Ordinance on Biocidal Products (OBP)
Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
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 General Provisions
Art. 3 Authorisation or declaration and labelling
1 Biocidal products may only be placed on the market or used professionally or commercially if they are authorised by the Notification Authority and labelled in accordance with this Ordinance. 2 For biocidal products which are imported for professional or commercial purposes, the condition specified in paragraph 1 must be fulfilled before they are first supplied or first used. 3 The following biocidal products may be placed on the market or used professionally or commercially without authorisation, provided that they have been declared to the Notification Authority in accordance with Article 13c, 13d or 13f and no opinion has been issued by the Notification Authority within the time limits specified in Article 19 paragraph 2: a. biocidal products which have been authorised in an EU or EFTA Member State under the simplified procedure specified in Article 26 of Regulation (EU) No 528/2012; b. biocidal products belonging to an authorised biocidal product family; c. biocidal products relea
Art. 3 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 3 let. a — See footnote to Art. 1b para. 3. Para. 4 — SR 814.912 Para. 4 — SR 814.911 Para. 5 — SR 451.61 Para. 5 — Inserted by Annex No 3 of the Nagoya Ordinance of 11 Dec. 2015, in force since 1 Feb. 2016 (AS 2016 277).
Art. 4 Biocidal products not eligible for authorisation
1 Biocidal products of the following product types according to Annex 10 are not to be authorised: a. Product type 15 (avicides); b. Product type 17 (piscicides); c. Product type 20 (control of other vertebrates). 2 Biocidal products as specified in paragraph 1 may be used for purposes of research and development in accordance with Articles 13e and 13f. 3 They may be authorised in order to deal with exceptional situations in accordance with Article 30. 4 Use or authorisation according to paragraphs 2 and 3 are subject to the restrictions specified in the Chemical Risk Reduction Ordinance of 18 May 2005 (ORRChem) and the provisions of the ContainO and the RO.
Art. 4 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 4 — SR 814.81 Para. 4 — SR 814.912 Para. 4 — SR 814.911
Art. 5 Scope of authorisation and person making the application
1 Authorisation applies: a. to an individual biocidal product: 1. with a particular composition, 2. with a particular trade name or two or more trade names, 3. for a particular use or two or more uses, 4. from a particular manufacturer or two or more manufacturers; b. to a biocidal product family. 2 Authorisation is granted to one person only. 3 Only persons domiciled in Switzerland or with a registered office or branch in Switzerland may apply for and hold an authorisation. This is without prejudice to the provisions of an international treaty.
Art. 5 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 let. a — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 2 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Art. 6
Repealed by No I of the O of 20 June 2014, with effect from 15 July 2014 (AS 2014 2073).
Art. 7 Types of authorisation
1 The following types of authorisation exist for biocidal products: a. authorisation AL based on a comprehensive evaluation of the biocidal product: for biocidal products which: 1. contain at least one active substance listed in Annex 2, and otherwise contain only active substances that are listed in Annex 1, or 2. contain only active substances listed in Annex 1 but are not eligible for the simplified authorisation procedure under Article 25 letters c and d of Regulation (EU) No 528/2012; b. authorisation AnL based on a comprehensive evaluation of the biocidal product and its active substances: for biocidal products containing at least one active substance which is not listed either in Annex 1 or in Annex 2 or included in the list of notified active substances for use in biocidal products referred to in Annex II of Regulation (EU) No 1062/2014 (list of notified active substances); c. authorisation AN: for biocidal products: 1. containing at least one active substance included in the l
Art. 7 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 let. a — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 1 let. a let. 2 — See footnote to Art. 1b para. 3. Para. 1 let. b — Amended by No I of the FOPH O of the of 5 Sept. 20232019, in force since 1 Oct. 2023 (AS 2023 518). Para. 1 let. b — Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic exam
Art. 8 Period of validity
1 Authorisations in accordance with Article 7 and the placing on the market of biocidal products for which authorisation is not required (Art. 3 para. 3) are subject to a time limit. The following maximum periods of validity apply: a. for authorisation AL: 1. 10 years, without prejudice to numbers 2–4,[tab]2. 5 years for biocidal products with an active substance which is a candidate for substitution, if a comparative assessment has been performed in accordance with Article 23 of Regulation (EU) No 528/2012,3. 5 years for biocidal products with active substances authorised in accordance with Article 5 paragraph 2 of Regulation (EU) No 528/2012,4. 4 years for biocidal products with an active substance which is a candidate for substitution, if no comparative assessment has been performed in accordance with Article 23 of Regulation (EU) No 528/2012; b. for authorisation AnL: 1. 4 years, or2. if earlier, until the following time:– until 3 years after the last active substance in the biocid
Art. 8 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 1 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 1 — See footnote to Art. 1b para. 3. Para. 1 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 1 — Correction of 24 Sept. 2019 (AS 2019 3037). Para. 1 — Amended by No
Section 2 Active Substances
Art. 9 Lists of active substances
1 With regard to authorisation, the following lists of active substances apply: a. the list of active substances under Article 25 letter a of Regulation (EU) No 528/2012 (list of active substances eligible for the simplified procedure) contained in Annex 1; b. the list of approved active substances in accordance with Article 9 paragraph 1 letter a of Regulation (EU) No 528/2012 (Union list of approved active substances) contained in Annex 2; c. the list of notified active substances for use in biocidal products in accordance with Regulation (EU) No 1062/2014 (list of notified active substances). 2 The correspondence of expressions used in the EU acts referred to in the Union list of approved active substances and those used in this Ordinance is set out in Annex 3 Number 3. 2bis Where reference is made in this Ordinance to provisions of EU implementing acts on approvals of active substances which themselves refer to other provisions of EU law, the Swiss law set out in Annex 3 Number 4 a
Art. 9 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 1 let. a — See footnote to Art. 1b para. 3. Para. 1 let. c — See footnote to Art. 7 para. 1 let. b.
