APPROVAL OF PRODUCTS FOR
USE WITH DRINKING WATER
Regulation 31 Enquiries,
Tel: +44 (0) 300 068 6400
Email:
Website: www.dwi.gov.uk/drinking-water-products/index.htm

APPLICATION FORM: FILTER MEDIA USED IN DRINKING WATER TREATMENT

COMMERCIAL IN CONFIDENCE

Please complete the first two lines of this table – the last line is for DWI use only.
Your organisation
Name of your product
* Reference Number : DWI 56.4. / Date received by the DWI :

* - this number will be assigned to your product once the DWI has received your completed form.

IMPORTANT NOTES
1. This form should be used for applications for the approval of filter media under under the appropriate regulations within the United Kingdom[1]. Separate forms are available from our website for other product types, including pipe systems & site applied products – http://www.dwi.gov.uk/drinking-water-products/advice-and-approval/index.htm
Separate forms are available from our website for other product types – http://www.dwi.gov.uk/drinking-water-products/advice-and-approval/index.htm
2. Many filter media are now covered by published European Standards (ENs). You should note that DWI can no longer accept applications for approval of single ingredient filter media that are covered by a relevant published EN standard.
3. Before you start completing this form, please read Advice Sheets Numbers 1,2 and 3 (available from our website - http://www.dwi.gov.uk/drinking-water-products/advice-and-approval/index.htm), together with the information in the shaded boxes.
4. We can only consider products that are offered for sale to UK public or private drinking water suppliers and will be used by them in the provision of drinking water supplies. Unlike the Water Regulations Advisory Scheme we cannot consider for approval products used in building water systems, or approve materials in isolation from their end use.
5. Please make sure you clearly mark any supporting information with the name of your organisation and the name of the product(s). Once allocated, always use the DWI reference number in relation to this application for your product.
6. You must accept the responsibility for ensuring that ALL information required has been sent to us, either by yourself or directly by your suppliers. Incomplete applications will be returned to you for amendment and will not be considered by DWI until ALL the required information has been received. DWI cannot process incomplete applications.
7. Please e-mail the completed form, as an MS Word® document, to , together will the Instructions for Use documentation and other supporting information. A scanned copy of the signed declaration must be emailed to the email address above.


1. APPLICANT DETAILS

Please complete the following details.

Name of your organisation
Contact name* & position
Contact address
Postcode
Telephone number
E-mail
Website

* the person who will be taking responsibility for this application

1.1. CONSULTANT (Optional)

You should note that DWI cannot provide help or consultancy with your application, including help in completing this form or in resolving outstanding issues or omissions in your application documents.

If you intend to use a consultant to help you with your application please complete the following details; this consultant will then be our main point of contact throughout the approval process, and final confirmation of approval, if granted, will be sent to them.

Name of organisation
Contact name*
Contact address
Postcode
Telephone number
E-mail

* the person who will be dealing with this application


2. PRODUCT DETAILS

2.1. GENERAL DETAILS – ALL PRODUCTS

Please complete this table.

Product name Note 1
Nature of product - description & use
Raw material source(s)
Does the product contain any “natural” ingredients? – if “yes” please detail / Yes/No
Water types in contact with the product -
raw water / Yes/No
water during treatment / Yes/No
treated water / Yes/No
other (explain)
Which public or private drinking water suppliers will be using this product? Note 2

NOTES

1 – the product must have a unique reference that does not infringe any registered trademark or have the same name(s) as any other approved product(s).

2 – we can only consider products that are offered for sale to UK public and private drinking water suppliers and will be used by them in the provision of drinking water supplies.


