland NZ

Mandatory declaration of royal jelly, bee pollen and propolis Supports the removal of the term ‘fatalities’. Mandatory warning statement for Royal Jelly only. Support definitions for Royal Jelly, Pollen, Bee Pollen and Propolis Supports the same regulation for Foods and Dietary Supplements.

9 Ms Liz Hicks National Council of Women New Zealand

Mandatory warning statement for Royal Jelly only. Foods and dietary supplements be treated in the same way, both may pose the same risk. Mandatory declaration of Royal Jelly, Bee Pollen and Propolis. Supports the removal of the term ‘fatalities as it may be overstated and cause panic and concern

10 Mrs Chrystal Griffiths Narara NSW

Opposes the weakening of the Royal Jelly warning statement and supports retention of the term ‘fatalities’, in large print. Supports the removal royal jelly products from the market in the interest of public health

11 Mr Bren Milsom Complementary Healthcare Council of Australia

Support the definitions and labelling requirements for Royal Jelly, Propolis, and Bee Pollen Support mandatory warning statement in products containing Royal Jelly. Oppose the use of ‘very’ in the Royal Jelly warning statement as being superfluous. Support consistency in regulation of these products, between foods and therapeutics.

12 Mr MA Apollonov Food Advisory Committee NSW Health Dept

Does not support the removal of the term ‘fatalities’ in reference to Royal Jelly presented as a food. Suggests the need to convey a sense of being life threatening. Supports the proposed warning statement for Royal Jelly that is mixed with other forms of food. Supports the tenor of warning statement on labels of foods containing Royal Jelly, although makes the point that the risk also applies to non-asthmatics.

13 Dr Peter Williams, Chair Food Standards Advisory Committee, Dietitians Association of Australia

Supports all items proposed, expect for the deletion of the warning statement on pollen food products because of the risk of severe allergic reactions.

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ATTACHMENT 5 SUMMARY OF ISSUES RAISED IN SUBMISSIONS ON DRAFT FINAL ASSESSMENT REPORT, May 2002 Submitter Submission 1 Dr Bob Boyd

New Zealand Ministry of Health

Accepts the content of the Report and appreciates the importance of consistency with TGA requirements.

2 Mr Michael Apollonov, Food Branch, NSW Health,

Supports maintenance of the current warning statement and is supportive of TGA completing its processes to declare royal jelly in capsules, phials and powders to be therapeutic goods.

3 National Nutritional Foods Association of New Zealand

Supports reliance on mandatory declaration for foods containing propolis or pollen. Rejects ANZFA’s proposed reincarnation of the unfair and scientifically indefensible warning statement for royal jelly imposed in Australia, which they contend, is contrary to good regulatory practice. Insist on adoption of the statement proposed by the Independent Ministerial Scientific Review “royal jelly may cause serious allergic reactions. Most reports have been in asthma sufferers”. If this is not implemented, NNFA advise that it “will make every effort to get the New Zealand Parliament to invoke the opt-out clause of the ANZFA Treaty.”

4 Mr David Gill Food Technology Association Victoria

Supports ANZFA’s preferred option, Option 2..

5 Mr Graeme Boyd, Chief Executive Officer, Comvita NZ Ltd

Believes that the proposed warning statement is too severe; the softer statement proposed by the Independent Ministerial Scientific Review. Concerned that too little weight appears to have been given to the New Zealand independent review and that CMEC’s conclusions have displaced the Review’s recommendations. Support the submission of the National Nutritional Foods Association.

6 Ms Barbara Glenie, President, National Council of Women of New Zealand

Reaffirms previous submission and supports the (softer) statement proposed at Preliminary Inquiry.

7 Dr Virginia McLaughlin, Chairperson, Western Australian Food Advisory Committee

Opposes the proposed warning statement is as being extreme as in support of this position, compares the labelling approach with peanut labelling . Gives qualified support to the deletion of the four definitions providing it can be demonstrated that there are sufficient means with the Food Standards Code or associated mechanisms to provide surety on their definition of required for enforcement purposes.

8 Ms Sue Cassidy, Dietitians Association of Australia

Supports the reaffirmed current warning statement. Is concerned that the unintentional contamination of foods with royal jelly, for example, honey would not be required to display the warning statement. DAA suggests it be appropriate for such foods to bear on the label a ‘may contain royal jelly statement’.

