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FORMALDEHYDE BPR
Article 95 compliant PT22 Formaldehyde
Medenta’s parent company the MazWell Group Limited support formaldehyde as a biocidal active substance for embalming purposes in the European Union (EU) and are compliant with the EU BPR.
There is a requirement within the EU-BPR that an active substance in a biocidal product must be sourced from an approved supplier. Approved suppliers are identified on the EU specific list – known as the ‘Article 95’ list. The requirement to source active substance(s) from these suppliers has been in place in the EU since September 2015 and the BPR states that biocidal products must not be made available on the market unless the active substance supplier or product supplier is on the Article 95 list for the relevant product type. Non-compliance, if identified by an enforcement agency, may lead to the removal of products from the market and the imposition of administrative sanctions or criminal penalties.
All companies making biocidal products available on the EU market must be able to demonstrate a clear auditable purchase / supply trail from an ‘Article 95’ listed supplier.
Evidence must:
• account for each step of the supply chain – from supply of the active substance to the supply of the biocidal product to the user
• come from the listed EU Article 95 supplier – a distributor of the active substance cannot state that they purchase from a EU Article 95 listed supplier – the EU Article 95 listed supplier must state that they supply to the distributor
• be clear and specific – the active substance or product must be clearly named
Acceptable evidence from an Article 95 listed supplier could be:
• an invoice
• a delivery note
• a supply agreement, or written evidence that active substance has been supplied
The MazWell Group Limited are a BPR Article 95 listed supplier for PT22 formaldehyde both in the EU (represented by Medenta GmbH) and GB. As such, Medenta GmbH can provide Article 95 compliant PT22 formaldehyde for use in embalming fluids and thereby ensure compliance with Article 95 of BPR.
If you would like to discuss this further or require an agreement to purchase Article 95 compliant PT22 formaldehyde, please get in touch for more information.
Useful BPR links and resources:
The Article 95 list of active biocidal substance and product suppliers becomes enforceable
https://www.hse.gov.uk/biocides/uk-article-95-basics.htm
Understanding BPR - ECHA (europa.eu)
Evaluation process for active substances under the review programme - ECHA (europa.eu)
Authorisation of biocidal products - ECHA (europa.eu)
Product family - ECHA (europa.eu)
Practical guide on BPR (ECHA produced pdf document)
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