3. MANUFACTURER’S OFFICIAL INSTRUCTIONS FOR USE (IFU)

IMPORTANT NOTES
This is a very important document; your product will be considered, assessed and tested on the basis of its contents and any final approval given makes it a legal requirement for the water supplier[2] to adhere to the instructions given in this document. To avoid any delay to your application please make sure that your IFU is –
·  comprehensive and up to date
·  specific for the use of your product with water intended for human consumption
·  meets the full requirements set out in the current version of our Advice Sheet 2 – see link below
Please complete the table below and include an electronic copy (MS WordÒ format) of the IFU document with this application form.
More detailed advice on the requirements for the IFU is given in Advice Sheet 2 available from our website –
http://www.dwi.gov.uk/drinking-water-products/advice-and-approval/advicesheet2.pdf
Please read this Advice Sheet before submitting your IFU.
We are submitting a copy of the IFU for use with the product in MS WordÒ electronic format.
IFU Title
Issue date
Issue number
We confirm that this document conforms with the following requirements / Tick to confirm
Has full product name and full contact details
Is specific to the product (or range of related products) for which approval is sought
Is written in English
Has a version/issue number and date of issue as detailed above
Has each page numbered sequentially out of the total number of pages
Is written specifically for water suppliers[2] and exclusively for use with drinking water
Does not contain reference to use of the product in either building or waste water systems
Does not include either advertising copy/literature or claims of efficacy
Does not include reference to "DWI approval" or give a DWI reference number
Does not include references to foreign standards*
Uses only metric/SI units, other than in product names/descriptions
Includes all pre-commissioning conditions, storage, handling & disposal of waste
Includes all the relevant information specified in Advice Sheet Number 2, including the relevant information specified in Table 2 of that Advice Sheet.

Note* - references should be to British Standards (including BS EN standards) where available. If equivalent BS (EN) standards are not available the appropriate requirements should be quoted in full.


4. MANUFACTURER

4.1 Name of Manufacturer and Place of Manufacture

Please provide details of who makes the product and their address, if different from your own.

Name of the manufacturer
Contact name at the manufacturing site
Address of the manufacturing site
Postcode
Telephone number
E-mail
Website

4.2 Manufacturing Quality Management System

Please provide details of the quality management systems covering the manufacture and supply of your products.

We confirm that this product is manufactured in accordance with a quality management system
Organisation & address
Quality management system
ISO 9000 series
In-house procedures / Please provide separate details
Other procedures / Please provide separate details
Certifying body
(responsible for third party auditing of the quality management system)

5. EVIDENCE OF THE PRODUCT’S EFFECT ON WATER QUALITY

Depending upon the nature of your product, DWI may require specific testing to be carried out on leachate for the product. Since the test requirements will vary according to the nature of the product please consult DWI before arranging for ANY testing to be carried out.

NOTE: leachates of filter media will normally be prepared in accordance BS EN 12902.

6. PRODUCT MANUFACTURE AND SPECIFICATION

Please supply, or arrange for others to supply, the following details for the product.

Description of the Manufacturing Process of the Product
1. Type and amount of raw materials and reagents used including additives and catalysts
2. Processes such as crushing, sieving etc. and the particle size range achieved
3. Details of any product activation or finishing processes
4. Any other relevant information
Technical Specification for the Product
Please supply the following information about your product -
Particle size distribution
Density
Adsorption characteristics
Typical bed volume (litres)
Chemical composition (make sure that the sum of all components adds up to 100%)
Compound / CAS number / %


7. DECLARATION - ALL APPLICANTS

Before we can process your application we need your signed acceptance of the requirements and conditions set out below.

7.1 Product formulation details

With this application you are asked to provide certain information, some of which you may regard as confidential. DWI will need to copy parts of this information to its appointed analysts and possibly other colleagues for the purposes of the application and cannot process the application unless you agree to its doing so. Therefore please give your consent (see Section 7.3 below) to DWI’s passing this material to DWI’s partner analyst and any other DWI colleague who, in DWI’s reasonable opinion, needs to see it to carry out a function necessary to process the application. Your consent on this application form will be taken to override any standard disclaimer in any email message from you that is inconsistent with this requirement.
DWI and its analysts and colleagues will take all reasonable care to preserve the confidentiality of your material.
NOTES:
1. if you do not consent as above, DWI cannot process your application
2. DWI cannot enter into a confidentiality agreement with either yourselves or your suppliers – see http://www.dwi.gov.uk/drinking-water-products/faqs/FAQ3.pdf for further information.
3 DWI may also require a third party (for example, a manufacturer of an ingredient or raw material used in the manufacture of your product) to provide confidential information. If such a third party refuses to provide information, it may not be possible to process your application.
4 Most delays associated with applications are due to inadequate product information or supporting Instructions for Use in the initial application documents, or reluctance or unwillingness of applicant suppliers to submit confidential formulation information to the Inspectorate. The Inspectorate cannot accept any responsibilities for delays caused by these issues.


