Fertilising products

As of 4 March 2025, following an assessment carried out by PCBC S.A. and a positive decision, new certificates in Module B to Regulation (EU) 2019/1009 will be issued for a period of 5 years, unless the technical documentation for the EU fertilising product changes.

In connection with the above, PCBC S.A. enables Manufacturers to apply for an extension of the period of validity for the certificates of EU-type examination in module B, already issued by PCBC S.A. in module B of Regulation (EU) 2019/1009.

The validity date of certificates issued for 3 (three) years in Module B to Regulation (EU) 2019/1009 may be extended to 5 (five) years from the original date of issue, provided that the following documents and submitted to the PCBC the required documents i.e.:

–   a completed Application for Conformity Assessment (FBS-N-01) for the specified product  – extension of the validity of the certificate, with the provision that the application must be received by PCBC before the current certificate expires.

– declaration of confirming that no modifications have been made to  the fertilising product for which conformity assessment has been carried out and the EU type examination certificate has been issued.

and upon signing the relevant Annex to the existing contract.

The exchange of documents is connected with the payment of a fee for each exchanged certificate.

This statement is effective from March 04, 2025.

Conformity assessment of EU fertilising products in accordance with Regulation (EU) 2019/1009 can be carried out in modules:

• A – internal production control
• A1 – internal production control plus supervised product testing
• B – EU type examination + module C – conformity to type based on internal production control
• D1 – quality assurance of the production process

The notified body is involved in conformity assessment in modules A1, B and D1.

Conformity assessment / inspection carried out in module A1 is performed by PCBC Inspection Body – information available here

Each module applies to different fertilising products depending on their product function category (PFC) and component material category (CMC).

PFC 1 may include the following products:

• PFC 1A – organic fertiliser
• PFC 1B – organo-mineral fertiliser
• PFC 1C – inorganic fertiliser
• macro-nutrient – straight or compound
• micro-nutrient – straight or compound

Soil improvers can be divided into :

• PFC 3A – organic soil improver
• PFC 3B – inorganic soil improver

Biostimulants can be divided into:

• PFC 6A – microbial plant biostimulant
• PFC 6B – non-microbial plant biostimulant

As of 04.12.2021. PCBC S.A. is a notified body with the identification number 1434 assigned by the European Commission, in the field of conformity assessment of EU fertilising products in accordance with the Regulation (EU) 2019/1009 for module B – EU type testing and module D1 – quality assurance of the production process.

On 01.11.2024, the EC notification to PCBC S.A. in the scope of Regulation (EU) 2019/1009 was extended to include further groups of component materials for Fertilising Product Function Categories from PFC 1 to PFC 6, i.e.:

CMC 12: Precipitated phosphate salts and derivates

CMC 13: Thermal oxidation materials and derivates

CMC 14: Pyrolysis and gasification materials

CMC 15: Recovered high purity materials

Within the scope of our competence, we are evaluating the following products:

Information on the types and scope of certification processes is provided below:

• Scope of notification – powers to assess compliance – link

• Scope of accreditation – certification powers – link

• The course of the process of conformity assessment of EU fertilising products is described in detail in DBS-N-02- Guide to conformity assessment of EU fertilising productsThe main stages of the process of conformity assessment of EU fertilising products:
  • Submission of the application by the Manufacturer
  • Review of the submitted application
  • Registration of the application and preparation of the contract and cost estimate
  • Signing of the contract
  • Payment of the initial fee and delivery to PCBC S.A. of the product documentation – indicated in the application
  • Assessment (including audit in module D1)
  • Review of information and evaluation results
  • Decision on certification
  • Issuance of certificate
  • Certificates confirming compliance with the applicable requirements for the EU fertilising product contained in Regulation (EU) 2019/1009 of the European Parliament and of the Council are issued, respectively, under:

1. Module B – for a period of 5 years, unless the technical documentation of the EU fertilising product has changed.
2. Module D1 – for a period of 3 years, provided that the Manufacturer maintains a production quality assurance system and performs an annual surveillance audit confirming compliance with the requirements of the QMS. After the expiration of this period, the certificate can be extended for another 3 years.

