Defra Aquaculture Disinfectant Listing Scheme

What is the Defra Aquaculture Disinfectant Listing Scheme?

The Aquaculture Disinfectant Listing scheme has been developed to publicly list disinfectant products tested to set standards which prove their effectiveness against bacterial and/or viral diseases of aquaculture relevance.

This scheme was developed because the Defra statutory disinfectant approval scheme doesn’t extend to the pathogens of fish and shellfish. It focuses on products used in the control of notifiable diseases of terrestrial animals and birds.

The Aquaculture Disinfectant Listing scheme is voluntary and operated on behalf of Defra by the Fish Health Inspectorate (FHI) at the Centre for Environment, Fisheries and Aquaculture Science (Cefas). It is also supported by Marine Scotland Science and Agri-Food and Biosciences Institute, Northern Ireland (AFBINI).

The list is publicly available (Aquaculture Disinfectant List) and can be used by aquaculture and related industries to aid selection of effective products.

The Defra Aquaculture Disinfectant Listing Scheme is not an endorsement. Additionally we reserve the right to alter the application process or fees at any time.

Who can apply?

The scheme is open to any disinfectant manufacturer wishing to market their product in the UK.

Does the listing scheme have a statutory remit?

Currently statutory authorisation is not required for disinfectants used against viral and bacterial diseases of aquaculture relevance. However all products submitted for listing must meet the requirements of the Biocidal Products Directive (BPD) 98/8/EC (as amended). It is the manufacturer’s responsibility to ensure their product meets these requirements prior to application.

To what standards should the product have been tested before applying?

Before applying please ensure your products have been tested for efficacy against:

• Bacterial Diseases: using the specified modification of EN Standard 1656:2000

And/or

• Viral Diseases: using the specified modification EN Standard 14675:2006

More information regarding test modifications, quality assurance and test reporting is available from appendices 1-6 in the application form.

Tests must be completed by a laboratory which adheres to a recognised international laboratory quality system and performs quality assurance (QA) checks. The QA checks must be completed by a QA auditor who is independent to the test department and with experience of quality assurance. This could be a Quality or Technical Manager.

On submission, applications undergo a technical review of the product information, supporting test data and quality assurance checks, to assess whether the product meets the criteria for listing.

Please note that these standards are for freshwater efficacy. Test standards are being developed for saltwater efficacy and will become available when complete.

What exactly is listed?

Successful applications will have the following listed on the efishbusiness website:

• Product trade names, the address and contact details for the manufacturer and other distributors, as applied for by the manufacturer
• The effective dilution of the product under the mandatory testing conditions
• The effective dilution of the product under the optional testing conditions – where this data has been supplied with the application and has been supported by the technical review

The disinfectant listed and sold must be identical to the original sample tested and reviewed.

How much does it cost?

For first time applications, the following options are available:

• Single scheme application (viral or bacterial efficacy) - £1355 excluding VAT
• Combined application (viral and bacterial efficacy) - £1855 excluding VAT

However, please note that fees are non-refundable for unsuccessful applications. If an application is unsuccessful we will inform you of the reasons why.

Renewals

Each listing is valid for 5 years, after which the manufacturer must reapply. However, retesting is not always necessary.

Please note - where changes have been made to the product composition, the manufacturer should notify Cefas immediately. Product changes require a retest and the manufacturer must reapply for listing in the same way as for new products.

Changes to trade names (back to back listings)

You need to apply for an amendment if you wish to add distributors for valid listed products. Use the same application form omitting section 3 and the appendices.

There is no charge for this amendment.

Check tests

Cefas, acting on behalf of defra, reserve the right to undertake ‘check’ tests on all listed disinfectant products. Products are obtained for testing from the point of sale and tested for efficacy under laboratory conditions to the appropriate model standard (as modified).

The application process

This is an example application timeline:

1. Your product is tested by a laboratory
2. You submit your application form by post and pay on line
3. On receipt your application will be checked and acknowledged within 5 working days, then passed for technical review
4. It can take up to 20 working days for a technical review. Then the technical reviewer sends their report to the Cefas Disinfectant Listing Team, with a recommendation
5. Within 5 working days of receipt of the technical review report your results are sent to you. If successful we request your signed confirmation of the terms and conditions of the listing scheme
6. After receipt of your signed confirmation, your product is listed on efishbusiness within 5 working days. You will also receive a letter to confirm listing

Application

Aquaculture Disinfectant Listing Scheme application form

Aquaculture Disinfectant Listing Scheme application payment.