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FEPA1 Guidance notes

This electronic form should be complete and submitted online.

You can preview the data you have entered at any stage by pressing the Form Preview button.

Printing or saving a copy of the information you have entered can be done in the “Form Preview window”.

With the Form Preview window open:

- choose File > Print to print the page to your local printer; or

- choose File > Save/Save as to save the Form Summary page to a local folder on your computer

(Ensure you select the File type Web Page HTML only (*htm, *html), otherwise your notification details will not be saved, ie you will just get a blank page).

If more space is required than is available in any section(s) of the form, please use the 'Additional Information' box towards the end of page 4.

Should you have product data (e.g. toxicological or physical chemical data) which you wish to submit in support of your application form. You should attach these and provide brief details (eg study report numbers/report titles, etc) of these data submissions in the box on page 5 entitled 'details of attachments.'

Page 1 – Product Name & Company details

Product name

The precise name (i.e. trade name) which will appear on the product label.

Your details

To be completed by the person authorised (by the company applying for approval) to complete the application form.

Company details

NB: More than one checkbox can be checked if the organisation and its address is the same for more than one option eg Approval Holder and Marketing Company are the same organisation.

Approval holder

The eventual holder of the legal document signifying approval. They will be required to pay the annual levy. The Approval Holder can be based anywhere in the world.

Applicant

This should only be completed if the applicant is a party other than the approval holder, egg a consultant acting on behalf of a company. Please provide a letter of authority from the Approval Holder to confirm you are acting on their behalf.

Marketing company

The company which will market the product, i.e. the company whose name will appear on the label. This company may also be the approval holder. The Marketing Company can be based anywhere within the European free grade area.

Invoice company

If the invoice for the application is being paid by someone other than the approval holder, marketing company or applicant, their details should be completed here. Where no details are provided, the invoice will be sent to the prospective approval holder.

Page 2 - Composition details – active and non-active ingredients

Composition details

Active Ingredients & Non-Active Ingredients - at least one active ingredient and one non-active ingredient needs to be listed.

Name of component

A common or IUPAC name should be given for each component (according to BSI). For biological agents, the scientific name, strain/serovar (as appropriate) should be stated.

Source of active ingredient(s)

The source, or sources of each active ingredient. For some active ingredients, we will only accept certain specific suppliers. Additionally, for certain active ingredients which attract data protection we will require a letter of access from the data holder granting HSE access to these data on your behalf before approval can be granted. It is your responsibility to approach the data holder for such a letter. Such a letter must state the name of your product (as it appears on the product label) and the name of your company. Further information on data protection is available.

Concentration

This should be stated as a percentage in terms of weight/weight of the technical material. For liquid products (excluding pre-pressurised hand-held aerosol packs) each active ingredient concentration should be stated in grammes per litre. For biological products, the concentration should be stated as % w/w and in the gl-1 column the number of activity units/units of potency (as appropriate) relating to a defined unit of formulation (eg per gram or per litre) should be stated.

Trade name of active substance

If applicable, the trade name of the active substance should be stated here.

EINECS, ELINCS or CAS numbers

The numbers assigned to the component in either the European Inventory of Existing Commercial Chemical Substances (EINECS) or the European List of Notified Chemical Substances (ELINCS), or the Chemical Abstracts System (CAS) number.

Classification and risk phrase(s)

The classification and risk phrases assigned to ingredients under CHIP (the Chemicals (Hazard Information and Packaging for Supply) Regulations) and/or CLP (Classification, Labelling and Packaging of Substances and Mixtures Regulations). Entries should be represented as the symbol and risk phrase number(s), eg Xi (R36/38) or Eye Irrit. 2 H319/Skin Irrit. 2 H315.

Commercial confidentiality

If some or all of the non-active ingredients are confidential to another party, then please tick 'yes'; otherwise answer 'no'. Further details can be provided in the any other additional information at the bottom of page 4 of this form

If there are components which are confidential, then you should contact your supplier and ask them to send us the full formulation details. However, if the formulation is identical to an existing approved product, then you do not need to do this, as we have the details in our records.

Page 3 - Product classification and formulation information

Classification and risk phrase(s) for the product

The classification and risk phrases assigned to the product under CHIP (the Chemicals (Hazard Information and Packaging for Supply) Regulations) and/or CLP (Classification, Labelling and Packaging of Substances and Mixtures Regulations). Entries should be represented as the symbol and risk phrase number(s), eg Xi (R36/38) or Eye Irrit. 2 H319/Skin Irrit. 2 H315

Flash point

The flashpoint is required if the product is a liquid or low melting point solid and contains flammable components.

Viscosity

Kinematic viscosity is required for substances and preparations containing >10% aliphatic, aromatic or alicyclic hydrocarbons, to classify them for the aspiration hazard.

Surface tension

The surface tension is only required where the product meets the aspiration hazard criteria and it is used to remove the classification.

