WRITTEN QUESTION E-3483/00

by Heidi Hautala (Verts/ALE) to the Commission

(10 November 2000)

Subject: Code of conduct on the use of menstrual tampons

In order to minimise the risk of the toxic shock syndrome related to the use of tampons, the European Parliament has on several occasions requested that the Commission should initiate either European legislation or a voluntary code of practice. The original demand, presented by the European Parliament's Petitions Committee as early as 1996, was reiterated in a resolution in 1999 on the state of health of women in the European Union.

The European Commission and EDANA concluded a voluntary code of conduct on the use of menstrual tampons in June 1999. Could the Commission in view of the adopted text and the content of the letter by the responsible Director-General of 21 December 1999 clarify how the code will be enforced and controlled? What legal actions are possible in case (non)-EDANA manufacturers and importers bring non-conform products onto the internal market?

Could the Commission explain the reasons that have led it to accept a transitional period of two years for industry to implement the code which has been in force since 1 January 2000? Could the Commission clarify whether this voluntary code of conduct also applies to tampons exported to third countries, including the applicant countries of the European Union? If not, what steps does the Commission intend to take to protect also women outside the borders of the European Union against toxic shock syndrome?

The main aim of the voluntary code of conduct is to inform and protect women against toxic shock syndrome. Does the code provide for an obligation on the importer and/or the producer of tampons to include a warning on the tampon package in case the tampons contain genetically modified cotton? If not, will the Commission, in the interest of free choice for the consumer and as a precautionary measure, take an initiative which would make such labelling compulsory?

Answer given by Mr Byrne on behalf of the Commission

(22 December 2000)

In response to the risks related to the toxic shock syndrome and the concerns raised by the Parliament, the Commission has had repeated contacts with the manufacturers of tampons to explore the possibilities for self-regulatory measures with regard to these problems. As a result, in June 1999 the European Disposables And Non-wovens Association (EDANA) adopted a voluntary code of conduct on the use of menstrual tampons.

Under Council Directive 92/59/EEC of 29 June 1992 on general product safety(1), codes of good practice form part of the criteria to be used to assess the conformity of a product to the general safety requirement, in the absence of specific rules. The Commission has therefore presented this code to the Member States, responsible for the enforcement of this Directive, as a standard for the assessment of safety aspects.

The different types of legal action that are at the disposal of the authorities are regulated in the national legislation transposing the Directive, but these should be based on the examples given in Article 6 of the Directive, such as product checking, product sampling, warning, temporary sales prohibition or even product withdrawal.

The two-year transition period for the implementation of the code of practice is necessary to allow manufacturers to complete the practical aspects of the Code. They have to start the labelling of the tampon-packs and also to ensure a total replacement of non-labelled packs by labelled packs before the end of the period. It is estimated that well over 90 % of all the tampons now sold in the Community fulfill the requirements of the code.

The Community is not in a position to prescribe the conditions for the placing on the market of products in third countries, as this is within the competence of these countries. Candidate countries are however implementing Community legislation and hence the General Product Safety Directive. It is therefore likely that in the long term the code of practice will also have an effect in those countries.

The issue of tampons containing genetically modified cotton is not related to the toxic shock syndrome and was therefore not included in the discussions between the Commission and EDANA on the code of practice. The Commission is aware of the concerns raised and is for the moment assessing the genetically modified organisms (GMO) related issues in a more general way. Any further measures will have to await the outcome of this assessment.

(1) OJ L 228, 11.8.1992.