Whether you want to approve a new active substance or register your biocidal product, LAUS supports you with the information requirements of the Biocidal Products Regulation.
We have extensive experience and offer customized test strategies for biocides that are difficult to test, such as in situ generated active substances.
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For the approval of an active substance or the authorization of a plant protection product under Regulation (EU) 1107/2009, LAUS can support you with state-of-the-art analytical methods, stability studies and other endpoints for safety assessment for human health and the environment.
For the safety assessment of Cosmetics, Personal Care Products (rinse-off or leave-on) and their Ingredients, LAUS could support you with non-animal alternative methods (NAMs), in vitro genotoxicity and biodegradability testing as well as physico-chemical properties.
LAUS tests your surfactants, detergents, washing and cleaning products in the area of ecotoxicology and environmental behavior as well as human health for regulatory purposes. We also offer biodegradability studies for ecolabels and sustainability certifications.
In the area of Human Medicinal Products LAUS offers genotoxicity testing for pharmaceuticals in the preclinical phase and for impurities of pharmaceuticals. We can also support you with experimental data for your Environmental Risk Assessment (ERA). All studies will be performed according to the principles of Good Laboratory Practice (GLP).
Human Medicinal Products - Genotoxicity Environmental Risk Assessment ERA
For the registration of your veterinary medicinal products LAUS can support you with experimental endpoints for the environmental risk assessment (ERA). We offer studies for Phase II Tier A as well as Phase II Tier B.
In the food sector, LAUS offers a wide range of tests in accordance with EFSA specifications. Examples include genotoxicity tests on nanomaterials and novel foods or the in vitro simulation of the physiological conditions in the gastrointestinal tract.
LAUS GLP studies are also recognized by the EPA (United States Environmental Protection Agency) for testing requirements under TSCA (Toxic Substances Control Act), FIFRA (Federal Insecticide, Fungicide and Rodenticide Act) and FFDCA (Federal Food, Drug, and Cosmetic Act). Find our services here.
LAUS offers a broad spectrum of physico-chemical studies for either the characterization of your substances or determination of safety-relevant data. We work according to OECD, EU, UN CIPAC and other common standards that are internationally recognized. Performance with and without GLP is possible.
In the field of New Approach Methodology / non-animal alternative methods (NAMs) LAUS offers in vitro and in silico tests to provide human health hazard endpoints for skin or eye irritation and corrosion as well as skin sensitization.
For genotoxicity and mutagenicity endpoints we offer a number of OECD studies on bacteria, mammalian cells and human lymphocytes. We support you with individual approaches that might be required for certain substances, e.g. nanomaterials.
In the area of aquatic and terrestrial ecotoxicology, LAUS carries out acute, subacute and reproduction studies. We are equipped with state-of-the-art technology for dose verification analysis, including nanomaterials.
The environmental fate of certain substances can be assessed by determining their biodegradability, their transformation or metabolism and their bioaccumulation potential.Biodegradability studies are also often used for eco-labels.
LAUS analytical laboratories are not only equipped with the newest technology, which enables us to carry out analyses even in trace amounts, we also have experts with many years of expertise. We work according to SANTE and SANCO guidance. We develop and validate methods for the determination of content or concentration control for other studies.
The assessment of substances with endocrine activity becomes increasingly important in our regulatory framework. To be prepared for upcoming requirements, we already have some studies available, are in the process of establishing a number of key studies and have a network of partners to support you in a comprehensive way.
Non-GB companies (manufacturers, formulators and suppliers) could appoint an Only Representative (OR) in the UK as one option to gain or maintain access to the GB market. LAUS Group Ltd can act as your OR in the UK.
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