ORGANIC HETEROGENEOUS MATERIAL
Definition and marketing regime
In April 2018, after several years of tough negotiations at the European scale, the sustainable seed sector won a crucial battle in Brussels, through the adoption of a new European Regulation on organic production.
Among various positive changes, Regulation n°2018/848 on organic production has opened the possibility, for all operators and from January 2022, to place seeds of "organic heterogeneous material" on the market, for use in organic farming, home gardening but also in conventional farming.
This possibility should enable organic farming to achieve its fundamental objectives, and in particular "to contribute to a high level of biodiversity", as well as to facilitate "the control of pests and weeds" by preventing damage caused by them, according to the terms of the Regulation itself (Article 4 and Annex II Part I - point 1.10.1).
It should also enable to meet one of the essential requirements of organic production: for the production of plants and plant products, only organic plant propagating material (seeds, tubers, etc.) may be used. The availability on the market of new categories of organic seed should help to put an end to the numerous derogations to this basic rule.
Article 3 (18) of Regulation No. 2018/848 defines OHM as:
"a plant grouping within a single botanical taxon of the lowest known rank which:
(a) presents common phenotypic characteristics ;
(b) is characterized by a high level of genetic and phenotypic diversity between individual reproductive units, so that the plant grouping is represented by the material as a whole, and not by a small number of units ;
(c) is not a variety within the meaning of Article 5(2) of Council Regulation (EC) No 2100/94 (2) ;
(d) is not a mixture of varieties; and
(e) has been produced in accordance with this Regulation;"
In other words, these are 'varieties' - in the common sense of the term - whose individuals (the 'different reproductive units') are not absolutely identical or homogeneous, but instead show a great diversity of botanical traits between them, while retaining common characteristics, which make it possible to link these individuals as belonging to a particular 'variety'.
OHM cannot be a 'variety' within the meaning of Article 5 (2) of Regulation N° 2100/94 "on community plant variety rights", because it is not uniform. The intellectual property regime created by that Regulation lays down a definition, exclusive of any other, of the 'variety': in order to receive that designation, the plant grouping must be new, distinct, uniform and stable. Upon these conditions, it is possible to obtain plant breeder's right on the 'variety'. OHM cannot therefore be protected by a plant breeder's right. It therefore belongs, because of its heterogeneity, to the public domain.
In the same sense, OHM may not be a mixture of 'varieties' - again, within the meaning of Regulation No 2100/94 - because it cannot be the addition, in the same batch, of homogeneous 'varieties', protected by intellectual property rights.
Finally, in order to be placed on the market under this designation, OHM must have been produced under organic farming conditions, i.e. as laid down in Point 1.8.2 of Annex II Part I (relating to the rules applicable to the production of plants) of the Regulation:
« To obtain organic plant reproductive material to be used for the production of products other than plant reproductive material, the mother plant and, where relevant, other plants intended for the production of plant reproductive material shall have been produced in accordance with this Regulation for at least one generation or, in the case of perennial crops, for at least one generation during two growing seasons. »
In other words, OHM must have been propagated under organic farming conditions for at least one generation for annual species and for at least two generations for biennial and other perennial species.
The marketing regime for this new category of seed is laid down in Article 13 of Regulation No. 2018/848, supplemented by a Commission’s Delegated Act of May 7th, 2021. This delegated act entitled "COMMISSION DELEGATED REGULATION (EU) .../... of 7.5.2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council as regards the production and marketing of plant reproductive material of organic heterogeneous material of particular genera or species" can be downloaded, together with its annex, either on the EU Commission website (all EU languages available) or hereunder, in English:
The species concerned by the marketing regime for OHM are those covered by the 11 sectoral directives on seed trade: Directives 66/401/EEC, 66/402/EEC, 68/193/EC, 98/56/EC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC, which concern in particular fodder plants, cereals, vegetables, ornamental plants, potatoes, oil and fibre plants, vegetative propagating material of vines, etc.
Among these large families of plants, species that are currently not regulated under the various directives referred to above naturally remain outside the scope of the marketing regime described here.
Additionally, the prior notification regime set up by Regulation n°2018/848 and its delegated regulation, does not apply to "any transfer of limited quantities of plant reproductive material of OHM intended for research on, and development of, organic heterogeneous material" (Article 1). It is not specified what quantities are tolerated under this exemption, but it should be considered that it is primarily the purpose of the transfer that will be decisive on that matter.
The Delegated Act details the elements that must be included in the notification dossier to describe the OHM to be placed on the market.
This description will have to be composed of 5 items of information:
1. the phenotypic (botanical) characteristics (description of the differences and similarities observed between individuals - common characteristics and heterogeneity) and/or agronomic characteristics (yield, resistance to pests, taste, etc.) of the material and the results of any available tests relating to these characteristics;
2. the type of technique used for the selection or production of this material (a breeding activity, in the contemporary sense of the term, is not necessarily required here);
3. the parental material used to breed or produce the material;
4. the selection and management practices of the material on the farm site;
5. the country of breeding or production, including information on the year of production and a description of the soil and climate conditions.
