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Government calls for reduction in tobacco additives demonstrates need for separate tobacco regulatory authority

Monday 16 July 2001




For immediate release: Monday 16th July 2001


Government demand for reduction in tobacco additives underlines need for greater tobacco regulation



Responding to the Government’s call for the tobacco industry to remove harmful additives from cigarettes ASH said that this underlined the need for a Tobacco Regulatory Authority to exert greater control over tobacco products and the industry.


ASH’s Research Manager, Amanda Sandford, commented: “Currently over 600 substances are allowed to be added to cigarettes on sale in the UK.  Under the present voluntary agreement the tobacco industry has huge leeway over what it can put into cigarettes.


“Some such as ammonia may make cigarettes more addictive while sweeteners may make them more palatable for children. Unless the tobacco companies can prove that additives do not have these properties, they should be banned.”


As well as removing additives, tobacco companies should be required to use existing technologies to remove some of the harmful components found in tobacco smoke.  These include cancer-causing nitrosamines, volatile organic compounds and carbon monoxide.


ASH endorsed the Government’s announcement to impose greater controls on cigarette production but said that this points to the need for an independent tobacco regulatory body to enforce these measures.


Amanda Sandford said: “While the Consumer Protection Act gives the Government  powers to require greater controls on the industry, it currently lacks the capacity to do this.  The handful of civil servants deployed to implement the tobacco control policy contrasts markedly with the thousands employed by the tobacco industry.  An independent Tobacco Regulatory Authority, made  up of scientists, lawyers and other experts would be able to enforce the regulations.”




The Health Select Committee, in its Second Report, The Tobacco Industry and the Health Risks of Smoking, (June 2000) recommended the establishment of a Tobacco Regulatory Authority.


For further information on tobacco additives and tobacco smoke see ASH’s summary Cigarette and smoke composition: sources of information

ASH’s report on tobacco additives: Additives in tobacco products


Contact: Amanda Sandford 020 7739 5902 or

Clive Bates 020 7739 5902(w) 077 6879 1237(m)

Tobacco companies engineer high addiction cigarettes with additives

Tobacco companies have added chemicals to cigarettes to increase the addictiveness of nicotine and keep smokers hooked.A new joint report by ASH, Imperial Cancer Research Fund and the US State of Massachusetts reveals over sixty tobacco industry documents dealing with the use of additives in cigarettes [1]. Over 600 tobacco additives are permitted in the UK. These include ammonia,pyridine and sugars which break down to acetaldehydes – each has a pharmacological impact.

Dr Martin Jarvis of Imperial Cancer Research Fund and a co-author of the report said: “Outside the tobacco industry,no-one knows which additives are used in which brands. The tobacco companies’ excuse for using additives is that they make low tar cigarettes easier to smoke. We know that low tar cigarettes are just as bad for you as regular cigarettes, so using additives can not be justified. As some additives can make cigarettes more addictive, tobacco companies are making it even harder for those smokers wanting to quit, to succeed.”

Clive Bates, co-author of the report and Director of ASH, said: “We have uncovered a scandal in which tobacco companies deliberately use additives to make their bad products even worse. Without telling anyone,they have been free-basing nicotine and engineering subtle changes to the brain chemistry of the smoker. The idea of taking an addictive product and making it more addictive is extremely disturbing. It is basically a further invasion of the freedom not to smoke, if you don’t want to.”

The US State of Massachusetts has forced tobacco companies to disclose which additives are used in which brands and why. The industry has responded by suing. Dr Gregory Connolly, Director of the Massachusetts Tobacco Control Program, is also a co-author and is in London for the launch. He said:”The tobacco industry’s documents raise serious questions about the way they have engineered cigarettes to be more addictive. We are starting to hold them to account in Massachusetts, and they really don’t like it. No-one should be doing anything to tobacco products that adds to the already unacceptable health burden – and we are determined to stop them even if it means fighting them in court.”

Dr Connolly will be guest speaker at a meeting of experts and Government officials on Wednesday afternoon.



