Amended proposal for a European Parliament and Council Directive amending Council Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition and Council Directive 1999/29/EC on undesirable substances and products in animal nutrition (presented by the Commission pursuant to Article 250 (2) of the EC Treaty)
Date: 2000-12-01
Institutions: European Commission
Subjects: animal health, animal nutrition, food inspection, foodstuffs legislation

27.3.2001

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Official Journal of the European Communities

C 96 E/279

Amended proposal for a European Parliament and Council Directive amending Council Directive
95/53/EC fixing the principles governing the organisation of official inspections in the field of
animal nutrition and Council Directive 1999/29/EC on undesirable substances and products in
animal nutrition (1)

(2001/C 96 E/24)

(Text with EEA relevance)

COM(2000) 777 final (cid:151) 2000/0068(COD)

(Submitted by the Commission pursuant to Article 250(2) of the EC Treaty on 1 December 2000)

(1) OJ C 274 E, 26.9.2000, p. 28.

INITIAL PROPOSAL

AMENDED PROPOSAL

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Unchanged

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,

Having regard to the opinion of
Committee,

the Economic and Social

Having regard to the opinion of the Committee of the Regions,

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

Whereas:

(1) The safety of products destined for animal nutrition is of
primary concern and it
is necessary to ensure that
products placed in the market for animal nutrition are
safe. Council Directive 95/53/EC (1) of 25 October 1995
fixing the principles governing the organisation of official
inspections in the field of animal nutrition contributes to
the achievement of such objective.
is necessary to
amend Directive 95/53 for the following reasons.

It

(2) Council Directive 74/63/EEC (2) has been replaced by
Council Directive 1999/29/EC (3) of 22 April 1999 on
the undesirable
in animal
nutrition,
to Directive 74/63/EEC
shall be amended.

therefore references

and products

substances

___________
(1) OJ L 265, 8.11.1995, p. 17.
(2) OJ L 38, 11.2.1974, p. 31, as last amended by Commission Directive

98/60/EC (OJ L 209, 25.7.1998, p. 50).

(3) OJ L 115, 4.5.1999, p. 32.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(3) With reference to the circulation of products to be used in
animal nutrition,
it is necessary to harmonise the defi-
nitions for products to be used in animal nutrition with
more recent Community legislation.

(4) Rules must be laid down for the organization of official
inspections of feedingstuffs in view of the very wide range
of products used, the large volume of consignments of
goods commercially traded,
the integrated structure of
the sector and,
in particular, the need to ensure both
the wholesomeness of the feedingstuff to be consumed
by animals and the quality of the food.

(5) As regards intra-Community trade, emphasis should be
placed on the checks to be carried out at the place of
origin; however, in the event of a presumption of irregu-
larity, the check may be carried out while the products are
in transit or at the place of destination.

(6) The authorities responsible for inspections may differ
from one Member State to another;
therefore
necessary to publish a list of the competent authorities
in the field in each Member State, with an indication of
the territories for which they are competent and the labo-
ratories authorized to carry out analyses in connection
with such inspections.

is

it

(7) Serious dioxin contamination recently occurred twice in
feed materials and feedingstuffs. The experience gained
from these contamination suggests that it is necessary to
improve the procedures taking protective measures and in
exchanging information between Member States and the
Commission in the event of detection of non-conformity
of products intended to be used in animal nutrition and in
the event of immediate risk to public health, animal health
or the environment.

(7) Serious dioxin contamination recently occurred twice in
feed materials and feedingstuffs. The experience gained
from these incidents suggests that
is necessary to
improve the procedures for taking protective measures
and exchanging information between Member States and
event
the Commission
of
the
intended to be used in
non-conformity of products
risk to public
animal nutrition and in the event of
health, animal health or the environment.

detection

of

in

it

identified

operational
the dioxin crisis.

(8) The result of a Commission inspection carried out
following dioxin contamination of feed and of the food
the
chain
management of
the
experience gained, it is necessary to introduce provisions
requiring the Members States to have in place contingency
plans to deal with emergencies in the animal feed sector.
Such contingency plans are also necessary to collect
properly the necessary information.

In the light of

deficiencies

in

Unchanged

(9) In case of a serious and immediate risk to animal health
appearing in a Member State due to contamination of feed
it is indispensable for the Commission to be able to take
all the necessary precautionary measures to protect public
and animal health. Therefore the Commission must have
in particular the ability to suspend trade and exports from
all or part of
the Member State concerned and/or to
establish special conditions for the relevant products or
substances.

