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31991L0356

Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use

Official Journal L 193 , 17/07/1991 P. 0030 - 0033 Finnish special edition: Chapter 13 Volume 20 P. 0206  Swedish special edition: Chapter 13 Volume 20 P. 0206

COMMISSION DIRECTIVE  of 13 June 1991  laying down the principles and guidelines of good manufacturing practice for medicinal products for human use  (91/356/EEC)THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (1), as last amended by Directive 89/381/EEC (2), and in  particular Article 19a thereof,  Whereas all medicinal products for human use manufactured or imported into the Community, including medicinal products intended for export, should be manufactured in accordance with the principles and guidelines of good manufacturing practice;  Whereas, in accordance with national legislation, Member States may require compliance with these principles of good manufacturing practice during the manufacture of products intended for use in clinical trials;  Whereas the detailed guidelines mentioned in Article 19a of Directive 75/319/EEC have been published by the Commission after consultation with the pharmaceutical inspection services of the Member States in the form of a 'Guide to good manufacturing  practice for medicinal products';  Whereas it is necessary that all manufacturers should operate an effective quality management of their manufacturing operations, and that this requires the implementation of a pharmaceutical quality assurance system;  Whereas officials representing the competent authorities should report on whether the manufacturer complies with good manufacturing practice and that these reports should be communicated upon reasoned request to the competent authorities of another  Member State;  Whereas the principles and guidelines of good manufacturing practice should primarily concern personnel, premises and equipment, documentation, production, quality control, contracting out, complaints and product recall, and self inspection;  Whereas the principles and guidelines envisaged by this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal  Products Sector set up by Article 2b of Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of  proprietary medicinal products (3), as last amended by Directive 89/341/EEC (4),  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I  GENERAL PROVISIONS   Article 1  This Directive lays down the principles and guidelines of good manufacturing practice for medicinal products for human use whose manufacture requires the authorization referred to in Article 16 of Directive 75/319/EEC.  Article 2  For the purposes of this Directive, the definition of medicinal products set out in Article 1 (2) of Council Directive 65/65/EEC (5), shall apply.  In addition,  - 'manufacturer' shall mean any holder of the authorization referred to in Article 16 of Directive 75/319/EEC,  - 'qualified person' shall mean the person referred to in Article 21 of Directive 75/319/EEC,  - 'pharmaceutical quality assurance' shall mean the sum total of the organized arrangements made with the object of ensuring that medicinal products are of the quality required for their intended use,  - 'good manufacturing practice' shall mean the part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.  Article 3  By means of the repeated inspections referred to in Article 26 of Directive 75/319/EEC, the Member States shall ensure that manufacturers respect the principles and guidelines of good manufacturing practice laid down by this Directive.  For the interpretation of these principles and guidelines of good manufacturing practice, the manufacturers and the agents of the competent authorities shall refer to the detailed guidelines referred to in Article 19a of Directive 75/319/EEC. These  detailed guidelines are published by the Commission in the 'Guide to good manufacturing practice for medicinal products' and in its Annexes (Office for Official Publications of the European Communities, The rules governing medicinal products in the  European Community, Volume IV).  Article 4  The manufacturer shall ensure that the manufacturing operations are carried out in accordance with good manufacturing practice and with the manufacturing authorization.  For medicinal products imported from third countries, the importer shall ensure that the medicinal products have been manufactured by manufacturers duly authorized and conforming to good manufacturing practice standards, at least equivalent to those  laid down by the Community.  Article 5  The manufacturer shall ensure that all manufacturing operations subject to an authorization for marketing are carried out in accordance with the information given in the application for marketing authorization as accepted by the competent  authorities.  The manufacturer shall regularly review their manufacturing methods in the light of scientific and technical progress. When a modification to the marketing authorization dossier is necessary, the application for modification must be submitted to the  competent authorities.  CHAPTER II  PRINCIPLES AND GUIDELINES OF GOOD MANUFACTURING PRACTICE   Article 6  Quality management  The manufacturer shall establish and implement an effective pharmaceutical quality assurance system, involving the active participation of the management and personnel of the different services involved.  Article 7  Personnel  1. At each manufacturing site, the manufacturer shall have competent and appropriately qualified personnel at his disposal in sufficient number to achieve the pharmaceutical quality assurance objective.  2. The duties of managerial and supervisory staff, including the qualified person(s), responsible for implementing and operating good manufacturing practice shall be defined in job descriptions. Their hierarchical relationships shall be defined in an  organization chart. Organization charts and job descriptions shall be approved in accordance with the manufacturer's internal procedures.  3. Staff referred to in paragraph 2 shall be given sufficient authority to discharge their responsibilities correctly.  4. Personnel shall receive initial and continuing training including the theory and application of the concept of quality assurance and good manufacturing practice.  5. Hygiene programmes adapted to the activities to be carried out shall be established and observed. These programmes include procedures relating to health, hygiene and clothing of personnel.  