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 528/2012³⁷;

b.

biocidal products belonging to an authorised biocidal product family;

c.

biocidal products released for purposes of research and development.

⁴ As regards the handling of biocidal products in accordance with paragraph 3 letter c, if these products are or contain microorganisms, they are subject to the provisions of the Containment Ordinance of 9 May 2012³⁸ (ContainO) and of the Release Ordinance of 10 September 2008³⁹ (RO).

⁵ The placing on the market of a biocidal product whose development is based on used genetic resources or on traditional knowledge based thereon, is subject to the provisions of the Nagoya Ordinance of 11 December 2015⁴⁰ (NagO).⁴¹

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 2005⁴³ (ORRChem) and the provisions of the ContainO⁴⁴ and the RO⁴⁵.

¹ Authorisation applies:

a.⁴⁷

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.⁴⁸

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.

¹ The following types of authorisation exist for biocidal products:

a.⁵¹

authorisation A_L 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 528/2012⁵²;

b.⁵³

authorisation A_nL 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 1062/2014⁵⁴ (list of notified active substances);

c.

authorisation A_N: for biocidal products:

1.

containing at least one active substance included in the list of notified active substances but for which a decision on listing in Annex 1 or 2 is still outstanding, and

2.

whose other active substances are included in one of these lists;

d.

authorisation A_C (confirmation) based on a summary procedure: for biocidal products:

1.

containing at least one active substance included in the list of notified active substances but for which a decision on listing in Annex 1 or 2 is still outstanding,

2.

whose other active substances are included in one of these lists,

3.

for which an application for authorisation A_C was submitted to the Notification Authority no later than 31 July 2006, and

4.

which are still on the market when the Amendment of 20 June 2014 to this Ordinance comes into force;

e.⁵⁵

derogations: for biocidal products used to deal with exceptional situations;

f.

simplified authorisation: for biocidal products which are eligible for the simplified procedure in accordance with Article 25 of Regulation (EU) No 528/2012⁵⁶;

g.

recognition: for biocidal products:

1.⁵⁷

which have been authorised in an EU or EFTA Member State in accordance with Article 33 of Regulation (EU) No 528/2012, or

2.

for which an application has been submitted in accordance with Article 34 of Regulation (EU) No 528/2012;

h.

recognition of a Union authorisation: for biocidal products for which a Union authorisation has been granted by the European Commission;

i.

authorisation of the same biocidal products: for biocidal products which:

1.

are identical to biocidal products already authorised, and

2.

are placed on the market by the authorisation holder or by third parties under the same terms and conditions as the biocidal products already authorised;

j.⁵⁸

authorisation for parallel trade: for biocidal products :

1.

that are authorised in an EU or EFTA member state and are identical to a biocidal product that has been granted authorisation Z_L or recognition in Switzerland, or

2.

that are placed on the market in an EU or EFTA member state in accordance with the national provisions and are identical to a biocidal product that has been granted authorisation Z_N or Z_B in Switzerland.

² Unless otherwise indicated by a provision of this Ordinance, authorisation in this Ordinance is to be understood as referring to all the types of authorisation listed in paragraph 1.

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:⁶⁰

^2-4 ...⁶⁸

⁵ If the authorisation has expired, Article 26a governs any further placing on the market, supply to end consumers and the professional or commercial use of the biocidal product.⁶⁹

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 528/2012⁷¹ (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 1062/2014⁷² (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 applies instead of the EU law.

³ Active substances on the Union list of approved active substances that are considered candidates for substitution in accordance with Article 10 of Regulation (EU) No 528/2012 are designated as such in Annex 2.

⁴ For active substances containing nanomaterials, Article 4 paragraph 4 of Regulation (EU) No 528/2012 applies mutatis mutandis.

⁵ The FDHA, in consultation with DETEC and the EAER, shall issue a list of substances which may be used under an authorisation A_nL, indicating their uses.

The FOPH, in consultation with the FOEN and SECO, shall amend:⁷⁴

a.

Annexes 1-3;

b.

the reference in Article 7 paragraph 1 letter b to the list of notified active substances.

¹ Without prejudice to Article 11g, a biocidal product shall be granted authorisation A_L or A_nL if the following conditions are met:

a.

It is established, according to the common principles specified in Annex VI to Regulation (EU) No 528/2012⁷⁷, 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 environment,

-

contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,

-

the impact of the biocidal product on non-target organisms,

-

the impact of the biocidal product on biodiversity and the ecosystem.

b.⁷⁸

The chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined using analytical methods referred to in Annexes II and III to Regulation (EU) No 528/2012.

c.

