Scientific expertise for biocidal products

Delivering the data required for regulatory approval and market access

To date, many companies face the challenge of properly registering different product types in accordance with the Biocidal Products Regulation (Regulation (EU) No. 528/2012). 

The Eurofins network of laboratoroes has been carrying out physico-chemical, stability, toxicological and ecotoxicological studies and stability studies on active substances and formulations with biocidal activity in accordance with this Regulation since the 1990s.

Together with you, our scientists develop the optimal test strategy for evaluating the safety and efficacy of your product. Our team of consultants supports you in all phases of the registration process, from pre-registration to dossier submission.

Why choose the Eurofins network of laboratories?

We support you during the entire registration process according to the Biocidal Products Regulation (EU) No. 528/2012). Alternatively, we offer you a complete solution for the successful registration of existing or new active ingredients and biocidal products.

We support you in the safety assessment of your products with our state-of-the-art technologies and our experience in this field.

For the successful marketing of your products, we provide you with a wide range of efficacy studies for all mandatory and specific requirements.

And finally, our expertise in scientific solutions helps you avoid costly production and delays.

Contact us to discuss your needs

Our service portfolio

Quantitative suspension and surface test against microorganisms

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Quantitative suspension and surface test against gram-positive and gram-negative bacteria

  • CEN-standards: EN 13727, EN14651, EN1656, EN14349, EN 1276, EN13697, EN16437

Quantitative suspension and surface test against Mycobacteria

  • CEN-standards: EN 14348, EN14563, EN14204, OECD guidelines

Quantitative suspension and surface test against fungi (yeasts and forms)

  • CEN-standards: EN 13624, EN 14562, EN 1657, EN 1650, EN 13697, EN 16438

Quantitative suspension and surface test against bacterial spores

  • CEN-standards: EN 13704, EN 14347 AFNOR NF T 72-190, C. difficile

Quantitative suspension and surface test against Legionella

  • CEN-standard: EN 13623

Efficacy studies for biocides

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Efficacy studies for skin disinfectants

  • Hygienic hand washing & hand disinfection
    EN1499, EN1500
  • Pre-surgical hand disinfection
    EN12791

Efficacy studies against viruses

  • CEN test method applicable
    EN14476, EN14675, prEN16777, EN13610
  • Specific viruses
    Wide specific virus portfolio

Efficacy of aerosol disinfection systems

  • standard studies against micro-organisms and viruses
    AFNOR NF T 72-281
  • customer-specific studies
    on the basis of the sponsor's functions
  • Surfaces aerosol disinfection for USA
    GLP-tailored protocols for EPA registration of "fogging" disinfection devices

Efficacy studies for disinfection wipes

  • For wet wipes and customer-specific options
    EN16615

Efficacy studies for laundry products

  • Launder-O-Meter tests (Petrocci & Clarck method)
    ASTM standards
  • Chemical and chemo-thermal laundry disinfection
    EN16616

Efficacy studies against other targets

  • Biofilm
    amended EN ISO / TS 15883-5
  • Insects
    Subcontracting to partner laboratories
  • Rodents

Efficacy studies for US market

  • For EPA and FDA registration of antimicrobial agents
    ASTM and AOAC standards

Ecotoxicological studies and biodegradability studies

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Algae, daphnia and fish toxicity tests

  • OECDs 201, 202, 203, 211

Biodegradability

  • OECD 310, ISO14593, ISO 11734, OECD 209, OECD 224

Stability studies

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  • Accelerated (CIPAC MT 46) and long-term stability studies
  • Storage and analysis
    under different temperatures and RH% conditions

Chemical tests of active substances and impurities

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  • Analytical state-of-the-art method design
  • Validation of analytical methods
    for identification and quantification of a.i. or impurities (GC, GC-MS, HPLC-UV, HPLC-ELSD, HPLC-MS, ICP-OES, ICP-MS, AAS, titration methods) according to SANCO, BPR, ICH, USP guidelines.
  • Physical-chemical properties
    according to OECD / CE protocols

 

Toxicological studies

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In vitro tests:

  • Skin irritation: OECD 439
  • Skin corrosion: OECD 431
  • Eye irritation/-corrosion: OECD 437 and OECD 492
  • Sensitisation: OECD 442C (DPRA), OECD 442D (KeratinoSens), OECD 442E (h-CLAT)

Acute toxicity:

  • Dermal toxicity: OECD 402
  • Inhalation toxicity: OECD 403
  • Oral toxicity: OECD 420/423/425
  • Eye irritation test: OECD 405
  • Sensitisation test: LLNA (OECD 429 or OECD 442B)