Art. 10 Amendment of the active substance lists
The FOPH, in consultation with the FOEN and SECO, shall amend: a. Annexes 1–3; b. the reference in Article 7 paragraph 1 letter b to the list of notified active substances.
Art. 10 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Amended by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125).
Section 2a Conditions for Authorisations AL and An
Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 11 General conditions
1 Without prejudice to Article 11g, a biocidal product shall be granted authorisation AL or AnL if the following conditions are met: a. It is established, according to the common principles specified in Annex VI to Regulation (EU) No 528/2012, that: 1. the biocidal product is sufficiently effective; 2. it has no unacceptable effects on target organisms, such as unacceptable resistance or cross-resistance, or unnecessary suffering or pain for vertebrates; 3. no immediate or delayed unacceptable effects are to be expected, from the biocidal product or its residues, on the health of humans, and in particular that of vulnerable groups, or animals, either directly or indirectly, through drinking water, food, feed, air, or through other indirect effects; and 4. no unacceptable effects are to be expected, from the biocidal product or its residues, on the environment, having particular regard to the following considerations: – the fate and distribution of the biocidal product in the environmen
Art. 11 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 let. a — See footnote to Art. 1b para. 3. Para. 1 let. b — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 1 let. e let. 1 — SR 817.02. 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. 1 let. e let. 2 — SR 916.307 Para. 4 — The reference was amended on 1 May 2017 pursuant to
Art. 11a Request for setting of limits
1 In connection with an application for authorisation, the applicant may submit a request to the Notification Authority for maximum levels, maximum concentrations or specific migration limits to be set for active substances for which none are specified in the legislation referred to in Article 11 paragraph 1 letter e. 2 The Notification Authority shall forward the request referred to in paragraph 1: a. for Article 11 paragraph 1 letter e number 1: to the Federal Food Safety and Veterinary Office (FSVO); b. for Article 11 paragraph 1 letter e number 2: to the Federal Office for Agriculture (FOAG).
Art. 11a — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 11b Evaluation factors
The evaluation of whether a biocidal product meets the criteria specified in Article 11 paragraph 1 letter a shall take into account the following factors: a. realistic worst case conditions under which the biocidal product may be used; b. the way in which treated articles treated with or containing the biocidal product may be used; c. the consequences of use and disposal of the biocidal product; d. cumulative effects; e. synergistic effects.
Art. 11b — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 11c Restriction of authorisation to particular uses
The Notification Authority shall only authorise a biocidal product for those uses for which the information required in accordance with Annex 5 is available.
Art. 11c — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 11d Biocidal products for use by the general public
A biocidal product shall not be authorised for placing on the market for use by the general public if: a. it meets the criteria of the CLP Regulation in order to be classified as follows: 1. acute oral toxicity category 1, 2 or 3, 2. acute dermal toxicity category 1, 2 or 3, 3. acute inhalation toxicity (gases and dust/mist) category 1, 2 or 3, 4. acute inhalation toxicity (vapours) category 1 or 2, 5. specific target organ toxicity by single or repeated exposure category 1, 6. a category 1A or 1B carcinogen, 7. a category 1A or 1B mutagen, or 8. toxic for reproduction category 1A or 1B; b. it consists of, contains or generates a substance with properties meeting the criteria for being PBT or vPvB in accordance with Annex XIII to the REACH Regulation; c. it has endocrine-disrupting properties meeting the criteria specified in Delegated Regulation (EU) 2017/2100; or d. it has developmental neurotoxic or immunotoxic effects.
