New development
Folpet: postponement in effect only for product type 9
EU · biocides and chemical safety · entry into force
On 18 October, Implementing Decision (EU) 2026/2151 entered into force, postponing until 31 March 2029 the expiry of the approval of folpet for biocidal products of product-type 9. This is a new stage of an act published on 28 September and not a newly adopted decision. The postponement does not cover product-type 7 and does not constitute an individual authorisation for each product. Suppliers and authorisation holders should check the product type, the applicable conditions and the compliance documentation. Particular attention should be paid to the period between the previous deadline of 30 September and today's entry into force: the decision should not be interpreted as automatically settling all supplies and stocks during this interval. The specific regime should be clarified with the competent authority.
MIT: new approval deadline for product type 13
EU · biocides and industrial products · entry into force
On 18 October, Implementing Decision (EU) 2026/2127 for 2-methylisothiazol-3(2H)-one, known as MIT, in biocidal products of product-type 13 enters into force. The expiry of the approval is postponed until 31 March 2029, pending the assessment of the renewal, including data on developmental neurotoxicity. This is not a final renewal and does not repeal the original conditions of use. Manufacturers and product authorisation holders should update their regulatory registers and check the applicability to specific products. The previous deadline is 30 September 2026; the act should not be considered as an automatic arrangement for supplies in the interval until its entry into force. A check with the competent authority is required for this period.
Granulated copper: wood preservative approval extended
EU · biocides and wood protection · entry into force
As of 18 October, Implementing Decision (EU) 2026/2134 postpones the expiry of the approval of granulated copper for biocidal products of product-type 8 until 31 July 2029. The previous expiry date was 31 December 2026. The measure provides time to complete the renewal assessment without replacing individual product authorisations or introducing new test criteria. It is important for wood preservative manufacturers and treated wood suppliers to distinguish between the lifetime of the active substance and the product-specific conditions. Authorisations, restrictions of use and contractual requirements for demonstrating compliance should be checked. The original conditions under Implementing Regulation (EU) 2016/1094 remain applicable.
Upcoming deadlines
Dental care: fourth treatment activity from November 1
Bulgaria · dental care and documentary control · start of implementation · T–14
From 1 November 2026, health insured persons over 18 years of age who have sought dental care are entitled to a fourth treatment activity outside the scope specified in Article 104, paragraph 1, point 2, letter „b“ of the Dental NRD. The rule is in § 6 of the contract for 2026–2028, promulgated on 25 September, and applies to 2026. This is a reminder two weeks before implementation, and not a new standard or change in accreditation. Contractors under contract with the NHIF should check the eligible activities, their documentation and reporting, as well as patient information. It should not be assumed that every dental procedure is automatically covered by public funding.
Strategic Watch
MSHA: 30 days until hearing on respiratory protection in mines
USA · OSH and respiratory protective equipment · consultation · T–30 to hearing
On November 17, 2026, MSHA will hold a virtual hearing on the draft for the use of powered air-purifying respirators (PAPRs) in certain underground areas of gas-hazardous mines. The hearing will begin at 9:00 a.m. EST, or 4:00 p.m. in Sofia. The draft addresses the conditions for the use of devices without MSHA approval under the relevant requirements, as well as their characteristics and maintenance; it does not constitute an effective general permit. The reminder of T–30 is useful for manufacturers, testing organizations, and mine operators with U.S. market interest. They can prepare technical arguments for the safety and verifiability of the proposed conditions. The reopening of the consultation announced on October 16 does not appear to be a new development today.
Veterinary antibodies: 30 days for opinions under VICH GL62
USA / international harmonization · veterinary products and testing · consultation · T–30
The FDA is accepting comments on draft GFI #298, VICH GL62, for the safety assessment of veterinary monoclonal antibodies in target animals, through November 17, 2026. This is a reminder to reach T–30 on the announced calendar date; the notice was published on September 18. The draft addresses laboratory and field studies in companion animals and farm animals and is part of the international harmonization of technical requirements. It is not definitive guidance and does not automatically establish a uniform regime in all participating countries. Developers, laboratories, and testing organizations should compare their programs with the proposed principles, the relationship to VICH GL43, and the need for prior regulatory discussion of specific studies.
Biosimilars: consultation on future evidence is on T–30
USA · biopharmaceuticals and analytical testing · consulting · T–30
On October 18, there are 30 calendar days left until the FDA’s November 17 deadline for comments on the draft BsUFA III follow-up strategy for interchangeable biosimilars. The document and notice are from September; this is a reminder of a consultation, not a new authorization or change to the current criteria. The strategy addresses the development of analytical evidence, user interfaces, and human factors for relevant products. The topic concerns developers, manufacturers, and laboratories preparing dossiers for the US market. The practical step is to identify specific uncertainties in comparative analyses and testing programs and submit reasoned comments. A blanket waiver of clinical studies or automatic recognition of interchangeability should not be accepted.
Published by MG Global in partnership with ERPI.
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