[1] Tobacco Additives: cigarette engineering and nicotine addiction, ASH, Imperial Cancer Research Fund. 14th July 1999


Tobacco Additives: Cigarette engineering and nicotine addiction

In the European Union over 600 additives may be used in the manufacture of tobacco products under an extremely loose and de-centralised regulatory framework. Although tobacco additives are generally screened for their direct toxicity, there is virtually no assessment of the impact additives have on smoking behaviour or other undesirable external consequences. If a small quantity of a relatively benign substance added to a tobacco product can make the product more addictive, make it easier to start smoking or facilitate continued smoking then it may be causing great harm by ‘leveraging’ additional smoking. The additional smoking brings increased exposure to over 4,000 chemicals, including many that are highly toxic and carcinogenic. Given that over 500,000 people die prematurely in the European Union each year as a result of smoking-related disease, even a one per cent change in smoking attributable to the use of additives would have large absolute health consequences – tens of thousands of lives annually. For this reason, tobacco additives should be seen as major public health issue in their own right.

Tobacco Additives report

Product regulation and labelling

Regulation Description
United Kingdom
Tobacco and Related Products Regulations 2016 UK regulations implementing the EU Tobacco Products Directive.
Standardised Packaging of Tobacco Products Regulations 2015 (PDF) These regulations introduced standardised plain packaging for cigarettes and hand-rolled tobacco, including removing visual brand elements and increasing the size of graphic health warnings.
Children and Families Act 2014
(External Web Page)
This Act, passed in March 2014, enabled the Government to bring in regulations to require standardised tobacco packaging. In addition it allowed for regulations to prohibit smoking in vehicles when children are present; to prohibit the purchasing of tobacco by adults for children (proxy purchasing); and to prohibit the sale of nicotine products (electronic cigarettes) to persons under the age of 18.
Tobacco Additives
UK Voluntary agreement on the use of new additives in tobacco products (Voluntary Agreement In Force)
(External Web Page)
Over 600 additives are allowed in the manufacture of tobacco products in the UK. Additives are controlled under a loose and decentralised regulatory framework.The scrutiny of the additives rests with the Department of Health and its Technical Advisory Group (TAG).

The agreement also includes mutual recognition arrangements that require additives approved in other EU countries to be permitted in the UK. This is a major loophole.

European Union
Product Regulation and Labelling
Article 20(5), Tobacco Products Directive: proposals for UK law Article 20(5) of the Tobacco Products Directive 2014/40/EC requires EU member states to introduce restrictions on the advertising of electronic cigarettes. In the UK, the proposed implementation will consist of changes to the Communications Act 2003, free-standing new regulations and changes by Ofcom (the communications regulator in the UK) to the BCAP Code and Broadcast Code.From 20 May 2016, across the EU, e-cigarettes and re-fill containers cannot be advertised or promoted, directly or indirectly: on TV or on-demand TV; on radio; through information society services (this includes for example internet advertising and commercial e-mail); and in certain printed publications-newspapers, magazines, periodicals and similar publications.
EU Advocate General’s Opinions on legal challenges to the Tobacco Products Directive. (Dec 2015)
ECJ press release (pdf)
Case C-547/14 – This case brought by the tobacco industry challenges the fundamental basis for the Directive, arguing that it is disproportionate and infringes the principle of subsidiarity.
Case C-477/14 – E-cigarette manufacturer Pillbox 38 (UK) Ltd, trading as Totally Wicked, argues that the Directive is in contravention of EU law and that it is in appropriate to apply rules banning advertising of tobacco products to electronic cigarettes.
Case C-358/14 – The Polish government is challenging the ban on menthol flavouring of cigarettes.
EU Advocate General Kokott dismissed 3 separate legal challenges to the Directive in Opinions released on 23 December 2015. Although not binding, AG Opinions help to inform the Court of Justice on the outcome of these challenges. The court is expected to make a ruling on each of these cases in March 2016.
EU Tobacco Products Directive 2014/40/EU
(External Web Page)
The Tobacco Products Directive, replacing Directive (2001/37/EC), lays down rules governing the manufacture, presentation and sale of tobacco and related products. As well as tobacco products, the Directive includes the regulation of electronic cigarettes and herbal products for smoking. Member States will be required to transpose the Directive into domestic law by 20 May 2016. See the European Commission website for further information.
The Directive:

