Get your disinfectant approved by Defra

If there is an outbreak of a notifiable animal or zoonotic disease,disease, only Defra approved disinfectants can be used for cleaningto clean and disinfectingdisinfect hard surfaces. Hard surfaces likeinclude buildings, farm equipment, crates,crates and vehicles.

You are breaking the law if you market and sell a disinfectant as Defra approved awhen disinfectantit that has not been tested and listed as approved.approved.

To get your product approved by Defra, it must:

• conformcomply towith biocide regulations – read the Biocidalguidance Productson Directivethe HSE website
• pass efficacy tests at a Defra approved laboratory

Legislation

The Animal and Plant Health Agency (APHA) approves disinfectants on behalf of Defra.

This scheme is underpinned by the The Diseases of Animals (Approved Disinfectants) (England) Order 2007

2007.
The costs are set out in TheArticle Diseases3 and Schedule 1 of AnimalsThe (ApprovedAnimal Disinfectants)Health (Fees(Poultry Compartments, Approved Disinfectants and Amendment)Animal Gatherings) (Fees) (England) (Amendment) Order 20112022.

You will need to follow a different process to get your disinfectant approved for use on fish farms.

Before you apply for approval

You need to decidedecide:

• which categories you want to apply for approval under
• which dilution of your product you want to have tested. tested

Defra and Animal and Plant Health Agency (APHA) can’tcannot advise you which formulation or dilution will pass the tests.

Youtests, mustor makewhich surecategories youryou productshould meetsapply thefor.

Check followingwhat Healthis andcovered Safetyunder Executiveapproval (HSE) standards:for:

• chemicalsfoot legislationand suchmouth asdisease Classification,– LabellingThe Foot-and-Mouth Disease (England) Order 2006
• poultry diseases, avian influenza and Packaginginfluenza of Substancesavian andorigin Mixturesin Regulationmammals (CLP– Regulation)
• GeneralDiseases Productsof SafetyPoultry Regulations(England) Order 2003 (GPSR)and The Avian Influenza and Influenza of Avian Origin in Mammals (England) (No.2) Order 2006
• advertisingtuberculosis requirements– The Tuberculosis in theAnimals Biocidal(England) ProductsOrder Regulations2021 (BPR) 2001

The swine vesicular disease category only covers approval of disinfectants for use with swine vesicular disease. Other diseases listed within The Diseases of Swine Regulations 2014 are covered under ‘Other notifiable disease requirements’, also known as a ‘General Order’.

You must also:make sure your product meets Health and Safety Executive (HSE) standards on:

• informclassification, thelabelling Nationaland Poisonspackaging
• product Information Service safety
• checkadvertising
• the liabilityGB forBiocidal theProducts GeneralRegulation Industry Charge (GB-BPR)

You must also inform the National Poisons Information Service.

Apply for disinfectant approvalefficacy testing

YouTo mustapply for testing, complete the DDA1 application form and post or email a signed copy to:

Email:email disinfectant@apha.gov.uk.

APHA will assess your application and decide if your product can be accepted for testing for Defra approval. They willaim letto youreply knowwithin:

• 48 theirhours decisionif withinyou 5apply by email
• 10 working days.
  days if you apply by post

Download details of the APHA efficacy methodologies (PDF, 189 KB, 7 pages) for more information.

Submit samples for efficacy testing

If APHA accepts your product is accepted for testingtesting, youthey will betell toldyou where to send your samples and yoursend purchaseyou orderan invoice for the tests you want.

SeeDo thenot application form for instructions on how to submit samplesa andsample packaging labels. You must not send any samples until APHA asks you toto.

See dothe so,DDA1 orapplication makeform afor paymentinstructions toon APHAhow untilto yousubmit havesamples receivedand anpackaging invoice raised for your purchase order.labels.

ApprovalPay efficacy testing fees

You must pay in advance for testing,testing. butYou should wait until youAPHA knowhas assessed and accepted your productapplication hasand beensent acceptedyou foran testing. invoice.

You can pay by bank transfer, credit card or bycheque.

All chequefees onceare APHAexempt hasfrom sent you an invoice for your purchase order.VAT.

UKFees companies will haveincrease to pay VAT on the1 feesDecember shown in the following table. Companies outside the UK do not have to pay VAT.2023.

