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Exporting biopesticides to the European Union (EU) requires meeting a series of regulatory requirements that depend on the type of product, its composition and its intended use.
EU legislation does not set a single category for all biopesticides. Instead, it regulates them mainly as plant protection products or as biocides.
1. Product classification
Biopesticides may fall under two main regulatory frameworks, depending on their purpose:
- Plant protection products: intended to protect crops against pests and diseases. They are regulated by Regulation (EC) No 1107/2009 and include products based on microorganisms, plant substances, peptides, RNA technology, bacteriophages and pheromones.
- Biocidal products: intended to control harmful organisms in certain non-agricultural settings. They are regulated by Regulation (EU) No 528/2012 (BPR), depending on the use and the product type.
For example, a microorganism used to protect crops from fungi is processed as a plant protection product, while a natural insect repellent for household use is processed as a biocide.
Some products marketed as biopesticides stimulate the plant’s nutritional processes without acting directly against pests or diseases. In these cases, they may be regulated as fertilisers under Regulation (EU) 2019/1009 or under each country’s national legislation, depending on product characteristics such as composition and uses. The purpose and claims of the product determine the applicable regulatory pathway.
2. Active substance approval and product authorisation
It is important to distinguish between the approval of the active substance and the authorisation of the commercial product. The procedures vary depending on the category.
Active substance approval
- Plant protection products: the evaluation is carried out under Regulation 1107/2009. The European Food Safety Authority (EFSA) assesses the risks, while the European Commission and the Member States take part in the approval process.
- Biocides: the active substance is approved under the BPR, following the evaluation of a competent authority (the European country chosen) and the opinion of the European Chemicals Agency (ECHA).
Commercial product authorisation
The approval of an active substance does not automatically authorise any product that contains it. Authorisation is also required for the formulated product and its intended uses.
- Plant protection products: authorisations are granted by the Member States once the active substances have been approved (products cannot be marketed before that). The EU is divided into North, Central and South zones for certain procedures, and mutual recognition can make it easier to obtain authorisation in other countries once the first authorisation has been granted.
- Biocides: depending on the status of the active substance (approved or under review), national or European regulatory procedures may be used (these would be initial authorisation or mutual recognition, and Union authorisation is also an option).
3. Requirements for manufacturers outside the EU
EU-established entity
Non-EU manufacturers must check which entity needs to assume the regulatory obligations. For biocides, the authorisation holder must be established in the EU. For plant protection products, the requirement applicable to the applicant must be verified. Depending on the case, importers, distributors or regulatory consultants established in the Union may be involved.
The Only Representative is provided for in certain circumstances under REACH, but it is not a mandatory role for all biopesticides.
Authorised active substance supplier in the EU
For plant protection products, the supplier must be authorised as such in each European country where you want to access the market with a plant protection product. For biocidal products, on the other hand, it is only necessary to register as a supplier with ECHA under the guidelines of Article 95 of the BPR.
Labelling and chemical obligations
The CLP Regulation (EC) No 1272/2008 sets classification, labelling and packaging requirements for the substances and mixtures within its scope. Where applicable, pictograms, hazard statements and the required information must be included, respecting the language requirements of the destination country.
The REACH Regulation may also impose obligations on substances present in the product, such as co-formulants. Its application depends on the composition, the use, the quantities and any possible exemptions. The natural origin of a substance does not automatically mean it is exempt.
Likewise, both the plant protection product and biocide regulations establish specific labelling rules.
4. Customs and logistics requirements
In addition to complying with marketing regulations, exporting requires preparing the documentation needed for customs clearance and import.
- Customs documentation: commercial invoice, transport documents and customs declaration, as applicable.
- EORI number: the operator responsible for customs operations in the EU must have this number when it is mandatory.
- Product authorisation: before marketing the product, the authorisations needed for the use and the destination market must be checked.
- Labelling and safety: the applicable requirements must be met and a safety data sheet must be available when required.
The specific requirements depend on the product, the destination country and the characteristics of the operation. You can consult the European Commission’s market access guide.
How Kaeltia can help you
Exporting biopesticides to the EU requires a detailed study of the product’s uses, its composition and its potential risks. From there, you can identify the applicable regulations, check the status of the active substances it contains and determine the necessary authorisations.
Kaeltia can help you assess the regulatory requirements for your biopesticide and define the steps needed to access the European market. Contact our team to review your case.
