Pursuant to section 6 (1) of the Contraception, Sterilisation, and Abortion Act 1977, I, Annette King, hereby approve the International Standard "ISO 4074:2002 (E) Natural Latex Rubber Condoms - Requirements and Test Methods, including Technical Corrigendum 1" for the purpose of manufacturing for sale or selling condoms, subject to the modifications set out below:
(1) Insert after paragraph 11.2.3.2 the following paragraphs:
11.2.3.3 Labelling of condoms
The following claims may be included on either the outside consumer package or a leaflet contained within the consumer package:
(a) Condoms can help reduce the risk of pregnancy.
(b) Condom use may help reduce the risk of transmission of HIV/AIDS and other sexually transmitted infections (STIs).
11.2.3.4 Labelling of condoms containing nonoxinol 9
In relation to the labelling of, and package inserts for, condoms containing nonoxinol 9:
(a) Claims implying that the addition of nonoxinol
9 helps reduce or prevent HIV/AIDS or sexually transmitted infections (STIs) shall not be included.
(b) Any claim for "added protection" shall specify that this claim is limited only to added protection against pregnancy.
(c) The label or package insert shall bear the following information:
"The presence of nonoxinol 9 has not been shown
to reduce the risk of transmission of HIV/AIDS or other sexually transmitted infections (STIs)."
This approval shall take effect six months from the date it
is gazetted.
The standard for the manufacture and sale of condoms appearing in the New Zealand Gazette, 30 April 1998, No. 60, page 1343, is hereby revoked.
Dated at Wellington this 10th day of May 2004.
ANNETTE KING, Minister of Health.