EU Plant Biostimulant Definition
What counts as a plant biostimulant in the EU?
In the EU, a plant biostimulant is a fertilising product that works by stimulating the plant's own nutrition processes, independently of any nutrients it contains. Its sole aim must be to improve one or more of four things in the plant or its rhizosphere: (a) nutrient use efficiency, (b) tolerance to abiotic stress, (c) quality traits, or (d) the availability of confined nutrients in the soil or rhizosphere. This is Product Function Category (PFC) 6 in Annex I of the Fertilising Products Regulation, (EU) 2019/1009 [1].
Approach: I read the in-force consolidated text of Regulation (EU) 2019/1009 (version dated 1 July 2026) and the recitals of the 2019 base act.
The definition, word for word
- Annex I, PFC 6 point 1 (from the regulation's consolidated text): "A plant biostimulant shall be an EU fertilising product the function of which is to stimulate plant nutrition processes independently of the product's nutrient content with the sole aim of improving one or more of" the four characteristics above [1].
- Article 47 of the FPR added the same definition to the Plant Protection Products Regulation (EC) No 1107/2009, as Article 3(34). It also changed Article 2(1)(b) of that regulation. Plant protection products now cover products that influence plant life processes "other than as a nutrient or a plant biostimulant" [2].
Where the line is drawn
- Recital 22 gives the reasoning. Biostimulants are "not as such inputs of nutrients". Where they aim solely at the four effects, they are "more similar to fertilising products than to most categories of plant protection products". They therefore qualify for CE marking and fall outside Regulation 1107/2009 [3].
- Three practical limits follow:
- The four effects are the only ones allowed.
- The stress must be abiotic. Pests and diseases are biotic stresses and are not covered.
- An EU fertilising product may contain an active substance under 1107/2009 "only if" it has no plant protection function (Annex I Part II point 5a) [4].
- The claimed function "shall be supported by the product's mode of action, the relative content of its various components, or any other relevant parameter" (Annex I Part II point 3) [4].
- The product "shall have the effects that are claimed on the label for the plants specified thereon" (PFC 6 point 4) [1].
- Article 80(8) of 1107/2009 is a transitional rule. Products authorised as plant protection products on applications submitted before 15 July 2019, which now meet the biostimulant definition, stay under 1107/2009 for the duration of their authorisation [2].
Subcategories
- PFC 6(A), microbial: "shall consist of" a micro-organism or consortium of micro-organisms referred to in CMC 7 (Annex II Part II). Pathogen limits apply; for example, Salmonella must be absent in 25 g or 25 ml. Liquid forms need a pH that suits both the micro-organisms and the plants [1].
- PFC 6(B), non-microbial: any plant biostimulant that is not microbial, with its own pathogen limits [5].
Other requirements for qualifying as PFC 6
| Requirement | Detail |
|---|---|
| Contaminant limits (mg/kg dry matter) | Cd 1.5; Cr VI 2; Pb 120; Hg 1; Ni 50; inorganic As 40 [1] |
| Copper and zinc | Cu ≤ 600 mg/kg dry matter; Zn ≤ 1 500 mg/kg dry matter [1] |
| Conformity assessment | Module A (internal production control) "must not be used" for PFC 6 [6] |
| Label (Annex III) | Physical form; production and expiry date; application method(s); effect claimed for each target plant; efficacy-relevant instructions, including incompatibility with plant protection products. Microbial products must list all intentionally added micro-organisms or strains, give their concentration (e.g. cfu/g), and carry the phrase "Micro-organisms may have the potential to provoke sensitising reactions" [7] |
| Tolerances | Quantity ± 5 %; microbial concentrations ≤ 15 % deviation [8] |
These rules only apply to products sold as CE-marked EU fertilising products. I could look up which micro-organisms CMC 7 currently allows, or which harmonised standards cover biostimulant claims.
How do I get a biostimulant CE marked?
For a plant biostimulant there is no self-certification: you must bring in a notified body. Module A (internal production control) "must not be used" for PFC 6 [6]. You have two routes. One is EU-type examination by a notified body (Module B) followed by conformity to type (Module C). The other is approval of your quality system by a notified body (Module D1). Once conformity is shown, you draw up the EU declaration of conformity and put the CE marking on the product with the notified body's number [9][10].
Approach: I read the in-force consolidated text of Regulation (EU) 2019/1009 (version of 1 July 2026): Articles 4 to 18 and Annexes IV and V.
