Pro Teeth Whitening (Aust) Pty Ltd v Parliamentary Secretary to the Treasurer, David Bradbury MP

IN THE FEDERAL COURT OF AUSTRALIA QUEENSLAND DISTRICT REGISTRY GENERAL DIVISION QUD 242 of 2013

ON APPEAL FROM THE FEDERAL CIRCUIT COURT OF AUSTRALIA

AND: PARLIAMENTARY SECRETARY TO THE TREASURER, DAVID BRADBURY MP

JUDGE: RANGIAH J DATE OF ORDER: 20 DECEMBER 2013 WHERE MADE: BRISBANE

1. The appeal is allowed.
2. The orders of the Federal Circuit Court made on 9 May 2013 and 17 June 2013 are set aside.
3. The respondent's decision made on 6 February 2012 to certify that a recall notice be issued without delay in respect of the appellant's products is set aside.
4. The matter is otherwise remitted to the Federal Circuit Court for hearing.
5. The respondent pay the appellant's out of pocket expenses in the fixed sum of $700.00. Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.

IN THE FEDERAL COURT OF AUSTRALIA QUEENSLAND DISTRICT REGISTRY GENERAL DIVISION QUD 242 of 2013

ON APPEAL FROM THE FEDERAL CIRCUIT COURT OF AUSTRALIA

AND: PARLIAMENTARY SECRETARY TO THE TREASURER, DAVID BRADBURY MP

JUDGE: RANGIAH J DATE: 20 DECEMBER 2013 PLACE: BRISBANE

REASONS FOR JUDGMENT 1 This is an appeal against a judgment of the Federal Circuit Court of Australia dismissing an application for judicial review of the respondent's decisions. 2 The respondent had certified, pursuant to s 132J(1) of the Competition and Consumer Act 2010 (Cth), that a recall notice for two teeth whitening products supplied by the appellant should be issued without delay. The respondent also decided to issue a recall notice pursuant to s 122(1) of Sch 2 of that Act. 3 The appellant applied to the Federal Court for judicial review of those decisions under ss 5 and 6 of the Administrative Decisions (Judicial Review) Act 1977 (Cth) ("the ADJR Act") and s 39B(1) of the Judiciary Act 1903 (Cth). The application was remitted to the Federal Circuit Court, which then heard and dismissed the application. 4 It will be necessary to discuss the judgment of the Federal Circuit Court, the decisions made by the respondent and the preceding correspondence in some detail. It is convenient to first set out something of the statutory scheme under which the decisions were made.

The statutory scheme 5 Part XI of the Competition and Consumer Act carries the heading "Application of the Australian Consumer Law as a law of the Commonwealth". Section 131(1) of that Act provides, relevantly, that "Schedule 2 applies as a law of the Commonwealth to the conduct of corporations". Schedule 2 is called the Australian Consumer Law. 6 Part 3-3 of Ch 3 of the Australian Consumer Law deals with the safety of consumer goods and product related services. It sets out four substantive powers which the relevant Commonwealth Minister may use to protect consumers when it appears that consumer goods pose a risk of injury. They are: to make or declare a safety standard; to impose an interim or permanent ban; to issue a recall notice; and to publish a warning notice about the goods. 7 The procedural mechanisms and requirements for the exercise of the Minister's powers are set out in Div 3 of Part XI of the Competition and Consumer Act. Both the substantive powers and the procedural provisions are based upon Div 1A of Part V of the now repealed Trade Practices Act 1974 (Cth). 8 The present case is concerned with the recall of the appellant's products, so it is only necessary to set out in detail the provisions of the scheme dealing with recall notices. 9 Section 122 of the Australian Consumer Law provides, relevantly: 122 Compulsory recall of consumer goods (1) A responsible Minister may, by written notice published on the internet, issue a recall notice for consumer goods of a particular kind if: (a) a person, in trade or commerce, supplies consumer goods of that kind; and (b) any of the following applies: (i) it appears to the responsible Minister that such goods will or may cause injury to any person; … (c) it appears to the responsible Minister that one or more suppliers of such goods have not taken satisfactory action to prevent those goods causing injury to any person. (2) It is not necessary for the purposes of subsection (1)(c) for the responsible Minister to know the identities of any of the suppliers of the consumer goods of that kind. 10 Section 131E(1)(h) of the Competition and Consumer Act provides that a notice under s 122(1) of the Australian Consumer Law is to be made by legislative instrument. 11 Section 123 requires that the recall notice specify the actions to be taken by a supplier and how those actions are to be taken. The notice may require the supplier to recall the goods, disclose to the public the nature of a defect in the goods and replace the goods or refund their price. 12 Section 127(1) requires a supplier to comply with a recall notice. Section 127(2) prohibits a person from, in trade or commerce, supplying consumer goods of the kind to which the notice relates. One purpose of requiring that a recall notice be made by legislative instrument must be to ensure that where the notice is concerned with the recall of goods of a particular type, even suppliers who have not been identified are bound to comply with it. 13 Division 3 of Part XI of the Competition and Consumer Act carries the heading "Conference for proposed bans and recall notices". The procedures prescribed under that Division are administered by the Australian Competition and Consumer Commission ("the ACCC"). 14 Section 132A provides: 132A Commonwealth Minister must issue a proposed recall notice (1) The Commonwealth Minister must issue a proposed recall notice if the Commonwealth Minister proposes to issue a recall notice for consumer goods of a particular kind. (2) Subsection (1) does not apply in relation to a recall notice if the Commonwealth Minister has issued a notice under section 132J certifying that the recall notice should be issued without delay. (3) The proposed recall notice must: (a) be in writing; and (b) be published on the internet; and (c) set out a copy of a draft recall notice; and (d) set out a summary of the reasons for the proposed issue of the recall notice; and (e) invite any person who supplies, or proposes to supply, consumer goods of that kind to notify the Commission, in writing and within a period specified in the notice, if the person wishes the Commission to hold a conference in relation to the proposed issue of the recall notice. (4) The period specified in the proposed recall notice under paragraph (3)(e): (a) must be a period of at least 10 days, or such longer period as the Commonwealth Minister specifies in the notice; and (b) must not commence before the day on which the notice is published. (5) A proposed recall notice is not a legislative instrument. 15 Section 132K provides that if the Minister issues a proposed recall notice, he or she must cause a copy of the notice to be given to each person who, to the knowledge of the Minister, supplies the consumer goods. 16 Section 132C requires that if any person notifies the ACCC in accordance with the proposed recall notice that they wish to hold a conference, the ACCC must appoint a day, time and place for the holding of a conference. Under s 132H(1), a person who notified the ACCC in accordance with a proposed recall notice is entitled to be present or represented at a conference. 17 Section 132D provides, relevantly: (2) As soon as is practicable after the conclusion of a conference held under this Subdivision in relation to the proposed issue of a recall notice, the Commission must: (a) by written notice given to the Commonwealth Minister, recommend that the Commonwealth Minister: (i) issue the recall notice in the same terms as the draft recall notice referred to in paragraph 132A(3)(c); or (ii) issue the recall notice with such modifications to that draft recall notice as are specified by the Commission; or (iii) not issue the recall notice; and (b) cause a copy of the notice given under paragraph (a) to be given to each person who was present or represented at the conference. (3) The Commonwealth Minister must: (a) have regard to a recommendation made under paragraph (1)(a) or (2)(a); and (b) if he or she decides to act otherwise than in accordance with the recommendation - the Commonwealth Minister must, by written notice published on the internet, set out the reasons for his or her decision. 18 Section 132H provides, relevantly: (3) The Commission must, as far as is practicable, ensure that each person who is entitled to be present, or who is representing such a person, at the conference is given a reasonable opportunity at the conference to present his or her case and in particular: (a) to inspect any documents…which the Commission proposes to consider for the purpose of making a recommendation after the conclusion of the conference; and (b) to make submissions in relation to those documents. 19 Importantly for the present case, s 132J creates an exception to the requirement to issue a proposed recall notice and conduct a conference. It provides, relevantly: 132J Interim ban and recall notice without delay in case of danger to the public (1) If it appears to the Commonwealth Minister that consumer goods of a particular kind create an imminent risk of death, serious illness or serious injury, he or she may, by written notice published on the internet, certify that: (a) an interim ban on consumer goods of that kind should be imposed without delay; or (b) a recall notice for consumer goods of that kind should be issued without delay. … (4) A notice under subsection (1) or (2) is not a legislative instrument.

