Resource Library

Authors: Felix M. Kluxen · Edgars Felkers · Steve McEuen · Philip Fisher · Christian Strupp · Christine Lorez · Jeanne Y. Domoradzki · Christiane Wiemann

Dermal absorption values are used to translate external dermal exposure into potential systemic exposure for non-dietary risk assessment of pesticides. In Europe, one risk assessment assumption is that dermal absorption, expressed as percentage penetration of the applied dose, increases with dilution. While this can be sometimes observed in in vitro dermal absorption studies, it is conflicting with basic toxicological assumptions, namely, that risk is driven by dose, and physiological properties of dermal absorption as described by Fick’s laws. Further, exposure models usually consider dose and not concentration, and other exposure scenarios, for example, exposure to dried residues, are not appropriately modelled by the default study designs.

One key observation of the current project was that applied dose and absolute amount absorbed seem to better characterize dermal absorption properties than concentrations and relative amount penetrated. This allows the derivation of an average relative dermal absorption value from dermal absorption studies conducted with multiple concentrations. Thus, exposure calculations can be tremendously simplified as potential systemic exposure depends only on exposure dose and not assumed and hypothetical exposure concentration.

If the regulatory framework was better implemented and strengthened with appropriate regulatory guidance, the EU could become a market more suitable for the development of biopesticides.
Indeed, the EU Farm to Fork Strategy seeks to accelerate a paradigm shift for sustainable food production and consumption in the European Union and beyond.

And with nature as a starting point, we have more opportunities to develop crop protection products that have a much greater potential to be sustainable.

We need to remember, though, that while offering many benefits, biopesticides are not a one-to-one replacement for conventional pesticides. Together these solutions play an important role in building a bigger, more robust toolbox for farmers through Integrated Pest Management (IPM) practices.

Just like medicines, pesticides are subject to regulations. Farmers must comply with Good Agricultural Practice (GAP), following the basic principle of using pesticides as little as possible and only when necessary.

The use of pesticides is authorised only after an independent expert risk assessment has checked that any residues remaining after correct use of the product will not lead to any consumer concern nor harm the environment.

The potential residues on a harvested crop are regulated by a Maximum Residue Level (MRL) which is set based on data and As Low As Reasonably Achievable; the ALARA principle.

CropLife Europe is constantly engaged in providing scientific input for improving methodologies to assess pesticidal products. In an interlaboratory ring-trial organized by us in collaboration with academia and conducting laboratories. This effort demonstrates the robustness and reproducibility of the in vitro methodology for dermal absorption and supports the applicability of animal-free test methods.

Genetically modified (GM) food and feed products can only be authorised in the EU if they have undergone a rigorous risk assessment by the European Food Safety Authority (EFSA), which evaluates their impact on human and animal health, and environmental safety.

GM food and feed products can only be authorised in the EU if they have undergone a rigorous safety assessment by the European Food Safety Authority (EFSA).

Genetically modified (GM) crops have been increasingly cultivated and consumed worldwide since the mid-1990’s. Between 1996 and 2019, the area of biotech crops increased 112-fold, making it the fastest adopted agricultural technology worldwide.An estimated 17 million farmers and their families benefit from GM technology today.

The import of genetically modified (GM) crops by the European Union contributes to environmental,
social and economic sustainability goals in the EU and in producing countries.

• Chemical Strategy for Sustainability and impacts on the PPP regulatory framework
• Guidance document on Operator exposure
• Guidance document on predicting environmental concentrations in soil
• Co-formulants/Annex III
• Allocation of Rapporteur Member States to facilitate pre submission meetings
• CropLife Europe conference

1.We support the EU ambition to act on global environmental issues in the framework of
international fora such as the United Nations Convention on Biological Diversity and
animal welfare via the sister organization to Codex with competence for animal health, the OIE1.

2. We call on the European Union to follow sound scientific evidence in setting Codex Alimentarius standards.

3. The integration of non – consumer safety and non – food trade related factors in Codex risk management could create unjustified barriers to trade or even block the important work of Codex.