Directive 2001/46/EC of the European Parliament and of the Council of 23 July 2001 amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on animal nutrition
Date: 2001-07-23
Institutions: Council of the European Union, European Parliament
Subjects: animal nutrition, food additive, food inspection, foodstuffs legislation, toxic substance

1.9.2001

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Official Journal of the European Communities

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DIRECTIVE 2001/46/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 23 July 2001

amending Council Directive 95/53/EC fixing the principles governing the organisation of official
inspections in the field of animal nutrition and Directives 70/524/EEC, 96/25/EC and 1999/29/EC on
animal nutrition

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European
Community, and in particular Article 152(4)(b) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Having consulted the Committee of the Regions,

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

(5)

Whereas:

(1)

(2)

(3)

(4)

The safety of products destined for animal nutrition is of
primary concern and it is necessary to ensure that prod-
ucts put
into circulation in the Community for the
purposes of animal nutrition are safe. Council Directive
95/53/EC of 25 October 1995 fixing the principles
governing the organisation of official inspections in the
field of animal nutrition (4) contributes to the achieve-
ment of that objective.

Council Directive 74/63/EEC has been repealed by
Article 16 of Council Directive 1999/29/EC of 22 April
1999 on undesirable substances and products in animal
nutrition (5). Therefore,
to Directive 74/
63/EEC have to be amended pursuant to the Table in
Annex IV to Directive 1999/29/EC.

references

As regards the reference to the circulation of products to
be used in animal nutrition, it is necessary to harmonise
the definitions used by Directives 70/524/EEC (6), 95/
53/EC and 96/25/EC (7) in the animal nutrition sector.

Serious dioxin contamination recently occurred twice in
products to be used in animal nutrition. Taking into
account the experience gained from these incidents, it is

(1) OJ C 274 E, 26.9.2000, p. 28 and OJ C 96 E, 27.3.2001, p. 279.
(2) OJ C 367, 20.12.2000, p. 11.
(3) Opinion of the European Parliament of 4 October 2000 (not yet
published in the Official Journal), Council Common Position of 12
February 2001 (OJ C 93, 23.3.2001, p. 1) and Decision of
the
European Parliament of 15 May 2001 (not yet published in the
Official Journal). Council Decision of 19 June 2001.

(4) OJ L 265, 8.11.1995, p. 17. Directive as last amended by Directive
2000/77/EC of the European Parliament and of the Council (OJ L
333, 29.12.2000, p. 81).
(5) OJ L 115, 4.5.1999, p. 32.
(6) Council Directive 70/524/EEC of 23 November 1970 concerning
additives in feeding stuffs (OJ L 270, 14.12.1970, p. 1). Directive as
last amended by Directive 1999/20/EC (OJ L 80, 25.3.1999, p. 20).
(7) Council Directive 96/25/EC of 29 April 1996 on the circulation of
feed materials
last
amended by Directive 2000/16/EC of the European Parliament and
of the Council (OJ L 105, 3.5.2000, p. 36).

(OJ L 125, 23.5.1996, p. 35). Directive as

necessary to improve the procedures applicable to cases
where a product for animal nutrition poses a serious risk
to human or animal health or to the environment or
where certain infringements of Directive 1999/29/EC are
detected. The aim is in this way to improve the manage-
ment of risks which would preclude the level of protec-
tion of human or animal health and of the environment
provided for in the Community Regulation on animal
nutrition while not trivialising those special procedures
by systematically applying them to minor problems.

