Regulatory Affairs

Agricultural Science
Research and Development

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.

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. Agrolab can help with all parts of a submission from compiling the application to requests from authorities. The list below shows what services we can provide amongst others. For further details or questions please contact Jesper Yngvesson or Alex Schwartz.

  • Keep track on regulatory updates
  • Assist with any regulatory issues
  • Define the optimum strategy to obtain product authorization (e.g. completeness check)
  • Perform data gap analysis for your dossier
  • Prepare any type of dossier; Extention of use, change of composition, parallel import etc.
  • Prepare, submit and follow-up on applications to national authorities in the EU North zone as well as the rest of Europe
  • Reformat existing dossiers according to national requirements
  • Tailor the approval dossiers to the requirements of Member States
  • Communication with authorities
  • Advice on issues and prepare documents for the Central and Southern Zone

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 ensures 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.

Amongst others we can:

-Prepar the entire BAD based on the trial data package

-Update specific sections (crop safety, minimum effective dose, adverse effects, impact on adjacent and subsequent

crops, risks of resistance, impact on non-target plant, etc)

–    Update a BAD to the newest format (2015)

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 of your application. We also keep

up-to-date with the latest developments in EU human and environmental risk assessment.

We are experts in using models used in a product dossier for the different sections:

– Mammalian toxicology (EFSA guidance calculations and UK POEM amongst other models)

– Residues and consumer risk assessment (EFSA PRIMo, Dietary intake)

– Environmental fate (FOCUS, PELMO and MACRO amongst others)

– 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.

         Labels and Safety Data Sheets (SDSs)contain information that is important for using a pesticide the

proper way. The SDS advises you on the potential hazards associated with the product, whereas a

label informs about how to safely and legally handle and use the product. Here at Agrolab we have waste

experience in preparing and updating labels and SDSs according to national requirements.

     

         Amongst others we can:

         – Identify the CLP classification of a product and prepare the label and SDS

– Update a label and SDS according to national requirements

– Translate a label from/into English, Danish, Swedish, Lithuanian and Latvian in-house.

– Translate a label from/into Estonian, Norwegian and Finnish in collaboration with translators

Agrolab is an international company with trial stations in Denmark, Sweden, Latvia and Lithuania. This means, we have native speakers across the northern zone either in-house or as collaboration with  translators.

We can therefore translate all kinds of documents from/into:

– English, Danish, Swedish, Lithuanian and Latvian in-house.

– Estonian, Norwegian and Finnish in collaboration with translators

According to Article 50(1) of the Regulation (EC) No 1107/2009, Member States shall perform comparative
assessments, “when evaluating an application for a plant protection product containing an active
substance, that has been approved as a candidate for substitution”.

Amongst others we can:
– Prepare a comparative assessment according to national requirements and guidance documents
– Prepare a list of all registered products in the concerned Member state with information about uses,
dose rates, active ingredients and other

Jesper Yngvesson
Jesper YngvessonBusiness Development Manager
+46 70 34 84 85
Alex Schwartz
Alex SchwartzRegistration and Sales Manager
+45 60 24 61 75