Frequent CAPA's/non-conformities

FPR Criteria

When to conclude an NC

Justification

Annex 1 point 6

No declaration or test report present

The law speaks of ‘intention’ and so it must be verified that even very small quantities of Phosphonates are not added intentionally.

Even if a test report is present, it does not cover the intention as a manufacturer may add Phosphonates at <0,5% with intention…

For this reason, a standard declaration is asked.  

An auditor could, upon explicit justification, also accept an ingredient list + a test report.

CMC indication on the label

If the CMC code or the full name of the CMC is not on the label

The FPR requires the manufacturer to indicate the type of CMC on the label. This must be done in full including the number of the CMC and the name.

I.e. just CMC 1 is not enough, a label must state “CMC 1: virgin material substances and mixtures”

Chromium

No test report and no statement present .

A manufacturer must either declare the source of chromium or prove that they are below the limit value of FPR for regular chromium.

If no information is present, they may not fully comply on this point.

A CAPA will be concluded on the labelling requirements point 1 in CETOOL.

N or P2O5 at over 0.5% and not declared in PFC1

Or NPK in case of a soil improver

No test report and not detectable from the ingredient list

Required and otherwise is not objectively verifiable. If we don’t have this info conformity cannot be declared. If a statement is also not present a CAPA must be concluded. 

Pathogen testing

No 5x replicates.

AND

No declaration of a single test series + a declaration why it was done this way

If pathogen testing is present but only in 1 series this may be allowed by virtue of point 4 of the general PFC requirements.

FPR does say that pathogen testing must be done.

If compliance is shown via ‘1 series + a declaration’ this must be explicitly mentioned in the justification and the auditor must document the reason for accepting.

PFC 1 organic carbon

If no declaration confirming the organic carbon content and no test showing <1%

Required by the regulation, if not present then an automatic CAPA.

Ingredient information

If no ingredient list with both the CMC categorization AND the percentage of composition (either the actual percentage or the range)

The FPR does not explicitly require an ingredient list with % and CMC’s for the TD’s but this should be required.

CMC 1 point 1 and 2 compliance

If no confirmation of REACH/CMC 1(through the SDS) with at least one of the below:

-        no declaration from manufacturer of the ingredient confirming origin.

-        no production info

-        no other evidence of the origin of the ingredient

An NC cannot be concluded if a REACH form is supplied that explicitly confirms registration and the origin of the ingredient, i.e. see the EFCI Register template

No specific justification needed. 

Label explicit statements

If any of the explicit statements required by FPR (i.e., for inhibitors or for cocoa shells) are not verbatim on the label an NC can be concluded.

This includes on nutrients, cocoa, inhibitors e.t.c.

The FPR will sometimes say the label must include specific statements enclosed in quotation marks (‘’).

The wording of the law is so explicit that this can only mean explicit inclusion is the only way to show compliance.….

Phosphonates or TD.040

If no statement present.

Even if a test report is present a manufacturer might be adding phosphonates at a miniscule amount violating FPR.

Thus the statement is needed.

A statement without test is sufficient evidence and TD.040 should cover this requirement. 

CMC 1 Water Soluble polymers

- No explicit statement confirming water solubility by the supplier.

- No explicit statement and no test report confirming water solubility by the supplier.

If no evidence is present on the water solubility of polymers either through a declaration or a test report, then no compliance can be shown.

An SDS confirming water solubility is not sufficient.

SDS

If no SDS is present or warnings (such as the ‘Danger’ signal word or H+P) are not on the FPR label.

The SDS is required to perform the audit of the label.

CLP applies to the FPR label.

If the actual SDS does not comply with any relevant regulation, then a CAPA can be raised but this is not denial of certification – but the client will have to respond.

UFI Number

If a UFI number is required by REACH and its not on the FPR label

Obligatory by REACH, see also above.

Tolerance

Any declared content is not in the tolerance with the uploaded test reports…

Even though the tolerance limits are something that are usually reserved to be audited by MSA’s if a test report shows deviation from declared contents which are covered by the tolerance limits this would not comply.

A manufacturer would have to adjust the relevant labelling parameters or perform additional testing.

Analytical information supplied

If analytical results are not expressed in a format that makes it readily assessable by an auditor this means auditing is not possible.

Some examples include:

-        No expression of dry matter/kg content

-        No expression of relative micronutrient content.

-        Any others to the discretion of EFCI Register.

In some cases, it might be possible to perform calculations of the analytical results to still prove compliance, but this is the manufacturers task.

Test reports must be expressed in mg/kg dry matter (where needed) and in the case of nutrient declarations these must be expressed in the format prescribed by the FPR.

This should already be performed by the manufacturer as part of drawing up the TD.

Limit of detection

If a contaminant must be absent and the   report does not declare such a contaminant to be absent without justifying this using the laboratories limit of detection

In chemistry (and in microbiology also, even if here it's a different meaning) we use LOD (Detection limit) and LOQ (Quantification limit).

As an example, in case of Biuret for PFC1(A) Organic fertiliser: "biuret must not be present in an organic fertiliser" means <LOD

PFC naming on label

If the name of the PFC (as stated in Annex 1) or the product PFC number is not on the label

Required by the regulation.

Note if the correct name is mentioned no PFC code is needed.

Technical Specifications

Section in contact of PFC 6 Plant Biostimulant assessments

TS General + Coordination group

The TS is optional, but for PFC 6 Plant Bio stimulant assessments within EFCI Register we see it as applicable unless the manufacturer proposes (explicitly) another standard. 

In case of Justification from the TS, a justification of this may be asked. 

As concluded by the PFC 6 subgroup the TS are the guiding standards for efficacy trial assessments. 

We must be strict in this regard and see this document as mandatory. So for any PFC 6 assessment we always

This includes verifying the research organization and trial report for all TS points.

Deviations are not possible unless discussed with the other auditors, to ensure harmonization.

The document by the coordination group is seen as inserted and repeated.

TS 4.5

If nutrient calculation shows too much applied and no evident control.

Must be explicitly verified by the auditor.

Deviation from this criteria must be explicitly documented, justified and accepted or a CAPA must be concluded.

TS.Methods

If the application rates (including timing) do not correspond to what is included on the label.

 Note: Application method is, currently, not something directly included here but this may change in the future.

See also coordination group. These points must correspond.