1995L0053 — EN — 29.12.2000 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE 95/53/EC
of 25October 1995
fixing the principles governing the organization of official inspections in the field of animal
nutrition
(OJ L 265, 8.11.1995, p. 17)
Amended by:
Official Journal
No page date
►M1Council Directive 1999/20/EC of 22 March 1999 L 80 20 25.3.1999
►M2Directive 2000/77/EC of the European Parliament and of the Council of
14 December 2000 L 333 81 29.12.2000
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COUNCIL DIRECTIVE 95/53/EC
of 25October 1995
fixing the principles governing the organization of official inspec-
tions in the field of animal nutrition
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, andin particular Article 43 thereof,
Having regard to the proposal from the Commission(
1),
Having regard to the opinion of the European Parliament(2),
Having regard to the opinion of the Economic and Social Committee(3),
Whereas animal nutrition has become a very important aspect of
Community agriculture;
Whereas fixing at Community level the principles governing the
organization of official inspections in the field of animal nutrition helpssafeguard animal health, human health and the environment, ensure the
fairness of commercial transactions and protect the interests of
consumers;
Whereas 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 ensureboth the wholesomeness of the feedingstuff to be consumed by animalsand the quality of the foodstuff;
Whereas, in order to attain the desired objective, the rules laid down in
this Directive must cover all products and substances used in animalnutrition in the Community; whereas inspections should therefore be
organized to cover products imported into or released for free circulation
in the Community;
Whereas the definition of ‘competent authority’ does not prevent
Member States from delegating in whole or in part the responsibility ofthe authority for the purpose of carrying out officials checks in the fieldof animal nutrition, provided that inspections continue to be carried outunder their authority;
Whereas, to be effective, inspections must be carried out regularly;
whereas they must not be restricted as to the subject, stage or moment atwhich they are carried out; whereas they must take the most suitable
forms to ensure their effectiveness;
Whereas, in order to ensure that inspection procedures are not evaded, it
is necessary to provide that Member States shall not exclude a product
from appropriate inspection on the grounds that it is intended for exportoutside the Community;
Whereas products from third countries must be subject to random
documentary and identity checks on entry into the Community territory;
Whereas provision should be made for Member States to have the
possibility of designating entry points in order to ensure the efficientconduct of inspections of imported products, without prejudice to theprovisions laid down in other relevant Community legislation, inparticular Directives 90/675/EEC(
4) and 92/118/EEC(5) concerning
veterinary checks and animal health and public health requirements;1995L0053 — EN — 29.12.2000 — 002.001 — 2
(1) OJ No C 313, 19. 11. 1993, p. 10.
(2) OJ No C 128, 9. 5. 1994, p. 97.
(3) OJ No C 127, 7. 5. 1994, p. 10.
(4) OJ No L 373, 31. 12. 1990, p. 1. Directive as last amended by Regulation
(EEC) No 1601/92 (OJ No L 173, 27. 6. 1992, p. 13).
(5) OJ No L 62, 15. 3. 1993, p. 49. Directive as last amended by Commission
Decision 94/723/EC (OJ No L 288, 9. 11. 1994, p. 48).
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Whereas principles should be laid down to govern the organization of
and steps to be taken following the physical checks to be carried out bythe competent authorities;
Whereas, as regards intra-Community trade, emphasis should be placed
on the checks to be carried out at the place of origin; whereas, however,
in the event of a presumption of irregularity, the check may,
exceptionally, be carried out while the products are in transit or at theplace of destination;
Whereas this solution requires greater confidence in the inspections
carried out by the Member State of dispatch; whereas the Member Stateof dispatch must ensure that such checks are carried out in anappropriate fashion;
Whereas provision should be made for action to be taken where a check
discloses that a consignment is irregular;
Whereas, for reasons of effectiveness, it is for the Member State of
dispatch to ensure that the products comply with Community rules;
whereas, in the event of infringements, the Commission must be able to
take action, in cooperation with the Member States concerned,particularly by making on-the-spot visits and adopting measuresappropriate to the situation;
Whereas, in accordance with Council Directive 70/373/EEC(
1), all
methods of sampling and methods of analysis necessary for carrying outofficial checks on feedingstuffs should be adopted at Community level;
Whereas, although undertakings should not have the right to oppose
inspections, their legitimate rights must nevertheless be preserved, inparticular the right to manufacturing secrecy and the right of appeal;
Whereas the authorities responsible for inspections may differ from one
Member State to another; whereas it is therefore desirable 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 thelaboratories authorized to carry out analyses in connection with suchinspections;
Whereas, although it is primarily for the Member States to lay down
their inspection programmes, it is necessary, with a view to the properfunctioning of the internal market, to arrange also for coordinated
programmes at Community level;
Whereas the Commission should be entrusted with the task of adopting
measures for applying this Directive,
HAS ADOPTED THIS DIRECTIVE:
CHAPTER I
INTRODUCTORY PROVISIONS
Article 1
1. This Directive sets out the principles governing the organization of
official inspections in the field of animal nutrition.