Art. 11d — Inserted by No I of the O of 20 June 2014 (AS 2014 2073). Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). let. a — See footnote to Art. 2 para. 2 let. a No 2. let. a — Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). let. b — Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), est
Art. 11e Exceptions to the requirements
1 A biocidal product which does not fully meet the conditions specified in Article 11 paragraph 1 letter a numbers 3 and 4 or which has the properties specified in Article 11d letter b may be authorised in exceptional cases where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation. 2 The use of a biocidal product authorised in accordance with paragraph 1 shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised.
Art. 11e — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 — The reference was amended on 1 March 2018 in application of Art. 12 para. 2 of the Publications Act of 18 June 2004 (SR 170.512).
Art. 11f Special provisions for biocidal product families
1 A biocidal product family must be assessed according to the common principles specified in Annex VI to Regulation (EU) No 528/2012. The assessment must consider the maximum risks to human health, animal health and the environment and the minimum level of efficacy over the whole potential range of products within the biocidal product family. 2 A biocidal product family shall only be authorised if: a. the following are explicitly identified in the application: 1. the maximum risks to human health, animal health and the environment, and the minimum level of efficacy, on which the applicant’s assessment is based, and 2. the permitted variations in composition and uses referred to in Article 2 paragraph 2 letter b, together with the respective classification, hazard and precautionary statements and any appropriate risk mitigation measures; and b. it is evident from the assessment referred to in paragraph 1 that all the biocidal products within the family comply with the conditions specifi
Art. 11f — 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.
Art. 11g Comparative assessment of biocidal products with an active substance which is a candidate for substitution
1 In the examination of an application for authorisation of a biocidal product containing an active substance which is a candidate for substitution, the assessment authorities shall perform a comparative assessment in accordance with Article 23 of Regulation (EU) No 528/2012 as part of the evaluation specified in Article 17. 2 The Notification Authority, in consultation with the assessment authorities, shall prohibit or restrict the placing on the market or the professional or commercial use of a biocidal product containing an active substance which is a candidate for substitution if the comparative assessment demonstrates that: a. for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages; and b. the chemical
Art. 11g — 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.
Section 2b Conditions for Simplified Authorisation
Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 11h
A biocidal product shall be authorised under a simplified procedure if the following conditions are met: a. all the active substances contained in the biocidal product are listed in Annex I and satisfy any restriction specified in that Annex; b. the biocidal product does not contain any substance of concern; c. the biocidal product does not contain any nanomaterials; d. the biocidal product is sufficiently effective; e. the handling of the biocidal product and its intended use do not require personal protective equipment.
Section 3 Conditions for Recognition, Authorisatio
Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 12 Recognition
1 An authorisation from a Member State of the EU or EFTA shall be recognised if there is nothing to suggest that the product could not also be authorised in Switzerland. 2 The Notification Authority, in consultation with the assessment authorities, may amend the conditions or requirements imposed with the authorisation in an EU or EFTA Member State on the basis of the evaluation in accordance with Article 17 or a comparative assessment in accordance with Article 11g, provided that such a measure can be justified on the following grounds: a. the protection of the environment; b. the protection of health and life of humans, particularly of vulnerable groups, or of animals or plants; c. public policy or public security; d. the protection of national treasures possessing artistic, historic or archaeological value; or e. the target organisms not being present in harmful quantities. 3 The labelling and safety data sheet must be adapted to the requirements set out in Articles 38 and 40. 4 Aut
Art. 13 Authorisation AN
1 A biocidal product shall be granted authorisation AN provided the applicant demonstrates that, according to the latest scientific and technical knowledge, and when used as intended: a. no unacceptable effects on humans, animals or the environment are to be expected from it or its residues; and b. in the case of a wood preservative or a disinfectant: it is sufficiently effective. [tab] 2 It shall only be authorised for placing on the market for use by the general public if it has none of the properties mentioned in Article 11d.
