The marketing authorisation of a biocidal product is issued only if the active substances forming the product have all been approved for the PT of interest. Therefore, if the active ingredient has been approved for a PT relative to a different use of the biocide preparation, it is not possible to request authorisation of that biocidal product.
All biocides must be authorised before being placed on the market. There are several processes for authorisation according to the characteristics of the product and the number of countries in which one wishes to market.
You can request this procedure in the event that you wish to sell the product in a single country. The applicant must submit the request through the R4BP. The competent authority of the Member State assesses the application and expresses its evaluation on the authorisation within 365 days.
Once authorised, the following will be available within the R4BP:
- The terms and conditions of the authorisation
- The summary of product characteristics
- The report of the evaluation
Where an active substance that is a candidate for substitution is identified, the Member State shall carry out a comparative evaluation to determine whether there are other approved biocidal products, or methods of non-chemical control or prevention which have a significantly lower risk for human and animal health and the environment.
In the case in which these exist and they are sufficiently effective and have no other significant economic and practical disadvantages and do not alter the probability
to cause resistance to the target organism, the use of the new product will be limited or prohibited.
This can be used in the event that you wish to authorise the marketing of the biocidal product in more countries. There are two types of mutual recognition:
- Mutual recognition in sequence: applies in the case where the biocidal product has already been authorised in one Member State and the holder intends to extend the authorisation in other countries. In this case, the holder must apply to those Member States to recognize the authorisation
- Mutual recognition in parallel: applies in cases where the owner wish to authorise a biocidal product in more Member States which has not previously been authorised in any other Member State. The application, with a list of all the Member States where authorisation has been requested, is submitted to the “Reference Member State”
In Both options, applications must be submitted via the R4BP.
The process of mutual recognition requires about five months after the validation of the application by the competent authority for evaluation.
If the other Member States do not agree on mutual recognition, the procedure will be referred to the coordination group, which has 60 days to seek an agreement.
The coordination group is a body consisting of representatives of the Member States and the Commission. If the coordination group fails to reach an agreement, the matter will be submitted to the Commission, which may ask the ECHA to deliver an opinion on scientific or technical aspects of the case.
This is a procedure that allows you to obtain a single authorisation valid throughout Europe for specific types of biocidal products with similar conditions of use throughout the European Union.
This authorisation provides the same rights and obligations in all Member States, such as those provided by national authorisations.
The Union authorisation may be granted only to biocides with similar conditions of use throughout the European Union, with the exception of those containing active substances that meet the criteria of exclusion and those belonging to PT 14, 15, 17, 20 and 21.
The length of time for the launching of the authorisation process is different according to whether the product contains existing or new active substances.
New active substances
A product containing a new active substance, even in combination with existing active substances, may qualify for a Union authorisation as from September 1, 2013.
Existing active substances
For biocides containing only existing active substances it is possible to apply for Union authorisation in three different stages, depending on the type of product:
- From 1 September 2013 for product types 1, 3, 4, 5, 18 and 19
- From 1 January 2017 for the product types 2, 6 and 13
- From 1 January 2020 onwards for the remaining product types 7, 8, 9, 10, 11, 12, 16 & 22
This authorisation is intended to encourage the use of biocides that are less harmful to the environment, human and animal health. In order to be eligible for the simplified authorisation procedure, biocidal products must comply with the following conditions:
- All the active substances contained in the biocidal product are listed in Annex I of Biocide Regulation and comply with the specified limits
- The biocidal product does not contain any potentially dangerous substance
- The biocide does not contain nanomaterials
- The biocidal product is sufficiently effective
- The management of the biocidal product and its intended use does not require personal protective equipment
If all these conditions are met, the applicant must submit a request to the ECHA via the R4BP, indicating the competent authority of the Member State that will assess the application.
If the simplified authorisation is granted, the biocidal product can be made available on the market in other Member States without the need for mutual recognition. The marketing authorisation holder must nevertheless notify each Member State concerned 30 days before placing the product on the market in each territory.
If a company intends to maintain a certain PMC on the market or a free sale product whose active ingredient has been included in the Union List, the company must request an authorisation as a biocide.