               30.4.2004

               EN

               Official Journal of the European Communities

               L 157/45

         DIRECTIVE 2004/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 29 April 2004
   on the enforcement of intellectual property rights
   (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),
   After consulting the Committee of the Regions,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               The achievement of the Internal Market entails eliminating restrictions on freedom of movement and distortions of competition, while creating an environment conducive to innovation and investment. In this context, the protection of intellectual property is an essential element for the success of the Internal Market. The protection of intellectual property is important not only for promoting innovation and creativity, but also for developing employment and improving competitiveness.

               (2)

               The protection of intellectual property should allow the inventor or creator to derive a legitimate profit from his invention or creation. It should also allow the widest possible dissemination of works, ideas and new know-how. At the same time, it should not hamper freedom of expression, the free movement of information, or the protection of personal data, including on the Internet.

               (3)

               However, without effective means of enforcing intellectual property rights, innovation and creativity are discouraged and investment diminished. It is therefore necessary to ensure that the substantive law on intellectual property, which is nowadays largely part of the acquis communautaire, is applied effectively in the Community. In this respect, the means of enforcing intellectual property rights are of paramount importance for the success of the Internal Market.

               (4)

               At international level, all Member States, as well as the Community itself as regards matters within its competence, are bound by the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPS Agreement"), approved, as part of the multilateral negotiations of the Uruguay Round, by Council Decision 94/800/EC (3) and concluded in the framework of the World Trade Organisation.

               (5)

               The TRIPS Agreement contains, in particular, provisions on the means of enforcing intellectual property rights, which are common standards applicable at international level and implemented in all Member States. This Directive should not affect Member States' international obligations, including those under the TRIPS Agreement.

               (6)

               There are also international conventions to which all Member States are parties and which also contain provisions on the means of enforcing intellectual property rights. These include, in particular, the Paris Convention for the Protection of Industrial Property, the Berne Convention for the Protection of Literary and Artistic Works, and the Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organisations.

               (7)

               It emerges from the consultations held by the Commission on this question that, in the Member States, and despite the TRIPS Agreement, there are still major disparities as regards the means of enforcing intellectual property rights. For instance, the arrangements for applying provisional measures, which are used in particular to preserve evidence, the calculation of damages, or the arrangements for applying injunctions, vary widely from one Member State to another. In some Member States, there are no measures, procedures and remedies such as the right of information and the recall, at the infringer's expense, of the infringing goods placed on the market.

               (8)

               The disparities between the systems of the Member States as regards the means of enforcing intellectual property rights are prejudicial to the proper functioning of the Internal Market and make it impossible to ensure that intellectual property rights enjoy an equivalent level of protection throughout the Community. This situation does not promote free movement within the Internal Market or create an environment conducive to healthy competition.

               (9)

               The current disparities also lead to a weakening of the substantive law on intellectual property and to a fragmentation of the Internal Market in this field. This causes a loss of confidence in the Internal Market in business circles, with a consequent reduction in investment in innovation and creation. Infringements of intellectual property rights appear to be increasingly linked to organised crime. Increasing use of the Internet enables pirated products to be distributed instantly around the globe. Effective enforcement of the substantive law on intellectual property should be ensured by specific action at Community level. Approximation of the legislation of the Member States in this field is therefore an essential prerequisite for the proper functioning of the Internal Market.

               (10)

               The objective of this Directive is to approximate legislative systems so as to ensure a high, equivalent and homogeneous level of protection in the Internal Market.

               (11)

               This Directive does not aim to establish harmonised rules for judicial cooperation, jurisdiction, the recognition and enforcement of decisions in civil and commercial matters, or deal with applicable law. There are Community instruments which govern such matters in general terms and are, in principle, equally applicable to intellectual property.

               (12)

               This Directive should not affect the application of the rules of competition, and in particular Articles 81 and 82 of the Treaty. The measures provided for in this Directive should not be used to restrict unduly competition in a manner contrary to the Treaty.

               (13)

               It is necessary to define the scope of this Directive as widely as possible in order to encompass all the intellectual property rights covered by Community provisions in this field and/or by the national law of the Member State concerned. Nevertheless, that requirement does not affect the possibility, on the part of those Member States which so wish, to extend, for internal purposes, the provisions of this Directive to include acts involving unfair competition, including parasitic copies, or similar activities.

               (14)

               The measures provided for in Articles 6(2), 8(1) and 9(2) need to be applied only in respect of acts carried out on a commercial scale. This is without prejudice to the possibility for Member States to apply those measures also in respect of other acts. Acts carried out on a commercial scale are those carried out for direct or indirect economic or commercial advantage; this would normally exclude acts carried out by end-consumers acting in good faith.

               (15)

               This Directive should not affect substantive law on intellectual property, Directive 95/46/EC of 24 October 1995 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (4), Directive 1999/93/EC of the European Parliament and of the Council of 13 December 1999 on a Community framework for electronic signatures (5) and Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (6).

               (16)

               The provisions of this Directive should be without prejudice to the particular provisions for the enforcement of rights and on exceptions in the domain of copyright and related rights set out in Community instruments and notably those found in Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs (7) or in Directive 2001/29/EC of the European Parliament and of the Council of 22 May 2001 on the harmonisation of certain aspects of copyright and related rights in the information society (8).

               (17)

               The measures, procedures and remedies provided for in this Directive should be determined in each case in such a manner as to take due account of the specific characteristics of that case, including the specific features of each intellectual property right and, where appropriate, the intentional or unintentional character of the infringement.

               (18)

               The persons entitled to request application of those measures, procedures and remedies should be not only the rightholders but also persons who have a direct interest and legal standing in so far as permitted by and in accordance with the applicable law, which may include professional organisations in charge of the management of those rights or for the defence of the collective and individual interests for which they are responsible.

               (19)

               Since copyright exists from the creation of a work and does not require formal registration, it is appropriate to adopt the rule laid down in Article 15 of the Berne Convention, which establishes the presumption whereby the author of a literary or artistic work is regarded as such if his name appears on the work. A similar presumption should be applied to the owners of related rights since it is often the holder of a related right, such as a phonogram producer, who will seek to defend rights and engage in fighting acts of piracy.

               (20)

               Given that evidence is an element of paramount importance for establishing the infringement of intellectual property rights, it is appropriate to ensure that effective means of presenting, obtaining and preserving evidence are available. The procedures should have regard to the rights of the defence and provide the necessary guarantees, including the protection of confidential information. For infringements committed on a commercial scale it is also important that the courts may order access, where appropriate, to banking, financial or commercial documents under the control of the alleged infringer.

               (21)

               Other measures designed to ensure a high level of protection exist in certain Member States and should be made available in all the Member States. This is the case with the right of information, which allows precise information to be obtained on the origin of the infringing goods or services, the distribution channels and the identity of any third parties involved in the infringement.

               (22)

               It is also essential to provide for provisional measures for the immediate termination of infringements, without awaiting a decision on the substance of the case, while observing the rights of the defence, ensuring the proportionality of the provisional measures as appropriate to the characteristics of the case in question and providing the guarantees needed to cover the costs and the injury caused to the defendant by an unjustified request. Such measures are particularly justified where any delay would cause irreparable harm to the holder of an intellectual property right.

               (23)

               Without prejudice to any other measures, procedures and remedies available, rightholders should have the possibility of applying for an injunction against an intermediary whose services are being used by a third party to infringe the rightholder's industrial property right. The conditions and procedures relating to such injunctions should be left to the national law of the Member States. As far as infringements of copyright and related rights are concerned, a comprehensive level of harmonisation is already provided for in Directive 2001/29/EC. Article 8(3) of Directive 2001/29/EC should therefore not be affected by this Directive.

               (24)

               Depending on the particular case, and if justified by the circumstances, the measures, procedures and remedies to be provided for should include prohibitory measures aimed at preventing further infringements of intellectual property rights. Moreover there should be corrective measures, where appropriate at the expense of the infringer, such as the recall and definitive removal from the channels of commerce, or destruction, of the infringing goods and, in appropriate cases, of the materials and implements principally used in the creation or manufacture of these goods. These corrective measures should take account of the interests of third parties including, in particular, consumers and private parties acting in good faith.

               (25)

               Where an infringement is committed unintentionally and without negligence and where the corrective measures or injunctions provided for by this Directive would be disproportionate, Member States should have the option of providing for the possibility, in appropriate cases, of pecuniary compensation being awarded to the injured party as an alternative measure. However, where the commercial use of counterfeit goods or the supply of services would constitute an infringement of law other than intellectual property law or would be likely to harm consumers, such use or supply should remain prohibited.

