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Parliamentary questions
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4 March 2019
Question for written answer E-001151-19
to the Commission
Rule 130
Philippe Juvin (PPE)

 Subject:  Legislative framework for the marketing of tampons, in particular as regards their composition
 Answer in writing 

Women’s hygiene products such as tampons are, in the absence of a lex specialis, covered by the General Product Safety Directive (2001/95/EC) which provides that ‘producers shall be obliged to place only safe products on the market’.

Regulation (EU) 2017/745 on medical devices (MDs) will enter into force on 26 May 2020. It will allow the sound regulatory framework for MDs to be brought up to date in order to ensure a high level of safety and health protection while fostering innovation. In particular, the regulation provides that ‘devices shall be designed and manufactured in such a way as to reduce as far as possible the risks posed by substances or particles’ especially devices which are ‘invasive’ or ‘come into direct contact with the human body’.

Would it not be appropriate to include tampons in the list of MDs in order, in particular, for users to be aware of the composition of those products?

Does the Commission plan to deal differently with this matter in order to protect consumers in the best possible way?

Original language of question: FR 
Last updated: 2 April 2019Legal notice