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 pesticides, bio pesticides or biocides, please contact our Business Development Manager Jesper Yngvesson.

Agrochemicals registration

The regulatory team at Agrolab are 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 dRR as core assessments on zonal level and adjustments to suite national specific requirements for the member states of the EU zones.

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 pesticide dossiers according to current legislation.

We give guidance on data requirements for registration of plant protection products in the EU North Zone, both at the active substance and the product level, and in close collaboration with our GEP field trial units we advise on necessary trial planning and requirements for efficacy and selectivity trials.

We prepare, submit and follow-up on applications to national Environmental Protection Agencies in the EU North Zone as well as the rest of Europe. We have experience with 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 documents needed for your application, including for example:

– 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.

Risk assessments

Agrolab can carry out PPP-related risk assessments. We have a long experience of the specific requirements of the Northern Zone and the options available to achieve successful registration and we can help you with screening and planning ahead your application. We are always keeping up-to-date with the latest developments in EU human and environmental risk assessment.

We are well-versed 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 whole ecotoxicology section in the terrestrial and aquatic environments.

Biological Assessment Dossiers

Through its team of experienced agronomists, Agrolab is able to advise on and provide complete efficacy programs in order to support your product registrations. 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 handling of efficacy data resulting in quality expertise for preparation of BADs. We have a dedicated team of BAD specialists, who are working at the interface between field GEP work, and BAD preparation.

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

Registering your 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 and we can assist you with expert consultancy in the whole data package of a dossier: chemistry, efficacy, toxicology and environment. We can take the responsibility of submitting your dossier and following-up with the relevant authorities when 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 beneficial contacts with Nordic countries authorities thanks to our presence in DK, SE, LV and LT.