New development
The BSA Executive Agency has determined the steps for transition to ISO 14001:2026
Bulgaria · environmental management systems · accreditation guideline
The Bulgarian Accreditation Service (BAS) published on September 10 a guideline for transition to BDS ISO 14001:2026. Accredited management system certification bodies must submit a declaration, gap analysis, plan and evidence of readiness by January 31, 2027. The client transition is scheduled to end on April 30, 2029. The bodies should update the competence of the staff, procedures and assessment plans, and the certified organizations should coordinate their transition audits. The guideline contains a contradictory interim date, which requires clarification by the BSA. The indicated national approach should not be presented as a finally adopted global rule.
Mandatory reporting under the Cyber Resilience Act has begun
EU · digital products and cybersecurity · start of implementation
From 11 September 2026, the reporting obligations under Article 14 of Regulation (EU) 2024/2847 — Cyber Resilience Act apply. Manufacturers of covered products with digital elements must report actively exploited vulnerabilities and serious incidents affecting the security of products. The regime provides for early warning within 24 hours and subsequent notification within 72 hours of knowledge. ENISA indicates the single reporting platform as the relevant channel. Manufacturers should verify responsibilities, escalation and evidence at the time of knowledge. This is a specific phase started; the general application of the remaining basic framework from 11 December 2027 is not brought forward.
New product taxes for electrical equipment come into effect
Bulgaria · electrical and electronic equipment · entry into force
On 12 September 2026, the amendment to the product fees for electrical and electronic equipment under Decree No. 131 of 3 September, published in the State Gazette, issue 82 of 8 September, enters into force. The table distinguishes six groups of equipment: for example, for lamps the rate is 1.04 euros per kilogram, and for small information and telecommunications equipment - 0.15 euros per kilogram. Producers and importers should check the classification, mass, reporting systems and the applicable way to fulfill waste obligations. The fee should not be assumed to be automatically due for each delivery, without checking the conditions and exemptions.
Pyraclostrobin: the act is in force, the renewal begins in October
EU · plant protection and laboratories · separate action dates
Implementing Regulation (EU) 2026/1976 for pyraclostrobin enters into force on 12 September, but the renewed approval applies from 1 October 2026 to 30 September 2041. The difference between the two dates is important for regulatory dossiers and testing planning. Manufacturers, authorisation holders and laboratories should check the specification of the technical material, the impurity limits and the risk assessment conditions. The applicant has until 12 September 2028 to provide confirmatory information on metabolite 500M07 and the effects of water treatment. The renewal of the substance does not replace the authorisation of a specific product.
Registration of imports of welded steel mesh from China and Turkey
EU · metal products and trade · customs registration
Since 12 September 2026, EU customs authorities have been registering certain imports of welded steel mesh and fences originating in China and Turkey. Implementing Regulation (EU) 2026/2022, published on 11 September, provides for a nine-month registration in the anti-dumping procedure. This is not a definitive anti-dumping duty but may be relevant for a possible subsequent retroactive assessment under the legal conditions. Importers and suppliers should verify the exact description of the goods, tariff classification, origin and delivery documents. The commercial assessment should take into account separately the registration and the not yet established final customs outcome.
Chinese steel racks fall under import registration
EU · warehouse equipment · customs registration
Implementing Regulation (EU) 2026/2023 introduces, from 12 September 2026, registration of imports of certain steel shelving and components originating in China. The scope includes bolted and boltless structures and specifically described uprights and beams; the material of the shelving does not in itself exclude the product. The registration is for nine months and does not constitute a definitive anti-dumping duty. Importers, distributors and suppliers of storage systems should compare the technical specifications with the legal description, including the way the components are connected. Keeping evidence of origin, classification and deliveries is important for possible subsequent customs consequences.
Mecoprop-P has been renewed as a replacement candidate
EU · plant protection · renewed approval with conditions
By Implementing Regulation (EU) 2026/2025, published on 11 September, the EU renews the approval of mecoprop-P as an active substance, candidate for substitution. The new period is from 1 October 2026 to 30 September 2033. The status does not imply a general ban, but requires a careful examination of the applicable assessments and conditions when authorising products. Regulatory teams and laboratories should take into account the requirements for users, operators, workers and non-target organisms. The applicant is required to submit a full report on a reproduction study in birds according to OECD 206 by 1 April 2027. Specific uses remain subject to product authorisation.
