CCM Document CCM/M2 - Application Form for the Approval of a Material

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

APPLICATION FORM: SITE & IN-SITU APPLIED PRODUCTS 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 only for applications for the approval of on-site and in-situ applied products under the appropriate regulations within the United Kingdom1. 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. Before you start completing this form, please read Advice Sheets Numbers 1, 2 and 8 (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 on this form. If you fail to provide all the information necessary it is likely that your application will be delayed. 3. 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. 4. 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. 5. 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. 6. Please e-mail the completed form, as an MS Word® document, to [email protected], together will the Instructions for Use documentation and other supporting information. A scanned copy of the signed declaration must be sent to the email address above.

1 Regulation 31 of the Water Supply (Water Quality) Regulations 2016/2010 (England & Wales). There are separate legislative and approval processes for Scotland and Northern Ireland, but the Drinking Water Inspectorate carries out the approval process for the whole of the United Kingdom. Further information on regional requirements can be obtained from the Drinking Water Quality Regulator for Scotland ( PO Box 23598, Edinburgh EH6 6WW or e-mail [email protected]), or from Chief Inspector of Drinking Water for Northern Ireland ( DWI (NI), Northern Ireland Environment Agency, Klondyke Building, Gasworks Business Site, Belfast, BT7 2JA or e-mail to [email protected]). These three organisations are collectively referred to as “the Authorities”.

Site Applied Products Page 1 of 18 June 2016 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

Site Applied Products Page 2 of 18 June 2016 2. PRODUCT DETAILS

2.1. GENERAL DETAILS

Please complete this table. Product name Note 1

Nature of product - description & use

Main material type, e.g. epoxy resin

Does the product contain any “natural” ingredients? – if “yes” please detail

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

Typical surface area of product/volume of cm2 in contact with 1 litre of water water ratio Note 3

Recycled materials – does your product Yes/No contain any recycled materials Note 4

Method of application On-site applied Yes/No

In-situ applied Yes/No

Temperature of cure (ºC) see Note 5 Duration of cure (hours) Any special curing conditions Return to service recommendations Is approval required for use in conjunction with other coating materials, e.g. primers and undercoats? see Note 6 Will the product be applied by an authorised and trained contractor? Yes/No If “no” can the product be used by anyone? Yes/No For authorised contractors please provide details of the system of assessment and certification of them.

NOTES – see next page

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). Site Applied Products Page 3 of 18 June 2016 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 – for lined pipes calculate this on the basis of the smallest diameter pipe to be coated.

4 – if recycled materials are used please provide, as separate documents –

a) details of the source(s) of the recycled materials and an outline of the manufacturing process(es) b) content of the recycled materials in the finished product (as a percentage) and confirmation, if appropriate, of conformity with published standards. c) copies of procedures you have in place to control the source and quality of the recycled materials

5 – For products used for in-situ relining of water mains a cure temperature of 3°C will be used in the preparation of all test samples. Other site-applied products will be cured using the minimum cure time at the minimum temperature specified in the Instructions for Use (IFU).

6 – Approval of coatings is given on the basis of a complete system, including all appropriate undercoats. Approval may also be granted for use over other existing coating materials. It is important that full details are provided of how the coatings will be used and of any potential compatibility issues, since subsequent disclosure of possible uses not covered by the original approval application might involve further testing before approval can be granted.

2.2. SITE-APPLIED PRODUCTS

2.2.2. Linings, coatings and repair products only Type of substrate(s) to which product will be applied Preparation of the substrate including cleaning, priming & undercoating Type and method of application Method for touching-up/repairing damage

Site Applied Products Page 4 of 18 June 2016 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 supplier2 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 submit an electronic copy (MS Word 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 Word 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 suppliers2 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 1 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.

2 Undertakers, inset appointees, and combined licensees - see The Water Act 2003 (Consequential and Supplementary Provisions) Regulations 2005, together with private drinking water suppliers 2 Site Applied Products Page 5 of 18 June 2016 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)

Site Applied Products Page 6 of 18 June 2016 5. EVIDENCE OF THE PRODUCT’S EFFECT ON WATER QUALITY (BS 6920)

IMPORTANT NOTES. 1. DWI uses the results of BS 6920 testing (or equivalent) as a means of pre-screening a product’s effects on water quality. This information is normally required BEFORE the DWI can specify any further tests that will be required. BS6920 test reports must meet the requirements set out in Annexes B and C of Advice Sheet 1 - http://www.dwi.gov.uk/31/drinking-water-products/advice-and-approval/Advicesheet1.pdf