  • prohibits cigarettes and roll-your-own tobacco with characterising flavours,
  • requires the tobacco industry to submit detailed reports to the Member States on the ingredients used in tobacco products, in particular cigarettes and roll-your-own tobacco,
  • requires that health warnings appear on packages of tobacco and related products. Combined (picture and text) health warnings must cover 65% of the front and back of cigarette and roll-your-own tobacco packages,
  • sets minimum dimensions for warnings and eliminates small packages for certain tobacco products,
  • bans all promotional and misleading elements on tobacco products,
  • enables Member States to introduce standardised tobacco packaging,
  • introduces EU-wide tracking and tracing to combat illicit trade of tobacco products,
  • allows Member States to prohibit internet sales of tobacco and related products,
  • sets out safety and quality requirements for consumer electronic cigarettes,
  • obliges manufacturers to notify novel tobacco products before placing them on the EU market

Technical specifications for the layout, design and shape of the combined health warnings.

Report summarising the public consultation on the revision of the Tobacco Products Directive. July 2011
(external link)

EU Tobacco Products Directive
(external link)
Council Directive 2001/37/EC incorporates measures from directive 92/41/EC, which bans the sale of oral tobacco in the EC countries with the exception of Sweden.The tobacco product directive introduced a range of measures relating to the formulation of cigarettes and their packaging. The directive required:

  • new, large, written warnings to appear on the front and back of tobacco packaging.
  • maximum yields for tar, nicotine and carbon monoxide
  • the banning of misleading descriptors such as “light” or “mild”
  • the disclosure of ingredients
  • a review of the directive
  • and enabled Member States to add picture warnings to tobacco packaging
EU Council Directive 2001/37/EC (In Force)
(External Web Page)
This directive replaces two previous directives on labelling (see 89/622/EEC, 92/41/EC) and tar levels (90/239/EEC).Directive 2001/37/EC requires a range of measures to be taken by manufacturers of tobacco products such as dedicating more surface area to health warnings on tobacco product packaging, the proscribing of misleading descriptors such as ‘mild’, ‘low-tar’, ’light’, ‘ultra-low’ and setting ceilings to the yields of tar (10mg), nicotine (1mg) and carbon monoxide (10mg) for all cigarettes manufactured within the community irrespective of whether for consumption or export.

Council Directive 2001/37/EC also incorporates measure from directive 92/41/EC, which bans the sale of oral tobacco in the EU countries with the exemption of Sweden.

The European Commission is required to carry out a review of the Directive every two years. The first review, due in December 2004 was delayed until July 2005. The second review is due in December 2007.

Time-table for implementation of Council Directive 2001/37/EC measures was as follows:

30 Sept 2002: New warnings on packs

31 Dec 2002: Picture specifications proposed by the Commission – delayed until late 2005

31 Dec 2002: Ingredients disclosure

30 Sept 2003: Branding – misleading descriptors etc banned

1 Jan 2004 : Max tar, nicotine, CO yields to apply

31 Dec 2004: First review of the directive was due. This was delayed until July 2005

31 Dec 2004: Commission proposal for common ingredients list – delayed due to lack of agreement on data collection

1 Jan 2007: Max yields applied to exports

Annex 1. Revised set of written health warnings Member States have until 28 March 2014 to implement the changes.
Statutory Instrument 2007 no. 2473 Tobacco Products (Manufacture, Presentation and Sale) (Safety) (Amendment) Regulations 2007 (Picture warnings)
Statutory Instrument 2002 N. 3041 (External Web Page) Consumer Protection. The Tobacco Products (Manufacture, Presentation and Sale) (Safety) Regulations 2002 Statutory Instrument 2002 N. 3041 implements the Directive.
Department of Health Consultation on Tobacco Regulation Directive 2001/37/EC (pdf)
Consultation on the Tobacco Products Manufacture, Presentation and Sale (Safety) Regulations 2002 implementing Directive 2001/37/EC of the European Parliament and the Council concerning the Manufacture, Presentation and Sale of Tobacco Products.
Summary of submissions to Department of Health Tobacco Regulation Directive 2001/37/EC (pdf)
Submissions received to the Department of Health Consultation on Tobacco Regulation Directive 2001/37/EC
Opinion by the Advocate General
(External Web Page)
The Directive 2001/37/EC was subject to a challenge by British American Tobacco over the proscription of descriptors such as ‘mild’ and ‘light’. However, on 10 September 2002 opinion by the Advocate General declared provisions contained in the directive 2001/37/EC as valid.
Press release by Advocate General
(External Web Page)
Press release by the Advocate General around Directive 2001/37/EC.
ECJ Ruling C-491/01
(External Web Page)
10 December 2002 a ruling by the High Court of Justice of England and Wales. This ruling deemed the banning of descriptors for tobacco product intended for the European market as valid. Tobacco products for export, however, are exempt from the restrictions on descriptors.
The provisions of the directive enter force over several years – this means that previous UK statutory instruments implementing the EC directives still stand until they are superseded. The remaining instrument still in force is Part of Council Directive 92/41/EEC (ban on oral tobacco) is implemented in England by UK Statutory Instrument 1992 No 3134 as the Tobacco for Oral Use (Safety) Regulations 1992.
UK Statutory Instrument 1992 No 3134
(External Web Page)
The Tobacco for Oral Use (Safety) Regulations 1992
European Commission first report on the application of the Tobacco Products Directive 2001/37/EC (pdf)
The report is based on the feedback from Member States. The Report demonstrates the positive effects of the regulation of tobacco products emerging at EU level.
Review of the implementation of the European Tobacco Products Directive 2001/37/EC (pdf)
The report makes the following observations:

