That question should actually be rephrased into “what is the role of a Regulatory Affairs Manager” because Regulatory Affairs deal with anything that concerns (highly) regulated products.

This, in turn, means, that some products can not simply be placed on the market: they have to comply with rules and regulations that are applicable in a given country and/or region.

The role of a regulatory affairs manager is to ensure compliance of products before they can be placed on the market.

Regulatory Affairs and Regulatory Science both apply to products or substances that are (highly) regulated. To show compliance with these regulations, certains tests and studies have to be performed.

This is what regulatory science is about.

Regulatory affairs deal with anything from understanding the legislation in a given country or region up to the regulatory science that provides the necessary input for any regulatory dossier, which, itself, always comprises an administrative and a technical/scientific part.

We are not aware of such thing as a PhD in Regulatory Affairs but it should be possible in the context of, for instance, law or science studies. After all, regulatory affairs are about laws, legislations and regulations, guidelines, be it national or supra-national and they have an impact on business.

As there are no official, university lead, Scientific Regulatory Affairs degrees in the agricultural sector, there are several optional backgrounds that can tremendously help understand and gain an advantage in the field.

This list is non-exhaustive, as anyone, no matter the background, that is motivated and eager to learn can become a scientific regulatory affairs manager/consultant.

- A degree in agronomy

- At minimum bachelors degree in Biology, Chemistry and related fields (environmental science or other)

- To some extent, a degree in law

There are many types of biostimulant products. Also, there are combinations possible between regular fertilisers with a biostimulant effect due to one or several special components.

The most popular biostimulant products may contain :

- humic acids

- seaweed extracts

- liquid manure composting

- beneficial bacteria

- fungi.

Biostimulants offer several benefits in crop growing :

- enhancing plant health

- nutrient intake

- overall yield.

They help plants cope with environmental stresses such as :

- drought

- extreme temperatures

- soil salinity

- enhancing stress tolerance

- improving overall resilience.

Biostimulants play a crucial role in improving grain fill in crops like corn, leading to better quality and yield. They contain growth-promoting substances that can boost seedling development, leaf area, and overall plant growth, contributing to healthier and more vigorous crops.

In summary, the benefits of biostimulants in crop growing encompass stress protection, improved quality and yield of grains or fruits, and enhanced plant growth through the promotion of essential processes within the plants.

Microbial Biopesticides: Bacillus thuringiensis, or "Bt" is one of the most widely used microbial biopesticides.

Different strains of Bt produce proteins that target specific insect larvae, such as moth larvae, flies, and mosquitoes.

Another type of biopesticide are plant-Incorporated Protectants or "PIPs".

These biopesticides involve genetic material inserted into plants to produce pesticidal substances. For example, plants can be engineered to express proteins from Bt that are toxic to certain insects.

As of June 2024, several PIPs have been authorized for cultivation and marketing in Europe. While some EU member states have embraced GMO technology and approved certain PIPs for use, others have imposed restrictions or bans on GMO cultivation within their borders.

More common in Europe are biochemical biopesticides.

These are based on naturally occurring substances that control pests or weeds. One example is insect sex pheromones and scented plant extracts that disrupt mating or attract pests to traps.

Biopesticides offer several advantages over conventional pesticides, making them an attractive option for sustainable agriculture and pest management:

- Lower Toxicity: Biopesticides are usually inherently less toxic than conventional pesticides. They are derived from natural materials such as animals, plants, bacteria, and minerals, which tend to have lower toxicity levels compared to synthetic chemicals used in conventional pesticides.

- Environmental Safety: Biopesticides decompose quickly and often have lower persistence in the environment compared to conventional pesticides. This characteristic helps in reducing pollution problems caused by chemical residues in soil, water, and food products.

- Effective in Small Quantities: Some biopesticides are often effective in small quantities due to their specific mode of action. This means that lower volumes of biopesticides are needed for pest control compared to conventional pesticides, leading to reduced overall pesticide usage.

- Safer Handling: Due to their lower toxicity levels and specific modes of action, biopesticides can be safer to handle for farmers, agricultural workers, and consumers who may come into contact with treated crops or produce.

Yes, biopesticides can be considered organic as they are composed of components found in nature in their natural state.

There are no chemically engineered elements in biopesticides.

Warning, this does not mean that biopesticides are less effective or less dangerous than conventional, chemical pesticides.

Amont the three most important types of Biopesticides there are:

- microbial

- biochemical biopesticides

- Plant-Incorporated Protectants or "PIPs".

