Aug. 29, 2018
“Things are about to change with the implementation of an updated fertilizing products regulation that will cover the full range of fertilizing products, including plant biostimulants.”
Until now, European biostimulant manufacturers have been faced with a fragmented European market, forcing them to navigate different sets of national rules and regulations to penetrate each local market individually. Mineral fertilizers and liming materials were only covered in the 2003 regulations, so other fertilizing materials like biostimulants, organic fertilizers and growing media could only be placed on the market according to national rules. However, things are about to change with the implementation of an updated fertilizing products regulation that will cover the full range of fertilizing products, including plant biostimulants to be sold under one set of rules across 34 countries.
The right regulatory framework will open market access and boost innovation and competition.
Over and above creating a single market, an agile and adaptable fertilizing products regulation is essential. This updated regulation will promote innovation and create incentives for manufacturers to invest in research and development. If the right regulation is implemented, the biostimulant industry will be set to contribute significantly to a circular economy. The industry will be able to promote renewable resources, create jobs and enable farmers to increase the quality and quantity of their yields to meet consumer demand for sufficient good quality food and reduce the impact on the environment.
Current state of play
In March 2016, the European Commission published its proposal to replace the 2003 fertilizing products regulation. Since then, the European Parliament (EP) and the Council (representing the 28 Member States) have been preparing their negotiating positions. A draft text was proposed for the new regulation, through the work of several committees within the Commission. In early 2018, the EP and the Council entered into negotiations brokered by the Commission (known as Trilogue) to reach an agreement on the final text. If the process goes to plan and a consensus is achieved by the end of this year, the regulations on biostimulants should become fully operational from 2020/21 onwards.
Fertilizing Products Regulatory Timeline
A stable regulatory framework that favours the development of the European biostimulant industry is beginning to emerge. An example of this is the umbrella definition of plant nutrition products that has been revised by the Parliament, acknowledging that all products under the regulation contribute to increasing yields and plant vigour. This is essential in enabling biostimulant manufacturers to promote the added value that their products bring to farmers and reinforce the credibility of these products in the eyes of the farming community.
EBIC has been working with the EU officials, national authorities and related industries since 2012 on a clear definition of a Plant Biostimulant which is:
‘plant biostimulant’ means a product containing ANY substance or micro-organism (or any combination thereof) stimulating plant nutrition processes independently of its 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) crop quality
A global consensus is growing around the essential points of this definition, which was included in the U.S. House of Representatives 2018 Farm Bill. The draft law also proposes a Federal Standard for the regulation of Biostimulants in the USA.
Improving the draft proposal
As the negotiations continue, it is essential that several priority issues are included in the final text to create a well-functioning market that distributes safe, effective and affordable biostimulant products.
To prevent the misuse of the legislation to pass Plant Protection Products off as biostimulants, it will be crucial that a clear boundary is drawn between the claims of fertilizing products (abiotic stress) and plant protection products (biotic stress).
By signing EBIC's Code of Conduct, all EBIC members have committed to never make unauthorized plant protection claims and to be able to demonstrate the validity of their biostimulant claims with empirical data.
The new regulations are an integral part of all the EU farming, safety and environmental legislation. All fertilizer products will be regulated:
• On their safety both at the component material and product level.
• Their claims (to be demonstrated at the product level).
Safety criteria will be developed and complemented by global harmonized standards, to allow the safety of biostimulant products to be evaluated by conformity assessment bodies in a cost efficient and timely manner.
To avoid the creation of new regulatory bodies to manage the identity and safety of inorganic or organic substances that biostimulants contain, the safety criteria approach will build on existing evaluations, such as Europe's chemical legislation (called "REACH"), the EU Animal By-Products Regulation or others, as relevant.
Biostimulants and other fertilizing products that conform to the requirements in the regulation will bear the “CE” mark, which will allow free market access to all EU Member States. In contrast, products placed on the market under national rules, which not be able to cross borders easily. A new set of Standards is being developed under CEN/TC 455 to cover “how” to support label claims, obtain a positive listing for microorganisms, safety studies and labelling. These standards will be incorporated into the EU Fertilizing Products Regulation and should be in force 2-3 years after the regulations come into force. The rules to manage a wide range of animal and industrial by-products which are used as raw materials and active substances are currently under negotiation.
Negotiations are just one step, and the industry needs to stay engaged. There is no doubt that the technical nature of the legislation and the complexity of the products has made this topic extremely challenging for all the policy makers and regulators involved. It is critical that the text is finalized before European elections in May 2019, or the legislation could be stalled indefinitely. While there is every reason to believe that negotiations will be finalized before the end of 2018, the biostimulant industry continues to be proactive to advocate for progress. Agreement on the legislative text is not the end of the road as implementation depends on the harmonized standards that define analytical methods, claims justification and other critical aspects of biostimulant commercialization.
The European Biostimulant Industry Council (EBIC) represents the majority of players in the EU biostimulant market including dozens of SMEs as well as multinationals. EBIC engages actively with the EU institutions, farmers and other stakeholders to promote biostimulants and their contribution to more sustainable agriculture.