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
Date: 2000-03-21
Institutions: European Commission
Subjects: EC Directive, EU control, animal health, animal nutrition, food inspection

C 274 E/28

EN

Official Journal of the European Communities

26.9.2000

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

(2000/C 274 E/04)

(Text with EEA relevance)

COM(2000) 162 final (cid:151) 2000/0068(COD)

(Submitted by the Commission on 21 March 2000)

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,

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
is necessary to
the achievement of such objective.
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(2) Council Directive 74/63/EEC (2) has been replaced by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

(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) Serious dioxin contamination recently occurred twice in
feed materials and feedingstuffs. The experience gained
from these contaminations suggests that it is necessary

(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.

and

in exchanging

to improve the procedures both in taking protective
information between
measures
Member States and the Commission in the event of the
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.

identified

operational
the dioxin crisis.

(5) The result of a Commission inspection carried out
following dioxin contamination of feed and of the food
chain
the
the
management of
experience gained, it is necessary to introduce provisions
requiring the Member 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

(6) 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
the Member State concerned and/or to
all or part of
establish special conditions for the relevant products or
substances.

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

in order

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

(9) 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

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Official Journal of the European Communities

C 274 E/29

(10) 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
health, animal health or
and for
purposes of improving the inspection system as a whole.

environment

the

(11) It is not possible to list all potentially dangerous contami-
nations of biological or chemical origin, which may
happen by accident or by illegal actions, and may affect
products to be used in animal nutrition.

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

(13) 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.

a

for

together with a proposal

(14) 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
coordinated
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 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 circulation
and use of products intended for animal nutrition, can
be better analysed when provided in harmonised and stan-
dardised form; it is therefore appropriate to monitor the
occurrence of certain cases of contamination or contami-
nation occurring in certain products or practices which
may lead to hazards.

at Community

(15) 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 regards its implementation
than a recommendation, and that this has to be taken into
account when setting coordinated control programmes.

the legal

essential

level

is

(16) 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,

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

HAVE ADOPTED THIS DIRECTIVE:

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)(h) is replaced by the following:

((cid:147)circulation(cid:148)):

(cid:145)(cid:147)putting into 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)

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

(cid:145)Article 4a

1. Member States shall set up national contingency oper-
ational plans to deal with emergencies relating to the
detection of serious risks for public health, animal health
or the environment from products for animal nutrition.

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 regular basis with
particular reference when changes in the structure of the
relevant control services takes place, and the plans shall be
amended as necessary.(cid:146)

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

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

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The Commission shall notify the Council and Member
2.
States of any decision adopted in accordance with paragraph
1.

Except in emergencies, the Commission shall consult the
Member States before taking the measures referred to in
paragraph 1.

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

refer

informs

a Member

State officially

that Member State may adopt

4. Where
the
Commission of the need to take protective measures and
where the Commission has not acted in accordance with
temporary
paragraph 1,
a
protective measures with regard to trade. Where
Member State adopts temporary protective measures,
it
shall 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.(cid:146)

5. The following Chapter (cid:145)III A(cid:146) is added after Article 16:

(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 possess or has
possessed or has had direct contact with a consignment of
in its broader
products to be used in animal nutrition,
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;

(cid:151) the consignment of feed materials does not comply with
the provisions laid down in Directive 1999/29/EC;

risk for animal and/or public health or

and therefore is aware that such a consignment constitutes a
serious
the
environment, such a person or operator shall immediately
inform the official authorities even if the destruction, with-
drawal from the market or reprocessing of the consignment
is envisaged.

In verifying the information received, the official auth-
2.
orities shall take the necessary measures to ensure that the
consignment
is not used in animal nutrition and in
particular shall put the consignment under restriction and
investigate immediately:

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

the contamination;

(cid:151) the possible origin of

the contamination or of

the

hazard.

Member States shall ensure that the final destination of the
contaminated consignment,
including possible decontami-
nation, reprocessing 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:

including live animals

(cid:151) trace and put under restriction any batch of the product
deemed hazardous,
fed with
hazardous feed and products or by-products thereof
ensuring coordination between the relevant control
services with
the
hazardous products from being placed on the market
and to the enforcement of recall procedures for the
products already on the market;

particular

reference

avoid

to

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

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

chain

(cid:151) inform immediately the Commission with particular
reference to sufficient information to trace and identify
feed materials, live animals and products thereof and on
safeguard measures envisaged or already taken, in order
to enable the Commission to inform properly the other
Member States.

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

The Commission and the Member States shall operate
4.
this system for exchange of information in 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)

6. Article 22 is amended as follows:

1. The following paragraph (cid:145)2a(cid:146) 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.

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.

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

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

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

They shall forthwith inform the Commission thereof.

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 2

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

Article 4

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

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive not
than (31 December 2000). They shall
apply these provisions from (1 January 2001).

later

Article 5

This Directive is addressed to the Member States.