PPP

The Plant Protection Products Regulation – Regulation (EC) No 1107/2009

Regulation of plant protection products in the European Union

Plant protection products (PPP), often referred to as pesticides, are typically formulated products containing active substances intended to protect cultivated plants from harmful organisms such as insects, weeds and fungi.

Regulation (EC) No 1107/2009, known as the Plant Protection Products Regulation (PPPR), sets out the rules and procedures for placing professional and amateur-use PPPs on the market in EU Member States. The regulation applies to both conventional PPPs containing chemical active substances and biopesticides containing active substances of biological origin, such as microorganisms and plant extracts.

A primary goal of the regulation is to ensure PPPs placed on the market are safe for humans, animals and the environment, while also ensuring they have been demonstrated to be sufficiently effective. To achieve this, the regulation establishes a two-stage process to registration of PPPs, including:

  • EU-wide Active Substance Approval: Any active substance that is to be used in a PPP must first have been approved at EU level.
  • national authorisation of the PPP: Following approval of an active substance, any PPPs containing that active substance must first be authorised for use in the EU states where it is to be placed on the market.

Supporting active substance approvals and gaining PPP authorisations can be lengthy and complex processes with comprehensive packages of technical information on the active substance and PPP being required to be generated by applicants to support registration. While the PPPR aims to harmonise rules for bringing PPPs to market across the EU, many Member States have nation-specific requirements that must be addressed as part of the PPP authorisation process.

Enviresearch’s diverse team of regulatory specialists and scientists, with backgrounds from agrochemical manufacturers, chemical regulators and research institutions, has been routinely supporting the agrochemicals industry with PPP registrations since the introduction of the PPPR in June 2011. Our team will work with you to develop a flexible and tailored service package to support each step of your pathway to successful authorisation of your PPPs, covering:

  • regulatory strategy development for authorisation of PPPs in Member States across northern, central and southern EU zones
  • project management for each step of the regulatory pathway to gaining PPP authorisation
  • complete data gap analysis of active substance and product data packages, including assistance in devising and implementing strategies to address identified gaps
  • technical support in the analysis, interpretation and reporting of active substance and product data in the appropriate regulatory context and specific to the intended use patterns of the product
  • performing all human health and environmental risk assessments required to support product authorisation
  • providing full dossier preparation and submission to support new product authorisations, Article 43 product renewals, mutual recognition and label extensions
  • providing full dossier preparation and submission support for technical equivalence applications for new active substance sources for use in PPPs.

Regulation of plant protection products in Great Britain

Following the United Kingdom’s exit from the EU, an independent regulatory framework for plant protection products has been in operation in GB as of 1 January 2021. The GB framework was established via a ‘lift and shift’ of Regulation (EC) No 1107/2009 into UK law, with amendments made where necessary to the text to make it operable in a GB-only context. In practice, the ‘retained’ regulation in GB is still known as ‘Regulation (EC) No 1107/2009’ and continues to broadly mirror the rules and instruments laid down in the EU PPPR. However, the GB PPPR is entirely independent of the EU PPPR, meaning separate active substance approvals and PPP authorisations under the GB PPPR must be gained before products can be placed on the GB market. There are no longer mechanisms in place for ‘mutual recognition’ of product authorisations that have been granted under the EU PPPR as a route to market in GB.

To add further complexity, Northern Ireland (NI) remains subject to the EU law (and hence the EU PPPR) due to the NI Protocol that was established as part of the UK’s exit from the EU. Hence, when seeking market access to both GB and NI, applicants may be required to submit separate applications for each region. Since the outcome of the Brexit vote, Enviresearch has been closely working with our clients to manage the transition to the new GB framework and ensure continued market access in the region. Our consultants are proactively engaging with the adoption of the GB PPPR in parallel with our continuing work to support our clients with product registrations and compliance under the EU PPPR. When looking to bring your products to both GB and EU/NI markets, Enviresearch can support you in developing and managing consolidated GB/EU/NI strategies toward achieving cost-efficient product registrations across each region.

Regulations

PPP
BPR
REACH
CLP
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