The physical and chemical properties are acceptable for purposes of use, transport and storage.

d.

The risk to human health and the environment posed by nanomaterials used in the biocidal product has been assessed separately.

e.

Existing or, where appropriate, newly specified maximum concentrations, maximum residue levels or specific migration limits in or on food or feed, in accordance with the following provisions, are complied with:

1.

Article 49 paragraphs 3 and 4 letter c and 10 paragraph 4 letter e FUO⁷⁹;

2.

Article 36 paragraph 1 of the FsO⁸⁰.

² Biocidal products with active substances listed in Annex 1 or 2 must additionally meet the requirements specified for the active substances in these lists.

³ If biocidal products contain active substances which are not listed in Annex 1 or 2 or included in the list of notified active substances, the active substances must meet the requirements specified in Articles 4 and 5 of Regulation (EU) No 528/2012.

⁴ Biocidal products intended for direct application to the human body may only contain non-active substances designated by the FDHA as permissible for the category concerned in accordance with Article 54 FUO.⁸¹ This does not exclude the presence of technically unavoidable residues, provided that they do not pose a health risk.

⁵ Biocidal products consisting of or containing genetically modified organisms must meet the requirements of the RO⁸².

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).

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.

The Notification Authority shall only authorise a biocidal product for those uses for which the information required in accordance with Annex 5 is available.

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 Regulation⁸⁷ in order to be classified as follows:⁸⁸

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 Regulation⁸⁹;

c.⁹⁰

it has endocrine-disrupting properties meeting the criteria specified in Delegated Regulation (EU) 2017/2100⁹¹; or

d.

it has developmental neurotoxic or immunotoxic effects.

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 b⁹³ 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.

¹ A biocidal product family must be assessed according to the common principles specified in Annex VI to Regulation (EU) No 528/2012⁹⁵. 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 specified in Article 11.

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 528/2012⁹⁷ 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 diversity of the active substances is adequate to minimise the occurrence of resistance in the harmful organism.

³ By way of derogation from paragraphs 1 and 2, a biocidal product may, in exceptional cases, be authorised without a comparative assessment if it is necessary to acquire experience first through using the product in practice.

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.

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 Authorisations of biocidal products consisting of or containing genetically modified microorganisms shall not be recognised.

⁵ Article 14a^bis applies to the recognition of a Union authorisation.

¹ A biocidal product shall be granted authorisation A_N provided the applicant demonstrates that, according to the latest scientific and technical knowledge, and when used as intended:¹⁰⁰

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.

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.¹⁰¹

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.¹⁰²

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 accordance with the same manufacturing process.

b.

The products are identical in specification and content in respect of the active substances and the type of formulation.

c.

The products are identical in respect of the non-active substances present.

d.

The products are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on human health, animal health or the environment.

³ The authorisation for parallel trade shall contain the same conditions for placing on the market and use as in the authorisation for the reference product.¹⁰³

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 RO¹⁰⁵.

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 528/2012¹⁰⁷ 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.

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.¹⁰⁸

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.

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.

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 RO¹¹⁰.

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 A_L or A_nL: Annex 5;

b.

for applications for simplified authorisation: Annex 6;

c.

for applications for recognition: Annex 7;

d.

for applications for authorisation A_N: 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 RO¹¹².

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 official language.

⁵ The Notification Authority may, at the request of an assessment authority, require the provision of models or drafts of the packaging, labelling or leaflets.

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 ChemO¹¹⁴.

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.

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, having regard to the criteria specified in Article 12 paragraph 2.

³ If a biocidal product has a UFI, the Notification Authority must be notified at least 30 days before the product is placed on the market for the first time of:

a.

the UFI;

b.

the information required in connection with the UFI under Annex VIII of the EU CLP Regulation in the electronic format that the Notification Authority specifies.¹¹⁶

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 528/2012¹¹⁷.

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.

¹ A biocidal product that is the same as a biocidal product which has already been granted authorisation A_N, A_C, A_L 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 528/2012¹¹⁸.

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.

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 genetically modified microorganisms, it shall conduct the authorisation procedure itself, taking account of the RO¹¹⁹.