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ATTACHMENT 6 EXECUTIVE SUMMARY FROM PROPOSAL P154 - PRELIMINARY INQUIRY REPORT This Preliminary Inquiry to Proposal 154 assesses the regulatory requirements for royal jelly, bee pollen and propolis, and their food products following action taken, as a matter of urgency in 1997, under section 37 of the Australia New Zealand Food Authority (ANZFA) Act 1991. The action strengthened the former warning statement in the label of royal jelly presented as food, and food products containing royal jelly to refer to the risk of fatality, consistent with the warning required for royal jelly regulated as therapeutic goods. The scope of this Proposal, was originally confined to foods presented as, and containing royal jelly but was expanded in 1999 to include propolis, bee pollen and their food products, because of separate safety assessments available in the intervening period for these substances from the Australian Therapeutic Goods Administration (TGA) and the New Zealand Ministry of Health (NZMOH). Given that bee products cross the regulatory spectrum as foods or therapeutics in Australia; and foods including dietary supplements in New Zealand; this Proposal, while applying only to foods, aims ultimately to facilitate clarification of the regulatory status of royal jelly products and to achieve a coordinated approach to the labelling requirements for all regulated bee products. NZMOH has indicated that the warning labelling statements adopted for food, also would be made mandatory for dietary supplements, as foods and dietary supplements that pose the same risks should be managed so as to achieve the same outcome. For New Zealand, this consultation applies to both foods and dietary supplements (refer section 11.2 and Attachment 11 for details). Although this Proposal considers royal jelly, bee pollen and propolis and their food products, it does not refer to such substances when naturally present in a food (i.e. bee pollen naturally present in honey) or in cases where their presence is due to unintentional contamination. 1.1 Assessment of risk There is a general consensus that, although reactions to royal jelly are rare, they occur more readily than reactions to propolis or bee pollen and are more severe and serious. The population subgroup that suffers from asthma and related allergies is most at risk. A targeted warning statement in the label of royal jelly and its food products is necessary in order to inform susceptible people of the risk of consumption of such products because they are not common and are promoted as health foods. Consumers generally take royal jelly for its therapeutic benefits and would not expect a severe allergic reaction from such a product. In relation to bee pollen, there is no evidence to suggest that bee pollen causes severe life threatening reactions. However, bee pollen has been implicated in allergic reactions and therefore the requirement to declare its presence in a food will alert those people who are aware of their allergy to avoid bee pollen. Similarly, there is evidence to suggest that propolis may cause serious adverse reactions; however, such reactions are very rare and there is little evidence to warrant a warning or advisory statement on propolis food products. However, propolis has been implicated in allergic reactions and therefore the requirement to declare its presence in a food will alert those people who are aware of their allergy to avoid propolis. 1.2 Conclusions in relation to food standards This report concludes that, on the basis of assessed risk to public health, a warning statement in the label of a food presented as royal jelly or containing royal jelly remains justified because of the considerable potential for royal jelly to cause severe allergic reactions, including life threatening reactions, as assessed by the TGA’s Complementary Medicines Evaluation Committee (CMEC), and the New Zealand Report on the Findings of the Bee Products Warning Review Working Group, August 1999 (Working Group). The wording of the statement is proposed to be amended to omit reference to “fatalities”, consistent with the assessed risk. It is also proposed to require definitions of royal jelly, propolis, bee pollen and pollen, as well as the declaration of all three bee products in the label of foods containing such ingredients. Therefore this report proposes amendments to: Standard K2 – Honey and Related Products, of the Australian Food Standards Code; and

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Standard 1.2.3 – Mandatory Warning and Advisory Statements and Declarations of the draft Joint Australia New Zealand Food Standards Code. The proposals relevant to Standard K2 of the Australian Food Standards Code are to: a) Reaffirm the present requirement for royal jelly and its products to carry a warning statement that alerts

consumers, particularly asthma sufferers to a potential health risk; but to amend the wording of the warning statement consistent with the assessed risk, as follows: ROYAL JELLY MAY CAUSE VERY SERIOUS ALLERGIC REACTIONS. ASTHMA SUFFERERS ARE MOST AT RISK

b) Retain the existing definitions of pollen and royal jelly and insert new definitions for bee pollen and propolis;

c) Require the presence of royal jelly, bee pollen and propolis to be declared in the label of foods containing these substances, at all times, including irrespective of their concentration in the final product, and when declared on small packages; and

d) Delete the present warning statement required in the label of pollen products. The proposals relevant to Standard 1.2.3 of the draft Joint Australia New Zealand Food Standards Code are to: a) Reaffirm the present requirement for royal jelly and its products to carry a warning statement that alerts

consumers, particularly asthma sufferers, to a potential health risk; but to amend the wording of the warning statement, consistent with the assessed risk, as follows: ROYAL JELLY MAY CAUSE VERY SERIOUS ALLERGIC REACTIONS. ASTHMA SUFFERERS ARE MOST AT RISK

b) Confirm insertion of definitions for royal jelly, pollen, bee pollen, and propolis as proposed by P161; and c) Confirm requirement for the presence of royal jelly, bee pollen or propolis to be declared in the label of

foods containing these substances at all times, including irrespective of their concentration in the final product, and when declared on small packages, as proposed by P161.

1.3 Recommendations to other agencies This Proposal recommends to the TGA that it finalises the draft proposal issued in 1998 under section 7 of the Therapeutic Goods Act 1989 to declare royal jelly presented in capsule, phial or powder form to be a therapeutic good. Because royal jelly in capsule, vial or powder form in New Zealand is regulated as a food including dietary supplements under the New Zealand Food Act 1981, the above recommendations made for royal jelly, pollen and propolis as foods should also relate to royal jelly, pollen and propolis sold as dietary supplements in New Zealand. The NZMOH has proposed that any warning statement for royal jelly and labelling requirements for bee pollen and propolis that result from this consultation process, also applies to dietary supplements containing these substances (refer section 11.2 and Attachment 11 for details). 1.4 Regulatory impact statement A Regulatory Impact Statement has been prepared for the amendments to the Food Standards Code, the New Zealand Food Standards 1996, and the draft Joint Australia New Zealand Food Standards Code (each Code). The conclusion of this impact statement indicates that: �� provisions should be included in each Code to require that where royal jelly is presented as a food, or

used as an ingredient in food, a warning statement must appear in the label of that food as stipulated by each Code; and

�� where royal jelly is presented as a food, or where foods contain royal jelly, bee pollen or propolis, the presence of these substances should be declared in the label of the food.

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1.5 TBT Notification There are no standards for royal jelly, propolis or bee pollen in Codex or other international food regulations. These recommendations will be submitted to the WTO as a Technical Barrier to Trade notification.

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