Use of data according to current state of science

New guidelines and methodologies related to this ruling will be published in due course, along with updates to existing versions. These new aspects will be considered, and if they comply with two criteria that are listed below, they will be implemented from that point in time when assessing all applications. 

Using the new assessment framework for pending applications has implications for the assessment time and capacity involved in an application for authorisation of a product. To ensure the effectiveness and feasibility of the methodology, two criteria have been identified that a new guideline or methodology must comply with: 

1. More stringent than the previous assessment framework - Under the new assessment framework, an unacceptable risk is identified sooner. 
   According to the ECJ ruling, a Member State may deviate from the risk assessment made by another Member State when authorising a plant protection product, specifically if more recent or more reliable scientific evidence shows that the product "poses an unacceptable risk to human or animal health or the environment". This shows that the intended purpose of the ruling is to identify unacceptable risks sooner and thus increase the level of safety. This happens only if the new assessment framework is more stringent. Some guidelines only clarify the existing framework without affecting the risk assessment itself, while others do not focus on risk assessment but on aspects such as the chemical characterisation of a substance or product. The latter category, therefore, does not meet this stringency criterion.  
    

2. Completely feasible based on the available data package - No additional studies are needed to determine whether there is actually an unacceptable risk when using the relevant assessment framework. 
   
   This means that a guideline or methodology can be fully implemented, including all the levels (tiers) described in it. The purpose of this criterion is to avoid unnecessary delays in the assessment process. This is not only in the interest of feasibility, but it also enhances the level of protection. When applicants have to conduct new studies that then need to be assessed, delays can add up quickly, which is not conducive to overall safety: 

• When renewing a product authorisation, it is important to avoid unnecessary delays in the relevant assessment: if an unacceptable risk is identified, the authorisation should be restricted as soon as possible, subjected to risk mitigation measures (RMMs), or rejected altogether.  

• Moreover, for applications for authorisation of new products, unnecessary delays are also not in the interest of safety: the required additional capacity negatively impacts other assessments. This is relevant for both substances and products with an unacceptable risk and substances and products that contribute to enhanced sustainability. For the former, quick rejection contributes to safety, while for the latter, sufficient capacity is crucial to authorise them as soon as possible. 

The following assessment framework elements are currently being used for applications submitted from 2023; from 1 October 2025, these elements will also be used to assess all pending applications for plant protection products submitted before 2023: 

• The WUR Drift Calculator (WDC, 2021) for calculating the deposition of spray mist (drift) on surface water and terrestrial non-target areas. 

• The most up-to-date versions of PEARL and PELMO (2022) for calculating the behaviour of plant protection products in soil and leaching to groundwater. 

• The latest version of the OPEX model (2022) for calculating exposure of operators, workers, residents and bystanders. 

These models are expected to lead to higher exposure estimates more often, thus identifying a potentially unacceptable risk sooner than in the original assessment framework. The use of the WDC helps protect the environment, while the latest version of the OPEX model (2022) contributes to improved human health protection. The latest versions of PEARL and PELMO contribute to both human and environmental safety. 

The procedure applies to new cMS and zRMS as well as mutual recognition applications for product authorisation and pending cMS and zRMS as well as mutual recognition applications that are still in the assessment phase. This policy will be in force from 1 October 2025.  

INVOEGEN FIGURE 1

Capacity and turnaround times 

The new approach directly affects the assessment of pending applications, but the impact on capacity, turnaround times and costs remains limited. However, consideration must be given to the time required to carry out additional modelling calculations and process applicants' responses, possibly including the assessment of a limited number of additional studies (e.g. if use of the WDC reveals a risk to certain terrestrial non-target arthropods, non-target plants or aquatic organisms). It cannot be determined in advance how many applications will require additional assessment.  

Implications for decision-making 

If the product assessment identifies an unacceptable risk that would not have been identified using the previous assessment framework, this could lead to different outcomes. In many such cases, however, risk mitigation measures (RMMs) can be used. These include: 

• a higher DRT class in case of excessive drift to surface water or terrestrial non-target areas, possibly in combination with a larger cultivation-free zone (TVZ), or 

• mandatory use of personal protective equipment in case of risks to operators or workers. 

There are also situations where a risk cannot be mitigated with an RMM, as in the case of increased exposure of local residents. In that case, the specific use, or even the entire application for product authorisation, should be rejected.  

Applicants in all such cases will have the opportunity to express their views if an unacceptable risk is identified that would not have been identified with older assessment frameworks. The following approach has been adopted: 

• For applications where the request for additional information under the new framework has not yet taken place, a response can be given within the standard framework, as described in Article 37 of Regulation 1107/2009, with a response time of six months. 

• For applications where the request for additional information has taken place, a response time of four weeks is offered. 

• In both situations, additional data or studies will be considered.