¹ The assessment authorities shall evaluate the documents within their area of responsibility as follows:

a.

documents for A_L and A_nL authorisations and simplified authorisations, and for recognitions: according to the principles specified in Annex VI to Regulation (EU) No 528/2012¹²⁰;

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 354/2013¹²¹; this also applies to the evaluation of amendments and extensions to Union authorisations;

c.¹²²

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 1062/2014¹²³; the foregoing also applies when evaluating the extension of the approval of an active substance;

c^bis.¹²⁴

documents for Z_N authorisations: from the point of view of whether the active substance is suitable for the use and product type applied for; in the event of increased risk or in other justified cases, an assessment shall be carried out in accordance with letter d;

d.

other documents: according to the latest scientific and technical knowledge.¹²⁵

² ...¹²⁶

³ For biocidal products containing an active substance which is a candidate for substitution, the assessment authorities shall perform a comparative assessment as specified in Article 11g.

⁴ The assessment authorities shall inform the Notification Authority of the results of their evaluation.

⁵ In the case of applications for authorisation A_L, A_nL and simplified authorisation, the Notification Authority, after validation, shall, in consultation with the assessment authorities, within the set time limit (Art. 19 para. 1 let. d-j), prepare an assessment report summarising the conclusions of the evaluation and the reasons for granting or refusing to grant authorisation.

⁶ Where it appears that additional information is necessary to carry out the evaluation, the Notification Authority shall ask the applicant to submit such information within a specified time limit. The Notification Authority may ask the applicant to provide samples, if this is necessary for the evaluation.

⁷ The Notification Authority shall send the draft assessment report to the applicant and provide him with the opportunity to submit comments within 30 days.

Repealed

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:

² For biocidal products for which authorisation is not required, as specified in Article 3 paragraph 3, the Notification Authority shall, if necessary, issue an opinion within the following time limits:

³ If the Notification Authority asks for additional documents, the time limit «clock» shall be stopped until the additional information has been submitted. Altogether, the clock shall be stopped for no more than 180 days, unless a longer period is justified on account of the type of additional information requested or exceptional circumstances.

⁴ The FDHA may, in consultation with DETEC and the EAER, specify further time limits for processing. Otherwise, the limits specified in the Ordinance of 25 May 2011¹²⁸ on Principles and Time Limits for Authorisation Procedures apply.

¹ The Notification Authority shall decide on authorisation in the form of a ruling.

² The ruling, except in the case of an authorisation A_N, 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 composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; in the case of a biocidal product family, a minimum and maximum percentage shall be indicated for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0%,

9.

the hazard and precautionary statements,

10.

the target harmful organisms,

11.

the application doses and instructions for use,

12.

the particulars of likely direct or indirect adverse effects,

13.

first aid instructions and emergency measures to protect the environment,

14.

instructions for safe disposal of the product and its packaging,

15.

conditions of storage and shelf-life of the biocidal product under normal conditions of storage,

16.

where relevant, other information about the biocidal product;

c.

information on the amount of fees.

³ The ruling for an authorisation A_N shall include:

a.

the conditions for the placing on the market and use of the biocidal product;

b.

the trade name of the biocidal product;

c.

the name and address of the authorisation holder;

d.

the date of the authorisation and the date of its expiry;

e.

the Swiss authorisation number;

f.

the product type and, where relevant, an exact description of the authorised use;

g.

the categories of users;

h.

the name and address of the manufacturer of the biocidal product and of the active substances it contains;

i.

each active substance and its content in the product;

j.

where relevant, other information or details of the safety data sheet;

k.

information on the amount of fees;

l.

where relevant, other information.

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.

¹ Where the European Commission approves a notified active substance or its inclusion in Annex I to Regulation (EU) No 528/2012¹³⁰ 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 A_N or A_C 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 A_L,

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 A_L or for recognition in parallel is pending for an identical product; or

b.

evidence that authorisation under letter a or Union authorisation is being sought.

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.

¹ The Notification Authority, in consultation with the assessment authorities, shall amend an authorisation if:

a.¹³¹

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.¹³²

a review in accordance with Article 9 paragraph 3 of the Waters Protection Act of 24 January 1991¹³³ 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 proportionate to the extent of the proposed change.

³ The FDHA, in consultation with DETEC and the EAER, shall specify the details of the procedures referred to in paragraph 2; in so doing, it shall take into consideration the implementing act adopted by the European Commission in accordance with Article 51 of Regulation (EU) No 528/2012¹³⁴.

