Crop Health and Plant Nutrition

For over 30 years, we have been serving the industry with our hands-on regulatory expertise supporting our clients throughout the entire approval process for their actives and products.

In 2022, we established the Agriculture Regulatory and Scientific Affairs business unit to bundle our technical and scientific expertise within a team of more than 70 scientists, best suited to support you with 360° solutions for your regulatory challenges.

We are happy to provide you with regulatory and technical advice on:

The range of our scientific services extends over all dossier sections, including:
  • Study monitoring
  • Physico-chemical properties, including PCN and MSDS
  • Toxicology
  • Residues
  • Environmental fate
  • Ecotoxicology
  • Efficacy

We are your best choice when it comes to ensuring the success of your submission in all conventional formats – Word, CADDY or IUCLID.

 

 

 

 

Sustainable Farming

Integrated Pest Management (IPM)

In the EU, Integrated Pest Management (IPM) is one of the key elements of Integrated Production (IP), being mandatory for professional users since 2014.

The Sustainable Use Directive 2009/128 defines IPM as “careful consideration of all available plant protection methods and subsequent integration of appropriate measures that discourage the development of populations of harmful organisms and keep the use of plant protection products and other forms of intervention to levels that are economically and ecologically justified and reduce or minimise risks to human health and the environment. ‘Integrated pest management’ emphasises the growth of a healthy crop with the least possible disruption to agro-ecosystems and encourages natural pest control mechanisms”.

National Action Plans and national guidance have not considered IPM sufficiently until now. On European level, the new EU Green Deal, including Farm to Fork and Biodiversity Action Plans, calls for an EU-harmonised approach for IPM implementation. This opens new possibilities offering real benefits across the value chain of active substances and products. IPM compliance is a value-add not only for marketing and sales of plant protection active substances and products, but also a significant benefit in the registration procedure. This applies both for biorationals and agrochemicals. One example is the implementation of reduced dose rates and the number of necessary applications if an agrochemical is incorporated in a suitable IPM-strategy.

To fulfil the requirements for a more thorough implementation of IPM in the agricultural practise, IPM methods have to be integrated, for example, in product performance and efficacy testing and evaluation. This is often possible without increasing the costs for product testing through using “statistical spare treatments” for testing of IPM strategies.

Precision Farming

Precision agriculture or precision farming is a farming management concept using digital techniques for monitoring and optimising agricultural production processes, e.g. weather-based forecasting models. Forecasting models can be integrated in Decision Support Systems (DSS), combining disease monitoring data, use of decision thresholds and predictive models.

Integrated model-based decision support systems have the potential to improve the effectiveness for controlling crop diseases, while minimizing economic costs, environmental impacts, and yield losses. They also play a key role in the successful implementation of long-term Integrated Pest Management (IPM strategies) as required by Directive 2009/128/EC concerning the sustainable use of pesticides and the National Action Plans.

Organic Farming

The framework for organic production on the European level is set by Regulation (EU) 2018/848 (basic act). Further requirements regarding organic farming are implemented by detailed secondary legal acts.

The new legal/regulatory rules for organic farming are accompanied by a comprehensive organic action plan for the European Union pursuing the aim to achieve the European Green Deal target of 25% of agricultural land under organic farming by 2030.

Our services for IPM, Precision and Organic Farming

SCC helps you examine your portfolio to identify products with IPM, organic and precision farming potential and advise you on regulatory and scientific aspects of sustainable integrated crop management. Our services include:
  • In-depth data analysis
  • Survey of products and portfolios
  • Developing sustainable registration strategies
  • R&D support
  • Comprehensive dossier support
  • Notification and registration support

 

Regulation of Adjuvants

Adjuvants are products added and mixed with plant protection products, fertilisers or biostimulants to improve their efficacy and allow better adherence of products for seed treatment or to prevent excessive foam formation.

In general, adjuvants for plant protection products fall within the scope of the Plant Protection Products Regulation 1107/2009. Detailed rules for the authorisation of adjuvants, however, have not been harmonised on EU level until now. Consequently, adjuvants are in practice still regulated under the national laws of the European Member States.