2. You need to supply a report showing conformity of your product with the current BS 6920 (Suitability of non-metallic products for use in contact with water intended for human consumption with regard to their effect on the quality of the water) test requirements, when prepared and cured in accordance with the Instructions for Use under the supervision of the test laboratory.. Notes: - WRAS approval, together with BS 6920 test reports, are valid for 5 years – after this period the DWI will require evidence on continuing conformity. approval/reports are valid for 5 years – after this period the DWI will require evidence of continuing conformity. - copies of equivalent European test reports can be considered but applicants must provide copies of test reports (in English); a copy of the test certificate alone will not suffice. For more advice on the reporting requirement please see Annex D of Test Protocol 1 - http://www.dwi.gov.uk/drinking-water-products/advice-and-approval/protocol1.pdf 3. Test conditions used for the BS 6920 testing (or equivalent European testing) must be relevant to all the uses for which approval is being sought, and - - for paints - primer, undercoats and top coats must be tested together. - for reservoir repair systems - both strip and adhesive must be tested together. - for reservoir linings - linings and jointed sections must be tested together. In some instances, this may necessitate doing BS 6920 testing (or equivalent) under more than one set of conditions. Alternatively, one set of test conditions may be considered sufficient, provided that the DWI is satisfied that these conditions represent the worst case in relation to the proposed use. Please contact Regulations 31 Enquiries (DWI) for further advice. If touch-up kits are to be supplied for on-site use in conjunction with factory applied linings/coatings of the same formulation, the BS 6920 tests (or equivalent) should be carried out on plates that include an area coated by the test laboratory using the touch-up kit.

4. You may have to contact your suppliers to obtain copies of the appropriate test reports.

5. DWI reserves the right to request additional BS 6920 testing.

Please list the BS 6920 (or equivalent) reports being submitted in support of this application.

Product Report Ref. Number Report Date

Site Applied Products Page 7 of 18 June 2016 6. PRODUCT FORMULATION

Please supply (as appropriate), or arrange for others to supply, the following details for each of the components listed in 6.1. Please do NOT ask your suppliers and others to send us confidential product information until our reference number has been provided.

NOTES FOR TABLES 6.1 & 6.2. 1. Please complete copies of tables 6.1 and 6.2 for each material/component used in your test product. 2. If you intend to source a material/component from more than one supplier, make sure you provide the details of ALL the alternatives you wish to use. 3. Please make sure you list ALL ingredients in each material – it is likely that you may not be able to supply this information for some or all of your materials. If this is the case please ask your supplier of the materials to submit this information, in confidence, to the DWI using the letter format available from our website - . 4. Please ensure that the chemical name of each ingredient (in addition to any trade name) is submitted, together with the appropriate CAS number. 5. For each ingredient please supply or arrange for others to supply the appropriate Material Safety Data Sheets (MSDS). Please note that MSDS that refer to “proprietary” or “confidential” ingredients are inadequate – DWI will require a full disclosure of all product ingredient formulations. Failure to provide this information will delay the processing of your application. 6. For each product/material the list of ingredients should add up to 100%. 7. Approval is given on the basis that there will be no changes in the ingredients of the product – both in their nature and concentration. It is recognised, however, that for a minority of products there will be a degree of variability between batches of a product ingredient, for example sand or cement; in this case it is important that you provide an outline explanation of such variables. 8. If you need extra space please use additional copies of these tables.

Site Applied Products Page 8 of 18 June 2016 Description of the Manufacturing Process of the Product – Information requested 1. Amounts of reagents used including additives and catalysts 2. Details and specification of reagents, including Material Safety Data Sheets (MSDSs) 3. Description of the manufacturing process - order of additions & details of important process parameters 4. The chemical/physical reactions and any side reactions 5. Details of any product finishing processes 6. Any other relevant information Technical Specification for Each Component 1. You are responsible for providing complete detailed information of ALL components of the product formulation, including ALL constituents of each primary component that has been listed in Section 6.1. 2. Applicants may need to contact their suppliers to obtain this information. 3. DWI does not enter into confidentiality agreements but all product information is treated in confidence and it is used for the purposes of assessing this application for approval only – see http://www.dwi.gov.uk/drinking-water-products/faqs/FAQ3.pdf. 4. Suppliers may send information direct to the DWI – see appropriate letter and form on the website - http://www.dwi.gov.uk/drinking-water-products/advice-and-approval/forms/letter.doc. 5. This information must be in ENGLISH and the relevant applicant, product names and DWI reference number must be quoted so that the information can be linked to the correct application for approval. 6. For each COMPONENT of the formulation please supply material safety data sheets and technical specification data that includes, as appropriate - Trade name Melting and boiling points Chemical name Viscosity Chemical formula Density CAS number(s) Particle size Concentration, as a percentage of the whole pH Vapour pressure Odour Solubility in water Flash point Appearance/colour Impurities, as a percentage of the whole Any supporting toxicological information

Any other information relating to the application for approval of your product, not requested elsewhere on this form, should be provided along with this form and all other information requested.

Site Applied Products Page 9 of 18 June 2016 Table 6.1 Full formulation of all components of your product

Component Trade Name Chemical Name CAS Number % by weight

TOTAL 100

Note - if touch-up kits are supplied for on-site application in association with factory coated products, then the full formulation of this coating should be supplied separately, including if the only difference relates to the mix ratios of the component parts.

