Plant Protection Products Regulation (EU)

The Regulation sets out comprehensive approval criteria for active substances at the EU level and procedures for product assessment within a zonal authorization framework. It also provides the basis for a comprehensive renewal programme for existing approved active substances (the ‘AIR’ programme).

Whilst the regulation derives from the EU, authorisation of plant protection products is the responsibility of each EU Member State. Despite ongoing efforts at harmonization and mutual recognition procedures, some Member States maintain different administrative, regulatory or data requirements. These requirements and their constant evolution represent a challenge for companies wishing to place their plant protection products on the market.

TSG's EU plant protection regulation consulting

We offer a wealth of expertise, gained from industry, government, and research providing you with effective support and guidance for ensuring and gaining regulatory compliance for active substances and plant protection products
Our multidisciplinary team of scientists, regulatory and registration specialists allows us to provide support across a variety of areas, including study monitoring, task force management and dossier preparation, including CADDY services
We hold core knowledge and expertise in the use of the IUCLID software application. Our regulatory experts routinely use IUCLID for Biocidal Products Regulation and REACH submissions. We are thus well placed to support PPP clients with the new IUCLID submission requirements arising from the EU Transparency Regulation (2019/1381)
We have a proven record of achieving numerous successful regulatory outcomes with applications for new active substances and renewals of existing active substances (under the AIR programmes)
We are experienced in all types of product authorisations (reauthorisation under Art. 43, zonal applications under Art. 33, mutual recognition, and other types of national authorisations)
We have extensive experience in dealing with regulators; and with our network of offices in France, Spain, Germany and the UK, we continue to provide an extensive pan-European product registration and reauthorisation service
We provide strong and proactive project management to ensure that our clients’ needs are identified and met in a timely manner

Why TSG

TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.

Our professionals

TSG's team of scientists and regulatory consultants manage all aspects of approving active substances and products for the plant protection industry.

Meet our consultants

EU plant protection products - frequently asked questions

How long does it take to obtain active substance approval in the EU?

The procedure for obtaining approval for a new active substance is complex and can take anywhere between 3 to 5 years. One of the key things that will help expedite the process is good advice during pre-submission preparation.

We’re created a handy guide outlining the process, which can be download here: 12 steps to secure EU active substance approval for plant protection products.

Our consultants routinely support companies in the active substance approval process, helping evaluate the options available so clients can decide on the best way forward.

Get in touch at [email protected] to have a no-obligation chat with our plant protection team about obtaining EU active substance approval for your products.

When do I need to apply to renew my active substances in the EU?

Applicants must apply for renewal of their active substances 3 years before the expiry date. The first step is to analyse all the current data requirements, identify data gaps and focus the the GAP where needed. Then, the dossier must be prepared and submitted to the Rapporteur Member State at least 36 months before the expiry date.

TSG has created a handy guide outlining the process, which can be downloaded here: 11 steps to secure EU active substance renewal for plant protection products.

Get in touch at [email protected] to learn more about how TSG can support you through the application and dossier submission process.

What is the AIR programme?

The Annex I Renewal - or AIR - programme relates to EU regulation that has been put in place to control the process of renewing EU approval of active substances in plant protection products.

In the EU, the approval status of an active substance has a maximum period of 10-15 years. After this (although it could be earlier if the authorities deem it appropriate), the active substance must be re-approved for use and sale in the EU.

How are biopesticides regulated?

Although biopesticides are perceived as a more ‘natural’ type of product, they are still regulated under the Plant Protection Regulation (EU) No. 1107/2009.

What format should I use to submit an active substance dossier in the EU?

The format for EU active substance dossier submission in the EU is mandated in regulation. Typically this is EU format, with CADDY being a convenient electronic format for the dossier (CADDY is mandatory in certain geographies).

2021 is seeing the introduction of mandatory IUCLID submission platform use for all active substance and MRL dossiers.

Which submissions do I need to make through the IUCLID platform?

The EU Transparency Regulation (2019/1381), which comes into effect on 27 March 2021, requires the following plant protection product submission types to be made via the IUCLID platform:

Submission and management of active substance dossiers (Regulation (EC) No 1107/2009)
Maximum residue limit (MRL) and import tolerance (IT) applications (Regulation (EC) No 396/2005)

For support in using the IUCLID platform and guidance on the related EFSA Hypercare programme, get in touch with us at [email protected]. Our regulatory experts routinely use IUCLID for Biocidal Products Regulation and REACH submissions and are well placed to support you in this new, challenging process.

EU Plant Protection Products Regulation