TerpeneTech is listed as Substance Supplier for geraniol based on an Art. 95 submission as of 1 December 2015. To obtain this listing TerpeneTech submitted an application based on an “alternative dossier”, and not based on a Letter of Access (LoA) from the participants in the BPD/BPR review programme. ECHA accepted this dossier following validation which means that it can be considered equivalent to the dossier as submitted in the review programme.
As a data submitter TerpeneTech has the rights to allow competent authorities data access to this dossier to support applications for product authorisations of his clients. This right is granted by issuing a Letter of Access to this dossier, different from the dossier submitted by the participants in the review programme.
The dossier (IUCLID format, ECHA) is accessible to the national competent authorities and they can use the information to grant product authorisation in their national/transitional biocide scheme, applicable until geraniol is approved as active substance for use in Product Types (PT) 18 and 19.
Approval date of Geraniol.
There is little information available on the expected approval date of geraniol in PTs 18 and 19.
Indeed, geraniol was mentioned “evaluation in progress in eCA” (evaluating Competent Authority) in a CA meeting document of November 2015 on the progress of the review programme of existing active substances. In similar documents of more recent CA meetings, it does not show up anymore.
In the minutes of the 14th BPC (Biocidal Product Committee) meeting of 16 February 2016 (underline added):
With regard to the first priority list the Chairman informed the meeting that ECHA will prepare a letter to the Commission containing those active substance PT combinations for which it is foreseen that the Agency cannot meet its legal obligations by initiating to work on the preparation of the opinion by March 31. Currently these are: empenthrin, d-tetramethrin, tetramethrin, d-allethrin, esbiothrin, prallethrin, carbon dioxide, sodium cacodylate, lavandin oil, zinc pyrithione, polymeric betaine and geraniol.
It is clear that there is a significant delay in the evaluation of geraniol in the review programme. As geraniol is not mentioned in the most recent BPC Work Programme (22 August 2018) covering the period 2018-2019, it is rather unlikely that it will go to the BPC working group meetings and the general BPC before the end of 2019.
The earliest date for a BPC opinion on geraniol will be in 2020. Taking into account that the BPC opinion needs to be adopted in a Commission Implementing Regulation, taking about 6 months with a formal approval date about 2 years following the BPC opinion, the earliest date for approval will be in the first quarter of 2022.
What does this mean for companies having biocidal products based on geraniol on the European market?
- They can continue selling under the transitional biocide legislation until the approval date,
- Beyond that date when a BPR compliant biocidal product dossier is submitted at the latest the day before the approval date.
In the next newsletters information will be provided on the process of the review of the active substance and biocidal product and the content, timing and cost of a “BPR compliant” dossier.
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