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EU Regulation 1107/2009 requires new/extended PPPs to undergo comparative assessments to reduce the potential risk to humans, animals and the environment from the use of products containing ‘active substances’.

What is a Comparative Assessment?

When authorising the use of new PPPs the potential risks posed by these products are considered and compared to other, lower risk, alternatives.

Mandatory CA

Under Regulation 1107/2009, a new PPP containing an ‘active substance approved as a candidate for substitution’ (CFS), known as a candidate product (CP), must undergo a comparative assessment before it can be authorised. This applies to new PPPs and new uses for existing PPPs. This process reduces risk by reviewing the CP and where practical, replacing it with products of lesser concern.

Optional CA

In some circumstances, a PPP not containing a CFS may need to undergo assessment. For example, if a non-chemical control or prevention method already exists and is in general use in that EU Member State. These are known as optional comparative assessments.

CA Schedule

CAs are carried out by Member States at the same time as the application for PPP authorisation, and when:

  • A review for an existing PPP is required at renewal
  • An application is submitted for:
  • Amendment of the registration of a PPP
  • A new PPP

Step-by-Step

Prior to starting a CA, potential alternative products must be identified. At every step, the PPP and its CP are considered against the alternatives.

 

Further environmental risk mitigation measures may be considered for the CP, including:

  • Avoiding breeding and flowering seasons
  • Use of larger buffer zones, vegetative buffer strips, and low drift technology
  • Restrictions on the soil types
  • Use of unsprayed headlands

Derogation is available when the active substance controls a pest that can ‘cause serious danger to plant health’. The alternative product identified under the CA must be authorised, and widely available for a minimum of five years, in order to allow for sufficient experience of the product to be gained. Withdrawal of the use of the PPP becomes effective three years after the Member State decision, or at the end of the active substance approval period.
Currently, there is some debate as to whether it is appropriate for manufacturers to conduct CAs for their own products. It may be more appropriate for independent companies to carry out these assessments.

SGS Services

SGS has relevant experience in all areas of comparative assessment including:

  • Efficacy: field trials, BADs
  • Residues: minor uses, field trials, dossiers, dietary risk calculations
  • Environmental: testing, EIS preparation, modelling: FOCUS, OpEx, dossiers
  • Ecotox: testing, dossiers, modelling: bird and mammal risk, TER’s, risk mitigation
  • Biologicals: alternative biological agents, IPM

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For further information, please contact:

Dr.Sue McMillan-Staff BSC., PHD., C. CHEM. M.R.S.C
Regulatory Affairs Manager
SGS United Kingdom Limited
The Meadows, Alkerton Oaks Business Park Upton Estate,
Stratford Road, Banbury OX15 6EP
t: +44 1295 671933