In March 2016, the European Commission published its long-awaited proposal for a regulation on several families of “fertilising products”, including biostimulants. In its announcement of the proposal, the Commission expressed its ambition for the regulation to “create new market opportunities for innovative companies while at the same time reducing waste, energy consumption and environmental damage.”
EBIC welcomes the Commission’s intention to foster innovation in the area of fertilisation and to provide a long-overdue single market for many of the concerned products. Overall, EBIC has a positive outlook on the draft. However, EBIC feels there are a number of points that should be modified in order to:
- Achieve greater consistency and clarity;
- Better promote innovation within the bioeconomy and Circular Economy;
- Ensure equitable competitive conditions among product functional categories.
EBIC’s main comments are summarised below. The line numbers point to specific lines of EBIC’s detailed feedback where we provide explicit suggestions for modifying the draft text.
The right definitions are the foundation for everything
The bedrock of any regulation is found in the definitions of the terms it uses. While EBIC supports the basic principles of the definitions in the Commission’s draft, it feels that redrafting could reduce ambiguity about scope, boundaries, functions that are covered by the regulation and other critical points for operationalising the regulation. Furthermore, definitions are missing for key terms used in the regulation, notably ‘product’ and ‘material’. EBIC has suggested modifications to the definitions of ‘fertilising product’, ‘plant biostimulant’, the sub-categories of plant biostimulant and some Component Material Categories as well as proposing definitions for the missing terms. [See lines 2, 7, 8, 9, 12, 13, 16, 20, 21, 22, 23, 24, 25, 26, 27 of EBIC’s detailed comments]
Respect the importance of intellectual property, trade secrets and confidentiality for innovation and competitiveness
As currently framed, several aspects of the Commission’s proposal would undermine the right of companies to protect their know-how and business information such as research data. The importance of confidential business information for competitiveness and innovation was recently recognized in a new directive approved by the European Parliament and Council in mid-April. The Commission’s proposal is particularly weak on providing the necessary provisions for bio-based technologies, especially micro-organisms. Unless the draft is corrected, the regulation will miss a huge opportunity to promote the bioeconomy and the Circular Economy. EBIC suggests a number of changes that would improve how the regulation acknowledges and respects acquired safeguards of critical business know-how. [See lines 1, 5, 10, 11, 29, 36, 37 of EBIC’s detailed comments]
Correct the institutional bias towards chemical-based products by providing equitable treatment for bio-based products, especially micro-organisms
Under this regulation, substance-based products benefit from precise characterization and data protection, through the REACH framework. By failing to recognise and correct the fact that there is no parallel to REACH for micro-organisms, the Commission’s proposal perpetuates an institutional bias against bio-based products and hampers the ability of industry to deliver the full potential of the Circular Economy. To address this problem, EBIC suggests how the use of existing frameworks, common specifications and harmonised standards can allow microbial products to be certified with a similar approach to substance-based products within the New Legislative Framework. [See lines 14, 17, 18, 19, 26, 31 and 33 of EBIC’s detailed comments]
Ensure that components with multiple possible effects can be incorporated into fertilising products
To promote innovation, EU regulation must provide a pathway for additional functions of components to be recognised as research improves knowledge. This would ensure any fertilising product claims are assessed consistently with other products making similar claims and allow manufacturers of products outside the scope of this regulation to add a second set of fertilising product claims without calling into question any stricter authorisation processes. EBIC suggests how to clarify these points, notably by defining the distinction between a component and a product. [See lines 3, 6 and 8 of EBIC’s detailed comments]
Implement and enforce the proposed provision related to the effects of biostimulants on plant quality traits
Manufacturers should have the freedom to make any biostimulant claim regarding plant quality traits as long as such claims are verifiable and products have been demonstrated to be safe. To allow companies to choose how best to market their products, guidelines on making and justifying verifiable claims should not resort to a positive list of permitted claims. [See line 15 of EBIC’s detailed comments]
Various other comments
- Data requirements should be proportional to ensure safety while still fostering innovation. [See line 4 of EBIC’s detailed comments]
- The initial list of allowed animal by-products should include all those currently deemed as having met endpoint status. The draft list should be submitted as quickly as possible to allow time for stakeholder feedback. [See line 28 of EBIC’s detailed comments]
- Label requirements should foresee all requirements stemming from other related regulations. [See line 30 of EBIC’s detailed comments]
- Labelling requirements should not be imposed for irrelevant criteria. [See line 32 of EBIC’s detailed comments]
- The concept of “content” to be declared on labels should be clarified. [See line 34 of EBIC’s detailed comments]
- Tolerances for micro-organisms, UVCB substances and other substances should be differentiated, in accordance with how REACH is applied. [See line 35 of EBIC’s detailed comments]
- Because all language versions have equal legal weight, it is important that translations into other EU languages besides English are accurate.