I- Regulatory reminders: different approaches to budget for biocides
Authorisation of marketing :
To market your biocidal products, you have to submit an authorisation dossier. There are three types of authorisation of marketing. This can be national, in other words, specific to a single Member State (with the possibility of mutual recognition if you market your product in other countries of the European Union), or may arise from the Union European: we then speak of a EU authorisation.
A- National authorisation
Regarding national authorisation, the applicant shall submit an application to the competent authority of the country. The National Authority has 1 year to validate or reject the request
B- Mutual recognition
After the authorisation, the applicant may then apply for mutual recognition if he wishes to market the product in other EU countries.
C- European Union approval
The authorisation of the Union allows placing biocidal products on the entire European market after a year without obtaining a specific national authorisation. However this authorisation only applies to new active substances. The existing active substances may be permitted only during the regulatory deadlines. The next is 1 January 2017 and concerns the TP 2, 6 and 13. Duration of authorisation : The authorisation is valid for five years, renewal is valid for life. The applicant shall submit an application to the competent authority of the country where it wishes to sell its product. The duration of the authorisation varies depending on the biocidal product. For more information please refer to the table "duration of authorisation" at the bottom of this page.
II- Budgeting: rates in individual cases for the French State
The French government by ministerial decree of 13 June 2014 fixed the amount of compensation due for approval and authorisation of the marketing of biocidal substances and products.
1- EVALUATION OF A DOSSIER REQUESTING APPROVAL OF AN ACTIVE BIOCIDAL SUBSTANCE
In accordance with Article 9 of Regulation (EU) No 528/2012 you must pay the following amounts:
- 200,000 Euros for a type of biocidal product
- 100,000 Euros per additional type of biocidal product
- 120,000 Euros if the active substance is a microorganism (for a biocidal PT)
- 60,000 Euros if the active substance is a microorganism (for an additional biocide PT)
2- EVALUATION OF A DOSSIER APPLICATION FOR RENEWAL OF APPROVAL OF AN ACTIVE SUBSTANCE BIOCIDE
In accordance with Article 14 of Regulation (EU) No 528/2012 you must pay the following amounts:
- 50,000 Euros per additional type of biocidal product
- 60,000 Euros if the active substance is a microorganism (for a biocidal TP)
- 30,000 Euros if the active substance is a microorganism (for an additional biocide TP)
3- EVALUATION OF DOSSIER MARKETING AUTHORISATION
Implementation of 2 of Article 55 of Regulation (EU) No 528/2012:
- If the reference product for the new active substance dossier for which France is the evaluating competent authority you do not have to pay: € 0
- If the reference product folder of the new active substance for which France is not the evaluating competent authority: €40,000
4- EVALUATION OF AN APPLICATION REQUESTING FIRST AUTHORISATION FOR NATIONAL OR UNION MARKETING OF A BIOCIDAL PRODUCT
Implementation of Article 30 or Article 43 of Regulation (EU) No 528/2012:
- 40,000 Euros for a type of biocidal product and user category
- 8000 Euros for a type of biocidal product, by additional user category
- 20,000 Euros for a category of user, by type of additional biocidal product
- 12,000 Euros for a biocidal product strictly identical to the reference product that allowed the approval of the active substance
- 5000 Euros for a product whose marketing has been provisionally authorised (Article 55 § 2 of the Regulation)
5- EVALUATION OF DOSSIER APPLICATION FOR RENEWAL OF FIRST MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT ON THE NATIONAL OR EU MARKET
Implementation of Article 31 or Article 45 of Regulation (EU) No 528/2012:
- 10,000 Euros for a partial evaluation (Article 31)
- 40,000 Euros for a comprehensive assessment
6- EVALUATION OF APPLICATION PACKAGE OF FIRST MARKETING AUTHORIZATION OF A BIOCIDAL PRODUCT
Implementation of Article 25 of Regulation (EU) No 528/2012:
- 12,000 Euros for a type of biocidal product and user category
- 2400 Euros for a type of biocidal product, by additional user category
- 6000 Euros for a category of user, type of additional biocidal product
