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The Applicant Guide: The Application Overview For Re-Registration Applications

General information

The Application Overview supporting a re-registration application for a product containing a new active substance should clearly demonstrate that the product is supported by a dossier satisfying the requirements of Annex III and in accordance with the Uniform Principles. Appropriate references to data and/or information previously considered at the Community level or if not, by CRD, should be provided in each area.

Data gaps:

You will need to address any areas highlighted in the Review Report as requiring particular attention at MS level. Where changes are required to conditions of use/risk mitigation measures, you should fully explain these.

Uses considered acceptable at Community level for a new active substance are listed in the Evaluation Table in Background Document B to the Review Report or EFSA conclusions (for List 2 onwards). Where a UK use was not considered, you will need to provide an appropriate justification in each area of the assessment.

Other points to bear in mind at re-registration are highlighted in the following sections. These are not exhaustive; it is your responsibility to ensure that all requirements are addressed and Uniform Principles are met. If you are seeking additional changes to the conditions of approval for your product as part of your re‑registration application (such as approval for new packaging or new crops), you will need to submit the appropriate data and assessments of these data.

Summaries and overall assessments

Identity

Please indicate whether the proposed technical specification for the active substance is the same as previously approved under PPPR. Any differences should be fully addressed and supported by the appropriate data.

You should confirm where the technical specification has changed but the differences have already been assessed at Community level and accepted.

You should address any changes to the product formulation in a similar way.

Physical and chemical properties

You should address any outstanding data gaps and/or open points (see General information).

Details of uses and further information

You should address any outstanding data gaps and/or open points (see General information).

Classification and labelling

You should include details of proposed classification and labelling for your product (and how these were arrived at) in order to comply with the ‘Chemicals (Hazard Information and Packaging for Supply) Regulations 2009’ (CHIP 4). Information on CHIP can be found on the HSE website.

Annexes IV (Special Risk Phrases) and V (Safety Precaution Phrases) of Council Directive 91/414/EEC were recently adopted and you should propose suitable phrases for any Special Risks or Safety Precautions arising from the use of your product as a pesticide.

Methods of analysis

You should address any outstanding data gaps and/or open points (see General information).

Impact on human and animal health

You should address any outstanding data gaps and/or open points (see General information).

Operators, bystanders and workers

Estimates of operator, bystander and worker risk under UK conditions will already have been considered in the granting of provisional approvals under PPPR. However, different Acceptable Operator Exposure Levels (AOEL) or dermal absorption values may have subsequently been agreed at Community level for the Annex I Inclusion. You will need to address the implications of these differences and provide confirmation that the risks posed are still acceptable.

Where the Annex I agreed dermal absorption value is different to the one that we have previously used, you will need to provide revised estimates of systemic operator, bystander and worker exposure using the agreed value.

You should use appropriate UK models (see Data Requirements contents page) in any new assessments. You should fully explain any assumptions used to derive exposure rates (such as work rates, container sizes or application equipment).

Consumers

We will previously have carried out an estimate of UK consumer intake , in the granting of provisional approvals under PPPR prior to Annex I Inclusion. However, a different Acceptable Daily Intake (ADI) value/Acute Reference Dose (ARfD) (if applicable) may have subsequently been agreed at Community level for the Annex I Inclusion. You will need to address the implications of any differences and provide confirmation that acceptable margins of safety exist for consumers.

Residues

You should address any outstanding data gaps and/or open points (see General information). These may include further supervised trials to confirm MRLs of various commodities.

EC temporary Maximum Residue Levels (MRLs)

EC temporary MRLs agreed for the active substance at Community level in Regulation 396/2005 should be listed.

Where we consider that a change to the temporary MRL or a new MRL is supported by the available data, then we will also apply to EFSA to have this MRL changed.

Fate and behaviour in the environment

You should address any outstanding data gaps and/or open points (see General information).

The environmental fate of the active substance under UK conditions will already have been considered in the granting of provisional approvals under PPPR prior to Annex I inclusion.

Where the Annex I agreed endpoints, such as degradation/dissipation rates (DT 50/90 values), are different to those used in the original assessment supporting the UK approval, then you may need to provide revised Predicted Environmental Concentration (PEC) calculations. These must be relevant to the UK situation and take into account statutory conditions and timings of use (including the earliest application timings) for each crop and use approved on the product label.

You must remember to consider relevant routes of exposure (for example, spray drift and drainage). You should submit a groundwater assessment as outlined in Data Requirements. You may reference these assessments where they have already been carried out at Community level and cover the UK situation.

You should use our environmental checklist to help prepare your environmental assessment.

Effects on non-target species

You should address any outstanding data gaps and/or open points (see General information).

The impact on non-target species arising from the use will already have been considered in the granting of provisional approvals under PPPR prior to Annex I inclusion.

You will need to provide revised Toxicity/Exposure Ratio (TER) calculations and Hazard Quotient calculations should the Annex I agreed endpoints for non-target species differ or if revised PEC calculations (see 'Fate and behaviour in the environment' above) are being presented for the UK situation.

You should reference or provide a risk assessment, where the environmental risk assessment exposure values do not originate from PECs calculated in the fate and behaviour evaluation. Any exposure calculation methodology should be as agreed by MS for the Annex I inclusion of the active substance. Alternatively, you may follow more recent methodology may be followed if you wish to do so.

You should use our environmental checklist to help prepare your environmental assessment.

Overall conclusions

You should consider whether sufficient information has been presented to support a standard approval under PPPR, ie to confirm that Annex II and III requirements are met and that the use of the product under UK conditions satisfies the Uniform Principles and Annex I agreed end points.

You should detail any further information that still needs to be submitted (for example to address a minor and non-safety deficiency), together with an indication of when you will be able to submit these data.

Registration Report

Submit a draft Registration Report (dRR) as detailed in the EU Guidance document which is available on the Commission website:

The Application Overview supporting a re-registration application for a product containing a new active substance must clearly demonstrate that the product is supported by a dossier satisfying the requirements of Annex III and in accordance with the Uniform Principles. Appropriate references to data and/or information previously considered at the Community level or if not, by CRD, must be provided in each area.

Further information

Updated 2017-01-06