Key Services

• • Strategic advice and guidance.

Regulation No 1107 2009 of the European parliament and of the council of 21October 2009 concerning the placing of plant protection products on the market. The process for plant product registration entails two steps: first, an assessment and possible approval of the active substance at EU level and then an assessment and authorization of the final products by the Member States. Active substances can only be approved for use in plant protection products if they fulfil the approval criteria that are laid down in Regulation No 1107/2009.

• • Data generation management and study monitoring

Study management and monitoring is one of the most robust tasks in the whole application process. Our team is highly qualified and extensively experienced in study management. We identify and have associated with the network of best GLP certified labs globally and certainly support you in the study placement, monitoring GLP and BPE studies, and proofreading the report. We support you in identification of required studies for registering your products and utilising the end points and studies in dossiers. However, managing efficacy field trial according to EPPO zones is one of a key area of our bio-efficacy department. Our team help you in designing trial programs and developing study plans.

• • Risk Assessment

In risk Assessment we support you for environmental fate modelling, according to FOCUS and national requirements. Human health, human exposure and environmental risk assessment and assessment of potential endocrine disrupting substances.

• • Data Gap Analysis

We help you in identifying the gap in your available data set. And do gap analysis by demonstrating what studies required to be generated to comply with the data requirements for the substance or formulation and help you in data generation with fitting test methods, recognised by respective authorities for evaluation and cost of study generation. The technical requirements are divided into various areas such as:

• • 1. Physical and chemical properties
    2. Toxicology
    3. Residues
    4. Fate and behaviour in the environment
    5. Ecotoxicology
    6. Efficacy

• • Dossier preparation, submission and post submission

The data requirements are set out in Regulation (EU) No. 283/2013 for the active substance and in Regulation (EU) No. 284/2013 for the product formulation along with national requirements which are specific to each Member State. However, writing EU regulatory dossiers is one of the most important tasks. Therefore, we support you in dossier preparation, submission and post submission completely. Data must be provided in a draft Registration Report dRR. The report consists of core assessment for zone and national addenda as per MS requirement. We have been supporting our clients for Part A risk management, Part B data evaluation and risk assessment (B0 to B10) and Part C confidential information. Below are some of the kye solution:

• • 1. Compilation and preparation of dossier
    2. Authority comment’s reply with scientific justification
    3. Communication with authorities
    4. Support you for Task Force identification and management
    5. Management of the entire authorisation process

• • Project Management

At Auxilife we are aware of the fact that some time deciding about a regulatory strategy is disproportionately cumbersome. Therefore, to lift up the burden Auxilife has designed a procedural model that begins with the understanding of your aspiration and your product and then gearing to the development of tailored strategies suiting to your product and budget estimates. In the summation we evaluate and analyse relevant factors that will come on the way of registering your product. We advise, do preliminary assessments and design a way forward to meet all regulatory compliance.
Regulation No 1107 2009 of the European parliament and of the council of 21 October 2009 concerning the placing of plant protection products on the market. The process for plant product registration entails two steps: first, an assessment and possible approval of the active substance at EU level and then an assessment and authorization of the final products by the Member States. Active substances can only be approved for use in plant protection products if they fulfil the approval criteria that are laid down in Regulation No 1107/2009.
Tier 1: Active substance approval. Active substance is a chemical, microorganism or substance of plant origin that exerts an insecticidal, herbicidal, fungicidal or other action used in products meant for agriculture use. Active substance is the active ingredient(s) in a plant protection product that enables it to efficaciously protect crops. Type of authorization of active substances in EU

• • 1. Approval of active substances
    2. Renewal of approval of active substances
    3. Equivalency of technical material for active substances
    4. Data matching

• • Data requirements for active substance authorization

The current data requirements for the EU dossier of an active substance are set out in. Regulation (EU) 283/2013. These data facilitate an in-depth assessment of the active substance. The data are sub divided into various sections:

• • 1. Physical and chemical properties
    2. Information regarding use
    3. Methods of analysis
    4. Efficacy
    5. Toxicology and metabolism
    6. Residues in food and feed
    7. Fate and behaviour in the environment and
    8. Ecotoxicology
    9. Endocrine disruption

In addition, data of at least one representative formulation which contains the intended active substance is required. The data requirements are laid down in Regulation (EU) 284/2013.
Renewal of approval of active substances:
The initial approval of an active substance is valid for a limited period and the approval of an active substance needs to be reviewed periodically. Regulation (EU) 844/2012 lays down the renewal procedure for active substances whose approval period ends before March 27, 2024. Regulation (EU) No 2020/1740 applies to active substances whose approval period ends on or after March 27, 2024.
1. AIR 4 programme: For active substances whose initial approval expires between 1 January 2019 and 31 December 2021
2. The 5th renewal programme: For active substances whose approval expires between 1 January 2022 and 31 December 2024
3. The 6th renewal programme and beyond: For active substances whose approval period ends between 31 March 2025 and 27 December 2028.
Tier 2: Authorization of formulated products:
1. Zonal application
2. Mutual recognition
3. Product Renewals
4. Change in product authorization
          -amendment of uses
          -extension of uses
          -change in restriction sentences
          -change in the legal instructions for use
          -major change in product composition
          -Minor or administrative changes
          -Minor uses and extension with minor uses