Third country (non-EU countries) animal feed establishment representatives: your questions answered

In general, the following types of establishment are covered:

(i) manufacturers of certain feed additives
(ii) manufacturers of certain novel protein source products
(iii) manufacturers of premixtures containing certain feed additives
(iv) compound feed manufacturers that incorporate the products mentioned at (i) and (ii) above

More detailed list of activities requiring a representative in the EU can be found below.

The main categories are:

Feed additives

• trace elements
• vitamins
• carotenoids and xanthophylls
• micro-organisms and enzymes
• antioxidants with a maximum permitted level
• other additives with a maximum permitted level, not included in the above categories
• coccidiostats, histomonostats and growth promoters

For coccidiostats, histomonostats and growth promoters, applications should be sent to the Veterinary Medicines Directorate (VMD). The VMD should also receive applications regarding compound feedingstuffs and premixtures that contain coccidiostats, histomonostats and growth promoters. The contact details for the VMD are:

Janis McDonald
Veterinary Medicines Directorate
Woodham Lane
New Haw
Addlestone
Surrey KT15 3LS
email: j.mcdonald@vmd.defra.gsi.gov.uk

Certain novel protein sources

• proteins obtained from micro-organisms belonging to the group of bacteria, yeasts (except yeasts cultivated on substrates of animal or vegetable origin), algae and lower fungi
• co-products of the manufacture of amino acids by fermentation
• amino acids and their salts
• hydroxy analogues of amino acids

The requirement for a non-EU country establishment to have a representative in the EU will depend on the particular activity being carried out.

EC animal feed legislation does not provide a definition of representatives. However, the representative will need to be capable of providing an understanding (Article 6.2 of 98/51/EC) that the non-EU establishment fulfils, and will continue to fulfil, certain conditions relating to quality standards (for example equipment, facilities, storage, personnel and record keeping). Representatives should make their application to the Member State authority where they are based. This is the Food Standards Agency in the UK.

Only one representative in the EU is required for each non-EU country establishment.

Formally, it is a declaration that needs to be made. There are no official forms to make a declaration but a model letter that applicants can use can be found below. The model letter requests the following details:

• the name (or business name) and address of the person making the declaration
• the non-EU establishment (the name and address) in respect of which the declaration is made
• details of each establishment activity that the non-EU establishment is exercising or, as the case may be, intends to exercise on that establishment (please find below a link to a detailed list of activities)
• a statement that the establishment complies, and an undertaking that when the establishment activity is exercised on it, it will comply
• an undertaking of the kind described in the second indent of Article 6.2 of direction 98/51/EC
• a signature by or on behalf of the person making the declaration

Applicants will also wish to note:

• Declarations should include details of each activity exercised by the establishments. (Details of these activities can be found at the links below).
• As indicated above, for the purposes of the legislation only one Community representative for each non-EU country establishment is required and he/she should make the declaration to the Member State in which he/she is located. Thus, for example, if a representative of a non-EU manufacturer based in France has made a declaration in France, an application to the UK is not required.
• Declarations should be made on a UK basis. Therefore representatives located in Scotland, Wales and Northern Ireland should also send their declarations to the FSA address in London given below.
• Declarations relate to premises where an activity is carried out and not to a company as a whole. For example, if a non-EU company owns several manufacturing plants then the declaration will need to cover each of these specifically. However, the same representative can cover each set of premises.

The completed declarations should be sent to:

Joseph Nicholas
Animal Feed Branch (Room 3c)
Food Standards Agency
Aviation House
125 Kingsway
London WC2B 6NH

Tel: 020 7276 8462
Fax: 020 7276 8910
email: joseph.nicholas@foodstandards.gsi.gov.uk

Applications on coccidiostats, histomonostats and growth promoters should be sent to the VMD at:

Janis McDonald
Veterinary Medicines Directorate
Woodham Lane
New Haw
Addlestone
Surrey KT15 3LS
email: j.mcdonald@vmd.defra.gsi.gov.uk

If the declaration is accepted, the FSA will provide the declarant with an acknowledgement confirming that the declaration has been accepted. The name of the representative and details of the non-EU establishment is placed on a register/list, which is published on the FSA website and updated quarterly. The register can be found below.

These are the conditions that are at least equivalent to those set out in the annexes of Directive 95/69/EC, which apply to EU establishments. These are very similar to the requirements of EC Regulation 183/2005 and relate mainly to standards of equipment, storage facilities, personnel and record keeping.