WRITTEN QUESTION No. 558/96 by Spalato BELLERE' , Amedeo AMADEO to the Commission. Prevention of Aids and use of condoms
Date: 1996-03-11
Institutions: AMADEO, BELLERE, European Parliament
Subjects: AIDS, Catholicism, contraception, harmonisation of standards, product quality, technical standard













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91996E0558

WRITTEN QUESTION No. 558/96 by Spalato BELLERE' , Amedeo AMADEO to the Commission. Prevention of Aids and use of condoms  


Official Journal C 217 , 26/07/1996 P. 0057 





WRITTEN QUESTION E-0558/96 by Spalato Belleré (NI) and Amedeo Amadeo (NI) to the Commission (11 March 1996)Subject: Prevention of Aids and use of condomsGiven that condoms are very often not prophylactic because of their poor quality, that Aids is continuing to spread, frequently because the use of condoms is not widespread enough, and that the French Curia has also expressed an interest in the problemDoes the Commission not think it should draw up a regulation governing the manufacture of high-quality condoms and promote awareness campaigns?Joint answer to Written Questions E-0498/96 and E-0558/96 given by Mr Bangemann on behalf of the Commission (9 April 1996)Within the context of the programme on the prevention of AIDS and certain other transmissible diseases ((COD/94/0222.)), promoting the use and proper usage of condoms is considered a way of reducing the risk of transmitting the HIV virus and other sexually transmitted diseases. As a result, for the programme to be implemented, the Commission is committed to promoting the use and availability of good-quality, easily-accessible condoms accompanied by instructions for their usage.The Commission's action to promote both the availability and correct usage of good-quality condoms is on two levels:- implementation of Council Directive 93/42/EEC ((OJ L 169, 12.7.1993.)) concerning medical devices, including condoms. This Directive allows condoms to be made available and freely accessible on the Community market, on condition that they satisfy the essential requirements relating to their safety and effectiveness. In order to conform to these essential requirements, the condoms must be certified by a third body (a body recognised by a national authority). This certification comprises strict control of the condoms' properties and quality of manufacture, and only such condoms as conform to this control bear the CE marking.Until 14 June 1998, manufacturers can market either condoms conforming to pre-existing national legislation (this being a temporary measure) or CE marked condoms. After that date, only CE marked condoms will be permitted on the market;- standardization of condoms. The Commission has requested the European Committee for standardization to draw up and publish a European harmonized standard. Standard EN600 in particular, adopted in November 1995, lays down the requirements regarding the condoms' strength and leak-tightness. It also defines the minimum requirements for the user to be clear on how to use the condom correctly. It reflects the general state of art and provides technical compliance with the safety requirements as stipulated in Directive 93/42/EEC.