2. This Directive shall apply without prejudice to more specific
Community rules, in particular Community customs rules and Commu-nity veterinary rules.1995L0053 — EN — 29.12.2000 — 002.001 — 3
(1) OJ No L 170, 3. 8. 1970, p. 2. Directive as last amended by Regulation (EEC)
No 3768/85 (OJ No L 362, 31. 12. 1985, p. 8).
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Article 2
1. For the purposes of this Directive the following definitions shall
apply:
(a) ‘official inspection in the field of animal nutrition’, hereinafter
called ‘inspection’, means an inspection by the competentauthorities to check compliance with the Community provisionslaid down in:
— Council Directive 70/524/EEC of 23 November 1970 concerning
additives in feedingstuffs(
1),
— Council Directive 74/63/EEC of 17 December 1973 on the fixing
of maximum permitted levels for undesirable substances andproducts in feedingstuffs(
2),
— Council Directive 96/25/EC of 29 April 1996 on the circulation
of feed materials, amending Directives 70/524/EEC, 74/63/EEC,82/471/EEC and 93/74/EEC and repealing Directive 77/101/
EEC,
— Council Directive 79/373/EEC of 2 April 1979 on the marketing
of compound feedingstuffs(
3),
— Council Directive 82/471/EEC of 30 June 1982 concerning
certain products used in animal nutrition(4),
— Council Directive 93/74/EEC of 13 September 1993 on
feedingstuffs intended for particular nutritional purposes(5), and
— any other rules in the field of animal nutrition in which provision
is made for official inspections to be carried out in accordance
with the provisions of this Directive;
(b) ‘documentary check’ means verification of the documents accom-
panying a product or of any other information provided on theproduct;
(c) ‘identity check’ means verification, by visual inspection only, for
consistency between the documents, the labelling and the products;
(d) ‘physical check’ means a check of the product itself, including,
where appropriate, sampling and laboratory testing;
(e) ‘product’ means feedingstuffs and all substances used in animal
nutrition;
(f) ‘competent authority’ means the Member State's authority respon-
sible for carrying out official checks in the field of animal nutrition;
(g) ‘establishment’ means any undertaking which produces or manu-
factures a product or which holds the product at an intermediatestage before marketing or which markets the products;
(h) ‘marketing’ means the holding of products with a view to their sale
or other forms of disposal to others, by way of gift or in return forpayment, and also sale and other forms of disposal themselves.
2. The definitions given in the Community legislation relating to the
field of animal nutrition shall apply where appropriate.
Article 3
1. Member States shall take all the necessary measures to ensure that
inspections are carried out in accordance with this Directive.1995L0053 — EN — 29.12.2000 — 002.001 — 4
(1) OJ No L 270, 14. 12. 1970. Directive as last amended by Commission
Directive 94/77/EC (OJ No L 350, 31. 12. 1994, p. 113).
(2) OJ No L 38, 11. 2. 1974, p. 31. Directive as last amended by Commission
Directive 94/16/EC (OJ No L 104, 23. 4. 1994, p. 32).
(3) OJ No L 86, 6. 4. 1979, p. 30. Directive as last amended by Directive 93/74/
EEC (OJ No L 237, 22. 9. 1993, p. 23).
(4) OJ No L 213, 21. 7. 1982, p. 8. Directive as last amended by Directive 93/74/
EEC (OJ No L 237, 22. 9. 1993, p. 23).
(5) OJ No L 237, 22. 9. 1993, p. 23.▼M1
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2. Member States shall not exclude a product from appropriate
inspection on the grounds that it is intended for export.
Article 4
1. Inspections shall be carried out:
(a) at regular intervals;
(b) where non-compliance is suspected;
(c) using means proportionate to the desired objective and particularly
in the light of the risks and of experience gained.
2. Inspections shall cover all stages of production and manufacture,
the intermediate stages prior to marketing, including importation, andthe use of products.
The competent authority shall select the stage or stages most appropriate
for the intended purpose of the inspection.
3. As a general rule, inspections shall be carried out without prior
warning.
4. Inspections shall also cover uses prohibited in relation to animal
nutrition.
