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Aktdetaljer
Akttitel: Bio-Rad question on PFAS restriction dossier and life-sciences analytical equipment Aktnummer: 286 Sagsnummer: 2023 - 11008
Akt-ID:
8228498
Dato:
30-08-2023 11:16:59
Type:
Indgende
Dokumenter:
[1] Bio-Rad question on PFAS restriction dossier and life-sciences analytical equipment.eml (MEDTAGES IKKE)
[2] Bio-Rad Summary of Inquiry MST.pdf
Den 12. juli 2024
== AKT 8228498 == [ Bio-Rad question on PFAS restriction dossier and life-sciences analytical equipment ] == Dokum... ==
30 August 2023
Sandi Muncrief Head of the Chemicals and Biocides Unit Environmental Protection Agency Denmark
Dear Ms Muncrief,
I am writing on behalf of Bio-Rad Laboratories1 regarding the ongoing public consultation on the proposed restriction of per- and polyfluoroalkyl substances (PFAS) in Europe2, on which the Danish EPA was a submitting authority.
Bio-Rad will be submitting a consultation response to the ECHA consultation and, in preparation, would like to ask for additional clarification on the categorisation of life science research and analytical laboratory devices in Bio-Rad's product portfolio, which are often critical to public health and related services across Europe.
Due to the sophistication and engineering requirements of some of our platforms, Bio-Rad products include limited quantities of compounds (fluorinated liquids) that qualify under the broad category of PFAS in the restriction proposal. In our interpretation of the proposed restriction, Bio-Rad's use cases, for devices in life sciences and public health domains that do not fall under IVD registered devices3, do not conform to any of the identified main applications and sub-uses.
The specific PFAS provided by Bio-Rad are used for laboratory equipment functions. Notably, these products are not consumer products in design and are utilized by highly trained users in research and diagnostic laboratories, which themselves possess a level of sophistication in handling and disposing of chemically sensitive materials in accordance with local regulations.
Bio-Rad's non-IVD (Research Use Only - RUO) laboratory equipment consists of tools for the separation, amplification, and analysis of nucleic acids (DNA, RNA),
1 Bio-Rad Laboratories is a global leader in developing, manufacturing, and marketing a broad range of innovative products for the life science research and clinical diagnostics markets. www.bio-rad.com 2 https://echa.europa.eu/restrictions-under-consideration/-/substance-rev/72301/term 3 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32021D1195&qid=1692632308119
proteins and cells. Examples include but are not limited to: Polymerase Chain Reaction (PCR), Real-Time Quantitative PCR (RT-PCR, QPCR, RT-QPCR), Droplet Digital PCR (ddPCR), Nucleic Acid Extraction and Purification, Flow Cytometry, Western Blotting, Electrophoresis and Gel Imaging, Electroporation, Lab Chromatography, Process Chromatography (Pharmaceuticals), Single-Cell Enrichment and Enumeration, Sequencing Library Preparation, Protein Detection and Quantification. Each of these laboratory devices also utilizes consumables and reagents during its operation, including but not limited to buffers, engineered fluids, analyze-specific reagents, and disposables.
Based on the above description of Bio-Rad's use case of relevant compounds we would, therefore, like to request clarification as to how our use case is covered by the restriction proposal, and on which industry sector we should base our consultation response.
Bio-Rad is currently participating in a consultation submission as a member of MedTech Europe for the parts of our business that fall under the existing proposed derogation for Diagnostic Laboratory Testing (Medical devices) given the sufficiently strong evidence that alternatives are not available.
Warmest regards, P1
Penta Group On behalf of Bio-Rad