               (26)

               With a view to compensating for the prejudice suffered as a result of an infringement committed by an infringer who engaged in an activity in the knowledge, or with reasonable grounds for knowing, that it would give rise to such an infringement, the amount of damages awarded to the rightholder should take account of all appropriate aspects, such as loss of earnings incurred by the rightholder, or unfair profits made by the infringer and, where appropriate, any moral prejudice caused to the rightholder. As an alternative, for example where it would be difficult to determine the amount of the actual prejudice suffered, the amount of the damages might be derived from elements such as the royalties or fees which would have been due if the infringer had requested authorisation to use the intellectual property right in question. The aim is not to introduce an obligation to provide for punitive damages but to allow for compensation based on an objective criterion while taking account of the expenses incurred by the rightholder, such as the costs of identification and research.

               (27)

               To act as a supplementary deterrent to future infringers and to contribute to the awareness of the public at large, it is useful to publicise decisions in intellectual property infringement cases.

               (28)

               In addition to the civil and administrative measures, procedures and remedies provided for under this Directive, criminal sanctions also constitute, in appropriate cases, a means of ensuring the enforcement of intellectual property rights.

               (29)

               Industry should take an active part in the fight against piracy and counterfeiting. The development of codes of conduct in the circles directly affected is a supplementary means of bolstering the regulatory framework. The Member States, in collaboration with the Commission, should encourage the development of codes of conduct in general. Monitoring of the manufacture of optical discs, particularly by means of an identification code embedded in discs produced in the Community, helps to limit infringements of intellectual property rights in this sector, which suffers from piracy on a large scale. However, these technical protection measures should not be misused to protect markets and prevent parallel imports.

               (30)

               In order to facilitate the uniform application of this Directive, it is appropriate to provide for systems of cooperation and the exchange of information between Member States, on the one hand, and between the Member States and the Commission on the other, in particular by creating a network of correspondents designated by the Member States and by providing regular reports assessing the application of this Directive and the effectiveness of the measures taken by the various national bodies.

               (31)

               Since, for the reasons already described, the objective of this Directive can best be achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

               (32)

               This Directive respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union. In particular, this Directive seeks to ensure full respect for intellectual property, in accordance with Article 17(2) of that Charter,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER I
   Objective and scope

      Article 1

   Subject-matter
   This Directive concerns the measures, procedures and remedies necessary to ensure the enforcement of intellectual property rights. For the purposes of this Directive, the term "intellectual property rights" includes industrial property rights.

      Article 2

   Scope
   1.   Without prejudice to the means which are or may be provided for in Community or national legislation, in so far as those means may be more favourable for rightholders, the measures, procedures and remedies provided for by this Directive shall apply, in accordance with Article 3, to any infringement of intellectual property rights as provided for by Community law and/or by the national law of the Member State concerned.
   2.   This Directive shall be without prejudice to the specific provisions on the enforcement of rights and on exceptions contained in Community legislation concerning copyright and rights related to copyright, notably those found in Directive 91/250/EEC and, in particular, Article 7 thereof or in Directive 2001/29/EC and, in particular, Articles 2 to 6 and Article 8 thereof.
   3.   This Directive shall not affect:

               (a)

               the Community provisions governing the substantive law on intellectual property, Directive 95/46/EC, Directive 1999/93/EC or Directive 2000/31/EC, in general, and Articles 12 to 15 of Directive 2000/31/EC in particular;

               (b)

               Member States' international obligations and notably the TRIPS Agreement, including those relating to criminal procedures and penalties;

               (c)

               any national provisions in Member States relating to criminal procedures or penalties in respect of infringement of intellectual property rights.

         CHAPTER II
   Measures, procedures and remedies
   Section 1
   General provisions

      Article 3

   General obligation
   1.   Member States shall provide for the measures, procedures and remedies necessary to ensure the enforcement of the intellectual property rights covered by this Directive. Those measures, procedures and remedies shall be fair and equitable and shall not be unnecessarily complicated or costly, or entail unreasonable time-limits or unwarranted delays.
   2.   Those measures, procedures and remedies shall also be effective, proportionate and dissuasive and shall be applied in such a manner as to avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.

      Article 4

   Persons entitled to apply for the application of the measures, procedures and remedies
   1.   Member States shall recognise as persons entitled to seek application of the measures, procedures and remedies referred to in this Chapter:

               (a)

               the holders of intellectual property rights, in accordance with the provisions of the applicable law,

               (b)

               all other persons authorised to use those rights, in particular licensees, in so far as permitted by and in accordance with the provisions of the applicable law,

               (c)

               intellectual property collective rights management bodies which are regularly recognised as having a right to represent holders of intellectual property rights, in so far as permitted by and in accordance with the provisions of the applicable law,

               (d)

               professional defence bodies which are regularly recognised as having a right to represent holders of intellectual property rights, in so far as permitted by and in accordance with the provisions of the applicable law.

      Article 5

   Presumption of authorship or ownership
   For the purposes of applying the measures, procedures and remedies provided for in this Directive,

               (a)

               for the author of a literary or artistic work, in the absence of proof to the contrary, to be regarded as such, and consequently to be entitled to institute infringement proceedings, it shall be sufficient for his name to appear on the work in the usual manner;

               (b)

               the provision under (a) shall apply mutatis mutandis to the holders of rights related to copyright with regard to their protected subject matter.

         Section 2
   Evidence

      Article 6

   Evidence
   1.   Member States shall ensure that, on application by a party which has presented reasonably available evidence sufficient to support its claims, and has, in substantiating those claims, specified evidence which lies in the control of the opposing party, the competent judicial authorities may order that such evidence be presented by the opposing party, subject to the protection of confidential information. For the purposes of this paragraph, Member States may provide that a reasonable sample of a substantial number of copies of a work or any other protected object be considered by the competent judicial authorities to constitute reasonable evidence.
   2.   Under the same conditions, in the case of an infringement committed on a commercial scale Member States shall take such measures as are necessary to enable the competent judicial authorities to order, where appropriate, on application by a party, the communication of banking, financial or commercial documents under the control of the opposing party, subject to the protection of confidential information.

      Article 7

   Measures for preserving evidence
   1.   Member States shall ensure that, even before the commencement of proceedings on the merits of the case, the competent judicial authorities may, on application by a party who has presented reasonably available evidence to support his claims that his intellectual property right has been infringed or is about to be infringed, order prompt and effective provisional measures to preserve relevant evidence in respect of the alleged infringement, subject to the protection of confidential information. Such measures may include the detailed description, with or without the taking of samples, or the physical seizure of the infringing goods, and, in appropriate cases, the materials and implements used in the production and/or distribution of these goods and the documents relating thereto. Those measures shall be taken, if necessary without the other party having been heard, in particular where any delay is likely to cause irreparable harm to the rightholder or where there is a demonstrable risk of evidence being destroyed.
   Where measures to preserve evidence are adopted without the other party having been heard, the parties affected shall be given notice, without delay after the execution of the measures at the latest. A review, including a right to be heard, shall take place upon request of the parties affected with a view to deciding, within a reasonable period after the notification of the measures, whether the measures shall be modified, revoked or confirmed.
   2.   Member States shall ensure that the measures to preserve evidence may be subject to the lodging by the applicant of adequate security or an equivalent assurance intended to ensure compensation for any prejudice suffered by the defendant as provided for in paragraph 4.
   3.   Member States shall ensure that the measures to preserve evidence are revoked or otherwise cease to have effect, upon request of the defendant, without prejudice to the damages which may be claimed, if the applicant does not institute, within a reasonable period, proceedings leading to a decision on the merits of the case before the competent judicial authority, the period to be determined by the judicial authority ordering the measures where the law of a Member State so permits or, in the absence of such determination, within a period not exceeding 20 working days or 31 calendar days, whichever is the longer.
   4.   Where the measures to preserve evidence are revoked, or where they lapse due to any act or omission by the applicant, or where it is subsequently found that there has been no infringement or threat of infringement of an intellectual property right, the judicial authorities shall have the authority to order the applicant, upon request of the defendant, to provide the defendant appropriate compensation for any injury caused by those measures.
   5.   Member States may take measures to protect witnesses' identity.
   Section 3
   Right of information

      Article 8

   Right of information
   1.   Member States shall ensure that, in the context of proceedings concerning an infringement of an intellectual property right and in response to a justified and proportionate request of the claimant, the competent judicial authorities may order that information on the origin and distribution networks of the goods or services which infringe an intellectual property right be provided by the infringer and/or any other person who:

               (a)

               was found in possession of the infringing goods on a commercial scale;

               (b)

               was found to be using the infringing services on a commercial scale;

               (c)

               was found to be providing on a commercial scale services used in infringing activities; or

               (d)

               was indicated by the person referred to in point (a), (b) or (c) as being involved in the production, manufacture or distribution of the goods or the provision of the services.

