BOTTLED WATER REGISTRATION REGULATIONS
ARRANGEMENT OF REGULATIONS
3. Forms, etc.
BOTTLED WATER REGISTRATION REGULATIONS
[S.I. 18 of 1996.]
under sections 5 and 29
[2nd January, 1996]
(1) Every bottled water manufactured, imported, exported, advertised, sold or distributed in Nigeria shall be registered in accordance with the provisions of these Regulations.
(2) Notwithstanding the provisions of sub-paragraph (1) of this regulation the manufacture or importation of any bottled water as a sample for registration shall be undertaken with the approval of the Agency.
(1) An application for registration of a bottled water shall be-
(a) submitted only if the bottled water was manufactured in an establishment that has been approved by the Agency; and
(b) made on such form as may be prescribed from time to time by the Agency and on the payment of such non-refundable fee as may be prescribed by the Agency.
(1) A form submitted for registration of bottled water under these Regulations shall have attached thereto-
(a) adequate samples of the bottled water;
(b) the original certificate of analysis on the bottled water;
(c) the samples of the labels of the bottled water;
(d) the evidence of any special labelling claims of the character, quality and
safety of the bottled water;
(e) the original certificate of manufacture and free sale for imported bottled
water from the statutory body in charge in the country or origin responsible for the safety of the product;
(f) the radio-active test certificate where demanded by the Agency;
(g) the power of attorney or an agreement from the manufacturer to register
the product in Nigeria if it is imported bottled water; and
(h) an undertaking that every advertisement of the bottled water shall be submitted to the Agency for approval before publication.
(2) A person given a power of attorney under sub-paragraph 3 (1) (g) of this regulation shall be required to satisfy the Agency that he has the resources and facilities to execute an effective recall of the product if the need arises.
(1) Where the submissions in respect of a bottled water are satisfactory, the product shall be issued with a certificate of registration and a registration number.
(2) Where the submissions in respect of an application are unsatisfactory the applicant shall be informed of the reasons for the disapproval.
The certificate of registration of a bottled water shall be for a period of five years.
The Agency may suspend, withdraw or cancel the certificate of registration of a bottled water if-
(a) the grounds on which the bottled water was registered were false or incomplete; or
(b) the circumstances under which the bottled water was registered no longer exist; or
(c) any of the conditions or undertaking under which the bottled water was registered have been contravened; or
(d) the standard of quality, safety or efficacy as prescribed in the documentation for registration is not being complied with; or
(e) the premises in which the bottled water is imported, processed, manufactured or stored by or on behalf of the holder of the certificate of registration are unsuitable for the importation, processing, manufacturing or storage of the bottled water.
A manufacturer or importer of bottled water shall be required to produce the original certificate of registration in respect of any bottled water manufactured or imported by him within 48 hours of its demand by any person duly authorised by the Agency.
If any person contravenes any of the requirements of these Regulations, the Agency shall prohibit that person from carrying on the importation, exportation, manufacture, distribution, sale or use of the bottled water either absolutely or for such period of time as the Agency may declare in addition to the payment of a fine of N50,000.
The provisions of these Regulations shall be applicable to any person seeking to register the manufacture, importation, exportation, advertisement, sale and distribution of bottled water in Nigeria.
For the purposes of these Regulations, unless the context otherwise requires-
“Agency” means the National Agency for Food and Drug Administration and Control;
“Director-General” means the Director-General of the Agency;
“establishment” means any place, building and any forecourt or yard where any operation for the purpose of manufacturing bottled water is carried out;
“label” in relation to any bottled water or as packaged, includes any legend, word or mark attached thereto, included in, belonging to or accompanying that bottled water or a package of it.
These Regulations may be cited as the Bottled Water Registration Regulations.