To obtain authorisation for a product that is subject to the requirements of different directives (e.g. both the Biocidal Products Directive and the Cosmetics Directive), do I need to submit more than one application?
Yes, you need to submit two applications: one for biocidal products and one for cosmetics. However, the dossiers need to be sent to different authorities, depending on product usage. For biocidal products, please contact ANSES.
What different types of authorisation application are accepted in France?
The different types of application are listed in the “Procedures” section. This section explains applications for first authorisations, mutual recognition, among others.
Form R4BP is used for notification of first authorisation applications and intentions regarding mutual recognition. Do I also need to submit any intentions for other types of application at the same time?
When submitting your intentions via R4BP form, if you know of other types of application you wish to submit they must be done at the same time.
I want to change the classification of my product due to the implementation of new classification regulations. Do I need to submit a new application?
My product contains several active substances that belong to the same product types. What is the procedure for submitting my application?
An authorisation application must be submitted before the deadline indicated on the Inclusion Directive for the last active substance. For example, your product contains substance X and substance Y, which both belong to PT12. If the Inclusion Directive for substance X states a deadline of 01 May 2011 and the Directive for substance Y a deadline of 01 November 2011, then your application must be submitted no later than 31 October 2011.
If I have a product that contains several substances that do not all belong to the same product types, what is the procedure for submitting my application?
You must not wait for all of the active substances to be included in Annex I or IA of Directive 98/8/EC. As soon as one as the substances is included, you must submit a authorisation application. An initial evaluation of the dossier will be carried out. When another active substance is included, you will have to submit another application and this step will have to be repeated for each active substance.
For example, your product contains substance X belonging to PT8 and substance Y belonging to PT18. The Inclusion Directive for substance X states a deadline of 01 April 2010 and the Directive for substance Y a deadline of 01 June 2011. You will thus have to submit your dossier for the first time no later than 31 March 2010. It will be assessed by our services. You will then submit your dossier for the second time no later than 31 May 2011. Another evaluation will be carried out and you will then be granted a authorisation, if applicable.
I want to apply for authorisation for a biocidal product that contains 10% of active substance, but has been authorised for use at 4%. Can I submit an application and, if so, what additional information is required?
According to discussions with the European Commission, an authorisation cannot be issued for a product at 10% as long as the Inclusion Directive for the active substance remains unchanged. The procedure to follow to amend this inclusion has yet to be clarified. Two options are being considered:
- either submitting a special application requesting an amendment to the Inclusion Directive,
- or submitting an authorisation application for the product at 10%, clearly showing that the risks are controlled, the product is effective and the dose is justified, and also indicating that you would like an amendment made to the Inclusion Directive.
Can I submit an application for mutual recognition for a product approved in another country with a bittering agent concentration of 10 ppm when France requires 50 ppm, or is additional information required?
The bittering agent concentration currently in force in France was set in accordance with the existing system’s regulations, and will remain valid during the transitional period for the implementation of the Biocidal Products Directive. French practices and requirements in this matter may therefore change in the future with authorisation applications for biocidal products. In any case, regardless of the bittering agent content, you are required to justify and provide arguments for the dose and its adequacy (e.g.: exposure of workers during formulation, efficacy of repulsion/aversion if ingested by a child or a non-target organism, etc.). All of these elements will enable our experts to issue an opinion on which the French Ministry of Ecology will base its decision regarding an authorisation application or an assessment of mutual recognition.
Can I submit a first authorisation application for a new formulation created from a product that is currently on the French market and that I would like to stop marketing?