         2.   The information referred to in paragraph 1 shall, as appropriate, comprise:

               (a)

               the names and addresses of the producers, manufacturers, distributors, suppliers and other previous holders of the goods or services, as well as the intended wholesalers and retailers;

               (b)

               information on the quantities produced, manufactured, delivered, received or ordered, as well as the price obtained for the goods or services in question.

         3.   Paragraphs 1 and 2 shall apply without prejudice to other statutory provisions which:

               (a)

               grant the rightholder rights to receive fuller information;

               (b)

               govern the use in civil or criminal proceedings of the information communicated pursuant to this Article;

               (c)

               govern responsibility for misuse of the right of information; or

               (d)

               afford an opportunity for refusing to provide information which would force the person referred to in paragraph 1 to admit to his own participation or that of his close relatives in an infringement of an intellectual property right; or

               (e)

               govern the protection of confidentiality of information sources or the processing of personal data.

         Section 4
   Provisional and precautionary measures

      Article 9

   Provisional and precautionary measures
   1.   Member States shall ensure that the judicial authorities may, at the request of the applicant:

               (a)

               issue against the alleged infringer an interlocutory injunction intended to prevent any imminent infringement of an intellectual property right, or to forbid, on a provisional basis and subject, where appropriate, to a recurring penalty payment where provided for by national law, the continuation of the alleged infringements of that right, or to make such continuation subject to the lodging of guarantees intended to ensure the compensation of the rightholder; an interlocutory injunction may also be issued, under the same conditions, against an intermediary whose services are being used by a third party to infringe an intellectual property right; injunctions against intermediaries whose services are used by a third party to infringe a copyright or a related right are covered by Directive 2001/29/EC;

               (b)

               order the seizure or delivery up of the goods suspected of infringing an intellectual property right so as to prevent their entry into or movement within the channels of commerce.

         2.   In the case of an infringement committed on a commercial scale, the Member States shall ensure that, if the injured party demonstrates circumstances likely to endanger the recovery of damages, the judicial authorities may order the precautionary seizure of the movable and immovable property of the alleged infringer, including the blocking of his bank accounts and other assets. To that end, the competent authorities may order the communication of bank, financial or commercial documents, or appropriate access to the relevant information.
   3.   The judicial authorities shall, in respect of the measures referred to in paragraphs 1 and 2, have the authority to require the applicant to provide any reasonably available evidence in order to satisfy themselves with a sufficient degree of certainty that the applicant is the rightholder and that the applicant's right is being infringed, or that such infringement is imminent.
   4.   Member States shall ensure that the provisional measures referred to in paragraphs 1 and 2 may, in appropriate cases, be taken without the defendant having been heard, in particular where any delay would cause irreparable harm to the rightholder. In that event, the parties shall be so informed without delay after the execution of the measures at the latest.
   A review, including a right to be heard, shall take place upon request of the defendant with a view to deciding, within a reasonable time after notification of the measures, whether those measures shall be modified, revoked or confirmed.
   5.   Member States shall ensure that the provisional measures referred to in paragraphs 1 and 2 are revoked or otherwise cease to have effect, upon request of the defendant, if the applicant does not institute, within a reasonable period, proceedings leading to a decision on the merits of the case before the competent judicial authority, the period to be determined by the judicial authority ordering the measures where the law of a Member State so permits or, in the absence of such determination, within a period not exceeding 20 working days or 31 calendar days, whichever is the longer.
   6.   The competent judicial authorities may make the provisional measures referred to in paragraphs 1 and 2 subject to the lodging by the applicant of adequate security or an equivalent assurance intended to ensure compensation for any prejudice suffered by the defendant as provided for in paragraph 7.
   7.   Where the provisional measures are revoked or where they lapse due to any act or omission by the applicant, or where it is subsequently found that there has been no infringement or threat of infringement of an intellectual property right, the judicial authorities shall have the authority to order the applicant, upon request of the defendant, to provide the defendant appropriate compensation for any injury caused by those measures.
   Section 5
   Measures resulting from a decision on the merits of the case

      Article 10

   Corrective measures
   1.   Without prejudice to any damages due to the rightholder by reason of the infringement, and without compensation of any sort, Member States shall ensure that the competent judicial authorities may order, at the request of the applicant, that appropriate measures be taken with regard to goods that they have found to be infringing an intellectual property right and, in appropriate cases, with regard to materials and implements principally used in the creation or manufacture of those goods. Such measures shall include:

               (a)

               recall from the channels of commerce,

               (b)

               definitive removal from the channels of commerce, or

               (c)

               destruction.

         2.   The judicial authorities shall order that those measures be carried out at the expense of the infringer, unless particular reasons are invoked for not doing so.
   3.   In considering a request for corrective measures, the need for proportionality between the seriousness of the infringement and the remedies ordered as well as the interests of third parties shall be taken into account.

      Article 11

   Injunctions
   Member States shall ensure that, where a judicial decision is taken finding an infringement of an intellectual property right, the judicial authorities may issue against the infringer an injunction aimed at prohibiting the continuation of the infringement. Where provided for by national law, non-compliance with an injunction shall, where appropriate, be subject to a recurring penalty payment, with a view to ensuring compliance. Member States shall also ensure that rightholders are in a position to apply for an injunction against intermediaries whose services are used by a third party to infringe an intellectual property right, without prejudice to Article 8(3) of Directive 2001/29/EC.

      Article 12

   Alternative measures
   Member States may provide that, in appropriate cases and at the request of the person liable to be subject to the measures provided for in this Section, the competent judicial authorities may order pecuniary compensation to be paid to the injured party instead of applying the measures provided for in this Section if that person acted unintentionally and without negligence, if execution of the measures in question would cause him disproportionate harm and if pecuniary compensation to the injured party appears reasonably satisfactory.
   Section 6
   Damages and legal costs

      Article 13

   Damages
   1.   Member States shall ensure that the competent judicial authorities, on application of the injured party, order the infringer who knowingly, or with reasonable grounds to know, engaged in an infringing activity, to pay the rightholder damages appropriate to the actual prejudice suffered by him as a result of the infringement.
   When the judicial authorities set the damages:

               (a)

               they shall take into account all appropriate aspects, such as the negative economic consequences, including lost profits, which the injured party has suffered, any unfair profits made by the infringer and, in appropriate cases, elements other than economic factors, such as the moral prejudice caused to the rightholder by the infringement;
               or

               (b)

               as an alternative to (a), they may, in appropriate cases, set the damages as a lump sum on the basis of elements such as at least the amount of royalties or fees which would have been due if the infringer had requested authorisation to use the intellectual property right in question.

         2.   Where the infringer did not knowingly, or with reasonable grounds to know, engage in infringing activity, Member States may lay down that the judicial authorities may order the recovery of profits or the payment of damages, which may be pre-established.

      Article 14

   Legal costs
   Member States shall ensure that reasonable and proportionate legal costs and other expenses incurred by the successful party shall, as a general rule, be borne by the unsuccessful party, unless equity does not allow this.
   Section 7
   Publicity measures

      Article 15

   Publication of judicial decisions
   Member States shall ensure that, in legal proceedings instituted for infringement of an intellectual property right, the judicial authorities may order, at the request of the applicant and at the expense of the infringer, appropriate measures for the dissemination of the information concerning the decision, including displaying the decision and publishing it in full or in part. Member States may provide for other additional publicity measures which are appropriate to the particular circumstances, including prominent advertising.
   CHAPTER III
   Sanctions by Member States

      Article 16

   Sanctions by Member States
   Without prejudice to the civil and administrative measures, procedures and remedies laid down by this Directive, Member States may apply other appropriate sanctions in cases where intellectual property rights have been infringed.
   CHAPTER IV
   Codes of conduct and administrative cooperation

      Article 17

   Codes of conduct
   Member States shall encourage:

               (a)

               the development by trade or professional associations or organisations of codes of conduct at Community level aimed at contributing towards the enforcement of the intellectual property rights, particularly by recommending the use on optical discs of a code enabling the identification of the origin of their manufacture;

               (b)

               the submission to the Commission of draft codes of conduct at national and Community level and of any evaluations of the application of these codes of conduct.

