What is the European Biocidal Products Regulation (EU) 528/2012?
The European Biocidal Products Regulation (BPR) controls the use of all biocides (substances or microorganisms which deter, render harmless, or exert a controlling effect on any harmful organism – like a bug spray which stops mosquitoes from biting) manufactured or sold within the European Union. It came into force on 1 September 2013, replacing the European Biocidal Products Directive 98/8/EC (BPD), and is now law in every European member state.
The aim of the BPR is to limit the use of those biocides that are unable to meet strict requirements for efficacy (showing it really works), consumer health and safety to the environment. There are many categories of biocides, ranging from hand sanitizers to wood preservatives and rodent control. Insect repellents fall within product type 19 (PT19) of the BPR, which covers repellents and attractants. Every biocide being placed on the market must now be authorised through a uniform submission and review process. This is true whether your product comes from nature or is entirely synthesised.
The use of other substances such as citronella oil and tea tree oil is no longer allowed in personal insect repellents as they were not notified under the BPD and are not being supported through the authorisation process.
What is the current status of Citriodiol® under the BPR?
The Citriodiol® dossier was under evaluation by the UK Health & Safety Executive (HSE), its evaluating Competent Authority, however as a result of Brexit, ECHA identified the Czech Republic competent authority to take over the dossier which has now been transferred to them. The CZCA are currently reviewing the EC Oil (H/C) dossier and we estimate that the earliest anticipated date for the BPC decision would be September of 2023. This is only an estimate as the actual date will be determined by the authorities and Member States. It is therefore in the “transitional period” where products must follow national regulatory requirements. As we now approach this date it is important to take into account the market freeze period.
Market Freeze Period
After formal Union listing of Citriodiol®, only products already on the market and with submitted Product Authorisation (PA) dossier (or submitted letter of intent to seek Mutual Recognition) may remain on the market. Authorities may stop accepting new national registrations up to 18 months prior to formal Union listing, depending on Member State (MS). This is dependent on the length of time each MS product registration process takes in that country. Therefore please ensure that all your products are registered in each target country before the start of the market freeze period. Failure to do this will mean you cannot put a new product on the market for several years (3 years minimum). For more information about this please contact us.
Click here to view the current timeline for Citriodiol® under the BPR.
Citrefine EU Limited as an Article 95 listed supplier
Through our Irish entity, Citrefine is able to issue the relevant documentation to confirm that we are an Article 95 listed supplier under the BPR. Please ask us for this information if required. You can also find the most recent article 95 listing by clicking here, downloading the relevant pdf file, and searching for Citriodiol® by its CAS No. 1245629-80-4
Gaining access to data to support your registrations
If you have your own formulation, you will probably need to develop your own phys/chem and efficacy data to support your product submission. You may be able to rely on Citrefine’s data to support some or all of the toxicity endpoints required.
If you wish to rely on one of our 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 that gives us your commitment that you will purchase the Citriodiol® you require for your product from us. There may also be a data access fee. Please contact us to discuss these terms in more detail.
There is more information available about Citriodiol® and the BPR in the Regulatory section of our FAQs.
Useful BPR links and resources:
** Important information about the redefinition of Citriodiol® under the BPR**
Citriodiol® was originally notified under the BPD/R as “a mixture of cis- and trans-p-menthane-3,8-diol/citriodiol” under the CAS No. 42822-86-6. As of October 2016, it has been redefined as “Eucalyptus citriodora oil, hydrated, cyclized” under the CAS No. 1245629-80-4 (abbreviated for informal use as EC Oil (H/C)) to better reflect its botanic origin.
The whole substance i.e. Citriodiol® (which includes a minimum 64% p-menthane-3,8-diol), sourced from Eucalyptus citriodora oil is continuing to be supported by Citrefine under the new name “Eucalyptus citriodora oil, hydrated, cyclized”.
Please contact us for further information and with any questions you may have.
The regulatory situation in the USA and the rest of the World
In the United States, Citriodiol® is more commonly known as Oil of Lemon Eucalyptus, or OLE. It was first registered with the Environmental Protection Agency in 2002, since then, it has been sold nationwide in a 30% or 40% formula. It is the only naturally sourced non-GMO repellent whose efficacy against mosquitoes that carry Zika virus and West Nile virus is recognised by the Centers for Disease Control and Prevention. Please see this direct link to a published document on the US CDC website.
At Citrefine’s request the description of Citriodiol® in Canada has been formerly changed by PMRA from p-menthane-3,8-diol and related oil of lemon eucalyptus compounds, to Oil of lemon eucalyptus, hydrated, cyclized (effective October 2017). This new name is more consistent with chemical identification used by authorities in the US, EU and other jurisdictions and emphasises that it is Citriodiol®’s inclusion of the many naturally occurring components found in the botanical source that give it its remarkable efficacy, and not the PMD content alone.
Rest of the World
Citriodiol® based products for dermal application to humans have been approved by the regulatory authorities in a number of countries including the USA, Australia, Spain, Sweden and the Netherlands. Please contact us for further information about any of these countries, or if you have any questions regarding other countries not listed here. We will be able to discuss with you how best to achieve your regulatory goals.
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