Updated authorization for the LANXESS CMIT/MIT biocide family
EU · industrial biocides · amendment of authorisation
Implementing Regulation (EU) 2026/2024 amends the Union authorisation of the LANXESS CMIT/MIT biocidal product family. Published on 11 September, the act enters into force on 1 October 2026 and replaces the summary of product characteristics. The changes include an extension of the shelf life for products in meta-SPC groups 1–6, as well as the addition of manufacturers and trade names. Suppliers and industrial users should check the exact product, authorised use, label and storage conditions with the updated annex. The same extension should not be accepted for all stocks or for other products with similar active substances.
Bee additive permitted with specific restrictions on use
EU · feed and beekeeping · additive authorisation
Implementing Regulation (EU) 2026/2027 authorises from 1 October 2026 molybdenum chelate with EDTA as a zootechnical feed additive for honey bees, held by Oligofeed SAS. The authorisation is subject to specific identity, analytical methods and conditions of administration via sugar feed. The application provides for 8 mg per hive in feeding and prohibits use in established honey stores and in the two months prior to honey collection. Producers, distributors, beekeepers and laboratories must verify the dosage, traceability and seasonality. This is not a general authorisation for any molybdenum compound or for veterinary medicinal claims.
ELOCLEAR received EU authorization with analytical data condition
EU · disinfection and food establishments · biocide authorisation
Implementing Regulation (EU) 2026/2028 granted a Union authorisation for the biocidal product family ELOCLEAR for the period 1 October 2026 to 30 September 2036. The family uses active chlorine generated by the electrolysis of sodium chloride for certain professional uses in product types 2 and 4. The holder Arrow Regulatory (Ireland) Limited shall submit further data on analytical accuracy by recovery testing or a justified exemption by 1 April 2027. Site operators and suppliers should check the authorised surfaces, concentrations and procedures. The authorisation is product specific and not a general approval of any electrolysis system.
Changes in control and audit trail for European funding
Bulgaria · European funds · organizational and regulatory change
Decree No. 133 of September 9, 2026, promulgated in the State Gazette, issue 84 of September 11, changes the functions of the Ministry of Finance, including the National Fund Directorate. The main amendments apply from October 1 and cover management, control, payment packages and coordination under the Recovery and Resilience Mechanism and the Social Climate Plan. Work with audit documentation is explicitly envisaged after 2026. Beneficiaries, contractors and control teams should verify the current instructions, evidence of expenditure and measures against fraud and conflict of interest. The act does not introduce a universal new period for storing all company documents.
Temporary relief changes the market risk control framework
EU · banks and risk management · delegated regulation adopted
Delegated Regulation (EU) 2026/1221, published on 11 September, entered into force on 12 September and applies from 1 January 2027. It introduces temporary measures until the end of 2029 for the calculation of capital requirements for market risk, including for the profit and loss attribution test and evidence of modellability of risk factors. Banks’ models, data, risk and internal audit teams should verify the permissible reliefs, supervisory notifications and parallel reporting. The changes do not remove the obligations for adequate risk management and data aggregation. They are a sectoral supervisory framework and not a new certification standard.
Supervisory reference for third-country bank branches corrected
EU and Bulgaria · banking governance · official correction
A corrigendum to the Bulgarian text of Directive (EU) 2024/1619 was published in the Official Journal of 11 September 2026. In Article 48g(2) concerning third-country branches in Category 1, the reference to Article 76(6) is replaced by a reference to paragraphs 5 and 6. Legal, supervisory and audit teams using the Bulgarian text should check their regulatory matrices and the references in the procedures. The corrigendum is not a new common ESG standard and does not create a stand-alone date for the application of the entire Directive. The practical effect should be assessed against the basic act and the relevant national measures.
Upcoming deadlines
T–30 for certain protection zones for sheep and goat pox
Bulgaria · livestock and transport · reminder T–30
On 12 September, 30 days remain until 12 October 2026, the specified end of the protection measures for specific areas in the districts of Haskovo and Stara Zagora under the Annex for Haskovo to Implementing Decision (EU) 2026/2052. The relevant surveillance continues until 30 October. This is a calendar reminder under the already published act, and not a new outbreak or a general lifting of restrictions. Livestock farms, transporters and traders must check the exact coordinates, the applicable area and veterinary documents before movement. The specified dates are subject to change and the end of the protection period does not mean an automatic exemption from all other measures.
T–14 for the UK consultation on drug identification devices
England and Wales · forensic examination · consultation T–14
The UK Forensic Science Regulator is accepting submissions on the future regulation of drug detection devices until 25 September 2026, 23:00 UK time — 26 September, 01:00 Sofia time. Thus, on 12 September the T–14 threshold was reached according to the calendar used. The consultation covers draft documents for quality, validation and implementation of regulatory requirements in England and Wales. Laboratories, device suppliers and organisations using the results as evidence can check the proposed criteria and submit reasoned submissions. Drafts and transitional proposals should not be presented as already final requirements.
