S.L. 449.63 Art. 4Exemptions.    S.L. 449.44

(1) The provisions of these regulations shall not apply to:

(a) natural mineral waters recognised as such by the entity responsible for the recognition of natural mineral waters, in accordance with the Natural Mineral Waters Regulations and

Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (recast); or

(b) waters which are medicinal products within the meaning of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.

(2) Maritime vessels that desalinate water, carry passengers and act as water suppliers shall only be subject to regulations 3 to 7 and regulations 10, 11, 14 and 15 and the relevant Schedules:

Provided that priority shall be given to existing international regulations or internationally acknowledged standards for Union flag maritime vessels that comply with the international regulatory framework when sailing in international waters, such as the vessel sanitation programme developed by the United States Public Health Service, or the ship sanitation certificate issued in accordance with EU SHIPSAN ACT Joint Action (2012 2103) – European Manual for Hygiene Standards and Communicable Disease Surveillance on Passenger Ships.

(3) The following shall be exempt from these regulations:

(a) water intended exclusively for those purposes for which the competent authority is satisfied that the quality of the water has no influence, either directly or indirectly, on the health of the consumers concerned;

(b) water intended for human consumption from an 3 individual supply providing less than ten cubic meters (10 m ) a day as an average or serving fewer than fifty (50) persons, unless the water is supplied as part of a commercial or public activity.

(4) When the competent authority grants the exemption in accordance with sub-regulation (3), it shall ensure that the population concerned is informed thereof and of any action that may be taken to protect human health from the adverse effects resulting from any contamination of water intended for human consumption. In addition, when a potential danger to human health arising out of the quality of such water is apparent, the population concerned shall immediately be informed about this.

(5) Food business operators shall be exempt from these regulations with regards to the water used for the specific purposes of the food business, if the competent authority is satisfied that the quality of such water cannot affect the safety of the foodstuff in its finished form:

Provided that the water supply of the food business shall comply with relevant obligations, in particular under the procedures on hazard analysis and critical control point principles and remedial actions under the relevant legislation on food, be it on a national level or at Union level:

Provided further that it shall be ensured that producers of water intended for human consumption that is put into bottles or containers comply with regulations 2 to 6, and Parts A and B of the Second Schedule:

Provided further that the minimum requirements set out in Part A of the Second Schedule shall not apply to spring water as referred to in Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on exploitation and marketing of natural mineral waters (recast).

(6) Without prejudice to regulation 10, the water suppliers 3 supplying less than ten cubic meters (10m ) a day as an average or serving fewer than fifty (50) persons as part of a commercial or public activity, shall only be subject to regulations 2 to 7 and regulations 14, 15 and 16 and the relevant Schedules.