biopreparados.es

Legislation on bio-preparations

Legislation on bio-preparations

Making bio-preparations for your own use is widely tolerated. The rules mainly concern placing on the market (sale, donation, transfer) and claims: what is promised about a product determines its legal regime. This page brings together the European, French and Spanish frameworks in a documentary summary.

→ Substances authorised in Europe

Authorised recipes by country

Choose a country or territory to see the bio-preparation recipes authorised there, with a summary of the legal framework and the official texts.

See the 22 countries →

What the icons mean: ✅ Authorised ⚠️ Tolerated 🟠 Not prohibited ⛔ Not authorised EU 🔎 Status being verified Full details →

Authorised, tolerated, not prohibited: what our icons mean

What the icons mean: ✅ Authorised ⚠️ Tolerated 🟠 Not prohibited ⛔ Not authorised EU 🔎 Status being verified Full details →

Every recipe on the site has a regulatory status. Hover over or tap an icon anywhere on the site to see its definition. Here are the details.

IconStatusDefinitionExamples
✅AuthorisedThe substance or recipe appears on an official list: EU basic substance (Article 23 of Regulation (EC) 1107/2009), PNPP in France, or a national list of inputs permitted in organic farming. The flags show the territories.Horsetail, willow, whey, bicarbonate (EU); Bordeaux mixture (Brazil, Mexico); fermented plant juice (Philippines).
⚠️ToleratedAllowed only under conditions: certification body approval ('restricted'), maximum dose, limited use or crop, origin of the materials.Copper: 28 kg/ha over 7 years in EU organic farming, 6 kg/ha/year in the Philippines and Morocco, 8 kg/ha/year in East Africa; manure: never from factory farming.
🟠Not prohibitedNo rule forbids it when it is made and used on your own farm. The rules cover sale and claims: no effect against pests or diseases is attributed to it and it is not sold without authorisation.Farm-made liquid plant fertilisers (tithonia tea), manure ferments (jeevamrut).
⛔Not authorised in the EUNo authorisation covers this farm-made preparation in the EU. It may be allowed in other countries: see the flags.Neem decoction: not authorised in the EU, allowed in India, the Philippines, East Africa, Colombia…
🔎Being verifiedThe regulatory status has not been validated yet.New recipes under review.

The same preparation falls under a different regime depending on what is claimed for it: feeding the plant (fertiliser), stimulating its natural processes (biostimulant) or protecting it against a pest or disease (plant protection product, subject to authorisation). A 'not prohibited' recipe remains so as long as it is not sold and no protective effect is attributed to it.

Detailed conditions by territory:

TerritoryOfficial textNotable conditions
European UnionRegulation (EC) 1107/2009, Art. 23; Regulations (EU) 2018/848 and 2021/1165Basic substances: only the uses, doses and preparation methods of their review report. Organic: copper limited to 28 kg/ha over 7 years; manure from factory farming prohibited; at most 170 kg nitrogen/ha/year from livestock manure.
FranceLow-concern natural preparations (PNPP), Rural CodeNatural substances with a biostimulant use on the official list, prepared by a process accessible to any end user.
BrazilLaw 10.831/2003; Portaria MAPA 52/2021, Annex VIIList of substances allowed in organic crop production; several under conditions set by the control body.
MexicoOrganic Products Law (2006) and its LineamientosNational list of allowed substances (sulphur, copper sulphate, lime…).
ColombiaResolution 199 of 2016 (MADR)Most protection products require recognition by the control body; manure from intensive farming only if no organic manure is available; bovine bone and blood meal prohibited (ICA).
PeruD.S. 044-2006-AG; Law 29196Two columns: 'free' or 'restricted' (certifier approval); sulphur, copper, neem and bicarbonate are restricted.
Costa RicaDecree 29782-MAGA = accepted, R = restricted (consult the certifier); manure from intensive farming only composted and when there is no alternative.
ChileLaw 20.089; Decree 2/2016Manure limited to 170 kg nitrogen/ha/year; fresh manure composted unless incorporated 90 to 120 days before harvest; inputs authorised by the certifier in the management plan.
ArgentinaLaw 25.127; SENASA Resolution 374/2016'Preparados caseros intraprediales' (made on the farm for its exclusive use, following organic principles and the Codex) are recognised; manure limited to 170 kg nitrogen/ha/year.
EcuadorAgrocalidad Resolution 0099/2013Manure limited to 200 kg nitrogen/ha/year; microbial preparations allowed for the soil.
UruguayDecree 175/022; DGSA Resolution 673/022List of registered commercial products: copper, sulphur, neem, chitosan, soybean oil.
IndiaNPOP, 8th edition 2024 (APEDA)Preparations made on the farm from local plants, animals and microorganisms are allowed (§3.1.10(iv)); copper under certifier supervision and temporarily; factory-farm manure prohibited if brought in.
JapanJAS for organic plant products (MAFF)Priority to residues from the field; copper sulphate only to make Bordeaux mixture; trace elements only in case of deficiency.
PhilippinesPNS/BAFS 07:2016 and 183:2020Copper limited to 6 kg/ha/year; slaked lime as foliar spray only; fermented plant juice, fermented fruit juice and fish amino acids named in the standard.
South KoreaEnvironmentally-friendly Agriculture Act, Annex 1Copper kept to the strict minimum; slaked lime never directly on the soil; chitosan meeting national standards; neem as a natural extract.
IndonesiaPermentan 64/2013Soap, sulphur, copper and plant extracts only in case of serious threat; manure from organically raised animals.
East Africa (Kenya, Uganda, Tanzania, Rwanda, Burundi)EAS 456 standardCopper limited to 8 kg/ha/year; indicative list (other substances meeting IFOAM or Codex criteria may be accepted); neem, plant teas and milk allowed.
MoroccoLaw 39-12; Order 271-15Copper limited to 6 kg/ha/year (30 kg/ha over 5 years for perennial crops); materials from intensive livestock farming prohibited; at most 170 kg nitrogen/ha/year from manure.
TunisiaLaw 99-30; Order of 28 February 2001Manure from landless livestock farming prohibited; lime sulphur restricted to fruit trees, olive and vine; neem limited to mother plants and ornamentals; copper if the need is recognised.

These rules apply to certified organic operators. Without certification, making preparations on the farm for your own use is generally not regulated; sale and claims, however, are regulated everywhere. Each country has its own 'authorised bio-preparations' page with its official texts.

Documentary summary based on official texts consulted in October 2026. It does not replace legal advice or the opinion of your certification body.

The key principle: the claimed function determines the regime

The same product may fall under different regimes depending on what is announced to the user. The question is never "what is it?" in the abstract, but "what effect is claimed?".

Claimed functionApplicable regimeReference text
Feeding the plantFertiliser (PFC 1)Regulation (EU) 2019/1009
Improving the soilSoil improver (PFC 3)Regulation (EU) 2019/1009
Stimulating the plant's natural processesBiostimulant (PFC 6)Regulation (EU) 2019/1009
Protecting against a harmful organismPlant protection productRegulation (EC) 1107/2009

A product that claims action against a pest or a disease moves from fertiliser or biostimulant status to plant protection product status, which requires authorisation.

The European foundation

TextSubject
Regulation (EU) 2019/1009EU fertilising products (CE marking): fertilisers, soil improvers, growing media, biostimulants. Applicable since 16 July 2022.
Regulation (EC) 1107/2009Plant protection products, active substances, basic substances (Art. 23) and low-risk substances (Art. 22).
Regulation (EU) 2018/848Organic production and labelling of organic products.
Implementing Regulation (EU) 2021/1165Positive lists of products authorised for use in organic production (Annex I: plant protection; Annex II: fertilisers and soil conditioners).
Regulation (EC) 1069/2009Animal by-products: preparations based on bone, shells, blood or fish.
REACH and CLP RegulationsChemical substances: registration, classification and hazard labelling.