Certificates issued by PCBC S.A. are provided with a qualified electronic signature

Supervision of the granted certification – if applicable

In order to verify the validity of the certificate, the inquiry with attached certificate should be sent to nawozy@pcbc.gov.pl

With the entry into force of Regulation (EU) 2019/1009 of the European Parliament and of the Council on the making available on the market of fertilising products bearing the CE marking, the first certificates issued in module D1 were given a three-year validity period. They are now approaching their expiry date, which means that action must be taken to renew them.

Re-certification in module D1 allows for continuity of certification and confirms compliance with the requirements of Regulation (EU) 2019/1009. The process includes both updating the technical documentation (if the manufacturer’s documentation differs from that submitted for the conformity assessment process) and conducting a re-certification audit.

Why is Re-certification important?

• it ensures the continuity of the certificate – without interruptions and the risk of losing the right to mark fertiliser products with the CE mark with the notified body number,
• it confirms that the production process quality assurance system continues to meet the legal and normative requirements of Regulation (EU) 2019/1009,
• enables the safe introduction of EU fertiliser products onto the EU market.

Re-certification conditions

• Holders of certificates issued by PCBC – may use the re-certification procedure, which includes: analysis of documentation (if there have been changes indicated by the Manufacturer), re-certification audit and possible corrective actions.
• Holders of certificates issued by other notified bodies – may apply to PCBC to transfer their certificates from another body during their period of validity, in this case, the process will be considered on an individual basis.

Stages of Re-certification in Module D1

1. The manufacturer submits an application for conformity assessment [FBS-N-01]* to PCBC and accepts the cost estimate submitted by PCBC. The application must be submitted no later than 3 months before the expiry of the certificate to avoid the risk of interruption in its validity. This applies to products that have been assessed by PCBC – SN Team.
2. Submission – of product labels and the technical documentation review form [FBS-N-73] presenting the changes made to the documentation and providing access to attachments/documents in which the changes were made (if applicable).
3. Analysis and assessment of documentation – checking the completeness and correctness of technical documentation.
4. Re-certification audit – carried out at the manufacturer’s premises where the EU fertiliser product is manufactured or stored, covering all locations.
5. Corrective actions – removal by the Manufacturer of any non-conformities identified during the audit (if justified).
6. Issuance of a new certificate – for a period of up to 3 years for a production process quality assurance system that meets the requirements of Regulation (EU) 2019/1009, confirmed by an annual surveillance audit. The annex to the certificate lists the products covered by the system that have undergone conformity assessment.

* Form can be found in the tab: Documents to download.

Summary

Re-certification in module D1 is a key step for EU fertiliser manufacturers wishing to maintain their certificate and ensure that their production process quality assurance system complies with the requirements of Regulation (EU) 2019/1009. By submitting the application early enough, completing the procedure efficiently and receiving a positive decision as a result of the assessment, it is possible to smoothly extend the certificate for another 3 years.

For further information on the recertification process, please contact us at: nawozy@pcbc.gov.pl

How much does the conformity assessment cost?

A quote will be prepared on the basis of the application FBS-N-01 completed by the Manufacturer and sent to PCBC S.A.

How long does the conformity assessment take?

Up to 180 days (for module B and D1), excluding the time allocated for the Manufacturer to complete the documentation

What is the time for submitting the required documents?

From the signing of the contract by PCBC S.A., the Applicant has 30 days to provide all the required documents, listed in the application

What documents are needed for conformity assessment?

The list of required documents can be found on the penultimate page of the application for conformity assessment of a fertilising product.

Who is responsible for commissioning tests under module B and D1?

Within the framework of EU type examination in module B – PCBC orders sampling and testing on samples obtained from the Manufacturer. The manufacturer should agree with the notified body on the location where sampling and testing will be carried out. In order to prepare a bid for sampling and testing. PCBC will prepare in consultation with the Manufacturer the proposed range of parameters based on the technical documentation provided.

As part of the EU type testing in Module B, the Manufacturer may also provide the PCBC with a report of accredited product testing, not older than 2 years.

In Module D1, the Manufacturer provides a report on the tests performed.

Where can EU fertilising product testing be done?

Fertilizer and Chemical Product Laboratory, Testing and Certification Branch Office in Piła, PCBC, contact: jfinster@pcbc.gov.pl

What reports and test results are recognized by PCBC S.A. in the D1 module?

