Voluntary Report - public distribution

**Date:** 11/18/2005

**GAIN Report Number:** E35222

E35222

**EU-25**

**FAIRS Product Specific**

**Community Register of Feed Additives**

**2005**

**Approved by:**

![](media/image1.wmf)Norval Francis

U.S. Mission to the EU

**Prepared by:**

Tania De Belder

**Report Highlights:**

The European Commission published a consolidated register of all feed
additives authorized on the European market. The register was published
for the first time in November 2005 and will be updated whenever
authorizations are modified. The Register does not replace Community
legal acts but has only informative purposes.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Brussels USEU \[BE2\]

\[E3\]

# Register legally required

Current rules for authorization, marketing and labeling of feed
additives are established in [Regulation
1831/2003](http://europa.eu.int/eur-lex/pri/en/oj/dat/2003/l_268/l_26820031018en00290043.pdf).
This Regulation requires the publication of the Community Register for
feed additives. The European Commission is responsible for the
establishment of the register and has to keep it up to date. The current
version of the register basically includes all feed additives that were
legally already on the market before Regulation 1831/2003 entered into
force. The register can be downloaded from
<http://europa.eu.int/comm/food/food/animalnutrition/feedadditives/comm_register_07112005.pdf>

# Regulation 1831/2003

In November 2003, Regulation 1831/2003 on additives for use in animal
nutrition entered into force but it became only fully applicable from
October 2004. Only feed additives that were granted an authorization
following a scientific evaluation by the European Food Safety Authority
(EFSA) may be put on the market and the Regulation sets out rules for
the marketing and labeling of feed additives. 

The regulation covers the following feed additive categories:\
- Technological additives (e.g. preservatives, antioxidants,
emulsifiers, stabilizing agents, acidity regulators, silage additives)\
- Sensory additives (e.g. flavors, colorants)\
- Nutritional additives (e.g. vitamins, minerals, amino acids, trace
elements)\
- Zootechnical additives (e.g. digestibility enhancers, gut flora
stabilizers)\
- Coccidiostats and histomonostats

The authorization granted shall be valid for 10 years and shall be
renewable. Regulation 1831/2003 also completes the ban on antibiotic
growth promoters in feed by prohibiting the use of four antibiotic
substances as of January 1, 2006.

# 

# Development of the Community register of feed additives

The first publication of the register essentially reflects the situation
prior to the entry into force of 1831/2003 and contains products that
were authorized under old EU legislation or did not previously require
EU authorization.

Previously, most feed additives were authorized under Directive
70/524/EEC. Urea and derivatives, amino acids and their salts and
analogues of amino acids were authorized in a separate Directive
(82/471/EEC) and silage additives did not require authorization. At the
time of publication of 1831/2003 a number of additives were also
undergoing review under the old rules.

Only those additives that were notified to the European Commission were
eligible to be retained in the Community Register. The notification
period ended on November 7, 2004.

# The structure of the register

The Register contains the following information: an identification of
the additive and its categorization according to the authorization, the
date on which the product concerned was first entered in the Register
and, where applicable, the expiry date of the existing authorization.
The Register also contains the reference to the relevant Community
act(s) granting the authorization(s) for the additive. People interested
in detailed information on the authorization of additives should consult
the specific Community Acts granting the authorization.

These Community acts contain all the particulars included in the
authorization such as:

a)  the designation of the additive and other elements relevant to the
    identification of the additive (Community registration or
    identification number, chemical description or formula,
    authorization holder if applicable),

b)  the conditions of use: such as animal species or categories, maximum
    and/or minimum contents in complete feedingstuffs, specific other
    provisions,

c)  the dates of applicability of the authorization, and, where
    applicable, the expiry date of the authorization.

# 

# Re-evaluation for authorization under the new rules

# Applications for re-evaluation of additives already included in the register and applications for evaluation leading to new authorization now all follow the same procedure. 

An application is sent to the Commission, who informs the Member States
and the EFSA. Any information and documents on the feed additive is sent
directly to EFSA, as well as a written statement that three samples of
the feed additive have been sent by the applicant directly to the
Community Reference Laboratory (CRL). The analytical methods to
determine the presence of an additive in feed and its possible residues
in foods are evaluated by the Community Reference Laboratory (CRL).

Two types of authorizations are determined, namely authorizations issued
or not issued to the holder of authorization. The type of authorization
depends on the category to which the additive belongs.

In both cases, the authorization granted shall be valid for 10 years and
shall be renewable. The application for re-evaluation has to be
submitted at least one year before the expiry date of the authorization.
The actual data for re-evaluation of feed additives previously
authorized under 70/524 without a time limit and for bioproteins
authorized under 82/471/EEC are not determined yet. However the
application has to be submitted within a maximum of seven years after
the entry into force of Regulation 1831/2003, i.e. at the latest before
November 2010. For silage additives the deadline for submission is seven
years after entry into force of the regulation, in other words by
November 2010. If the application for re-evaluation is not received in
due time, the product will be withdrawn from the market.

  -------------------- ------------------ --------------------------------
                                          Deadline for submission of the
                                          application of re-evaluation

  Additives authorized Additives          At least 1 year before the
  pursuant to          authorized with a  expiry date of the time limited
  Directive 70/524/EEC time limited       authorization
                       authorization      

                       Additives          Within a maximum of 7 years
                       authorized without after the entry into force of
                       a time limit       Regulation (EC) No 1831/2003 (=
                                          detailed calendar for
                                          re-evaluation may be adopted
                                          later)

  Products authorized  Urea and           Within a maximum of 7 years
  pursuant Directive   derivatives, amino after the entry into force of
  82/471/EEC and       acids & their      Regulation (EC) No 1831/2003 (=
  listed in points     salts, and         detailed calendar for
  2.1, 3 and 4 of the  analogues of amino re-evaluation may be adopted
  Annex to this        acids              later)
  Directive                               

  Silage additives     Substances,        7 years after the entry into
                       micro-organisms &  force of Regulation (EC)
                       preparations used  N°1831/2003 (= before November
                       in the Community   2010)
                       as silage          
                       additives on the   
                       market before the  
                       18 October 2004    
  -------------------- ------------------ --------------------------------

See also:
<http://europa.eu.int/comm/food/food/animalnutrition/feedadditives/index_en.htm>