(9) In the event of a serious risk to human or animal health
or the environment appearing in a Member State due to
harmful feed it is indispensable for the Commission to be
able to take all the necessary precautionary measures to
protect public and animal health and the environment.
Therefore the Commission must have in particular the
ability to suspend trade and exports from all or part of
the Member State concerned and/or to establish special
conditions for the relevant products or substances.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(10) It is appropriate for the Commission to be able to take
provisional protective measures, applicable at an early
stage in the food chain,
in particular in feed materials
to improve efficiency in
and feedingstuffs,
reducing the spread of a hazard. This efficiency is also
dependent on the uniform application throughout
the
Community of these provisional protective measures.

in order

(10) It is necessary for the Commission to be able to take
provisional protective measures, applicable at an early
stage in the food chain,
in particular in feed materials
to improve efficiency in
and feedingstuffs,
reducing the spread of a hazard. This efficiency is also
dependent on the uniform application throughout
the
Community of these provisional protective measures.

in order

(11) Directive 1999/29/EC establishes the maximum limits for
and products whose
substances
certain undesirable
presence cannot be totally excluded in a certain number
of feed materials or feedingstuffs.

Unchanged

(12) A system is established by Directive 1999/29/EC, at
official inspection level, to enable the Member States to
be informed by operators, at all
the feed
producing chain, of cases of non-compliance with the
above directive on undesirable products and substances.
At present the obligation to inform the other Member
States and the Commission is only required when a
batch of feed materials or feedingstuffs, which is not in
compliance with the directive, is likely to be sent to other
Member States.

stages of

(13) It is necessary to incorporate such information system
into Directive 95/53/EC so that
it can be applied in
future in all cases where a product endangers public
environment and for
health,
purposes of improving the inspection system as a whole.

animal health or

the

(14) it is not possible difficult to list all potentially dangerous
contaminations of biological or chemical origin, which
may happen by accident or by illegal actions, and may
affect to be used in animal nutrition,

(14) Although it is difficult to list all potentially dangerous
contaminations of biological or chemical origin, which
may happen by accident or by illegal actions, and may
affect products to be used in animal nutrition, it would be
scientific
desirable,
knowledge, as in the case of the directive on undesirable
substances and products,
for a non-exhaustive list of
biological and chemical contaminants to be established

framework

current

the

of

in

(15) The risk of hazards originated by mislabelling or orig-
inating during handling, transport, storage or processing
shall be considered.

Unchanged

(16) To improve the effectiveness of the inspection system and
the relevant inspection measures Member States must be
obliged to verify the nature and extent of the contami-
nation and to make every effort to identify its origin in
order to detect any other possible contamination.

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INITIAL PROPOSAL

AMENDED PROPOSAL

for

following

(17) Directive 95/53/EC lays down that Member States shall
submit to the Commission information on the results of
inspections carried out each year before 1 April 2000 for
the first time; it is also laid down that these 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 coordinated inspection
Information
year.
the
programme
concerning contamination affecting the
a
safety of
product to be used in animal nutrition shall be considered
by the Member States and the Commission in fixing the
priorities for annual coordinated inspection programmes;
All the information gathered on risks for public health,
animal health or the environment, relating to the circu-
lation and use of products intended for animal nutrition,
can be better analysed when provided in harmonised and
standardised form; it is therefore appropriate to monitor
the occurrence of certain cases of contamination or
contamination occurring in certain products or practices
which may lead to hazards.

level

at Community

(18) The uniform and harmonised application of control
programmes
to
guarantee the safety of products to be used in animal
instrument of a decision
nutrition and that
provides better guarantees as regard its implementation
than a recommendation, and that this has to be taken
into
control
setting
programmes.

account when

coordinated

the legal

essential

is

(19) Procedures have been established for the exchange of
information in emergency situations under Council
Directive 92/59/EEC (1) on general product safety, and
taking into account that such procedures, may be used,
for a matter of harmonisation and efficiency for the
exchange of information in emergency related to animal
nutrition.

(19) Procedures have been established for the exchange of
information in emergency situations under Council
Directive 92/59/EEC (1) on general product safety, and
taking into account that such procedures, may be used,
after certain changes in the interest of harmonisation and
efficiency for the exchange of information in emergency
related to animal nutrition.

