title: Directive 2006/7/EC of the European Parliament and of the Council of  15 February 2006  concerning the management of bathing water quality and repealing Directive 76/160/EEC

text:
               4.3.2006

               EN

               Official Journal of the European Union

               L 64/37

      DIRECTIVE 2006/7/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 15 February 2006
   concerning the management of bathing water quality and repealing Directive 76/160/EEC
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,
   Having regard to the proposal from the Commission (1),
   Having regard to the opinion of the European Economic and Social Committee (2),
   Having regard to the opinion of the Committee of the Regions (3),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (4), in the light of the joint text approved by the Conciliation Committee on 8 December 2005,
   Whereas:

               (1)

               Building on the Commission's Communication on sustainable development, the European Council has singled out objectives as general guidance for future development in priority areas such as natural resources and public health.

               (2)

               Water is a scarce natural resource, the quality of which should be protected, defended, managed and treated as such. Surface waters in particular are renewable resources with a limited capacity to recover from adverse impacts from human activities.

               (3)

               Community policy on the environment should aim at a high level of protection, and contribute to pursuing the objectives of preserving, protecting and improving the quality of the environment and of protecting human health.

               (4)

               In December 2000, the Commission adopted a Communication to the European Parliament and the Council on the development of a new bathing water policy and initiated a large‐scale consultation of all interested and involved parties. The main outcome of this consultation was general support for the development of a new Directive based on the latest scientific evidence and paying particular attention to wider public participation.

               (5)

               Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 laying down the Sixth Community Environment Action Programme (5) contains a commitment to ensuring a high level of protection of bathing water, including by revising Council Directive 76/160/EEC of 8 December 1975 concerning the quality of bathing water (6).

               (6)

               Pursuant to the Treaty, in preparing policy on the environment the Community is, inter alia, to take account of available scientific and technical data. This Directive should use scientific evidence in implementing the most reliable indicator parameters for predicting microbiological health risk and to achieve a high level of protection. Further epidemiological studies should be undertaken urgently concerning the health risks associated with bathing, particularly in fresh water.

               (7)

               In order to increase efficiency and wise use of resources, this Directive needs to be closely coordinated with other Community legislation on water, such as Council Directives 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (7), 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (8) and Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (9).

               (8)

               Appropriate information on planned measures and progress on implementation should be disseminated to stakeholders. The public should receive appropriate and timely information on the results of the monitoring of bathing water quality and risk management measures in order to prevent health hazards, especially in the context of predictable short-term pollution or abnormal situations. New technology that allows the public to be informed in an efficient and comparable way on bathing waters across the Community should be applied.

               (9)

               For the purpose of monitoring, harmonised methods and practices of analysis need to be applied. Observation and quality assessment over an extended period are necessary in order to achieve a realistic bathing water classification.

               (10)

               Compliance should be a matter of appropriate management measures and quality assurance, not merely of measuring and calculation. A system of bathing water profiles is therefore appropriate to provide a better understanding of risks as a basis for management measures. In parallel, particular attention should be attached to adherence to quality standards and coherent transition from Directive 76/160/EEC.

               (11)

               On 17 February 2005 the Community ratified the UNECE Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (the Århus Convention). It is therefore appropriate for this Directive to include provisions on public access to information and to provide for public participation in its implementation to supplement Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (10) and Directive 2003/35/EC of the European Parliament and of the Council of 26 May 2003 providing for public participation in respect of the drawing up of certain plans and programmes relating to the environment (11).

               (12)

               Since the objectives of this Directive, namely the attainment by the Member States, on the basis of common standards, of a good bathing water quality and a high level of protection throughout the Community, cannot be sufficiently achieved by the Member States and can be better 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 those objectives.

               (13)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (12).

               (14)

               The continued importance of a Community bathing water policy is evident each bathing season as it protects the public from accidental and chronic pollution discharged in or near Community bathing areas. The overall quality of bathing waters has improved considerably since Directive 76/160/EEC came into force. However, that Directive reflects the state of knowledge and experience of the early 1970. Patterns of bathing water use have since changed, as has the state of scientific and technical knowledge. Therefore, that Directive should be repealed,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER I
   GENERAL PROVISIONS
   Article 1
   Purpose and scope
   1.   This Directive lays down provisions for:

               (a)

               the monitoring and classification of bathing water quality;

               (b)

               the management of bathing water quality; and

               (c)

               the provision of information to the public on bathing water quality.