The course of dealings between the ACCC and the appellant 20 The appellant operated a business that involved the selling of teeth whitening products over the internet. Two of the appellant's products contained hydrogen peroxide in concentrations exceeding 6%. 21 On 11 December 2011, the ACCC sent an email to Mr Harrison, the director of the appellant, saying: The ACCC has reason to believe that some products currently being supplied directly to the public may contain concentrations of hydrogen peroxide or carbamide peroxide that exceed the recognised safe limits for cosmetics that will foreseeably be taken into the mouth for significant periods of time. DIY teeth-whiteners that contain concentrations of more than 6% hydrogen peroxide and/or more than 18% carbamide peroxide should not be supplied to consumers as they are unsafe. The recognised safe limits are based on the requirements of the Poisons Standard 2011, expert clinical advice published by the Australian Dental Association and a scientific risk assessment published by the European Commission. References for those documents are provided at the end of this correspondence. If you are presently supplying, or have ever supplied, DIY teeth-whiteners that contain concentrations of more than 6% hydrogen peroxide and/or more than 18% carbamide peroxide in Australia, you should immediately take all reasonable steps necessary to cease supply of the goods and recall them from the market. I have attached details about the regulatory requirements for cosmetics, including suppliers' recall obligations as an appendix. 22 Mr Harrison replied on the same day indicating that the appellant had received no serious injury or safety complaints in relation to any of its products and seeking clarification regarding the ACCC's authority to demand the withdrawal of the appellant's products from the market. In that email, Mr Harrison, amongst other things, said that the same rules should be applied to the sales of teeth whitening products by dentists, challenged the European Union's risk assessment and indicated that the appellant's products were not in breach of the Poisons Standard 2011 (Cth) and that its products were different to those of other suppliers and were safe. 23 Mr Harrison wrote again to the ACCC on 13 December 2011. He said that it was his understanding that if the Minister proposed to impose a ban, a conference would have to be held and he requested an invitation to meet the Minister or participate in a conference. 24 The ACCC responded on 14 December 2011, saying: As noted previously, the Parliamentary Secretary to the Treasurer has powers to impose bans, mandatory safety standards and compulsory recalls of consumer goods that will or may cause injury to any person. As a number of suppliers of DIY teeth whiteners have already voluntarily taken steps to remove unsafe products from the market, the ACCC has not yet recommended that the Minister intervene. This course of action will be taken, however, should any consumer good that presents a risk of injury to any person continue to be supplied. 25 Mr Harrison responded on 15 December: Other vendors' products may well be considered "unsafe" by their owners or by the ACCC due to excessive injury complaints, inadequate design, warnings or instructions and this is the decision of each owner respectively to make about voluntary removal from the market. There is no evidence to suggest our products have been, or ever will be "unsafe" and we do not consider them unsafe. We have never hidden the composition or concentration of our products. Our at-home teeth whitening kits for consumer use contain 12% Hydrogen Peroxide and are all clearly labeled [sic] as such. We offer a Home Teeth Whitening Kit and Teeth Whitening pen currently for sale in Australia. I can still find no definition of "unsafe" levels as you refer to in the Poisons Standard 2011, or reference to any standard over 6% HP except labeling [sic] requirements. I have requested what I consider to be basic information from you in two separate prior emails and none of the answers have been provided. Should you provide me the information requested, and should that information clearly define a law which we are breaking by providing 12% Hydrogen Peroxide products, we are prepared to consider a recall and withdrawal of these products from the market. However, until you provide the information which will allow us to make an informed decision, we do not intend to voluntarily recall or remove our products which have a proven track record of safety and fit for purpose to consumers. I also note that your application of these voluntary recall requests appears to be inconsistent with many vendors not apparently providing voluntary recalls and product withdrawals. These include Ebay sellers, other much larger vendors such as Bdazzled.com.au, Prowhitening.com.au and Dentists selling "DIY" whitening products. Every product in existence has the potential to cause injury. Products such as cigarettes and junk food have proven medical data and associated deaths and severe health risks linked to them which are inflicted on large percentages of the population every year. Yet these products are not banned, recalled etc. It is therefore about putting the safety risk a product "does or may" cause into context. If it is the ACCC's intent to engage the Minister to solicit a Ban, Mandatory Safety Standard or Compulsory Recall - as requested previously, I formally request to participate in a conference prior to issuing such actions. 26 The ACCC wrote again to Mr Harrison on 16 December 2011 saying: As you have indicated that you are supplying DIY teeth-whiteners that contain concentrations of more than 6% hydrogen peroxide, you should immediately take all reasonable steps necessary to cease supply of the goods and recall them from the market. In that context, please provide written notification of your intentions by 4.00 pm on Monday 19 December 2011. After that time, the ACCC will consider the options available under the Australian Consumer Law including a possible recommendation to the Parliamentary Secretary to the Treasurer to consider a compulsory product safety recall. Any such action would of course take account of the legislative requirements relevant to opportunities to hold a conference in relation to the matter. 27 On 19 December 2011, the ACCC wrote again, saying: DIY teeth whitening kits with more than 6% hydrogen peroxide / 18% carbamide peroxide are considered unsafe for general consumer 'take home' use. As foreshadowed in our previous correspondence, the ACCC has therefore started considering the available options to ensure that the risk of injury to consumers is addressed. We will inform you of any legislative actions, as required, that we initiate in this regard. 28 Mr Harrison responded on 21 December 2011: My business and the entire industry has been damaged by the sensationalism portrayed via the media as a result of these potentially illegal activities. …As our DIY products are mostly sold over the internet and shipped to the customer, you will note that as an interim measure we have supplied a sheet of paper containing additional warnings, which I believe to the best of my knowledge comply with the Poisons Standard 2011… We are doing our best to comply with applicable laws and provide a safe, fit for purpose product to consumers. Please provide the requested labeling [sic] information as soon as possible. 29 On 12 January 2012, the ACCC replied, saying: Health authorities have also advised the ACCC that this Poisons Standard limit represents the safe limit for peroxides, supported by injury reports and the clinical and scientific reports referenced in previous correspondence. Based on this, the ACCC considers it is unsafe to supply consumers with a product that is required to be labelled a 'poison' for placement in their mouth in an unsupervised setting. The ACCC continues to identify and negotiate with suppliers of 'home-use' teeth whitening products, including suppliers marketing direct to consumers and those marketing to dental and cosmetic clinics for subsequent 'home-use' supply. We are concerned, however that there may be a misunderstanding in relation to teeth whiteners administered by trusted intermediaries (such as dental or cosmetic practitioners) or self-administered by clients or patients under the direct supervision of such practitioners in a clinical setting. The ACCC is not currently concerned with the supply of teeth whiteners in such environments. The ACCC will continue to monitor the safety of clinical use of teeth whiteners but at this time only 'home-use' supply is our primary safety concern. The ACCC is aware that some suppliers, after being contacted by the ACCC, have decided to restrict their supply of teeth whiteners with poisonous peroxide levels (> 6%) to clinical environments for use under direct supervision by a trusted intermediary such as a dental or cosmetic practitioner and to supply only products with less than 6% peroxide (or equivalent) for 'home-use'. The ACCC has been satisfied with this approach, provided suppliers have also considered the need for recall of any unsafe products that were previously supplied for 'home-use'. The ACCC is also aware that, as other suppliers act to recall unsafe teeth whiteners and other intermediaries act to restrict supply of teeth whiteners with poisonous peroxide levels, Pro Teeth Whitening (Aust) Pty Limited and any other members of the Australian Cosmetic Teeth Whitening Association (ACTWA) that continue to supply teeth whiteners with poisonous peroxide levels for 'home-use' may be endangering their reputation for the supply of safe cosmetics. The ACCC is interested in working with ACTWA and its members in achieving an acceptable safety outcome for consumers. In summary, the ACCC does not suggest that Pro Teeth Whitening (Aust) Pty Limited products are illegal, but is concerned about the safety of consumers using unsupervised 'home-use' teeth whitening products with hydrogen peroxide concentration over 6%. It is on the basis of that safety concern that the ACCC asked you to consider cessation of supply and recall of any such products. As previously indicated, the ACCC has started considering the available options to ensure that the risk of injury to consumers is addressed, and we will inform you of any legislative actions, as required, that we initiate in this regard. 30 On 13 January 2012, Mr Harrison responded, challenging a number of the ACCC's contentions and reiterating that he considered the warning labels on the appellant's products to be adequate to ensure safety. He also sought the negotiation of a solution between the appellant, the Australian Cosmetic Teeth Whitening Association (of which the appellant was a member) and the ACCC, and set out some proposals for such a solution. He attached "one of the many" clinical studies which he suggested refuted the studies that the ACCC relied upon. 31 There was no further correspondence between the ACCC and Mr Harrison. 32 On 3 February 2012, the ACCC provided a minute, or memorandum, to the Parliamentary Secretary to the Treasurer. It invited the Parliamentary Secretary to certify under s 132J that a recall notice be issued without delay and to issue a recall notice pursuant to s 122 of the Australian Consumer Law. 33 It is not clear whether the Parliamentary Secretary to the Treasurer was "the relevant Minister" for the purposes of the legislation, or whether he was a delegate of the relevant Minister. I will assume that he was the relevant Minister, and will refer to him as "the Minister" in these reasons. 34 The relevant parts of the minute provided to the Minister are as follows: ISSUE In early December 2011, the ACCC provided you with a briefing about a series of voluntary recalls of do-it-yourself (DIY) teeth whiteners and the associated media release issued by the ACCC on 9 December 2011. Since then the ACCC has contacted the known suppliers of DIY teeth whiteners and eight suppliers have voluntarily recalled 22 DIY teeth whitening products that contained unsafe concentrations of hydrogen peroxide and/or carbamide peroxide. While most suppliers have cooperated with the ACCC, Pro Teeth Whitening (Aust) Pty Limited continues to supply products with declared concentrations of hydrogen peroxide in excess of the recognised safe limits. This Minute seeks your agreement to issue a compulsory recall notice for two teeth whitening products supplied by Pro Teeth Whitening (Aust) Pty Limited. BACKGROUND • Teeth whitening has become a common cosmetic procedure and numerous products are available directly to the public for DIY teeth whitening. The main active bleaching ingredients in these products are hydrogen peroxide and carbamide peroxide. The concentrations of these ingredients in DIY consumer products available in Australia have increased over recent years. • Typical injury complaints from teeth whitening kits are: tooth sensitivity and gum and throat irritation. More serious injuries reported include: • painful chemical burns to the gums, mouth tissues and the oesophagus • blistering or ulceration of the mouth and throat • marbled or unnatural coloured teeth • sensitive and painful teeth, tissue "tingling", and headaches • potential increased risk of mouth and tongue cancer for tobacco users. • The Australian Dental Association has also reported that dentists are seeing an increasing number of patients presenting with mouth injuries attributed to at-home teeth bleaching. Some cases have also been treated in emergency departments of hospitals. Poisons Information Centres in Queensland, New South Wales and Victoria have received a combined total of at least 58 reports of injuries involving teeth whiteners since 2004. • The ACCC is also aware of regulatory action being taken in the European Union and overseas injury reports associated with the use of these products. • In Australia, the Poisons Standard 2011 classifies preparations containing more than 6% hydrogen peroxide as Schedule 6 "POISONS". This classification limits products intended to be taken into the mouth to below this concentration. Enforcement of the Poisons Standard 2011 is the responsibility of State and Territory health authorities. • The 6% hydrogen peroxide limit is also supported by expert clinical advice published by the Dental Board of Australia, the Australian Dental Association, and a scientific risk assessment published by the European Union Scientific Committee on Consumer Products. • The ACCC has advised consumers who have purchased a DIY teeth-whitening kit to check the label and immediately cease using the product if it contains more than 6% hydrogen peroxide. PRO TEETH WHITENING (AUST) PTY LIMITED • Pro Teeth Whitening (Aust) Pty Limited supplies two DIY products containing syringes labelled as 9%, 12% and 16% hydrogen peroxide: - "brightwhite express - Advanced Teeth Whitening Kit" and - "PROTEETHWHITENING - Professional Teeth Whitening Pen". • The ACCC first raised safety concerns with Pro Teeth Whitening (Aust) Pty Limited on 12 December 2011 and has made several unsuccessful approaches to this supplier aimed at stopping the supply of the unsafe goods and recalling the goods already supplied. • The ACCC correspondence with Pro Teeth Whitening (Aust) Pty Limited has been with a Director of the company, Mr Gavin Harrison. Pro Teeth Whitening (Aust) Pty Limited is one of 9 member companies of the Australian Cosmetic Teeth Whitening Association. • Pro Teeth Whitening (Aust) Pty Limited has refused to halt supply or to voluntarily recall the goods, arguing that: • there had been no reports of injury associated with their products • a small level of risk is normally associated with any consumer good and this does not necessarily mean that such goods are unsafe • the ACCC had unfairly targeted the non-dental teeth whitening industry without similar action against dental practices • a 2004 clinical study for another supplier's product containing 14% hydrogen peroxide was provided in support of the safety claim • the supplier argued that the Poisons Standard 2011 limits relate to labelling requirements only and do not represent safety limits for teeth whitening. • The ACCC accepts that to date there have been no known reports of injury associated with this supplier's products. However, many teeth whitening injuries are not reported and injuries have been reported to Poisons Information Centres from products very similar to those supplied by Pro Teeth Whitening (Aust) Pty Limited. • The ACCC clarified with Pro Teeth Whitening (Aust) Pty Limited that recent actions have been directed at DIY teeth whitening products supplied for unsupervised home use, and not directed at teeth whitening products intended for consumers under the direct supervision of a trusted intermediary such a [sic] dental professional or trained beautician. • Despite this clarification, the products in question continue to be specifically marketed as 'At-Home Products' with instructions for use by consumers and no reference to administration under the supervision of a trusted intermediary. In responses to the ACCC, the supplier has not indicated that the products are supplied in any manner other than for consumers to use 'at-home'. • The 2004 clinical study relates to a different supplier's dental strips that contained very small volumes of hydrogen peroxide. The 2004 study is not transferable to the products in question which are gels applied to the teeth in much larger quantities. • Furthermore, health authorities have confirmed that in addition to stipulating labelling requirements, the Poisons Standard 2011 reflects the hydrogen peroxide limits currently considered to be safe. • The ACCC will also consider in due course whether enforcement action is warranted in relation to possibly misleading claims and undeclared ingredients in teeth whiteners supplied by Pro Teeth Whitening (Aust) Pty Limited. The ACCC will also work with State and Territory health authorities to enable enforcement of the Poisons Standard 2011 in relation to teeth whitening products. COMPULSORY RECALL … • The ACCC considers that the risk to consumers from these products is so significant that it warrants the recall of the products without delay. The recall should apply to all supplied units of these products since they appear to be exclusively marketed for unsupervised use by consumers 'at-home'. • Subsection 132J (1)(b) of the CCA (Attachment 5) allows that you may certify that a recall notice should be issued without delay, and without a conference process, if it appears to you that the goods create an imminent risk of serious injury. A notice under section 132J is not a legislative instrument but must be published on the internet. • The ACCC recommends that you exercise your powers under the CCA and issue both a compulsory recall notice and a notice that the recall must occur without delay to compel Pro Teeth Whitening (Aust) Pty Limited to recall two do-it-yourself teeth whitening products on the basis that the goods create an imminent risk of serious injury. 35 On 6 February 2012 the Minister accepted the ACCC's recommendations. He certified pursuant to s 132J(1)(b) of the Competition and Consumer Act that a recall notice for two teeth whitening products supplied by the appellant should be issued without delay on the basis that it appeared to him that such goods created imminent risk of serious injury. 36 The Minister also, pursuant to s 122(1) of the Australian Consumer Law, issued a notice in accordance with s 123 requiring the appellant to take specified actions. These actions were to recall the goods, disclose to the public a dangerous characteristic of the goods, specifically that the goods contain levels of hydrogen peroxide exceeding recognised safe limits, and inform the public that it would undertake to either replace the goods or refund the price of the goods. The notice set out the manner in which the required actions were to be undertaken.