Para. 1 — Amended by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125). Para. 1 let. tab — Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Art. 13a Authorisation for parallel trade
1 For a biocidal product which is authorised in an EU or EFTA Member State (state of origin), the Notification Authority, in consultation with the assessment authorities, shall, on receiving an application to this effect, grant an authorisation for parallel trade if it determines that the biocidal product is identical to a biocidal product which it has already authorised (reference product). 1bis For a biocidal product that is placed on the market in the state of origin with a notified active substance in accordance with the national provisions there, the Notification Authority shall, on receiving an application to this effect, grant an authorisation for parallel trade provided the applicant can demonstrate that the biocidal product is identical to a reference product. 2 A biocidal product shall be considered identical to the reference product if the following requirements are met: a. It has been manufactured by the same company, by an associated undertaking or under licence in accorda
Para. 1bis — Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 2 let. tab — Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Section 3a Liability Guarantee for Biocidal Produc
Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 13b
Anyone who wishes to place biocidal products consisting of or containing pathogenic microorganisms on the market must comply with the obligation to guarantee liability in accordance with Article 14 of the RO.
SR 814.911
Section 3b Declaration Requirements for Biocidal P
Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 13c Biocidal products from the EU or EFTA authorised under the simplified procedure
Anyone who professionally or commercially imports biocidal products which have been authorised in an EU or EFTA Member State under the simplified procedure specified in Article 26 of Regulation (EU) No 528/2012 must declare the trade name and the authorisation number to the Notification Authority at least 30 days before placing them on the market for the first time.
See footnote to Art. 1b para. 3.
Art. 13d Biocidal products within a biocidal product family
1 The holder of an authorisation for a biocidal product family must declare to the Notification Authority each product within the biocidal product family at least 30 days before placing it on the market for the first time. 2 The declaration must indicate the exact composition, the trade name, the authorisation number for the biocidal product family and if applicable a unique formula identifier (UFI) in accordance with Article 14a. 3 Declaration is not required if: a. a particular product is explicitly identified in the authorisation for the biocidal product family; or b. the variation in composition concerns only pigments, perfumes and dyes within the variations permitted according to the authorisation, unless the variation is associated with a change in the trade name.
Para. 2 — Amended by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125).
Section 3c Record-keeping and Declaration Requirem
Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 13e Record-keeping requirements for research and development
1 Anyone who, for purposes of research and development, handles unauthorised biocidal products or non-approved active substances for use in biocidal products must keep records detailing the following: a. identity of the biocidal products or active substances; b. labelling data; c. quantities supplied; d. name and address of the person receiving the biocidal products or active substances; e. all available data concerning possible effects on humans, animals or the environment. 2 The records shall be made available to the Notification Authority on request. 3 The Notification Authority may, if necessary, request further information.
Art. 13f Declaration requirements for handling in release tests
1 Anyone who, for purposes of research and development, handles unauthorised biocidal products or non-approved active substances for use in biocidal products in such a way that they may be released into the environment must declare this to the Notification Authority 45 days before they are so handled for the first time. 2 The declaration must include the records specified in Article 13e paragraph 1. 3 If the proposed release tests could have unacceptable effects on humans, particularly on vulnerable groups, on animals or on the environment, the Notification Authority may: a. make the conduct of the test subject to conditions, concerning in particular: 1. the duration of experiments or tests, 2. the maximum quantities to be used, 3. restriction of the area of use; b. prohibit the test. 4 If the biocidal products or active substances under investigation are genetically modified or pathogenic microorganisms, or if they contain such microorganisms, the procedure shall be based on the RO.
Para. 4 — SR 814.911
Section 4 Procedure for Applications for Authorisa
Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 14 General provisions
1 An application for authorisation of a biocidal product must be submitted to the Notification Authority. 2 The content of the application shall be in accordance with the following Annexes: a. for applications for authorisation AL or AnL: Annex 5; b. for applications for simplified authorisation: Annex 6; c. for applications for recognition: Annex 7; d. for applications for authorisation AN: Annex 8; e. for applications for authorisation for parallel trade: Annex 8a. 3 An application for authorisation of a biocidal product consisting of or containing genetically modified microorganisms must additionally comply with the requirements of the RO. 4 The application and documents must be submitted: a. in the electronic format specified by the Notification Authority; b. in an official language or in English; if the application concerns a biocidal product consisting of or containing genetically modified or pathogenic microorganisms, at least the summary of the application must be written in an
Para. 3 — SR 814.911
Art. 14a Unique formula identifier
1 Applications under Article 14 paragraph 2 letters a, c, d and e must, if the biocidal product must be labelled in accordance with Article 38a with a UFI or already has a UFI, also indicate the UFI in addition to the information specified in Article 14. 2 The UFI is generated in accordance with Article 15a paragraph 2 ChemO. 3 If no UFI is available when the application is submitted, it must be communicated to the Notification Authority no later than 30 days before the product is placed on the market for the first time. 4 In the case of applications for the recognition of authorisation, the information required in connection with the UFI under Annex VIII of the EU CLP Regulation must be submitted to the Notification Authority in the electronic format that it specifies at least 30 days before the product is placed on the market for the first time.
