(1)

Sulfuryl fluoride was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) 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. Applications for the renewal of 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.

(2)

Commission Implementing Decision (EU) 2024/2402 (3) found 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 and that, as a consequence, the approval of sulfuryl fluoride for use in biocidal products of product-types 8 and 18 was not renewed.

(3)

Pursuant to Article 55(3) of Regulation (EU) No 528/2012, on 4 December 2024, Germany 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. Together with Germany, five other Member States submitted similar applications (the ‘requesting Member States’): on 31 March 2025 Austria, on 14 April 2025 Sweden, on 22 April 2025 France, on 30 April 2025 the Netherlands and on 9 May 2025 Belgium.

(4)

‘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.

(5)

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.

(6)

According to the information provided by the requesting Member States, 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 outbreaks, where continued infestations, even in the short term, may cause structural damage.

(7)

As indicated in the applications, the use of in situ generated nitrogen appears not to be suitable for the treatment of this type of buildings, due to their large scale, which does not allow for the required concentrations to be maintained long enough to have an efficacious treatment.

(8)

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 applications, each of those techniques has limitations in terms of damage that could occur to certain materials during treatment.

(9)

As stated in the applications, other biocidal active substances that could be used for the control of harmful organisms (for instance, 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 not approved for use in biocidal products of product-type 8.

(10)

Discussions related to a possible derogation pursuant to Article 55(3) of Regulation (EU) No 528/2012 for the biocidal product ‘Vikane’ took place in March 2025 (4) at a meeting of the Commission expert group of Competent Authorities for Biocidal Products. The comments provided by Member States’ experts in the meeting and in writing, after the meeting, were in favour of granting such a derogation.

(11)

The requesting Member States have indicated 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 applications submitted by the requesting Member States show that no appropriate alternatives are available for the treatment of large-scale, non-movable objects with wooden parts in those Member States, since all the alternative techniques currently available either present disadvantages due to non-suitability for the treatment of all materials or are not feasible.

(13)

Based on all those arguments, it is appropriate to conclude that the biocidal product ‘Vikane’ is essential for the protection of cultural heritage in the requesting Member States and that no appropriate alternatives are available. The requesting Member States should therefore be allowed to authorise the making available on the market and use of 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.

(14)

The possible approval of sulfuryl fluoride for use in biocidal products of product-type 8 and the subsequent authorisation by Member States of biocidal products containing that active substance requires time. It is therefore appropriate to allow a derogation for a period that would allow the completion of the underlying procedures,

(1)

the Kingdom of Belgium;

(2)

the Federal Republic of Germany;

(3)

the Republic of France;

(4)

the Kingdom of the Netherlands;

(5)

the Republic of Austria;

(6)

the Kingdom of Sweden.