Borderline substances in Europe: Plant protection products or fertilising products

The regulation of European Union defines plant protection products and fertilising products.

Regulation (EC) No 1107/2009 is the main legislative framework regulating the placing on the market of plant protection products. According to the regulation, a plant protection product contains substances, including chemicals, plant extracts or micro-organisms, that protect or preserve plants, influence their growth or destroy undesired plants.

Fertilising Products Regulation (EU) 2019/1009 shows that ″a fertilsing product is a substance, mixture, micro- organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, either on its own or mixed with another material, for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency.″ 

A plant biostimulant is included in the category of fertilising product in the European Union. Such products, according to (EU) 2019/1009, ″stimulate 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 the soil or rhizosphere″

However, borderline product is considered as a product that is difficult to determine whether it is a plant protection product or a fertilising product. 

How can borderline products get approved for marketing? Dr. Sean McCarthy, Head of Division Regulatory Affairs Crop Protection, Nutrition & Biologicals at Dr Knoell Consult Ltd, will give a speech to share his insight into this topic at BioEx 2024. 

Sean McCarthy is a Regulatory Affairs professional with over 25 years’ experience gained in consultancy, industry, and government sectors. Working in multiple legislative areas including plant protection, fertilizers, and biocides. He has a proven track record in the strategic development of new products and bringing them to the market. In his current role Sean is currently managing knoell’s Division that specializes in supporting clients with their regulatory and registration requirements for both conventional and biological plant protections products, and fertilizer products. The Division has Regulatory Affairs professionals based in Europe, China and the USA. In addition to this, knoell has developed a network of Global Partners to increase their regulatory service coverage.

Come to BioEx 2024 to learn more!