Agro/Biocides:
Ethanol CAR Published – Join Our Task Force!
The Competent Authority Report (CAR) for Ethanol has been officially published. In response to this update, we are setting up a dedicated Task Force. If you are interested in participating or would like to collaborate, please contact us directly.
Source: https://echa.europa.eu/documents/10162/3780f812-dddd-2a51-3f40-96b97acbb7fb
Open Consultation on biocidal products: DRAFT Guidance on Substances of Concern (SoC)
A public consultation is currently underway for the draft “Guidance on Substances of Concern (SoC)”. This document describes how to identify a SoC and perform its assessment under the Biocidal Products Regulation (EU) No 528/2012 (BPR).
Source: DRAFT Guidance on the Biocidal Products
ECHA Opinions On Active Substances
Renewals on:
- Aluminium phosphide releasing phosphine for Product Types (PT) 14, 18, and 20.
- Magnesium phosphide releasing phosphine PT 18.
- Peanut butter, seeds of the groundnut (Arachis hypogaea L.) roasted, peeled and crushed for PT 19.
- Zinc pyrithione for PT 21.
Medical Devices:
FDA official recognition of the ISO 10993-1:2025
The FDA has officially recognized ISO 10993-1:2025 for the biological evaluation of medical devices, marking a major step toward global harmonization in biocompatibility.
Here are the key takeaways for your regulatory strategy:
- Partial Recognitions: Note that the phrase “consumer products or” (Clause 6.5.11.3) and Biological risk estimation (Clause 6.9) are only partially recognized.
- Transition Timeline: The 2018 version is being phased out. The FDA will accept declarations of conformity to ISO 10993-1:2018 until July 1, 2029. After this date, only the 2025 version will be accepted.
- Action Item: Manufacturers should begin gap assessments and plan updates to their biological evaluation processes, testing strategies, and upcoming premarket submissions.
New WET Delegated Regulations Published in the Official Journal of the EU
On June 29, 2026, the two Delegated Regulations expanding the list of Well-Established Technologies (WET) under the Medical Devices Regulation (MDR) were published in the Official Journal of the European Union. The Regulations will enter into force 20 days after publication, introducing new regulatory simplifications for the devices covered, including specific exemptions from clinical investigation requirements and streamlined conformity assessment provisions for eligible technologies.
Source: https://ec.europa.eu/newsroom/sante/items/945829/en
MedTech Europe Outlines Priorities for the IVDR Revision
As the debate around the future of European medical regulations intensifies, MedTech Europe has published a targeted supplement paper titled “An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?”. Released on June 3, 2026, the document outlines critical pillars to safeguard and advance the In Vitro Diagnostics (IVD) sector:
- Risk-Proportional Approach: Supports eliminating the fixed 5-year recertification cycles in favor of reviews based on the actual risk profile.
- Orphan Diagnostics: Proposes aligning the “orphan diagnostic” definition with the EU rare disease threshold (5 in 10,000 people per year) to protect essential testing.
- SME Simplification: Advocates for reduced administrative burdens and more predictable conformity assessment timelines to support small and medium-sized enterprises.
- Digitalization & Innovation: Promotes electronic technical file submissions, e-IFUs, and accelerated market pathways for breakthrough diagnostic innovations.Source:
Source: https://www.medtecheurope.org/wp-content/uploads/2026/06/260526_ivd-specific-paper_final.pdf
Food:
Vitamins/Minerals and Novel Foods: EFSA Rejects Zinc L-Carnosine as a Source of Zinc
On June 17, 2026, EFSA published its opinion on the safety of zinc L-carnosine as a novel food and on the bioavailability of zinc from this source in the context of Directive 2002/46/EC on food supplements.
The assessment highlights concerns regarding characterization, particle/nanoparticle behavior, dissolution, and bioavailability.
EFSA concludes that the novel food is not sufficiently characterized and that neither bioavailability nor safety can be established.
This affects producers and suppliers working on new mineral sources. The use of a new form of zinc in dietary supplements is not merely a “nutritional” issue: it may require a novel food assessment and proof of bioavailability to be approved as a permitted source.
It is crucial to monitor any R&D developments or supplier requests regarding zinc L-carnosine. Do not treat it as a simple alternative form of zinc without regulatory verification. Request a complete dossier from suppliers covering characterization, particles, dissolution, and bioavailability.
June 2026 Authorizations from the European Commission
The Commission adopted two significant implementing regulations in June 2026:
- Implementing Regulation (EU) 2026/1219 of June 9, 2026, authorizing inulin propionate ester as a novel food;
- Implementing Regulation (EU) 2026/1306 of June 11, 2026, authorizing carrot extract enriched with rhamnogalacturonan-I / cRG-I as a novel food.
For cRG-I, the application covered various foods intended for the general population, including food supplements.
Opportunities for R&D and ingredient scouting, but to be handled with caution. Novel food authorization does not equate to unrestricted use: it is necessary to review the Union list entry, authorized categories, maximum levels, specifications, conditions of use, labeling, and any data protection provisions.
Source:https://eur-lex.europa.eu/eli/reg_impl/2026/1306/oj/eng
