Application for the authorisation of a biocidal product family AN/AC

The concept of the biocidal product family represents a further development of the concept of frame formulations. Under certain conditions, an authorisation as a biocidal product family is more flexible and enables a plurality of products to be brought to the market by means of a single authorisation.

A biocidal product family is a group of biocidal products that have the following common characteristics:

  • similar uses,
  • same active substances,
  • similar composition with specified deviations,
  • similar risk potential,
  • similar efficacy.

The risk assessment for humans, animals and the environment as well as the efficacy is based on the same requirements as for a single biocidal product AN. For more detailed information please consult the internet page of the Notification Authority for Chemicals (Authorisation AN).

A biocidal product family contains defined concentration ranges of the specified ingredients. These concentration ranges, with the exception of the concentration range for the active substance, can also be defined by the concentration range zero.

Biocidal product families can also consist of a plurality of sub-families. In this case the concentration ranges of the variable ingredients have also to be defined for the sub-families. All biocidal products of a sub-family have to have the same classification and labelling, but they can differ in the type of product, use, methods of use, use categories, preparation and/or packaging.

Swiss authorities have elaborated two examples to illustrate the concept of the biocidal product family (examples (PDF, 52 kB, 22.05.2017)).

Important: If you intend to submit an application for an authorisation of a biocidal product family with sub-families, it is recommended to consult the guidance (PDF, 187 kB, 19.10.2016) document of the European competent authorities (CA meeting) for the union authorisation, the authorisation (AL) and recognition and to contact the Notification Authority for Chemicals beforehand.

Additional members of a biocidal product family can be notified to the Notification Authority for Chemicals at a later date (see below "2. Notification of biocidal products that are brought to the market at a later date").

Application

For applications for authorisation AN as a biocidal product family, the form "Application for authorisation AN as a biocidal family (DOC, 221 kB, 22.05.2017)" provided by the Notification Authority for Chemicals must be used. If the biocidal product family consists of a plurality of sub-families, then one form must be filled out for each sub-family. For biocidal product families without sub-families only one form needs to be filled out.

For all applications for the authorisation AN of a biocidal product family, the applicant has to fill out the form “information family (XLS, 17 kB, 05.09.2017)” as illustrated in the examples (PDF, 52 kB, 22.05.2017). If necessary additional rows for the composition or columns for additional members of the family may be added.

The applicant has to justify (example of a justification (PDF, 67 kB, 22.05.2017)) why the biocidal products, belonging to a biocidal family and subfamily (the later is necessary if the family consists of sub-families), comply with the aforementioned characteristics (according to art. 2, para 2, let. b OBP).

The applicant has also to provide a completed document “Excel-Template art 62d” in which he has to indicate the active substance supplier for each biocidal product (see provision of evidence under art 62d OBP). 

An electronic form has also to be filled out in the product register for each biocidal product (member) of the family (as for a single biocidal product).

Exception: If the members of a family or sub-family differ by nothing else (i.e. also not by use, methods of use etc.) than by the concentration of pigments, colorants or fragrances, then an electronic form does not need to be filled out in the product register. In this case only one form for the family and for each sub-family respectively needs to be filled out. Please take note that in this case the active substance concentration, solvent concentration and total content of pigments, colorants or fragrances within the family or sub-families have to be the same (constant) for all biocidal products (members).

On the “Documents” tab in the RPC the following documents should be uploaded:

Please note: documents with confidential content should have an access level “author & federal authorities”. The access level can only be assigned after the document has been uploaded.

Per sub-family/ (family without sub-family):

Per family:

After transmission of the completed electronic form via the Chemicals Register, an email with the following information has to be sent to the Notification Authority for Chemicals (cheminfo@bag.admin.ch):

  • Trade name and the CPID number of all biocides of the family
  • Specifying, that the application concerns a first application of a biocidal product family AN
  • Specifying under which product (CPID no.) the documents “Application for authorisation AN as a biocidal family”, justification and “information family” have been uploaded.

Notification of biocidal products brought to the market at a later date

New members, whose composition lies within the defined deviations of an already authorised biocidal product family, can be notified to the Notification Authority for Chemicals at a later date and brought to the market 30 days after the notification (Art. 13d para. 1 OBP).

For a biocidal product family for the authorisation AN, the notification of a new biocidal product must be made through the product register (as for a single biocidal product). After transmission of the completed electronic form via the Chemicals Register, an email with the following information has to be sent to the Notification Authority for Chemicals (cheminfo@bag.admin.ch):

  • Name of the biocidal product and CPID number,
  • Statement that it concerns a notification of a member of a biocidal product family
  • Authorisation number of the biocidal product family,
  • Authorisation number of the biocidal product1.

Specific case for pigments, colorants and fragrances (authorisation AN)

Biocidal products of a biocidal product family whose members within the family or sub-family do not differ (i.e. also not in the use, method of use etc.) other than by the concentration of pigments, colorants or fragrances and which lie within the concentration deviation defined in the authorisation, can be brought to the market without prior notification to the Notification Authority for Chemicals. Please take note that the active substance concentration and solvent concentration within the family or sub-families have to be the same for all biocidal products (members). If a new member of a family or sub-family is marketed under another trade name (Art. 13d para. 3 let. b OBP) then the biocidal product must be notified. If the colour of the product is appended to the name of the biocidal product, such as e.g. "Biocide Red", "Biocide Blue", "Biocide Yellow" etc. then these product names are considered as the same by the Notification Authority. It should also be noted that the total fraction of pigments, colorants or fragrances must remain constant in all biocidal products within a family or sub-family, in order that they can be brought to the market without notification. The biocidal product brought to the market without notification receives the same authorisation number as the biocidal product of the family or sub-family to which it belongs.

Processing time

The time for processing the application depends on the type of authorisation of the biocidal product family (Art. 19 para. 1 Ordinance on Biocidal Products OBP).For an application for an authorisation AN as a biocidal product family this is 60 days.

Fees

On 1.03.2018, when the revised Biocidal Products Ordinance came into force, a new system came into operation in which fees for biocidal product families are charged according to the actual cost.

The fee for biocidal product families is made up of the basic fee for the relevant authorisation (e.g. Authorisation AN, CHF 1000). In the case of biocidal product families with one sub-family, the basic fee is increased by 50%. An increase of a further 25% is made for each additional sub-family. 10 biocidal products may be included in each sub-family. For each additional biocidal product in a sub-family, the fee increases by one per cent. No additional charge is made for biocidal products in a biocidal product family or sub-family that do not differ (i.e. whether in their use, method of use etc.) other than by their concentration of pigments, colorants or fragrances.

Remark

The processes and procedures for the authorisation of biocidal products can be modified at short notice. Consequently, we advise interested parties to regularly consult the website of the Notification Authority Chemicals and to subscribe to the Consumer Protection newsletter from the FOPH.

 

1] Authorisation holders must allocate the authorisation end number of the notified biocidal product themselves, i.e. the authorisation number of the biocidal product family and sub-family are retained. The authorisation end number is allocated sequentially. Example: product family authorisation number, CHZN1000; authorisation number of sub-family 1 or biocidal product family with no sub-family, CHZN1000.01; authorisation number if two biocidal products in sub-family 1 have already been approved, CHZN1000.01.01 and CHZN1000.01.02. If the authorisation holder intends to bring a third biocidal product onto the market through a notification, the product will have the authorisation number CHZN1000.01.03. The last two digits ‘03' is the authorisation end number, which has to be defined by the authorisation holder.

Last modification 24.04.2018

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