Commission Regulation (EC) No 256/2002 of 12 February 2002 concerning the provisional authorisation of new additives, the prolongation of provisional authorisation of an additive and the permanent authorisation of an additive in feedingstuffs (Text with EEA relevance)
Date: 2002-02-12
Institutions: European Commission
Subjects: animal nutrition, food additive, market approval, microorganism

L 41/6

EN

Official Journal of the European Communities

13.2.2002

COMMISSION REGULATION (EC) No 256/2002

of 12 February 2002

concerning the provisional authorisation of new additives, the prolongation of provisional author-
isation of an additive and the permanent authorisation of an additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Commission Regulation (EC) No 2205/2001 (2),
and in particular Articles 3, 9d and 9e thereof,

Whereas:

(1)

(2)

(3)

(4)

Directive 70/524/EEC provides that new additives may
be authorised following the review of an application
made in accordance with Article 4 of the Directive.

Article 9e(1) of Directive 70/524/EEC provides that
provisional authorisation of a new additive may be given
if the conditions of Article 3a(b) to (e) of that Directive
are satisfied and if it is reasonable to assume, in view of
the available results, that when used in animal nutrition
it has one of the effects referred to in Article 2(a). Such
provisional authorisation may be given for a period of
up to four years in the case of additives referred to in
Part II of Annex C to that Directive.

The assessment of the dossiers submitted in respect of
the anti-caking agents ‘sodium ferrocyanide’ and ‘potas-
sium ferrocyanide’ described in Annex I shows that these
additives satisfy the abovementioned conditions. The
Scientific Committee for Animal Nutrition (SCAN) deliv-
ered a favourable opinion with regard to the safety of
these anti-caking agents on 3 December 2001. They
should therefore be authorised on a provisional basis for
a four-year period.

laying hens,

Commission Regulation (EC) No 937/2001 (3) renewed
the micro-organism
the provisional authorisation of
preparation Bacillus cereus var.
(NCIMB 40 112;
toyoi
for the animal categories chickens for
Toyocerin)
fattening,
fattening,
breeding does and rabbits for fattening. Authorisation
was granted only until 1 March 2002,
in order to
provide sufficient time for the safety reassessment of the
strain with regard to the resistance to tetracycline, as
requested by SCAN in the light of evidence which had
become available since the substance was first provision-
ally authorised.

calves,

cattle

for

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 297, 15.11.2001, p. 3.
(3) OJ L 130, 12.5.2001, p. 25.

The required data were received by the Commission on
17 September 2001. On the basis of
this, SCAN
concluded, in its report on product Toyocerin adopted
on 5 December 2001,
the
that
dossiers submitted showed that the product may be
considered safe as regards toxin production and as
regards resistance to antibiotics.

the assessment of

The new data having satisfied the Commission that the
conditions of Article 3a(b)
to (e) of Directive 70/
524/EEC are satisfied, provisional authorisation for the
preparation Bacillus cereus var. toyoi (NCIMB 40 112) for
the animal categories chickens for fattening, laying hens,
calves, cattle for fattening, breeding does and rabbits for
fattening should therefore be granted for the remainder
of the maximum permitted five-year period. Taking into
account the interruption of the provisional authorisation
between 21 February 2001 and 31 May 2001, the end
of the provisional authorisation should be 7 October
2004.

the micro-organism
The provisional authorisation of
preparation Bacillus cereus var. toyoi (NCIMB 40 112) for
the animal categories piglets, pigs and sows expired on
21 April 1999 at the end of the maximum permitted
five-year period.

SCAN, in its report on product Toyocerin adopted on
5 December 2001, confirmed that the product, when
used in the animal categories piglets, pigs for fattening
and sows, satisfies the conditions of Article 3a(b) to (e)
of Directive 70/524/EEC. The SCAN report
also
concluded favourably on the efficacy of the product
Toyocerin when used in the animal categories piglets
to 2 months and sows.

As all conditions of Article 3a of Directive 70/524/EEC
are satisfied, a permanent authorisation should therefore
be granted for the micro-organism preparation Bacillus
cereus var. toyoi (NCIMB 40 112) for use in the animal
categories piglets and sows under
conditions
described in Annex III.

the

(6)

(7)

(8)

(9)

(10)

The assessment of the dossier shows that certain proced-
ures may be required to protect workers from exposure
to the additives. Such protection should however be
assured by the application of Council Directive 89/
391/EEC of 12 June 1989 on the introduction of meas-
ures to encourage improvements in the safety and health
of workers at work (4).

(4) OJ L 183, 29.6.1989, p. 1.

