1. Is Citriodiol® registered under the BPR in Europe?
Citriodiol® is being supported by Citrefine for use under Product Type 19 (repellents and attractants) under the BPR. It was originally notified under the BPD/R as “a mixture of cis- and trans-p-menthane-3,8-diol/citriodiol” under CAS No. 42822-86-6. As of October 2016, it has been redefined as “Eucalyptus citriodora oil, hydrated, cyclized” under CAS No. 1245629-80-4 (abbreviated for informal use as EC Oil (H/C)) to better reflect its botanic origin. For more information about this redefinition please see our BPR update by clicking here, however if you have any questions regarding this change and how it will affect you, please contact us directly.
Citrefine is an Article 95 approved supplier of Citriodiol®. We anticipate an inclusion decision no sooner than December 2017, which would mean Citriodiol®-based product authorisation dossiers would have a deadline for submission of approx. December 2019. Needless to see these dates are our best estimate only as the speed of the review is in the hands of the authorities.
2. Can I still place a product on the market in Europe?
Because Citriodiol® is still going through the BPR evaluation process, you are free to place a Citriodiol® product for use as a repellent on the market by obtaining a national registration as required in your territory. At the point of formal inclusion you will need to submit your Product Authorisation (PA) dossier in line with the BPR requirements. It is critical to have your product on the market by the inclusion deadline in order to continue selling it while your PA dossier is being considered (this product evaluation takes 3 years). Our best estimate of the earliest date for this deadline is December 2019, so if the authority where you are seeking to sell this product is slow at issuing national registrations, you will want to be sure to have this submission made well before this deadline to avoid the 3-year market freeze period. Please contact us for more information if you are unsure about how this will affect you. Please see the latest BPR timeline for Citriodiol® by clicking here
3. How do I gain access to data to support product registrations?
If you have your own formulation, you will almost certainly need to develop your own phys/chem and efficacy data to support your product submission. You may be able to rely on Citrefine data to support the toxicity endpoints required. If you wish to use one of Citrefine’s formulations, we can assist further as we have a large body of data to support such product registrations. Relying on our data typically involves our providing you with citation rights to certain studies through a letter of access (LoA). Depending on the access required, we may ask you to sign an agreement and there may also be a data access fee. Please contact us for more information about this
4. How do I register my products?
Most jurisdictions require some sort of registration to sell insect repellent products. However, this can vary from a simple notification, to a much more complicated authorisation as a biocide or bio-pesticide. You will need to find out which authority is responsible for regulating repellents in the market of you wish to enter (an answer that may well be driven by the claims you wish to make on your product label). You should then contact the relevant authority to determine specifically what data and fees are required to make a submission, and what is the timeline for the evaluation. If there are any gaps in your own data set or data we can provide, it may be a good idea to discuss these points directly with the authority. Our regulatory team is also here to assist you in this process. If you require significant support, we would suggest that you retain the services of a specialist regulatory consultant.
5. What is the CAS No. for Citriodiol®?
In 2011 the American Chemical Society assigned the substance described as “oils, eucalyptus, E. citriodora, hydrated, cyclized” the CAS No. 1245629-80-4.
When Citriodiol® was first notified under the European BPD in 2001, the CAS No. above did not exist and so it was notified more generally as “a mixture of cis- and trans-p-menthane-3,8-diol/citriodiol” relying on the CAS No. 42822-86-6. As of October 2016, however, ECHA redefined the substance Citriodiol® to better reflect its botanic origin. It is now properly referenced for regulatory purposes as “Eucalyptus citriodora oil, hydrated, cyclized” (abbreviated for informal use as EC Oil (H/C)) under CAS No. 1245629-80-4.
Rest of the World
Citriodiol® is registered as an active ingredient for use in insect repellents under the CAS No. 1245629-80-4 in most jurisdictions, including with the EPA (USA), PMRA (Canada) and APVMA (Australia). There are a few jurisdiction in which its original CAS No. 42822-86-6 is still recognised, so if you are in doubt, please check with us before making your submission.
6. Which products/formulations will be registered under the BPR and what data supports this?
Citrefine is committed to supporting its reference product (an alcohol-based spray containing 30% Citriodiol®) as well as a 30% Citriodiol® roll-on product (a lotion) through Product Authorisation under the BPR. It is likely that these will be registered via a Biocidal Product Family. This may include a 32% stick and/or 40% spray, depending on customer interest.
Phys/chem data including stability data is currently being generated on these products where data gaps exist. Analytical methods to measure the amount of PMD have been developed for these products and external accelerated stability testing has been successfully performed.
7. Where else is it registered? Which product types are registered?
Citrefine has a number of formulations registered globally, in countries such as the USA, Canada, Australia and Sweden. Please provide us with information on the territories and product types you are interested in, and we can provide further information.