Proceedings in the Federal Circuit Court 37 Before the Federal Circuit Court, the respondent submitted that the issuing of a recall notice under s 122 of the Australian Consumer Law was not a decision of an administrative character, but was rather, action of a legislative character. The primary judge did not rule upon the respondent's submission, merely saying: For the purposes of this application, I am prepared to assume that the issue of such notices was a legislative action rather than an administrative action. 38 Neither party addressed any argument to this Court as to the effect of his Honour's failure to rule upon that argument. 39 The Minister also argued before the Federal Circuit Court that the decision under s 132J(1) to certify that the compulsory recall notice be issued without delay was not a decision of an administrative character, but was a legislative action. The primary judge rejected that argument, ruling that the decision was reviewable under the ADJR Act. The respondent did not challenge that ruling before this Court. 40 Before the Federal Circuit Court, the appellant submitted that the rules of natural justice apply to a decision of the Minister to certify under s 132J of the Competition and Consumer Act that a recall notice should be issued without delay. His Honour accepted that the appellant had an entitlement to natural justice, but decided that there had been no denial of natural justice because the ACCC had given "clear and adequate notice of the case that was put against the applicant's products". His Honour held that the appellant had been given, and had taken up, the opportunity to respond to that case. 41 The appellant submitted that the Minister did not follow procedures required by law to be followed before he certified that the recall notices should be issued without delay. His Honour considered that there were no relevant procedures that were not followed. This ground also overlapped with the ground concerning denial of natural justice and the argument was rejected for the reasons given in relation to that ground. 42 The appellant argued that the Minister acted in bad faith because there was evidence that the respondent did not believe that the appellant's products presented an imminent risk of serious injury. It contended that no action had been taken against other suppliers of similar products and that it was singled out. In a judgment given on 9 May 2013, the primary judge rejected that argument on the basis that the evidence showed that other suppliers had voluntarily recalled teeth whitening products, so that the factual basis upon which the applicant advanced its submission was not made out. In addition, there was evidence before the Minister that could have engaged the requirements of s 132J and there was nothing in the evidence to establish any improper purpose. 43 His Honour rejected an argument which seemed to have been that the respondent failed to take into account a relevant consideration, namely that the appellant had offered to voluntarily effect a recall of its offending products. His Honour found that the appellant had not informed the ACCC or the respondent that the appellant had voluntarily ceased selling the offending products. Accordingly, under s 122 it was open to the respondent to decide that it appeared that the supplier had not taken satisfactory action to prevent the goods causing injury. 44 The appellant argued that the Minister had taken into account irrelevant considerations, namely the Poisons Standard, injury reports referred to in the minute given to the respondent, an email from the Australian Dental Association suggesting that there had been injuries associated with the use of do-it-yourself tooth whitening and risk assessments from the European Union. His Honour held, however, that there was nothing in the legislation which expressly or by implication prevented the respondent from taking into account that information. 45 The appellant argued that there was no evidence to justify the making of the decision. His Honour held that the words "if it appears to the Commonwealth Minister" in s 132J are important because they make it clear that the Minister is not required to demonstrate that there was in fact an imminent risk of serious injury or serious illness. Rather it is the appearance of those things that is relevant. His Honour held that there was information placed before the respondent indicating that products containing more than 6% hydrogen peroxide had caused serious injury or serious illness and that the risk of such injuries was imminent. Therefore, the ground was not made out. 46 The appellant argued that the decision was illogical and so unreasonable that no reasonable person could have reached that decision. His Honour held that, having regard to the fact that there was evidence before the respondent that products containing more than 6% hydrogen peroxide posed an imminent risk of serious injury if used in an uncontrolled way, the decision was open to the respondent. 47 Accordingly the primary judge dismissed the application.