The Delegated Act further specifies which techniques may be used for the breeding or production of OHM:
1. techniques leading to the creation of "composite cross populations";
2. "On-farm management" practices, including farmer selection and maintenance or conservation of the material;
3. any other technique of breeding or production of OHM.
Options thus remain very open and will allow the notification of both "traditional" or "local" material, conserved by natural selection or by farmer selection, and new material, resulting from relatively informal breeding activities or, on the contrary, following precise agronomic protocols.
The rules on minimum quality requirements, particularly as regards health, specific or analytical purity and germination, are laid down by reference to the 11 applicable sectoral directives. References are thus made to specific provisions contained in these directives, which require compliance with the same standards as those applicable to the same species of seed and plant propagating material.
However, as regards germination rate, the Delegated Regulation provides for the possibility of placing on the market seed of organic heterogeneous material not complying with the minimum rates set by these standards, provided that the supplier indicates the actual germination rate on the label or directly on the package.
Regarding packaging, a distinction is made between small packages (see opposite), as defined in Annex II of the Delegated Act, and other packages.
Small packages may be packed without the need for a special closing device. Larger packages must be closed in such a way that they cannot be "opened without leaving evidence of tampering on the package or container".
A yellow label with a green diagonal cross (see opposite) must be affixed to packages or containers of heterogeneous material, providing the information listed in Annex I of the Delegated Regulation (name of the organic heterogeneous material, name and address of the operator, country of production, etc.). This information may also be printed directly on the packaging or container, in which case the green cross on a yellow background is not required.
For small transparent packages, the label may be placed inside the package, provided that it is clearly legible.
By way of derogation from these rules, it is foreseen that seed of OHM may be sold directly to final users in unmarked and unsealed packages, at most in the maximum quantities provided for in Annex II of the Regulation, provided that the purchaser can be provided, on request, in writing and at the time of delivery, with the information concerning the species, the denomination of the material and the reference number of the lot.
Operators must keep, for a period of 5 years, a copy of the notification file sent to the competent authority, a copy of the declarations made in the context of the organic certification controls, a copy of the organic certificate obtained, as well as information allowing the identification of operators who have supplied them with parental material for the breeding or production of their “organic heterogeneous material”, if applicable.
In addition, operators will have to keep a register containing the following information: species and denomination of the notified "organic heterogeneous material", type of technique used for its production, description of this material, place of breeding, place of production and areas used for production, as well as quantities produced.
This register must be accessible to the competent authorities in the event of an inspection.
Under Article 37 of Regulation No. 2018/848, organic production is subject to the official controls provided for in Regulation No. 2017/625 of March 15th, 2017.
Within this framework, OHM will be subject to official risk-based controls to ensure compliance with the rules described above.
This is therefore a system of non-systematic a posteriori or post-marketing controls, similar to those that apply to so-called "standard" seed (vegetable seed) under the horizontal legislation on the marketing of seeds and distinct from those applicable to so-called "certified" seeds, which are subject to a priori or pre-marketing controls under the horizontal legislation.
Maintenance requirements are mainly relevant for varieties protected by plant breeder's right. Indeed, plant breeder's right lapses when the holder of the right has not taken any maintenance measures and is therefore no longer able to provide the competent authority with plant propagating material showing the very characteristics described at the time when the protection was granted.
In the case of "organic heterogeneous material", which cannot be protected by plant breeder’s right and whose genetic diversity and dynamic nature will necessarily lead to changes in its characteristics over time, maintenance becomes a heavy constraint, especially when the diversity of the material offered is great and the target market is small.
In these circumstances, the Delegated Regulation only requires operators to carry out maintenance activities, recorded in a register, if they are "possible" and only for the period during which the material is placed on the market.
Article 26 of Regulation No. 2018/848 provides for the obligation for Member States to create a regularly updated database aiming at listing, in particular, plant reproductive material (seed and other propagating material) available on their territory in organic quality or in conversion.
These databases should be designed to enable operators themselves, where they are able to supply such material in sufficient quantities and within a reasonable time, to make public the following information together with their names and contact details, on a voluntary basis and free of charge: the material made available, including any 'organic heterogeneous material', the quantity by weight of such material and the period of the year when it is available. This material should be listed using, as a minimum, its scientific name in Latin.
Operators will then have to ensure that the information they publish in this framework is regularly updated and removed from the lists once the material is no longer available.
Member States may continue to use the relevant information systems already in place, provided that they offer the possibilities described above.
These databases will in particular allow organic farmers to know what is available on the market in organic quality, but also to diversify their production, if they wish to do so, by acquiring OHM.
The Seeds4All initiative is precisely in line with this perspective, making it possible to know the European operators who keep and distribute traditional or local varieties, which could possibly be placed on the market, from January 2022, under the designation of "Organic Heterogeneous Material".