Plant Protection Products

If you have a product which is classified as a Plant Protection Product, whether it contains one or several active substances, our team of scientists can help.

Is it intended for one or more of the following uses:

  • to protect plants or plant products against harmful organisms or prevent the action of such organisms (for example agricultural/horticultural fungicides and insecticides)
  • to influence the life processes of plants, other than as a nutrient (for example as a growth regulator)
  • to preserve plant products, in so far as such substances or products are not subject to provisions of Community law on preservatives
  • to destroy undesired plants or destroy parts of plants or check or prevent the undesired growth of plants (for example herbicides)?
Plant Protection Products containing approved active substances are authorised by Member States working within three geographical zones. The Regulation also applies to safeners and synergists in plant protection products. New safeners and synergists will need to undergo the same procedures and satisfy the same requirements as for active substances.

Plant Protection Products are regulated in the EU by Regulation (EC) 1107/2009, which aims to harmonise, as far as possible, the registration of plant protection products throughout the European Union. Active substances are approved at EU level, following assessment of both their intrinsic properties (hazard), and the risks arising from the use of the plant protection products which contain them. Active substances that have been shown to be without unacceptable risk to people or the environment are added to the list of approved active substances. Whilst such inclusion in the approved list is time-limited, it can be renewed, or reviewed at any time.


Registration of Plant Protection Products in the EU
  • Active substances – companies must submit a complete data package (dossier) on both the active substance and at least one formulated plant protection product containing that active
  • Hazard and risk assessment – to operators, workers, consumers, the environment and non-target plants and animals
  • Plant Protection Products – Commission Regulation (EU) No. 545/2011 details studies required for formulated products, either to support an application at Member State level following approval of an active, or to support the initial application for approval of that active
  • Uniform Principles – harmonised criteria for evaluating plant protection products at a national level
  • Classification and labelling under the Dangerous Substances Directive, Dangerous Preparations Directive and the EU Regulation on Classification, Labelling and Packaging of Substances and Mixtures
  • Endocrine Disruption An amendment to the plant protection products regulation (Regulation (EU) 2018/605, applying as of 20 October 2018) sets out the scientific criteria for the assessment of the endocrine-disrupting properties of plant protection products. A guidance document produced jointly by ECHA and the European Food Safety Authority (EFSA), provides a detailed methodology for gathering, evaluating and considering all relevant information and fulfilling these regulatory obligations. Bibra has experience of filling the recommended Excel template (Appendix E1) with the relevant data, following the accompanying instructions (Appendix E2) (both available by clicking on “Supplements” in the top left-hand corner of the guidance webpage), and evaluating the resultant “Lines of evidence”


Looking to register outside of Europe? Our team of toxicologists can still help. We have experience in assisting manufacturers intending to sell their pesticides in countries including the USA, putting together “six-pack” (acute toxicity, irritation and sensitisation) datasets to meet the requirements of the US EPA.


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