      Article 18

   Assessment
   1.   Three years after the date laid down in Article 20(1), each Member State shall submit to the Commission a report on the implementation of this Directive.
   On the basis of those reports, the Commission shall draw up a report on the application of this Directive, including an assessment of the effectiveness of the measures taken, as well as an evaluation of its impact on innovation and the development of the information society. That report shall then be transmitted to the European Parliament, the Council and the European Economic and Social Committee. It shall be accompanied, if necessary and in the light of developments in the Community legal order, by proposals for amendments to this Directive.
   2.   Member States shall provide the Commission with all the aid and assistance it may need when drawing up the report referred to in the second subparagraph of paragraph 1.

      Article 19

   Exchange of information and correspondents
   For the purpose of promoting cooperation, including the exchange of information, among Member States and between Member States and the Commission, each Member State shall designate one or more national correspondents for any question relating to the implementation of the measures provided for by this Directive. It shall communicate the details of the national correspondent(s) to the other Member States and to the Commission.
   CHAPTER V
   Final provisions

      Article 20

   Implementation
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... (9). 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 texts of the provisions of national law which they adopt in the field governed by this Directive.

      Article 21

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

      Article 22

   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 29.4.2004.

         For the European Parliament
         The President
         P. COX

         For the Council
         The President
         M. McDOWELL

      (1)  OJ C 32, 5.2.2004, p. 15.

      (2)  Opinion of the European Parliament of 9 March 2004 (not yet published in the Official Journal) and Council Decision of 26 April 2004.

      (3)  OJ L 336, 23.12.1994, p. 1.

      (4)  OJ L 281, 23.11.1995, p. 31. Directive as amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

      (5)  OJ L 13, 19.1.2000, p. 12.

      (6)  OJ L 178, 17.7.2000, p. 1.

      (7)  OJ L 122, 17.5.1991, p. 42. Directive as amended by Directive 93/98/EEC (OJ L 290, 24.11.1993, p. 9).

      (8)  OJ L 167, 22.6.2001, p. 10.

      (9)  Twenty-four months after the date of adoption of this Directive.


title: Commission Directive (EU) 2015/2117 of 23 November 2015 amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards chloromethylisothiazolinone and methylisothiazolinone, both individually and in a ratio of 3:1 (Text with EEA relevance)

text:
               24.11.2015

               EN

               Official Journal of the European Union

               L 306/23

         COMMISSION DIRECTIVE (EU) 2015/2117
   of 23 November 2015
   amending, for the purpose of adopting specific limit values for chemicals used in toys, Appendix C to Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys, as regards chloromethylisothiazolinone and methylisothiazolinone, both individually and in a ratio of 3:1
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46(2) thereof,
   Whereas:

               (1)

               In order to ensure a high level of protection of children against risks caused by chemical substances in toys, Directive 2009/48/EC establishes certain requirements with regard to chemical substances such as those classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2), allergenic fragrances and certain elements. In addition, Directive 2009/48/EC empowers the Commission to adopt specific limit values for chemicals used in toys which are intended for children under 36 months and in other toys intended to be placed in the mouth in order to ensure adequate protection in the case of toys involving a high degree of exposure. The adoption of such limit values takes the form of an inclusion in Appendix C to Annex II to Directive 2009/48/EC.

               (2)

               For a number of chemicals, currently applicable limit values are either too high in the light of available scientific evidence or do not exist. Specific limit values should therefore be adopted for them, taking into account the packaging requirements for food as well as the differences between toys and food contact materials.

               (3)

               In order to advise the European Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission established the Expert Group on Toys Safety. The mission of its subgroup ‘Chemicals’ is to provide such advice with regard to chemical substances which may be used in toys.

               (4)

               5-Chloro-2-methylisothiazolin-3(2H)-one (CMI) and 2-methylisothiazolin-3(2H)-one (MI) in a ratio of 3:1 (CAS number 55965-84-9) (3) as well as its individual components CMI (CAS number 26172-55-4) and MI (CAS number 2682-20-4) are used as preservatives in water-based toys (4) including hobby paints, finger paints, window/glass paints, glues and soap bubbles (5).

               (5)

               In its deliberations about CMI and MI in a ratio of 3:1 as well as the individual components CMI and MI the subgroup ‘Chemicals’ took as a basis the related opinion of the Scientific Committee on Health and Environmental Risks (SCHER) noting that neither CMI and MI in a ratio of 3:1 nor the individual components CMI or MI are recommended for use in toys, due to contact allergic reactions observed with these substances in cosmetics (6). The subgroup ‘Chemicals’ also took account of the related SCCS opinion which considers CMI and MI in a ratio of 3:1 an extreme contact allergen in humans as demonstrated by available data (7).

               (6)

               CMI and MI in a ratio of 3:1 is classified under Regulation (EC) No 1272/2008 as a skin sensitiser; CMI and MI individually are not classified under the Regulation. Directive 2009/48/EC has currently no specific limit value for CMI/MI 3:1, nor for CMI or MI individually, nor a general limit value for sensitisers.

               (7)

               In the light of the above the subgroup ‘Chemicals’ recommended at its meeting of 15 February 2012 that CMI and MI in a ratio of 3:1 should not be used in toys.

               (8)

               According to the German Federal Institute for Risk Assessment (BfR, Bundesinstitut für Risikobewertung) (8) limit values for CMI and MI, which are strongly allergenic, should be set at a concentration considered protective for individuals who are already sensitised. This is the strictest way to limit allergens, since already sensitised individuals suffer from an allergy outbreak at even lowest allergen concentrations. According to the abovementioned SCCS opinion such concentration is below 2 mg/kg (9).

               (9)

               According to the BfR, market surveillance is able to routinely quantify CMI down to 0,75 mg/kg and MI down to 0,25 mg/kg (10) (limits of quantification, LOQs).

               (10)

               In the light of the above, the Expert Group on Toys Safety recommended at its meeting of 23 May 2014 to also limit the uses of CMI and MI individually to their LOQs.

               (11)

               While there is a specific migration limit for MI individually as an additive for use in certain food contact materials, the basic assumptions for deriving that migration limit are different from those for the content limit for MI in toys. The uses of CMI and MI in a ratio of 3:1 and of CMI individually are not regulated for food contact materials.

               (12)

               In view of the above, Appendix C of Annex II to Directive 2009/48/EC should be amended to include content limits for CMI and MI in a ratio of 3:1, as well as for CMI and MI individually, in toys.

               (13)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in Article 47 of Directive 2009/48/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Appendix C of Annex II to Directive 2009/48/EC, the following entries shall be added:

                  Substance

                  CAS No

                  Limit value

                  ‘reaction mass of: 5-chloro-2- methyl-4-isothiazolin-3-one [EC no. 247-500-7] and 2-methyl-2H -isothiazol-3-one [EC no. 220-239-6] (3:1)

                  55965-84-9

                  1 mg/kg (content limit) in aqueous toy materials

                  5-Chloro-2-methyl-isothiazolin-3(2H)-one

                  26172-55-4

                  0,75 mg/kg (content limit) in aqueous toy materials

                  2-methylisothiazolin-3(2H)-one

                  2682-20-4

                  0,25 mg/kg (content limit) in aqueous toy materials’

   Article 2
   1.   Member States shall adopt and publish, by 24 November 2017 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from 24 November 2017.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   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, 23 November 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 170, 30.6.2009, p. 1.

      (2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

      (3)  Trade names are Kathon, Acticide, Microcare, etc., according to the Scientific Committee on Consumer Safety (SCCS), Opinion on the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one. Opinion adopted on 8 December 2009, p. 6.

      (4)  Danish EPA (2014) Survey and health assessment of preservatives in toys. Survey of chemical substances in consumer products No 124, 2014, table 24 on p. 56.

      (5)  Danish EPA (2014) Survey and health assessment of preservatives in toys. Survey of chemical substances in consumer products No 124, 2014, pp. 38-39.

      (6)  Scientific Committee on Health and Environmental Risks (SCHER), Opinion on ‘CEN's response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys’, adopted on 29 May 2007, p. 8 and table 1 on p. 9.