National data requirements and procedures for adjuvants in EU Member States differ significantly and range from free market entry, through simple notification procedures to full registration processes, including the requirement to submit a draft Registration Report (dRRs) similar to plant protection product dossiers.

Our Services for Adjuvant Registration

Expert knowledge of national requirements is essential for an adjuvant registration in the European Member States. SCC provides scientific and regulatory support for national adjuvant registration, including:

  • Feasibility check or data gap analysis
  • Developing a registration strategy
  • Preparing and submitting final application documents
  • Subsequent defence

 

Our Services for the Crop Health and Plant Nutrition Industry

SCC helps register your active substances and products. Together with you, we develop sustainable registration strategies, prepare, submitt and defence your dossiers.

Contact our experts

They answer your questions and advise you on how you can make your agrochemicals and biorationals fit for your target markets.

Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).

 

Biostimulants and Fertilisers

The European Fertiliser Regulation 2019/1009 for CE-marked products, applicable since July 2022, regulates all products of the so-called Product Function Categories (PFCs) of organic, organo-mineral and inorganic fertilisers, liming materials, soil improvers, growing media, nitrification, denitrification and urease inhibitors, plant biostimulants, and fertilising blends.

For placing a fertilising product on the EU market, different types of conformity assessments are foreseen. The assessment is based on the component materials and the product category (PFC) of the fertilising product. For example, Module A only includes an internal production control. Module A1 consists of an internal production control and external product testing and Modules B+C require an external technical review by a notified body. In the EU, fertilising products can only be placed on the market if they are sufficiently effective.

In parallel to the EU harmonised procedure, national commercialisation of fertilisers and fertilser-like products, such as biostimulants, is possible. National requirements vary from free market entry to registration procedures, including registration dossiers. To facilitate the free movement of goods in the European Union, mutual recognition between Member States is possible in many countries.

Our range of services for biostimulants and fertilisers includes:

  • Review of products and product portfolios
  • R&D, advice on testing and registration of CE-marked fertilisers of all Product Function Categories (PFCs)
  • Handling the transition from current to new regulations/requirements or from national to EU requirements
  • National efficacy monitoring and assessment
  • Handling of national and EU registration procedures
  • Support for Mutual Recognition between Member States

 

Registration of plant growth regulators, plant strengtheners, soil conditioners, biostimulants and fertilisers

The entry into force of Commission Regulation (EC) 1107/2009 and Directive 2009/128 has led to the revision of national plant protection laws in all European Member States. This is of special interest with regard to plant protection since, in several member states, special provisions exist with respect to substances and products used in agriculture, such as growth regulators, soil conditioners, biostimulants, plant strengtheners, fertilisers, etc. There are currently several efforts from industry and the authorities to incorporate some of these substances or products into the European (EC type fertiliser, EC fertiliser) and national fertiliser regulation.

For national registrations of fertilisers in general, Regulation 764/2008 applies. Once a product has been legally placed on the market in one Member State, registration in another member state using the mutual recognition principle according to Regulation 764/2008 may be difficult due to different definitions of the specific substance. Additionally, national requirements regarding risks to the environment and human health have to be considered in applying mutual recognition.

 

Agrochemicals and Biopesticides

Approval and authorisation requirements for crop health active substances and products have undergone several changes in the last decades. SCC has been following the legal, regulatory and political developments for more than 30 years, while continually advising our customers on the ever-changing approval and renewal procedures as well as the zonal and interzonal evaluations of products.
SCC experts confidently guide you through the approval and authorisation processes of plant protection active substances and products – the agrochemicals.

According to European legislation, 'biopesticides' are not a regulatory defined group of active substances and products. Instead, Europe distinguishes between conventional, basic and low risk active substances, regardless of their natural or synthetic origin. Biopesticides represent a diverse and inhomogeneous group of active substances, such as fungi, bacteria, plant extracts and microbial metabolites.

Following the principles of Integrated Pest Management (IPM), we advise our customers on effective R&D and registration strategies for the whole range of agricultural products based on classical chemical, biological and low risk substances.

Take advantage of our long-standing expertise and do not hesitate to contact us to learn how we can help you fulfil your regulatory needs.