The requirement to have an 'adequate analysis of risk'

Modified on Mon, 16 Sep at 7:33 PM

According to the FPR Annex IV, all conformity assessment modules require an adequate analysis of risk. Specifically they say something like:

The documentation shall make it possible to assess the EU fertilising product’s conformity with the relevant requirements and shall include an adequate analysis and assessment of the risk(s).

However this requirement does not mean that each product is subject to a risk assessment outside of all the other work done to comply with the FPR.

The attached Safety Data Sheet (SDS) is the result of the risk assessment done (sections 2 – 8). If the product at hand is simple or well known (such as a common water soluble mineral fertiliser) there would be no other risks than the ones covered by the Safety Data Sheet.

Additionally complying with the FPR already shows that risk mitigation was performed and the annexes of FPR are already a risk assessment and mitigation excercise.

The obligation for the risk assessment is thus to be seen as risks outside of the requirements of FPR that the manufacturer has identified. If any of these exist they must be mitigated. This is the responsibility of the manufacturer. If no risks exist to the knowledge of the manufacturer outside of the above then the requirement is fulfilled.

As a Notified Body it is our responsibility to verify that a risk assessment exists but not to evaluate it, so the file would not need such an assessment. We will ask for a confirmation if risks outside of the FPR + SDS are part of the product in a signed statement. Under Module D1 we may however ask how the risk assessment is part of Quality Policy.

A a manufacturer can also indicate that outside of compliance with the FPR there are no specific risks which is a justification that can be used.

From the EU FPR 2019/1009 FAQ = 10.11 What is expected by ‘adequate analysis and assessment of the risk(s) to be included in the technical documentation’
Broadly speaking, the risks of fertilising products are covered by the FPR, in particular Annexes I and II. Therefore, in principle the requirements of the FPR applicable to the product as well as the product’s conformity with the relevant requirements in the Regulation must be documented. However, it is also recognised in Article 4(2) that there might be aspects not covered by Annexes I and II. Risks in a specific field are usually known by diligent manufacturers operating in that field, and the technical documentation should identify them and document how they have been addressed.