13.2.2002

EN

Official Journal of the European Communities

L 41/7

(11)

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
for Feedingstuffs,

HAS ADOPTED THIS REGULATION:

Article 1

Article 2

The provisional authorisation of the preparation belonging to
the group ‘micro-organisms’
is extended
listed in Annex II
under the conditions laid down in that Annex.

Article 3

The preparation belonging to the group ‘micro-organisms’
listed in Annex III is authorised without a time limit for use as
additive in animal nutrition under the conditions laid down in
that Annex.

The additives belonging to the group ‘binders, anti-caking
agents and coagulants’ listed in Annex I are authorised for use
as additives in animal nutrition under the conditions laid down
in that Annex.

Article 4

This Regulation shall enter into force on the day following its
publication in the Official Journal of the European Communities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 February 2002.

For the Commission

David BYRNE

Member of the Commission

ANNEX I

Binders, anti-caking agents and coagulants

Number
(or EC
number)

Additive

Chemical formula,
description

Species or category
of animal

Maximum
age

Minimum
content

Maximum
content

mg/kg of complete
feedingstuff

Other provisions

End of period of
authorisation

E 535

Sodium ferrocyanide

Na4[Fe(CN)6]. 10H2O

All species or categories of
animals

—

—

—

E 536

Potassium ferrocyanide

K4[Fe(CN)6]. 3H2O

All species or categories of
animals

—

—

—

Maximum content:
80 mg/kg NaCl
ferrocyanide anion)

(calculated as

Maximum content:
80 mg/kg NaCl
ferrocyanide anion)

(calculated as

1.3.2006

1.3.2006

L

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i
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i
e
s

.

.

1
3
2
2
0
0
2

Number
(or EC
number)

1

ANNEX II

Micro-organisms

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete feedingstuff

Other provisions

End of period
of authorisation

Bacillus cereus var. toyoi
NCIMB 40112/
CNCM I-1012

Preparation of Bacillus cereus var.
toyoi containing a minimum of
1 × 1010 CFU/g additive

Chickens for fattening

—

0,2 × 109

1 × 109

Laying hens

—

0,2 × 109

1 × 109

Calves

6 months

0,5 × 109

1 × 109

Cattle for fattening

—

0,2 × 109

0,2 × 109

7.10.2004

7.10.2004

7.10.2004

7.10.2004

indicate

and premixture,

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting
May be used in compound feed
containing the premitted coccidiostats:
lasalocid sodium,
monensin sodium,
salinomycin
decoquinate,
robenidine, narasin, halofuginone

sodium,

and premixture,

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting

indicate

and premixture,

In the directions for use of the addi-
the
tive
storage temperature, storage life and
stability to pelleting

indicate

indicate

and premixture,

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting
The quantity of Bacillus cereus var. toyoi
in the daily ration must not exceed
1,0 × 109 CFU for 100 kg body
weight. Add 0,2 × 109 CFU for each
additional 100 kg body weight

.

.

1
3
2
2
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0
2

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Number
(or EC
number)

Additive

Chemical formula, description

Species or category
of animal

Maximum age

Minimum
content

Maximum
content

CFU/kg of complete feedingstuff

Other provisions

Breeding does

—

0,1 × 109

5 × 109

Rabbits for fattening

—

0,1 × 109

5 × 109

indicate

and premixture,

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting
May be used in compound feed
containing the permitted coccidiostat:
robenidine

indicate

and premixture,

In the directions for use of the addi-
tive
the
storage temperature, storage life and
stability to pelleting
May be used in compound feed
containing the permitted coccidiostats:
robenidine, salinomycin sodium

End of period
of authorisation

7.10.2004

7.10.2004

L

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1
0

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s

.

.

1
3
2
2
0
0
2

ANNEX III

Micro-organisms

Number
(or EC
number)

E 1701

Additive

Chemical formula, description

Species or category
of animal

Maximum
age

Minimum
content

Maximum
content

CFU/kg of
complete feedingstuff

Other provisions

End of period
of authorisation

Bacillus cereus var. toyoi
NCIMB 40112/
CNCM I-1012

Preparation of Bacillus cereus var. toyoi
containing a minimum of 1 × 1010
CFU/g additive

Piglets

2 months

1 × 109

1 × 109

In the directions for use of the
additive and premixture indicate
the storage temperature, storage
life and stability to pelleting

Without a time
limit

Sows

From 1
week
prior to
farrowing
until
weaning

0,5 × 109

2 × 109

In the directions for use of the
additive and premixture indicate
the storage temperature, storage
life and stability to pelleting

Without a time
limit

.

.

1
3
2
2
0
0
2

E
N

O

f
f
i
c
i
a
l

J
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n
a
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