Article 8  Premises and equipment  1. Premises and manufacturing equipment shall be located, designed, constructed, adapted and maintained to suit the intended operations.  2. Lay out, design and operation must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid contamination, cross contamination and, in general, any adverse effect on the quality of the product.  3. Premises and equipment intended to be used for manufacturing operations which are critical for the quality of the products shall be subjected to appropriate qualification.  Article 9  Documentation  1. The manufacturer shall have a system of documentation based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the various manufacturing operations that  they perform. Documents shall be clear, free from errors and kept up to date. Pre-established procedures for general manufacturing operations and conditions shall be available, together with specific documents for the manufacture of each batch. This set  of documents shall make it possible to trace the history of the manufacture of each batch. The batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates or at least five years after the  certification referred to in Article 22 (2) of Directive 75/319/EEC whichever is the longer.  2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall have validated the systems by proving that the data will be appropriately stored during the anticipated period of storage.  Data stored by these systems shall be made readily available in legible form. The electronically stored data shall be protected against loss or damage of data (e.g. by duplication or back-up and transfer onto another storage system).  Article 10  Production  The different production operations shall be carried out according to pre-established instructions and procedures and in accordance with good manufacturing practice. Adequate and sufficient resources shall be made available for  the in-process controls.  Appropriate technical and/or organizational measures shall be taken to avoid cross contamination and mix-ups.  Any new manufacture or important modification of a manufacturing process shall be validated. Critical phases of manufacturing processes shall be regularly revalidated.  Article 11  Quality control  1. The manufacturer shall establish and maintain a quality control department. This department shall be placed under the authority of a person having the required qualifications and shall be independent of the other  departments.  2. The quality control department shall have at its disposal one or more quality control laboratories appropriately staffed and equipped to carry out the necessary examination and testing of starting materials, packaging materials and intermediate and  finished products testing. Resorting to outside laboratories may be authorized in accordance with Article 12 of this Directive after the authorization referred to in Article 5b of Directive 75/319/EEC has been granted.  3. During the final control of finished products before their release for sale or distribution, in addition to analytical results, the quality control department shall take into account essential information such as the production conditions, the  results of in-process controls, the examination of the manufacturing documents and the conformity of the products to their specifications (including the final finished pack).  4. Samples of each batch of finished products shall be retained for at least one year after the expiry date. Unless in the Member States of manufacture a longer period is required, samples of starting materials (other than solvents, gases and water)  used shall be retained for at least two years after the release of the product. This period may be shortened if their stability, as mentioned in the relevant specification, is shorter. All these samples shall be maintained at the disposal of the  competent authorities.  For certain medicinal products manufactured individually or in small quantities, or when their storage could raise special problems, other sampling and retaining conditions may be defined in agreement with the competent authority.  Article 12  Work contracted out  1. Any manufacturing operation or operation linked with the manufacture which is carried out under contract, shall be the subject of a written contract between the contract giver and the contract acceptor.  2. The contract shall clearly define the responsibilities of each party and in particular the observance of good manufacturing practice by the contract acceptor and the manner in which the qualified person responsible for releasing each batch shall  undertake his full responsibilities.  3. The contract acceptor shall not subcontract any of the work entrusted to him by the contract giver without the written authorization of the contract giver.  4. The contract acceptor shall respect the principles and guidelines of good manufacturing practice and shall submit to inspections carried out by the competent authorities as provided for by Article 26 of Directive 75/319/EEC.  Article 13  Complaints and product recall  The manufacturer shall implement a system for recording and reviewing complaints together with an effective system for recalling promptly and at any time the medicinal products in the distribution network. Any  complaint concerning a defect shall be recorded and investigated by the manufacturer. The competent authority shall be informed by the manufacturer of any defect that could result in a recall or abnormal restriction on the supply. In so far as possible,  the countries of destination shall also be indicated. Any recall shall be made in accordance with the requirements referred to in Article 33 of Directive 75/319/EEC.  Article 14  Self-inspection  The manufacturer shall conduct repeated self-inspections as part of the quality assurance system in order to monitor the implementation and respect of good manufacturing practice and to propose any necessary corrective  measures. Records of such self-inspections and any subsequent corrective action shall be maintained.  CHAPTER III  FINAL PROVISIONS   Article 15  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 January 1992. They shall forthwith inform the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  Article 16  This Directive is addressed to the Member States. Done at Brussels, 13 June 1991. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 147, 9. 6. 1975, p. 13. (2) OJ No L 181, 28. 6. 1989, p. 44. (3) OJ No L 147, 9. 6. 1975, p. 1. (4) OJ No L 142, 25. 5. 1989, p. 11. (5) OJ No 22, 9. 2. 1965, p. 369/65.