  • Maximum tar/nicotine/CO yields: All 15 EU countries complied with the deadline. The accession countries did not request transitional periods for compliance.
  • Measurement of tar, nicotine and carbon monoxide levels: The Commission acknowledges that the use of machines to measure yields does not reflect actual smoker intake of these substances. However, the Commission is not proposing to revise the current standards until “solid evidence shows that better methods exist to replace them”.
  • Labelling: Implementation overall is satisfactory but there have been reports of industry attempts to circumvent the legislation by attempting to hide the warnings, e.g. by the placing of cardboard covers or stickers over the warnings. However such practices are now limited. Evidence suggests that the large warnings are having an impact, with smokers being more motivated to quit smoking. The warnings appear to have been particularly effective among 15-24 year olds.
  • Ingredients: There has been little progress in developing a proposal for a common list of ingredients. The Commission argues that the WHO should co-ordinate regulatory efforts through the Framework Convention on Tobacco Control.
Tobacco Additives
Consultation on tobacco additives
(External Web Page)
Results of the public consultation on the addictiveness and attractiveness of tobacco additives. 

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British Health Groups demand radical change to cigarette & nicotine regulation

Wednesday 28 October 1998

BMJ Press Conference – 28th October 1998 at 12:30pm

The machine measured tar and nicotine yields [2] to be abandoned as a basis for labelling and regulation because they are extremely misleading and likely to cause harm if people believe the numbers in reflect health impact (they do not);
The heads of seven UK health groups [1] have called on the Minister for Public Health, Tessa Jowell, to support a thorough overhaul the current regime for testing and regulating the tar, nicotine and additives in cigarettes. In a letter to the released today (pdf) at a joint press conference with the BMA and American Medical Association [2] the groups call for:

  • Low tar, light, mild etc. branding is an implied health claim based on these tar and nicotine yield numbers and should be banned or justified by evidence that these brands do actually reduce harm.  Most evidence suggests there is little or no health benefit [3];
  • Additives to cigarettes, especially those that increase addictiveness, improve the taste for children or cause cigarettes to keep burning, to be banned or subject to a test of public interest.  There are currently minimal controls over additives [4].
  • Cigarettes to be recognised as a drug (nicotine) delivery system and regulated as such.

Clive Bates, Director of ASH said, “Nicotine is a powerfully addictive and legal drug with over 12 million users in Britain, but smoking tobacco is like using a dirtysyringe to deliver the drug.  Nicotine delivery could be very substantially cleaned up, but the current tobacco regulations are ineffective and probably doing more harm than good.”

“Brands like Marlboro Lights and Silk Cut Ultra should be taken off the market.  The branding is misleading the public into thinking they are significantly less dangerous, but they are basically a con trick.” said Bates.