Site Applied Products Page 10 of 18 June 2016 Table 6.2. Supplier names and address for each formulation component listed in table 6.1.

IMPORTANT NOTES

1. Alternative Suppliers Where you intend to use more than one supplier of any of the components of your product, it is important that you tell us about them, in the table below. If you fail to do this and subsequently manufacture or supply your product using a component from an undeclared source, you will contravene the conditions of any approval given for your product, and approval may be revoked.

2. Supply of confidential formulation information from your suppliers.  It is the applicant’s responsibility to ensure that their supplier sends any confidential product formulation information direct to DWI.  Do not arrange for this information to be sent to us until we have assigned a reference number to your application.  Please use the model letter and form, provided on our website (last item in Section 3 of webpage - http://www.dwi.gov.uk/drinking-water-products/advice-and-approval/index.htm), when requesting this information.  We are unable to take on the responsibility for requesting this information.  Without a signed copy of the letter from your supplier(s) we may be unable to progress this application.

Component Number* Component name Supplier name Contact person Full postal address

Postcode E-mail address Tel No Component Number* Component name Supplier name Contact person Full postal address

Postcode E-mail address Tel No

* - as given in Table 6.1

Site Applied Products Page 11 of 18 June 2016 Table 6.2. Supplier names and address for each formulation component listed in table 6.1 – sheet 2.

Site Applied Products Page 14 of 18 June 2016 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 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.

Site Applied Products Page 15 of 18 June 2016 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

Site Applied Products Page 16 of 18 June 2016 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 suppliers3 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 Regulations4 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

3 Undertakers, inset appointees, and combined licensees - see The Water Act 2003 (Consequential and Supplementary Provisions) Regulations 2005 4 Regulation 33(5) the Water Supply (Water Quality) Regulations 2016/2010 in England & Wales, Regulation 35(3) of the Public Water Supplies (Scotland) Regulations 2014; Regulation 31A(1) of the Water Supply (Water Quality) (Amendment) Regulations (Northern Ireland) 2009. Site Applied Products Page 17 of 18 June 2016 7.5 Summary of Final Approval Conditions If your application is successful, approval will be subject to the following conditions –

1. Water suppliers shall be provided with a copy of the Instructions for Use and the approved product is used only in accordance with these. 2. The agreement of the Drinking Water Inspectorate (DWI) shall be obtained, in advance and in writing, in respect of any change in the Instructions for Use, the formulation of the approved product, source or identity of raw materials, the manufacturing process, location of manufacture, or quality systems, the designation of the approved product, or the name or ownership of the organisation holding the approval. 3. The approval holder agrees to undertake any further testing subsequently requested by the appropriate Authorities; the results of such testing shall be submitted for review. 4. The use of either the Authorities’5 name(s) or logo(s), in respect of any approved product (including on the product or in editorial or advertising copy) is not permitted. 5. Final listing of the approved product will be subject to your written acceptance of these conditions. If we do not receive this within 6 months the approval will lapse and could lead to the revocation of the product approval. Approvals are granted for a period of 5 years.

8 FINAL CHECKLIST

Before sending your application form to the DWI, please check once again that you have provided, or arranged for your suppliers to provide, ALL of the following information: 1. The product name (this is the name that will be used for any approval recommended after consideration by the DWI). 2. The name of the person to whom future correspondence should be addressed. 3. The name of the manufacturer (if different) and the place of manufacture. 4. A separate instructions for use (IFU) document conforming fully to the requirements of Section 3 of this form and Advice Sheet 2. Note: - technical manuals are not necessarily the same as IFU documents, unless they conform to the requirements of Advice Sheet 2. 5. Information about your product ingredients (you may need to arrange for others, e.g. your suppliers or their suppliers, to send some of this information directly to us) – a. full product formulation, including all constituent ingredients b. chemical name of each ingredient c. CAS number(s) for each ingredient d. Material Safety Data Sheets (MSDS) for all constituent ingredients and all sub- ingredients NOTE – MSDS that refer to “proprietary” or “confidential” ingredients are not acceptable – the full formulation, including relevant concentrations, must be provided – see FAQ 14 for further information - http://www.dwi.gov.uk/drinking-water-products/faqs/FAQ14.pdf e. approximate molecular weights for any polymers. 6. For the approval process a 3 tier charging system applies. Please ensure that you have paid the appropriate preliminary fee of £350. Once the initial application has been assessed, most new applications (except low risk products) will receive a follow up invoice of £2000 and for approvals requiring complex testing a 3rd charge of £800 will be invoiced. IMPORTANT NOTE Applications that have missing or inadequate information will not be considered by DWI until ALL the information required has been received.

5 The Drinking Water Inspectorate, the Drinking Water Quality Regulator for Scotland, and the DWI, Northern Ireland.

Site Applied Products Page 18 of 18 June 2016