title: Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (recast) (Text with EEA relevance)

text:
               20.5.2009

               EN

               Official Journal of the European Union

               L 124/21

      DIRECTIVE 2009/39/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 6 May 2009
   on foodstuffs intended for particular nutritional uses
   (recast)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity.

               (2)

               Differences between national laws relating to foodstuffs for particular nutritional uses impede their free movement, may create unequal conditions of competition, and thus have a direct impact on the functioning of the internal market.

               (3)

               The approximation of national laws presupposes the drawing-up of a common definition, the determination of measures enabling the consumer to be protected against fraud concerning the nature of these products and the adoption of rules to be complied with in labelling the products in question.

               (4)

               The products covered by this Directive are foodstuffs the composition and preparation of which must be specially designed to meet the particular nutritional requirements of the persons for whom they are mainly intended. It may be necessary, therefore, to provide for derogations from the general or specific provisions applicable to foodstuffs in order to achieve the specific nutritional objective.

               (5)

               Although foodstuffs intended for particular nutritional uses which are the subject of specific provisions can be efficiently monitored on the basis of the general rules for monitoring all types of foodstuffs, this is not always the case for those foodstuffs in respect of which no such specific provisions exist.

               (6)

               For the latter the usual means available to the monitoring bodies might not, in certain cases, enable them to check whether a foodstuff actually has the particular nutritional properties attributed to it. It is necessary, therefore, to provide that, where necessary, the person responsible for placing that foodstuff on the market should assist the monitoring body in carrying out its activities.

               (7)

               Specific provisions applicable to certain groups of foodstuffs should be laid down by means of specific Directives.

               (8)

               A procedure should be laid down which allows the foodstuffs resulting from technological innovations to be placed on the market on a temporary basis in order that proper benefit may be derived from the fruits of industry research pending the amendment of the specific Directive concerned. However, on the grounds of consumer health protection, marketing authorisation may be granted only after consultation of the European Food Safety Authority.

               (9)

               Since it is not clear whether an adequate basis exists for specific provisions to be adopted for the group of foods intended for persons suffering from carbohydrate metabolism disorders (diabetes), the Commission should be allowed to adopt or propose the relevant provisions at a later stage, after consultation of the European Food Safety Authority.