CHAPTER II
IMPORTS FROM THIRD COUNTRIES
Article 5
Notwithstanding Article 4 (1), Member States shall take all the
necessary steps to ensure that when products are introduced into thecustoms territory of the Community they are subjected by the competentauthorities to a documentary check of each batch and to random identitychecks in order to verify:
— their nature,
— their origin,
— their geographical destination,
so as determine the customs procedure applicable to them.
Where appropriate, detailed rules for the application of this Article shall
be adopted in accordance with the procedure laid down in Article 23.
Article 6
For the purpose of the checks provided for in Article 5, Member States
may designate particular entry points in their territory for the various
types of products.
To the same end they may require notice to be given to them of arrival
of products at a particular entry point.
Article 7
Member States shall ensure the conformity of products by means of
random physical checks before they are marketed.
Where appropriate, detailed rules for the application of this Article shall
be adopted in accordance with the procedure laid down in Article 23.
Article 8
1. Where the checks show that products do not meet the requirements
of the rules, the Member State shall prohibit their entry or marketing andorder their redispatch out of Community territory; it shall immediately1995L0053 — EN — 29.12.2000 — 002.001 — 5
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inform the Commission and the other Member States that it has rejected
the products, indicating the infringements found.
2. Notwithstanding paragraph 1, Member States may authorize the
carrying out, under the conditions laid down by the competent authority,of one of the following operations:
— bringing the products into line with the requirements within a
deadline to be determined, or
— decontamination where appropriate, or— processing in any other suitable manner, or
— use for other purposes, or
— destruction of the products.
Member States shall ensure that the operations listed in the first
subparagraph do not give rise to any adverse effects on human and
animal health or on the environment.
3. The costs incurred in the measures taken in accordance with
paragraphs 1 and 2 shall be borne by the authorization holder or hisrepresentative.
Article 9
1. Where products are not marketed in the territory of the Member
State which carries out the checks referred to in Article 5 and, whereappropriate, a physical check, that Member State shall provide the
person concerned with a document indicating the type of check carried
out and its outcome. Commercial documents shall contain a reference tothis document.
However, the right of the Member State of destination to carry out
random checks on products shall not be affected.
2. A standard document and, where appropriate, detailed rules for the
application of paragraph 1 shall be adopted in accordance with theprocedure laid down in Article 23 before the 30 April 1998.
Article 9a
1. Where a problem likely to pose a serious risk to human or animal
health or the environment appears or spreads on the territory of a thirdcountry, the Commission, on its own initiative or at the request of aMember State, shall immediately depending on the gravity of thesituation take the following measures, in accordance with the procedure
laid down in Article 23a:
— suspend imports of products from all or part of the third country
concerned or from one or more specific production establishments
and, where appropriate, any third country of transit and/or
— lay down special conditions for products intended for import from all
or part of the third country concerned.
2. However, in emergencies, the Commission may provisionally
adopt the measures referred to in paragraph 1 after informing theMember States. It shall submit the matter to the Standing Committee forFeedingstuffs within ten working days for its opinion, in accordancewith the procedure laid down in Article 23a, with a view to theextension, amendment or repeal of those measures. For such time as the
measures adopted by the Commission have not been replaced by another
legal act, they shall continue to apply.
3. Where a Member State officially informs 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 imports. Where a MemberState adopts temporary protective measures, it shall immediately informthe other Member States and the Commission. The Commission shallsubmit the matter to the Standing Committee for Feedingstuffs withinten working days in accordance with the procedure laid down in Article1995L0053 — EN — 29.12.2000 — 002.001 — 6
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23 with a view to the extension, amendment or repeal of the national
temporary protective measures.
Article 9b
1. Where necessary, on-the-spot inspections may be carried out by
Commission and Member State experts in third countries to verifywhether guarantees, offered by those countries, regarding the conditions
for the production and putting into circulation of products can be
considered as at least equivalent to those required in the Community.
2. The inspections referred to in paragraph 1 shall be carried out on
behalf of the Community, which shall bear the costs thereof.
3. The Commission shall inform the Member States of the results of
the inspections referred to in paragraph 1.
4. Where necessary, detailed rules for the application of this Article
shall be adopted in accordance with the procedure laid down in Article23.
CHAPTER III
TRADE WITHIN THE COMMUNITY
Article 10
Member States shall take all necessary measures to ensure that products
intended for dispatch to another Member State are inspected with the
same care as those intended to be marketed in their own territory.
Section 1
Checks at source
Article 11
1. Member States shall ensure that the competent authority carries out
checks on establishments in order to satisfy itself that they meet their
obligations under Community rules and that products intended to bemarketed comply with Community requirements.