ApprovalEfficacy teststest	Current fees per test	Fees per test (£)from 1 December 2023
Foot and mouth disease	1,920£2,543	£3,166
Swine vesicular disease	1,920£2,543	£3,166
DiseasesPoultry ofdiseases, poultry and the avian influenza and influenza of avian origin in mammals:
- single dilution test	1,040£2,409	£3,778
-Poultry diseases, avian influenza and influenza of avian origin in mammals: triple dilution test	1,400£2,786
Tuberculosis:£4,172
-Tuberculosis: single dilution test	1,300£1,483	£1,666
-Tuberculosis: triple dilution test	1,620£1,835
General Orders:£2,050
-Other notifiable disease requirements: single dilution test	715£874	£1,032
-Other notifiable disease requirements: triple dilution test	815£973
Administrative charge£1,131	1,000

The ‘Other notifiable disease requirements’ category is also known as ‘General Orders’. This category applies if you are legally required to use an approved disinfectant for a notifiable disease not covered by the 4 disease-specific approval categories.

You should receive the results within 12 weeks of submitting your samples. This may take longer dueduring tobusy urgenttimes, statutorysuch workas (eg responding to a disease outbreak).outbreak.

ProductPay approvaladministrative fees

You willmust getpay administrative fees when you apply:

• for new tests – there is a ‘conditionsfee of approval’£1,199 letterper ifapplication, regardless of the number of categories you apply for (increasing to £1,399 on 1 December 2023)
• to sell your approved product passesunder an additional trade name (a back-to-back approved trade name) – there is a fee of £355.21
• for up to 10 trade certificates in the name of your Defra approved disinfectant – there is a fee of £177.60
• for a retrospective disinfectant efficacy test report for your Defra approved disinfectant – there is a fee of £512.48

You can pay by bank transfer, credit card or cheque.

You must pay in advance. You should wait until APHA tests.send you an invoice.

To keep your ‘parent’ product approved, you must pay an annual fee of £482 per approval category per product. This fee will increase to £590 on 1 December 2023. APHA will send you an invoice each year, which you must pay before 1 September.

A parent product is the product tested and approved by Defra. You do not need to pay an annual fee for each back-to-back approved trade name.

Get your product listed as approved

APHA will send your efficacy test results to the email you provided when applying. If you are happy with the results and wish to have your disinfectant listed as approved, respond to this email.

APHA will then send you a ‘conditions of approval’ letter.
This letter will include a text box with some wording specific to your disinfectantdisinfectant. andYou you must add this to your label. Email disinfectant@apha.gov.ukDefra Disinfectants Approvals Administration at APHA for more information about this wording.wording: disinfectant@apha.gov.uk.

YouTo needget toyour product listed as approved, sign and return the letter with a copy of your prepared label to Defra Disinfectants Approvals Administration at disinfectant@apha.gov.uk.

APHA beforewill yourusually productlist canyour be added to the list. Your product is usually listed within 5 working days of APHA receiving your signed letter.

You can only label, market and sell your product as Defra approved when itthe isname onof the approveddisinfectant list.and Youdetails canof find the completeapproval listappear of Defra approved disinfectants on the approved disinfectants list.

Approval lasts for 2 years.

You Therecan isrenew ayour renewalapproval. procedureAPHA andwill conditionswrite to extendyou approval.before your approval is due to expire, inviting you to renew. There is no fee and you may not need to submit samplessamples, but APHA will ask you to provide some information.

ApplicationReport forchanges Defrato approvalyour ofproduct

You amust Tradenametell ofAPHA anif alreadyyou intend to change:

• the formula of your approved disinfectant

  The

• any manufacturerdetails ofyou asupplied Defraduring Approvedapplication or renewal, such as disinfectant thatmanufacturing issite currentlyor oncompany thecontact approveddetails

APHA disinfectantsand listDefra canmay selldecide theirto retest your product to othermake companiessure whoit wishis still effective. You will have to renamepay andfor sellthese ittests.

If asyour theirproduct ownfails anda withrandom thecheck sametest

APHA Defraruns Approval.random check tests on approved disinfectants.

ForYou thismay toonly beknow legallyif soldyour withproduct thehas samebeen Defrachosen Approvalfor ascheck testing if it fails the alreadycheck approvedtests. product,You will be told the proposedtest newresults tradenameas mustsoon firstas possible.

Your product may be addedsuspended tofrom the listlist. byTo APHA.get Samplesyour ofdisinfectant thereapproved, disinfectantyou undercan resubmit the proposedproduct newfor nametesting. areYou usuallywill notneed requiredto forpay APHAthe full test fees.

Apply to test,get buta thereback-to-back isapproved antrade administrativename

If feeyour fordisinfectant processingis on the applicationapproved disinfectants list, other companies can buy it from you, rename and listingresell it with the additionalsame approval.

For other companies to legally sell your renamed product namewith asthe same Defra approved.approval, you must apply to have the proposed new trade name added to the approved list. This is a ‘back-to-back’ approved trade name.

The manufacturer of the already approved product must complete the DDA1 application form,.

Email following the guidancecompleted notesform onto whichDefra sectionsDisinfectants ofApprovals theAdministration format toAPHA: fill out.disinfectant@apha.gov.uk.

