Appendix 1 fees for biocidal active substances and products A. Fees for evaluation of applications* * All articles refer to (EU) No 528/2012 Before the Norwegian Environment Agency begins its work with applications or notifications, fees shall be paid. Fees are claimed by the Norwegian Environment Agency by sending out invoices containing the corresponding fee. Active substances fees Basis of the fee Approval of an active substance for a single product type Basis of the fee according to article 8 Chemical active substances Fee in NOK Microorganisms as active substances Fee in NOK 2,260,000 1,130,000 Approval per additional product type 1,130,000 565,000 Evaluation of an active substance for Annex I (simplified procedure) Renewal of approval of an active substance for a single product type Renewal of approval per additional product type Evaluation according to article 28 according to article 14 1,130,000 565,000 2,260,000 1,130,000 Limited evaluation 1,130,000 565,000 according to article 14 1,130,000 565,000 Limited evaluation 565,000 282,000
Biocidal products fees Type of approval Basis of the fee Fee in NOK Comments in the first State of the EU/EEA Union authorization of biocidal products evaluation of a product on behalf of EU's chemical agency ECHA 4) Mutual recognition in Norway of products authorised for the first time in another EU/EEA State according to the simplified procedure Application for product authorisation for a single product 1) Application for product authorisation for a single product when product and use are identical to the reference product assessed for the active substance approval 2) 452,000 90,400 Biocidal product family 904,000 Supplemental fee in case an application for product authorisation contains a complete new data package for an active substance Union authorization of biocidal products which is valid in all EU/EEA States according to article 44 Mutual recognition of a single product Mutual recognition of a product family according to the simplified procedure (Annex I active substances) Making available on the Norwegian market of a biocidal product authorised according to the simplified procedure 1,130,000 904,000 56,500 113,000 article 20 Reduced fee in case product already was evaluated during active substance evaluation. articles 3 (1) point (s) and article 19 (6) Relevant for applications for product authorisation when the data package for the active substance is submitted by a new actor on the market and the data have not been evaluated at active substance evaluation. article 43 According to articles 33 and 34 According to articles 33 and 34 Single product according to 45,200 article 25 Reduced fee if the single product and its use are 13,600 identical to the reference product assessed during active substance evaluation 67,800 Biocidal product family 9,000 18,100 Single product notification in accordance with article 27 (1) Biocidal product family notification in accordance with article 27 (1)
Type of approval Basis of the fee Fee in NOK Comments Changes to product authorisation Renewal of product authorisation Addition of a biocidal product to a biocidal product family 3) Changes to product authorisation as laid down by Regulation (EU) No 354/2013 2) Renewal of product authorisation in accordance with article 31 2) 13,600 Notification in accordance with article 17 (6) 181,000 Major changes as rms 22,625 Major changes by mutual recognition 27,100 Minor changes as rms 9,000 Minor changes by mutual recognition 4,500 Administrative changes in 339,000 accordance with article 31 (5) as rms in 42,375 accordance with article 31 (5) by mutual recognition 113,000 Limited evaluation in accordance with article 31 (5) as rms 14,125 Limited evaluation in accordance with article 31 (5) by mutual recognition 1) ECHA recommends the fee for first product authorisation of a single product to be 20 % of the relative amount to be paid for the first approval of an active substance. Other relative amounts in this table are relative to the fee for a first single product authorization. 2) Concerning procedures relating to product families, twofold fees will be charged. 3) For mutual recognition procedures the fee to be collected represents 1/8 th of that fee 4) Twofold fees will be charged compared to a first application for product authorisation for a single product due to extended workload and coordination toward ECHA.