Step 1: Make the product meet Annexes I to III
The product "shall" meet the PFC 6 requirements in Annex I and the requirements for its component material categories (CMCs) in Annex II. It must also be labelled under Annex III (Article 4(1)) [11]. Conformity with harmonised standards published in the OJ, or with Commission common specifications, gives a presumption of conformity for the requirements they cover (Articles 13 and 14) [12][13].
Step 2: Choose the conformity assessment module (Annex IV Part I)
| Route | When it can be used for a biostimulant |
|---|---|
| Module B + Module C | Only if the product is made solely of the listed CMCs. These are: CMC 2 (plants, plant parts or plant extracts); CMC 7 (micro-organisms); CMC 9 (polymers other than nutrient polymers); CMC 10 (animal by-product derived products); a nitrification, denitrification or urease inhibiting compound under CMC 1; and the CMCs in point 1.1 (CMC 1 virgin materials, CMC 4 fresh crop digestates, CMC 6 food industry by-products, CMC 8 nutrient polymers, CMC 11 by-products) [6] |
| Module D1 | "May be used for any EU fertilising product" [6]. So if any ingredient falls in a CMC outside the B+C list (for example CMCs 3, 5, 12 to 15), D1 is the route. |
Step 3: Build the technical documentation
You "shall" draw up the technical documentation before placing the product on the market (Article 6(2)) [9]. It must include a risk analysis and assessment and, where applicable, at least the following [14][15]:
- a product description, the claimed PFC and the intended use;
- the component materials, their CMCs, and their origin or manufacturing process;
- a description of the manufacturing process;
- a specimen label or leaflet meeting Annex III;
- the harmonised standards or common specifications applied (and which parts, if only partly applied);
- calculations, examinations and test reports;
- for animal by-product derived products, the commercial documents or health certificates and evidence that the end point has been reached;
- for waste by-products, evidence of compliance with the by-product criteria;
- where total chromium is above 200 mg/kg dry matter, its maximum quantity and exact source.
Under D1, materials from CMCs 3, 5, 12, 13, 14 or 15 also need a written description and a diagram of the production process [16].
Step 4a: Module B (EU-type examination) then Module C
- Application: lodge it with "a single notified body of his or her choice". Include a written declaration that no other notified body has the same application, the technical documentation, representative samples, and supporting evidence that the design is adequate (point 3) [15].
- Assessment: the notified body examines the documentation and tests the samples. It checks that harmonised standards or common specifications were applied correctly. Where they were not applied or do not exist, it checks that your own solutions meet the Regulation [17].
- Certificate: if the type complies, the notified body issues an EU-type examination certificate. If not, it refuses with detailed reasons. Any change to the approved type that may affect conformity needs an addition to the certificate [17].
- Module C: you make sure production conforms to the certified type. You then affix the CE marking to each package and draw up the declaration of conformity [18].
Step 4b: Module D1 (quality assurance of the production process)
- You run a documented quality system covering production, final inspection and testing [19].
- You apply to the notified body of your choice with the quality system documentation and the technical documentation [20].
- The audit "shall include an assessment visit to the manufacturer's premises" [21].
- After approval, the notified body carries out periodic audits and may make unannounced visits with product testing. You must notify it of any intended change to the quality system [21].
Step 5: EU declaration of conformity
- It follows the Annex V model. It names the product, the manufacturer, the standards or specifications used, and the notified body's name, number, intervention and certificate or approval number [22].
- It "shall be continuously updated" and translated into the languages required by each Member State where the product is placed or made available.
- By drawing it up, you take responsibility for the product's compliance (Article 16) [23].
Step 6: Affix the CE marking
- It "shall be affixed visibly, legibly and indelibly". It goes on the packaging or, for unpackaged product, on an accompanying document, before the product is placed on the market.
- It is followed by the notified body's identification number (Article 18) [10].
After you place the product on the market
- Records: keep the technical documentation and declaration of conformity for 5 years after placing on the market [9].
- Ongoing duties under Article 6:
- Authorised representative: one appointed by written mandate cannot take over drawing up the technical documentation (Article 7) [25].
- Importers: if you import, you must check that the conformity assessment and documentation are in place, and put your own name and address on the pack (Article 8) [26].
If you tell me which component materials your biostimulant contains, I can check whether it qualifies for Module B+C or has to go through D1.