Ordinance on Biocidal Products (OBP)

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In The Matter OfOrdinance on Biocidal Products (OBP)
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Art. 35 Classification

1 Articles 6 and 7 of the ChemO apply mutatis mutandis to the classification of biocidal products and of active substances for use in biocidal products; where the ChemO refers to the manufacturer, this shall be understood for the purposes of this Ordinance as the applicant. 2 Where appropriate, the information included in the ruling referred to in Article 20 shall be taken into account.

Art. 35 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 1 — [AS 2005 2721; 2007 821; 2009 401, 805; 2010 5223; 2011 5227; 2012 6103, 6659; 2013 201, 2673, 3041 No I 3; 2014 2073 Annex 11 No 1, 3857. AS 2015 1903 Art. 91]. See now: the O of 5 June 2015 (SR 813.11).

Art. 36 Packaging

1 Biocidal products and active substances for use in biocidal products must be packaged in accordance with Articles 8 and 9 of the ChemO mutatis mutandis. Where the ChemO refers: a. to the manufacturer, this shall be understood for the purposes of this Ordinance as the authorisation holder; b. to dangerous substances and preparations, this shall be understood for the purposes of this Ordinance as all biocidal products and active substances for use in biocidal products. 2 Where appropriate, the information included in the ruling referred to in Article 20 shall be taken into account. 3 Biocidal products which may be mistaken for foodstuffs within the meaning of the Foodstuffs Act of 20 June 2014 or for animal feedstuffs within the meaning of Article 3 paragraph 1 of the Feedstuffs Ordinance of 26 May 1999 must be packaged to minimise the likelihood of such a mistake being made.

Art. 36 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 — SR 813.11 Para. 1 — Amended by Annex 10 No II 3 of the Plant Protection Products Ordinance of 20 Aug. 2025, in force since 1 Dec. 2025 (AS 2025 565). Para. 3 — SR 817.0. The reference was amended on 1 May 2017 pursuant to Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512). Para. 3 — [AS 1999 1780, 2748 Annex 5 No 6; 2001 3294 No II 14; 2002 4065; 2003 4927; 2005 973, 2695 N

Art. 37 Denaturation

Biocidal products which may be mistaken for foodstuffs or animal feedstuffs and which are available to the general public must contain components to discourage their consumption.

Art. 38 Labelling

1 The label must not be misleading in respect of the risks from the biocidal product to human health, animal health or the environment or its efficacy. It must not, in any case, mention the indications «low-risk biocidal product», «non-toxic», «harmless», «natural», «environmentally friendly», «animal friendly» or similar indications. 2 Biocidal products and active substances for use in biocidal products must be labelled: a. in accordance with the summary of the biocidal product characteristics referred to in Article 20 paragraph 2 letter b; and b. in accordance with Articles 10, 11 and 93 paragraph 1 letter b of the ChemO mutatis mutandis; where the ChemO refers: 1. to the manufacturer, this shall be understood for the purposes of this Ordinance as the authorisation holder, 2. to dangerous substances and preparations, this shall be understood for the purposes of this Ordinance as all biocidal products and active substances for use in biocidal products. 3 In addition to the details spe

Art. 38 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 2 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 2 let. b — SR 813.11 Para. 2 let. b — Amended by Annex 10 No II 3 of the Plant Protection Products Ordinance of 20 Aug. 2025, in force since 1 Dec. 2025 (AS 2025 565). Para. 3 — Amended by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125). Para. 3 let. c — Amended by No I of the

Art. 38a Labelling of specific biocidal products classified as dangerous

Where a biocidal product is placed on the market that is classified as dangerous within the meaning of Article 3 ChemO because of the physical or health hazards it presents, the authorisation holder must not only indicate the information in accordance with Article 38 paragraphs 2–4 but also the UFI in accordance with the provisions of Article 15a paragraphs 3 and 4 ChemO.

Art. 38a — Inserted by No I of the O of 18 Nov. 2020 (AS 2020 5125). Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). SR 813.11

Art. 39 Labelling for genetically modified microorganisms

1 In addition to the requirements specified in Article 38, biocidal products consisting of or containing genetically modified microorganisms must be appropriately labelled. 2 One of the following descriptions must be used for the labelling: a. «aus gentechnisch verändertem X/produit à partir de X modifié par génie génétique/da X modificato/a con tecnologia genetica»; or b. «aus genetisch verändertem X/produit à partir de X génétiquement modifié/da X geneticamente modificato/a». 3 The information specified in Article 38 paragraph 4 letter b shall be indicated on the label. The other information shall be indicated in accordance with Article 38 paragraph 5 letter a or b, depending on the conditions met. 4 No labelling is required for biocidal products containing unintentional traces of approved genetically modified microorganisms accounting for less than 0.1 per cent by mass.

Art. 39 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Art. 39 — Amended by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125).

Art. 40 Safety data sheet

1 For biocidal products and for active substances for use in biocidal products, safety data sheets must, if applicable, be compiled, provided and updated in accordance with Articles 5 and 18–22 of the ChemO mutatis mutandis; where the ChemO refers to the manufacturer, this shall be understood for the purposes of this Ordinance as the authorisation holder. 2 For active substances included in the lists specified in Article 9 paragraph 1 letters a–c, the exposure scenarios referred to in Article 20 paragraph 2 of the ChemO need not be attached.

Art. 40 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 1 — SR 813.11 Para. 1 — Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709).

Art. 40a Documentation and samples

1 The manufacturer of a biocidal product shall maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal product to be placed on the market. 2 The documentation shall include as a minimum: a. safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product; b. records of the various manufacturing operations performed; c. results of internal quality controls; d. identification of production batches. 3 The manufacturer shall store production batch samples. [tab] 4 The documentation and the samples must be retained in accordance with Article 45 paragraph 2 of the ChemO. [tab] 5 Safety data sheets must be retained in accordance with Article 23 ChemO.

Art. 40a — Inserted by No I of the O of 28 Feb. 2007 (AS 2007 851). Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 3 let. tab — [AS 2005 2721; 2007 821; 2009 401, 805; 2010 5223; 2011 5227; 2012 6103, 6659; 2013 201, 2673, 3041 No I 3; 2014 2073 Annex 11 No 1, 3857. AS 2015 1903 Art. 91]. See now: the O of 5 June 2015 (SR 813.11). Para. 3 let. tab — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 3 let. tab —