The appeal to this Court 48 Mr Harrison, the appellant's director, was granted leave to represent the appellant. The supplementary notice of appeal contains 30 grounds. Some are incomprehensible. Many are repetitive or overlap with others. Some are at the same time verbose and lacking in detail as to the critical points sought to be made. In that category, for example, there are references to possible breaches of the Constitution without specifying what provisions may be breached and in what way. Some of the grounds allege failure of the primary judge to find for the appellant on the merits or facts of its case, although dressed up in language designed to suggest errors of law. The appellant's written and oral submissions refer to only some of the grounds set out in the notice of appeal, but also seem to raise new grounds. I mention these matters to explain the difficulty in ascertaining precisely what the grounds of the appeal are, not to criticise Mr Harrison, who is not legally qualified. 49 As best as can be distilled from the notice of appeal and the written and oral submissions, the grounds of appeal raised by the appellant can be summarised as follows: (1) The primary judge erred in failing to find that the appellant had been denied natural justice and, in particular, in failing to find that the appellant had been denied the opportunity to make submissions as to why the respondent should not decide to certify that a recall notice should be issued without delay. (2) The primary judge erred in failing to find that the respondent had acted in bad faith because he did not believe that the appellant's products posed an imminent risk of serious injury. (3) The primary judge erred in denying the appellant's request that it be permitted to cross-examine the respondent. (4) The primary judge erred in failing to order the production of communications between the Minister or the ACCC and major suppliers of similar teeth whitening products, so that the appellant could demonstrate that its products were singled out. (5) The primary judge erred in failing to decide that the Minister had taken into account irrelevant considerations, namely information placed before the Minister that was false, misleading, inconclusive or irrelevant to the case against the appellant. (6) The primary judge erred in failing to consider the appellant's argument that the respondent had exercised a discretionary power in accordance with a rule or policy without regard to the merits of the particular case. (7) The primary judge erred in his interpretation of the word "appears" in s 132J of the Competition and Consumer Act. (8) The primary judge erred in failing to find that there could be no reasonable assessment that the appellant's products posed an "imminent risk" of "serious injury". (9) The primary judge erred in failing to find that there was no evidence capable of sustaining the respondent's decision that there was an "imminent risk" of "serious injury". (10) The primary judge erred in failing to find that the ACCC and the respondent had misinterpreted and misapplied the Poisons Standard.

