Chemicals Omnibus (VI) agreement delivers on EBIC’s requests for microbials and REACH+

European Regulatory Policy Update

Chemicals Omnibus (VI) agreement delivers on EBIC’s requests for microbials and REACH+

EU Council Confirms Simplified Rules for Biostimulants, Striking Down Extended REACH Hurdles for Non-Hazardous Inputs

In a major policy milestone for the European bio-input sector, the Chemicals Omnibus (VI) agreement delivers on EBIC’s requests for microbials and REACH+. Confirmed by the Council of the EU on June 26, 2026, following a June 16 accord with the European Parliament, this simplification regulation completely updates the EU Fertilising Products Regulation (FPR). The new legal framework introduces a decentralized, criteria-based conformity pathway for novel microbial biostimulant strains, bypassing the restrictive positive-list additions under CMC 7. Furthermore, the agreement scales back burdensome extended REACH registration requirements for non-hazardous baseline substances (CMC 1), introduces mandatory digital conformity data carriers, and creates a strict 36-month timeline to evaluate innovative circular economy components.

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On 26 June 2026, the Council of the EU confirmed its agreement with the European Parliament on 16 June 2026 on the Regulation simplifying certain requirements and procedures for chemical products, also known as the Chemicals Omnibus (VI), and sent a letter to the European Parliament for their subsequent endorsement of the agreement.

The agreed text of the Chemicals Omnibus (VI) marks a major achievement for the European Biostimulants Industry Council (EBIC), delivering a successful outcome to the association’s intense advocacy efforts over the past year. It also delivers two of EBIC’s main simplification objectives for the FPR since it was published in 2019: a criteria-based pathway for new micro-organisms to be used in microbial plant biostimulants and significantly more proportionate and workable REACH requirements for chemical substances used in EU fertilising products.

Amendments Relevant to Microbial Plant Biostimulants

The Chemicals Omnibus (VI) establishes a criteria-based pathway for new micro-organisms to be used in microbial plant biostimulants, in line with EBIC’s position. Article 42(4) in the FPR is amended to allow the European Commission to adopt delegated acts to set out criteria and a methodology for the conformity assessment of microbial strains other than those listed in Annex II.

“If a manufacturer demonstrates and the notified bodies confirm (…) compliance with those criteria (…) in accordance with that methodology, this strain may be used as component material in EU fertilising products”, without the need for each strain to be added to the positive list under CMC 7.

While the amendment provides elements to consider (taxonomic relation to QPS, production process, identity and residue levels of toxins, susceptibility to antimicrobial agents, etc.), the specific criteria and methodology will be established after the publication of the Chemicals Omnibus (VI).

REACH Registration for Virgin Materials (CMC 1)

The Chemicals Omnibus (VI) removes the extended REACH registration requirements in the FPR for CMC 1 substances used in EU fertilising products, except for substances with certain severe hazardous properties identified by reference to specific hazard classes under the CLP regulation. In essence:

Substances with severe hazardous properties must exceed the concentration cut-off values set out in Article 11(3) of CLP to trigger extended REACH requirements.
Exemptions from extended REACH requirements are expanded to include the general obligation exemption for product and process orientated research and development (PPORD).

Digitalisation and Innovative Materials Pathways

The Chemicals Omnibus (VI) amends the FPR to make it mandatory for manufacturers to draw up the EU declaration of conformity in electronic form, accessible via an internet address or data carrier. Furthermore, a new paragraph mandates that the European Commission adopt a delegated act establishing general assessment criteria for materials other than those in Annex II (excluding micro-organisms) within 36 months of entry into force. This reflects a joint effort led by the European Consortium of the Organic-Based Fertiliser Industry (ECOFI) through the Joint Task Force on New Materials.

The process for adding new derived products within the meaning of the Animal By-products Regulation (ABPR) to CMC 10 has also been clarified. Once an end point is determined under the ABPR, a risk assessment for soil, water, and agronomic efficiency must initiate within 12 months, leading to inclusion in CMC 10 if no risks are found.

Strategic Market Context

The streamlined European regulatory framework under the Chemicals Omnibus (VI) matches an accelerating agtech trend where commercial inputs shift away from synthetic compounds toward high-performance biologicals. By lowering the administrative barriers for microbial strain registration and raw materials, the EU is enabling manufacturers to scale products quickly. This policy shift runs parallel to major commercial movements across global input channels, such as Amoéba securing a 15-year French marketing clearance for its AXPERA biofungicide to launch an EU-wide rollout with Koppert, and Certis Belchim and Greenhas Group forming a joint development venture to co-commercialize science-backed biostimulants, reinforcing the mainstream integration of molecular crop biology.

“Replacing rigid positive-list restrictions with a flexible, criteria-based compliance framework to accelerate sustainable biological innovation.”

European Biostimulants Industry Council (EBIC)

Brussels, Belgium | EU Chemicals Omnibus Policy Briefing | July 2026 | biostimulants.eu