EmailYou thewill completednot formusually need to disinfectant@apha.gov.uk.provide samples of the disinfectant.

There is an administrative fee for APHA willto emailprocess anthe invoiceapplication toand list the applicantadditional product name as Defra approved. APHA will email you an invoice once the DDA1 application form has been assessed and the new tradenameback-to-back approved trade name can be accepted.

If ThereAPHA isdeclines noyour feeapplication, foryou assessingwill applicationsnot thatbe arecharged. subsequentlyFor declinedexample, (forthis example,could happen if there is already a disinfectant under the same name on the list).list.

Application for a Tradetrade Certificatecertificate infor theyour nameapproved of a Defra Approved disinfectant

TheIf importingyou authoritiesare inexporting your product to some non-EU countriescountries, requireyou documentationmay asneed to give proof of ayour disinfectant’s Defra Approval.approval.

Although the approved disinfectants list is the first point of reference, some countries do not accept it.

ManufacturersIf you are a manufacturer of a Defra Approvedapproved disinfectantdisinfectant, you can purchasebuy a documenttrade certificate from APHA. whichThis is letter-headed, signed and dated to confirm the Defra Approvalapproval of the named disinfectant.

There is an administrative fee for this service.

To make a request for a Tradetrade Certificate,certificate, the manufacturer must sign the Application for approved disinfectant trade certificate (PDF,(PDF, 222139 KB,KB, 2 pages) pages) and email it to Defra Disinfectants Approvals Administration at APHA: disinfectant@apha.gov.uk.

APHA will email you an invoice tobefore the applicant for payment prior to issuing the certificates.

ApplicationApply for a retrospective disinfectant efficacy test report infor theyour name of a Defra Approvedapproved disinfectant

ForIf manufacturersyou’re ofapplying Defra Approved disinfectants preparing dossiers for submission to theget HSEyour (ordisinfectant EC)authorised for product authorisation under the BPRBiocidal (biocideProducts productRegulation regulations)(BPR), partyou ofwill theneed assessmentto undertakenprove byany theefficacy competentclaims authorityyou inhave eachmade. EUThese member state (e.g. for UK it is the HSE) is to assess proof of efficacy claims themay manufacturerappear states on ayour product label andor in the product information literature.information.

ForIf disinfectantsyour thatdisinfectant areis listed as Defra Approved,approved, APHA can compilegive you a report stating theits efficacy of a Defra Approved disinfectant in the tests conducted forduring Defra Approval.approval.

There is an administrative fee for this service.

To makerequest athis requestreport, foremail thisDefra reportDisinfectants manufacturersApprovals mustAdministration emailat APHA: disinfectant@apha.gov.uk.

APHA can only accept requests directly from the manufacturer of the Defra Approvedapproved disinfectant.

An invoice is raised upon receipt of the request and emailed to the applicant prior to issuing the report. APHA will email you an invoice towhen thethey applicantreceive foryour paymentrequest, priorbefore to issuing theyour report.

AdministrativeGet chargeshelp

YouIf mustyou payneed administrativehelp chargeswith for:

• Defrayour approvalapplication, ofemail a tradename of an already Approved disinfectant
• Trade certificate in the name of a Defra ApprovedDisinfectants disinfectant
• RetrospectiveApprovals disinfectantAdministration efficacyat test report in the name of a Defra Approved disinfectant

You can pay by bank transfer, credit card or by cheque once APHA: has sent you an invoice for your purchase order.disinfectant@apha.gov.uk.

2014 2022 updates

AdministrativePublished charges	Fees3 (£)
Back-to-backJuly approved tradename	355.21
Trade Last certificateupdated (up2 toDecember 10 copies in one disinfectant name	177.60
Retrospective+ show disinfectantall efficacy test report	512.48

Product

1. 2 changes

YouDecember must2022

Efficacy telltesting APHA if you change the formula of your approved disinfectant, or if any details you originally supplied have changed. APHA and Defrasome mayadministrative decidefees toincreased retest a product to make sure it is still effective. You will have to pay for these tests.

Product check tests

APHA runs random check tests on approved1 disinfectants.December You2022 willand only know if your product has been chosen for check testing if it fails the tests.

You will beincrease toldagain thein testDecember results2023. asAll soonfees asare possible.exempt Your product may be suspended from theVAT. Reference list. You can re-submit the product for testing for which you have to pay the fullGeneral testIndustry fees.

FishCharge farmhas disinfectantalso approval

Tobeen getremoved. yourThis productno listedlonger asneeds anto approvedbe disinfectant for fish farms, visit the Centre for Environment, Fisheries and Aquaculture Science (Cefas) websitepaid.

Disinfectant enquiries

Email APHA for a list of frequently asked questions.