LabAnalysis Life Science can provide the full package of studies required by Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerning the placing on the market and use of biocidal products in EU.
Biocides are crucial for disease prevention and environmental protection, targeting microorganisms that include bacteria, viruses, and fungi. They ensure our collective well-being but are subject to strict regulation for safety and efficacy.
With over 20 years of experience in Good Laboratory Practice (GLP) we are one of the leading companies in Europe in this field. Our testing offer fulfills also the requirements of Italian Presidential Decree 392 of 6 October 1998 to register “Presidi Medico Chirurgici (PMC)” in Italy.
We adhere to international guidelines and offer a wide range of services, from physical and chemical property analysis to ecotoxicology studies and regulatory support.
Product identity and composition
The analyses we perform:
Preliminary screening of active ingredient, relevant and significant impurities, metals, ions and solvents
5-batch analysis (analysis of active ingredient, relevant and significant impurities, water content)
Separation of impurities by HPLC preparation
Spectra (UV/Vis, IR, MS, NMR)
Certificates of analysis
Methods development and validation
Activities performed in support of method development and validation:
Method development and validation for a.i. and impurities according to SANCO/3030/99
Development and validation of the method for residues in various matrices according to SANTE/2020/12830
Emulsifiability, re-emulsifiability and emulsion stability
Disintegration time (tablets)
Particle size distribution
Mass Medium Aerodynamic Diameter (MMAD)
Dustiness
Attrition charateristics
Attrition of tablets
Persistent foam
Pourability
Surface tension
Viscosity
Melting and boiling points
Freezing point
Miscibility with hydrocarbon oil
Flowability of granular preparations
Spray performance test for aerosol formulation
FAO 8.11.4.1 Net content of formulation
FAO 8.11.4.3 Note 9 Discharge rate
FAO 8.11.4.5 Note 11 Clogging of aerosol dispenser valves
Evaluation of aerosol spray patterns
Internal Pressure
Spray pattern for RTU (ready to use) formulation
Spray diameter from varying spray distances (spray pattern)
Images of the spray pattern
Trigger spray
Observations on the trigger head (build-up of crystallised material in the nozzles, nozzle blockage or leaks from the trigger head)
Hazard properties
Hazard properties of the products:
Explosive properties and Self-reactive Substances and Mixture with DSC screening test
Explosive properties for liquids and solids
Flash point and flammability
Auto-ignition temperature (liquids) and Self-Ignition temperature (solid)
Oxidizing properties for liquids and solids
Corrosive to metals
Storage stability studies
Studies performed:
Accelerated storage stability (different times and temperatures)
Low temperature stability
Shelf life stability (different times and temperatures)
Acquatic and terrestrial ecotoxicological studies
Experienced study directors, state-of-the-art facilities and state-of-the-art equipment in the ecotoxicology unit have enabled LabAnalysis Life Science to become an international centre of excellence for this type of study.
The experience gained over the years in the preparation of UVCB substance assays according to OECD guideline 23, and the experience in environmental and pharmaceutical matrices, have enabled LabAnalysis Life Science to expand its ecotoxicological assay offering to a wide range of matrices to be tested, from agrochemicals to waste, end-of-waste products and drugs.
The reconstituted water production facility and the recent implementation of the new fish assay system also allow long-term testing from the embryonic stage of fish through to development (FET, FELS). Furthermore, it is possible to test for the potential of chemicals as endocrine disruptors.
Aquatic ecotoxicity
Short-term studies:
Acute test under static or semi-static regime with Daphnia magna according to EU C.2, OECD 202, USA OPPTS850.1010
Algal growth test: Scenedesmus subspicatus, Pseudokirchneriella subcapitata, Anaboena flos aquae according to EU C.3, OECD 201, USA OPPTS 850.5400
Acute fish mortality test: Danio rerio, Oncorhynchus mykiss according to EU C.1, OECD 203; USA OPPTS 850.1075
Acute Fish Embryo Test -(FET) Test according to OECD 236.