2. Where there are grounds for suspecting that requirements are not
being met, the competent authority shall carry out the necessary checks
and, if the suspicion is confirmed, take the appropriate measures.
Section 2
Control at destination
Article 12
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 randomchecks.
2. However, where the competent authority of the Member State of
transit or the Member State of destination has information leading it to
suspect an infringement, checks may also be carried out during thetransport of products in its territory.
Article 13
1. If, during a check carried out at the place of destination of a
consignment or during transport, a Member State establishes the non-compliance of the products with the provisions of Article 2 (1) (a), itshall take the appropriate measures and formally require the consignor,the consignee or any other person entitled to carry out, under the1995L0053 — EN — 29.12.2000 — 002.001 — 7
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conditions laid down by the competent authority, one of the following
operations:
— bringing of the products into compliance within a deadline to be
determined, or
— decontamination where appropriate, or
— processing in any other suitable manner, or
— use for other purposes, or
— redispatch to the country of origin, after informing the competent
authority of the country of the establishment of origin, or
— destruction of the products.
2. The costs incurred in the measures taken in accordance with
paragraph 1 shall be borne by the consignor or any other person entitled,
including where appropriate the consignee.
Section 3
Cooperation in the event of infringements
Article 14
In the event of the destruction, use for other purposes, redispatch to the
country of origin or decontamination of the products as provided for in
Article 13 (1), the Member State of destination shall contact the MemberState of dispatch without delay. In other cases, the Member State ofdestination may contact the Member State of dispatch. The MemberState 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.
If the Member State of destination fears that such measures are
inadequate, the two Member States shall together seek ways and meansof remedying the situation; if appropriate this may involve a joint on-the-spot inspection.
Where the checks carried out in accordance with Article 12 show
repeated irregularities, the Member State of destination shall inform theCommission and the other Member States.
Article 15
1. At the request of the Member State of destination or on its own
initiative, taking into account the nature of the infringementsestablished, the Commission may:
— send representatives, in cooperation with the Member State
concerned, to the establishment in question,
— request the Member State of dispatch to intensify its checks on the
products of the establishment concerned.
2. The Commission shall inform the Member States concerned of its
findings.
Pending the Commission's findings, the Member State of dispatch must,
if so requested by the Member State of destination, intensify checks onproducts coming from the establishment in question.
The Member State of destination may, for its part, intensify checks on
products coming from the same establishment.
3. The Commission may review the situation within the Committee
referred to in Article 23. It may adopt the necessary decisions, includingthose relating to intra-Community movements of products, in accor-dance with the procedure laid down in the same Article.1995L0053 — EN — 29.12.2000 — 002.001 — 8
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Section 4
Inspections on holdings
Article 16
Member States shall ensure that the competent authority has access to
places where agricultural production is carried on and where theproducts are manufactured or used in order to carry out the prescribed
checks.
CHAPTER IV
GENERAL PROVISIONS AND INSPECTIONS
Article 17
1. Member States shall ensure that inspections are carried out in such
a way that delays in the delivery of products are minimized and thatinspections do not result in unjustified obstacles to the marketing
thereof.
2. Member States shall provide that officials responsible for
inspection are subject to professional confidentiality.
Article 17a
1. Without prejudice to Article 15, and insofar as necessary for the
uniform application of the requirements of this Directive, Commission
and Member State experts may carry out on-the-spot inspections, incooperation with the competent national authorities, to verify that theprovisions of this Directive, and in particular Articles 4, 5, 7, 11 and 12,are being applied.
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 tocarry out their duties.
3. The outcome of the inspections made shall be discussed with the
competent authority of the Member State concerned before a final reportis drawn up and circulated.
The Commission shall inform the Member States and the European
Parliament of the results of inspections carried out.
4. Where the Commission or a Member State considers that the
results of an inspection justify it, these shall be examined in the StandingCommittee for Feedingstuffs. The Commission shall adopt anynecessary decisions in accordance with the procedure laid down in
Article 23.
5. The Commission shall monitor the situation and amend or repeal
the decisions referred to in paragraph 4 in accordance with the procedure
laid down in Article 23.
6. Detailed rules for the application of this Article shall be adopted in
accordance with the procedure laid down in Article 23.
Article 18
1. Where products are sampled for the purpose of analysis, Member
States shall adopt the provisions necessary:
— to ensure that those subject to checks are entitled to a second
opinion,
— to ensure that officially sealed reference samples are preserved.1995L0053 — EN — 29.12.2000 — 002.001 — 9
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2. Member States shall draw up a list of laboratories responsible for
carrying out analyses; they shall ensure that such laboratories aredesignated on account of their capabilities.
