Feed Additives Authorisation Consortia – EEIG-European Economic
Interest Groupings
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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 Hygiene
of the Feed Chain (HYFAC)Consortium Silage Additives (SILAC)Consortium Trace Elements (TREAC)Consortium Vitamins (VITAC)
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Joint IMA-Europe/FEFANA Consortium Mineral Binders and Anti-Caking
(MINAC)
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:
130A Avenue Louise
1050 Brussels
Belgium
Tel.: +32 (0)2 639.66.60
Fax: +32 (0)2 640.41.11
E-mail: eeig.additives@fefana.org