Lemna sp. growth inhibition test according to OECD 221, USA OPPTS 850.4400
Test for aquatic plant growth toxicity: Myriophyllum aquaticum according to OECD 238 (without sediment), OECD 239 (with sediment)
Acute immobilisation test for Chironomus sp. according to OECD 235
Long-term studies:
FELS test under static, semi-static or continuous flow according to OECD 210
Juvenile fish growth test according to OECD 215
Long-term toxicity test on crustacean reproduction: Daphnia Magna according to EU.20, OECD 211 and US OPPTS 850.1300
Terrestrial ecotoxicity
Short-term studies:
Acute worm toxicity test: Eisenia fetida according to EU C.8, OECD 207
Toxicity test on soil microorganisms - inhibition of nitrification capacity according to OECD 216, EU C.21
Toxicity test on soil microorganisms - inhibition on carbonation capacity according to OECD 217, EU C.22 Long-term test
Chronic toxicity test on worms: Eisenia fetida - OECD 222
Sub-lethal toxicity test on worms: Eisenia fetida - US OPPTS 850.6200
Terrestrial plants - emergence and growth test according to OECD 208
Terrestrial plants - vigour test according to OECD 227
Non-target soil organisms: Folsomia candida and Hypoaspis aculeifer according to OECD 232, OECD 226
Bee tests
Oral and contact toxicity test for pollinators on adults of Apis mellifera (honey bee) according to OECD 213/214
Acute contact and oral toxicity test on adults of Bombus terrestris L. (bumblebee) according to OECD 246/247
Larval toxicity test - single and multiple exposure on Apis Mellifera (honey bee) according to OECD 237 (single exposure) and OECD 239 (multiple exposure)
Chronic oral toxicity test (feeding for 10 days) on adults of Apis Mellifera (honey bee) according to OECD 245
Bee brood test under semi-field conditions according to OECD 75
EPPO 170: field study of honey bees
Oomen method (Oomen et al., 1992): brood feeding study of honey bees
Field studies on honey bees according to EFSA guidance (EFSA, 2013)
SANTE/11956/2016 rev. 9 Residue tests for the establishment of MRLs in honey
Biodegradability studies
Biodegradability test (OECD 301) is performed
In-vitro toxicology and mutagenesis
The following studies and tests are performed:
Skin irritation and corrosion (OECD 439, OECD 431)
Eye irritation and corrosion (OECD 492, OECD 437)
Ames test (OECD 471)
Efficacy testing on bacteria, fungi, yeast and viruses
Test strategies implemented and executed:
Efficacy testing strategy against bacteria (EN 1499, EN 1500, EN12791, EN13727, EN1276, EN1656, EN14349, EN14561, EN13697, EN16615, EN16616, EN16437)
Effectiveness testing strategy against mycobacteria (EN14348, EN14563, EN14204, EN16616)
Strategy for efficacy testing against fungi and yeasts (EN13624, EN14562, EN1657, EN1650, EN16615, EN16616, EN16437)
Efficacy testing strategy against viruses (EN14476, EN16777, EN14675)
Effectiveness testing strategy against spores (EN13704, AFNOR NF T 72-190, EN14347, EN13704)
Strategy for efficacy testing against legionella (EN13623)
Efficacy testing strategy against other organisms
Air surface disinfection system against target organisms (EN 17272)
Regulatory services
We offer regulatory consultancy services to help you comply with local and international regulations. Our services include assistance with the preparation and submission of regulatory dossiers, simplifying the submission process. We help you gather the necessary information for dossier submission, ensuring that all information is accurate, complete and meets regulatory standards.
For the registration of your biocidal active substance or product family under the Biocides Regulation (BPR, EU Regulation 528/2012), we support you with the following services:
Definition of regulatory strategy, data gap analysis and preliminary risk assessments.
Preparation of a complete dossier (IUCLID and SPC Editor and draft biocide or active substance assessment report).
Applications for inclusion in the list of suppliers of active substances (Article 95 list)
All normal applications for registration via R4BP3 (Register for Biocidal Products) and according to national requirements (BPR).
R4BP3 account/dossier submission manager
Technical equivalence applications
National applications under the transitional regime in different EU countries
Meetings with authorities, contracting institutions and customers