  1. Royal College of Physicians, British Heart Foundation, Cancer Research Campaign, Imperial Cancer Research Fund, British Medical Association, Health Education Authority, and ASH.
  2. EU Directive 90/239/EEC requires cigarettes sold in the EU to have a maximum tar yield of 12 mg. There is no nicotine limit, but tar and nicotine tend to come in a ratio of around 10:1. Changes to regulations on tobacco product contents would require action at the EU level
  3. For an explanation of why this measurement is no longer useful and how the tobacco industry has exploited it, see ASH’s report on Low Tar Cigarettes (pdf)
  4. Over 600 additives are licensed for use in the UK. New additives are regulated under a 1997 UK voluntary agreement, but new additives licensed anywhere in the EU must be permitted in the UK.


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ASH Daily news for 15 October 2015


  • Brighton: Beach smoking ban report delayed after flood of consultation responses
  • London: Croydon Council seizes £500,000 worth of illicit tobacco
  • Scotland: Leading academic criticises “harmful” e-cigarette marketing
  • Ireland: Tobacco smuggling threatens revenue boost
  • US: Democrats want to raise smoking age to 21

    Brighton: Beach smoking ban report delayed after flood of consultation responses

    The consultation on a proposed smoking ban on Brighton and Hove’s beaches and parks received such a high volume of responses that the report analysing the consultation has been put back two months.

    More than 1,500 people took part in the consultation, which asked people what they thought about a voluntary smoking ban in a range of public outdoor spaces, including beaches, parks and pavements outside pubs and restaurants.

    The report was originally planned to go to the Health and Wellbeing board in December, but due to the amount of responses and interest in the consultation it will now go in February.

    Source: Brighton and Hove News, 14th October 2015

    London: Croydon Council seizes £500,000 worth of illicit tobacco

    An illegal tobacco factory that rolled out thousands of kilograms of counterfeit tobacco worth at least half a million pounds has been shut down.

    Six officers from the Croydon trading standards team, backed by police, found some 4,600 50g packets of bogus Golden Virginia rolling tobacco during a swoop on the production plant.

    The factory, which was equipped to produce industrial quantities of tobacco, is the first large-scale criminal manufacturing site to have been found in the borough.

    Officers discovered recipes, instructions and equipment for shredding, steaming and mixing raw leaves, as well as for packing and sealing the finished product.

    The raid, in late August, uncovered counterfeit tobacco ready for sale with an approximate street value of £85,000 and “significant quantities” of raw and part-processed leaves, additives, security labels and packets, Croydon Council said.

    Source: Croydon Guardian, 14th October 2015

    Scotland: Leading academic criticises “harmful” e-cigarette marketing

    Linda Bauld, Professor of Health Policy at Stirling University, has criticised “harmful” e-cigarette marketing tactics and called for new guidelines to regulate the industry.

    E-cigarette companies are currently allowed to advertise their products within a regulatory framework, meaning they cannot make smoking cessation claims or target youngsters.
    However, Ms Bauld believes there is “cause for concern” in the way companies are pushing their products.

    She said: “The evidence of marketing being targeted at children is mixed, but there’s definitely a lot of it…It’s a cause for concern and we need marketing regulations. The Advertising Standards Authority has a role to protect the public against harmful advertising.”

    See also:
    Expert calls for ad ban on e-cigarettes  – The Times (£)

    Source: Herald Scotland, 14th October 2015

    Ireland: Tobacco smuggling threatens revenue boost

    The 50c tax increase on cigarettes will not generate €60 million in extra revenue unless there is a clampdown on the sale of illegal tobacco, a public health charity and cigarette manufacturers have warned.

    Action on Smoking Health (ASH) Ireland said the failure to prevent easy access to cut-price tobacco could negate the measure’s positive effect on public health.

    Dr Ross Morgan, the chairman of ASH Ireland, welcomed the increase but said that easily accessible untaxed cigarettes encouraged more people to smoke.

    Source: The Times, 15th October 2015

    US: Democrats want to raise smoking age to 21

    Senate Democrats are pushing to increase the legal minimum age to smoke from 18 to 21.

    Democrats suggested that while the United States has made progress in curbing smoking, raising the legal minimum age could curb smoking-related diseases among younger Americans.

    The legislation follows a report released earlier this year by the Institute of Medicine that found raising the legal smoking age to 21 could result in 50,000 fewer deaths from lung cancer for people born between 2000 and 2019.