(19a) The obligation on persons and operators to inform the
official authorities when a batch of feed materials or
animal
a
feedingstuffs
and/or human health and/or for the environment must
not be seen as encouraging denunciation but basically as
a means to enable the inspection services to take the
necessary measures to withdraw a batch from circulation.

constitutes

risk for

serious

(19b) Member States should provide that officials responsible
for inspection are subject to professional confidentiality
in respect of information which, if disclosed, would be
likely to damage the activities of an undertaking.
Protection of trade secrets must not, however, prevent
publication of
in the public
information which is
from an environmental and health protection
interest
point of view,

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

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

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INITIAL PROPOSAL

AMENDED PROPOSAL

HAVE ADOPTED THIS DIRECTIVE:

Unchanged

Article 1

Directive 95/53/EC is amended as follows:

1. Article 2(1)(a) second indent is replaced by the following:

(cid:145)Council Directive 1999/29/EC of 22 April 1999 on the
undesirable substances and products in animal nutrition.(cid:146)

2. Article 2(1)(g) is replaced by the following:

(cid:145) (cid:147)establishment(cid:148): means any undertaking which produces
or manufactures a product intended for animal nutrition
or which holds the product at an intermediate stage before
marketing or which markets the products;(cid:146)

3. Article 2(1)(h) is replaced by the following:

3. Article 2(1)(h) is replaced by the following:

(cid:145) (cid:147)putting into circulation(cid:148) ((cid:147)circulation(cid:148)): the holding of
products to be used in animal nutrition for the purposes
of sale, including 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.(cid:146).

(cid:145) (cid:147)putting into circulation(cid:148) ((cid:147)circulation(cid:148)): the holding of
any type of products to be used in animal nutrition for
including offering for sale, or any
the purposes of sale,
other form of
to third
parties, and the sale and other forms of transfer them-
selves.(cid:146).

transfer, whether free or not,

4. The following Article 4a is added after Article 4:

Unchanged

(cid:145)Article 4a

1. Member States shall set up national contingency
operational plans to deal with emergencies relating to
the detection of serious risks for public health, animal
health or
for animal
nutrition.

the environment

from products

The Commission shall,

in accordance with the
2.
procedure laid down in Article 23,
set criteria for
drawing up minimum requirements for the contingency
plans by (October 2000). Such criteria may be amended
taking into account the experience gained.

3.
The Commission shall examine the plans in order to
determine whether they permit the desired objective to be
attained and shall suggest to the Member State concerned
any amendment required.

4.
The efficiency of such contingency plans shall be
verified by blind simulations, and on a regular basis,
with particular reference when changes in the structure
of the relevant control services take place, and the plans
shall be amended as necessary.(cid:146)

5. Article 13(1), second indent, is replaced by the following:

(cid:145)(cid:151) rendering the products harmless where appropriate,
or(cid:146)

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INITIAL PROPOSAL

AMENDED PROPOSAL

6. Article 14, first paragraph,

is replaced by the following:

(cid:145)In the event of the destruction, use for other purposes,
redispatch to the country of origin or rendering harmless
the
of
the products as provided for in Article 13(1),
the Member
Member State of destination shall contact
the
State of dispatch without delay.
the Member
Member State of destination may contact
State of dispatch. 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.(cid:146)

In other cases,

7. The following Section 3a is added after Article 15:

Unchanged

(cid:145)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 or
animal health or to the environment appears or spreads on
the territory of the European Union, the Commission, on
its own initiative or at the request of a Member State, shall
immediately, depending on the seriousness of the situation:

(cid:151) suspend the putting into circulation within the
Community and exports to third countries from all
or part of the Member State(s) concerned and/or

(cid:151) suspend the putting into circulation within the
Community, exports to third countries and prohibit
the feeding to animals of products from all or part
of the Member State(s) concerned or

(cid:151) lay down special conditions for the putting into circu-
lation in the Community and/or, exports to third
countries of products
the
Member State(s) concerned.

from all or part of

(cid:151) lay down special conditions for the putting into circu-
lation in the Community, exports to third countries
and the feeding to animals of products from all or
part of the Member State(s) concerned.

(cid:151) require the Member State(s) concerned to ensure that

the products are recalled where appropriate.