      (7)  See the SCCS opinion in footnote 3, p. 35.

      (8)  Position paper of the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) of 24.9.2012, p. 4.

      (9)  See the SCCS opinion in footnote 3, p. 33.

      (10)  See footnote 8.


title: Commission Directive 2005/13/EC of 21 February 2005 amending Directive 2000/25/EC of the European Parliament and of the Council concerning the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors, and amending Annex I to Directive 2003/37/EC of the European Parliament and of the Council concerning the type-approval of agricultural or forestry tractors (Text with EEA relevance)

text:
               1.3.2005

               EN

               Official Journal of the European Union

               L 55/35

      COMMISSION DIRECTIVE 2005/13/EC
   of 21 February 2005
   amending Directive 2000/25/EC of the European Parliament and of the Council concerning the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors, and amending Annex I to Directive 2003/37/EC of the European Parliament and of the Council concerning the type-approval of agricultural or forestry tractors
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2000/25/EC of the European Parliament and of the Council of 22 May 2000 on action to be taken against the emission of gaseous and particulate pollutants by engines intended to power agricultural or forestry tractors and amending Council Directive 74/150/EEC (1), and in particular Articles 6 and 7 thereof,
   Having regard to Directive 2003/37/EC of the European Parliament and of the Council of 26 May 2003 on type-approval of agricultural or forestry tractors, their trailers and interchangeable towed machinery, together with their systems, components and separate technical units and repealing Council Directive 74/150/EEC (2), and in particular Article 19(1)(a) thereof,
   Whereas:

               (1)

               Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in no-road mobile machinery (3) as amended by Directive 2004/26/EC sets out more stringent emission requirements for engines installed in non-road mobile machinery, and introduces three new stages for emission limits.

               (2)

               Directive 2000/25/EC, which is one of the separate Directives in the framework of the type approval procedure under Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors (4), should be aligned with Directive 97/68/EC as amended by Directive 2004/26/EC, in particular as regards the introduction of the flexibility scheme provided for in the latter.

               (3)

               Annexes I and II to Directive 2000/25/EC need to be adapted, notably to take account of the introduction by Directive 97/68/EC as amended by Directive 2004/26/EC of new emission limits for combined emission of hydrocarbons and oxides of nitrogen. Other changes should be introduced in those annexes to ensure consistency between the provisions on information documents laid down in Directives 2000/25/EC, 97/68/EC and 2003/37/EC. In addition, Annex III to Directive 2000/25/EC needs to be adapted in order to add the alternative type-approvals to be recognised for the new stages III A, III B and IV.

               (4)

               It is also necessary to adapt Annex I to Directive 2003/37/EC in order to ensure consistency between the provisions on information documents laid down in Directives 2000/25/EC, 97/68/EC and 2003/37/EC. In particular, discrepancies in terminology should be eliminated in the interests of clarity.

               (5)

               Directives 2000/25/EC and 2003/37/EC should therefore be amended accordingly.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 20(1) of Directive 2003/37/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2000/25/EC is amended as follows:

               1.

               In Article 1, the following indent is added:

                           ‘—

                           “replacement engine” means a newly built engine which replaces an engine in a machine and which has been supplied for this purpose only;’

               2.

               In Article 3, the following paragraph is added:
               ‘3.   Replacement engines shall comply with the limit values that the engine to be replaced had to meet when originally placed on the market.
               The text “REPLACEMENT ENGINE” shall be attached to a label on the engine or inserted into the owner’s manual;’

               3.

               The following Article 3a is inserted:
               ‘Article 3a
               Flexibility Scheme
               By way of derogation from Article 3(1) and (2), Member States shall provide that, at the request of the tractor manufacturer, and subject to permission being granted by the approval authority, the engine manufacturer may, during the period between two successive limit value stages, place on the market a limited number of engines that comply only with the emission limit value stage immediately preceding the currently applicable stage, or tractors with such engines, provided that he complies with the procedure set out in Annex IV.’;

               4.

               Article 4 is amended as follows:

                           (a)

                           In paragraph 2, the following points (c), (d) and (e) are added:

                                       ‘(c)

                                       in stage III A

                                                   —

                                                   after 31 December 2005 for engines of categories H, I and K (power range as defined in Article 9(3a) of Directive 97/68/EC),

                                                   —

                                                   after 31 December 2006 for engines of category J (power range as defined in Article 9(3a) of Directive 97/68/EC);

                                       (d)

                                       in stage III B

                                                   —

                                                   after 31 December 2009 for engines of category L (power range as defined in Article 9(3c) of Directive 97/68/EC),

                                                   —

                                                   after 31 December 2010 for engines of categories M and N (power range as defined in Article 9(3c) of Directive 97/68/EC),

                                                   —

                                                   after 31 December 2011 for engines of category P (power range as defined in Article 9(3c) of Directive 97/68/EC);

                                       (e)

                                       in stage IV

                                                   —

                                                   after 31 December 2012 for engines of category Q (power range as defined in Article 9(3d) of Directive 97/68/EC),

                                                   —

                                                   after 30 September 2013 for engines of category R (power range as defined in Article 9(3d) of Directive 97/68/EC).’;

                           (b)

                           in paragraph 3, the following indents are added:

                                       ‘—

                                       after 31 December 2005 for engines of category H,

                                       —

                                       after 31 December 2006 for engines of categories I,

                                       —

                                       after 31 December 2006 for engines of categories K,

                                       —

                                       after 31 December 2007 for engines of category J,

                                       —

                                       after 31 December 2010 for engines of category L,

                                       —

                                       after 31 December 2011 for engines of categories M,

                                       —

                                       after 31 December 2011 for engines of categories N,

                                       —

                                       after 31 December 2012 for engines of category P,

                                       —

                                       after 31 December 2013 for engines of category Q,

                                       —

                                       after 30 September 2014 for engines of category R.’;

                           (c)

                           paragraph 5 is replaced by the following:
                           ‘5.   For engines of categories A to G Member States may postpone the dates laid down in paragraph 3 for two years with respect to engines with a production date prior to the said date. They may grant other exceptions under the conditions laid down in Article 10 of Directive 97/68/EC.’;

                           (d)

                           the following paragraphs 6, 7 and 8 are added:
                           ‘6.   For engines of categories H to R, the dates laid down in paragraph 3 shall be postponed for two years with respect to engines with a production date prior to the said date.
                           7.   For engine types or engine families meeting the limit values set out in the table in section 4.1.2.4, 4.1.2.5 and 4.1.2.6 of Annex I to Directive 97/68/EC before the dates laid down in paragraph 3 of this Article, Member States shall allow special labelling and marking to show that the equipment concerned meets the required limit values before the dates laid down.
                           8.   In accordance with the procedure referred to in Article 20(2) of Directive 2003/37/EC, the Commission shall align the limit values and dates of stages IIIB and IV with the limit values and dates decided following the revision procedure provided for in Article 2(b) of Directive 2004/26/EC, with a view to the needs of agricultural or forestry tractors and, in particular, tractors of categories T2, T4.1 and C2.’;

               5.

               Annexes I, II and III are amended in accordance with Annex I to this Directive.

               6.

               Annex IV, the text of which is set out in Annex II to this Directive, is added.

         Article 2
   Annex I to Directive 2003/37/EC is amended in accordance with Annex III to this Directive.
   Article 3
   1.   Member States shall adopt and publish, by 31 December 2005 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 January 2006.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 21 February 2005.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 173, 12.7.2000, p. 1. Directive as amended by the Act of Accession of 2003.

      (2)  OJ L 171, 9.7.2003, p. 1. Directive as amended by Council Directive 2004/66/EC (OJ L 168, 1.5.2004, p. 35).

      (3)  OJ L 59, 27.2.1998, p. 1. Directive as last amended by Directive 2004/26/EC (OJ L 146, 30.4.2004, p. 1).

      (4)  OJ L 84, 28.3.1974, p. 10. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

      ANNEX I
      Annexes I, II and III to Directive 2000/25/EC are amended as follows:

                  1.

                  Annex I is amended as follows:

                              (a)

                              Appendix 1 is replaced by the following:

                                 ‘Appendix 1

                              (b)

                              in Appendix 2, section II, subsection 2.4 is replaced by the following:
                              ‘2.4.   Test results
                              Measured in accordance with the requirements of Directive 97/68/EC

                                          CO
                                          (g/kWh)

                                          HC
                                          (g/kWh)

                                          NOx
                                          (g/kWh)

                                          HC + NOx
                                          (g/kWh)

                                          Particulates
                                          (g/kWh)’

                  2.

