Commission Implementing Decision (EU) 2026/2142 of 25 September 2026 allowing Italy to authorise a biocidal product containing sulfuryl fluoride for the protection of cultural heritage (notified under document C(2026) 6676) (Only the Italian text is authentic)
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Address https://gelex.eu/eli/EU/decision/2026/2142@2026-09-25/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular Article 55(3) thereof,
After consulting the Standing Committee for Biocidal Products,
Whereas:
(1) Sulfuryl fluoride was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council as an active substance for use in biocidal products of product-types 8 and 18. Pursuant to Article 86 of Regulation (EU) No 528/2012, sulfuryl fluoride was therefore considered approved until 31 December 2018 for use in biocidal products of product-types 8 and 18.
(2) Applications for the renewal of the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 were submitted on 28 June 2017, in accordance with Article 13(1) of Regulation (EU) No 528/2012.
(3) Commission Implementing Decision (EU) 2024/2402 provided that it could not be determined whether sulfuryl fluoride meets the criteria referred to in Article 5(1), points (c) and (d), of Regulation (EU) No 528/2012 and whether the conditions set out in Article 4(1) of Regulation (EU) No 528/2012 were still satisfied. Therefore, the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 was not renewed.
(4) In accordance with Article 55(3) of Regulation (EU) No 528/2012, on 16 April 2026, Italy submitted to the Commission an application for a derogation from Article 19(1), point (a), of that Regulation, in which it asked to be allowed to authorise the biocidal product Vikane for the protection of cultural heritage, specifically for the protection of large-scale, non-movable cultural heritage objects with wooden parts, such as churches, windmills and other historical buildings.
(5) Vikane is a biocidal product of product-type 8 (wood preservatives), as defined in Annex V to Regulation (EU) No 528/2012, containing sulfuryl fluoride as an active substance, and it is intended for use by fumigation by trained professionals.
(6) Cultural heritage can be damaged by a wide range of harmful organisms, from insects to microorganisms. Some species of insects that use wood as a food source can cause serious damage to building timbers and must be controlled. Preventing damage and retaining as much original material as possible are at the core of heritage conservation practices. Wood-boring insects can cause serious damage to valuable building fabric (for instance, beams, floorboards, panelling) and fixtures (for instance, built-in cabinets, church altars). Severe insect attacks can also have structural consequences where building timbers are unacceptably weakened. Without an appropriate treatment, buildings could be irremediably damaged, putting the cultural heritage at serious risk.
(7) According to the information provided by Italy, the use of Vikane appears to be the only effective technique for the control of harmful organisms that can be used for large-scale, non-movable cultural heritage objects with wooden parts without causing damage. Severe or widespread insect infestations that may extend deep into the wood can be hard to treat using other methods with more limited or localised penetration compared to sulfuryl fluoride. Due to its rapid action, sulfuryl fluoride is also better suited for highly active infestation outbreaks, where continued infestations, even in the short term, may cause structural damage.
(8) As indicated by Italy in the application, the use of in-situ generated nitrogen appears not to be suitable for the treatment of such type of wood-containing buildings, due to their large size, which does not allow for the required concentrations of this substance to be maintained long enough to have an efficacious treatment.
(9) According to Italy, other techniques for the control of harmful organisms are available, such as heat treatment, low temperature treatment, humidity-controlled warm air treatment. However, according to the information in the application, each of those techniques has limitations in terms of damage that could occur to certain materials during the treatment.
(10) As stated by Italy in the application, other biocidal active substances that could be used for the control of harmful organisms (ethylene oxide, hydrogen cyanide or phosphine) have a worse hazard profile than sulfuryl fluoride. Moreover, those substances may react with the materials of the cultural heritage objects, causing irreversible changes, and some are even not approved for use in biocidal products of product-type 8.
(11) The Commission is aware that the manufacturer of the active substance contained in the biocidal product Vikane, which is the previous authorisation holder for the biocidal product, has expressed its intention to submit a new application for approval of sulfuryl fluoride for use in biocidal products of product-type 8. If an approval were granted, it would allow Member States in the future to authorise products containing sulfuryl fluoride in product-type 8 without the need for a derogation under Article 55(3) of Regulation (EU) No 528/2012. However, performing the evaluation of such an application and subsequently obtaining product authorisations require time.
(12) The information and justification contained in the application submitted by Italy shows that the biocidal product Vikane is essential for the protection of cultural heritage and that there are no appropriate alternatives for the treatment of cultural heritage objects in Italy, in particular for the treatment of large-scale, non-movable objects with wooden parts, since all the currently available alternative techniques either present disadvantages due to non-suitability for the treatment of all materials or are not feasible.
(13) Based on the information and justification provided by Italy, it is appropriate to conclude that the biocidal product Vikane is essential for the protection of cultural heritage in Italy and that no appropriate alternatives are currently available in that Member State. Italy should therefore be allowed to authorise the biocidal product Vikane for the protection of cultural heritage, specifically for the protection of large-scale, non-movable cultural heritage objects with wooden parts,
HAS ADOPTED THIS DECISION:
Article 1
Italy may authorise the biocidal product Vikane of product-type 8 for the protection of large-scale, non-movable cultural heritage objects with wooden parts, until 30 September 2031.
Article 2
This Decision is addressed to the Italian Republic.
Done at Brussels, 25 September 2026. For the Commission Olivér Várhelyi Member of the Commission