               (10)

               It is still possible to harmonise, at Community level, rules applicable to other groups of foodstuffs for particular nutritional uses, in the interests of consumer protection and the free movement of such foodstuffs.

               (11)

               The drawing-up of specific Directives implementing the basic principles of Community rules and amendments thereto are implementing measures of a technical nature. Their adoption should be entrusted to the Commission in order to simplify and expedite the procedure.

               (12)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5).

               (13)

               In particular, the Commission should be empowered to adopt certain specific Directives, a list of substances with specific nutritional purposes and of other substances intended to be added to foodstuffs intended for particular nutritional uses, together with the purity criteria applicable to them, and, where appropriate, the conditions under which they should be used, provisions rendering it possible to indicate on foodstuffs for normal consumption that they are suitable for a particular nutritional use, special provisions for foods for persons suffering from carbohydrate metabolism disorders (diabetes), rules for the use of terms concerning the reduction or absence of sodium or salt content or the absence of gluten, which may be used to describe the products, as well as conditions under which reference may be made in labelling, presentation and advertising to a diet or to a category of persons. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (14)

               When, on imperative grounds of urgency, the normal time limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption and amendment of a list of substances with specific nutritional purposes and of other substances intended to be added to foodstuffs intended for particular nutritional uses, together with the purity criteria applicable to them and, where appropriate, the conditions under which they should be used, as well as for adoption of amendments to this Directive or to specific Directives when it is established that a foodstuff intended for a particular nutritional use endangers human health although it complies with the relevant specific Directive.

               (15)

               The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.

               (16)

               This Directive should be without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex II, Part B,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   1.   This Directive concerns foodstuffs for particular nutritional uses.
   2.   Foodstuffs for particular nutritional uses are foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability.
   3.   A particular nutritional use shall fulfil the particular nutritional requirements:

               (a)

               of certain categories of persons whose digestive processes or metabolism are disturbed; or

               (b)

               of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs; or

               (c)

               of infants or young children in good health.

         Article 2
   1.   The products covered by points (a) and (b) of Article 1(3) may be characterised as ‘dietetic’ or ‘dietary’.
   2.   In the labelling, presentation and advertising of foodstuffs for normal consumption the following shall be prohibited:

               (a)

               the use of the adjectives ‘dietetic’ or ‘dietary’ either alone or in conjunction with other words, to designate those foodstuffs;

               (b)

               all other markings or any presentation likely to give the impression that one of the products referred to in Article 1 is involved.

         However, in accordance with provisions to be adopted by the Commission, it shall be possible for foodstuffs for normal consumption which are suitable for a particular nutritional use to indicate such suitability.
   Such provisions may lay down the arrangements for indicating that suitability.
   The measures referred to in the second subparagraph, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
   Article 3
   1.   The nature or composition of the products referred to in Article 1 shall be such that the products are appropriate for the particular nutritional use intended.
   2.   The products referred to in Article 1 shall also comply with any mandatory provisions applicable to foodstuffs for normal consumption, save as regards changes made to them to ensure their conformity with the definitions given in Article 1.
   Article 4
   1.   The specific provisions applicable to the groups of foodstuffs for particular nutritional uses appearing in Annex I shall be laid down by means of specific Directives.
   Such specific Directives may cover in particular:

               (a)

               essential requirements as to the nature or composition of the products;

               (b)

               provisions regarding the quality of raw materials;

               (c)

               hygiene requirements;

               (d)

               permitted changes within the meaning of Article 3(2);

               (e)

               a list of additives;

               (f)

               provisions regarding labelling, presentation and advertising;

               (g)

               sampling procedures and methods of analysis necessary for checking compliance with the requirements of the specific Directives.

         Such specific Directives shall be adopted:

               —

               in the case of point (e), in accordance with the procedure laid down in Article 95 of the Treaty,

               —

               in the case of the other points, by the Commission. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).