                  Annex II is amended as follows:

                              (a)

                              Appendix 1 is amended as follows:

                                          (i)

                                          section 2, subsections 2.1.17 and 2.1.18 are replaced by the following:

                                                      ‘2.1.17.

                                                      Intake system: maximum allowable intake depression at rated engine speed and at 100 % load: … kPa

                                                      2.1.18.

                                                      Exhaust system: maximum permissible exhaust back pressure at rated engine speed and at 100 % load: … kPa’;

                                          (ii)

                                          the following is added:
                                          ‘2.6.   Porting configuration

                                                      2.6.1.

                                                      Position, size and number’;

                              (b)

                              in Appendix 2, section 2, subsection 2.2.4, is replaced by the following:
                              ‘2.2.4.   Test results
                              Measured in accordance with the requirements of Directive 97/68/EC

                                          CO
                                          (g/kWh)

                                          HC
                                          (g/kWh)

                                          NOx
                                          (g/kWh)

                                          HC + NOx
                                          (g/kWh)

                                          Particulates
                                          (g/kWh)’

                  3.

                  Annex III is replaced by the following:

                     ‘ANNEX III
                     RECOGNITION OF ALTERNATIVE TYPE-APPROVALS
                     1.   For stage I the following certificates of type-approvals are recognised to be equivalent for engines of categories A, B and C as defined in Directive 97/68/EC:
                     1.1.   certificates of type-approvals according to Directive 97/68/EC;
                     1.2.   certificates of type-approvals according to Directive 88/77/EEC, complying with the requirements of stage A or B regarding Article 2 and Annex I, Section 6.2.1 of Directive 88/77/EEC as amended by Directive 91/542/EEC, or UN-ECE Regulation 49.02 series of amendments corrigenda I/2;
                     1.3.   certificates of type-approvals according to UN-ECE Regulation 96.
                     2.   For stage II the following certificates of type-approvals are recognised to be equivalent:
                     2.1.   certificates of type-approvals according to Directive 97/68/EC, stage II for engines of categories D, E, F and G;
                     2.2.   type-approvals to Directive 88/77/EEC as amended by Directive 99/96/EC which are in compliance with stages A, B1, B2 or C provided for in Article 2 and section 6.2.1 of Annex I;
                     2.3.   UN-ECE Regulation 49.03 series of amendments;
                     2.4.   UN-ECE Regulation 96 stage B approvals according to paragraph 5.2.1 of the 01 series of amendments of Regulation 96.
                     3.   For stage III A the following certificates of type-approvals are recognised to be equivalent:
                     Certificates of type-approvals according to Directive 97/68/EC, stage III A for engines of categories H, I, J and K.
                     4.   For stage III B the following certificates of type-approvals are recognised to be equivalent:
                     certificates of type-approvals according to Directive 97/68/EC, stage III B for engines of categories L, M , N and P.
                     5.   For stage IV the following certificates of type-approvals are recognised to be equivalent:
                     certificates of type-approvals according to Directive 97/68/EC, stage IV for engines of categories Q and R.’

      ANNEX II
      The following Annex IV is added to Directive 2000/25/EC:

            ‘ANNEX IV
            PROVISIONS FOR TRACTORS AND ENGINES PLACED ON THE MARKET UNDER THE FLEXIBILITY SCHEME LAID DOWN IN ARTICLE 3A
            1.   ACTIONS BY THE ENGINE AND THE TRACTOR MANUFACTURERS
            1.1.   A tractor manufacturer, who wishes to make use of the flexibility scheme, shall request permission from his approval authority to place or to source from his engine suppliers, in the period between two emissions stages, the quantities of engines described in section 1.2 and 1.3 that do not comply with the current emission limit values, but are approved to the nearest previous stage of emission limits.
            1.2.   The number of engines placed on the market under a flexibility scheme shall, in each engine category, not exceed 20 % of the tractor manufacturer’s annual sales of tractors with engines in that engine category (calculated as the average of the latest 5 years sales on the EU market). In the case that a tractor manufacturer has marketed tractors in the EU for a period of less than five years the average will be calculated based on the period for which the tractor manufacturer has marketed tractors in the EU.
            1.3.   As an alternative option to section 1.2, the tractor manufacturer may seek permission for his engine suppliers to place on the market a fixed number of engines under the flexibility scheme. The number of engines in each engine category shall not exceed the following values:

                        Engine Category

                        Number of Engines

                        19-37 kW

                        200

                        37-75 kW

                        150

                        75-130 kW

                        100

                        130-560 kW

                        50

                  1.4.   The tractor manufacturer shall include in his application to an approval authority the following information:

                        (a)

                        a sample of the labels to be affixed to each tractor in which an engine placed on the market under the flexibility scheme will be installed. The labels shall bear the following text: “TRACTOR NO … (sequence of tractors) OF … (total number of tractors in respective power band) WITH ENGINE NO. … WITH TYPE APPROVAL (Directive 2000/25/EC) NO …”; and

                        (b)

                        a sample of the supplementary label to be affixed on the engine bearing the text referred to in section 2.2 of this Annex.

                  1.5.   The tractor manufacturer shall provide the approval authority with any information connected with the implementation of the flexibility scheme that the approval authority may request necessary to make a decision.
            1.6.   The tractor manufacturer shall file a report every six months to the approval authorities of each Member State, where the tractor or engine is put on the market, on the implementation of the flexibility schemes he is using. The report shall include cumulative data on the number of engines and tractors placed on the market under the flexibility scheme, engine and tractor serial numbers, and the Member States where the tractor has been entered into service. This procedure shall be continued as long as a flexibility scheme is still in progress.
            2.   ACTIONS BY THE ENGINE MANUFACTURER
            2.1.   An engine manufacturer may supply engines to a tractor manufacturer under a flexibility scheme covered by an approval in accordance with section 1 of this annex.
            2.2.   The engine manufacturer must put a label on those engines with the following text: “Engine placed on the market under the flexibility scheme”.
            3.   ACTIONS BY THE APPROVAL AUTHORITY
            The approval authority shall evaluate the content of the flexibility scheme request and the enclosed documents. As a consequence it will inform the tractor manufacturer of its decision as to whether or not to allow use of the flexibility scheme.’

      ANNEX III
      In Annex I to Directive 2003/37/EC, Model A, section 3 ‘Engine’, is replaced by the following:


Avis juridique important

|

32001L0064

Council Directive 2001/64/EC of 31 August 2001 amending Directive 66/401/EEC on the marketing of fodder plant seed and Directive 66/402/EEC on the marketing of cereal seed