Art. 14a — Inserted by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125). Para. 2 — SR 813.11
Art. 14abis Recognition of a Union authorisation
1 For the recognition of a Union authorisation, the same regulations apply as for the recognition of an authorisation from an EU or EFTA Member State, unless the Union authorisations are the subject of an international treaty with the EU. 2 If the Union authorisations are the subject of an international treaty with the EU, and if the data specified in Article 14b paragraph 3 letter b is accessible to the Notification Authority, the following provisions apply for the recognition of a Union authorisation: a. An application submitted to the European Chemicals Agency (ECHA) for the granting, renewal, amendment or withdrawal of a Union authorisation shall be considered to have been submitted to the Notification Authority at the same time. b. The Notification Authority, in consultation with the assessment authorities, shall take a decision on the application within 30 days after the adoption of a decision by the European Commission; it shall be guided by the European Commission’s decision, h
Art. 14abis — Originally: Art. 14a. Para. 3 let. b — Inserted by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125).
Art. 14b Waiving of data requirements
1 Data which it is not scientifically necessary to supply or which it is not technically possible to generate need not be provided. The justification for adaptations to data requirements shall be stated in the application. 2 The FDHA, in consultation with DETEC and the EAER, shall define when the waiving of data requirements is justified on the basis of likely exposure; in so doing, it shall take into consideration delegated acts adopted by the European Commission in accordance with Article 21 paragraph 3 of Regulation (EU) No 528/2012. 3 The Notification Authority shall indicate the data which does not need to be provided because: a. it has been published by the ECHA; or b. it is accessible to the Notification Authority under an international treaty.
Para. 2 — See footnote to Art. 1b para. 3.
Art. 15 Identical biocidal products
1 A biocidal product that is the same as a biocidal product which has already been granted authorisation AN, AC, AL or recognition, or for which an application to this effect is pending, may be authorised as an identical biocidal product under a special procedure. 2 The FDHA may, in consultation with DETEC and the EAER, specify the details of the procedure referred to in paragraph 1; in so doing, it shall take into consideration any implementing act adopted by the European Commission in accordance with Article 17 paragraph 7 of Regulation (EU) No 528/2012. 3 If the applicant is not identical with the holder of the authorisation for the same biocidal product already authorised, or with the submitter of a pending application, then the applicant must submit a letter of access under the procedure referred to in paragraph 1.
Para. 2 — See footnote to Art. 1b para. 3.
Art. 16 Advance on costs, validation and forwarding
1 The Notification Authority shall require the applicant to pay an advance on costs. 2 Upon receipt of the advance on costs, the Notification Authority shall verify, within the set time limit (Art. 19 para. 1 let. a and b), if necessary in consultation with the assessment authorities, whether the application is complete (validation), without assessing the quality or the adequacy of the data or justifications submitted. 3 If the application is incomplete, it shall, after consulting the applicant, set a reasonable time limit for the submission of additional information. This time limit shall not normally exceed 90 days. 4 It shall validate the additional information submitted, if necessary in consultation with the assessment authorities, within the set time limit (Art. 19 para. 1 let. c). 5 After validation, it shall forward the application with the complete documentation to the assessment authorities. 6 If the application concerns a biocidal product consisting of or containing genetical
Para. 6 — SR 814.911
Art. 17 Evaluation
1 The assessment authorities shall evaluate the documents within their area of responsibility as follows: a. documents for AL and AnL authorisations and simplified authorisations, and for recognitions: according to the principles specified in Annex VI to Regulation (EU) No 528/2012; b. documents for the evaluation of Union authorisations that are submitted to the Notification Authority on the basis of international agreement: under the provisions of Articles 43–46 of Regulation (EU) No 528/2012 and Implementing Regulation (EU) No 354/2013; this also applies to the evaluation of amendments and extensions to Union authorisations; c. documents for the evaluation of an active substance that are submitted to the Notification Authority on the basis of international agreement: under the provisions of Chapters II and III of Regulation (EU) No 528/2012 and Chapter II of Delegated Regulation (EU) No 1062/2014; the foregoing also applies when evaluating the extension of the approval of an active
Para. 1 let. a — See footnote to Art. 1b para. 3. Para. 1 let. b — Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council, Amended by OJ L 109 of 19.4.2013, p. 4. Para. 1 let. c — Amended by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). Para. 1 let. c — Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on
Art. 18
Repealed
Art. 19 Time limits for processing
