Explanatory note
This note is not part of the regulations, but is intended to indicate their general effect.
These regulations, which come into force on the day after the date of their notification in the Gazette, amend the Medicines Regulations 1984 by inserting a new regulation 58B. Regulation 58B declares that neither fluoridating agents for use in fluoridating drinking water nor fluoridated drinking water are medicines or related products for the purposes of the Medicines Act 1981.
These regulations are in response to New Health New Zealand Inc v Attorney-General [2014] NZHC 2487, in which the High Court held that hydrofluorosilicic acid and sodium silicofluoride as currently used to fluoridate drinking water are not medicines for the purposes of the Medicines Act 1981. In its judgment, the High Court suggested that the Ministry of Health consider exempting fluoridating agents from the definition of medicine in the Medicines Act 1981.
The Drinking-water Standards for New Zealand 2005 (Revised 2008) provide requirements for drinking water safety. Those standards state that the maximum acceptable value for fluoride in drinking water is 1.5 milligrams per litre of water. The standards can be found at www.health.govt.nz/publication/drinking-water-standards-new-zealand-2005-revised-2008 
Issued under the authority of the Legislation Act 2012.
Date of notification in Gazette: 29 January 2015.
These regulations are administered by the Ministry of Health.