Which procedure should I follow?
There are various rules of procedure, dossier requirements and assessment frameworks. These depend on the characteristics of the product, the application or the type of authorisation being requested (see Types of applications). Furthermore, two competent authorities make decisions on applications: the European Chemicals Agency (ECHA) and the Ctgb.
Procedure Biocidal Products Regulation
The procedures for each type of application are described in brief below. For more information, please refer to the Biocidal Products Regulation. The role of the Board is also described in brief. Our tool 'How to apply?' leads you through a series of questions to the relevant application type.
Procedure for simplified authorisation
Relative to Directive 98/8/EC, this is a new procedure. A number of conditions apply to a simplified authorisation. The most important is that for the active substance in the biocidal product to be eligible for a simplified authorisation, it must be included in Annex I. This Annex contains a list of active substances that are not substances of concern, and therefore have a low risk. Applications for Union authorisation of a biocidal product are submitted to ECHA; the product is assessed and authorised by one Member State that is chosen by the applicant. The simplified authorisation process, including assessment and decision-making, takes 90 days. When one of the Member States has granted a simplified authorisation, the biocidal product can be placed on the market without mutual recognition. Within 30 days, the authorisation holder is required to notify the Member State concerned that the biocidal product with a simplified authorisation is being placed on the market.
See Chapter V of the Biocidal Products Regulation.
Procedure for national authorisations
This procedure is comparable with that under Directive 98/8/EC. The Ctgb is the competent authority for national authorisations in the Netherlands. In principle, the national authorisation procedure takes 365 days.
See Chapter VI of the Biocidal Products Regulation.
Procedure for mutual recognition
There are two types of mutual recognition procedures:
a. sequential mutual recognition;
b. parallel mutual recognition. These are new procedures.
An application for sequential mutual recognition (a) can be made if the biocidal product has already been authorised in the reference Member State (RMS).
An application for parallel mutual recognition is submitted simultaneously with the application for the primary assessment in the RMS. In principle, the mutual recognition is authorised under the same conditions as the first authorisation by the RMS. Article 37 of the Biocidal Products Regulation lists the grounds for rejection and the grounds for modifying the conditions of authorisation in a mutual recognition procedure.
See Chapter VII of the Biocidal Products Regulation.
Procedure for Union authorisation
Relative to Directive 98/8/EC, this is a new procedure. Applications for a Union authorisation are submitted to the ECHA. The assessment is conducted by one of the Member States. The authorisation decision is made by the ECHA. These authorisations are valid in the entire Union, unless expressly stated otherwise. Only biocidal products that have comparable conditions for use can be eligible for this type of authorisation. See Chapter VIII of the Biocidal Products Regulation.
When it withdraws, amends or decides not to extend an authorisation, the Ctgb – or the Commission in the case of a Union authorisation – provides a grace period for the disposal, sale and use of existing stocks, except where continued availability on the market or use of the biocidal product implies an unacceptable risk to human health, animal health or the environment. The duration of the grace period must not be more than 180 days for offering the product on the market, and at least 180 days extra for removal and use of existing stocks of the biocidal products in question.
See Article 52 of the Biocidal Products Regulation .
Approval of active substances
Under the Biocidal Products Regulation, active substances are assessed and approved or rejected. Directive 98/8/EC referred to the inclusion of active substances in Annex I or IA. In principle, that is a comparable procedure. Ctgb is therefore ancillary to the ECHA.
Procedure for transitional legislation
Articles 44-50 of the Act contain provisions about the application procedure, (Article 44) the dossier requirements (Articles 45-47) and the conditions of authorisation (Article 49). These general provisions are based on the provisions in Article 121 of the Act for the authorisation and the extension of the authorisation period of a biocidal product containing active substances that are still being evaluated in the review programme.
General aspects of the application procedure
For biocidal products with active substances that are still being evaluated in the review programme, the following provision applies: Additional regulations about submitting an application, whether or not to take the application into consideration, the further processing and the timelines are described in Article 7 of the Decree (Besluit gb) and in Chapter 4 of the Administrative regulations. The fees and charges are specified in the Ctgb Tariffs Decree.
Applications for authorisation of a new biocidal product and applications for major amendments to existing authorisations can be submitted to the Ctgb up to one year before the date of European approval of the last PT-substance combination for the corresponding biocidal product.
Regarding the dossier requirements, Article 45 Wgb and Article 3 of the associated Decree refer to the provisions in Annex IIA or IVA and the relevant provisions in Annex IIIA of Directive 98/8 (substance data), and to the provisions in Annex IIB or IVB and the relevant provisions in Annex IIIB (substance dossier). The decree establishes additional regulations concerning the dossier to be submitted and the research methods to be used (Articles 3, 4 and 5 of the Decree). The dossier requirements have been used to create the application forms with their corresponding instructions. See also the Letter of Access and the information in the Regulation about repeating animal tests unnecessarily.
Decree on administrative regulations, dossier requirements and application forms Ctgb 2008
This Decree is based on the provisions in the Act (Wgb), which gave the Ctgb the mandate to enact administrative regulations concerning the operation of the Board, and the division of tasks between the members of the Board (Article 8, clause 1, under a) and – specifically in this context – other matters that concern the implementation of the Act and additional measures based on the Act (Article 8, clause 1, under b).
The Decree on administrative regulations, dossier requirements and application forms Ctgb 2008 goes into force two days after publication in the Staatscourant. As this Decree does not yet cover all application forms, it will be expanded in the coming months with the missing applications.
Article 49 of the Wgb and Article 12 of the associated Decree refer to the conditions which the intended use of a biocidal product must satisfy. The efficacy of the product must be adequate, and it must not cause any unacceptable harm to the health of humans, animals and the environment.
Common Principles and Assessment Methods
The assessment takes place after applying the Common Principles in Annex VI of Directive 98/8/EEC, while making use of the assessment methods referred to in this Annex. However, based on the provisions in Article 121 Wgb and Article 10.1 Rgb, the Board is not obligated to comply with the above. The Ctgb is obligated to apply the General Principles according to the Directive only for applications that are assessed based on the provisions in Article 91 of the Regulation, and is required to use only the assessment methods in the European guidance documents that are designated by the Minister (Article 12 of the Decree). The list of designated guidance documents (TNGs) is published on the Ctgb website.
The Minister may adopt different assessment methods. The Regulation (gb) prescribes various other assessment methods (Article 3.5 – 3.8 Regulation gb). These concern the risk assessment for the operator and the assessment of biocidal products that contain microorganisms.
Chapters 1 through 3 'Physicochemical Properties and Analysis Methods' in the Evaluation Manual, and Chapter 5 'Environmental behaviour and environmental fate' in Article 3.15 of the Regulation gb have been declared applicable.
If an assessment method is not available, the Board will make an assessment based on scientific insight.