What is Azole Fungicide Resistance?

Aspergillus fungi can cause certain infections and allergic reactions. To prevent such conditions, drugs known as azole fungicides are used. However, according to a report prepared with the support of the European Commission Joint Research Centre, excessive use of these drugs may increase the risk of Aspergillus fungi developing resistance to antifungal treatments.

Where Are Azole Fungicides Used?

Some common applications of azole substances include:

Plant protection products (pesticides),
Veterinary medicines,
Wood preservatives,
Industrial chemicals,
Cosmetics.

The report highlights that the widespread use of azoles outside of human medicine, particularly in agriculture, increases the risk of Aspergillus developing resistance.

About the One Health Approach

According to ECHA, addressing azole resistance in Aspergillus requires cross-sector collaboration. In this context, European Union agencies have collaborated under the One Health approach to tackle the azole fungicide issue.

The agencies contributing to the One Health approach are:

European Chemicals Agency (ECHA)
European Food Safety Authority (EFSA)
European Centre for Disease Prevention and Control (ECDC)
European Environment Agency (EEA)
European Medicines Agency (EMA)

As part of their study, these agencies examined evidence related to the issue, identified factors that contribute to azole resistance, and proposed measures to control this resistance. ECHA shared the following recommendations with its audience:

Additional approval and authorization requirements may be introduced for azole fungicides.
Research and development of new fungicides that do not contribute to resistance against antifungal drugs used in human medicine can be encouraged.
Following good agricultural and horticultural practices, organic waste can be properly stored, waste can be effectively managed, and azole-treated products can be responsibly used and disposed of.
Effective waste management measures can be applied to wood treated with azole-based biocides.
More data can be collected on the use of azole-based fungicides and azole-based antifungal drugs.
Specific technical guidance and risk assessment methodologies can be developed to support regulatory decisions on the approval of azole substances and the reduction of azole resistance in Aspergillus.
Further research can be conducted to address existing uncertainties.

For a more detailed review of the study, click here.

What Can Companies Expect?

The increasing severity of azole fungicide resistance may also have implications for the registration and authorization of chemicals.

Additional approval and authorization requirements may be set for biocidal products and industrial chemicals containing azole fungicides.
Research into new fungicides that do not contribute to antifungal drug resistance may be encouraged.
Good agricultural and horticultural practices may become mandatory, leading to additional obligations for companies using pesticides and biocidal products.
Stricter waste management and disposal regulations may be implemented for wood products treated with azole-based biocides.
Increased reporting and data-sharing requirements regarding the use of azole-based fungicides and antifungal drugs may be imposed.
Companies may be required to maintain detailed records related to these substances.
New technical guidelines and risk assessment procedures may be introduced to regulate the use of azole-based chemicals.
Before licensing a new fungicide or renewing an existing one, a pre-assessment of the cross-resistance risks with antifungal drugs used in human medicine may be required or conducted.
Licensed biocidal product formulations may need to be modified or updated with alternative substances.

Stay tuned for potential updates on the issue and benefit from our support in EU REACH and BPR compliance processes.