BPR

The BPR is the legislation concerning the authorisation of biocides for use in the European Union (EU)

The BPR process has been in progress for many years but is nearing its conclusion. Our products contain biocidal actives which cannot be marketed within the EU without authorisation. It is Redditch Medical’s intention to ensure all of our biocides comply with the BPR. This enables continued supply of the InSpec™ Contamination Control range for use in Biopharma and Medical Device industries. Specifically this covers Annex V, Main Group 1 Disinfectants, Pt2 Disinfectants and algaecides not intended for direct application to humans or animals.

All biocidal actives used in the InSpec™ range are listed in Article 95 (the relevant list of biocidal actives and suppliers). The next stage of the process is for formulations containing listed actives to be registered. Responsibility for managing the authorisation of different actives and formulations has been divided between member states of the EU. At this point different formulations, are at different stages in the BPR process. It is anticipated that in the next 1 to 4 years our formulations will be listed and trade names registered for use within the EU. InSpec™ products will be registered in those member states where the range is currently for sale and in any other member states in the future as required.


IPA requires a BPR Technical Dossier Submission to ECHA by September 2016. Redditch Medical is in the process of finalising the technical data to submit the dossier by approximately of July/August 2016, ahead of the deadline date. At this stage it is Redditch Medical intention to register InSpec 70/30 IPA throughout the whole of Europe. This registration will allow all distributors and users of InSpec IPA to be fully compliant with the BPR.


DE requires a BPR Technical Dossier Submission to ECHA by June 2017. Redditch Medical is in the process of gathering the technical data to submit the dossier by approximately April 2017, ahead of the deadline date. At this stage it is Redditch Medical intention to register InSpec 70/30 DE throughout the whole of Europe. This registration will allow all distributors and users of InSpec DE to be fully compliant with the BPR.


Redditch Medical has obtained the relevant Letters of Access (LoA) to support the BPR submissions from the relevant consortiums and suppliers. These LoA’s make available specific data to regulatory authority at the time of submission.


Redditch Medical can supply further and more specific information to our customer upon request.

Please do not hesitate to contact a member of the Redditch Medical team if you have any further questions.

Contact us

Please call our team on U.K. 0845 0739529, International +44 (0) 1527 830942 or fill in the form below, and we will be in touch at the earliest opportunity:

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InSpec Burstable Pouch Wipes

InSpec Burstable Pouch Wipes

Sterile biocidal and sporicidal session wipes. Maximum convenience via wipe format, with the maxiumum power of InSpec rotationals: OX, HA, AN, QT.

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Contamination Control

Contamination Control

Explore our InSpec product range for validated cleanroom contamination control solutions.

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