Denial of natural justice 50 The appellant submits that it was denied natural justice because the ACCC represented that a conference would be held before any action was taken, and no such conference was held (I will also adopt the expression "natural justice" in these reasons, rather than the term "procedural fairness"). It argues that it was led to expect that the procedures set out in ss 132A - 132D of the Competition and Consumer Act would be followed. It argues that it was then deprived of the opportunity to make full submissions as to why the ACCC should not recommend to the Minister that a recall notice be issued. 51 The appellant further submits that it was given no warning that the ACCC intended to recommend to the Minister that the procedure under s 132J be utilised on the basis of an imminent risk of serious injury and that it did not have the opportunity to make submissions as to why a recall notice should not be issued without delay. 52 The appellant also argues that the ACCC did not comply with its representation that it would inform the appellant of any legislative actions that it initiated. 53 The appellant raised an argument to the effect that the Minister did not take into account relevant considerations because the appellant did not have the opportunity to place matters it considered relevant before the Minister. This argument seems to be merely another way of stating the natural justice ground. 54 The following matters emerge from an examination of the emails exchanged between the appellant and the ACCC. 55 Firstly, the ACCC was careful to avoid being specific about the course of action that it proposed to recommend that the Minister take. It left open each of the possibilities of a mandatory safety standard or a ban or a compulsory recall. Although the ACCC's email of 16 December 2011 tended to suggest that it might recommend that the Minister issue a proposed recall notice, it was written in terms that did not foreclose the other possibilities. In its last email of 19 December 2011, the ACCC said merely that it had "started considering the available options". 56 Secondly, Mr Harrison, the appellant's director, held a belief or expectation that any proposed ban or recall notice would result in the holding of a conference. However, that belief or expectation developed from his own understanding of the legislation, rather than any representation by the ACCC. 57 Thirdly, the ACCC's emails requested that the appellant voluntarily withdraw its products that contained more than 6% hydrogen peroxide and explained why it considered such products to be unsafe. It explained that the basis for its position was advice published by the Australian Dental Association, a scientific risk assessment published by the European Commission and the fact that the Poisons Standard classified such products as a poison. It also explained that it considered that the lack of safety arose when such products were used in an unsupervised home setting, but not when there was supply or supervision by a dentist or trained beautician. 58 Fourthly, the appellant did have an opportunity to respond to the issues and concerns described above that were raised by the ACCC. The appellant was able to respond, in particular, that: the Poisons Standard was only relevant to labelling requirements, rather than the safety of the product; every product has the potential to cause injury, but the risk of such injury must be seen in context; some other suppliers had not voluntarily withdrawn similar products; there had been no reports of any serious injuries or safety complaints in respect of its products; it had attempted to reduce any risk by providing additional warnings; there were other possible solutions to ensure that the products were used safely; and it would suffer financially and its reputation would be damaged if the products were banned or recalled. 59 Fifthly, the ACCC did not tell the appellant that it considered that there was an "imminent risk" of "serious injury" or that it was considering recommending that the Minister certify that the recall notice should be issued without delay pursuant to s 132J. The ACCC submits that its view that there was an imminent risk of serious injury should have been apparent from its emails of 16 December and 19 December 2011. The first of those emails said that as the appellant supplied products that contained concentrations of more than 6% hydrogen peroxide, it should immediately take reasonable steps to cease supply of the goods and recall them. The second said that teeth whitening kits with more than 6% hydrogen peroxide were considered unsafe for general home use. I do not accept that those emails were intended to communicate, nor were they capable of communicating, that the products created an "imminent risk" of "serious injury" or that the ACCC proposed to recommend that the Minister certify that a recall notice be issued without delay. In fact, such an intention would be contrary to other parts of the same emails which were careful to leave it entirely open as to what recommendation the ACCC proposed to make to the Minister. 60 There are references in the ACCC's emails to various web pages. It is possible to speculate that these might have been the sources of the information in the minute provided to the Minister as to the nature of the injuries that could be caused by teeth whitening products, but these web pages were not placed before the Court. It was not submitted by the Minister that these pages should be taken to have somehow communicated to the appellant that there was an imminent risk of serious injury. 61 Sixthly, the ACCC told the appellant in its email of 12 January 2012 that it had started considering the available options to ensure that the risk of injury to consumers was addressed and represented that, "we will inform you of any legislative actions, as required, that we initiate in this regard". The action that the ACCC did initiate was to recommend that the Minister certify that a recall notice should be issued without delay under s 132J of the Competition and Consumer Act and that a recall notice be issued under s 122 of the Australian Consumer Law. It did not inform the appellant that it had initiated such action. The ACCC's submission that it had complied with its representation by informing the appellant of the Minister's decisions after they had been made is without merit. To any reasonable person reading the email, the representation was that the appellant would be informed of the actions when they were initiated, not when they were completed. 62 In this Court, the submissions of both parties focussed on the Minister's decision made under s 132J of the Competition and Consumer Act and not the decision made under s 122 of the Australian Consumer Law. 63 The primary judge held that the principles of natural justice apply to a decision to issue a certificate pursuant to s 132J of the Competition and Consumer Act. The respondent did not challenge that aspect of the primary judge's decision. In fact, the respondent conceded that natural justice is not excluded under s 132J, although it submitted that the content is circumscribed by the circumstances of urgency and risk to safety. The concession made by the respondent should be accepted, at least where the suppliers of the relevant product are known, as there are no plain words of necessary intendment that exclude the principles of natural justice: cf Annetts v McCann (1990) 170 CLR 596 at 598; Ainsworth v Criminal Justice Commission (1992) 175 CLR 564 at 576; Saeed v Minister for Immigration and Citizenship (2010) 241 CLR 252 at [15]. 64 As to the content of the requirement to accord natural justice, in SZBEL v Minister for Immigration and Multicultural and Indigenous Affairs (2006) 228 CLR 152, the High Court said at [26]: It has long been established that the statutory framework within which a decision maker exercises statutory power is of critical importance when considering what procedural fairness requires. It is also clear that the particular content to be given to the requirement to accord procedural fairness will depend upon the facts and circumstances of the particular case. 65 In the present case, the ACCC asked the appellant to voluntarily recall its products, but the appellant refused to do so, as was its right. The options then open to the ACCC were to recommend that the Minister make or declare a safety standard, impose an interim or permanent ban upon the products, issue a recall notice and to publish a warning notice about the goods. The most extreme of these measures is a recall notice because of the cost to the supplier of recalling the goods and replacing them or refunding their price, as well as the reputational damage to the supplier. 66 The statutory scheme balances competing considerations. Section 122 of the Australian Consumer Law is aimed at protecting consumers of goods from risk of injury. However, it recognises, by giving the responsible Minister a discretion as to whether to issue a recall notice, that goods should not necessarily be recalled merely because it appears that such goods may cause injury and suppliers have not taken satisfactory action to prevent such injury. There are, of course, very many useful products that can cause some form of injury, regardless of any safety precautions that can feasibly be taken by the supplier. The exercise of the discretion will often involve the assessment and balancing of a broad range of matters, including the nature and extent of the risk of injury, the safety precautions that can be taken to reduce the risk of injury, the reputational and financial damage that may be suffered by suppliers if a recall notice is issued, the utility of the product to the community and the economic cost to the community if the product is recalled and not supplied. 67 One of the ways in which the legislation attempts to balance the risk of damage to suppliers against the risk of injury to consumers is by giving suppliers the opportunity to take action to improve the safety of the goods, including by voluntarily recalling the goods: s 122(1)(c) of the Australian Consumer Law. Another is by providing the opportunity to suppliers to present a case as to why the proposed actions should not be taken, at least in cases not involving great urgency. 68 The width of the matters that may influence the Minister's decision and, in particular, the potential for reputational and financial harm to suppliers, demonstrates why the legislature intended that suppliers should ordinarily have an opportunity to make a case against the issuing of a recall notice and why it enacted particular procedures to give suppliers that opportunity. 