7.2 Payment

Payment Tier 1 is payable upon receipt of an application via invoice. Further payments may be required in order to complete the application process and will be invoiced accordingly.
Payment tiers:
Tier 1 (Product Code on invoice DEFRA0023) =£350
Tier 2 (Product Code on invoice DEFRA0024) = £2000
Tier 3 (Product Code on invoice DEFRA0025) = £800
Please tick the relevant box below for payment method.
Payment Method / Tick here
Purchase Order Number : ______
Enclosed Cheque made payable to “DEFRA”
Bank Transfer – Please do not pay until you have been invoiced as the payment needs to match the invoice number.
Sort Code: 60-70-80 Account number:10004777
IBAN: GB84NWBK60708010004777
SWIFT: NWBKGB2L
Quote DWI, your company name, invoice number and product.
Credit / Debit Card (Anything but American Express)
Please do not pay by this method until you have been invoiced
Tel: 01904 455395
Quote DWI and your product and company name and invoice number.
Contact name for billing purposes:
Billing Contact address and Postcode:
Telephone number of Billing dept:
E-mail address of Billing contact:

7.3 The documents submitted with this application

Please confirm, by ticking the appropriate boxes, the documents you are submitting to us.

I confirm that we have submitted - / Tick here
A completed signed and dated application form (this form)* – incomplete or unsigned forms will not be considered
A covering letter
The Instructions for Use (IFU), as an MS Word® file, conforming with Advice Sheet 2
List of suppliers contacted for confidential formulation and/or toxicological Information
Material Safety Data Sheets for each ingredient
Other technical information if relevant
Confirmation that all submitted documents are written in English
Billing Information for Tier 1 payment of £350


7.4 The application process

Please confirm, by ticking the boxes, your agreement to the basic conditions under which all applications for approval are handled.

On behalf of the applicant I confirm that - / Tick here
Any Intellectual Rights relating to the product, its packaging and labelling and any associated trade marks, are held by either the applicant or their suppliers†
This product is designed for use with public drinking water supplies and will be sold to water suppliers[3] in the United Kingdom
The applicant consents to DWI disclosing any technical or commercial information supplied by the applicant in connection with this application to DWI’s analysts and to any other person, body or authority who, in DWI’s opinion, needs access to that information for a purpose connected with processing this application.
The applicant agrees that this consent overrides any inconsistent statement in an email message, unless it explicitly withdraws this consent. The applicant understands that if it withdraws this consent DWI will treat this application as withdrawn.
The applicant also understands that if DWI requires information from a third party in connection with the application, and the third party either refuses to provide the information, or refuses to allow it to be disclosed to DWI’s analysts and colleagues on the same basis as the information the applicant has provided, DWI will not process this application further.
The applicant understands that their name and the name of the product for approval will be placed on the DWI website; other details relating to the application will be treated in confidence. The final outcome of the application (including refusals) will also be placed in the “List of Approved Products for use in public water supply in the United Kingdom” published on the Drinking Water Inspectorate’s website.
The applicant understands that it is their responsibility to ensure that all information required in connection with this application, including that provided in confidence directly to the Inspectorate by a third party, is supplied in the required format and in a timely manner
The applicant understands and accepts that the Inspectorate cannot be held responsible for any losses incurred as a result of delays in the approval process.
The applicant understands that any approval given for the product under Regulation 31 relates only to potential effects on drinking water quality, and will be subject to the conditions detailed overleaf (Section 7.4). It does NOT imply fitness-for-purpose or an endorsement of the product, and no claim of “Drinking Water Inspectorate (DWI) approval” should be made.
The applicant accepts the conditions of approval set out in Section 7.4 overleaf
The relevant Regulations[4] make it a criminal offence, punishable by a heavy fine, knowingly or recklessly to make a false statement in an application for approval.
I confirm that the information given in this application form is true to the best of my knowledge and belief.
Signed
If you are a consultant acting on behalf of the applicant please confirm that the applicant is aware of, and has agreed to these conditions and requirements – applicant is aware – YES/NO
Name / Date

†Note – ticking this box confirms that such suppliers are aware of this application