Official Journal L 234 , 01/09/2001 P. 0060 - 0061

Council Directive 2001/64/ECof 31 August 2001amending Directive 66/401/EEC on the marketing of fodder plant seed and Directive 66/402/EEC on the marketing of cereal seedTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 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:(1) For the reasons set out below, Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed(4) and Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seeds(5) should be amended.(2) Commission Decision 94/650/EC(6) organised a temporary experiment under specified conditions, with the aim of assessing whether the marketing of seed in bulk to the final consumer would have no adverse effect on the quality of the seed compared with the level of quality achieved under the present system under Directives 66/401/EEC and 66/402/EEC.(3) Following that temporary experiment, it is appropriate to permit the marketing of seed in bulk to the final consumer on a permanent basis, subject to the observance of specific conditions, and Directives 66/401/EEC and 66/402/EEC should be amended accordingly.(4) The measures necessary for the implementation of Directives 66/401/EEC and 66/402/EEC 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(7),HAS ADOPTED THIS DIRECTIVE:Article 1Directive 66/401/EEC is hereby amended as follows:1. The following Article shall be inserted: "Article 10d1. Member States may, by way of derogation from Articles 8, 9 and 10, provide a simplification of the provisions relating to the closing device and the marking of packages in the case of marketing of seed of the category 'certified seed' in bulk to the final consumer.2. Conditions for the application of the derogation under paragraph 1 above shall be determined in accordance with the procedure referred to in Article 21(2).Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 94/650/EC(8) shall apply."2. Article 21 shall be replaced by the following: "Article 211. The Commission shall be assisted by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry established by Article 1 of Council Decision 66/399/EEC (hereinafter 'the Committee').2. Where reference is made to this paragraph, Articles 4 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(9) shall apply.The period provided for in Article 4(3) of Decision 1999/468/EC shall be set at one month.3. The Committee shall adopt its rules of procedures."Article 2Directive 66/402/EEC is hereby amended as follows:1. The following Article shall be inserted: "Article 10a1. Member States may, by way of derogation from Articles 8, 9 and 10, provide a simplification of the provisions relating to the closing device and the marking of packages in the case of marketing of seed of the category 'certified seed' in bulk to the final consumer.2. Conditions for the application of the derogation under paragraph 1 above shall be determined in accordance with the procedure referred to in Article 21(2).Until such measures are adopted, the conditions set out in Article 2 of Commission Decision 94/650/EC(10) shall apply."2. Article 21 shall be replaced by the following: "Article 211. The Commission shall be assisted by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry established by Article 1 of Decision 66/399/EEC (hereinafter 'the Committee').2. Where reference is made to this paragraph, Articles 4 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(11) shall apply.The period provided for in Article 4(3) of Decision 1999/468/EC shall be set at one month.3. The Committee shall adopt its rules of procedures."Article 31. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 March 2002. 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 main provisions of domestic law they adopt in the field covered by this Directive.Article 4This Directive shall enter into force on the date of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 31 August 2001.For the CouncilThe PresidentL. Michel(1) OJ C 212 E, 31.7.2001.(2) Opinion delivered on 4 July 2001.(3) Opinion delivered on 11 July 2001.(4) OJ 125, 11.7.1966, p. 2298/66. Directive as last amended by Directive 98/96/EC (OJ L 25, 1.2.1999, p. 27).(5) OJ 125, 11.7.1996, p. 2309/66. Directive as last amended by Commission Directive 1999/54/EC (OJ L 142, 5.6.1999, p. 30).(6) OJ L 252, 28.9.1994, p. 15. Decision as last amended by Commission Decision 2000/441/EC (OJ L 176, 15.7.2000, p. 50).(7) OJ L 184, 17.7.1999, p. 23.(8) OJ L 252, 28.9.1994, p. 15. Decision as last amended by Commission Decision 2000/441/EC (OJ L 176, 15.7.2000, p. 50).(9) OJ L 184, 17.7.1999, p. 23.(10) OJ L 252, 28.9.1994, p. 15. Decision as last amended by Commission Decision 2000/441/EC (OJ L 176, 15.7.2000, p. 50).(11) OJ L 184, 17.7.1999, p. 23.


Avis juridique important

|

31998L0053

Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs (Text with EEA relevance)

