CMC10 WEBINAR - 1st of July 2024

ON THE CERTIFICATION AND MARKETING OF YIELD PROMOTERS ACCORDING TO REGULATION (EU) 2019/1009

CerTrust Vizsgáló és Tanúsító Kft., founded in Hungary, provides assistance in certification according to the new regulation.

Changes in the licensing of fertilizers and crop enhancers

The main aim of Regulation (EU) 2019/1009 on the distribution of EU plant-fertilizers is to achieve uniform quality requirements, a harmonized labeling system and higher product safety in order to supply the EU common market. Regulation 2003/2003/EC applied to fertilizers produced from inorganic materials, but in addition, the harmonized legislation also covers organic, recycled and by-product raw materials. This decree still provides the opportunity to place crop enhancers on the market in accordance with national legislation. In our country, the authorization procedure according to the national legislation (FVM decree 36/2006 (V.18)) is the activity of the NÉBIH, certification according to the EU decree is carried out by notified organizations.

Innovations of Regulation (EU) 2019/1009

The harmonized legislation contains many innovations, the most important of which are:

· in addition to inorganic fertilizers, the legislation also covers organic fertilizers, soil conditioners, liming agents, inhibitors, growing media, plant biostimulants and mixtures of yield-enhancing substances

· introduces the types of functional product categories (PFC) and the concept of component categories (CMC)

· introduces and limits the amount of pollutants for each PFC and CMC category

· encourages the strengthening of the circular economy by ensuring the possibility of using various industrial (agricultural, food, etc.) and animal by-products as input materials for yield-enhancing substances

· the application of the CE marking is subject to a successful conformity assessment based on the provisions of the regulation

PFC AND CMC categories according to Regulation (EU) 2019/1009

When can a fertility enhancer be certified according to Regulation (EU) 2019/1009?

A fertility enhancer can be CE marked if it meets all the requirements of the harmonized legislation applicable to it, which are as follows:

· the crop-enhancing material can be classified in at least one product category according to function (Annex I)

· all components of the crop-enhancing material can be classified in at least one product category according to the component (Annex II)

· the product label meets the labeling requirements of the harmonized legislation (Annex III)

· an evaluation procedure is carried out based on the module defined by the PFC and CMC categories of the crop-enhancing substance (Annex IV) – in the case of certain modules, the involvement of the notified body is mandatory

· if the fertility enhancer complies with the provisions of the regulation and has been marked with the CE mark, the manufacturer must issue an EU declaration of conformity before placing it on the market (Annex V)

The module system in the harmonized legislation

CerTrust Kft.: the first notified organization in the EU that certifies crop breeders

In 2021, CerTrust Vizsgáló és Tanúsító Kft., founded and operated in Hungary, was the first in the European Union to obtain the right to conduct the conformity assessment procedure of crop-enhancing substances according to the EU regulation (NAH-60-066/2021/K). Our company provides a full range of services to domestic and international manufacturers, since as a notified body (Notified Body 2806), in addition to the type certification of crop-enhancing substances (module B), we also carry out product inspection supervision of high-N fertilizers (module A1) and system certification of the production of crop-enhancing substances ( module D). As an independent certification organization – i.e. in a non-notified organizational status – we can also provide assistance to those market players who only decide on the conformity assessment procedure according to the internal production control task (module A) in order to supply their fertilizers with the CE mark.

Our services are broadly based on the high level of expertise of our company, as we are available to our customers with precise and flexible work. Feel free to contact us with questions about the introduction of crop-enhancing substances into the EU market or about it!

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