1 Subject to receipt of the advance on costs, the Notification Authority shall take a decision, without undue delay and at the latest within the following time limits, on: a. validation of an application for authorisation AL or AnL: 30 days b. validation of an application for recognition: 30 days c. validation of additional information for an application for authorisation AL or AnL: 30 days d. evaluation of an application for authorisation AL: 365 days e. evaluation of an application for authorisation AnL: 550 days f. evaluation of an application for recognition: 90 days g. evaluation of an application for recognition in accordance with Article 34 of Regulation (EU) No 528/2012 after receipt of the draft assessment report from the reference Member State: 120 days h. evaluation of an application for simplified authorisation: 90 days i. evaluation of an application for authorisation for parallel trade: 60 days j. evaluation of an application for authorisation AN: 60 days k. assessment of
Para. 1 — See footnote to Art. 1b para. 3. Para. 4 — SR 172.010.14
Art. 20 Ruling
1 The Notification Authority shall decide on authorisation in the form of a ruling. 2 The ruling, except in the case of an authorisation AN, shall include: a. the conditions for the placing on the market and use of the biocidal product; b. a summary of the biocidal product characteristics, comprising: 1. the trade name of the biocidal product, 2. the name and address of the authorisation holder, 3. the date of the authorisation and the date of its expiry, 4. the product type and, where relevant, an exact description of the authorised use, 5. the categories of users, 6. the Swiss authorisation number, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family, 7. the name and address of the manufacturer of the biocidal product and of the active substances it contains, including details of the manufacturing sites, 8. the type of formulation of the biocidal product, and the qualitative and quantitative
Art. 21 Obligation to report unexpected effects
The holder of an authorisation must spontaneously and immediately report to the Notification Authority any new information concerning the biocidal product or the active substances it contains which could affect the authorisation, and in particular: a. new findings on the adverse effects of any active substance or of the biocidal product for humans, in particular vulnerable groups, animals or the environment; b. development of resistance; c. new data or information indicating that the biocidal product is not sufficiently effective.
Art. 22 Listing of a notified active substance in Annex 1 or 2
1 Where the European Commission approves a notified active substance or its inclusion in Annex I to Regulation (EU) No 528/2012 and if the FOPH in agreement with the FOEN and SECO approves the listing of this notified active substance in Annex 1 or 2, the Notification Authority shall immediately inform the holder of an authorisation AN or AC for a biocidal product with this active substance accordingly, provided this is the last notified active substance in the biocidal product. 2 The holder of the authorisation for this biocidal product must, by the date of the inclusion of the last active substance, submit to the Notification Authority: a. an application for: 1. authorisation AL, 2. simplified authorisation, 3. recognition in parallel in accordance with Article 34 of Regulation (EU) No 528/2012, or 4. authorisation as the same biocidal product, if an application for authorisation AL or for recognition in parallel is pending for an identical product; or b. evidence that authorisation
Art. 22 — Amended by No I of the O of 18 Nov. 2020, in force since 15 Dec. 2020 (AS 2020 5125). Para. 1 — See footnote to Art. 1b para. 3.
Art. 23 Review
1 The Notification Authority may review an authorisation at any time. 2 It shall carry out a review if: a. it receives new information in accordance with Article 21; b. there are indications that the conditions for authorisation specified in Article 11 or 11b are no longer met. 3 Either on its own initiative or at the request of an assessment authority, it shall ask the holder for additional information, documents or investigations which are required for the review.
Art. 24 Amendment
1 The Notification Authority, in consultation with the assessment authorities, shall amend an authorisation if: a. the conditions for authorisation specified in Article 11 or 11b or in Section 3 are no longer met; b. the authorisation was granted on the basis of false or misleading information; c. after the authorisation was granted, the holder failed to comply with the obligations arising from this Ordinance. d. a review in accordance with Article 9 paragraph 3 of the Waters Protection Act of 24 January 1991 indicates that an amendment is required in order that the limits specified are no longer repeatedly and widely exceeded. 2 It shall amend an authorisation at the reasoned request of the authorisation holder. Such amendments shall be handled in accordance with the following procedures: a. administrative change: under a simplified notification procedure; b. minor change: under a procedure with a reduced evaluation period; c. major change: under a procedure with an evaluation period
Para. 1 let. a — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 1 let. d — Inserted by No I of the O of 15 Nov. 2023, in force since 1 Jan. 2024 (AS 2023 709). Para. 1 let. d — SR 814.20 Para. 3 — See footnote to Art. 1b para. 3.