69 One feature of the scheme is that, while it is the relevant Minister who is given the substantive powers to exercise, the procedural mechanism is administered by the ACCC. In Theo Holdings Pty Ltd v Hockey (2000) 175 ALR 89 at [48], Dowsett J said that structure of legislation effectively results in the Minister "delegating" part of his or her function to the ACCC. 70 The procedural mechanism for the scheme is set in train when it appears to the ACCC that consumer goods will or may cause injury to consumers: s 122(1)(b). In practical terms, when such a risk is apparent to the ACCC, it would normally write to any known suppliers of the product and request that it undertake a voluntary recall or take action to improve the safety of the product. That is because the power of the Minister to issue a recall notice will not arise unless it appears to the Minister that one or more suppliers of the goods have not taken satisfactory action to prevent the goods causing injury to any person: s 122(1)(c) of the Competition and Consumer Act. 71 In the event that the supplier fails to take satisfactory action, the ACCC can recommend, amongst other things, that the Minister issue a proposed recall notice: s 132A of the Competition and Consumer Act. If a proposed recall notice is issued, the supplier can require the ACCC to hold a conference: ss 132C, 132D. That gives the supplier an opportunity to present its case against a recall: s 132H. Following the conference, the ACCC must make a recommendation that the Minister issue a recall notice or not issue a recall notice: s 132D(2). The Minister takes the recommendation into account when making a decision: s 132D(3). The legislation does not envisage that the supplier will have an opportunity to make additional submissions directly to the Minister, except, perhaps, where the ACCC does not fairly or adequately present the supplier's submissions to the Minister. 72 However, there is a different process where s 132J of the Competition and Consumer Act is invoked. That section only applies where it appears to the Minister that the consumer goods create an "imminent risk of death, serious illness or serious injury". In that urgent situation, the ACCC and the Minister need not go through the lengthy and formalised process of issuing a proposed recall notice and conducting a conference. 73 Generally speaking, the requirements of natural justice will be heightened in proportion to the gravity of the consequences to a person affected by the decision: Gribbles Pathology (Vic) Pty Ltd v Cassidy (2002) 122 FCR 78 at [117] per Weinberg J; Telstra Corporation Ltd v Australian Competition and Consumer Commission (No 2) [2007] FCA 493 at [241] per Bennett J. Conversely, the more imminent the risk of death, serious injury or serious illness and the greater the extent of the risk, the lesser will be the opportunity required to be given to suppliers to present a case against a recall without delay. I accept the Minister's submission that circumstances of urgency will circumscribe what might otherwise be required to constitute a fair procedure: see Marine Hull and Liability Insurance Co Ltd v Hurford (1985) 10 FCR 234 at 241, per Wilcox J. What, if any, opportunity must be given to a supplier to comment will depend upon the particular combination of circumstances that are present. 74 In Commissioner for Australian Capital Territory Revenue v Alphaone Pty Ltd (1994) 49 FCR 576, at 591-592, the Full Court of the Federal Court said: Where the exercise of a statutory power attracts the requirement for procedural fairness, a person likely to be affected by the decision is entitled to put information and submissions to the decision-maker in support of an outcome that supports his or her interests. That entitlement extends to the right to rebut or qualify by further information, and comment by way of submission, upon adverse material from other sources which is put before the decision-maker. It also extends to require the decision-maker to identify to the person affected any issue critical to the decision which is not apparent from its nature or the terms of the statute under which it is made. The decision-maker is required to advise of any adverse conclusion which has been arrived at which would not obviously be open on the known material. Subject to these qualifications however, a decision-maker is not obliged to expose his or her mental processes or provisional views to comment before making the decision in question. For a statutory exception to the latter proposition see the pre-decision conference process provided for in the Trade Practices Act 1974 (Cth). (Underlining added.) 75 It may be noted that the conference procedure under the Trade Practices Act referred to in this passage is now found, relevantly, in ss 132A-132H of the Competition and Consumer Act. 76 I have indicated that the ACCC was careful to avoid being specific as to what course of action it proposed to recommend to the Minister. It was entirely vague as to whether it would recommend a mandatory standard or a ban or a recall. The ACCC informed the appellant of some of the issues that would be critical to whichever recommendation it would eventually decide to make to the Minister, particularly that it appeared that the appellant was supplying products that were consumer goods, that the products appeared to create a risk of injury and why they were assessed as creating that risk. 77 Once the Minister decided to consider whether to exercise his power under s 132J, some further issues became critical to the decision. Those further issues were that it appeared that the appellant's products created a risk of "serious injury" to consumers, that it appeared that the risk was "imminent" and that the Minister was considering certifying that a recall notice issue without delay. These further issues were not apparent from the statute because the ACCC was so non-committal about what statutory provision it proposed to recommend that the Minister act under. The respondent did not notify the appellant of these further matters. Neither, as I have already indicated, had the ACCC notified the appellant of these matters. If the ACCC had done so, the appellant would not be in a position to complain of any denial of natural justice. But, it did not. 78 In addition, the conclusion that there was an "imminent risk" of "serious injury" was not one that was obviously open on the known material. The ACCC's correspondence did not say that it appeared that there was any imminent risk, or that the risk was of serious injury, or describe particular injuries that were obviously serious and imminent. It is also relevant that the ACCC had been corresponding with the appellant for over a month before finally indicating that it had "started considering the available options to ensure that the risk of injury to consumers is addressed". The length of time over which the correspondence took place hardly suggests that the ACCC considered that there was an imminent risk of serious injury. 79 The respondent submitted that, although the principles of natural justice were not excluded under s 132J, the circumstances of urgency meant that the requirements of procedural fairness were reduced to the point where it was not necessary to specifically point out to the appellant that the ACCC considered that there was "imminent risk" of "serious injury". That submission is, however, quite inconsistent with the conduct of the ACCC in corresponding with Mr Harrison for over a month. It is true that sometimes urgency may abrogate the need to give any notice to the supplier of such matters. However, I do not accept that the circumstances of this case, taking into account the lack of urgency with which the ACCC had moved and the seriousness of the consequences for the appellant, reduced the requirement of natural justice to the point that the Minister, whether through the ACCC or personally, was not required to notify the appellant of the critical issues for the decision to be made under s 132J and give the appellant some chance to respond. 80 The primary judge decided that there had been no denial of natural justice because the ACCC had given the appellant clear and adequate notice of the case that was put against its products. However, the appellant did not have notice of some issues critical to the case made against its products, or of a conclusion that was not obviously open on the known material. The primary judge erred in finding that the appellant was not denied natural justice. 81 I reject the appellant's submission that the ACCC represented that a conference would be held prior to the making of any decision to issue a recall notice and that it was denied natural justice because of a failure to honour that representation. As I have indicated, the ACCC made no commitment as to the course of action it would recommend to the Minister, and it made no representation that it would proceed in a way that required a conference to be held. 82 I also reject the appellant's argument that there was a denial of natural justice as a result of the ACCC's misrepresentation in its email of 12 January 2012 that "we will inform you of any legislative actions, as required, that we initiate in this regard". Although I have found that the ACCC did not honour its representation, there was no evidence before the Court that the appellant relied upon the representation. The lack of evidence of reliance is fatal to the appellant's claim that it was denied natural justice as a result of the misrepresentation: Re Minister for Immigration and Multicultural and Indigenous Affairs; Ex parte Lam (2003) 214 CLR 1 at [37], [106], [122], [151]. 83 This is not a case where relief should be refused in the exercise of the Court's discretion on the basis that compliance with the requirements of natural justice could not possibly have made any difference to the outcome. The appellant could have submitted, amongst other things, that any risk of injury was not "imminent" and the risk was not of "serious injury". It could have relied upon the ACCC's own lack of urgency to support that submission. It could also have argued for an interim ban rather than a recall. There was a prospect that these arguments would be accepted by the Minister. 84 As I have said, the parties' submissions focussed upon the Minister's decision to certify that a recall notice issue without delay under s 132J of the Competition and Consumer Act. They did not specifically address the decision to issue the recall notice under s 122 of the Australian Consumer Law, an action which is required to be done by legislative instrument pursuant to s 131E(1)(h) of the Competition and Consumer Act. The Minister did not submit that it would be futile to set aside the decision made under s 132J on the basis that the Minister's decision to issue the recall notice under s 122 would remain intact. I therefore propose to order that the decision of the respondent under s 132J to certify that a recall notice issue without delay be set aside. I will deal later with the question of what is to happen in respect of the decision made under s 122.

