STAPHYT: Current State of Biostimulants Regulation in the EU markets

Date:07-21-2021

1.Background

The placement of biostimulants in the EU markets has been uncertain before 2019 in terms of definition, market placement and regulation. Often grouped with either fertilisers, plant hormones, or biopesticides; or considered to be a magical group of additives enhancing a broad range of quality aspects. The EU regulation 2019/1009, issued in 2019, has clearly placed Biostimulants in a regulatory legal framework.

Products considered to be biostimulants have been used in horticulture and agriculture for many years, these traditionally were acid types (humic and fulvic acid extracts; or seaweed (alginic acid)) and plant hormones; all advertised to improve an aspect of the plant for commercial benefit. The manufacture and finished product for sale was not always consistent, the mode of action not always known, however the benefits were often visible in the advertising and promotional materials: more vigorous growth, more vibrant flowering, and an overall improved plant compared to one without the biostimulant. It was often uncertain if the biostimulant directly affected the plant, a soil conditioner/improver, or was an adjuvant improving plant protection products, or indeed affected the general nutrition of the plant/crop as a fertiliser. It is important to now understand the function, composition and benefits because this directs the applicant for certification, to the regulatory framework and the route to market.

The products were previously not easy to place in a regulatory structure; fertilizer regulations in the EU were not adequate and PPP and EU Biocide regulations were clearly inappropriate.

Because of the perceived ease of access and slight regulation, and the environmental benefits to reuse waste products, and the obvious ecological benefits to reduce the application of fertilisers there has been a vast increase in products claiming a biostimulant effect. 

The market was previously dominated by small and medium sized companies, selling to local markets, now after Mergers & Acquisitions, and attracting trans-national supply companies to enjoy the benefits of this developing market.

2.Biostimulant Definitions

There are many definitions offered by companies marketing these products but the key definition in Europe is now taken from the regulations: the following is taken from EU Regulation 2019/1009:

"Certain substances, mixtures and micro-organisms, referred to as plant biostimulants, are not as such inputs of nutrients, but nevertheless stimulate plants' natural nutrition processes. Where such products aim solely at improving the plants’ nutrient use efficiency, tolerance to abiotic stress, quality traits or increasing the availability of confined nutrients in the soil or rhizosphere, they are by nature more similar to fertilising products than to most categories of plant protection products. They act in addition to fertilisers, with the aim of optimising the efficiency of those fertilisers and reducing the nutrient application rates."

“plant biostimulant” means a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:

(a) nutrient use efficiency;

(b) tolerance to abiotic stress; 

(c) quality traits;

(d) availability of confined nutrients in soil or rhizosphere.

3.Biostimulant regulations in the EU

The regulation:

REGULATION (EU) 2019/1009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003. 

The regulation is substantial, comprehensive and in detail for all fertiliser products. The relevant parts for Biostimulants are presented in this article and in particular the following key elements are summarised here and only for Biostimulants. 

Reasons for revision and preliminary remarks:

To include recycled and organic products whereas before the fertiliser regulations were principally for mined and inorganic fertilisers.

To include supplements to improve fertilizer efficiencies and improved uptake of nutrients and micro-nutrients (ie biostimulants).

To provide a legal framework for the free movement within the EU for a host of materials that previously had been included in plant protection regulations including biocides; and implemented by individual member states within the EU with varying. degrees of vigour.

To provide a registration and certification process [including quality control and responsibilities (including authorized persons)] for marketing and distribution of the products included in the regulations 2019/1009.

To provide a harmonized set of regulations for the EU market, although for non-regulated products it is interesting that non-certified products (not carrying the CE mark) will be allowed and not included in these regulations. This is because there are local products in local markets that may continue and not require to be certified. This is unusual and not consistent with other Harmonised regulations or intentions within the EU; the author believes there is an expectation for producers to comply with the regulations, that new products will need to comply and non-certified products will be encouraged to comply.

Their will be agencies in Member States with responsibilities to register regulated products, and notified bodies to prepare the testing, dossier and certifications. The product on the market is presumed to conform if the product complies with specific annexes and requirements in the regulations.

There will be a transition period to July 2022 – and the new laws will apply when the case arises before the end of the transition period.

Process – research to assess the product performance, development of product for consistent product to be marketed, data to provide evidence for the dossier, compilation of the dossier, appointment of Authorised Persons, application to Notified body. 

4.Experience - Case Studies:

There are 4 case studies presented here:

1.TOMATO & CUCUMBER crops – standard protocol

For tomatoes and cucumbers there is a standard protocol, used as a baseline for most crops

  1. Visual - color/vigor, general health

  2. height of the plant 

  3. Number of flowers 

  4. Chlorophyll content 

  5. Determination of analytical parameter in leaves pH, Nitrate, Calcium, Potassium, Salt, Sodium 

  6. Yield (marketable and non-marketable) 

    a. number of fruits. Calculate cumulative no. of fruits/ha

    b. weight of all harvested fruits

  7. Root measurement 

    a. weight of root

    b. root length

    c. root volume 

  8. weight of aerial parts of the plant. 

2.OILSEED RAPE (OSR):

  1. Phytotoxicity Percentage of total leaf area affected by chlorosis and necrosis. Record any other symptom or plot differences observed using a scale appropriate to symptom1 Plot

  2. Vigor 

  3. Biomass total weight

  4. number of branches

  5. number of pods per plant

  6. number of seeds per pod 

In addition other factors specific to OSR can be included:

  • Biomass sampling (fresh weight)

  • Biomass sampling (dry weight)

  • Number of first order branches on a sample of 20 plants per plot

  • Number of pods per plant on a sample of 10 plants per plot

  • Number of seeds per pod on a sample of 200 pods per plot

  • Number of grains per plant

  • Gross weight of grain per plot

  • percentage of moisture of grain

3.CLEMENTINE:

In addition to the standard protocols there can be measures of quality items for consecutive years

  1. height and width of tree 

  2. phytotoxicity 

  3. number of fallen fruits per tree

  4. harvested fruit weight (kg) on 3 trees/plot-number of harvested fruits/tree on 3 trees/plot-fruit grading (diameter, 3 classes) on 200 fruits/plot

  5. following year - flower production as % relative to the untreated control

Trial results:

  • from an overall point of view, were the treated plots visibly better than the untreated ones?

  • visible efficacy of test product(s) compared to the references (straight products)?

  • is there any treatment(s) faster than the others ?

  • is there a visible timing or adjuvant or dose effect? (if relevant)

4.PEARS:

A measure of effects of biostimulanmt. Product applied as label and the assessment against a control for:

  1.  Phytotoxicity  - as ap percentage of total leaf area affected by chlorosis and necrosis. Record any other symptom or plot differences observed using a scale appropriate to symptom 

  2.  Crop vigor – measured on a 0-100 linear scale, where 0 = no crop and 100 = the most vigorous plot within the replicate 

Other factors to be measured number of:

  • Flowers

  • Fruits

  • fruit setting

  • Fruit colour

  • Fruit weight 

  • Yield