Biocides and REACH Regulatory overview: November 2026

Dive into our team’s expertise on the Biocides and REACH markets.

Once a month, our experts will gather all the news and updates in Biocides and REACH markets. They will select major news to help you navigate in the regulations framework.

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BIOCIDES

1- BPR Efficacy Update: New ECHA TAB Entry (October 2026)

The October 2026 update of the Technical Agreements for Biocides (TAB) introduces a new entry (Version 1, agreed at WGIII2026) clarifying expectations for Main Groups 1 and 2 (Disinfectants and Preservatives) when standard efficacy test methods are unavailable.

Here are the main pillars to keep in mind:

• Universal Baseline & Guidance Alignment: All non-standardised simulated-use tests and field trials for Main Groups 1 and 2 must meet a newly defined set of basic universal requirements, while continuing to follow applicable efficacy guidance wherever available and feasible.
• Early Consultation Encouraged: Applicants are strongly advised to consult the evaluating Member State (MS) on the proposed test protocol before launching the study, especially for field trials.
• Justify Deviations: Any deviation from these basic requirements must be backed by a thorough scientific justification in the dossier.

2- Belgium: Important update for all Gestautor users

If Gestautor, the Belgian CA’s application for Biocidal product authorisation is part of your daily workflow, please note that the application has moved to a new web address.

To avoid any disruption in your access:

• Head over to the new Gestautor portal: https://apps.health.belgium.be/gestautor-frontoffice/
• Update your browser bookmarks and shortcuts with the new URL so you always land on the right page.

3- Spain updates its national biocides regulation

On 3 November 2026, Spain approved a new Royal Decree 952/2026, replacing Royal Decree 1054/2002 to complement the EU Biocidal Products Regulation (BPR). Effective 1 July 2027, it applies to biocide manufacturers, packers, distributors, and service providers.

Key changes:

• Stricter traceability and record-keeping requirements.
• Updated registration, storage and labelling rules.
• New training requirements for professional users.
• Reinforced market surveillance and inspections

Need support navigating these new requirements? At Staphytwe can help you understand your regulatory obligations and ensure compliance.

REACH

1- EU Parliament formally approves Omnibus VI

On 22 October the European Parliament formally approved the provisional agreement on Omnibus VI, a legislative package designed to streamline compliance, reduce administrative complexity, and enhance market competitiveness across the European chemical sector. This comprehensive text directly amends the CLP Regulation, the Cosmetics Regulation and the Fertilising Products Regulation. Companies should review the Omnibus VI updates and consider the impact to their business.

1a- Omnibus VI impact to CLP regulation

Changes to the CLP regulation include:

• Digital Contact Requirements: Suppliers must provide a direct, free-of-charge digital contact on product labels
• Font Size & Formatting Simplification: Mandatory font size rules apply exclusively to products sold to the general public. These rules do not apply to products destined solely for industrial and professional use
• Relabelling Deadlines Extended: The fixed deadline for updating physical product labels following an update to a products hazard classification has been extended from 6 months to 15 months.
• Advertising & Distance Sales Rules: Pure B2B advertisements and distance sales offers are exempt from general public display requirements, provided the online interface does not allow a member of the general public to conclude a distance purchase contract. Consumer-targeted advertisements must include the statement “Always read the label and product information before use” alongside applicable hazard pictograms or signal words.
• Small Packaging & Supplier Info Flexibility: Suppliers are permitted to place contact details for additional suppliers on a digital label. For small containers with severe space constraints, mandatory inner packaging elements (excluding hazard pictograms) may be placed on a digital label accessible via a physical data carrier, provided the outer packaging carries full legal markings.

1b- Omnibus VI impact to Fertilising Products regulation

Changes to the Fertilising Products regulation includes:

• Digitalization of Compliance Documents: Introduces digital contact integration and enables electronic EU Declarations of Conformity (DoC). Economic operators can deliver access to the electronic DoC via a single web address or data carrier on the product packaging.
• Micro-organisms & Component Material Categories (CMCs): The Commission is empowered to adopt delegated acts establishing standardized evaluation criteria and methodologies for assessing new strains of micro-organisms (CMC 7), streamlining market access for innovative biostimulants.
• Mandated Non-Microbial Criteria & Polymer Review: Establishes a strict 36-month deadline for the Commission to adopt delegated acts setting out general assessment criteria and methodologies for non-microbial raw materials (Article 42(4b)). Additionally, a mandatory 7-year review has been scheduled to re-evaluate requirements applicable to nutrient polymers under CMC 8 (Article 49b).
• REACH Alignment: Registration thresholds and Chemical Safety Report (CSR) obligations for fertilising product ingredients are aligned directly with REACH (Regulation (EC) No 1907/2006) to eliminate duplicate testing while maintaining high environmental safety controls.