Official Journal L 201 , 17/07/1998 P. 0093 - 0101

COMMISSION DIRECTIVE 98/53/EC of 16 July 1998 laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffs (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 85/591/EEC of 20 December 1985 concerning the introduction of Community methods of sampling and analysis for the monitoring of foodstuffs intended for human consumption (1), and in particular Article 1 thereof,Whereas Commission Regulation (EC) No 1525/98 of 16 July 1998, amending Commission Regulation (EC) No 194/97 setting maximum levels for certain contaminants in foodstuffs (2) fixes maximum limits for aflatoxins in certain foodstuffs;Whereas Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (3) introduces a system of quality standards for laboratories entrusted by the Member States with the official control of foodstuffs;Whereas sampling plays a crucial part in the precision of the determination of the levels of the aflatoxins which are very heterogeneously distributed in a lot;Whereas it seems necessary to fix general criteria which the method of analysis has to comply with in order to ensure that laboratories, in charge of the control, use methods of analysis with comparable levels of performance;Whereas the provisions for the sampling and methods of analysis have been drawn up on the basis of present knowledge and they may be adapted to take account of advances in scientific and technological knowledge;Whereas the methods of sampling used currently by the competent authorities largely differ in the Member States; whereas the competent authorities in certain Member States are not in a position to apply all the provisions of this Directive in a short time; whereas it is, therefore, necessary to provide a suitable period to apply these provisions;Whereas Member States will have to modify their methods of sampling gradually in order to comply with the provisions laid down in the Annexes to this Directive by the time the Directive has to be applied; whereas it is, therefore, appropriate to examine regularly with the Member States the application of these provisions;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 The Member States shall take all measures necessary to ensure that the sampling for the official control of the levels of aflatoxins in foodstuffs is carried out in accordance with the methods described in Annex I of this Directive.Article 2 The Member States shall take all measures necessary to ensure that sample preparation and methods of analyses used for the official control of the levels of aflatoxins in foodstuffs comply with the criteria described in Annex II of this Directive.Article 3 The Member States shall, not later than 31 December 2000, bring into force the laws, regulations or administrative provisions necessary to comply with the provisions of this Directive. They shall forthwith notify the Commission thereof.When Member States adopt these provisions, the provisions 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 4 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.This Directive is addressed to the Member States.Done at Brussels, 16 July 1998.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 372, 31. 12. 1985, p. 50.(2) See page 43 of this Official Journal.(3) OJ L 290, 24. 11. 1993, p. 14.ANNEX I Methods of sampling for official checking control of the levels of aflatoxins in certain foodstuffs 1. Purpose and scope Samples intended for official checking of the levels of aflatoxin content in foodstuffs shall be taken according to the methods described below. Aggregate samples thus obtained shall be considered as representative of the lots. Compliance with maximum limits laid down in Commission Regulation (EC) No 1525/98 shall be established on the basis of the levels determined in the laboratory samples.2. Definitions >TABLE>3. General provisions 3.1. Personnel Sampling shall be performed by an authorised person as specified by the Member States.3.2. Material to be sampled Each lot which is to be examined must be sampled separately. In accordance with the specific provisions in point 5 of this Annex, large lots should be subdivided into sublots to be sampled separately.3.3. Precautions to be taken In the course of sampling and preparation of the laboratory samples precautions must be taken to avoid any changes which would affect the aflatoxin content, adversely affect the analytical determination or make the aggregate samples unrepresentative.3.4. Incremental samples As far as possible incremental samples should be taken at various places distributed throughout the lot or sublot. Departure from this procedure must be recorded in the record provided for in 3.8.3.5. Preparation of the aggregate sample and the laboratory samples (subsamples) The aggregate sample is made up by uniting and sufficiently mixing the incremental samples. After mixing, the aggregate sample must be divided into equal subsamples in accordance with the specific provisions of point 5 of this Annex.The mixing is necessary to ensure that each subsample contains portions of the whole lot or sublot.3.6. Replicate samples The replicate samples for enforcement, trade (defence) and referee purposes are to be taken from the homogenised laboratory sample, unless this conflicts with Member States' rules on sampling.3.7. Packaging and transmission of laboratory samples Each laboratory sample shall be placed in a clean, inert container offering adequate protection from contamination and against damage in transit. All necessary precautions shall be taken to avoid any change in composition of the laboratory sample which might arise during transportation or storage.3.8. Sealing and labelling of laboratory samples Each sample taken for official use shall be sealed at the place of sampling and identified following the Member State's regulations. A record must be kept of each sampling, permitting each lot to be identified unambiguously and giving the date and place of sampling together with any additional information likely to be of assistance to the analyst.4. Explanatory provisions 4.1. Different types of lots Food commodities may be traded in bulk, containers, or individual packings (sacks, bags, retail packings, etc.). The sampling procedure can be applied to all the different forms in which the commodities are put on the market.Without prejudice to the specific provisions as laid down in point 5 of this Annex, the following formula can be used as a guide for the sampling of lots traded in individual packings (sacks, bags, retail packings, etc.):Sampling frequency (SF) = >NUM>Weight of the lot × weight of the incremental sample>DEN>Weight of the aggregate sample × weight of individual packing- Weight: in kgSampling frequency (SF): every nth sack or bag from which an incremental sample must be taken (decimal figures should be rounded to the nearest whole number).4.2. Weight of the incremental sample The weight of the incremental sample should be about 300 grams, unless otherwise defined in point 5 of this Annex. In the case of lots in retail packings, the weight of the incremental sample depends on the weight of the retail packing.4.3. Number of incremental samples for lots of less than 15 tonnes The number of incremental samples to be taken depends on the weight of the lot, with a minimum of 10 and a maximum of 100, unless otherwise defined in point 5 of this Annex. The figures in the following table may be used to determine the number of incremental samples to be taken.>TABLE>5. Specific provisions 5.1. General survey of the sampling procedure for groundnuts, nuts, dried fruit and cereals >TABLE>5.2. Groundnuts, pistachios and Brazil nuts Dried figs Cereals (lots ≥ 50 tonnes) 5.2.1. Sampling procedure- On condition that the sublot can be separated physically, each lot must be subdivided into sublots following Table 2 at point 5.1. Taking into account that the weight of the lot is not always an exact multiple of the weight of the sublots, the weight of the sublot may exceed the mentioned weight by a maximum of 20 %,- each sublot must be sampled separately,- number of incremental samples: 100. In the case of lots under 15 tonnes, the number of incremental samples to be taken depends on the weight of the lot, with a minimum of 10 and a maximum of 100 (see point 4.3),- weight of the aggregate sample = 30 kg which has to be mixed and to be divided into three equal subsamples of 10 kg before grinding (this division into three subsamples is not necessary in the case of groundnuts, nuts and dried fruit intended for further sorting or other physical treatment, however, this will depend upon the availability of equipment which is able to homogenise a 30 kg sample). In cases where the aggregate sample weights are under 10 kg, the aggregate sample must not be divided into three subsamples,- laboratory sample: a subsample of 10 kg (each subsample must be separately ground finely and mixed thoroughly to achieve complete homogenisation, in accordance with the provisions laid down in Annex II),- if it is not possible to carry out the method of sampling described above because of the commercial consequences resulting from damage to the lot (because of packaging forms, means of transport, etc.) an alternative method of sampling may be applied provided that it is as representative as possible and is fully described and documented.5.2.2. Acceptance of a lot or sublot- For groundnuts, nuts and dried fruit subjected to a sorting or other physical treatment:- acceptance if the aggregate sample or the average of the subsamples conforms to the maximum limit,- rejection if the aggregate sample or the average of the subsamples exceeds the maximum limit,- for groundnuts, nuts, dried fruit and cereals intended for direct human consumption:- acceptance if none of the subsamples exceeds the maximum limit,- rejection if one or more of the subsamples exceeds the maximum limit,- where the aggregate sample is under 10 kg:- acceptance if the aggregate sample conforms to the maximum limit,- rejection if the aggregate sample exceeds the maximum limit.5.3. Nuts other than groundnuts, pistachios and Brazil nuts Dried fruit other than figs Cereals (lots under 50 tonnes) 5.3.1. Sampling procedureFor these products, the sampling procedure laid down in point 5.2.1 may be applied. However, taking into account the low incidence of contamination for these products and/or the newer forms of packaging in which products can be traded, simpler sampling methods may be applied.For cereal lots under 50 tonnes, a sampling plan consisting of, depending on the lot weight, 10 to 100 incremental samples each of 100 grams, resulting in an aggregate sample of 1 to 10 kg may be used. The figures in the following table can be used to determine the number of incremental samples to be taken.>TABLE>5.3.2. Acceptance of a lot or sublotSee point 5.2.2.5.4. Milk 5.4.1. Sampling procedureSampling in accordance with Commission Decision 91/180/EEC of 14 February 1991 laying down certain methods of analysis and testing of raw milk and heat-treated milk (1):- number of incremental samples: minimum 5,- weight of aggregate sample: minimum 0,5 kg or litres.5.4.2. Acceptance of a lot or sublot- Acceptance if the aggregate sample conforms to the maximum limit,- rejection if the aggregate sample exceeds the maximum limit.5.5. Derived products and compound foods 5.5.1. Milk products5.5.1.1. Sampling procedureSampling in accordance with Commission Directive 87/524/EEC of 6 October 1987 laying down Community methods of sampling for chemical analysis for the monitoring of preserved milk products (2).Number of incremental samples: minimum 5.For the other milk products an equivalent method of sampling is used.5.5.1.2. Acceptance of a lot or sublot- Acceptance if the aggregate sample conforms to the maximum limit,- rejection if the aggregate sample exceeds the maximum limit.5.5.2. Other derived products with very small particle weight, i.e. flour, fig paste, peanut butter (homogeneous distribution of aflatoxin contamination)5.5.2.1. Sampling procedure- Number of incremental samples: 100. For lots of under 50 tonnes the number of incremental samples should be 10 to 100, depending on the lot weight (see Table 3 at point 5.3.1 of this Annex),- the weight of the incremental sample should be about 100 grams. In the case of lots in retail packing, the weight of the incremental sample depends on the weight of the retail packing,- weight of aggregate sample = 1-10 kg sufficiently mixed.5.5.2.2. Number of samples to be taken- The number of aggregate samples to be taken depends on the lot weight. The division of large lots into sublots must be done as defined for cereals under point 5.2,- each sublot must be sampled separately.5.5.2.3 Acceptance of a lot or sublot- Acceptance if the aggregate sample conforms to the maximum limit,- rejection if the aggregate sample exceeds the maximum limit.5.6. Other derived products with a relatively large particle size (heterogeneous distribution of aflatoxin contamination) Sampling procedure and acceptance as defined at points 5.2 and 5.3 of this Annex for the raw agricultural product.(1) OJ L 93, 13. 4. 1991, p. 1.(2) OJ L 306, 28. 10. 1987, p. 24.ANNEX II Sample preparation and criteria for methods of analysis used in official checking of the levels of aflatoxins in certain foodstuffs 1. Introduction 1.1. Precautions Daylight should be excluded as much as possible during the procedure, since aflatoxin gradually breaks down under the influence of ultra-violet light. As the distribution of aflatoxin is extremely non-homogeneous, samples should be prepared - and especially homogenised - with extreme care.All the material received by the laboratory is to be used for the preparation of test material.1.2. Calculation of proportion of shell/kernel of whole nuts The limits fixed for aflatoxins in Commission Regulation (EC) No 1525/98 apply to the edible part.The level of aflatoxins in the edible part can be determined by:- shelling samples of nuts 'in shell` and the level of aflatoxins is directly determined in the edible part,- homogenise the nuts 'in shell` by taking them through the sample preparation procedure. The sampling and analytical procedure must estimate the weight of nut kernel in the aggregate sample. The weight of nut kernel in the aggregate sample is estimated after establishing a suitable factor for the proportion of nut shell to nut kernel in whole nuts. This proportion is used to ascertain the amount of kernel in the bulk sample taken through the sample preparation and analysis procedure. Approximately 100 whole nuts are taken at random separately from the lot or are to be put aside from each aggregate sample. The ratio may, for each laboratory sample, be obtained by weighing the whole nuts, shelling and re-weighing the shell and kernel portions. However, the proportion of shell to kernel may be established by the laboratory from a number of samples and so can be assumed for future analytical work. But if a particular laboratory sample is found to be in contravention of any limit, the proportion should be determined for that sample using the approximately 100 nuts that have been set aside.2. Treatment of the sample as received in the laboratory Finely grind and mix thoroughly each laboratory sample using a process that has been demonstrated to achieve complete homogenisation.3. Subdivision of samples for enforcement and defence purposes The replicate samples for enforcement, trade (defence) and referee purposes shall be taken from the homogenised material unless this conflicts with Member States' rules on sampling.4. Method of analysis to be used by the laboratory and laboratory control requirements 4.1. Definitions A number of the most commonly used definitions that the laboratory will be required to use are given below:The most commonly quoted precision parameters are repeatability and reproducibility.>TABLE>4.2. General requirements Methods of analysis used for food control purposes must comply whenever possible with the provisions of points 1 and 2 of the Annex to Council Directive 85/591/EEC.4.3. Specific requirements Where no specific methods for the determination of aflatoxin levels in foodstuffs are prescribed at Community level, laboratories may select any method provided the selected method meets the following criteria:>TABLE>Notes:- Values to apply to both B1 and sum of B1+B2+G1+G2,- if sum of individual aflatoxins B1+B2+G1+G2 are to be reported, then response of each to the analytical system must be either known or equivalent,- the detection limits of the methods used are not stated as the precision values are given at the concentrations of interest,- the precision values are calculated from the Horwitz equation, i. e.:RSDR = 2 (1-0,5 logC)where:- RSDR is the relative standard deviation calculated from results generated under reproducibility conditions [(SR/x) × 100]- C is the concentration ratio (i. e. 1 = 100 g/100 g, 0,001 = 1 000 mg/kg).This is a generalised precision equation which has been found to be independant of analyse and matrix but solely dependent on concentration for most routine methods of analysis.4.4. Recovery calculation The analytical result is to be reported corrected or uncorrected for recovery. The manner of reporting and the level of recovery must be reported.4.5. Laboratory quality standards Laboratories must comply with Council Directive 93/99/EEC.