Third country 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.

Please find below a link to a more detailed list of activities requiring a representative in the EU.

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.

Zootechnical additives: certain antiobiotics, coccidiostats and other medicinal substances and growth promoters incorporated in feed. Applications for these should go to:

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

Certain 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 third country establishment to have a representative in the Community will depend on the particular activity being carried out. Please find below a link to a detailed list of activities.

The EC Directive (98/51/EC) does not provide a definition of representatives, except that they must be 'established within the Community'. Only a representative can make a declaration under regulations 33(1) or 35(1) of the Feeding Stuffs (Establishments and Intermediaries) Regulations 1999. See also Article 6.2 of 98/51/EC. This involves, among other things, an undertaking by the representative that the third country establishment fulfils, and will continue to fulfil, certain conditions relating to quality standards, for example equipment, facilities, storage, personnel and record keeping. It should be noted that representatives should make their application to the Member State authority where they are based.

Only one representative in the European Union is required for each third country establishment.

Formally, it is a declaration that needs to be made.

There are no official forms to make a declaration. Please find below a link to a model letter that applicants may wish to use. The following information should be included in the declaration, which should be made in writing (regulation 33 (1) of the Feeding Stuffs (Establishments and Intermediaries) Regulations 1999 refers).

• the name (or business name) and address of the person making the declaration;
• the third country establishment (the name and address) in respect of which the declaration is made;
• details of each establishment activity that the third country 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, with the applicable conditions as defined in regulation 39;
• 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.

Completed Declarations should be sent to:

Allyson Allman
Animal Feed Unit
Food Standards Agency
Aviation House
Room 415B
125 Kingsway
London WC2B 6NH

Tel: 020 7276 8465
E-mail: allyson.allman@foodstandards.gsi.gov.uk

The following points should be noted:

• Declarations should include details of each activity exercised by the establishments. Please find below a link to a detailed list of activities requiring a representative in the EU.
• It may be that an establishment only carries out a certain part of an activity. For example, a premixture manufacturer may only make premixtures that contain the additives vitamin A and D. However, in these types of cases, when a declaration is made it will cover the complete activity of 'manufacture of premixtures containing vitamins A and D, copper, selenium' as well, of course, any approval granted pursuant to the application.
• As indicated above, for the purposes of the legislation only one Community representative for each third 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 third country manufacturer based in France has made a declaration in France, an application to the UK is not required.
• Third Country intermediaries do not require a representative in the EU as the third country rules do not apply to intermediaries. In situations where, for example, a third country distributor imports an approvable/registerable product and it is subsequently exported to the EU, it is the manufacturer not the distributor that requires a representative in the Community.
• Under the Regulations, declarations are made on a UK basis. Therefore representatives located in, say, Northern Ireland should also send their declarations to the above FSA address in London.
• Declarations relate to premises where an activity is carried out and not to a company as a whole. For example, if a third country 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.

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 third country establishment will be placed on a register/list and published on the FSA website. Copies of the register and list are required to be sent to the European Commission on a yearly basis.

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 relate mainly to standards of equipment, storage facilities, personnel and record keeping.

The requirements in Directive 98/51/EC are likely to be replaced by provisions in a new Regulation on Feed Hygiene (currently being negotiated). This would require third country authorities to approve or register establishments in their country against the same criteria as applies to EU establishments.