REACH+

REACH+

REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) Regulation (EC) No 1907/2006 governs the registration of chemical substances in the EU. Its primary aim is to protect human health and the environment from risks posed by chemicals. While biostimulants largely contain natural substances, their use in the EU is still subject to REACH regulations, particularly for chemical safety. However, the cross-references to REACH in Regulation (EU) 2019/1009, also known as the Fertilising Products Regulation (FPR), impose stricter, more burdensome requirements for biostimulant manufacturers—what we call “REACH+” requirements for ease of reference. The Commission calls them “extended REACH registration.”

• Read our joint position paper with 11 other associations calling for the EU Fertilising Products Regulation to revert to using normal REACH requirements
• EBIC’s comments regarding extended REACH requirements on the Commission concept note on the “Reality check of the FPR”

Why does REACH+ pose challenges for biostimulants?

The Fertilising Products Regulation (FPR) introduced stricter regulatory conditions by cross-referencing REACH Regulation (EC) 1907/2006 but applying its most demanding obligations even to substances produced in quantities below 10 tonnes per year, which is a threshold typically considered low in the context of industrial production. These requirements were introduced without an impact assessment or clear safety rationale and affect innovative biostimulant ingredients and those produced in small quantities, leading to several challenges:

1. Unfeasible compliance for low-tonnage substances: Biostimulants often include innovative ingredients or technical additives used in very small quantities. REACH+ demands extended registration and data requirements, including Annex VIII-level dossiers and chemical safety reports (CSRs), even for substances below 1 tonne/year. This deviates from the graduated, risk-based approach of standard REACH and creates unsustainable costs, especially for SMEs. Suppliers frequently refuse to update REACH dossiers due to high costs or trade secret concerns, leaving formulators unable to comply.
2. Mandatory Chemical Safety Reports without added value: Under REACH+, all substances must include a Chemical Safety Report (CSR), regardless of quantity produced or hazard profile. However, the original purpose of a CSR (to assess worker safety and environmental release) does not add value for many fertilising products that are intentionally placed in the environment. If a product contains no hazardous substances, the CSR provides no new safety data, only added cost and complexity.
3. No recognition of Annex V exemptions or impurities: The FPR ignores key REACH exemptions, notably Points 1–4 of Annex V of Regulation 2006/1907, which exclude naturally occurring and non-isolated substances from registration. Worse, the FPR could be interpreted to imply that impurities and unintended substances (e.g. ionic species in solution) must meet REACH+ rules.
4. Distortion of market access and innovation suppression: By demanding extended REACH registration for ingredients already approved for use in food or feed, REACH+ creates redundant data requirements, administrative burden, and unnecessary animal testing. This not only increases costs but also forces companies to revert to older, less effective materials or remain under national rules. This reduces innovation, sustainability, and market harmonisation.
5. Economic burden and market distortion: Examples compiled from industry to illustrate the impacts of extended REACH registration show cost increases ranging from 26% to over 500% due to REACH+ compliance, even when substances are used at <0.5% w/w. For SMEs or companies trialling innovative substances at low volumes, this makes market entry nearly impossible and can exclude environmentally preferable additives or those allowed in organic agriculture simply due to cost.

What is EBIC’s position on REACH+?

EBIC worked with 11 other organisations to develop a joint position paper that argues that REACH+ imposes disproportionate and unworkable requirements that threaten both innovation and competitiveness, especially in the biostimulant sector. These rules conflict with the EU’s Better Regulation principles and create burdens without demonstrated safety benefits.

EBIC’s Proposed Solutions

1.Restore normal REACH tonnage thresholds and exemptions

Reinstate the original REACH approach. Exempt low-tonnage and low-risk substances from unnecessary data requirements and CSRs, especially if not classified as hazardous or already authorised for food or feed use.

2. Limit extended REACH registration to high-risk substances in EU Fertlising Products

Apply the REACH+ data and CSR requirements only to substances classified as CMR (Carcinogenic, Mutagenic, or Reprotoxic) or otherwise high-risk.

3. Clarify that impurities and unintended substances are exempt from the REACH+ registration

Codify in the FPR that impurities and non-isolated substances (e.g. ionic species in liquid formulations) are not component materials of EU Fertilising Products.

4. Introduce a 0.1% w/w threshold where REACH+ requirements do not apply for substances that fulfil the criteria below:

• the substance is not classified as hazardous or
• the substance is only classified for the following hazards:
  • Physical hazards (Hazard Class 2, except for 2.1 Explosives)
  • Skin corrosion/Irritation (Hazard Class 3.2)
  • Eye Damage/Eye Irritation (Hazard Class 3.3)
  • Aspiration hazard

For questions or collaboration, please contact ebic@biostimulants.eu