3. Member States shall ensure that sampling and analysis are carried
out in accordance with Community rules.
However, in the absence of Community rules and methods, Member
States shall take all necessary steps to satisfy themselves that inspectionsare carried out:
— in accordance with standards recognized by international bodies,
— in the absence of such standards, in accordance with scientifically
recognized national rules which comply with the general principlesof the Treaty.
4. Detailed rules for the application of this Article may be adopted in
accordance with the procedure laid down in Article 23.
Article 19
Each Member State shall take the measures required to ensure that all
the provisions of this Directive are applied in full. Penalties must be laid
down for the event of a failure to comply with those measures. Suchpenalties shall be effective, shall be commensurate with their purposeand shall have an adequate deterrent effect.
Article 20
Rights of appeal existing under the laws in force in the Member States
against decisions by the competent authorities shall not be affected by
this Directive.
Decisions taken by the competent authority where an infringement has
been found and the reasons for such decisions must be notified to the
operator concerned by such decisions or his representative.
If the operator concerned or his representative so requests, the said
decisions and reasons must be communicated to him in writing withdetails of the rights of appeal which are available to him under the law inforce in the Member State performing the checks and of the procedureand time limits applicable.
Article 21
Each Member State shall communicate to the Commission one year after
this Directive enters into force:
— the competent authority or authorities, their geographical coverage
and their sphere of competence,
— the laboratory or laboratories referred to in Article 18 (2),
— where appropriate, the list of entry points referred to in Article 6.
This information, together with subsequent amendments, shall be
published in the ‘C’ series of the Official Journal of the European
Communities .
Article 22
1. By 1 October 1998 at the latest, Member States shall drawn up
programmes setting out the national measures to be taken to achieve the
aim of this Directive.
These programmes must take into account the specific situation of each
Member State and specify the type and frequency of the inspections,
which must be performed regularly.
2. Before 1 April each year and before 1 April 2000 for the first time,
the Member States shall transmit to the Commission all relevant
information concerning the implementation of the programmes referredto in paragraph 1 during the previous year, specifying:
— the criteria used in drawing up the programmes,
— the number and type of inspections carried out,1995L0053 — EN — 29.12.2000 — 002.001 — 10
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— the results of the inspections, in particular the number and type of
infringements found,
— action taken where infringements have been found.
3. Before 1 October each year and before 1 October 2000 for the first
time, the Commission shall submit an overall summary report on theresults of inspections carried out at Community level, together with aproposal for a recommendation concerning a coordinated inspection
programme for the following year, for adoption in accordance with the
procedure under Article 23. This recommendation may be amended at alater date as required by the implementation of the coordinatedprogramme.
The coordinated programme shall indicate, in particular, the priority
criteriato be followed for its implementa tion.
The information provided for in paragraph 2 shall contain a separate
section specifically concerning implementation of the coordinated
programme.
4. Without prejudice to paragraphs 1, 2 and 3, where the protection of
human or animal health or the environment requires the promptintroduction of limited, specific, coordinated programmes of inspectionsat Community level, the Commission shall take the necessary measuresin accordance with the procedure laid down in Article 23.
These programmes shall in particular serve in situations provoked by a
specific incident.
Article 23
1. The Commission shall be assisted by the Standing Committee for
Feedingstuffs (hereinafter referred to as ‘the Committee’).
2. Where reference is made to this Article, Articles 5 and 7 of
Decision 1999/468/EC shall apply, having regard to the provisions ofArticle 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be 3
months.
3. The Committee shall adopt its rules of procedure.
Article 23a
1. The Commission shall be assisted by the Standing Committee for
Feedingstuffs (hereinafter referred to as ‘the Committee’).
2. Where reference is made to this Article, Articles 5 and 7 of
Decision 1999/468/EC shall apply, having regard to the provisions ofArticle 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
15 days.
3. The Committee shall adopt its rules of procedure.
Article 24
1. Member States shall adopt the laws, regulations and administrative
provisions necessary to comply with this Directive not later than 30
April 1998. They shall forthwith inform the Commission thereof.
When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such reference on
the occasion of their official publication. The methods of making such
reference shall be laid down by Member States.
2. Member States shall communicate to the Commission the text of
the provisions of national law which they adopt in the area covered bythis Directive.1995L0053 — EN — 29.12.2000 — 002.001 — 11
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Article 25
This Directive shall enter into force on the day following its publication
in the Official Journal of the European Communities .
Article 26
This Directive is addressed to the Member States.1995L0053 — EN — 29.12.2000 — 002.001 — 12