Among these types, Bacillus thuringiensis (Bt) is probably the famous and effective biopesticides due to its specificity in targeting insect pests and its successful integration into various crops for pest management purposes.

Here is a short description of the three most important types of biopesticides:

- Microbial Biopesticides: Bacillus thuringiensis (Bt) is one of the most famous and widely known microbial biopesticides. Bt is a soil bacterium that produces proteins toxic to many insect larvae. Various Bt products like DiPel, Du-Ter, and Javelin are registered for use on crops such as potatoes. The insect-killing genes of B. thuringiensis have also been genetically engineered into several crops to enhance their pest resistance.

- Biochemical Biopesticides: Biochemical biopesticides include substances like pheromones that disrupt mating cycles or attract insects to traps. While not directly toxic, these substances interfere with pest behavior and reproduction. They are commonly used in integrated pest management strategies.

- Plant-Incorporated Protectants (PIPs): PIPs involve genetically modifying plants to produce pesticidal proteins derived from organisms like Bacillus thuringiensis. These proteins help the plants defend themselves against specific pests by targeting the insects that feed on them.

sciBASICS offers a multitude of services. These include :

- Consultancy services. (Guidance, checks and handling of a dossier anywhere in Europe.)

- Regulatory legislation updates. Regular updates to allow you to read in matter of seconds what changed in the regulations in Europe, concerning biostimulants and biopesticides.

- Agricultural scientific regulatory affairs in-house trainings for companies.

- Agricultural scientific regulatory affairs video courses for beginners.

sciBASICS is a scientific regulatory affairs consultancy company established in November 2007 by Evelyne Güsken.

Based in Eupen, Belgium, Evelyne's journey began as a freelance regulatory consultant before she ventured into founding her own company.

The fusion of "science" and "basics" encapsulates the ethos of sciBASICS, emphasizing the importance of mastering the fundamentals of science to make well-informed decisions and develop robust dossiers.

Currently, Evelyne continues to lead as the CEO, steering a close-knit team of 4 dedicated individuals, including her daughter Elena Güsken.

Yes, sciBASICS has it’s own YouTube channel !

With both, long form videos as well as Shorts.

Every video is about scientific regulatory affairs in Europe, as well as interviews with notification bodies, such as Certrust.

Check out our videos here.

Absolutely ! sciBASICS and it’s team are on LinkedIN.

Check them all out here :

- sciBASICS

- Evelyne

- Elena
- Alberto

At sciBASICS, a dedicated team of regulatory experts collaborates to provide comprehensive support for clients seeking to register biostimulants and biopesticides in European countries.

With a vast network of consultants spanning across Europe, including Russia, sciBASICS ensures that all regulatory requirements are met.

The team's meticulous approach involves conducting data gap analyses and feasibility checks, empowering customers to make well-informed decisions and mitigate potential risks.

Furthermore, sciBASICS is actively developing compliance check tools to streamline the feasibility assessment process and provide strategic insights for successful project outcomes.

Are you looking for reliable and long-term consulting services for your company?

Look no further! sciBASICS offers permanent consulting solutions to support businesses in achieving their goals and staying ahead in the market.

When it comes to finding reliable regulatory information, the internet is filled with sources, but it's crucial to turn to the official websites of relevant authorities for the most trustworthy details.

Additionally, websites like www.biostimulants-legislation.com offer concise summaries of regulatory information specifically for biostimulants.

For those seeking European legislation, the EURLEX website stands out as an excellent source, while national legislations can be best found on the official websites of the national competent authorities.

Fertiliser manufacturers who are not complying with EU regulations may face fines and penalties from the European Commission based on the severity and frequency of the infraction.

Legal action, including injunctions and court orders, could be taken against non-compliant manufacturers, which may be costly and damage their reputation.

Non-compliant manufacturers may be required to recall products that do not comply with EU regulations, which can be expensive and erode consumer confidence.

In extreme cases, non-compliant manufacturers may lose access to the EU market, leading to a significant loss of revenue.

Some time ago, the impact of the BREXIT has been a topic of widespread discussion.

It is worth noting that this event has had significant implications, particularly in the realm of biopesticide work.

Previously, the UK played a crucial role as a valued Member State being able to act as zonal Rapporteur Member State within the EU, contributing to the evaluation of dossiers for the central zone.

However, with the UK's departure from the EU, it is now considered a third country, resulting in the loss of a valuable team member for evaluation work within Europe.

Additionally, the implications extend to mutual recognition processes and the fact to be a concerned Member State in biopesticide dossiers, which are exclusive to EU Member States.