G/TBT/N/EU/1201

23 March 2026

(26-2300)

Committee on Technical Barriers to Trade

Original: English

1.

Notifying Member: EUROPEAN UNION

If applicable, name of local government involved (Articles 3.2 and 7.2):

2.

Agency responsible:

European Commission

EU-TBT Enquiry Point,

Fax: +(32) 2 299 80 43,

E-mail: grow-eu-tbt@ec.europa.eu

Website: https://technical-barriers-trade.ec.europa.eu/en/home

3.

Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], 3.2 [ ], 7.2 [ ], Other:

4.

Products covered (HS codes or national tariff lines. ICS numbers may be provided in addition, where applicable): Biocidal products

5.

Details of notified document(s) (title, number of pages and languages, means of access): Draft Commission Implementing Decision on the non-approval of poly(dimethyloctadecyl[3-(trihydroxysilyl)propyl]ammonium chloride) generated from dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride as an existing active substance for use in biocidal products of product types 2, 7 and 9 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; (4 page(s), in English)

Link to notified document(s) and/or contact details for agency or authority which can provide copies upon request:

https://members.wto.org/crnattachments/2026/TBT/EEC/26_01599_00_e.pdf

European Commission

EU-TBT Enquiry Point

Fax: + (32) 2 299 80 43

E-mail: grow-eu-tbt@ec.europa.eu

The text is available on the Website: https://technical-barriers-trade.ec.europa.eu/en/home

6.

Description of content: This draft Commission Implementing Decision does not approve poly(dimethyloctadecyl[3-(trihydroxysilyl)propyl]ammonium chloride) generated from dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride as an existing active substance for use in biocidal products of product types 2, 7 and 9.

This active substance cannot be approved due to major data gaps, including validated analytical methods and physico-chemical properties of the substance. Since reliable analytical methods could not be established, it was not possible to conclude on the acceptability of the risks concerning human health and the environment. Due to the same reasons, it was not possible to conclude whether the active substance is carcinogenic, mutagenic or toxic for reproduction. Finally, sufficient efficacy was not demonstrated for any of the assessed product-types.

As a consequence, articles treated with or incorporating this active substance may not be placed on the market in the Union 180 days after a decision on the non-approval.

7.

Objective and rationale, including the nature of urgent problems where applicable: Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment; Harmonization

8.

Relevant documents:

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 (OJ L 167, 27.6.2012, p. 1.). Available in all EU languages.

EUR-Lex - 32012R0528 - EN - EUR-Lex (europa.eu)

9.

Proposed date of adoption: June 2026

Proposed date of entry into force: 20 days from publication in the Official Journal of the EU (Application 12 months after adoption)

10.

Provision of comments

Final date for comments: 22 May 2026

[X] 60 days from notification

Contact details of agency or authority designated to handle comments regarding the notification:

European Commission,

EU-TBT Enquiry Point,

Fax: + (32) 2 299 80 43,

E-mail: grow-eu-tbt@ec.europa.eu