RE : – BPR, Regulation (EU) 528/2012)
AGMA Ltd is a long established Chemical Formulator specialising in the manufacture of High Quality, Sterile and Non Sterile, Cleaning & Disinfection products for use within the Healthcare Sector where the need to control pathogenic organisms is paramount. The development, formulation & provision of Biocidal Products for this market is therefore at the core of our product offering and as such we manufacture a number of products affected by the Biocidal Products Regulations (BPR). BPR requires that all new and existing Biocidal Products must obtain prior authorisation before they can be made available on the EU market meaning that AGMA Ltd. has to now obtain authorisations under BPR for its core product lines even though these products have been manufactured and sold worldwide for many years. In accordance with BPR all formulators including AGMA Ltd must purchase their Biocidal Active Substances from companies whose products are Article 95 listed under the BPR process. We are in close and constant dialogue with our Active Substance suppliers monitoring their progress through the Biocidal Products Registration process and AGMA Ltd. are in the process of preparing dossiers for our own product authorisations where appropriate.
The complexity and scale of costs associated with the BPR registration process across EU may lead to many formulated products becoming non viable commercially. However at AGMA Ltd. we are fully confident that our core product range can and will be maintained as our Directors took the decision to protect their core products supply chain by becoming part of the ASD Consortium for Alcohols and Article 95 for IPA, Denatured Ethanol and n-Propanol.
We are now undertaking a significant investment plan to ensure our core products a safe passage through the BPR registration process for the specific applications for which they are utilised by our key customers.