Comparative Assessments for Plant Protection Products

Plant protection products containing active substances approved as a candidate for substitution must undergo a comparative assessment as part of the registration process in European Union Member States. Enviresearch can assist in identifying the need for, and conducting, comparative assessments to support your product registrations.

The regulation of the plant protection products in the European Union (EU) requires products containing active substances approved as a candidate for substitution (CfS) to undergo a comparative assessment as part of the evaluation process for authorisation in any EU Member State.

An active substance is classified as a CfS if its intrinsic hazardous properties meet any of the seven conditions defined in Annex II of Regulation (EC) No 1107/2009¹ that are considered less favourable in comparison to most active substances.

The aim of the comparative assessment is help improve the protection of health and the environment by replacing candidate products (i.e. the product containing a CfS) with alternative pest control methods of less concern, whilst minimising the economic and practical disadvantages presented to agriculture.

Approximately 1 in 6 active substances are approved in the EU as a CfS. Any plant protection product containing one of these active substances will therefore require a comparative assessment to be conducted when an authorisation for use of the product in an EU Member State is sought. A separate assessment is required for each Member State in which the plant protection product is intended to be authorized, with a number of Member States having their own national guidance to follow.

As outlined in the European Commission guidance document for comparative assessment and substitution of plant protection products (SANCO/11507/2013 rev. 12), the comparative assessment should cover the following basic steps:

• Step 1 – Identification of CfS in the plant protection product
  It is identified if the product contains any active substance which is approved as a candidate for substitution.

• Step 2 – Assessment of agronomic aspects
  All available alternative methods of chemical and non-chemical control of the target pest are identified. A comparative assessment of the efficacy (i.e. effectiveness, crop safety, and risk and developing resistance) of these alternative methods is made against the candidate product in accordance with EPPO standard PP 1/271.

• Step 3 – Initial assessment of risk to health and the environment
  The alternative methods are compared to the candidate product with respect to the criteria on which it was assigned as a CfS.

• Step 4 – Extended assessment of risk to health and the environment
  A further consideration of the risk assessments for health and the environment is performed which considers other aspects outside the scope of the CfS criteria, as well as the severity of the restrictions and PPE required for the use of the alternative method(s).

Based upon the above steps an overall conclusion is drawn as to whether the candidate product can be substituted by an alternative means of pest control without resulting in significant economic and practical disadvantages. Enviresearch has extensive experience in conducting comparative assessments to support the registration of plant protection products in EU Member States. We can assist in all aspects of the comparative assessment, from identifying products which contain a CfS and compiling lists of alternative pest control measures available in Member States, to conducting all aspects of the agronomic and health / environmental assessment steps.

If you wish discuss the need for a comparative assessment to support your product registrations in the EU please contact our Regulatory Affairs Team Lead, Rachel Gill, at This email address is being protected from spambots. You need JavaScript enabled to view it..

 

 

¹The seven conditions defined in Annex II of Regulation (EC) No 1107/2009 for active substances to be classified as a candidate for substitution are:

1. its ADI, ARfD, or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories;
2. it meets two of the criteria to be considered as a PBT substance;
3. there are reasons for concern linked to the nature of the critical effects (e.g. developmental neurotoxic or immunotoxic effects) which, in combination with the use/exposure patterns, amount to situations of use that could still cause concern;
4. it contains a significant proportion of non-active isomers;
5. it is classified as carcinogen category 1A or 1B;
6. it is classified as toxic for reproduction category 1A or 1B;
7. it is considered to have endocrine disrupting properties that may cause adverse effects in humans.