Art. 25 Cancellation
1 For cancellation, the conditions specified in Article 24 paragraph 1 and 2 apply. 2 ... 3 The Notification Authority may, in consultation with the assessment authorities, withdraw an authorisation for parallel trade if the authorisation of the biocidal product is cancelled in the state of origin for reasons of efficacy or safety.
Para. 1 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 2 — Repealed by No I of the O of 31 Jan. 2018, with effect from 1 March 2018 (AS 2018 817).
Art. 26 Renewal
1 The holder of an authorisation may apply for renewal. 2 The application for renewal must be submitted to the Notification Authority: a. 550 days before the expiry of an authorisation AL or AnL; b. 2 months before the expiry of a simplified authorisation; c. 550 days before the expiry of a recognition; d. 1 month before the expiry of an authorisation for exceptional situations. 3 For the renewal of an authorisation AL or AnL, the application must include the following: a. all the data required in accordance with Annex 5 which the applicant has generated since the initial authorisation or, where appropriate, previous renewal; b. the applicant’s assessment of whether the conclusions of the initial or, where appropriate, previous assessment remain valid and any supporting information. 4 The Notification Authority shall review the existing authorisation. In order to assess the risks of the biocidal product, it may ask the applicant to provide samples or additional information. 5 For autho
Para. 1 — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). Para. 2 let. c — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985). The correction of 22 Oct. 2019 concerns the French text only (AS 2019 3221). Para. 5 — See footnote to Art. 1b para. 3. Para. 8 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 10 — Inserted by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1
Section 4a Sales Deadlines following the Amendment
Inserted by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Art. 26a
1 If the Notification Authority revokes or does not extend an authorisation or if the time limit for the authorisation under Article 8 has expired, the Notification Authority shall grant the following sales deadlines, provided no unacceptable effects on humans, animals or the environment are anticipated: a. The biocidal product may remain on the market following the revocation, non-extension or expiry of its authorisation for no more than 360 days. b. The biocidal product may be supplied to end consumers for no more than 360 further days. 2 The Notification Authority shall prohibit the professional or commercial use of a biocidal product following the revocation, non-extension or expiry of its authorisation if unacceptable effects on humans, animals or the environment are anticipated. 3 If an authorisation is amended, the biocidal product may remain on the market with the same labelling and be supplied to end consumers following the amendment of the authorisation for the periods set ou
Section 5 Use of Data from Previous Applicants and
Art. 27 Use of other owners’ data
1 The Notification Authority shall waive the requirement for data from the applicant and rely on the owner’s data if: a. the applicant presents a letter of access from the data owner; or b. the data protection period has expired. 2 For all data submitted, the applicant shall indicate to the Notification Authority whether it is the data owner or is authorised to use the data on the basis of a letter of access. 3 If a letter of access is held, the applicant shall also indicate to the Notification Authority the name and address of the data owner. 4 The applicant shall inform the Notification Authority without delay about any changes to the ownership of the data. 5 Anyone who holds a letter of access to active substance data may allow applicants for authorisation of a biocidal product containing this active substance to make reference to this letter of access. 6 The provisions of this Section are without prejudice to the rules of competition law and intellectual property law.
Art. 27 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Art. 27a Letter of access
1 A letter of access must contain at least the following information: a. the name and contact details of the data owner and the beneficiary; b. the name of the active substance or biocidal product for which access to the data is authorised; c. the date on which the letter of access takes effect; d. a list of the submitted data to which reference may be made on the basis of the letter of access. 2 Revocation of a letter of access shall not affect the validity of the authorisation issued on the basis of the letter of access.
Art. 27a — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 let. a — Amended by No I of the O of 5 June 2015, in force since 1 July 2015 (AS 2015 1985).
Art. 28 Data protection period
1 For data submitted to the Notification Authority in accordance with this Ordinance, the following protection periods apply: a. for data submitted with a view to the approval of an existing active substance: 10 years from the first day of the month following the date of the approval of the relevant active substance for the particular product type by the European Commission in accordance with Article 9 of Regulation (EU) No 528/2012; b. for data submitted with a view to the approval of a new active substance: 15 years from the first day of the month following the date of the approval of the relevant active substance for the particular product type by the European Commission in accordance with Article 9 of Regulation (EU) No 528/2012; c. for data submitted with a view to the renewal or review of the approval of a new active substance: 5 years from the first day of the month following the date of the renewal or review of the approval by the European Commission in accordance with Article
Art. 28 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Para. 1 let. a — See footnote to Art. 1b para. 3. Para. 4 — See footnote to Art. 7 para. 1 let. b. Para. 4 — Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market, OJ L 123 of 24 April 1998, p. 1; last amended by Directive 2013/44/EU, OJ L 204 of 31 July 2013, p. 49. Para. 4 — Amended by No I of the O of 5 June 201
Art. 29 Obligation to make advance enquiries so as to avoid tests on vertebrates
1 For the applicant’s obligation to make advance enquiries so as to avoid tests on vertebrates, Article 31 paragraph 1 and Article 32 paragraphs 1, 3 and 4 of the ChemO apply mutatis mutandis; where reference is made in the ChemO to the notification of a substance, this shall be understood for the purposes of this Ordinance as the authorisation of a biocidal product, and where reference is made in the ChemO to the previous notifiers, this shall be understood for the purposes of this Ordinance as the data owners. 2 When making advance enquiries, the applicant must provide evidence that he intends to apply for an authorisation himself.
