OFFICIAL – SENSITIVE – COMMERCIAL (once completed by the applicant)
Application for Defra approval of a disinfectant under The Diseases of Animals
(Approved Disinfectants) (England) Order 2007 No. 448, for the purposes of
The Animal Health Act 1981
(Office use only)
APHA Office Address:
Defra Disinfectant Approvals Administration
Room SE175
Stewart Stockman Building
Animal and Plant Health Agency
Woodham Lane
New Haw
Addlestone
Surrey
KT15 3NB
Date
received:
Signed:
Reference:
Before submitting an application please read the guidance document on how to fill out this form
1.
Information is required for all applications
1.1
Name of applicant’s company1
1.2
Name of applicant’s company representative
1.3.1 Address of applicant
1.3.2 Address of manufacturing site (if different to 1.3.1)
Postcode
Postcode
1.4
Telephone number (including international dialling code where appropriate)
1.5
Email Address
1.7
Company VAT number
1.6
Fax Number
1To safeguard information about your product, this is the person the Animal and Plant Health Agency will use in all correspondence.
This should be the person who signs the form. There may be other representatives we can communicate with and the names of these
should be made known to us at your earliest convenience.
APHA DDA1v2 September 2015
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OFFICIAL – SENSITIVE – COMMERCIAL (once completed by the applicant)
2.
Parent Product Information
2.1
Parent product name (must be unique within the Defra list)
2.2
Physical form in which the disinfectant is to be
tested and sold
2.3
Batch number of the disinfectant sample
2.4
Date sample was manufactured
2.5
Expiry date of disinfectant sample
2.6
Storage instructions
2.7
Product composition including dyes, perfumes, etc.
Substance
CAS number
% active
biocide in
this
substance
% of
substance
used in your
product*
Active biocide or
inert substance
(i.e. non-biocidal)
Total 100%
*see guidance document on how to fill out this form
2.8
Directions for use
2.9
Proposed use
Please tick if any information has been supplied separately ..........................................................................
APHA DDA1v2 September 2015
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OFFICIAL – SENSITIVE – COMMERCIAL (once completed by the applicant)
3.
Complete this table for new tests only, i.e. not trade name applications
Please complete this table for ’parent’ products indicating which Order(s) you are applying for approval
under, the dilution and the fee being paid.
Solid products will be tested at a concentration of 1g to (x) millilitres of water.
1
2
3
4
5
Disease Orders
Fees per test
(GB£)
Tick
to
select
State the dilution to be made to
your product prior to testing (i.e.
end-use concentration). To be
stated as 1 part disinfectant to x
parts water.
Cost (GB£)
Foot and Mouth disease
1920
Swine Vesicular disease
1920
Diseases of Poultry and the
Avian Influenza and
Influenza of Avian Origin in
Mammals
1040
Tuberculosis
1300
1400
1620
*General Orders
715
815
Total
Administration fee
1000
VAT (add 20%. UK only)
Final total
* This category is for approval for use against animal diseases (other than the four specific named disease
Orders above) under the appropriate legislation, and for general use where there is a statutory requirement
for an approved disinfectant to be used.
See details of the test methods and the challenge pathogens used for the approval test.
APHA DDA1v2 September 2015
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OFFICIAL – SENSITIVE – COMMERCIAL (once completed by the applicant)
4.
Complete this table for trade name (back to back) approved products only
Manufacturers of an approved disinfectant may make it available under different tradenames or supply
it to a distributor wishing to make it available under a different name. The disinfectant approved and
supplied must be identical to the product originally tested and approved.
Please provide details as requested in the table below, for any new tradename for which ‘back to back’
approval is being sought.