1c- Omnibus VI impact to Cosmetics regulation

Changes to the Cosmetics regulation includes:

• CMR Derogations Streamlined: Requests for derogations from the ban on Carcinogenic, Mutagenic, or Reprotoxic (CMR) substances (Categories 1A, 1B, and 2) must be submitted within 3 months of a CLP classification update entering into force. The redundant requirement to prove compliance with food safety rules has been abolished. Clear criteria for evaluating “suitable alternatives” have been codified, focusing on safety, technical and economic feasibility (including reformulation costs), and commercial availability at scale.
• SCCS 12-Month Opinion Windows: A standardized 12-month evaluation window has been established for the Scientific Committee on Consumer Safety (SCCS) to deliver opinions on requests for listing colorants, preservatives, or UV filters (Article 14a), as well as for evaluating natural complex plant or fungi extracts containing CMR-classified constituents (Article 15(5)).
• Defined Transitional Periods: Standardized market phase-out windows have been established following CLP Annex II updates:
• Ingredient Nomenclature & Notifications: Manufacturers can directly use international standard nomenclature (such as INCI names) on product labels without waiting for the European Commission to compile and publish a glossed reference list. Pre-market notifications are simplified into a single submission, while preserving mandatory specific notification workflows for nanomaterials.

2- European Commission notifies draft Delegated Regulation amending CLP Annex VI

The European Commission’s draft updates harmonised classifications for 48 substances by adding 38 new entries and revising 10 existing ones to tighten reproductive, carcinogenic, sensitising, and aquatic hazard rules. Key changes include a new 0.3% concentration-addition rule (Note 13) for bromide salts alongside updated specific concentration limits and M-factors for substances like PFHxA, eugenol, and thymol. Mandatory 18 months after entering into force, with voluntary early application allowed, companies must review product compositions, labels, and safety data sheets against the stricter thresholds.

3- ECHA to prepare report assessing impacts of introducing/reviewing concentration limits for POP’s in waste

The European Chemicals Agency (ECHA) has been requested by the European Commission to prepare the first report assessing the impacts of introducing and reviewing concentration limit values for persistent organic pollutants (POP’s) in waste under Annexes IV and V of the POP’s regulation.

Annex IV sets out “low POP concentration limits” for POP substances in waste, waste containing or contaminated with POP’s above these limits must undergo suitable destructive treatment whereas waste containing POP’s below these thresholds can be disposed of or recovered through other means.

Annex V determines the maximum permitted POP concentration permitted in certain waste types. Depending on whether the POP concentration is above or below the maximum POP concentration limit will determine how severe disposal measures would have to be, for example permanent storage in deep underground facilities.

Companies should review these changes for potential impacts to their waste disposal measures.

4- Ukraine REACH CLP Deadline Postponement

The Ukrainian Authorities have published draft legislation proposing postponement of the deadlines for Preliminary State Registration from 26th January 2027 to 26th July 2028 and CLP notifications from 6th December 2026 to 5th December 2028 respectively. In parallel, new submission forms for use during Preliminary State Registration have been issues with Stakeholders being strongly encouraged to review the updated templates in preparation for possible changes to their regulatory submissions.

Finally, draft resolutions have been published proposing full alignment with EU CLP and REACH standards, including the establishment of poison control centres and UFI management systems.

5- Transitional period for new CLP classifications ends for substances already on the market

As of November 1 2026, substances placed on the market prior to May 1 2025 must now include the new hazard classes for endocrine disruption, PBT/vPvB and PMT/vPvM.

Substances placed on the market after May 1 2025 should have already been using these new hazard classes. Companies who have not already should assess their substances for these new classifications, update their REACH dossiers/C&L notifications where necessary and review their labels and SDS’s. Should any substances be classified with the new hazard classes, downstream users should be informed immediately.

As a reminder, this only impacts substances. The transitional deadline for updating mixtures is not until 1 May 2028.

Whether you need assistance about compliance, product registration or any other regulatory issue, our experts are here to provide support: Aviron-Violet Sophie, Elena Campagnoli, Benjamin Heal, ALESSANDRO CASELLATO, Hélène Detrimont, George Leathley

Contact us contact@staphyt.com or visit our website : staphyt.com