         Provisions likely to have an effect on public health shall be adopted after consultation of the European Food Safety Authority.
   2.   To enable foodstuffs intended for particular nutritional uses and resulting from scientific and technological progress to be placed on the market rapidly, the Commission may, after consulting the European Food Safety Authority, authorise for a two-year period the placing on the market of foodstuffs which do not comply with the rules as to composition laid down by the specific Directives for groups of foodstuffs for particular nutritional uses referred to in Annex I. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
   If necessary, the Commission may add in the authorisation decision labelling rules relating to the change in composition.
   3.   The Commission shall adopt a list of substances with specific nutritional purposes such as vitamins, mineral salts, amino acids and of other substances intended to be added to foodstuffs intended for particular nutritional uses, together with the purity criteria applicable to them, and, where appropriate, the conditions under which they should be used.
   Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
   On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 15(4).
   Article 5
   The Commission shall adopt rules for the use of terms concerning the reduction or absence of sodium or salt (sodium chloride, table salt) content or the absence of gluten, which may be used to describe the products referred to in Article 1.
   Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
   Article 6
   Before 8 July 2002, the Commission shall, after consulting the European Food Safety Authority, present to the European Parliament and to the Council a report on the desirability of special provisions for foods for persons suffering from carbohydrate metabolism disorders (diabetes).
   In the light of the conclusions of that report, the Commission shall either:

               (a)

               proceed with the preparation of the special provisions concerned; or

               (b)

               present, in accordance with the procedure laid down in Article 95 of the Treaty, any appropriate proposals for amendments to this Directive.

         The measures referred to in point (a), designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
   Article 7
   The Commission may adopt conditions under which reference may be made in labelling, presentation and advertising to a diet or to a category of persons for which a product referred to in Article 1 is intended.
   Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3).
   Article 8
   1.   The labelling and the labelling methods used, the presentation and the advertising of the products referred to in Article 1 shall not attribute properties to such products for the prevention, treatment or cure of human disease or imply such properties.
   Derogations from the first subparagraph may be provided for in exceptional and clearly defined cases. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). Derogations may be continued until that procedure has been completed.
   2.   Paragraph 1 shall not prevent the dissemination of any useful information or recommendations exclusively intended for persons having qualifications in medicine, nutrition or pharmacy.
   Article 9
   1.   Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (6) shall apply to the products referred to in Article 1 of this Directive, under the conditions set out in paragraphs 2, 3 and 4 of this Article.
   2.   The designation under which a product is sold shall be accompanied by an indication of its particular nutritional characteristics. However, in the case of the products covered by point (c) of Article 1(3), that reference shall be replaced by a reference to the purpose for which they are intended.
   3.   The labelling of products for which no specific Directive has been adopted in accordance with Article 4 shall also include:

               (a)

               the particular elements of the qualitative and quantitative composition or the special manufacturing process which gives the product its particular nutritional characteristics;

               (b)

               the available energy value expressed in kilojoules and kilocalories and the carbohydrate, protein and fat content per 100 grams or 100 millilitres of the product as marketed and, where appropriate, per specified quantity of the product as proposed for consumption.

         If, however, the energy value is less than 50 kilojoules (12 kilocalories) per 100 grams or 100 millilitres of the product as marketed, those particulars may be replaced either by the words ‘energy value less than 50 kilojoules (12 kilocalories) per 100 grams’ or by the words ‘energy value less than 50 kilojoules (12 kilocalories) per 100 millilitres’.
   4.   The particular labelling requirements for those products for which a specific Directive has been adopted shall be laid down in that Directive.
   Article 10
   1.   The products referred to in Article 1 shall only be allowed on the retail market in pre-packaged form, and the packaging shall completely cover the products.
   2.   Member States may permit derogations from paragraph 1 for purposes of the retail trade provided that the product is accompanied by the particulars provided for in Article 9 at the time when it is put on sale.
   Article 11
   1.   To permit efficient official monitoring of foodstuffs intended for a particular nutritional use which do not belong to one of the groups listed in Annex I, the following specific provisions shall apply:

               (a)

               when a product as referred to above is placed on the market for the first time the manufacturer or, where a product is manufactured in a third State, the importer, shall notify the competent authority of the Member State where the product is being marketed by forwarding it a model of the label used for the product;

               (b)

               where the same product is subsequently placed on the market in another Member State the manufacturer or, where appropriate, the importer, shall provide the competent authority of that Member State with the same information, together with an indication of the recipient of the first notification;

               (c)

               where necessary, the competent authority shall be empowered to require the manufacturer or, where appropriate, the importer, to produce the scientific work and the data establishing the product's compliance with Article 1(2) and (3) together with the information provided for in point (a) of Article 9(3). If such work is contained in a readily available publication, a mere reference to this publication shall suffice.

         2.   Member States shall communicate to the Commission the identity of the competent authorities within the meaning of paragraph 1 and any other useful information on them.
   The Commission shall publish this information in the Official Journal of the European Union.
   3.   Detailed rules for implementing paragraph 2 may be adopted in accordance with the regulatory procedure referred to in Article 15(2).
   4.   Every three years, and for the first time before 8 July 2002, the Commission shall send the European Parliament and the Council a report on the implementation of this Article.
   Article 12
   1.   Member States shall not, for reasons related to their composition, manufacturing specifications, presentation or labelling, prohibit or restrict trade in products referred to in Article 1 which comply with this Directive and, where appropriate, with Directives adopted in implementation of this Directive.
   2.   Paragraph 1 shall not affect national provisions which are applicable in the absence of Directives adopted in implementation of this Directive.
   Article 13
   1.   Where a Member State has detailed grounds for establishing that a foodstuff intended for a particular nutritional use which does not belong to one of the groups listed in Annex I does not comply with Article 1(2) and (3) or endangers human health, albeit freely circulating in one or more Member States, that Member State may temporarily suspend or restrict trade in that product within its territory. It shall immediately inform the Commission and the other Member States thereof and give reasons for its decision.
   2.   The Commission shall examine, as soon as possible, the grounds adduced by the Member State concerned, shall consult the Member States within the Committee referred to in Article 15(1), and shall then deliver its opinion without delay and take appropriate measures.
   3.   If the Commission considers that the national measure must be dispensed with or modified, it shall adopt the appropriate measures in accordance with the regulatory procedure referred to in Article 15(2).
   Article 14
   1.   Where a Member State, as a result of new information or of a reassessment of existing information made since one of the specific Directives was adopted, has detailed grounds for establishing that a foodstuff intended for a particular nutritional use endangers human health although it complies with the relevant specific Directive, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision.
   2.   The Commission shall examine as soon as possible the grounds adduced by the Member State concerned and shall consult the Member States within the Committee referred to in Article 15(1), and shall then deliver its opinion without delay and take appropriate measures.
   3.   If the Commission considers that amendments to this Directive or to the specific Directives are necessary in order to remedy the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall adopt those amendments.
   Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 15(3). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 15(4).
   The Member State which has adopted safeguard measures may in that event retain them until the amendments have been adopted.
   Article 15
   1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (7).
   2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
   3.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   4.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   Article 16
   Directive 89/398/EEC, as amended by the acts listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law and application of the Directives set out in Annex II, Part B.
   References made to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
   Article 17
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 18
   This Directive is addressed to the Member States.

      Done at Strasbourg, 6 May 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. KOHOUT

      (1)  OJ C 211, 19.8.2008, p. 44.

      (2)  Opinion of the European Parliament of 23 September 2008 (not yet published in the Official Journal) and Council Decision of 30 March 2009.

      (3)  OJ L 186, 30.6.1989, p. 27.

      (4)  See Annex II, Part A.

      (5)  OJ L 184, 17.7.1999, p. 23.

      (6)  OJ L 109, 6.5.2000, p. 29.

      (7)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

      ANNEX I

                  A.

                  Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by specific Directives (1):

                              1.

                              infant formulae and follow-on formulae;

                              2.