Biocidal products top-up fees Basis of the fee Fee in NOK Comments Additional active substance in a biocidal product 1),2) Substance of concern in a biocidal product 1),2) Additional fee per additional active substance contained in a biocidal product. Substances of concern as defined in article 3 (1) point (f), depending on the basis of the additional amount of work required. Per additional product type for a given biocidal product 1),2) Per additional user category if more than one user category 1),2) Comparative assessment 1),2) 90,400 MRLs (evaluation of maximum residue levels in 45,200 food, feedstuff and drinking water) 2) Relevant for products which shall be authorised in several of the 22 product types as defined in Annex V Relevant for products which require separate exposure assessments for different user categories (e.g. private vs. professional use) Per active substance for which a comparative assessment is required in accordance with Article 23 Applicable if a specific assessment is required with a view to make a recommendation regarding the establishments of MRLs (to EFSA for instance). Applications to be dealt with in accordance with Articles 19 (1) point (e) and 19 (7) 1) Concerning procedures relating to product families, twofold fees will be charged. 2) For mutual recognition procedures, the fee to be collected represents 1/8th of that fee. Other fees Basis of the fee Fee in NOK Comments Parallel trade permit 18,100 Applications in accordance with Article 53 Authorisation of the same product 1),2) 13,600 Applications in accordance with Article 17 (2). See separate Regulation (EU) No 414/2013 Research and development 4,500 Notifications made in accordance with Article 56 (2) Confidentiality claim 1,100 Per claim made for other information than the one covered under Article 67 (2) Special applications exceptions from product authorisations over a period of 180 days ("essential use") Interim authorisations of a biocidal product 1),2) 4,500 In accordance with procedures as laid down in Article 55 (1) 45,200 Applications for authorisation of new products containing a new active substance in accordance with Article 55 (2) 1) Concerning procedures relating to product families, twofold fees will be charged. 2) For mutual recognition procedures the fee to be collected represents 1/8th of that fee
B. Annual fees The annual fee consists of a fixed annual amount and a variable annual fee. The annual fee relates to authorised biocidal products on the Norwegian market. The basis of the calculation for the variable annual fee is the reported sales volume of the biocidal product of the single authorisation holder from the last year in the Product Register as well as the classification and labelling of the biocidal product. The annual fee in accordance with the Norwegian biocides regulation is claimed on an annual basis by the Norwegian Environment Agency. Classification and labeling of biocidal products is done in accordance with Article 69 of the Norwegian biocides regulation. For a product falling into several hazard classes and which are labeled with several symbols, the most severe hazard symbol is taken as basis for the calculation of the variable annual fee. Fixed annual fee Biocidal Products Fixed annual fee per authorised product (NOK) Fixed annual fee per authorised product family (NOK) 1,500 3,000 Addition variable annual fee for biocidal products (NOK) 1) Annual sales of the biocidal product Classification/labelling 0-100 kg 100-1,000 kg 1,000-10,000 kg > 10,000 kg No classification / labelling 150 400 1,150 2,250 Hazard category 2) 400 950 2,800 5,550 Hazard category 3) 1,100 2,800 8,350 16,700 1) Regarding product family, the addition of the annual fee will be calculated on the basis of the total sales volume of the biocidal products within the product family. 2) Products with one or more of the following classifications: Acute Tox. 4, Skin Corr. 1A/1B/1C, Skin Irrit. 2, Eye Dam. 1, Eye Irrit. 2, Resp. Sens. 1, Resp Sens. 1A, Resp. Sens. 1B, Skin Sens. 1, Skin Sens. 1A, Skin Sens. 1B, Muta. 2, Carc. 2, Repr. 2, STOT SE 2, STOT SE 3, STOT RE 2, Asp. Tox. 1, Aquatic Acute 1, Aquatic Chronic 1, Aquatic Chronic 2, Aquatic Chronic 3, Aquatic Chronic 4, Ozone 3) Products with one or more of the following classifications: Carc. 1A, Carc. 1B, Muta. 1A, Muta. 1B, Repr. 1A, Repr. 1B, Acute Tox. 1, Acute Tox. 2, Acute Tox. 3, STOT RE 1 eller STOT SE 1.