See list below: Last entry is for Hexafluorosilicic acid. Clink on this, go to last item on page Regulations on restriction/ Prohibition of Substances, enter more information.
Directive 98/8/EC covers biocidal products placed on the EU market. In the EU biocidal products must not be used, if they are not authorised.
The Health Authority in Ireland until recently sourced Hexafluorosilicic acid (a listed Biocidal product) for water fluoridation from Spain . The company that imports the product is Chemifloc Ltd.
Biocides definition: preparations containing one or more active substances that are intended to control harmful organisms by either chemical or biological, but not physical means.
In June 2003 the EU prepared a list of Notified substances, including hexafluorosilicic acid, that were subject to new regulation that required detailed supporting information to be provided to the EU, for the protection of human health and the environment by March 2004.
Hexafluoorosilicic acid list on page 24. EC number: 241-034-8: CAS number16961-83-4
Spain was requested as a manufacturer of this biocide to provide a dossier of information to the EU on the toxicology of the substance to include toxicological and metabolic studies, ecotoxicological studies, reproductive toxicity, medical data including medical surveillance data, epidemiological studies on general population, skin sensitivity studies and allergenicity studies, carcinogenicity studies, mutagenicity studies, sub chronic toxicity studies and measures to protect humans and the environment.
A full list of the assessment procedures are provided in pages 33 to 179 of this link from EU.
Where information was not provided the substance could no longer be used as active substances in biocidal products on the EU market.
No information was provided.
The substance was subsequently removed as an authorised biocide within EU. The phase out date was set as 01/09/2006. In 2006 France stopped producing Hexafluorosilicic acid.
Despite the lack of toxicological data or human health risk assessments, this remains the active substance that is used for water fluoridation of public water supplies in Ireland. No country in mainland Europe add this product to their water supplies on medical, environmental and ethical grounds. SO WHAT WE ACTUALLY HAVE IS A UNAUTHORISED BIOCIDE, WITH NO TOXICOLOGICAL DATA TO DEMONSTRATE THAT IT IS SAFE, BEING USED TO TREAT DENTAL CARIES, AN INFECTIOUS DISEASE, BY ADDING IT TO DRINKING WATER SUPPLIES.
The U.S National Academy of Sciences, National Research Council called for similar testing (in the interest of public safety) as requested by the EU in their report published in 2006.
In excess of fifty comprehensive epidemiological, toxicological, clinical medicine, and environmental exposure assessments were identified requiring further testing and examination by the U.S. National Research Council (NRC); similarly the European Commission‘s Scientific Committee on Health and Environmental Risks (SCHER) also called for further examination of human health risks of fluoridation due to a lack of available accurate data.
The undertaking of these studies is regarded as of paramount importance for the protection of public health in communities where water fluoridation is practised.
Both the NAS and SCHER found that the toxicological profile of Hexafluorisilicic Acid used for water fluoridation was incomplete.
No data has yet been provided subsequent to the NRC publication (2006) or the SCHER publication in 2010.
In the absence of any toxicological or health risk data the Health Authorities in Ireland continue to advise that the chemical is safe for consumers and the environment.
Under Annex IIIA of the Biocidal Directive Part iv, Additional data for active substances part VIII; fluoride is a identified substance requiring measures necessary to protect humans, animals and the environment. Fluoride is a list 2 substance under Directive 80/68/EC.
Separate to this the EU classification system for carcinogens and the EU Council Directive 67/548/EEC contains rules for the classification of dangerous substances.
Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances lists fluoride as a list 2 dangerous substance.
According to EU regulations Fluoride would be classified as a category 2 carcinogen, based on available evidence from the US. NTP. If not a category 2 then most definitely a category 3 carcinogen.
Category 2: Substances which should be regarded as if they are carcinogenic to man. There is sufficient evidence to provide a strong presumption that human exposure to a substance may result in the development of cancer, generally on the basis of:
- appropriate long-term animal studies,
- other relevant information.
Category 3: Substances which cause concern for man owing to possible carcinogenic effects but in respect of which the available information is not adequate for making a satisfactory assessment
The U.S NTP found 'equivocal evidence' that fluoride was carcinogenic
Ref: National Toxicology Program [NTP] (1990). Toxicology and Carcinogenesis Studies of Sodium Fluoride in F344/N Rats and B6C3f1 Mice. Technical report Series No. 393.
NIH Publ. No 91-2848. National Institute of Environmental Health Sciences, Research Triangle Park, N.C.
This is supported by published findings by Bassin et al. in the cancer research journal, Cancer Causes and Control in 2006.
Ref: Bassin EB, Wypij D, Davis RB, Mittleman MA. (2006). Age-specific Fluoride Exposure in Drinking Water and Osteosarcoma (United States). Cancer Causes and Control 17:
Finally fluorosilicates are derivative compounds of hexafluorosilicic acid in water, fluorosilicates are classified as a health, physicochemical and/or ecotoxicological hazard, according to the National Occupational Health and Safety Commission (NOHSC) Approved Criteria for Classifying Hazardous Substances.