Agrolab.dk | Regulatory Affairs
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For more detailed information about Agrolab and the services we provide within the Regulatory landscape and Field phase development of chemicals, including; plant protection products, biopesticides and biocides, please contact our Business Development Manager Jesper Yngvesson.

AGROCHEMICALS

The regulatory team at Agrolab is specialized in regulatory affairs of the EU North zone and offers full regulatory assistance for approval of plant protection products (PPP’s). Our services include preparation of dRRs as core assessments at zonal level and adjustments to suit specific, national requirements for individual member states.

The regulatory expertise at Agrolab extends from the former Council Directive 91/414/EEC to the current Regulation (EC) 1107/2009 for placing plant protection products on the market, and consequently we can prepare, adapt and update dossiers according to current legislation.

We provide guidance on data requirements for registration of plant protection products in the EU North zone, both for the active substance and the formulated product, and in close collaboration with our GEP field trial units, we advise on requirements for efficacy and selectivity trials.

We prepare, submit and follow-up on applications to national authorities in the EU North zone as well as the rest of Europe. We have produced numerous successful applications as zonal applications and mutual recognitions, and we can also help you prepare applications for parallel import (PI) registrations or emergency uses applications.

We can also help you with providing all the additional documentation needed for your application, including:

– Climatic comparability documents (for Mutual Recognitions)

– Appraisal of field studies for use in environmental fate sections (usually in Denmark)

– Comparative assessments for candidates for substitution according to Art. 50 and Annex IV of Regulation EU 1107/2009

All information is kept strictly confidential.

BIOCIDES

We also offer regulatory assistance in the field of biocides (council directive 98/8/EC, and Regulation EU no 528/2012). We can prepare your European or national registration in accordance with BPR (Biocidal Products Registration) and we can assist you with expert consultancy of the entire data package of the dossier, including: chemistry, efficacy, toxicology and environment. We can take responsibility for the timely submission of your dossier and follow-up with the relevant authorities as needed.

We manage inclusion of active substances as well as product dossiers, either during the transitional period (before inclusion of an active substance) or under the Biocidal Product Regulation.

Agrolab can also help you with contacts to authorities in Nordic countries thanks to our presence in DK, SE, LV and LT.

BIOPESTICIDES

Biopesticides are plant protection products based on microorganisms or natural products. Generally, biopesticides are classified in three categories:  microbial pesticides, bio-derived chemicals or plant-incorporated protectants. These compounds comprise biopesticidal metabolites produced by microorganisms that infect weeds or insects and naturally occurring compounds with biocontrol activity against weed plants or insects. Plant-incorporated protectants describe incorporated foreign DNA into the crops genetic material (GM) increasing the plants tolerance towards insect attack. For control of fungi, biofungicides with a wide range of modes of action are available. Formulations contain living organisms or natural metabolites effecting and compromising the activity, reproduction and competition capability of specific pathogens.

The regulatory expert team in Agrolab also offers support and advice for registration of Biopesticides on the European marked. Biopesticides are regulated as plant protection products under EU plant protection Regulation 1107/2009. Our regulatory team can prepare the required dossier for your European and national registration. We can take responsibility for the timely submission of your dossier as well as following up on requests from the relevant authorities.

In close collaboration with our GEP field trial unit, we can offer support for the necessary trial programs for efficacy and selectivity trials.

RISK ASSESSMENT

Agrolab can carry out PPP-related risk assessments. We have vast experience with the specific requirements of the Northern zone and the options available to achieve successful registration, and we can help you with screening and planning your application. We also keep up-to-date with the latest developments in EU human and environmental risk assessment.

We are experts with the different models used in a product dossier and the different sections:

– Mammalian toxicology

EFSA Guidance calculations, UK POEM, BBA “German model”, Dutch model for greenhouses, Seed tropex model, PHED, “Puffer pack” model, UK trigger spray model, EUROPOEM II

– Residues and consumer risk assessment

EFSA PRIMO 2.0, NEDI, NESTI and update of section 7

– Environmental fate

Surface water: FOCUS STEPS1-2, SWASH – MACRO – PRZM – TOXSWA, SWAN, HardSPEC

Groundwater: FOCUS PEARL, PELMO, PRZM, MACRO, FROGS and national approaches for Denmark, Lithuania, Sweden, Norway

Soil: Finnish PECsoil calculator, or PECsoil calculations according to SANCO/10558/2005

– Ecotoxicology

We perform ecotoxicology calculations and assessments according to the most recent guidance documents from EFSA or the Commission. We have a long experience of working with the Nordic authorities and we can guide you on refinements and higher-tier options for the entire ecotoxicology section in the terrestrial and aquatic environments.

BIOLOGICAL ASSESSMENT DOSSIER

Agrolab’s team of experienced agronomists are able to advise on, and provide complete efficacy programs in order to support your product’s registration. The efficacy data package of a dossier is summed up in the Biological Assessment Dossier (BAD), as required by the Regulation EC 1107/2009.

Our strong background in field research ensure an in-depth understanding and accurate presentation of efficacy data resulting in quality expertise for preparation of BADs. We have a dedicated team of BAD specialists, who work at the interface between GEP field work and BAD preparation.

We can help you with preparing the entire BAD based on the trial data package, or updating specific sections (crop safety, minimum effective dose, adverse effects, impact on adjacent and subsequent crops, risks of resistance, impact on non-target plant, etc).