Product type

Please tick the relevant box or boxes. Descriptions for each product type are available.

Formulation type

Please select a formulation type from List 1. This will enable list 2, which gives information on the choices available for the option chosen in list 1.

Where the product is in the form of an antifouling coating, the coating type is also required and should be stated as one of the following:

  • Insoluble matrix
  • Soluble matrix
  • TBT self-polishing co-polymer
  • TBT free self-polishing

Dry docking interval

This is only relevant to Antifouling products and is the time (expressed in months) between applications of the product onto the hull of the boat.

Page 4 - Product packaging, application and use information.

Packaging and application information:

Packaging details

The amount of product in each individual container to be supplied together with a description of the packaging type (eg Polypropylene Co-Polymer tub with snap on lid containing 500 g of Product). These details should appear for each user. The maximum amounts we will typically accept are:

Amateur:

5 litres (ready-for-use) and 1 litre (concentrate)

Professional:

210 litres (ready-for-use) and 25 litres (concentrate)

Industrial:

210 litres and bulk (ready-for-use and concentrate)

Who will use the product

This will be one or more of the following:

Amateur:

A product to be available to the general public.

Professional:

A product which can only be applied by operatives who are required to use pesticides during the course of their work and have received suitable training, eg operatives employed by a remedial wood treatment company.

Industrial:

A product which can only be used in an industrial pre-treatment situation (eg within a factory environment).

Application methods

How the product will be applied, eg brush, spray, dipping, bait, etc. Where the product is to be applied by more than one user, (ie amateur, professional or industrial), the application method(s) intended for each user should be stated.

Dilution rates

If the product is a concentrate, the dilution rate(s) should be expressed here (eg Dilute 1 part of product with x parts of water).

Application rate for the active

This should be expressed in terms of amount of active per unit area (eg 1 litre of active per square metre) or a length of application (eg dip for 3 minutes). For aerosols and sprays, a discharge rate should be included.

Application rate(s) for product

This should include the details which will appear in the directions for use on the product label, this should be expressed in terms of amount of product per unit area or a length of application (eg dip for 3 minutes). For aerosols and sprays, a discharge rate should be included.

Page 5 - Use patterns and efficacy claims

This section should contain all of the information that will be available to the end user, usually on the product label (or appropriate product literature) and should reflect all efficacy claims.

The efficacy claims are the claims you wish to make for the performance of your proposed product when it is used at the application rate(s) stated on the form.

Target pest(s)/organism(s) and 'beneficial effects' arising from use

The pest(s) / organism(s) against which product efficacy is claimed.
The beneficial (ie the desired) effects arising from use of your product (eg protection, prevention, knockdown, kill, repellancy, etc).

Other aspects such as residual activity, re-treatment periods, etc should also be described.

If your product is a public hygiene and/or stored product insecticide/acaricide and the target pest(s) / organism(s) range is relatively non-specific, you should indicate likely targets which your product will be used against.

Directions for use

You should describe aspects such as the end-use situation(s), the type(s) of surface to be treated and whether the product is for broadcast use, crack and crevice use, etc.

The area(s) to be treated should also be described, eg:

  • indoors in rooms in the home
  • indoors in commercial/industrial premises
  • indoors in confined spaces (such as ducting systems, wardrobes)
  • in more specialised areas such as on aircraft or ships
  • outdoors around domestic and commercial/ industrial buildings
  • outdoors on or around small rubbish tips (such as garden refuse)
  • outdoors on or around larger rubbish tips (such as municipal rubbish tips), or
  • outdoors in amenity areas (such as public parks)

Page 6 - Attachments

Please list all attachments in the details boxes to enable HSE to check they have received them. Additional attachments can be sent to pa.copr@hse.gsi.gov.uk.

Material safety data sheets (MSDS)

These should be provided for all substances/components of the product formulation (with exception of water). They should be less than 5 years old and in English.

Draft label

When considering your application, we need to see one copy of a draft label. Please attach a copy with your completed application form.

Although your draft label should, if possible, accurately reflect the information provided in this form, your final label must accurately reflect the approval conditions stipulated for the product, including the permitted target pests and areas of use.

Letter of access

Required for certain active ingredients which attract data protection. HSE requires a letter of access from the data holder granting HSE access to these data on your behalf before approval can be granted. It is your responsibility to approach the data holder for such a letter. Such a letter must state the name of your product (as it appears on the product label) and the name of your company. Further information on data protection is provided at http://www.hse.gov.uk/biocides/copr/dataprotection.htm

Letter of intent to supply active substance

Required for active ingredients under data protection. It should be provided from the manufacturer to confirm that the active substance in the formulation is being provided from the SAME manufacturing source that is claimed on the application form. In circumstances where distributors are used, it is the applicant’s responsibility to show a clear chain of supply between the Approval Holder and the active manufacturer.

HSE aims to reduce work-related death, injury and ill health.

Updated 15.03.13