The product shall be labelled correctly
The labelling requirements for authorised desinfection products are set out in § 5 of Danish Order No. 8 of 3. January 2023 on authorisation of disinfectants etc. in food establishments etc.
Note that the journal no. provided in the authorisation granted by the Danish Veterinary and Food Administration shall be included in the label.
The authorisation is only valid for the specific product
The authorisation granted by the Danish Veterinary and Food Administration is connected to the information provided in the application regarding product specifications, area of use and trade name.
The authorisation is only valid for the specific product and trade name given in the application. The trade name specified in the application shall thus be used when placing the product on the market.
A new application is required in case of changes to the product
A new application shall be submitted to the Danish Veterinary and Food AdministrationIf in case the authorisation holder wishes to change the product composition, area of use, product name etc. for an authorised product . An application for parallel authorisation can be used if the only change requested is related to the trade name or addition of trade names to the authorisation. Parallel authorisations can only be granted for products for which the original authorisation is less than five years old.
It is possible to place a product on the market in different sizes as long as the size variants are identical with respect to composition, use, concentration of the active substance etc.
The active substance supplier shall be included in the Article 95-list
The supplier of the active substance in your product shall be registered on the EU list of approved suppliers of active substances, the so-called Article 95-list.
As of 1. September 2015 disinfectants and teat disinfectants may thus only be placed on the market if the supplier of the active substance is included on ECHA's list of active substance suppliers. This is a general requirement for all biocidal products which contain or generate biocide active substances. Furthermore the products may only be placed on the market if the active substance supplier or the product supplier is included in the Article 95-list under the relevant product type.
Lablling of products authorised under the EU Biocidal Products Regulation
Once an active substance has been approved under the scope of the Biocidal Products Regulation, the responsibility for authorisation of products under PT3 and PT4 is transferred to the Danish Environmental Protection Agency. The Danish Environmental Protection Agency is the competent authority responsible for the Biocidal Products Regulation.
When a product under product type PT3 or PT4 has been authorised in accorcance with the Biodical Products Regulation the products will be included in ECHA's list of authorised products. The products will be labelled with a BPR registration no. xxx-xx, possibly supplemented with an authorisation number generated by ECHA in the form EU-xxxxxxx-yyyy or DK-xxxxxxx-yyyy in accordance with article 69 of the Biocidal Products Regulation. This replaces the current labelling requirements set out by the Danish Veterinary and Food Administration.