Europe - Need to know Regulations

By Vincent Dreze, Managing Director, Eurofins Agroscience Regulatory

If you’re interested in some insightful information on the European regulatory environment for Plant Protection Products (PPPs), then read on!

Vincent Dreze, Managing Director, Eurofins Agroscience Regulatory has put together the following article, ″Regulatory Need to Know″ for Europe.

We hope you enjoy this expert viewpoint on the current regulatory environment that is shaping your registration processes…

A solid starting point when considering the EU situation would be consideration of the current political context. 

On June 9^th, 2024, European citizens voted for the renewal of the Members of the EU Parliament (MEPs) and the results of those elections will impact the legislative framework and on how the PPP sector will be regulated.

The results were that right and far-right parties in many EU member-states gained a majority of seats. This outcome was driven by many factors including the opposition to the European Green Deal. 

Here are some indications on how the results may impact the registration of PPPs in Europe:

First, these parties often prioritize economic growth and reduced regulatory burden on business. So, one might expect a push to relax some of the regulations governing the approval and use of PPPs. This may include faster approval processes, less stringent safety and environmental assessments, and potentially a rollback of some measures aimed at reducing chemical pesticide use.

Second, they might emphasize agricultural productivity and competitiveness, potentially prioritizing the needs of farmers and the agricultural sector over environmental concerns. This could lead to policies that favour the continued use of conventional chemical pesticides to ensure high crop yields and this possibly at the expense of more restrictive and environmentally focused regulations.

In that context, the European Green Deal and its Farm to Fork Strategy, which aim to reduce chemical pesticide use by 50% by 2030, might face resistance as MEPs may argue that they impose excessive burdens on farmers and could negatively impact agricultural productivity and economic growth.

However, much legislation related to the deal has already been adopted in the last 5 years. 

The EU and the member-states are now in the process of implementing and enforcing that legislation. It might be weakened but cannot be simply undone. The challenge will arise when it comes to introducing new legislation – this will be more difficult.

That said, the current situation cannot be solely attributed to the recent election. In February 2024, in response to the farmers’ protest, the Sustainable Use Regulation was turned down by the European Commission. This is likely to lead to continued reliance on chemical pesticides, so, we are unlikely to see a fundamental shift away from chemical pesticides.

Contrary to this political turnaround, the overriding opinion from society is that one cannot neglect social and environmental responsibility and sustainability is still at the core of everything in Europe!

There are many initiatives launched in the EU, encouraging safer alternatives to conventional chemistry. For example, the Circular Bio-based Europe Joint Undertaking (CBE JU) is a €2 billion partnership between the European Union and the Bio-based Industries Consortium (BIC) that funds projects advancing competitive circular bio-based industries in Europe.

EAR contribute to the preparation of funding proposals, offering the regulatory support to stakeholders willing to push innovation to market, with at least four proposals currently underway for the upcoming September submission. This represents a unique opportunity for start-ups (as one example) to ramp up their technology with some financial security.

Now the current situation has been described, let’s move to the top 3 ″need-to-know″ details concerning EU regulations, with a specific focus on additional data requirements and harmonization of PPP assessments.

The EU regulation on safeners and synergists in PPPs was recently published (Commission Regulation 2024/1487 of 29 May 2024). 

The philosophy for safeners and synergists is the same as for the active substances. Authorities are implementing a review program for safeners and synergists that can only be used if approved at EU level in a similar way to active substances. Proposed dates are as follows:

• By 19 July 2024, the European Commission must publish a list of all safeners and synergists known to be used in plant protection products in the EU. 

• By 19 December 2024, any interested party may submit a notification of other safeners and synergists not listed by the Commission. 

• By 19 June 2025: any interested party may submit a request for a listed safener or synergists to be included in the EU’s review programme, i.e. where there is no request, the safeners or synergists will not be reviewed. 

• Eventually, by December 2025, the Commission will adopt a work programme specifying safeners and synergists to be reviewed, and the EU Member State responsible for managing the review (rapporteur)

• Finally, by 19 June 2028, companies must submit an application (IUCLID format) for approval to the rapporteur Member State.

Companies will need to meet stringent data requirements for safeners and synergists, involving additional testing, documentation and then costs. 

Some co-formulants are also at stake and today the regulation 2021/383 lists 144 co-formulants that are not authorized in the EU based on their  classification.

When assessing applications for authorisation of PPPs, Member States shall verify whether co-formulants contained in formulations could be considered as an unacceptable co-formulant (according to the regulation 2023/574 and criteria set out in its annex). One of the major impacts is that Member States shall not authorise the placing on the market or use of adjuvants containing co-formulants listed in Annex III to Regulation (EC) No 1107/2009, as amended by this Regulation. 

From a company’s perspective, it is critical to perform a review of the Safety Data Sheets classification for each co-formulant (less than 2 years old) and to check it aligns with the harmonised classification, if existing. Eventually, a new application may have to be submitted. Also note that for co-formulants classifying as mixtures, a detailed composition is required by authorities.

The authorities, from their side, do consider that a database containing all required information on a co-formulant and accessible to Member States would be desirable. There is currently no centralised database of information on co-formulants, which makes it difficult for regulators to assess their safety - this drives us to the next topic: 

The need to get common IT tools to harmonize way of collecting and assessing regulatory data.

So far, communication between MSs relies too heavily on manual data retrieval, transfer of data (which poses challenges in terms of timeliness), accuracy, and overall workflow efficiency. 

In this context, IUCLID is being considered in PPP authorisations. 

IUCLID has been used for the submission of active substance dossiers for some time now. It effectively stores a wealth of data and can be configured to generate a variety of reports. While the evaluation process itself occurs outside of IUCLID, its role as a centralised repository of chemical substance data aligns well with its potential application in the context of PPPs. It could serve as a central "hub" for data collection, facilitating frictionless data exchange and collaboration among MS and industry. 

However, over the past years several countries have developed their own software packages to manage various aspects of their national procedures. Understandably, member states that have developed such systems are reluctant or even unwilling to abandon them, as in addition to the investment made, they have been tailored to meet their specific needs. Both member-states and industry stakeholders’ express concerns about the potential for duplicating work, as requiring parallel entry in two separate systems could lead to discrepancies and increased workload rather than improved efficiency. 

To briefly conclude, Europe is a complex region where it’s necessary to meet the European and member-states requirements, with the current political context making the system more unpredictable. In any case, Europe remains a critical region for (bio)chemical manufacturers, and other stakeholders need to be strongly engaged as well. Eurofins Agroscience Services are one of these stakeholders and believe it is important to actively take part in the discussion. 

On this topic, we are pleased to share some news on the creation of the EACL (European Association of Regulatory Consultants and Contract Research Laboratories).

The objective of EACL is to set up a European level representative body for those CROs and regulatory consultants with a complementary professional interest in the regulatory procedures managed by the European Food Safety Authority (EFSA) for instance, along with other bodies.

Eurofins Agroscience Services and several other CROs, started the discussion around two years ago and we expect the official launch of the association by the end of 2024.

We will be monitoring current and future developments of relevant legislation in Europe, developing the Association’s opinions and positions on the legislation, presenting them before the relevant European bodies, national authorities and other relevant organizations and stakeholders.

If you have any question on this article, please don’t hesitate to get in touch!