Regulatory Services

The expertise of the APIS regulatory team covers Plant Protection Products ((EC) No 1107/2009) with particular reference to biopesticides, as well as Biocides ((EU) 528/2012) and Biostimulants ((EU) 2019/1009).

From the preliminary stages of data gap analysis and formal literature searches through to the development of pragmatic regulatory strategies in consultation with regulatory authorities we will manage your project at every step in the process from conception to commercialisation. We can produce CADDY and IUCLID dossiers for submission within the EU, and provide expert post-submission defence.

We can also advise on the development and selection of the representative formulation, helping to avoid regulatory pitfalls further down the line.

Batch Analysis and Quality Control Screening

The starting point for many work packages is a five-batch analysis. Using internally validated methods our bioanalytics team frequently returns tighter specification data for our clients than their own in-house labs, and for this reason many of our clients also use APIS for their routine Quality Control screening.

Human Pathogen Screening

APIS is the first biopesticide laboratory to adopt qPCR for the screening of microbial pesticides for human pathogens. PCR is far less susceptible to interference from microbial active ingredients than traditional culture-based methods, and is thus a much more sensitive means of detecting pathogenic contaminants and ensuring that the human protection goals of the pesticide legislation are met. Our self-validating custom PCR array ensures accuracy and reliability every time.

Metabolite Screening

In-house HPLC allows us to screen microbial products for the majority of secondary metabolites, with more complex or specialised molecules being subcontracted to one of our partner labs. Our analytical unit also provides dose verification support to our terrestrial and aquatic ecotox teams for plant extracts and chemical pesticides.

Antibiotic / Antimycotic Resistance and Sensitivity Testing

The resistance and sensitivity of microbial pesticides to human and veterinary medicines is an essential aspect of the risk assessment, and older disc diffusion assays have been largely replaced by the broth microdilution method in most territories. All antibiotic and antimycotic resistance and sensitivity assays at APIS are conducted in accordance with the latest EFSA and CLSI guidance.

Microbial Growth Profile Studies

Growth temperature studies are often used as the basis for waiving mammalian and avian toxicology studies. Our study designs were developed with input from leading regulatory authorities, thereby maximising their utility in risk assessment.

Storage Stability and Phys-chem Testing

We provide the full range of formulation-specific phys-chem tests either individually or as part of accelerated, low temperature and ambient storage stability studies.

Ensuring the constant integrity of studies that run for two or three years is critical. All our incubators are equipped with an automated temperature and humidity monitoring system that constantly logs and uploads data to our server, instantly alerting multiple members of the lab team by SMS to any deviation.

Pollinator Studies

APIS has particular expertise in honeybee and bumblebee studies. With multiple apiary sites and our streamlined laboratory procedures we can perform 22-day larval studies, acute and chronic adult studies and full-scale field trials on honeybees with ease. Bumblebee acute and chronic studies are also available, and have the advantage of being available all year round.

APIS also provides honeybee diagnostic services to beekeepers through our molecular bioanalytics unit.

Terrestrial Ecotoxicology

Our terrestrial ecotoxicology expertise covers the full range of non-target arthropods including soil-dwelling collembola and carabid beetles through to foliar mites, lacewings, ladybirds and parasitic wasps. Earthworm reprotox and soil microorganism studies are also available. All our terrestrial ecotox studies are supported by our in-house microbial and chemical analytical teams.

Aquatic Ecotoxicology

APIS offers aquatic ecotoxicology studies on standard freshwater species such as Oncorhynchus mykiss, Daphnia magna, Raphidocelis (=Pseudokirchneriella) subcapitata and Lemna gibba, and marine species such as Corophium volutator and Leptocheirus plumulosus. All our aquatic studies are backed up by our microbial and chemical analytical teams.

Non-target Plant Studies

Seedling emergence and vegetative vigour studies are available at APIS, along with bespoke phytotoxicity and compatibility studies.

Environmental Fate

In collaboration with regulatory authorities APIS has designed two studies – survival in water, and persistence, multiplication and transport in soil – to provide risk assessment data on the environmental fate of microbial pesticides.