The categories of Regulation (EU) 2019/1009

  • Organic fertiliser (PFC 1A): at least 15% organic carbon for a solid (5% for a liquid), with minimum declared nutrient contents.
  • Soil improver (PFC 3A): at least 95% material of biological origin, 20% dry matter and 7.5% organic carbon; this is the category of most compliant composts.
  • Biostimulant (PFC 6): defined by the claimed effect (nutrient use efficiency, tolerance to abiotic stress, quality), not by its nutrient content.
  • Microbial biostimulant (PFC 6A): micro-organisms from a closed list (Azotobacter, Azospirillum, Rhizobium, mycorrhizal fungi).
  • "Biofertiliser" is not a legal category: depending on the claimed function, it falls under PFC 1 or PFC 6A.

Basic substances

Basic substances (Article 23 of Regulation 1107/2009) are approved directly by the European Commission, for an unlimited period, and take effect in all Member States. Several common bio-preparation ingredients are among them:

  • Vinegar — Implementing Regulation (EU) 2015/1108.
  • Whey — Implementing Regulation (EU) 2016/560.
  • Sucrose — Implementing Regulation (EU) No 916/2014.
  • Field horsetail (Equisetum arvense) — Implementing Regulation (EU) No 462/2014.
  • Calcium hydroxide — Implementing Regulation (EU) 2015/762.
  • Lecithins — Implementing Regulation (EU) 2015/1116.

Point of caution: sodium hydrogen carbonate (baking soda), often cited as a basic substance, is in fact approved as a low-risk active substance (Article 22, Implementing Regulation (EU) 2020/1263). The approval of a substance covers the uses described in its review report, not every use.

France: fertilising materials and PNPP

In France, most bio-inputs fall under the rules on fertilising materials and growing media (MFSC, Rural Code, Articles L255-1 et seq.). There are four routes to the market:

RouteDescription
NF U standardProduct covered by a French standard made mandatory (e.g. NF U 44-051 for organic soil improvers and composts).
CE markingProduct compliant with Regulation (EU) 2019/1009.
French AMMMarketing authorisation (AMM) issued by ANSES.
Mutual recognitionProduct already authorised in another Member State.

PNPP (natural preparations of little concern) were created by Law No 2006-1772 of 30 December 2006 and are now governed by Article L253-1 of the Rural Code. "PNPP" covers two distinct regimes:

  • PNPP composed exclusively of basic substances: EU law, exempt from French authorisation.
  • PNPP composed of natural substances for biostimulant use (SNUB): a national category attached to fertilising materials, with the procedure laid down by Decree No 2016-532 of 27 April 2016.

The case of nettle manure: sold without a plant protection claim, it has SNUB status; as soon as a protection claim appears, it falls under the simplified authorisation of the Order (arrêté) of 18 April 2011. One product, two regimes, depending on what is promised to the buyer.

AuthorityRole
Ministry of Agriculture (DGAL)Regulatory texts, plant and animal health surveillance
ANSESAssessment and authorisations (E-Phy database)
INAOOrganic farming
DGCCRFCommercial and claims enforcement

Spain: fertilising products

In Spain, fertilising products are governed by Real Decreto 506/2013 on fertilising products and Real Decreto 1051/2022 on the sustainable nutrition of agricultural soils, which creates the REGFER register (Registro general de fabricantes y otros agentes económicos de productos fertilizantes). Plant protection products are listed in the Registro Oficial de Productos Fitosanitarios of the Ministry of Agriculture (MAPA), pursuant to Regulation (EC) 1107/2009.

Organic farming: two cumulative checks

A product may be legal to sell and yet prohibited for a certified organic operator, and vice versa. Two conditions must both be met:

  1. Can the product be legally placed on the market (CE marking, AMM, standard)?
  2. Is it listed by name in Annex I or II of Implementing Regulation (EU) 2021/1165, in its version currently in force?
  3. Are any conditions of use attached to it (origin, contaminants, source separation)?
  4. Can the supplier provide written evidence of this?

What this means for this site

biopreparados.es is a documentary collection. The recipes and ingredient sheets describe traditional practices and the composition of preparations; they constitute neither a recommendation for use nor a plant protection or veterinary claim. Before any use, and all the more before any sale or transfer, check the regulations in your country.

Sources

Documentary summary up to date as of 9 October 2026, not legal advice. The precise status of a preparation depends on its composition and use, and must be checked case by case.