Comparative assessment and substitution

Comparative assessment and substitution is required by retained Regulation (EC)1107/2009.

Article 50 of the regulation specifies a comparative assessment should be performed when evaluating an application for authorisation for a plant protection product that contains an active substance that has been approved as a candidate for substitution.

Article Annex IV explains the need to weigh up the risks and benefits in line with the regulation requirements when considering whether there is a significantly safer alternative. The alternative control or prevention method is suitable when it can be substituted without significant adverse consequences on crop protection.

A plant protection product must not be authorised, or must have its use restricted, where this assessment concludes that there is a suitable significantly safer alternative.

Applicants must provide information to HSE under Article 50.

When to provide information for comparative assessment

It has been required to provide information for comparative assessment since August 2015. This legislation has been carried over into UK law post EU exit.

You only need to provide the information in this guidance for the following application types:

new products and new or additional uses of plant protection products containing one or more active substances approved as a candidate for substitution
renewals of plant protection products containing one or more active substances approved as a candidate for substitution

Comparative assessment is not required for other applications even if the product contains a candidate for substitution, as these applications require no new risk assessment. As with other applications, any relevant conclusions will be applied to any parallel imports and identical ‘back-to-back’ products.

How to submit the information

You must include:

your conclusion on comparative assessment and substitution in the draft registration reports (dRRs), as shown in the form instructions
your detailed conclusion as the supporting ‘data’, using the form

What the information needs to cover

If the application is for additional uses, your comparative assessment only needs to consider the new uses requested. If the application is for renewal of an authorisation, you should consider all major uses of the product.

Consider steps 1-10 in the instructions for completion and decide which steps you need to complete for your product.

Optional comparative assessments Article 50(2)

GB/NI will not be undertaking any of the optional comparative assessments allowed for by Article 50(2). Therefore, this guidance only considers the requirements for essential comparative assessment and substitution.

How comparative assessments will be completed in GB and NI

We aim to enable both applicants and HSE to identify easily those uses of plant protection products where a substitution would not be appropriate even if a significantly safer alternative exists. A comparison of risk assessments will only be undertaken by HSE where it is initially identified that a substitution may be appropriate.

If your information in the form indicates that a substitution may be appropriate, HSE will complete a more detailed comparative assessment.

The properties of an active substance that mean it is a candidate for substitution will define the first aspect of the comparison to determine whether there are significantly safer options. For example, if the active substance is classified persistent and toxic (two of the Persistent, Bio accumulative and Toxic criteria), the comparative risk to the environment will be considered first; if the active substance is classified as a Category 1B Carcinogen, then comparative risk to humans will be considered first.

If in the first comparison, efficacy elements indicate that a substitution could be warranted then we will move on to consider whether risk mitigation measures in other areas of the risk assessment preclude the substitution.
Taking all these aspects into consideration, HSE will make an expert judgement on whether a substitution is appropriate and thus whether authorisation can be granted for the uses considered.

Regulatory action at the end of comparative assessment

If HSE concludes that a substitution for any of the uses of your product is appropriate, we will propose withdrawal or amendment of that use in line with Article 50(5).

This will take effect three years after the decision to withdraw or amend the authorisation, or at the end of the approval period for the candidate for substitution, where that period ends earlier.

You will have the opportunity to consider the proposals for an amendment or withdrawal of an authorisation in line with Article 44 of GB and NI Regulation 1107/2009. This provides an opportunity for the authorisation holder to submit comments or to provide further information.

When the availability of alternatives changes after a decision to substitute has been made

If you believe that suitable significantly safer alternatives to your product are no longer available and a comparative assessment would not reach the conclusion that a substitution is appropriate, you may make an application for re-instatement of your product using the appropriate regular application route.

If the active substance is still approved as a candidate for substitution, this application should include a new consideration for comparative assessment together with any other data or information that may be required for re-instatement at that time.

Implications for Prior Informed Consent (PIC)

PIC applies to substances that have been banned. As candidates for substitution are approved active substances, decisions taken under these comparative assessment arrangements do not have implications for PIC.

EU legislation

Throughout this page, reference to any EC/EU legislation means:

in relation to Great Britain, as it has effect in Great Britain
in relation to Northern Ireland, as it has effect by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement