Ordinance on Biocidal Products (OBP)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Confederation
Art. 50a Harmonisation of enforcement
1 In the enforcement of this Ordinance, the Swiss authorities shall be guided by the legislation currently applicable in the EU, and in particular by delegated acts or implementing acts adopted by the European Commission in accordance with Regulation (EU) No 528/2012 and by Technical Notes for Guidance issued by the European Commission and the ECHA. 2 The Notification Authority, in consultation with the assessment authorities, shall prepare guidelines for the harmonisation of enforcement. It shall publish the guidelines on its website.
Art. 50a — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 — See footnote to Art. 1b para. 3. Para. 2 — www.anmeldestelle.admin.ch > Topics > Chemicals Legislation and Guidelines > Chemicals Legislation > Ordinance on Biocidal Products (OBP) > MRA Switzerland-EU Para. 2 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985).
Art. 51 Notification Authority and steering committee
Provisions concerning the Notification Authority and the associated steering committee are set out in Article 77 of the ChemO.
Art. 51 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). [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. 52 Assessment authorities
The assessment authorities for biocidal products are: a. the FOPH: for matters concerning the protection of human life and health; b. the FOEN: for matters concerning protection of the environment and indirect protection of human beings; c. the SECO: for matters concerning the protection of workers; d. the FOAG: for agronomic matters; e. the FSVO: for matters concerning food safety and animal health.
let. d — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). let. e — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 53 Duties of the Notification Authority and cooperation
1 The Notification Authority has the following duties: a. it obtains the evaluations and opinions of the competent assessment authorities; b. it makes decisions in consultation with the assessment authorities; c. using random sampling, it analyses the composition of biocidal products placed on the market; d. it publishes the following lists in an appropriate form: 1. the list referred to in Article 95 paragraph 1 of Regulation (EU) No 528/2012, 2. the list of persons who have submitted the following documents: – documents complying with Annex II to Regulation (EU) No 528/2012 or with Annex IIA or IVA and, where relevant, IIIA to Directive 98/8/EC or – a letter of access to active substance data as referred to in letter d number 2 first indent, 3. the list of persons for whose benefit it has used data in accordance with Article 29a paragraph 5; e. it shall make available the electronic formats for the submission of applications for authorisation and for declarations. 2 It shall request
Para. 1 let. d — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 let. d let. 1 — See footnote to Art. 1b para. 3. Para. 1 let. d let. 2 — See footnote to Art. 28 para. 4. Para. 1 let. d let. 3 — Correction of 23 Dec. 2014 (AS 2014 4719). Para. 1 let. e — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 3 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985).
Art. 54 Toxicological Information Centre
Article 79 of the ChemO applies with regard to the Toxicological Information Centre.
Art. 54 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). [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. 54a Biocidal products helpdesk
1 The Notification Authority shall operate a biocidal products helpdesk in cooperation with the assessment authorities. 2 The helpdesk shall provide advice to applicants, in particular to SMEs, and to any other interested parties on their respective responsibilities and obligations under this Ordinance. 3 In particular, it shall provide advice to applicants about the possibility of adapting the data requirements specified in Annex 5 Number 2.2 paragraph 1.
Art. 54a — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014(AS 2014 2073).
Art. 55
Repealed by No I of the O of 20 June 2014, with effect from 15 July 2014 (AS 2014 2073).
Art. 56 Monitoring of imports and exports
1 Customs offices shall check, at the request of the Notification Authority, whether biocidal products or treated articles comply with the provisions of this Ordinance. 2 The assessment authorities may ask the Notification Authority to submit a request as specified in paragraph 1. 3 If they suspect any infringement, the customs offices are entitled to withhold biocidal products or treated articles at the border and call in the other executive authorities under this Ordinance. These authorities shall carry out further enquiries and take the required measures.
Para. 1 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 3 — Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Art. 57 Fees and advance on costs
1 The obligation to pay fees and the calculation of fees for administrative action by the federal enforcement authorities in accordance with this Ordinance is based on the Chemicals Fees Ordinance of 18 May 2005. 2 No fees are payable for the recognition of a Union authorisation in accordance with Article 14abis paragraph 2. 3 For an application for authorisation or for the amendment thereof, the applicant must pay an advance on costs. This shall be determined by the Notification Authority on the basis of the likely amount of fees. 4 Payment of the advance on costs is a prerequisite for the processing of the application by the Notification Authority. 5 Paragraphs 3 and 4 do not apply to authorisations AC and AN, or to authorisations of identical biocidal products which are identical to an authorisation AC or AN.
Art. 57 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 — SR 813.153.1
Section 2 Cantons
Art. 58 Further checks
1 The cantonal enforcement authorities shall inspect biocidal products and treated articles which are placed on the market or used by the manufacturers themselves. 2 They shall verify whether: a. the biocidal products placed on the market have an authorisation; b. for biocidal products used for purposes of research and development, the provisions of Articles 13e and 13f are being complied with; c. the rulings issued under Article 20 are being complied with, especially whether the rules concerning packaging and labelling and concerning the compilation of safety data sheets are being followed; d. the rules concerning the provision and retention of safety data sheets are being followed; e. the special provisions concerning the handling of biocidal products are being complied with; f. the requirements for treated articles specified in Articles 31 and 31a are being complied with; g. the provisions of Article 13a concerning parallel trade are being complied with. 3 They shall carry out rando
Para. 1 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 2 let. g — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 59 Order of the cantonal enforcement authority
If an inspection reveals infringements of the provisions set out in Article 58 paragraph 2, the competent authority in the canton in which the authorisation holder or the manufacturer, distributor or user is domiciled or has its registered office or branch must order the necessary measures. In the case of infringements of Articles 41–49, the competent authority in the canton in which the infringement took place may also issue the order. The cantons shall coordinate the required measures.
Art. 59 — Amended by Annex No 1 of the O of 11 March 2022, in force since 1 May 2022 (AS 2022 220).
Section 3 Delegation of Duties and Powers to Third
Art. 60
1 The competent federal bodies may delegate to appropriate public corporations or private persons all or some of the duties and powers assigned to them by this Ordinance. 2 To the extent that enforcement of health protection is concerned, delegation is limited to the following: a. analytical examination of random samples (Art. 53 para. 1 let. c); b. checking of applications for completeness in accordance with Article 16 paragraph 2 and evaluation of documents in accordance with Article 17.
Para. 2 let. b — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985).
Section 4 Passing-on of Data
Art. 61
Articles 74–76 of the ChemO apply mutatis mutandis to the passing-on of data concerning biocidal products.
Art. 61 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). [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).