LEGAL ISSUES RELATING TO THE PRACTICE OF WATER FLUORIDATION

Legislation permitting Water Fluoridation in the UKLegislation which argues against Water Fluoridation in the UK
The Water Industry Act 1991, Ss 87-91. Two compounds of fluoride are permitted: H2SiF6 and Na2SiF6An authoritative statement: British Standard 12175:2022, pp. 7-8, states that Hydrofluoric Acid (HF) is present in the Hexafluorosilicic Acid used to fluoridate drinking water.  Therefore, the product made by the fluoridating water companies is illegal because hydrofluoric acid is a 3rd compound.  
Health and Care Act 2022 supplements the WIA 1991 
 (Deregulation Act 2015, Schedule 21). Hydrofluoric acid is a Reportable Poison. Note it is a particularly corrosive acid.  
 An authoritative statement: British Standard BSEN 12175:2022, p.19 states that “hexafluorosilicic acid is used for the fluoridation of drinking water to reduce the resistance of consumers to dental decay”.    This strongly suggests that fluoridated water is medicinal water and not drinking water.  
 An authoritative statement: Annex 2 – List of Relevant British Standards https://dwi-content.s3.eu-west-2.amazonaws.com/wp-content/uploads/2020/12/01151220/Annex2.pdf .    Hexafluorosilicic Acid is not a compound used by Water Companies to make raw water potable. Hexafluorosilicic acid appears in this annex as being used to “Increase resistance of consumers to dental decay”.  
 Are water companies who sell medicinal water to consumers possibly violating their Licences?  
 Human Medicines Regulations 2012, No. 1916   The medicinal nature of fluoridated water would appear to be confirmed by the definition of a medicine in the Regulations.   The Medicines Directive (retained) defines what a medicine is, and fluoridated water falls clearly  within that definition regarding “purpose, nature and effects of the substance that is being used”. (Barrister’s opinion.) The Medicinal Products  for Human Use Directive 2001/83/EC (Retained) defines medicines and this definition appears in the UK Human Medicines Regulations 2012, No. 1916.               Article 2 defines a medicinal product:   “The fact that the fluoride is not being prescribed for individuals and the fact that most unusually this form of medical treatment is being delivered to, and imposed upon, individuals by being put in the public water supply does not mean they are not receiving medicine and being medicated. It merely means that this medicine is one that in practical terms is virtually compulsory for them. That is the real legal position that every member of the public will be put in where a fluoridation scheme comes into operation.” (Barrister’s Opinion)  
 Drinking Water Directive (Retained), Article 3. Medicinal water is not covered by the provisions and protections  afforded in the Directive (Retained). This confirms that  medicinal water is not drinking water.  
The Water Supply (Water Quality) Regulations 2016, No. 614 apply to drinking waterConsequently, the dependent UK Regulations, The Water Supply (Water Quality) Regulations 2016, No. 614  cannot be applied to, and cannot be cited in respect of medicinal water.    The Regulations exist to protect consumers of drinking water from harm.  Consumers of medicinal water are not protected by the Regulations because the Drinking Water Directive does not protect them.  In short, there are no water standards for medicinal water.  
 Therefore, the SoS (HSC) by observing the Water Industry Act 1991, s.87, requires five English water companies to provide consumers with medicinal water for which there are no safeguards which would allow legal redress should the medicinal water contain health-damaging pollutants.  


BSEN 12175:2022, Annex A, Section A.2.1 Function, p.19 “Hexafluorosilicic acid is used for the fluoridation of drinking water to increase the resistance of consumers to dental decay.”  The British Standard is not in the Public Domain.

Drinking Water Inspectorate LIST OF APPROVED PRODUCTS FOR USE IN PUBLIC WATER SUPPLY IN THE UNITED KINGDOM A search for Hexafluorosilicic acid was unsuccessful. https://dwi-content.s3.eu-west-2.amazonaws.com/wp-content/uploads/2024/03/21092740/SoS-list_Mar24.pdf

DWI’s LIST OF RELEVANT EUROPEAN STANDARDS A search of Annex 2 shows that Hexafluorosilicic acid is listed, but not as a water treatment chemical https://dwi-content.s3.eu-west-2.amazonaws.com/wp-content/uploads/2020/12/01151220/Annex2.pdf.