A Commission inspection carried out following dioxin
contamination of the feed and food chain revealed that
Member States had had difficulty in managing such an
unusual crisis. In the light of the experience gained, and
in order to ensure that serious risks involving a product
for animal nutrition are managed with equivalent guar-
antees of efficiency throughout the Community,
it is
necessary to introduce provisions requiring the Members
States to have in place contingency operational plans to
deal with emergencies in the animal nutrition sector.

satisfactorily

(6) Where a serious risk to human or animal health or to
the environment arises in a Member State due to prod-
ucts for animal nutrition, and where that risk cannot be
contained
State(s)
by
concerned, it is indispensable for the Commission to be
able to take all the necessary precautionary measures
and to have in particular the authority to suspend trade
in, and exports of, products for animal nutrition from all
or part of the Member State concerned or to establish
special
relevant products or
the
substances.

the Member

conditions

for

(7)

(8)

1999/29/EC

the maximum
Directive
permitted levels for certain undesirable substances and
products in feed materials and feeding stuffs.

establishes

A system has already been established to enable the
Member States to be informed by operators, at all stages
of the feed producing chain, of certain cases of non
compliance with the rules on undesirable products and
substances. In view of both the experience gained and
the similar arrangements provided for in the Community
rules on general product safety, that system should be
improved and extended to render it applicable to all

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cases where an operator finds that a product for animal
nutrition poses a serious risk to human or animal health
or to the environment.

risks to human health, animal health or to the environ-
ment, relating to the circulation and use of products for
animal nutrition, can be better analysed when provided
in harmonised and standardised form.

(9)

(10)

(11)

(12)

(13)

At present there is an obligation to inform the other
Member States and the Commission when a consign-
ment of feed materials or feeding stuffs which is not in
compliance with the maximum levels for undesirable
substances or products is likely to be sent to other
Member States.

is necessary to incorporate this rapid information
It
exchange system into Directive 95/53/EC and set
standard procedures for its operation, so that it can be
applied in future in all cases where a product endangers
human health, animal health or the environment and for
the purpose of improving the inspection system as a
whole. For reasons of simplicity and efficiency,
the
system should also apply where a Member State refuses
a product from a third country when checking it upon
importation. These standard procedures could, subject to
certain amendments, be the same as those laid down for
exchanging information in emergencies pursuant
to
Council Directive 92/59/EEC of 29 June 1992 on
general product safety (1).

It
is not possible to list all potentially dangerous
contaminations of biological or chemical origin, which
may happen by accident or by illegal action, and may
affect a product to be used in animal nutrition.

The risk of hazards deriving from mislabeling or from
transport, storage or processing should be
handling,
taken into consideration.

To improve the efficiency of the inspection system and
the relevant inspection measures, where there is a suspi-
cion of contamination posing a serious risk to human
health, animal health or to the environment, Member
States should be required to verify the nature and extent
of the contamination and to make every effort to iden-
tify its origin in order to detect any other possible
contamination.

(14) Directive 95/53/EC requires Member States to submit to
the Commission information on the results of inspec-
tions carried out each year, before 1 April 2000 for the
first time. It is also laid down that those reports will be
used by the Commission to prepare and submit an
overall summary report on inspections carried out at
Community level together with a proposal for a coordi-
nated inspection programme for the following year.
Information concerning contamination affecting the
safety of a product to be used in animal nutrition shall
be considered by the Member States and the Commis-
sion in fixing the priorities for annual coordinated
inspection programmes. All the information gathered on

(1) OJ L 228, 11.8.1992, p. 24.

(15)

Taking into account the foregoing, Directives 95/53/EC,
70/524/EEC, 96/25/EC and 1999/29/EC should be
amended,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Council Directive 95/53/EC is amended as follows:

1. Article 2(1) is amended as follows:

(a) in point (a), the second indent shall be replaced by the

following:

‘— Council Directive 1999/29/EC of 22 April 1999
on undesirable substances and products in animal
nutrition (*).

(*) OJ L 115, 4.5.1999, p. 32.’

