Regulatory Work under the European Fertiliser Regulation
Sneak a peak into our first guide book and training on the European Fertiliser Regulation 2019/1009
How to assess a fertilising product under Module A (and A1)?
Within the regulatory framework of the updated European Fertiliser Regulation, different modules outline specific compliance pathways for manufacturers, depending on the product type, the starting materials used and the product function (PFC - Product Function Category).
In this second guidebook in our series and first guide book concerning the European Fertiliser Regulation and how to implement the different modules, we will start with the first one and
- explore module A assessments for fertilisers, and
- explain the difference with module A1
There are, all in all, five modules under the EFR: A, A1, B, C and D1.
Module A is the main scope of this second guide book and first of the series pertaining to the EFR.
Module A
Referred to as "Internal production control”, whereas
“Internal production control” is the conformity assessment procedure whereby the manufacturer fulfils the obligations in terms of technical documentation, compliance and monitoring of manufacturing process is in line with the requirements, as well as the EU declaration of conformity and labelling, declared on his or her sole responsibility.
Module A1
Referred to as “Internal production control + supervised product testing”, whereas
Internal production control plus supervised product testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations in terms of technical documentation, compliance and monitoring of manufacturing process is in line with the requirements, product checks for oil retention and detonation resistance, as well as the EU declaration of conformity and labelling, and ensures and declares on his or her sole responsibility that the EU fertilising products concerned satisfy the requirements of this Regulation that apply to them. In addition, a notified body will perform the product testing before the EU declaration of conformity is issued.
Module A applies to fertiliser products belonging to Product function Categories (PFC) 1 to 4, and composed of one or more of the following Component Material categories (CMC): 1, 4, 6, 7, 8 and/or 11.
Module A can also be applied to PFC 7.
So far, so good. now, let's get into the practical side of things.
First, we need to have some basic background knowledge on the EFR and its provisions in order to conduct the assessment. This basic knowledge encompasses (though not limited to) the understanding of the different PFCs and CMSs.
PFCs under the EFR
And here is already the point where it becomes clear when Module A1 applies, it is in these cases:
* For ammonium nitrate fertiliser with high nitrogen content Module A1 is mandatory. It means that a notification body will need to be involved.
** For PFC 7 fertilisers with 28% or more nitrogen from a PFC 1 (C)(1)(a)(i-ii)(A), which corresponds to an ammonium nitrate fertiliser of high nitrogen content, module A1 is also mandatory. Also in this case, it means that a notification body will need to be involved.
Remark: Blends as defined under PFC 7 actually are eligible under all modules, depending on their composition. And while that might sound like a "hey! that's easy then, let's just present all our products as a PFC7 blend and do the assessment under Module A - it ain't that easy ... because, you will have to state the composition of the blend, the corresponding PFCs and CMCs and of course, all your components will need to be in compliance with the respective PFCs and CMCs....So, yes, once your have done your due diligence as regards to your components, you will have to comply also with our PFC 7 blend with the applicable module ... so no, blends are NOT the solution to be in Module A with any product you want to place on the market with a CE-mark!
Want to know more ?