Art. 29 — Amended by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073). Art. 29 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 1 — SR 813.11 Para. 1 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Art. 29a Compensation for data sharing
1 The applicant and the data owner shall make every effort to reach an agreement on the sharing of the data to be used in accordance with Article 31 paragraph 3 letter a of the ChemO. 2 The parties may seek an arbitrator’s opinion. 3 The Notification Authority shall be bound by the arbitrator’s opinion unless, within 30 days, the parties raise objections in accordance with Article 189 paragraph 3 of the Civil Procedure Code. 4 If no agreement can be reached between the parties, the applicant shall inform the Notification Authority accordingly, at the earliest one month after receipt of the information specified in Article 31 paragraph 3 letter b of the ChemO. At the same time, the applicant shall inform the data owner. 5 At the earliest 60 days after being informed by the applicant, the Notification Authority shall inform the parties that it will use the data for the benefit of the applicant, provided that the latter can demonstrate that he: a. has made every effort to reach an agreeme
Art. 29a — Inserted 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 No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817). Para. 3 — SR 272 Para. 4 — Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Art. 29b Use of data for subsequent applications
1 If the protection period specified in Article 28 has expired, the applicant may request that the data from an existing authorisation be used by the Notification Authority for his benefit, if he provides evidence: a. where the protection period has expired for data on the active substance used: that it is technically equivalent to the active substance in a biocidal product already authorised, including the degree of purity and the nature of any impurities; b. where the protection period has expired for data on the biocidal product: 1. that it is the same as the biocidal product already authorised, or 2. that the differences are not significant in relation to the risk assessment and the active substances are technically equivalent as defined in letter a. 2 The Notification Authority shall issue a general ruling, published in the Federal Gazette. It shall inform the holder of the existing authorisation and, if known, the owner of the data on the active substance or the biocidal product.
Art. 29b — Inserted by No I of the O of 20 June 2014, in force since 15 July 2014 (AS 2014 2073).
Section 6 Derogations
Amended by No I of the O of 31 Jan. 2018, in force since 1 March 2018 (AS 2018 817).
Art. 30 Authorisation of biocidal products to control an unforeseen danger
1 In order to control an unforeseen danger which cannot be contained by other means, the Notification Authority may, in consultation with the assessment authorities, authorise certain biocidal products for limited and controlled use in derogation from the provisions of Articles 4 and 5 and Sections 2–4 of this Chapter. The foregoing does not apply to biocidal products that are or contain genetically modified micro-organisms. 2 Biocidal products authorised under paragraph 1 may, in derogation from the provisions of Article 38 paragraph 2 letter b, be labelled solely in the official language of the place of use or in English. 3 With regard to biocidal products consisting of or containing pathogenic microorganisms, the requirements of the ContainO and the RO must additionally be met for authorisation under paragraph 1.
Para. 3 — SR 814.912 Para. 3 — SR 814.911
Art. 30a Provisional authorisation of biocidal products that contain an as yet unapproved active substance
1 The Notification Authority may in agreement with the assessment authorities provisionally authorise a biocidal product that contains an active substance that has yet to be approved. The provisional authorisation shall be granted if: a. the applicant for the as yet unapproved active substance submits a recommendation from an EU or EFTA member state that the active substance be approved; and b. the assessment authorities, having regard to Article 11b, take the view that the biocidal product provisionally meets the requirements of Article 11 paragraph 1 letters a–c. 2 The Notification Authority shall revoke the provisional authorisation if the European Commission decides not to approve the active substance.
Para. 1 let. a — The correction of 5 May 2022 concerns the French text only (AS 2022 274).
Art. 30b Authorisation of biocidal products to protect cultural heritage
Where it is essential for the protection of cultural heritage and if there is no suitable alterative available, the Notification Authority may in agreement with the assessment authorities authorise a biocidal product that contains an active substance that has not been approved.