¹ For cancellation, the conditions specified in Article 24 paragraph 1 and 2 apply.¹³⁵

² ...¹³⁶

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.

¹ The holder of an authorisation may apply for renewal.¹³⁷

² The application for renewal must be submitted to the Notification Authority:

a.

550 days before the expiry of an authorisation A_L or A_nL;

b.

2 months before the expiry of a simplified authorisation;

c.¹³⁸

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 A_L or A_nL, 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 authorisations A_L or A_nL, the Notification Authority, in consultation with the assessment authorities, shall decide within the set time limit (Art. 19 para. 1 let. k) whether a full evaluation is required in accordance with Article 31 paragraph 5 of Regulation (EU) No 528/2012¹³⁹, and it shall issue a ruling within the set time limit (Art. 19 para. 1 let. l and m), taking into account, where applicable, a comparative assessment carried out in accordance with Article 11g.

⁶ It may extend the period of validity of an existing authorisation until the final decision on renewal has been taken.

⁷ For renewals, the maximum periods of validity specified in Article 8 paragraph 1 apply.

⁸ The Notification Authority may renew an authorisation A_N or A_C if the evaluation of an application is delayed under Article 22 paragraph 2.¹⁴⁰

⁹ Authorisations A_nL based on an evaluation and recommendation of an EU or EFTA Member State cannot be renewed.

¹⁰ The FDHA may, in consultation with DETEC and the EAER, regulate the procedure for the renewal of recognitions; in doing so, it shall take account of delegated acts adopted by the European Commission in accordance with Article 40 of Regulation (EU) No 528/2012.¹⁴¹

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 out in paragraph 1.

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.

¹ A letter of access must contain at least the following information:

a.¹⁴⁵

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.

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 528/2012¹⁴⁷;

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 14 paragraph 4 of Regulation (EU) No 528/2012;

d.

for data submitted with a view to the authorisation of a biocidal product containing only existing active substances: 10 years from the first day of the month following the date of the authorisation by the Notification Authority or by the competent authority in accordance with Regulation (EU) No 528/2012;

e.

for data submitted with a view to the authorisation of a biocidal product containing a new active substance: 15 years from the first day of the month following the date of the authorisation by the Notification Authority or by the competent authority in accordance with Regulation (EU) No 528/2012;

f.

for data submitted with a view to the renewal or amendment of the authorisation of a biocidal product: 5 years from the first day of the month following the date of the authorisation by the Notification Authority or the date of the decision concerning the renewal or amendment of the authorisation by the competent authority in accordance with Regulation (EU) No 528/2012.

² The protection period shall start when data is submitted for the first time.

³ It cannot be renewed.

⁴ By way of derogation from paragraph 1, the data protection periods for existing active substances listed in combination with a product type in Annex II to Regulation (EU) No 1062/2014¹⁴⁸ - including data not involving tests on vertebrates - but for which a decision on inclusion in Annex I to Directive 98/8/EC¹⁴⁹ was not taken before 1 September 2013 shall expire no later than 31 December 2025.¹⁵⁰

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 ChemO¹⁵³ 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.¹⁵⁴

² When making advance enquiries, the applicant must provide evidence that he intends to apply for an authorisation himself.

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 ChemO¹⁵⁶.¹⁵⁷

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 Code¹⁵⁸.

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.¹⁵⁹

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 agreement; and

b.

has paid the owner a share of the costs incurred in producing the data or has undertaken to do so via a signed acknowledgement of indebtedness.

⁶ At the request of the owner, the Notification Authority shall determine the appropriate level of compensation, taking into account the acknowledgment of indebtedness issued by or the payment already made by the applicant.

⁷ In deciding on the level of compensation for data sharing, the Notification Authority shall ensure that due consideration is given to the principles of fairness, transparency and non-discrimination.

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.

³ Depending on the particular case, the applicant shall submit the following data to the Notification Authority:

a.

all the data required for the identification of the biocidal product, including its composition;

b.

the data required to identify the active substance and to establish technical equivalence;

c.

the data required to demonstrate that the biocidal product is comparable to the authorised biocidal product with regard to risks and efficacy.

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 ContainO¹⁶² and the RO¹⁶³ must additionally be met for authorisation under paragraph 1.

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.¹⁶⁴

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.

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.

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 528/2012²²⁸ 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 website²²⁹.²³⁰

Provisions concerning the Notification Authority and the associated steering committee are set out in Article 77 of the ChemO²³².