    Source: The Hill, 14th October 2015

Press briefing on Tobacco Product Directive

Monday 12 June 2000

Press Release
11th June 2000
Action on Smoking
and Health

Letter sent by ASH to British MEPs on 6th June

Dear …

Re: Tobacco Directive

I am sure you will be aware of the forthcoming important decisions to be made regarding the proposed tobacco Directive – which will be considered by the European Parliament during the plenary on or around 13th June with a vote at midday on the 14th.  In summary, the directive:

  • Reduces tar, nicotine and carbon monoxide yields for cigarettes
  • Increases the size and clarity of health warnings
  • Requires disclosure of additives to tobacco products and their purpose
  • Bans misleading light and mild branding
  • Creates a process for updating the directive in the light of evolving scientific knowledge.

This is an important package of public health measures aimed at ensuring that the single market operates with a high level of health and consumer protection, as required and justified by the Amsterdam Treaty.  In no other part of the single market is the need for health and consumer protection more pressing – over 500,000 EU citizens die each year as a result of smoking.  Even small changes in the total consumption of tobacco have enormous absolute public health implications.  For this reason every decision about tobacco policy is essentially a life and death matter.

We are calling on British MEPs to adopt a three-pronged approach to the directive in next week’s plenary:

  1. Resist wrecking delays

It is clear that there is a concerted campaign to stall the proposed Directive using procedural tactics.  I hope that British MEPs will do everything possible to ensure the Directive passes through the early stages of the plenary of 13th June.  If the Directive is delayed in its passage through the Parliament next week this will trigger a delay of 6 months and probably longer.

  1. Dismiss challenges to the legal base

The Directive is part of the European Union’s attempt to raise the level of health and consumer protection within a properly functioning single market.   Because the EU already regulates health warnings and tar yields of cigarettes, it is difficult for member states to take action independently and it is therefore properly a matter for the European Union.  There have been moves -notably in the Legal Affairs Committee – to suggest the Directive does not have a proper legal base.  In our view, this is a wrecking tactic primarily inspired by tobacco interests rather than rooted in any genuine concern for the correct application of EU law.   In fact, the Directive is well founded under Article 95 of the Amsterdam Treaty, which requires the single market to operate with a high level of health and consumer protection. The legal services of the European Parliament have recently issued an opinion to this effect and this concurs with the views of the legal services of the Council and the Commission – and, frankly, with common sense. The proposed Directive is a recasting of existing Directives whose legal base is assured and unchallenged and the legal objections really do not hold water.  I hope the Environment Committee will roundly dismiss spurious objections related to the legal base.

  1. Adopt the Environment Committee report and amendments

The report and package of 48 amendments proposed by the Environment Committee is carefully crafted and represent a very constructive development.  In total this a worthwhile improvement of the Directive beyond the Commission proposal and current view of the Council working party.  We are advocating a straightforward approach of endorsing the Environment Committee’s report (PE232.878) in full.

A note about health warnings

On the controversial matter of the size of warnings, the evidence supports the simple conclusion that ‘size matters’, and the bigger the warning the better the impact. We have assembled evidence to this effect with links to original documents on the ASH web site here. Even if the improved consumer information and warnings leads only to (say) a 0.1% change in consumption, the public health benefit would be several hundred lives saved each year – greater than many high profile public health issues confronting the EU. The evidence from Poland, where warnings were increased to 30% of the pack face is that the effect would be many times greater than this.

On this basis,we advocate warnings as large as possible, and we support the Environment Committee proposal to have warnings covering 40% of the front and 50% of the back of the pack.  We would strongly oppose any position taken in the parliament that led to warnings covering less than 30% of the pack face – it would be completely unacceptable for the EU to be setting standards below those already operating in Poland, and we should be aspiring to the best practice.  Warnings in Canada will soon be increased to 50% of both pack faces – located at the top and with pictorial content to strengthen the impact.

I would like to stress the importance of the Parliament’s deliberations to the health community in the UK.  Some 600 organisations from around the country are represented in the Tobacco Action Network co-ordinated by ASH. We are keen to involve them all in campaigning for the best possible outcome at the plenary.  You can, therefore,be assured of a considerable show of support in the UK for a progressive position adopted by the parliament during the plenary.

Please contact me by phone or e-mail if I can help in any way or clarify the points herein.

Yours sincerely
Clive Bates


Contact Clive Bates, ASH (020) 7739 5902

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