Module D1 Projects and Audits with Special CMCs
Module D1 Projects and Audits with Special CMCs
Opening Kerona Scientific’s second Dublin Fertiliser Symposium on the 19th of September 2024, was the Biostimulant Specialist from the Notified Body CerTrust Ltd, Dr. Ildikó Varga. Ildikó spoke about the Module D1 conformity assessment procedure and described the particularities of certain CMCs.
Since a Module D1 conformity assessment can also cover the rest of the conformity assessments (apart from A1), manufacturers can opt in for this type of assessment which also evaluates the quality assurance of the production procedure. In fact, Ildiko suggested that under certain circumstances it might be beneficial to do so to save time and resources. For instance, when a good quality assurance system is already in place, if multiple products registered under the FPR are produced in the same facility, or for manufacturers with continuous product development.
Ildikó provided a detailed description of the dossier required for Module D1 applications and mentioned there is a lot of overlap between the technical documentation requirements for Modules D1 and B (the latter is required for registering biostimulant products ). The registration under Module D1 only lasts for three years, however there is continuous involvement for the Notified Body, which performs audits to the quality assurance system and the sampling procedures for certain CMCs and tests the outputs.
An important element of the Module D1 conformity assessments is the sampling audits. It is crucial to keep in mind that when the fertilising product contains CMC 3 or 5 the frequency of this type of audit depends on the annual inputs, while when CMC 12 to 15 are present, it depends on the annual outputs. Sampling is performed both by the Notified Body and the manufacturers, but the frequencies might differ. The standard to be used for sampling soil improvers is PrEN 12579:2024.
Apart from performing regular samplings, manufacturers must prepare the technical documentation, draw up a declaration of conformity and ensure their product complies with the FPR requirements, affix the CE marking with the Notified Body number on the product’s label, keep records of all documents related to the products, and ensure the product is compliant with the production and quality management system.
If you missed the FPR Symposium, a copy of all the presentations is available on the publications section of the Kerona website at https://kerona.ie/product-category/publications/.
If you need assistance with CE marking of fertilising products in the EU, national registration, mutual recognition, please do not hesitate to contact the experts at Kerona at info@kerona.ie