It is an offence to label and market a product as Defra approved unless the name has been added to
the Defra list at http://disinfectants.defra.gov.uk/Default.aspx?Module=ApprovalsList_SI
*Proposed back to back
approved product
tradename (must be
unique within the Defra
approved disinfectants list)
Company name and
address
Company representative’s
name, email address and
telephone number
Company
representative’s
signature
Name:
Name:
Sign:
Address:
Email:
Date:
Phone:
Postcode:
Name:
Name:
Sign:
Address:
Email:
Date:
Phone:
Postcode:
Name:
Name:
Sign:
Address:
Email:
Date:
Phone:
Postcode:
*the name must be unique within the Defra approved disinfectants list. Please write exactly how you prefer
it to appear on the list i.e. upper/lower case characters.
Please tick if any information has been supplied separately
APHA DDA1v2 September 2015
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OFFICIAL – SENSITIVE – COMMERCIAL (once completed by the applicant)
5.
Applicant’s Declaration
Approval of disinfectants by the Secretary of State does not relieve manufacturers of their obligation to
obtain other statutory or non-statutory clearance, or of their general responsibilities to users of their
products. Attention is also drawn to legal requirements regarding classification, packaging, labelling and
provision of information on dangerous goods, both for supply and transport. Advice on these may be sought
from the Health and Safety Executive www.hse.gov.uk
It is an offence to make a false claim on this application form.
I confirm on behalf of the company named on this form that product named on this form is compliant with
all relevant legislation for it to be marketed and sold in the UK.
Company Representative’s Signature (person named at 1.1)
Date
Signed on behalf of (company name)
Confidentiality of data
Commercial information supplied to APHA/Defra and laboratories carrying out testing will be treated as
confidential. Any personal data supplied on this form or provided separately by you in connection with
this application will be used to contact you and process your application. Such data will be stored on a
database for the purpose of administering the disinfectant approvals mechanism and disclosed to the
laboratories that undertake statutory testing. Names and addresses of manufacturers and distributors of
disinfectants approved for statutory use under the Animal Health Act will be publically available on
GOV.UK.
To submit this application for the initial assessment described in the guidance document for this form
send one copy by post to:
Defra Disinfectant Approvals Administration
Room SE175
Stewart Stockman Building
Animal and Plant Health Agency
Woodham Lane
New Haw
Addlestone
Surrey
KT15 3NB
We aim to acknowledge receipt of your application within five working days.
Please do not send samples until you have received a response to your initial application
APHA DDA1v2 September 2015
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IMPORTANT INFORMATION - LABELLING REQUIREMENTS
You must use the templates below to prepare labels for the inner and outer packaging for disinfectant samples
you intend to submit to APHA for the purpose of this application for Defra approval. Failure to comply with these
instructions and the legal requirements for classification, labelling and packaging for supply and transportation of
your product (the CLP Regulations) will result in APHA rejecting the samples and halting your application.
NB: If you are submitting a market-ready container bearing labels and pictograms that already comply, please
contact the disinfectant approvals team at disinfectant@apha.gsi.gov.uk for instructions on sample submission.
For example, your product may already be marketed as Defra approved and you wish to submit an application
for approval testing.
OUTER PACKAGE LABEL REQUIREMENTS
Disinfectant Samples
Delivery address:
Bacteriology Department
Defra Disinfectant Approvals (building 17)
Animal and Plant Health Agency
Woodham Lane
Addlestone
Surrey
KT15 3NB
Disinfectant Name
Batch Number
Expiry Date
Contents (sample volume)
MSDS enclosed (tick)
Compliant with CLP Regulations (tick)
Signed :
INNER PACKAGE LABEL (SAMPLE CONTAINER) REQUIREMENTS
Disinfectant Samples for Defra Approval Efficacy Testing
Disinfectant Name
Batch Number
Expiry Date
Sender:
Company Name
Contents: samples (tick to confirm tests required and sample volumes enclosed)
FMDV
SVDV
NDV
single
triple
TB
single
triple
GO
single
triple
MSDS enclosed (tick)
Compliant with CLP Regulations (tick)
Signed :
APHA DDA1v2 July 2015
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