Informal Working Group will Seek Solution to Regulatory Obstacle on Innovative Biostimulants

Date:03-01-2017

A working group outside the formal negotiating process will seek a solution so that biostimulants, containing beneficial microorganisms, can be brought to market easily and quickly without compromising safety and quality.

One of the key objectives of the draft fertilising products’ regulation is to provide access to the Single Market for innovative fertilising products. The current proposal for a positive list of beneficial microorganisms is unlikely to meet this purpose as it inadvertently provides disincentives to some of the most innovative products to be covered by the future regulation.

Building on discussions already held within EBIC, an informal working group will outline safety criteria that can be combined with harmonised standards under the New Legislative Framework approach used in the Commission’s legislative proposal. Attending a recent workshop hosted by the Permanent Representation of Denmark to the EU, industry representatives, key Member States, and other stakeholders highlighted the importance of finding a solution without compromising health, safety and the environment.

The challenge for products containing microorganisms

Agreement on how to provide incentives for R&D and innovation within the biostimulants industry, while ensuring their safety evaluation, has been elusive since the European Commission released its proposal for a new fertilising products regulation. The proposed procedure for updating the positive list mirrors the one that has been used for new type-approvals under the existing Reg (EC) 2003/2003 relating to CE-marked fertilisers. However, in the Explanatory Memorandum to the draft regulation, the Commission itself underlined that this particular procedure “is lengthy and cannot keep up with the innovation cycle even for new, inorganic fertilisers from primary raw materials”. Reinvestment in R&D is on average 60 times higher in the biostimulants sector than the mineral fertilizer industry, and the pace of innovation much faster.

How do we get the right regulation for biostimulants?

Biostimulants are an extremely innovative technology and can help address key sustainability goals like reducing unwanted environmental impacts of agriculture. “But this can only come about if the right regulation is adopted by the EU”, stated H.E. Vibeke Pastemak Jørgensen, the Deputy Permanent Representative of Denmark to the EU. “This fast-paced industry must be supported by a regulatory framework that favours innovation and research & development”.

Willingness to sit down together to find new creative solutions

“Supporting R&D and innovation is a priority. It has become clear that we are not in the pesticides world with biostimulants”, recognized Eric Liégeois, Team Leader Fertilizers European Commission. “The impact assessment, conducted by the Commission before drafting its legislative proposal, observed that the traditional solutions for implementing legal frameworks in the agricultural sector are not fit for biostimulants”. Traditional approaches, such as registries, require extensive resources and are too costly to administer.

Defining new conditions for an emerging industry

Stakeholders attending the workshop agreed that this new product category requires an adapted approach, but one that fits within the New Legislative Framework proposed by the Commission. “We are persuaded that safety criteria can be agreed that would eliminate the need for a positive list and bring the regulation of biostimulants in line with the New Legislative Framework”, said Kristen Sukalac, spokesperson for the European Biostimulants Industry Council (EBIC). “We must work together so that safe, quality products, containing beneficial microorganisms, can be placed on the market simply and quickly. This will provide farmers across the EU with equal access to modern technologies like biostimulants, making them more profitable, competitive and sustainable. Consumers will also benefit through access to abundant, affordable, safe food with minimum impact on the environment. This approach will also ensure that the European industry remains the world leader”.

Industry representatives, key Member States, independent experts and other stakeholders will meet soon to define criteria that may help the future regulation better meet its stated objectives.