7- EVALUATION OF RENEWAL OF RECORD FIRST MARKETING AUTHORIZATION OF A BIOCIDAL PRODUCT
Implementation of Article 25 of Regulation (EU) No 528/2012:
- 3,000 Euros for a type of biocidal product and user category
- 800 Euros for a type of biocidal product, by additional user category
- 1500 Euros for a category of user, type of additional biocidal product
8- EVALUATION OF AN APPLICATION REQUESTING A MAJOR CHANGE OF A FIRST MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT
Implementation of Article 25 of Regulation (EU) No 528/2012:
- 6000 Euros for a type of additional product
- 2400 Euros for an additional category of user
9- EVALUATION OF MUTUAL RECOGNITION APPLICATION OF AN AUTHORISATION ISSUED BY ANOTHER MEMBER STATE
Implementation of Articles 33 or 34 of Regulation (EU) No 528/2012:
- 15,000 Euros for a type of biocidal product and user category
- 8000 Euros for a type of biocidal product, by additional user category
- 7500 Euros for a category of user, type of additional biocidal product
10- EVALUATION OF A RENEWAL APPLICATION OF MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT BY MUTUAL RECOGNITION
Implementation of Article 31 of Regulation (EU) No 528/2012:
- 15,000 Euros
11- EVALUATION OF A MINOR AMENDMENT APPLICATION OF MARKETING AUTHORISATION OF BIOCIDAL PRODUCT ON A NATIONAL OR EU MARKET
Implementation of Article 7 of the Implementing Regulation (EU) No 354/2013:
- 2000 Euros
12- EVALUATION OF MUTUAL RECOGNITION APPLICATION OF MINOR CHANGES OF MARKETING AUTHORISATION ON A NATIONAL MARKET
Implementation of Article 9a of Implementing Regulation (EU) No 354/2013:
- 800 Euros
13-EVALUATION OF AN APPLICATION REQUESTING A MAJOR CHANGE OF MARKETING AUTHORISATION OF A BIOCIDAL PRODUCT ON THE NATIONAL OR EU MARKET
Implementation of Article 8 or Article 13 of the Implementing Regulation (EU) No 354/2013:
- 20,000 Euros for a request to add a type of biocidal product
- 8000 Euros for other major change requests
14- EVALUATION OF MUTUAL RECOGNITION APPLICATION OF MAJOR CHANGE OF THE AUTHORISATION ON A NATIONAL MARKET
Implementation of Article 9a of Implementing Regulation (EU) No 354/2013:
- 8,000 Euros for a request to add a biocidal product type
- 3,000 Euros for other requests
15- EVALUATION OR NOTIFICATION OF A CHANGE OF ADMINISTRATIVE APPLICATION OF MARKETING AUTHORISATION ON THE NATIONAL MARKET
In accordance with Article 6 of Implementing Regulation (EU) No. 354-2013:
- 800 Euros
16- EVALUATION OF A MARKETING AUTHORISATION FILE OF THE SAME BIOCIDAL PRODUCT ON THE NATIONAL OR EU MARKET
In accordance with Article 5 or Article 6 of Implementing Regulation (EU) No 414/2013:
17- EVALUATION OF A REQUEST FILE TO REMOVE NATIONAL AUTHORISATION MARKETING OR WITHDRAWAL OF CLASS USER OF A BIOCIDAL PRODUCT TYPE OR OF A USE:
- 0 Euros
18- COMPENSATION OF AN EVALUATION FOR AN APPROVAL FOR MARKETING AUTHORISATION OF A PRODUCT FAMILY IS UP TO 200% OF THE AMOUNT OF THE COMPENSATION FOR THE SAME APPROVAL FOR A BIOCIDAL PRODUCT WITH THE EXCEPTION OF THE EVALUATION OF AN ADMINISTRATIVE AMENDMENT FILE APPLICATION
Implementation of Article 6 of Implementing Regulation (EU) No 354-2013
- 800 Euros
19- NOTIFICATION OF A PRODUCT BELONGING TO A PRODUCT FAMILY
Implementation of Article 17 of Regulation (EU) No 528/2012:
- 800 Euros
20- NOTIFICATION OF RESEARCH AND DEVELOPMENT ACTIVITY
Implementation of 2 of Article 56 of Regulation (EU) No 528/2012
- 800 Euros
21- EVALUATION OF AN APPLICATION DOSSIER FOR MARKETING AUTHORISATION OF AN ACTIVITY RESEARCH AND DEVELOPMENT
Mise en application du 3 de l'article 56 du Règlement (UE) n° 528/2012
- 3000 euros
22- EVALUATION OF A FILE APPLICATION FOR AUTHORISATION OF PARALLEL TRADE
Implementation of Article 53 of Regulation (EU) No 528/2012:
- 1000 Euros by product and country of origin
23- IN THE EVENT OF A COMPARATIVE EVALUATION
Accordance with Article 23 of Regulation (EU) No 528/2012 is required
- 20,000 euros
Table : A substance is approved for the following periods:
Duration of approval Renewal Period Active Subtance Max 10 years Max 15 years Active substance fulfilling the criteria for exclusion (Article 5) Max 5 ans NA Active substance that candidates for substitution Max 7 years Max 7 years
Table : Period of authorisation
Biocidal Product Max 10 years BP containing AS which are candidates for substitution Max 5 years BP containing a new AS* Max 3 years
*Under the conditions defined in Article 55 paragraph 2
Need help?
Any questions on your biocidal project? Want to get a detailed quote? Please contact us at contact@ecomundo.eu