         2.   The purpose of this Directive is to preserve, protect and improve the quality of the environment and to protect human health by complementing Directive 2000/60/EC.
   3.   This Directive shall apply to any element of surface water where the competent authority expects a large number of people to bathe and has not imposed a permanent bathing prohibition, or issued permanent advice against bathing (hereinafter bathing water). It shall not apply to:

               (a)

               swimming pools and spa pools;

               (b)

               confined waters subject to treatment or used for therapeutic purposes;

               (c)

               artificially created confined waters separated from surface water and groundwater.

         Article 2
   Definitions
   For the purposes of this Directive, the following definitions shall apply:

               1.

               the terms ‘surface water’, ‘groundwater’, ‘inland water’, ‘transitional waters’, ‘coastal water’ and ‘river basin’ have the same meaning as in Directive 2000/60/EC;

               2.

               ‘competent authority’ means the authority or authorities that a Member State has designated to ensure compliance with the requirements of this Directive or any other authority or body to which that role has been delegated;

               3.

               ‘permanent’ means, in relation to a bathing prohibition or advice against bathing, lasting for at least one whole bathing season;

               4.

               ‘large number’ means, in relation to bathers, a number that the competent authority considers to be large having regard, in particular, to past trends or to any infrastructure or facilities provided, or other measures taken, to promote bathing;

               5.

               ‘pollution’ means the presence of microbiological contamination or other organisms or waste affecting bathing water quality and presenting a risk to bathers' health as referred to in Articles 8 and 9 and Annex I, column A;

               6.

               ‘bathing season’ means the period during which large numbers of bathers can be expected.

               7.

               ‘management measures’ means the following measures undertaken with respect to bathing water:

                           (a)

                           establishing and maintaining a bathing water profile;

                           (b)

                           establishing a monitoring calendar;

                           (c)

                           monitoring bathing water;

                           (d)

                           assessing bathing water quality;

                           (e)

                           classifying bathing water;

                           (f)

                           identifying and assessing causes of pollution that might affect bathing waters and impair bathers' health;

                           (g)

                           giving information to the public;

                           (h)

                           taking action to prevent bathers' exposure to pollution;

                           (i)

                           taking action to reduce the risk of pollution;

               8.

               ‘short-term pollution’ means microbiological contamination as referred to in Annex I, column A, that has clearly identifiable causes, is not normally expected to affect bathing water quality for more than approximately 72 hours after the bathing water quality is first affected and for which the competent authority has established procedures to predict and deal with as set out in Annex II;

               9.

               ‘abnormal situation’ means an event or combination of events impacting on bathing water quality at the location concerned and not expected to occur on average more than once every four years;

               10.

               ‘set of bathing water quality data’ means data obtained in accordance with Article 3;

               11.

               ‘bathing water quality assessment’ means the process of evaluating bathing water quality, using the assessment method defined in Annex II;

               12.

               ‘cyanobacterial proliferation’ means an accumulation of cyanobacteria in the form of a bloom, mat or scum;

               13.

               the term ‘public concerned’ has the same meaning as in Council Directive 85/337/EEC of 27 June 1985 on the assessment of the effects of certain public and private projects on the environment (13).

         CHAPTER II
   QUALITY AND MANAGEMENT OF BATHING WATER
   Article 3
   Monitoring
   1.   Member States shall annually identify all bathing waters and define the length of the bathing season. They shall do so for the first time before the start of the first bathing season after 24 March 2008.
   2.   Member States shall ensure that monitoring of the parameters set out in Annex I, column A, takes place in accordance with Annex IV.
   3.   The monitoring point shall be the location within the bathing water where:

               (a)

               most bathers are expected; or

               (b)

               the greatest risk of pollution is expected, according to the bathing water profile.

