**Avis juridique important**

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# 31995L0053

**Council Directive 95/53/EC of 25 October 1995 fixing the principles governing the organization of official inspections in the field of animal nutrition***Official Journal L 265 , 08/11/1995 P. 0017 - 0022*

COUNCIL DIRECTIVE  95/53/EC of 25 October 1995 fixing the principles governing the organization of official  inspections in the field of animal nutrition

THE COUNCIL OF THE EUROPEAN UNION,

 Having regard to the Treaty establishing the European Community, and in 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 helps safeguard 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 ensure  both the wholesomeness of the feedingstuff to be consumed by animals and 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 animal nutrition 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 of the authority for the purpose of carrying out officials  checks in the field of animal nutrition, provided that inspections continue to be carried out under  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 at which 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 export outside 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 efficient conduct of inspections of imported products, without  prejudice to the provisions laid down in other relevant Community legislation, in particular  Directives 90/675/EEC  (4) and 92/118/EEC  (5) concerning veterinary checks and animal health and  public health requirements;

 Whereas principles should be laid down to govern the organization of and steps to be taken  following the physical checks to be carried out by the 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 the place of  destination;

 Whereas this solution requires greater confidence in the inspections carried out by the Member  State of dispatch; whereas the Member State of dispatch must ensure that such checks are carried  out in an appropriate 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 measures appropriate to the situation;

 Whereas, in accordance with Council Directive 70/373/EEC  (1), all methods of sampling and methods  of analysis necessary for carrying out official 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, in particular 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 the  laboratories authorized to carry out analyses in connection with such inspections;

 Whereas, although it is primarily for the Member States to lay down their inspection programmes, it  is necessary, with a view to the proper functioning 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 Community veterinary rules.

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 competent authorities to check compliance with the Community provisions laid  down in:

 -  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs  (2),

 -  Council Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for  undesirable substances and products in feedingstuffs  (3),

 -  Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs   (4),

 -  Council Directive 79/373/EEC of 2 April 1979 on the marketing of compound feedingstuffs  (5),

 -  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal  nutrition  (6),

 -  Council Directive 93/74/EEC of 13 September 1993 on feedingstuffs intended for particular  nutritional purposes  (7), 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 accompanying a product or of any other  information provided on the product;

 (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 responsible for carrying out official  checks in the field of animal nutrition;

 (g)  'establishment` means any undertaking which produces or manufactures a product or which holds  the product at an intermediate stage 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 for payment, 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.

 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, and the use of products.

 The competent authority shall select the stage or stages most apporpriate 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 the  customs territory of the Community they are subjected by the competent authorities to a documentary  check of each batch and to random identity checks in order to verify:

 -  their nature,

 -  their origin,

 -  their geographical destination,

 so as determine the customs procedure applicable to them.

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.

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 and order their redispatch out of Community  territory; it shall immediately 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 his representative.

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, where appropriate, 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 to this 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 the procedure laid down in Article 23 before the 30 April  1998.

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 be marketed 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 random checks.

 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 the transport 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), it shall take the appropriate measures and formally require the consignor,  the consignee or any other person entitled to carry out, under the 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  Member State of dispatch without delay. In other cases, the Member State of destination may contact  the Member 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.

 If the Member State of destination fears that such measures are inadequate, the two Member States  shall together seek ways and means of 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 the Commission 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 infringements established, 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 on products 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, including those relating to intra-Community movements of products,  in accordance with the procedure laid down in the same Article.

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 the products  are manufactured or used in order to carry out the prescribed checks.

CHAPTER IV 

GENERAL PROVISIONS 

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 that  inspections 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 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.

 2.  Member States shall draw up a list of laboratories responsible for carrying out analyses; they  shall ensure that such laboratories are designated 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 inspections are 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 principles of 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. Such penalties shall be effective, shall be commensurate with their  purpose and 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 with details of the rights of appeal which are available to him  under the law in force in the Member State performing the checks and of the procedure and 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  referred to in paragraph 1 during the previous year, specifying:

 -  the criteria used in drawing up the programmes,

 -  the number and type of inspections carried out,

 -  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 the results of inspections carried out at Community level,  together with a proposal 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 a later date as required by the implementation of the coordinated programme.

 The coordinated programme shall indicate, in particular, the priority criteria to be followed for  its implementation.

 The information provided for in paragraph 2 shall contain a separate section specifically  concerning implementation of the coordinated programme.

Article 23 

1.  The Commission shall be assisted by the Standing Committee for Feedingstuffs, set  up by Decision 70/372/EEC  (1), hereinafter referred to as 'the Committee`.

 2.  The representative of the Commission shall submit to the Committee a draft of the measures to  be taken. The Committee shall deliver its opinion on the draft within a time limit which the  chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the  majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is  required to adopt on a proposal from the Commission. The votes of the representatives of the Member  States within the Committee shall be weighted in the manner set out in that Article. The chairman  shall not vote.

 3.  (a)  The Commission shall adopt the measures envisaged if they are in accordance with the  opinion of the Committee.

 (b)  If the measures envisaged are not in accordance with the opinion of the Committee, or if no  opinion is delivered, the Commission shall, without delay, submit to the Council a proposal  relating to the measures to be taken. The Council shall act by a qualified majority.

 If, on the expiry of a period of three months from the date of referral to the Council, the Council  has not acted, the proposed measures shall be adopted by the Commission, save where the Council has  decided against the said measures by a simple majority.

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 by this Directive.

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.

Done at Luxembourg, 25 October 1995.

 For the Council The President L. ATIENZA 

(1)  OJ No L 170, 3. 8. 1970, p. 1.