                              processed cereal-based foods and baby foods for infants and young children;

                              3.

                              food intended for use in energy-restricted diets for weight reduction;

                              4.

                              dietary foods for special medical purposes;

                              5.

                              foods intended to meet the expenditure of intense muscular effort, especially for sportsmen.

                  B.

                  Groups of foodstuffs for particular nutritional uses for which specific provisions will be laid down by a specific Directive (1), dependent on the outcome of the procedure described in Article 6:
                  Foods for persons suffering from carbohydrate metabolism disorders (diabetes).

         (1)  It is understood that products already on the market when a specific Directive is adopted will not be affected by it.

      ANNEX II
      PART A

         Repealed Directive with list of its successive amendments

         (referred to in Article 16)

                  Council Directive 89/398/EEC
                  (OJ L 186, 30.6.1989, p. 27)

                  Directive 96/84/EC of the European Parliament and of the Council
                  (OJ L 48, 19.2.1997, p. 20)

                  Directive 1999/41/EC of the European Parliament and of the Council
                  (OJ L 172, 8.7.1999, p. 38)

                  Regulation (EC) No 1882/2003 of the European Parliament and of the Council
                  (OJ L 284, 31.10.2003, p. 1)

                  point 15 of Annex III only

            PART B

         Time limits for transposition into national law and application

         (referred to in Article 16)

                  Directive

                  Time limits for transposition

                  Permission of trade in products complying with this Directive

                  Prohibition of trade in products not complying with this Directive

                  89/398/EEC

                  —

                  16 May 1990 (1)

                  16 May 1991 (1)

                  96/84/EC

                  30 September 1997

                  —

                  —

                  1999/41/EC

                  8 July 2000

                  8 July 2000 (2)

                  8 January 2001 (2)

         (1)  In accordance with Article 15 of Directive 89/398/EEC:

         ‘1.   Member States shall amend their laws, regulations and administrative provisions in such a way as:

                     —

                     to permit trade in products complying with this Directive not later than 16 May 1990,

                     —

                     to prohibit trade in products not complying with this Directive with effect from 16 May 1991.

               They shall forthwith inform the Commission thereof.
         2.   Paragraph 1 shall not affect those national provisions which in the absence of the Directives referred to in Article 4 apply to certain groups of foodstuffs intended for particular nutritional uses.’.

         (2)  In accordance with Article 2 of Directive 1999/41/EC:
      ‘Member States shall bring into force the laws, regulations and administrative provisions necessary for them to comply with this Directive not later than 8 July 2000. They shall forthwith inform the Commission thereof.
      These measures shall be applied in such a way as to:

                  —

                  permit trade in products complying with this Directive by 8 July 2000,

                  —

                  prohibit trade in products not complying with this Directive by 8 January 2001.

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

      ANNEX III

         CORRELATION TABLE

                  Directive 89/398/EEC

                  This Directive

                  Article 1(1)

                  Article 1(1)

                  Article 1(2) point (a)

                  Article 1(2)

                  Article 1(2) point (b)

                  Article 1(3)

                  Article 1(2) point (b)(i), (ii) and (iii)

                  Article 1(3) points (a), (b) and (c)

                  Article 2(1)

                  Article 2(1)

                  Article 2(2)

                  Article 2(2), first subparagraph

                  Article 2(3)

                  Article 2(2), second and third subparagraphs

                  —

                  Article 2(2), fourth subparagraph

                  Article 3

                  Article 3

                  Article 4(1)

                  Article 4(1)

                  Article 4(1a)

                  Article 4(2)

                  Article 4(2)

                  Article 4(3)

                  Article 4a

                  Article 5

                  Article 4b

                  Article 6

                  Article 5

                  Article 7

                  Article 6

                  Article 8

                  Article 7

                  Article 9

                  Article 8

                  Article 10

                  Article 9, introductory words

                  Article 11(1), introductory words

                  Article 9, points 1, 2 and 3

                  Article 11(1)(a), (b) and (c)