Public Health (Control of Disease) Act 1984: Power to make regulations    21/07/08   [F145EMedical treatment (1)Regulations under section 45B or 45C may not include provision requiring a person to undergo medical treatment. (2)“ Medical treatment ” includes vaccination and other prophylactic treatment. ]Public Health (Control of Disease) Act 1984   Hexafluorosilicic acid is used to treat humans who are all patients of the NHS and is intended as a prophylactic treatment – a preventative.  It’s a public health measure and public health is all about tackling disease with a whole population “universal” approach.   However, it is not permissible to make Regulations under s.45C which are intended to medically treat people – see S.45E below  
 Mental Capacity Act 2005 This Act states “assume a person has the capacity to make a decision themselves, unless it’s proved otherwise.” The majority of people have capacity and can therefore refuse their consent to medical treatment including medicine.
 Legal judgements confirming that fluoridated water is medicinal water:   Supreme Court of Canada in Municipality of Metropolitan Toronto v. Village of Forest Hill (1957) 9 D.L.R. (2d) 113 which held that the fluoridation of the water supply was using the water for a medicinal purpose and Cartwright J. in that case (at page 124) described fluoridation of the water supply as “compulsory preventive medication of the inhabitants of the area”.  
 Court of Session, Edinburgh SC 225 (SLT, 1983).  Mrs Catherine McColl (A.P.) v Strathclyde Regional Council 1983. Lord Jauncey in 1983 in Scotland held that fluoride in whatever form it was provided by Strathclyde was a medicine. Mrs Catherine McColl (A.P.) against Strathclyde Regional Council. The transcript can be read at: https://vlex.co.uk/vid/mccoll-v-strathclyde-regional-807327357  
 Supreme Court of New Zealand  In 2018, the court ruled that fluoridated water is a medicine (Clause 100).  An interpretation can be found on https://fluoridealert.org/news/fluoridation-is-mass-medication-nz-supreme-court-rules/.  The decision was not appealed.   
 New Health New Zealand received a favourable judgement during a Judicial Review where the judge ruled that New Zealand’s Director General of Health should have considered NZ’s Bill of Rights before ordering mandatory water fluoridation. https://www.courtsofnz.govt.nz/assets/cases/2023/2023-NZHC-3183.pdf  
 New Zealand’s Bill of Rights (amended in 2022) contains two clauses about medical treatment: New Zealand Bill of Rights Act 1990 No 109 (as at 30 August 2022), Public Act – New Zealand Legislation  
 EU Reg 1925/2006, Article 17.  EU Reg 1170/2009, Annex II and III. UK Reg 1631/2007   It is not permitted to add hexafluorosilicic acid and disodium fluorosilicate to manufactured food.   The failure to include these two compounds when requested to do so by the EU means that they are not allowed as additives in food. As such, they cannot be sold to EU countries and because the law is retained law, such foods cannot be sold to the internal market.  Such foods would contain fluoridated water as one of the ingredients.  Fizzy drinks, for example, made up with fluoridated tap water where the major constituent is medicinal water.          
 Codified Pharmaceuticals Directive 2001/83/EEC Article 1 (amended by Directive 2004/27/EC) For the purposes of this Directive, the following terms shall bear the following meanings:   (a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’ The intent to medicate renders any substance presented as having any beneficial effect on a medical condition a medicinal substance under Article 1 of these Directives, irrespective of its efficacy.  All medicinal substances must be registered as such and subjected to full clinical testing for safety.   Fluorosilicates have not been so registered nor tested for safety. Manufacturing these chemicals under BS EN 12174/5 does not authorise their use as medicinal substances.  
 Codified Pharmaceuticals Directive 2001/83/EEC as amended by Directive 2004/27/EC. All products which are medicinal in function and presentation (see water utilities’ statements on why they add fluoride) require a marketing authority. Medicinal claims for unregistered substances is illegal under the Directive.   “Marketing authorization, Directive 2001/83/EEC retained post Brexit Article 6 [This para. Has not been amended by Directive 2004/27/EC]   [F121.[F13 [X1No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive …”  
 Article 6.1 of the Medicines for Human Use Directive 2001/83/EC, derived from the earlier version, 65/65/EEC, states that no medicinal product may be placed on the market unless it has a relevant marketing authorisation.   This product (medicinal fluoridated water) is therefore an unlicensed medicine.      
 Article 3(2) of Regulation 853/2004 https://www.legislation.gov.uk/eur/2004/853/article/3 Requirement that food business operators do not use any substance other than potable water or, when Regulation 852/2004 or Regulation 853/2004 permits its use, clean water, to remove surface contamination from products of animal origin unless use of the substance has been approved. Under the food safety and hygiene legislation, water used in the preparation or manufacture of foodstuffs must be the form of water that is regulated under the drinking water regulations.

But the wording of the drinking water regulations leads to the inevitable conclusion that, as a medicinal product, fluoridated water is not ‘potable water’ or ‘water for human consumption’. Its use in preparing foods is therefore prohibited.  

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