Feed Additives Authorisation
Consortia – EEIG-European Economic Interest Groupings
FEFANA Consortia
News Q&AConsortium Acids
(ACIAC)Consortium Amino
Acids (AMAC)Consortium
Antioxidants (ANTOXIAC)Consortium Carotenoids (CARAC)
Consortium Emulsifiers
(EMULAC)Consortium Feed Flavourings (FFAC)Consortium Silage
Additives (SILAC)Consortium Trace
Elements (TREAC)Consortium Vitamins
(VITAC)
Reg. (EC) No 1831/2003 rules the access to the EU market
for feed additives: this is a system of pre-market approval applying to all
additives on the market. It includes provisions for the feed additives
previously authorised, allowing them to stay on the market provided a sequence
of conditions are successfully fulfilled (Article 10 of the Regulation):
- notification of placing on the market of the authorised additives by the parties concerned (deadline November 2004);
- check of the validity of the submission by EFSA (European Food Safety Authority);
- inclusion of the additives successfully notified in the EU Register of feed additives by the EC (EU reference list of authorised additives initially established in November 2005 and regularly updated since then);
- tabling of a complete authorisation dossier to EFSA and EC by November 2010 in order to obtain a regular 10-year authorisation;
- authorisation under Reg. (EC) No 1831/2003 for 10 years.
According to the sequence of events foreseen by the Regulation, the additives that were successfully entered in the EU Register in 2004 must now undergo a complete authorisation process in order to stay on the EU market.
In order to launch this authorisation procedure, application dossiers must be provided to the authorities by 7 November 2010 at the latest.
These dossiers must be prepared according to a Guideline Regulation that the European Commission is about to finalise. For several years, FEFANA has been actively involved with the EC and EFSA in the preparation of this pivotal document. It recommends and supports its members to launch practical work immediately in order to meet the 2010 deadline.
While
the authorisation of feed additives subject to a holder-specific authorisation
(zootechnical additives and GMO-derived ones) is generally well under control
by the companies producing or placing them on the market, the situation of all
additives subject to non-holder-specific authorisation (sometimes incorrectly
referred to as “generic”) is more delicate. The authorisation is indeed
a shared responsibility of all the operators that produce, use or place a
certain additive on the market. All operators aware of these developments
realised that it would be very inappropriate to wait for somebody else to care
alone about the authorisation, not only because it would be unfair to their
competitors, but also because the specifications, purity criteria and
manufacturing processes are to be part of the evaluation and final
authorisation of each additive. Those who do not take part might well discover at
the end of the process that their additive has lost its market authorisation.
In order to help its membership, and industry in general, to establish the necessary coordination, FEFANA is progressively setting up authorisation consortia. They are established in the form of European Economic Interest Groupings (EEIGs), legally separate but closely related to FEFANA. Each EEIG is focusing on a specific group of feed additives, according to the need and priorities identified by FEFANA Members. The fact that a grouping is established does not mean that it will automatically take care of all the additives pertaining to it. Each grouping has defined objective criteria in order to bring (or not) specific additive under the scope of work of the grouping. The established EEIGs are open to non-FEFANA members.
Close cooperation is being established with EFSA in order to streamline the process as much as possible. Beside the access to the vast know-how established within FEFANA over the years, the reduction of individual burden, the sharing of cost, the legal framework it provides for companies to cooperate, the close relationship with EFSA can be seen as an important added value for these groupings. It is indeed of paramount importance for any applicant to avoid investing time and efforts leading to dead ends.
Information and application forms available from FEFANA Secretariat:
120
Avenue Louise -
1050 Brussels
Belgium
Tel.: +32 (0)2 639.66.60
Fax: +32 (0)2 640.41.11
E-mail: info@fefana.org
© FEFANA 2008.