2.
The Commission shall notify the Council and
Member States of any decision adopted in accordance
with paragraph 1. Except in emergencies, the Commission
shall
taking the
the Member States before
measures referred to in paragraph 1.

consult

Unchanged

Any Member State may, within thirty days of such
3.
notification,
the Commission’s decision to the
Council. The Council, acting by a qualified majority, may
take a different decision within thirty days.

refer

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INITIAL PROPOSAL

AMENDED PROPOSAL

a Member State officially informs

4. Where
the
Commission of the need to take protective measures and
where the Commission has not acted in accordance with
paragraph 1, that Member State may adopt temporary
protective measures with regard to trade. Where a
it
Member State adopts temporary protective measures,
shall
the
other Member
Commission. The Commission shall submit the question
to the Standing Committee for Feedingstuffs within ten
working days for its opinion in accordance with the
procedure laid down in Article 23 with a view to the
extension,
national
temporary protective measures.(cid:146)

inform the

amendment

repeal

States

and

the

or

of

a Member State officially informs

4. Where
the
Commission of the need to take protective measures and
where the Commission has not acted in accordance with
paragraph 1, that Member State may adopt temporary
protective measures with regard to the use or putting
into circulation of products. Where a Member State
adopts temporary protective measures, it shall immediately
inform the other Member States and the Commission. The
Commission shall submit the question to the Standing
Committee for Feedingstuffs within ten working days for
its opinion in accordance with the procedure laid down in
Article 23 with a view to the extension, amendment or
repeal of the national temporary protective measures.

The Commission

5.
Parliament of the measures taken.(cid:146)

shall

inform the

European

8. The following Chapter IIIA is added after Article 16:

Unchanged

(cid:145)CHAPTER III A

INFORMATION SYSTEM FOR HAZARDS FROM FEED-
INGSTUFFS

Article 16a

1. Member States shall prescribe that when an operator
(importer, intermediaries, producer, etc.) or a person who,
by virtue of his professional activities possesses or has
possessed or has had direct contact with a consignment
of products to be used in animal nutrition, in its broader
meaning, and has knowledge to the effect that:

(cid:151) the consignment of products to be used for animal
nutrition is contaminated by dangerous substances or
products or organisms, or hazard may derive from
mislabelling or from handling, transport, storage, or
manufacturing; products or organisms, or may be
hazardous as a result of mislabelling or by virtue of
its handling, transport, storage or manufacture.

(cid:151) the consignment of products to be used for animal
nutrition contains dangerous substances or products
or organisms, or hazard may derive from mislabelling
or from handling, transport, storage, or manufacturing

(cid:151) the consignment of feed materials does not comply
in Directive

provisions

down

laid

the

with
1999/29/EC.

(cid:151) the consignment of feed materials does not comply
in Directives
and

laid
70/524/EEC,

82/471/EEC

provisions

down

the

with
1999/29/EC,
96/25/EC (1).

and therefore is aware that such a consignment constitutes
a serious risk for animal and/or public health or the
environment, such a person or operator shall immediately
the destruction,
inform the official authorities even if
withdrawal
the
consignment is envisaged.

from the market or

reprocessing of

In verifying the information received,

2.
the official
authorities shall take the necessary measures to ensure
is not used in animal nutrition
that
and in particular
the consignment under
restriction and investigate immediately:

the consignment

shall put

Unchanged

___________
(1) OJ L 125, 23.5.1996, p. 35.

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INITIAL PROPOSAL

AMENDED PROPOSAL

(cid:151) the nature of the hazard and when necessary the level

(cid:151) the nature of the hazard and when necessary the level

of the contamination;

of the harmful content;

(cid:151) the possible origin of

the contamination or of

the

(cid:151) the possible origin of the harmful content or of the

hazard.

hazard.

Member States shall ensure that the final destination of the
contaminated consignment, including such as decontami-
nation, reprocessing or destruction, cannot have harmful
effects on public or animal health or on the environment.

Member States shall ensure that the final destination of the
harmful consignment,
including possible processes of
rendering it harmless such as decontamination, repro-
cessing or destruction, cannot have harmful effects on
public or animal health or on the environment.

3. Where it cannot be excluded that the contamination
or the hazard could have been extended to the feed and
food chain or occurred in other batches, the relevant auth-
orities of the Member State shall immediately:

Unchanged

(cid:151) trace and put under

restriction any batch of

the
product deemed hazardous, including live animals fed
with hazardous feed and products or by-products
thereof ensuring coordination between the relevant
control
the
hazardous products from being placed on the market
and to the enforcement of recall procedures for the
products already on the market;

services with

particular

reference

(cid:151) trace and put under

restriction any batch of

the
including live animals fed
product deemed harmful,
with hazardous feed and products or by-products
thereof ensuring coordination between the relevant
control services with particular reference to prevent
from being placed on the
the harmful products
market and to the enforcement of recall procedures
for the products already on the market;

(cid:151) carry out a preliminary risk assessment on:

Unchanged

a) possible cross contamination with other products

used or to be used in the feed chain;

b) possible recycling of hazardous products in the feed

b) possible recycling of harmful products in the feed

chain

chain

(cid:151) inform immediately

Commission

sufficient
the
live
information to trace and identify feed materials,
and on safeguard
animals
measures envisaged or already taken,
to
enable the Commission to inform properly the other
Member States.

and products

in order

thereof

(cid:151) inform immediately the Commission providing in
particular sufficient information to trace and identify
products intended for use in animal nutrition,
live
animals and products
thereof and details on any
in
safeguard measures envisaged or already taken,
order to enable the Commission to inform properly
the other Member States.

state

Any Member
inform the
concerned
Commission of any follow up measure taken in respect
of the notified hazards including information related to
the end of the risk situation.

shall

state

Any Member
inform the
concerned
Commission immediately of any follow up measure
taken in respect of
including
information related to the end of the risk situation.

the notified hazards

shall

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INITIAL PROPOSAL

AMENDED PROPOSAL

The Commission and the Member States
system for exchange of

shall
4.
information in
operate this
application of
this directive with the same procedure
applied for the rapid alert system established in Council
Directive 92/59/EC on general product safety.(cid:146)

Unchanged

9. Article 17(2) is replaced by the following:

information which,

(cid:145)2. Member States shall provide that officials responsible
for inspection are subject to professional confidentiality in
respect of
if disclosed, might be
assumed to prejudice the activities of an undertaking.
Such protection of trade secrets may not prevent publi-
cation of information which is of public interest from an
environmental and health protection point of view.(cid:146)

10. The following Article 17a is added after Article 17:

(cid:145)Article 17a

State

experts may

1. Without prejudice to Article 15, Commission and
carry out on-the-spot
Member
of
inspections with
national
the
cooperation
competent authorities to verify that
the provisions of
this Directive, and in particular Articles 4, 5, 7, 11 and
12, are being applied.

the

The Commission shall appoint Member State experts on a
proposal from the Member States.

2.
The Member State on whose territory an inspection
is carried out shall afford the Commission and Member
State experts full assistance to carry out
their duties.
After informing the Member State concerned and in full
collaboration with the competent authorities, an inspection
of an establishment may be carried out without giving the
operators prior notice.

The Commission shall inform the Member State and the
European Parliament of the results of inspections carried
out, and shall publish an inspection report.(cid:146)

11. Article 22 is amended as follows:

Unchanged

1. The following paragraph 2a is added:

(cid:145)Member States shall keep records of actions taken when
operating in conformity with Article 16a(2) and include
a summary of these actions in the annual report to the
Commission.

(cid:145)Member States shall keep records of actions taken when
operating in conformity with Article 16a(2) and include
a summary of these actions in the annual report to the
Commission. An annual report shall be drawn up by
the Commission on the basis of the annual reports from
the Member States and shall be presented to the
European Parliament.

When the frequency of a certain contamination or
hazard deriving from a certain product to be used in
animal nutrition increases, an interim report shall be
provided, without delay, to the Commission.

Unchanged

The information contained in interim reports shall be
discussed in the Standing Committee for Feedingstuffs
in order to take the appropriate measures.

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AMENDED PROPOSAL

Annual reports and interim reports shall be provided in
accordance with a model
established in
accordance with Article 23.(cid:146)

to be

2. The first sentence of Paragraph 3 is modified as follows:

2. Paragraph 3 is modified as follows:

1. After the words (cid:145). . . Community level,(cid:146) is inserted the

Unchanged

following text:

(cid:145)and a summary of the interim reports(cid:146).

2. The word
(cid:145)decision(cid:146).

(cid:145)recommendation(cid:146)

is

replaced with

12. Recitals 3, 11, 17 of Council Directive 95/53/EC are

deleted.

Article 2

Paragraphs 3 and 4 of Article 12 of Council Directive
1999/29/EC are repealed.

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive not
later than. They shall apply these provisions
from.

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive not
later than (30 June 2001). They shall apply
these provisions from (1 July 2001).

They shall forthwith inform the Commission thereof.

Unchanged

2. When Member States adopt these measures, they shall
contain a reference to this Directive or shall be accompanied
by such reference at the time of their official publication. The
methods of making such reference shall be laid down by the
Member States.

3. Member States shall communicate to the Commission the
text of the essential provisions of national law they adopt in
the field covered by this Directive.

Article 4

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

Article 5

This Directive is addressed to the Member States.