Bad faith 85 The appellant argued that the primary judge had erred in failing to find that the Minister had acted in bad faith. The appellant argued that the Minister did not believe that there was an imminent risk of serious injury. It argued that this was evidenced by the selective targeting of the appellant's products while failing to take any action to obtain the voluntary or compulsory recall of similar products supplied by dentists, major suppliers or eBay vendors. It argued that the actions of the respondent against the appellant were discriminatory, anti-competitive and unfair and, therefore, demonstrated bad faith. 86 Allied to this ground, was the ground that the primary judge erred in denying the appellant's request to cross-examine the respondent so that it could establish bad faith. The appellant also argued that the primary judge erred in failing to order the production of communications between the Minister or the ACCC and major suppliers of similar teeth whitening products, so that the appellant could demonstrate that its products were singled out. 87 In SBBS v Minister for Immigration and Multicultural and Indigenous Affairs (2002) 194 ALR 749 the Full Court of the Federal Court summarised the principles established by authority: [43] First, an allegation of bad faith is a serious matter involving personal fault on the part of the decision-maker. Second, the allegation is not to be lightly made and must be clearly alleged and proved. Third, there are many ways in which bad faith can occur and it is not possible to give a comprehensive definition. Fourth, the presence or absence of honesty will often be crucial. [44] The fifth proposition is that the circumstances in which the court will find an administrative decision-maker had not acted in good faith are rare and extreme. This is especially so where all that the applicant relies upon is the written reasons for the decision under review. [45] Sixth, mere error or irrationality does not of itself demonstrate lack of good faith. Bad faith is not to be found simply because of poor decision-making. It is a large step to jump from a decision involving errors of fact and law to a finding that the decision-maker did not undertake its task in a way which involves personal criticism. [46] Seventh, errors of fact or law and illogicality will not demonstrate bad faith in the absence of other circumstances which show capriciousness. [47] Eighth, the court must make a decision as to whether or not bad faith is shown by inference from what the Tribunal has done or failed to do and from the extent to which the reasons disclose how the Tribunal approached its task. [48] Ninth, it is not necessary to demonstrate that the decision-maker knew the decision was wrong. It is sufficient to demonstrate recklessness in the exercise of the power. (Citations omitted.) 88 The evidence before the Court does not demonstrate that the appellant was singled out. The minute to the Minister indicated that the known suppliers of "DIY teeth whiteners" had been contacted and most had co-operated with the ACCC. There is no evidence that the Minister decided that other suppliers, large or small, which failed to voluntarily withdraw their products from the market in circumstances that were not materially different would be treated more favourably than the appellant. Neither was there anything in the evidence to demonstrate that the ACCC was taking such a position. 89 The appellant relied upon the fact that the ACCC's attitude was that dentists could continue to supply tooth whitening products containing more than 6% hydrogen peroxide. But, the ACCC's concern was with the supply to, and use of, such products by consumers without supervision. It accepted that the products could be safely used if supplied under the direct supervision of a dental professional or trained beautician. The appellant was free to sell its products to dentists or trained beauticians for resupply by them. The ACCC's concern was with the risk of injury stemming from unsupervised retail sales. The Minister adopted the ACCC's view by his acceptance of the ACCC's recommendations. 90 In addition, there was evidence before the Minister capable of persuading him that the appellant's products appeared to create an imminent risk of serious injury. The minute listed several types of injury which had resulted from the use of teeth whitening products with concentrations of more than 6% hydrogen peroxide. These injuries included painful burns to the gums, mouth tissues and oesophagus, and blistering or ulceration of the mouth and throat. It was open to the Minister to conclude that it appeared that such injuries were "serious injuries". He was also able to conclude that it appeared that the risk of such injuries was "imminent" given that the products were in the market and that the nature of the injuries suggested that they might be incurred at the time of or shortly after use. It is not to the point that the ACCC might have been expected to present a more cogent, complete and explicit case to the Minister, given the seriousness of the decision which it recommended be made. It was open to the Minister to reach the conclusion on the material he was presented with that he should exercise his power, and that is consistent with the Minister acting honestly. 91 The primary judge could not be satisfied that the Minister did not have an honest belief that the appellant's products posed an imminent risk of serious injury. Therefore, the appellant has not demonstrated any error in the primary judge's decision to reject the ground of bad faith. 92 As to the appellant's complaint that the primary judge did not allow it to cross-examine the Minister, there was no occasion for cross-examination because the Minister did not swear an affidavit in the proceedings. 93 As to the appellant's submission that the primary judge denied the appellant's requests for the respondent to provide communications between himself or the ACCC and major suppliers which were selling similar products which are not subject to any recall notice, the complaint appears to be that the primary judge erred in refusing to order discovery of such documents. Any such order must be interlocutory. No application for leave to appeal against such a decision has been made. Accordingly, it cannot succeed. 94 The appellant sought to rely upon an affidavit of Mr Harrison that was not before the primary judge. It annexes a number of letters written by the ACCC to various suppliers of teeth whitening products demanding information concerning the suppliers' products. Mr Harrison asserts in his affidavit that those products also contained more than 6% hydrogen peroxide, but that no voluntary recall of the products was sought by the ACCC. This is said to be evidence of the selective targeting of the appellant's products. 95 I decline to allow the appellant to rely upon Mr Harrison's affidavit in the appeal. The letters from the ACCC do not indicate whether or not any action was taken against the suppliers' products. Mr Harrison's assertions that the products did contain more than 6% hydrogen peroxide and that no voluntary recall of the products was sought by the ACCC appear to be hearsay. The affidavit was not given to the respondent until the commencement of the hearing and it has had no opportunity to investigate the matters deposed to by Mr Harrison. I reject the affidavit because it lacks probative value, consists largely of hearsay and was served late.

