Plant Protection Products in Spain: Legal Guide to Regulation 1107/2009
By Daniel Zelvinsky | Lawyer | Martin & Pares Abogados
The marketing and use of plant protection products in the European Union is subject to one of the most demanding regulatory frameworks in the world. Regulation (EC) No 1107/2009 of 21 October establishes the conditions under which these products may be authorised, marketed and used in Member States, with the aim of protecting human health, animal welfare and the environment.
For companies in the agri-food sector — whether manufacturers, distributors or professional users of plant protection products — compliance with this framework is not a peripheral concern: it is a directly applicable obligation giving rise to administrative and, in certain cases, criminal liability. At Martin & Pares Abogados, with extensive experience in agricultural law and corporate compliance, we find that the main legal risks faced by many businesses in this sector stem precisely from inadequate knowledge or poor management of this regulatory framework.
This guide sets out the key legal aspects of Regulation 1107/2009 as they stand in 2026, with particular attention to authorisation requirements, the new digitalisation obligations and the applicable sanctions regime.
Scope and purpose of Regulation (EC) No 1107/2009
Regulation 1107/2009 establishes the authorisation system for plant protection products across the EU. Unlike the Directive 91/414/EEC it replaced, this is a directly applicable instrument in all Member States: it requires no transposition and has been binding since its publication.
Its scope covers:
- Plant protection products in their commercial form: herbicides, fungicides, insecticides, etc.
- Active substances, safeners, synergists and adjuvants contained in such products.
- The activities of marketing, distribution and professional use of those products.
The governing principle of the Regulation is the precautionary principle: no active substance may be approved if there is reasonable scientific uncertainty about its effects on health or the environment.
The authorisation system: two mandatory levels
The authorisation structure operates at two distinct levels that companies must understand:
Approval of active substances: EU level
The active substances that make up a plant protection product must be approved at European level by the European Commission, following an opinion from the European Food Safety Authority (EFSA). Only substances included on the EU positive list may be incorporated into products marketed across the Union.
Approvals are time-limited and subject to renewal. The Spanish Ministry of Agriculture (MAPA) maintains an up-to-date list of approved, excluded and under-review active substances. The most recent version, from April 2026, includes dozens of substances currently under evaluation or subject to recently modified use restrictions.
Product authorisation: national level
The plant protection product itself must obtain authorisation from the Member State where it is to be marketed. In Spain, responsibility lies with the Directorate-General for Plant Health of the MAPA, which administers the Official Register of Plant Protection Products.
For a plant protection product to be lawfully marketed in Spain, it must be registered with all authorised uses reflected on the label. Marketing an unauthorised product, labelling it for uses that differ from those authorised, or operating with expired registrations constitutes a serious infringement under Law 43/2002 on plant health.
2026 update: mandatory electronic records for phytosanitary treatments
One of the most significant obligations that came into force on 1 January 2026 is the mandatory electronic recording of phytosanitary treatments for all professional operators. This requirement derives from Commission Implementing Regulation (EU) 2023/564 of 10 March 2023 and was incorporated into Spanish law through Royal Decree 34/2025.
The practical implications are considerable:
- More than 800,000 agricultural operators in Spain are required to record every phytosanitary treatment in digital form.
- Records must include the product used, the date, dosage, crop and treated area, and must be available in real time for official inspections.
- Farmers may continue to maintain the rest of the farm diary in paper format until 31 December 2026, but phytosanitary treatment records are already compulsorily digital.
- From 1 January 2028, full digitalisation of the farm diary will be mandatory for holdings above certain size thresholds.
Penalties for non-compliance: a real and quantifiable risk
The sanctions regime established under Law 43/2002 on plant health clearly sets out the consequences of regulatory non-compliance in the plant protection products sector:
- Minor infringements: fines of up to EUR 3,000. These cover minor documentary deficiencies or formal breaches.
- Serious infringements: fines ranging from EUR 3,001 to EUR 60,000. These arise, among other circumstances, from marketing products without authorisation, providing false documentation or failing to comply with authorised conditions of use.
- Very serious infringements: fines from EUR 60,001 to EUR 600,000. These apply where non-compliance creates a serious risk to public health or the environment, or where there is repeat offending.
In addition to these administrative sanctions, businesses in receipt of CAP payments may face reductions in direct payments of up to 100% of their aid entitlement in cases of serious conditionality breach. For a mid-sized holding, that can translate into losses exceeding EUR 20,000 per year.
At Martin & Pares Abogados we have advised businesses in this sector in the context of sanctioning proceedings arising from expired authorisations, off-label use and inadequate record-keeping. Preventive legal defence — through a product portfolio audit and the implementation of a compliance protocol — is considerably more cost-effective than reactive management of a penalty.
Environmental impact on soil, water and biodiversity: regulatory risk in practice
Regulation 1107/2009 requires that, before any authorisation is granted, the impact of the product on groundwater, aquatic organisms, bees and other beneficial arthropods must be assessed. Automatic exclusion criteria apply to substances classified as mutagenic, carcinogenic or endocrine-disrupting.
In practice, this means that a product may be lawfully registered and still generate liability if the company applies it at doses or using methods that exceed the environmental limits set in the authorisation record. Inspections under the National Official Food Chain Control Plan specifically verify these parameters.
For companies operating in the agricultural inputs sector, a periodic audit of their product portfolio against the updated list of approved, excluded and under-review active substances is an essential compliance measure.
Frequently asked questions
A product we use is under EU review. Can we continue using it?
As long as the active substance has not been formally excluded from the EU positive list and the product remains on the Official Register, its use is lawful under the authorised conditions. That said, companies should monitor the review process and identify alternative products, as exclusions can take effect within relatively short adaptation windows.
What does the mandatory electronic record requirement mean for our business?
Since 1 January 2026, all phytosanitary treatments applied by professional operators must be documented electronically with the information prescribed by Implementing Regulation (EU) 2023/564. Non-compliance may result in administrative sanctions and loss of access to CAP support payments.
Can a distributor be penalised for the way a farmer uses a product?
Distributors are responsible for ensuring that products are marketed in accordance with their authorisation. If a distributor markets a product for unauthorised uses or with inaccurate label information, it may be liable for a serious infringement. The end user’s liability is independent, but both may be the subject of parallel sanctioning proceedings.
What is the difference between an excluded active substance and one under review?
An excluded substance may no longer be used in plant protection products in the EU. A substance under review remains lawful under its current authorisation, but is subject to an evaluation that may result in restrictions or exclusion. Companies must distinguish between these two scenarios in their portfolio management.
What kind of legal assistance does Martin & Pares Abogados offer in this area?
The firm provides legal audits of plant protection product portfolios, assistance in authorisation renewal proceedings before MAPA, representation in administrative sanctioning proceedings and the design of compliance programmes tailored to companies in the agricultural inputs and distribution sector.
Do you need legal advice on this matter? At Martin & Pares Abogados we offer a personalised analysis of your situation and a legal response tailored to your case. You can contact us by email at info@martinpares.com, or by telephone at our Madrid office: 910 888 452, or our Barcelona office: 931 164 108.