(b) point (e) shall be replaced by the following:

‘(e) “product

intended

animal nutrition” or
“product”: animal feed or any substance used in
animal nutrition;’

for

(c) point (h) shall be replaced by the following:

‘(h) “putting into circulation” or
“circulation”:
the
holding of any product
intended for animal
including
the purposes of
nutrition for
offering for sale, or any other form of transfer,
whether free or not,
to third parties, and the
sale and other forms of transfer themselves.’;

sale,

2. the following Article shall be added after Article 4:

‘Article 4a

1. Member States shall draw up contingency opera-
tional plans setting out measures to be implemented
without delay where a product for animal nutrition has
been found to pose a serious risk to human health,
to the environment and specifying
animal health or
powers and responsibilities as well as channels for trans-
mitting information. Member States shall review these
plans as appropriate, particularly in the light of changes
in the organisation of the inspection services and of the
including that gained in any simula-
experience gained,
tion exercises.

2. Member States shall
forward to the Commission
the contingency operational plans drawn up by them
and also any amendments thereto.

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The Commission shall examine the plans and
3.
suggest to the Member States concerned any amendment
which would help to ensure that Member States' contin-
gency operation plans offer equivalent guarantees of effi-
ciency. Where necessary in order to achieve that objec-
tive the Commission, acting in accordance with the
procedure provided for in Article 23, may issue guide-
lines to harmonise the contingency operational plans.’;

3. Article 12(1) shall be replaced by the following:

‘1.
The competent authority of the Member State of
destination may, at places of destination, check the
compliance of products with the provisions of Article
2(1)(a) by means of non-discriminatory random checks.
In particular, and only to the extent necessary for
carrying out these random checks, Member States may
ask operators to report the arrival of the products to
inform
that competent authority. Member States shall
the Commission when they avail
this
action.’;

themselves of

4.

in Article 13(1), the second indent shall be replaced by
the following:

‘— rendering the products harmless where appropriate,’;

5.

in Article 14, the first paragraph shall be replaced by
the following:

‘In the event of the destruction, use for other purposes,
re-dispatch to the country of origin or rendering harm-
less of the products as provided for in Article 13(1), the
Member State of destination shall contact the Member
State of dispatch without delay. The Member State of
dispatch shall take all necessary measures and notify the
Member State of destination of the nature and outcome
of the checks carried out, the decisions taken and the
reasons for such decisions.’;

the putting into
— lay down special conditions for
circulation in the Community,
the use in animal
nutrition or exports to third countries of products
from all or part of the Member State(s) concerned or
from one or more
in
Community territory.

establishments

situated

in emergencies,

the Commission may
2.
However,
provisionally adopt
the measures referred to in para-
graph 1 after consulting the Member State(s) concerned
and informing the other Member States. It shall submit
the matter to the Standing Committee for Feeding stuffs
set up by Article 1 of Decision 70/372/EEC (*) within
ten working days for its opinion, in accordance with the
procedure laid down in Article 23a, with a view to the
extension, amendment or repeal of those measures.

Where a Member State officially informs the Commis-
sion of the need to take protective measures and where
the Commission has not had recourse to the measures
referred to in paragraph 1,
that Member State may
adopt temporary protective measures with regard to use
or putting into circulation. Where a Member State
immediately inform the
it shall
adopts such measures,
other Member States and the Commission. The Commis-
sion shall
Standing
Committee for Feeding stuffs within ten working days
for its opinion in accordance with the procedure laid
down in Article 23a with a view to the extension,
amendment or repeal of the temporary protective meas-
ures taken by that Member State.

question to the

submit

the

Article 15b

The Commission shall
of the measures taken under Articles 9a and 15a.

inform the European Parliament

(*) OJ L 170, 3.8.1970, p. 1.’

7. the following Chapter shall be added after Article 16:

6. the following Section shall be added after Article 15:

‘CHAPTER IIIA

‘ S e c t i o n 3 a

Safeguard clause

Article 15a

1. Where a problem due to a product to be used in
animal nutrition, likely to pose a serious risk to human
health, animal health or to the environment, appears in
one or more Member States and cannot be contained
satisfactorily by means of
the measures taken by the
the Commission, acting in
Member State(s) concerned,
accordance with the procedure provided for in Article
23a on its own initiative or at the request of a Member
State, shall immediately, depending on the seriousness of
the situation adopt the following measures:

— suspend the putting into circulation within the
Community, the use in animal nutrition or exports
to third countries of products from all or part of the
Member State(s) concerned or from one or more
establishments situated in Community territory, or

INFORMATION SYSTEM FOR HAZARDS FROM FEEDING
STUFFS

Article 16a

Member States shall prescribe that the persons respon-
sible for the establishments must
immediately inform
the Member States' competent authorities if they have
evidence that a consignment of products for animal
nutrition which they have brought
into Community
territory from a third country or put into circulation,
and which they are holding or own:

— exceeds the maximum levels laid down in Section A
of Annex II to Directive 1999/29/EC beyond which
the product must not be fed as such to animals or
mixed with other products for animal nutrition, or

— does not comply with one of the other provisions
this Directive and,
referred to in Article 2(1)(a) of
owing to that non-compliance and,
in view of the
purpose for which it is intended, poses a serious risk
to human health, animal health or to the environ-
ment.

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responsible for

the establishments

shall
The persons
provide all details enabling precise identification of the
relevant product or consignment of products and as full
as possible a description of
the risk posed by the
product or products concerned, as well as all available
in tracing the product or products.
information useful
They shall also inform the competent authorities of the
Member States of action taken to prevent
to
human health, animal health or to the environment,
describing that action.

risks

The Member States shall lay down the same information
requirements concerning the risks posed by products for
carrying out health
animal nutrition for persons
monitoring of holdings such as those referred to in
Article 10 of Council Directive 96/23/EC of 29 April
1996 on measures to monitor certain substances and
residues thereof in live animals and animal products (*),
and for persons responsible for laboratories carrying out
analyses.

Where appropriate, the competent authorities shall apply
the provisions of Articles 8, 11 or 13.

Article 16b

1. Where the competent authorities of
the Member
States have information indicating, on the basis of the
risk assessment factors available, that a consignment of
products for animal nutrition poses a serious risk to
human health, animal health or to the environment they
shall verify the information received and, where appro-
priate, ensure that the necessary measures are taken so
that the consignment is not used in animal nutrition,
the consignment under restriction and investigate
put
immediately:

— the nature of the hazard and where appropriate the

level of undesirable substances,

— the possible origin of the undesirable substances or

of the hazard,

in order to assess the risk more closely.

the

risk

shall

assessment

appropriate,

Where
be
extended to other consignments of the same product or
to other products in the feed or
food chain which
might contain undesirable substances or in respect of
which such a hazard might exist, taking into account
any admixture of
the undesirable substances in other
products for animal nutrition and possible recycling of
dangerous products into the feed chain.

the final destination of

2. Where the existence of a serious risk is confirmed
in accordance with paragraph 1, Member States shall
ensure that
the consignment
including possible
containing undesirable
decontamination, further action to render the products
harmless,
cannot have
harmful effects on human or animal health or on the
environment and where it is possible that the undesir-
able substances or the risk of such substances being

reprocessing or destruction,

substances,

present has extended to other consignments or to the
feed or food chain they shall
immediately identify and
put under control other consignments of the products
deemed hazardous and also, where appropriate,
identify
live animals fed with hazardous products and implement
the measures provided for in Directive 96/23/EC or in
other relevant Community provisions relating to animal
to the food safety of products of animal
health or
origin ensuring
relevant
in order to avoid the hazardous prod-
control services,
into circulation and to ensure the
ucts being put
enforcement of
the products
recall procedures
already in circulation.

coordination between the

for

Article 16c

1. Where a Member State finds that a product
for
animal nutrition which has been put into circulation in
its own territory and in that of other Member States, or
a product originating in a third country which has been
brought
into Community territory in order to be put
into circulation in one or more Member States:

— exceeds the maximum levels laid down in Section A
of Annex II to Directive 1999/29/EC beyond which
the product must not be fed as such to animals or
mixed with other products for animal nutrition, or

— does not comply with one of the other provisions
referred to in Article 2(1)(a) of
this Directive and,
owing to that non-compliance and the purpose for
which it is intended, poses a serious risk to human
health, animal health or to the environment,

that Member State shall forthwith alert the Commission
by way of notification.