                  Article 9, point 4, first and second sentence

                  Article 11(2)

                  Article 9 point 4, third sentence

                  Article 11(3)

                  Article 9 point 5

                  Article 11(4)

                  Article 10

                  Article 12

                  Article 11

                  Article 13

                  Article 12

                  Article 14

                  Article 13(1) and (2)

                  Article 15(1) and (2)

                  Article 13(3)

                  —

                  —

                  Article 15(3) and (4)

                  Articles 14 and 15

                  —

                  —

                  Articles 16 and 17

                  Article 16

                  Article 18

                  Annex I

                  Annex I

                  Annex II

                  —

                  —

                  Annexes II and III


title: Directive 2014/64/EU of the European Parliament and of the Council of 15 May 2014 amending Council Directive 64/432/EEC as regards computer databases which are part of the surveillance networks in the Member States

text:
               27.6.2014

               EN

               Official Journal of the European Union

               L 189/161

         DIRECTIVE 2014/64/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 15 May 2014
   amending Council Directive 64/432/EEC as regards computer databases which are part of the surveillance networks in the Member States
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2),
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the ordinary legislative procedure (2),
   Whereas:

               (1)

               Council Directive 64/432/EEC (3) applies to trade in bovine animals and swine within the Union. It provides that the competent authority in a Member State may introduce a system of surveillance networks. Those networks include a computer database which is to contain, as a minimum, a number of elements laid down in Directive 64/432/EEC, including the identification code of each animal.

               (2)

               Regulation (EC) No 1760/2000 of the European Parliament and of the Council (4) establishes a system for the identification and registration of bovine animals. It requires as a general rule that the two official means of identification allocated to an animal bear the same identification code. However, during the initial phase of adjustment to the use of electronic identifiers as an official means of identification, it could not be excluded that, in certain cases, technical limitations related to the configuration of an animal’s original identification code could prevent the reproduction of that code on an electronic identifier. This could occur where the characters forming an animal’s existing identification code prevent that code from being converted into an electronic format. Therefore, Regulation (EC) No 1760/2000 provides for specific transitory derogations to allow the application of an electronic identifier also to those animals, provided that full traceability is ensured and that the animals can be identified individually, including the holding on which they were born. The possibility of using such electronic identifiers should be reflected in the list of elements of the computer databases laid down in Directive 64/432/EEC.

               (3)

               In the interest of consistency of Union legislation, the type of electronic identifier, if applied to the animals, should also be added to the list of elements to be included in the computer databases laid down in Directive 64/432/EEC.

               (4)

               Directive 64/432/EEC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   In part C of Article 14(3) of Directive 64/432/EEC, point (1) is replaced by the following:

               ‘(1)

               for each animal:

                           —

                           the unique identification code or codes, as regards the cases set out in Articles 4(1), 4b, 4c(1) and 4d of Regulation (EC) No 1760/2000 of the European Parliament and of the Council (5),

                           —

                           date of birth,

                           —

                           sex,

                           —

                           breed or colour of coat,

                           —

                           identification code of the mother or, in the case of an animal imported from a third country, the unique identification code of the individual means of identification allocated to the animal by the Member State of destination in accordance with Regulation (EC) No 1760/2000,

                           —

                           identification number of the holding where born,

                           —

                           identification numbers of all holdings where the animal has been kept and the dates of each change of holding,

                           —

                           date of death or slaughter,

                           —

                           the type of electronic identifier, if applied to the animal.

         Article 2
   1.   By 18 January 2016, Member States shall bring into force, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
   They shall apply those measures from 18 July 2019.
   When Member States adopt those 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 main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 15 May 2014.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         D. KOURKOULAS

      (1)  OJ C 43, 15.2.2012, p. 64.

      (2)  Position of the European Parliament of 2 April 2014 (not yet published in the Official Journal) and decision of the Council of 6 May 2014.

      (3)  Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (OJ 121, 29.7.1964, p. 1977/64).

      (4)  Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000, p. 1).