Irrelevant considerations 96 The appellant's next ground was that the primary judge should have found that the Minister had taken irrelevant considerations into account, namely information placed before the Minister that was false, misleading, inconclusive or irrelevant to the case against the appellant. This information was said to be information about injuries that had been sustained by the use of teeth whitening products. 97 This ground argues that the Minister should not have taken into account a conclusion that he drew from information that the appellant disagrees with. It is, in truth, merely an attempt at merits review of the decision. A court has no power to conduct merits review of a decision made under s 132J. Therefore, the ground must fail.

Failing to consider the merits of the case 98 The appellant contended that the primary judge erred in failing to consider the appellant's argument that the respondent had exercised a discretionary power in accordance with a rule or policy without regard to the merits of the case. I will assume that this argument was in fact raised before the Federal Circuit Court. 99 The appellant's argument seems to be that the policy or rule that was applied was that teeth whitening products containing more than 6% hydrogen peroxide appeared to create an imminent risk of serious injury. 100 The appellant argued in its emails to the ACCC that its circumstances were different because there had been no complaints of serious injury concerning its products. The appellant's contention was placed before the Minister, as was the ACCC's view that this factor was not determinative because many teeth whitening injuries are not reported and some reported injuries resulted from products very similar to those supplied by the appellant. 101 The Minister did take into account the circumstances that were placed before him concerning the appellant's products and, therefore, this ground is not made out.

Misinterpretation of "appears" in s 132J 102 The appellant argued that the primary judge erred in his interpretation of the word "appears" in s 132J of the Competition and Consumer Act. 103 The phrase "appears to the Minister" is well known in Commonwealth legislation. The purpose of that phrase is to make it plain that the exercise of the power depends upon the opinion of the Minister as to the existence of a state of facts, although that does not mean that the Minister's decision is beyond the reach of judicial review: Australian Securities Commission v Deloitte Touche Tohmatsu (1996) 70 FCR 93 at 121. 104 The appellant argued that the primary judge had adopted an interpretation of "appears to the Minister" that set the bar too low. The primary judge held, in the context of an argument that there was no evidence for the decision, that what was relevant was whether it appeared to the Minister that there was an imminent risk of serious injury, not whether there was in fact an imminent risk of serious injury. I cannot see anything which suggests that the primary judge misinterpreted that expression.

Irrationality, unreasonableness and no evidence 105 The appellant argued that the primary judge erred in failing to find that there could be no reasonable assessment that the appellant's products posed an imminent risk of serious injury. I interpret the appellant's argument to be that the Minister's decision was both irrational and so unreasonable that no reasonable decision-maker could have made it. 106 The appellant also argued that there was no evidence capable of sustaining the respondent's decision that there was an imminent risk of serious injury. 107 I have already discussed the material that was before the Minister concerning the nature of injuries which had been sustained by the use of teeth whitening products with concentrations of hydrogen peroxide of above 6%. This material was capable of leading the Minister to a rational conclusion that it appeared that there was an imminent risk of serious injury. There was no error on the part of the primary judge in rejecting these grounds.

Misinterpretation of the Poisons Standard 108 The appellant had argued in emails to the ACCC that the Poisons Standard requirements for hydrogen peroxide related to labelling requirements only and did not represent any safety limits for teeth whitening products. In the minute to the Minister, the ACCC wrote that health authorities had confirmed that, in addition to stipulating labelling requirements, the Poisons Standard reflects the hydrogen peroxide limits currently considered to be safe. 109 In the minute, the ACCC also said: In Australia, the Poisons Standard 2011 classifies preparations containing more than 6% hydrogen peroxide as Schedule 6 "Poisons". This classification limits products intended to be taken into the mouth to below this concentration. 110 The ACCC's interpretation of Sch 6 of the Poisons Standard was that preparations containing more than 6% hydrogen peroxide should not be taken into the mouth. By accepting the ACCC's recommendation apparently on the basis of the contents of the minute, the Minister must be taken to have adopted the same interpretation of Sch 6. 111 The Poisons Standard was made pursuant to s 52D(2)(b) of the Therapeutic Goods Act 1989 (Cth) ("the Act"). The Poisons Standard classifies poisons according to nine schedules. Schedule 6 is headed "Poison" and is described as: Substances with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label. 112 The principles of scheduling stated in the Poisons Standards include: Poisons are not scheduled on the basis of a universal scale of toxicity. Although toxicity is one of the factors considered, and is itself a complex of factors, the decision to include a substance in a particular Schedule also takes into account many other criteria such as the purpose of use, potential for abuse, safety in use and the need for the substance. The standard now lists poisons in nine Schedules according to the degree of control recommended to be exercised over their availability to the public. Poisons for therapeutic use (medicines) are mostly included in Schedules 2, 3, 4 and 8 with the progression through these schedules signifying increasingly restrictive regulatory controls. For some medicines, agricultural, domestic and industrial poisons, Schedules 5, 6 and 7 represent increasingly strict container and labelling requirements with special regulatory controls over the availability of the poisons listed in Schedule 7. 113 Hydrogen peroxide is included in Sch 5 where, relevantly, preparations contain 6% or less of hydrogen peroxide. It is also included in Sch 6 where, relevantly, preparations contain more than 6% hydrogen peroxide. 114 The Minister did not make any submissions concerning the appellant's arguments about the Poisons Standard. I have been unable to locate anything in the Poisons Standard which supports the Minister's construction that preparations containing more than 6% hydrogen peroxide should not be taken into the mouth. Section 52D(4A) of the Therapeutic Goods Act has the effect that the Poisons Standard is a legislative instrument. I consider that the Minister's misconstruction is an error of law. 115 However, I consider that the error of law had no effect upon the outcome of the decision. That is because the Minister accepted that health authorities had expressed a view that the Poisons Standard reflects the limits for hydrogen peroxide currently considered to be safe. His misunderstanding of the Poisons Standard was overcome by other evidence. Accordingly, the Minister acted upon evidence that taking products containing more than 6% hydrogen peroxide into the mouth created a risk of injury.

Disposition 116 The inevitable consequence of the Minister's decision under s 132J of the Competition and Consumer Act to certify that a recall notice be issued without delay was that he then issued a recall notice pursuant to s 122 of the Australian Consumer Law. 117 The primary judge proceeded on the assumption that the recall notice issued under s 122 was a legislative instrument, but did not go on to consider the consequences of that assumption. One obvious consequence is that the appellant may not obtain review of that decision under the ADJR Act because it is not of an "administrative character" within ss 5 and 6 of that Act. However, because the appellant also relied upon s 39B(1) of the Judiciary Act, there may be no practical significance of classifying the decision under s 122 as "legislative" rather than "administrative": cf Visa International Service Association v Reserve Bank of Australia (2003) 131 FCR 300 at [589] per Tamberlin J; Roche Products Pty Ltd v National Drugs and Poisons Schedule Committee (2007) 163 FCR 451 at [41] per Branson J. 118 I have found that the Minister's decision to certify that a recall notice should be issued without delay in respect of the appellant's products pursuant to s 132J of the Competition and Consumer Act denied the appellant natural justice. The same error flowed into and affected the decision to issue a recall notice pursuant to s 122 of the Australian Consumer Law. 119 It is appropriate to set aside the decision of the Federal Circuit Court. It is also appropriate to set aside the decision made by the Minister under s 132J of the Competition and Consumer Act. 120 However, I am reluctant to grant the same relief in respect of the decision under s 122 of the Australian Consumer Law without having been addressed by the parties on the significance, if any, of a recall notice being made by way of legislative instrument. I therefore propose to remit the matter to the Federal Circuit Court to decide the issue of whether any relief should be granted in respect of the decision under s 122 of the Australian Consumer Law. I certify that the preceding one hundred and twenty (120) numbered paragraphs are a true copy of the Reasons for Judgment herein of the Honourable Justice Rangiah.