Staying ahead in a rapidly evolving regulatory landscape
The landscape of plant protection products is evolving rapidly, driven by more stringent regulations and the emergence of innovative new active ingredients. Also, criticisms of NGOs and the European Parliament have sparked several initiatives from the EU Commission / EFSA / Member States around an ‘upgraded’ safety assessment of PPPs including their co-formulants.
At ARCHE Consulting, we stay at the forefront of these developments. Our multidisciplinary team of high-level, science-driven experts spans (eco)toxicology, chemistry, biosciences, environmental engineering, (micro)biology, in-silico modelling etc. We bring deep experience across different legal frameworks such as REACH, biocides, plant protection, fertilizers, CLP, and local impact assessment (including PFAS).
As EU legislations are expected to become more intertwined (through initiatives like the ‘one substance one assessment’ principle or evolving co-formulant data requirements), our deep understanding of the various regulatory frameworks, their interdependencies, and emerging trends (e.g PFAS, microplastics, upcoming polymer REACH registration) is a standout benefit when tackling the constantly evolving requirements for plant protection products.
We also go beyond compliance. With a strong focus on sustainability and innovation, ARCHE Consulting contributes to several forward-looking research projects. One example is the Horizon 2020 WASTE2FUNC project, which explores converting agricultural and food waste into ingredients for environmentally conscious cleaning agents and bioplastics.
Want to know how we can support your PPP strategy - whether for conventional synthetic chemicals or biocontrol solutions? Explore our key services below.
BIOCONTROL
In the EU, plant protection products fall under Regulation (EC) No 1107/2009, which governs the approval of active substances and the authorisation of products. This regulation currently applies to conventional synthetic chemicals as well as biocontrol solutions. However, changes may be on the horizon, as the European Commission has launched initiatives to promote biopesticides and accelerate their entry into the EU market.
At ARCHE Consulting, we actively follow up on data requirements/risk assessment for biocontrol products as an associate member of IBMA (International Biocontrol Manufacturers Association), in which we play an active role within IBMA working groups.
For your biocontrol products, we support you with:
Technical support
Dossier preparation
(Early-stage) strategic advice on key regulatory considerations for the development of active substances and product formulations, their intended uses and dossier building
TECHNICAL AND STRATEGIC SUPPORT
We track evolving legislation and guidance for your chemical or biocontrol products to help you with:
Strategic advice and roadmaps to ensure efficient paths to market
Data gap analysis and (preliminary) risk assessments
Expert statements
Literature reviews
Analyses of monitoring data and proposing emission-reduction measures
DOSSIER PREPARATION AND SUBMISSION
We deliver end-to-end support for robust dossier submissions:
Active substance and product dossiers (core dossier plus national addenda)
Basic substance applications
Technical equivalence applications
STUDY MONITORING
With a team of over 40 in-house experts, we manage and monitor studies across complex substance types, including:
Physico-chemical property and physical hazard studies
Residue studies
Toxicology assessments (including ED assessment)
Ecotoxicology and environmental fate assessment (including ED assessment)
HAZARD AND RISK ASSESSMENT
We conduct thorough and advanced assessments, including:
Human health exposure calculations (dietary/non-dietary)
Environmental fate exposure calculations
Ecotoxicological risk assessments
Higher tier exposure calculations and risk assessments (e.g. population modelling, inhalation exposure to volatilized residues)
Portfolio/co-formulant screenings based on systematic literature/database searches and QSAR models
SUSTAINABILITY STRATEGIES
The Farm to Fork (F2F) Strategy is part of the EU Green Deal and aims to make the EU food system more sustainable. At ARCHE Consulting, our dedicated sustainability team supports your goals with e.g Life Cycle Assessment (LCA), and Safe and Sustainable by Design (SSbD) services. We also offer portfolio screening (covering regulatory requirements or beyond), based on systematic literature/database searches and QSAR models.
Check out Inge Huygens’ presentation ‘Sustainable co-formulants in PPPs: A regulatory perspective and outlook’ at ABIM 2024 here.