It shall provide sufficient
information to identify the
products concerned, trace and put them under control
and, where appropriate, the live animals fed with them,
envisaged or
and shall
already taken, in order to enable the Commission prop-
erly to inform the other Member States.

specify safeguard measures

Any Member State concerned shall

immediately
2.
alert the Commission of any follow up measure taken
in respect of the notified hazards, including information
concerning the end of the risk situation.

3.
The Commission and the Member States shall set
up and operate a system for rapid exchange of informa-
tion under conditions set in accordance with the proce-
dure provided for in Article 23, with a view to expe-
diting transmission and dissemination of
alerts
referred to in paragraph 1 and the information referred
to in Article 8(1).

the

4.
The Commission shall inform the European Parlia-
ment of measures taken to expedite the transmission
and dissemination of alerts.

(*) OJ L 125, 23.5.1996, p. 10.’

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8. Article 17(2) shall be replaced by the following:

‘2. Member States shall provide that officials respon-
sible for inspection are subject to professional confiden-
tiality. However, this provision shall not affect the poss-
the Member
ibility for
States of disseminating information necessary to prevent
a serious risk to human health, animal health or to the
environment.’;

the competent authorities of

9. Article 17a shall be replaced by the following:

‘Article 17a

as

insofar

is necessary for

1. Without prejudice to Article 15, experts from the
Commission may,
the
uniform application of this Directive, make on-the-spot
inspections in cooperation with the competent authori-
ties of the Member States. The Member State on whose
territory inspections are made shall afford the experts all
the assistance necessary for carrying out
their duties.
The Commission shall inform the competent authorities,
the Member States and the European Parliament of the
results of the inspections made.

The detailed rules

the application of

2.
this
for
Article, and in particular those governing the arrange-
ments
for cooperation with the national authorities,
shall be adopted in accordance with the procedure
referred to in Article 23.’;

10. Article 22 shall be amended as follows:

(a) the following sentence shall be added at the end of

paragraph 2:

‘This information shall be presented in the form of
annual reports in accordance with a specimen to be
drawn up pursuant to Article 23.’

(b) the following subparagraph shall be added at

the

end of paragraph 3:

‘The overall summary report referred to in the first
subparagraph shall be communicated to the Euro-
pean Parliament.’

Article 2

parties, and the sale and other
themselves;’

forms of

transfer

Article 3

In Directive 96/25/EC, Article 2(b) shall be replaced by the
following:

‘(b) “putting into circulation” or “circulation”: the holding
of any product intended for animal nutrition for the
including offering for sale, or any
purposes of sale,
other form of transfer, whether free or not, to third
parties, and the sale and other
transfer
themselves.’

forms of

Article 4

Article 12(3) and (4) of Directive 1999/29/EC are hereby
repealed.

Article 5

1. Member States shall adopt and publish, not later than
1 September 2002 the laws, regulations and administrative
provisions necessary to comply with this Directive. They
shall forthwith inform the Commission thereof.

They shall apply these provisions from 1 May 2003.

When Member States adopt
they shall
contain a reference to this Directive or shall be accompanied
by such reference on the occasion of their official publica-
tion. The methods of making such reference shall be laid
down by Member States.

these measures,

2. Member States shall communicate to the Commission
the main provisions of national law which they adopt in the
field covered by this Directive.

Article 6

This Directive shall enter into force on the day of its publi-
cation in the Official Journal of the European Communities.

This Directive is addressed to the Member States.

Article 7

In Directive 70/524/EEC, Article 2(k) shall be replaced by
the following:

Done at Brussels, 23 July 2001.

‘(k) “putting into circulation” or “circulation”: the holding
of any product intended for animal nutrition for the
purposes of sale,
including offering for sale, or any
other form of transfer, whether free or not, to third

For the European Parliament

For the Council

The President

The President

N. FONTAINE

A. NEYTS-UYTTEBROECK