Fertilisers, Biostimulants & Soil Improvers

National Regulatory Support & Market Access

Placing fertilisers, plant biostimulants, soil improvers and related products on the market requires navigating diverse regulatory pathways. The correct route depends on your specific product and your target market.

Within the European Union, Regulation (EU) 2019/1009 sets out harmonised rules for EU fertilising products. However, companies can still choose to place fertilising products on individual national markets by complying with national legislation.

For companies choosing a national route to market, understanding country-specific requirements is essential. Registration, notification, documentation, composition, labelling and other requirements can vary considerably between countries.

At Artemisa, we specialise in national regulatory procedures. We guide companies through local requirements, ensuring smooth market entry across all our covered territories. We also assist clients with Mutual Recognition procedures for eligible products lawfully marketed in another EU Member State, as well as national registration processes in non-EU countries.

National Route To Market

Navigating National Requirements

What is required to place your product on a specific market? The answer depends on the product, its composition, intended function and claims, as well as the regulatory requirements of the target country.

Understanding these requirements early helps establish the appropriate regulatory pathway, identify potential gaps and plan market entry more efficiently.

Our local regulatory experts can support you with:

  • Product and regulatory status assessment
  • Assessment of national requirements
  • Identification of the appropriate market access pathway
  • Review of composition, intended use and claims
  • Comprehensive data and documentation gap assessment
  • National registrations and notifications
  • Compilation of country-specific national dossiers
  • Label and Safety Data Sheet (SDS) preparation and adaptation
  • Communication with competent authorities
  • Regulatory follow-up
  • Multi-country project coordination
EU Market Access

Mutual Recognition

For fertilising products placed on the market under national legislation, Mutual Recognition may provide a pathway to additional EU markets where the product is lawfully marketed in another Member State and the conditions of Regulation (EU) 2019/515 are met.

The principle of Mutual Recognition can facilitate market access across EU Member States, but its applicability needs to be assessed for each individual product and target market. National requirements and the regulatory approach of the destination Member State may also need to be considered.

Artemisa can support clients with:

  • Assessment of the applicability of Mutual Recognition
  • Review of lawful marketing status and available documentation
  • Assessment of requirements in the destination Member State
  • Preparation of Mutual Recognition Declarations
  • Preparation of supporting documentation
  • Label and Safety Data Sheet adaptation
  • Communication with competent authorities
  • Follow-up throughout the process

Our local experts evaluate whether Mutual Recognition is the right fit for your portfolio and manage the process while addressing the unique expectations of your target market.

Non-EU Markets

Market Access Beyond the EU

Outside the EU, fertilisers, biostimulants, soil improvers and related products are subject to national regulatory frameworks. Product categories, registration procedures, data and documentation requirements, labelling rules and authority practices can differ significantly between markets.

Artemisa supports national market access in a growing number of non-EU markets, including Albania, Armenia, Azerbaijan, Bosnia and Herzegovina, Egypt, Georgia, Kazakhstan, Kosovo, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, Ukraine and Uzbekistan.

Through our team and network of local regulatory experts, we help clients understand the applicable requirements and develop a country-specific pathway to market. Depending on your product and chosen destination, our services cover everything from initial status screening and gap analysis to the preparation, submission, and management of national applications, local labels, and authority communications until approval is secured.

Our Approach

From Product Assessment to Market Access

We support communication with competent authorities, follow the progress of applications and assist with ongoing regulatory requirements.
Local Expertise

Across Our Markets

When market access depends on national requirements, local regulatory knowledge makes the difference. Different countries may apply different product categories, procedures, documentation requirements and administrative practices. Our team and network of local regulatory experts understand these national requirements and support communication in the local language where needed.

For multi-country projects, Artemisa combines this local expertise with central project coordination, allowing clients to manage several markets through one regulatory partner. One contact. Local expertise. Multiple markets.
EU Countries

Baltics, Bulgaria, Croatia, Czech Republic, Greece, Hungary, Italy, Poland, Romania, Slovakia, Slovenia

Southeast Europe (SEE) & Türkiye

Albania, Bosnia and Herzegovina, Kosovo, Montenegro, North Macedonia, Serbia, Türkiye

Emerging markets

Armenia, Azerbaijan, Egypt, Georgia, Moldova, Ukraine, Kazakhstan, Uzbekistan

FAQ

Frequently Asked Questions

No. Regulation (EU) 2019/1009 establishes the unified framework for EU-wide fertilising products. However, manufacturers can still choose to place fertilising products on individual national markets by complying with domestic country legislation.

The appropriate regulatory pathway therefore depends on the product and the intended market.

Plant biostimulants are recognised as a Product Function Category under Regulation (EU) 2019/1009. Products marketed through national routes, however, need to be assessed according to the requirements applicable in the individual target market.

Yes. Requirements concerning product categories, composition, documentation, registration or notification, labelling and administrative procedures may differ between countries.

Our local experts assess the requirements for each target market individually.

Mutual Recognition can serve as a viable pathway for products falling within the non-harmonized (national) sector, provided the product is already lawfully commercialized in another EU Member State and complies with the criteria of Regulation (EU) 2019/515. Its applicability must be verified for each product and target market on a case-by-case basis.

Regulation (EU) 2019/515 provides for a voluntary Mutual Recognition Declaration that an economic operator may use to demonstrate that goods are lawfully marketed in another Member State.

Artemisa can support the preparation of the declaration and relevant supporting documentation.

Yes. Artemisa provides regulatory support across a number of non-EU markets, including Albania, Armenia, Azerbaijan, Bosnia and Herzegovina, Egypt, Georgia, Kazakhstan, Kosovo, Moldova, Montenegro, North Macedonia, Serbia, Türkiye, Ukraine and Uzbekistan.

Our local experts can support assessment of national requirements, regulatory strategy, documentation and applications, authority communication and follow-up throughout the regulatory process.

Yes. We can assess national requirements across several target markets and coordinate the regulatory activities centrally while involving the appropriate local experts in each country.

This provides clients with one point of contact while ensuring that country-specific requirements are addressed locally.

Planning To Enter A New Market?

Whether you are introducing a fertiliser, plant biostimulant, soil improver or related product into one country or planning expansion across several markets, understanding the applicable national requirements is the first step. Our local regulatory experts can help you identify the appropriate pathway and manage the process from initial assessment through market access.