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.²³³

the FOAG: for agronomic matters;

e.²³⁴

the FSVO: for matters concerning food safety and animal health.

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.²³⁵

it publishes the following lists in an appropriate form:

1.

the list referred to in Article 95 paragraph 1 of Regulation (EU) No 528/2012²³⁶,

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/EC²³⁷ or

-

a letter of access to active substance data as referred to in letter d number 2 first indent,

3.²³⁸

the list of persons for whose benefit it has used data in accordance with Article 29a paragraph 5;

e.²³⁹

it shall make available the electronic formats for the submission of applications for authorisation and for declarations.

² It shall request the cantonal enforcement authorities, where appropriate at the request of the assessment authorities:

a.

to carry out checks in accordance with Article 58;

b.

to take random samples for analyses in accordance with paragraph 1 letter c.

³ Where in this Ordinance provision is made for opinions to be obtained from the assessment authorities, their requests are binding on the Notification Authority.²⁴⁰

Article 79 of the ChemO²⁴² applies with regard to the Toxicological Information Centre.

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.

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.²⁴⁵

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.²⁴⁶

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 2005²⁴⁸.

² No fees are payable for the recognition of a Union authorisation in accordance with Article 14a^bis 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 A_C and A_N, or to authorisations of identical biocidal products which are identical to an authorisation A_C or A_N.

¹ The cantonal enforcement authorities shall inspect biocidal products and treated articles which are placed on the market or used by the manufacturers themselves.²⁴⁹

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.²⁵⁰

³ They shall carry out random sampling at the request of the Notification Authority.

⁴ In addition, they have the powers set out in Article 42 of the ChemA.

⁵ If the biocidal products inspected give grounds for complaint, the inspection authority must inform the Notification Authority and the cantonal authority responsible for issuing an order in accordance with Article 59.

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.

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.²⁵²

checking of applications for completeness in accordance with Article 16 paragraph 2 and evaluation of documents in accordance with Article 17.

Articles 74-76 of the ChemO²⁵⁴ apply mutatis mutandis to the passing-on of data concerning biocidal products.

¹ An application for authorisation A_L or A_nL, or for recognition of a biocidal product, which is pending at the time the Amendment of 20 June 2014 to this Ordinance comes into force shall be evaluated by the Notification Authority in accordance with existing legislation.

² The risk assessment of the active substance in the biocidal product for which an application for authorisation is pending shall, however, be carried out:

a.

in accordance with Articles 11-11f, if the active substance has not been approved by the European Commission or listed in Annex 2;

b.

in accordance with Article 11g, if the active substance is a candidate for substitution on the basis of a decision adopted by the European Commission.

³ Where the risk assessment of the active substance under the new legislation identifies concerns arising from the provisions newly applicable with the entry into force of the Amendment of 20 June 2014 to this Ordinance, the applicant shall be given the opportunity to submit additional information to the Notification Authority.

¹ By way of derogation from Article 31 paragraph 1, a treated article may, after the commencement of the Amendment of 20 June 2014 to this Ordinance, be placed on the market for the first time until the date specified in paragraph 2 if it meets one of the following conditions:²⁵⁹

a.

It was treated with or intentionally incorporates one or more biocidal products containing only active substances that are included in the list of notified active substances.

b.

For the active substances it contains, an application for approval for the relevant product type is submitted to the European Commission by 1 September 2016.

c.

It contains only a combination of active substances included in the list of notified active substances and active substances included in the list drawn up in Annex 2 for the relevant product type and use or included in Annex 1.

² The treated articles specified in paragraph 1 may be placed on the market for the first time until one of the following dates:²⁶⁰

a.

the date on which approval is granted by the European Commission for the relevant product type and use of the last active substance which is to be authorised and is contained in the biocidal product;

b.

the date falling 180 days after a decision by the European Commission not to approve one of the active substances for the relevant use.

³ …²⁶¹

The following biocidal products, notwithstanding that they do not have a UFI on 1 January 2022, may be placed on the market at the latest until 31 December 2025 without indicating the UFI in accordance with Article 14a:

a.

biocidal products intended for professional users;

b.

biocidal products intended for private users and placed on the market before 1 January 2022.

Biocidal products that are labelled in accordance with the previous law pursuant to Article 10 paragraph 3 letter b ChemO²⁶⁶ may be supplied to third parties until 31 December 2025.

This Ordinance comes into force on 1 August 2005.