Europe

 

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 EU BPR. 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). Please contact us to discuss these terms in more detail.

Why join our products family (BPF)

Due to the upcoming Biocidal Products Regulation (BPR) in Europe, Citrefine have developed a Biocidal Products Family (BPF) which includes multiple proven formulations. These are available in different application types including sprays, bag on valve, eco-friendly aerosol, roll-on, lotions and sprayable emulsion.

We offer our customers the option to access our BPF and our regulatory expertise in the insect repellent category to guarantee significant cost savings, easy access to the whole European market and a smooth transition to the upcoming Biocidal Products Regulation in Europe.

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 which are currently reviewing the EC Oil (H/C) dossier and it is therefore in the “transitional period” where products must follow national regulatory requirements. As we are approaching the Formal Union listing, 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 a product registration process takes in each European country. Therefore please ensure that all your Citriodiol® 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.

Useful BPR links and resources:
Important information about the redefinition of Citriodiol® under the BPR

Citriodiol® which includes an average of 71% p-menthane-3,8-diol (PMD) 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.

There is more information available about Citriodiol® and the BPR in the Regulatory section of our FAQs.

North America and rest of the World

 

USA

In the United States, Citriodiol® has been reviewed and exceeded the highest standards, obtaining registration and end-use product approval from EPA.

Citriodiol® is more commonly known as Oil of Lemon Eucalyptus, or OLE. It was first registered with the Environmental Protection Agency (EPA) in 2002, since then, it has been sold nationwide in 30% Citriodiol® formulations (spray and lotion).

We offer our customers the option to access our EPA registered formulations and our regulatory expertise in the insect repellent category to guarantee significant cost savings and easy access to the whole US market.

Oil of Lemon Eucalyptus (Citriodiol®) is the only naturally sourced non-GMO repellent registered with EPA and whose efficacy against mosquitoes that carry Zika virus and West Nile virus is recognised by the Centers for Disease Control and Prevention (CDC).

Please see this direct link to a published document on the US CDC. website.

Citriodiol® is not a 25(b) insect repellent active substance.

Usually, they are essential oils which are significantly limited in repellency claims. This 25(b) category is exempt from EPA registration as long as products only include those active substance and ingredients included in the EPA’s list of approved ingredients for minimum risk pesticide products. The EPA does not allow 25(b) products to make claims that they can protect the user from diseases like West Nile virus , Malaria, Dengue fever, Lyme disease, Zika virus, etc. States register 25(b) products, not the EPA, therefore it is responsibility of each state to monitor and enforce misleading 25(b) claims. Going forwards it is expected that some states will be increasing the efficacy data and evidence required for such products.

 

Canada

Citrefine offer our customers the option to access our PMRA registered formulation and our regulatory expertise in the insect repellent category to guarantee significant cost savings and simplified access to the whole Canadian market.

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.

 

Australia

We can offer our registered formulations to our customers interested in launching an insect repellent approved by  the Australian Pesticides and Veterinary Medicines Authority (APVMA) to allow a rapid access to the Australian market and significant cost savings.

 

Brazil 

Citrefine has worked closely with Anvisa (Agência Nacional de Vigilância Sanitária) to include Citriodiol® as an approved active ingredient for use in insect repellent products in Brazil under its INCI listing name: Cyclized Eucalyptus Citriodora Leaf/Twig Oil.  Citriodiol® is the only natural option for this function registered with Anvisa as it is the only one to satisfy the strict safety, stability, and efficacy requirements.

With the approved active ingredient, registering a new product for launch in the country becomes a normal procedure for Anvisa and our customers.

 

Rest of the World

Citriodiol® based products have been approved by the regulatory authorities in a number of countries and are sold worldwide.

Our experienced and dedicated team can help you navigate the insect repellent registration process, providing guidance for product authorisation in multiple jurisdictions.

Our services include

  • Access to data supporting the active substance Citriodiol® and our product formulations
  • Access to supplemental registrations for pre-existing formulations in various jurisdictions
  • Information on jurisdiction specific regulatory frameworks
  • Support & guidance with product authorisations/registrations
  • Assistance with classification and labelling
  • Guidance on insect repellence by species

Please contact us for further information about your markets of interest:

  • APAC
  • LATAM
  • Europe
  • North America
  • Africa

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