Biocontrol & Natural Products

Biopesticides

Strategic regulatory expertise for microorganisms, botanicals, and semiochemicals. Comprehensive support for biopesticide approvals under Regulation (EC) No 1107/2009.

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Biopesticides Regulatory Support

Active Substances

Support for approval of biopesticide active substances including microorganisms, botanicals, and semiochemicals.

N
Microorganisms (Reg 283/2013, Part B)
N
Botanicals (SANCO/11470/2012-rev.8)
N
Low-risk pathways exploration
N
Organic production positive list

Formulated Products

Authorization for biopesticide formulated products across EU Member States, including organic farming use.

N
Zonal applications & mutual recognition
N
Technical equivalence demonstrations
N
Organic farming compatibility
N
National catalogue listings

Active Substances

Strategic Analysis & Consulting

Obtain approval for new active substances and renew existing approvals under Regulation (EC) No 1107/2009.

N
Microorganisms: Part B Reg 283/2013 + metabolites (SANCO/2020/12258)
N
Botanicals: Adapt Part A requirements (SANCO/11470/2012-rev.8)
N
Low-risk pathways (Reg 2017/1432)
N
LMR exemption (SANCO/11188/2013 rev.2)
N
Pre-application meeting stewardship

Laboratory Studies & Trials

Specialized support for biopesticide-specific study requirements.

N
Laboratory selection & study design
N
Major components for botanicals
N
Pathogenicity & infectivity for microorganisms
N
Efficacy trials (Redebel/Rhizome network)

Approval Application Completion

Our team prepares active substance and representative product applications adhering to the latest requirements and technical guidelines, ensuring full compliance for microorganisms, botanicals, and semiochemicals.

Drafting of all sections (including risk assessments and CLP risk characterization):

Identity and mode of action, physico-chemical aspects, analytical methods, toxicology, environmental fate, ecotoxicology, residue (if necessary), and efficacy.

Submission & Evaluation

Submission of active substance and representative product application to relevant authorities
Submission of MRL application or exemption request to EFSA
Efficient monitoring of the evaluation process
Continuous interaction with DG Health and Food Safety
Liaison with DG Agriculture & Rural Development (for organic production list)

Our job does not end when the file is submitted. We remain available to respond to any requests for further information.

Our experts guide you through the different phases of drafting, submission and evaluation of your approval application for plant protection products based on microorganisms, botanicals and semiochemicals.

RRA is at the heart of the deliberation process that will enable you to find the best strategy and achieve your goal.

Formulated Products

Strategic Analysis & Consulting

Compare applications with regulatory requirements to advise on optimal procedures for biopesticides.

N
Microorganisms: Part B Reg 284/2013 + metabolites
N
Botanicals: Adapt Part A requirements
N
New authorization by zone
N
Use extension (minor/major) & renewals
N
Mutual recognition procedures
N
Pre-application meeting stewardship

Technical Equivalence

Assistance in demonstrating equivalence of new biopesticide sources with respect to reference sources.

N
Equivalence study design for biologicals
N
Data comparison & gap analysis
N
Documentation preparation
N
Submission to authorities

Application Drafting

Our team prepares applications adhering to the latest requirements and technical guidelines specific to biopesticides, ensuring full compliance while anticipating potential issues.

Drafting of all sections (including risk assessments and CLP risk characterization):

Physico-chemical aspects, analytical methods, toxicology, environmental fate, ecotoxicology, residue (if necessary), national and European biological dossiers (BAD).

Data Management & Submission

Management of access to active substance data (LoA and DMT)
Submission of application to relevant authorities in proper format
Efficient monitoring of the evaluation process
Continuous interaction with relevant authorities
Organic farming compatibility verification
National catalogue listing support

Laboratory Studies & Field Trials

Laboratory choice is vital. We take specific parameters into account such as the notion of 'major components' for botanicals and pathogenicity and infectivity for microorganisms.

Efficacy and residue trials are conducted in different countries through our company Redebel for trials in Belgium or through our Rhizome network for European projects.

Our job does not end when the file is submitted. We remain available to respond to any requests for further information.

RRA is at the heart of the deliberation process that will enable you to find the best strategy and achieve your goal.

Trusted by industry leaders

References & Testimonials

RRA has supported regulatory projects for leading agrochemical and specialty chemical companies worldwide. Our clients trust us to deliver compliant, high-quality dossiers on time.