PCBC S.A. recognizes / accepts in the certification process test results no older than 2 years as of the date of documentation evaluation, performed in an accredited laboratory (EN ISO/IEC 17025) or a non-accredited laboratory that has implemented the requirements of EN ISO/IEC 17025. The scope of tests performed depends on the type of PFC and is based on Regulation (EU) 2019/1009.

How many samples and what size will be tested during laboratory testing?

The number and size of samples are determined by the test method. Before the test is performed, it is necessary to complete and send a test order for the laboratory tests. Please contact us for details: jfinster@pcbc.gov.pl

When will I receive the certificate?

The certificate will be handed over to the Manufacturer after PCBC S.A. issues a positive decision on the basis of the conducted conformity assessment process and after the Manufacturer pays all fees for the certification process.

Regulation (EU) 2019/1009 – the Fertilising Products Regulation Frequently Asked Questions

COMMUNICATION FROM THE COMMISSION concerning the visual appearance of the label on EU fertilising products referred to in Annex III to Regulation (EU) 2019/1009 of the European Parliament and of the Council (2021/C 119/01)

Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003

Published Delegated Regulations amending the Regulation (EU 2019/1009) 

• Commission delegated regulation (EU) 2021/1768 of 23 June 2021 amending, for the purpose of its adaptation to technical progress, Annexes I, II, III and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council laying down rules on the making available on the market of EU fertilising products

• Commission delegated regulation (EU) 2021/2086 of 5 July 2021 amending Annexes II and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council for the purpose of adding precipitated phosphate salts and derivates as a component material category in EU fertilising products
• Commission delegated regulation (EU) 2021/2087 of 6 July 2021 amending Annexes II, III and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council for the purpose of adding thermal oxidation materials and derivates as a component material category in EU fertilising products
• Commission delegated regulation (EU) 2021/2088 of 7 July 2021 amending Annexes II, III and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council for the purpose of adding pyrolysis and gasification materials as a component material category in EU fertilising products
• Commission delegated regulation (EU) 2022/973 of 14 March 2022 supplementing Regulation (EU) 2019/1009 of the European Parliament and of the Council by laying down criteria on agronomic efficiency and safety for the use of by-products in EU fertilising products
• Commission delegated regulation (EU) 2022/1171 of 22 March 2022 amending Annexes II, III and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council for the purpose of adding recovered high purity materials as a component material category in EU fertilising products
• Commission delegated regulation (EU) 2022/1519 of 5 May 2022 amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the requirements applicable to EU fertilising products containing inhibiting compounds and the postprocessing of digestate
• Commission delegated regulation (EU) 2023/409 of 18 November 2022 amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the minimum content of calcium oxide in straight solid inorganic macronutrient fertilisers
• Commission delegated regulation (EU) 2024/1682 of 4 March 2024 amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards adding processed manure as a component material in EU fertilising products
•  Regulation (EU) 2024/2516 of the European Parliament and of the Council of 18 September 2024 amending Regulation (EU) 2019/1009 with regard to the digital labeling of EU fertilizer products
•  Commission Delegated Regulation (EU) 2024/2770 of July 15, 2024, amending Regulation (EU) 2019/1009 of the European Parliament and of the Council with regard to biodegradability criteria for pebbles and water retaining polymers 
• Commission Delegated Regulation (EU) 2024/2786 of July 23, 2024 amending Regulation (EU) 2019/1009 of the European Parliament and of the Council with regard to Enterococcaceae and presumption of conformity of EU fertilizer products without verification
• Commission Delegated Regulation (EU) 2024/2787 of July 23, 2024 amending Regulation (EU) 2019/1009 of the European Parliament and of the Council with regard to the inclusion of mulching films in the category of storage materials
• Commission Delegated Regulation (EU) 2024/2788 of July 23, 2024 amending Annex II to Regulation (EU) 2019/1009 of the European Parliament and of the Council with regard to polymers in the category of constituent materials 11
• Commission Delegated Regulation (EU) 2024/2790 of July 23, 2024 amending Annex II to Regulation (EU) 2019/1009 of the European Parliament and of the Council with regard to polymers in the category of component materials 1