Strategic Watch
UK response to POPs outlines upcoming changes
United Kingdom · chemicals and supply chains · strategic regulatory signal
In an updated response to the consultation on persistent organic pollutants on 10 September, the UK government outlined planned restrictions for MCCP, LC-PFCA, UV-328, Dechlorane Plus and chlorpyrifos, as well as changes to PFOS and PBDE. The intention is for the regulatory instrument to be introduced in October and to come into force in December 2026, subject to the necessary approvals. This is not yet a final regime. Manufacturers and exporters to England, Scotland and Wales should check material composition, supplier declarations and analytical capabilities. Northern Ireland requires a separate assessment under the applicable framework.
EMA opens consultation on clinical trials in migraine
EU · pharmacy and clinical trials · consultation
On 10 September 2026, the public consultation on revision 2 of the EMA guideline on clinical trials of medicines for migraine and cluster headache was launched, with a deadline of 31 January 2027. The draft EMA/137055/2026 covers approaches to trial design, participants and endpoints for acute and prophylactic treatment. Sponsors, clinical trial organisations and regulatory compliance teams can assess the implications for future protocols and evidence packages. The document is a draft and not a final new guideline. The practical step is to review the methodology and prepare a reasoned opinion, without prematurely changing approved trials.
New EMA project to study gastrointestinal interactions
EU · pharmacy and testing · consulting
EMA launched a consultation on 11 September 2026 on the project EMA/136069/2026 on the study of interactions in the gastrointestinal tract. Views are accepted until 31 December. The document addresses the influence of food, gastric pH, dosage form, excipients and complexation on absorption, as well as the design and interpretation of laboratory and clinical studies. Drug developers, research organisations and laboratories should check the possible implications for methods and regulatory dossiers. The project complements ICH M12 thematically, without constituting a new adopted version of it. The applicable step for now is participation in the consultation and planning of evidence.
European Radioisotope Initiative raises regulatory issues
EU · nuclear medicine and transport · strategic signal
The European Commission's Communication on the European Radioisotopes Valley Initiative, published in the Official Journal of 11 September 2026, outlines future coordination on radioisotope chains. Among the areas covered are the review of cross-border transport, dealing with international rules and issues of patient dosimetry, clearance and waste. For radioisotope producers, laboratories, healthcare facilities and specialised transporters, this is an early warning of possible future changes in evidence, authorisation and control. Communication C/2026/4833 does not in itself introduce a new transport or certification procedure. Specific follow-up acts and technical initiatives should be monitored before changing existing procedures.
FDA requests enhanced control of Cyclospora in fresh produce chains
US and international suppliers · food · official strategic signal
In a letter to industry dated September 11, 2026, the FDA urges participants in the fresh produce supply chain, including international suppliers, to strengthen Cyclospora prevention. The regulator focuses on water, hygiene, sanitation practices, and supplier verification within existing FSMA requirements. For European exporters, U.S. importers, and auditors, this is a signal to review hazard assessments and evidence under foreign supplier programs. The letter does not create a new regulation or a single new deadline. Actual chain controls should be verified, not just the availability of certificates.
Updated British Right to Work Checks Project
United Kingdom · labour and suppliers · draft guidance
On 11 September 2026, the Home Office updated the draft guidance for employers on right to work checks. The text clarifies the scope of employment relationships, the commissioning of checks and examples of application, specifying 1 October for the extended framework. This is draft guidance and should not be read as stand-alone evidence of any final legal changes. Employers and contractors organising work in the UK should check the contractual models, responsibilities and evidence held. Particular attention should be paid to individual subcontractors and platform relationships. The final guidance and applicable implementing acts should be consulted before changing procedures.
Tyrol offers a new standard alternative for emergency calls
Austria · lifting equipment · notified technical design
Austria notified on 11 September 2026 a draft amendment to the Tyrolean rules for lifts and lifting equipment. Notification TRIS 2026/0495/AT proposes ÖNORM B 2458:2025-03-15 as an alternative to the older version mentioned for emergency call systems. The official record shows the end of the waiting period as 14 December 2026, which is not an automatic date of entry into force. Manufacturers, installers and inspection bodies serving this market can assess the impact on specifications and proof of conformity. No Europe-wide mandatory replacement of the standard is introduced; follow-up of the final adoption and regional scope is necessary.
Published by MG Global in partnership with ERPI.
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