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Parliamentary questions
8 March 2018
E-001459-18
Question for written answer
to the Commission
Rule 130
José Inácio Faria (PPE)

 Subject:  Biocides vs. Medicines — Reaction to a response from the Commission
 Answer(s) 

In response to Written Question E-003631-17 on the non-standardised classification of skin disinfectants for certain medical interventions, the Commission stated that ‘disinfectants used for human hygiene purposes, and applied on or in contact with human skin, are biocidal products’ and that ‘a biocidal product for skin disinfection can be authorised provided it is safe for patients’.

This is in line with the position of Spain and Italy; it contradicts, however, the stance taken by some national regulatory bodies, namely the British, German and Belgian.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA)(1), the German Federal Institute for Drugs and Medical Devices (BfArM)(2) and the Belgian Federal Agency for Medicines and Health Products (AFMPS/FAGG)(3) only authorise medicinal products, and not biocides, for skin disinfection.

The use of different criteria is the result of divergent interpretations of medicinal and biocides EU directives by national regulatory bodies, resulting in a fragmented application of those directives.

Is the Commission aware of these contradictory positions?

If so, does it agree that there is a fragmented interpretation of EU directives as regards the classification of skin disinfectants for medical purposes, and that a response is needed to clarify this situation?

(1) Joint RCS/MHRA Statement on use of Topical Chlorhexidine for Skin Preparation Prior to Surgery, https://www.rcseng.ac.uk/about-the-rcs/government-relations-and-consultation/joint-rcs-mhra-statement-on-use-of-tropical-chlorhexidine-for-skin-prep/
(2) Press release 10/2009, https://www.bfarm.de/SharedDocs/Pressemitteilungen/EN/pm2009-10-en.html
(3) Lignes directrices relatives à la frontière Biocide-Cosmétique-Médicament à usage humain, https://www.afmps.be/sites/default/files/downloads/Borderline%20Hum%20Ver%202009%20fr%20final.pdf

Last updated: 23 March 2018Legal notice