         4.   A monitoring calendar for each bathing water shall be established before the start of each bathing season and for the first time before the start of the third full bathing season after the entry into force of this Directive. Monitoring shall take place no later than four days after the date specified in the monitoring calendar.
   5.   Member States may introduce monitoring of the parameters set out in Annex I, column A, during the first full bathing season following the entry into force of this Directive. In that case, monitoring shall take place with the frequency specified in Annex IV. The results of such monitoring may be used to build up the sets of bathing water quality data referred to in Article 4. As soon as Member States introduce monitoring under this Directive, monitoring of the parameters set out in the Annex to Directive 76/160/EEC may cease.
   6.   Samples taken during short-term pollution may be disregarded. They shall be replaced by samples taken in accordance with Annex IV.
   7.   During abnormal situations, the monitoring calendar referred to in paragraph 4 may be suspended. It shall be resumed as soon as possible after the end of the abnormal situation. New samples shall be taken as soon as possible after the end of the abnormal situation to replace samples that are missing due to the abnormal situation.
   8.   Member States shall report any suspension of the monitoring calendar to the Commission, giving the reasons for the suspension. They shall provide such reports on the occasion of the next annual report provided for in Article 13 at the latest.
   9.   Member States shall ensure that the analysis of bathing water quality takes place in accordance with the reference methods specified in Annex I and the rules set out in Annex V. However, Member States may permit the use of other methods or rules if they can demonstrate that the results obtained are equivalent to those obtained using the methods specified in Annex I and the rules set out in Annex V. Member States that permit the use of such equivalent methods or rules shall provide the Commission with all relevant information about the methods or rules used and their equivalence.
   Article 4
   Bathing water quality assessment
   1.   Member States shall ensure that sets of bathing water quality data are compiled through the monitoring of the parameters set out in Annex I, column A.
   2.   Bathing water quality assessments shall be carried out:

               (a)

               in relation to each bathing water;

               (b)

               after the end of each bathing season;

               (c)

               on the basis of the set of bathing water quality data compiled in relation to that bathing season and the three preceding bathing seasons; and

               (d)

               in accordance with the procedure set out in Annex II.

         However, a Member State may decide to carry out bathing water quality assessments on the basis of the set of bathing water quality data compiled in relation to the preceding three bathing seasons only. If it so decides, it shall notify the Commission beforehand. It shall also notify the Commission if it subsequently decides to revert to carrying out assessments on the basis of four bathing seasons. Member States may not change the applicable assessment period more than once every five years.
   3.   Sets of bathing water data used to carry out bathing water quality assessments shall always comprise at least 16 samples or, in the special circumstances referred to in Annex IV, paragraph 2, 12 samples.
   4.   However, provided that either:

               —

               the requirement of paragraph 3 is satisfied, or

               —

               the set of bathing water data used to carry out the assessment comprises at least eight samples, in the case of bathing waters with a bathing season not exceeding eight weeks,

         a bathing water quality assessment may be carried out on the basis of a set of bathing water quality data relating to fewer than four bathing seasons if:

               (a)

               the bathing water is newly identified;

               (b)

               any changes have occurred that are likely to affect the classification of the bathing water in accordance with Article 5, in which case the assessment shall be carried out on the basis of a set of bathing water quality data consisting solely of the results for samples collected since the changes occurred; or

               (c)

               the bathing water had already been assessed in accordance with Directive 76/160/EEC, in which case equivalent data gathered under that Directive shall be used and, for this purpose, parameters 2 and 3 of the Annex to Directive 76/160/EEC shall be deemed to be equivalent to parameters 2 and 1 of column A of Annex I to this Directive.

         5.   Member States may subdivide or group together existing bathing waters in the light of bathing water quality assessments. They may group existing bathing waters together only if these waters:

               (a)

               are contiguous;

               (b)

               received similar assessments for the preceding four years in accordance with paragraphs 2, 3 and 4(c); and

               (c)

               have bathing water profiles all of which identify common risk factors or the absence thereof.

         Article 5
   Classification and quality status of bathing waters
   1.   As a result of the bathing water quality assessment carried out in accordance with Article 4, Member States shall, in accordance with the criteria set out in Annex II, classify bathing water as:

               (a)

               ‘poor’;

               (b)

               ‘sufficient’;

               (c)

               ‘good’; or

               (d)

               ‘excellent’.

         2.   The first classification according to the requirements of this Directive shall be completed by the end of the 2015 bathing season.
   3.   Member States shall ensure that, by the end of the 2015 bathing season, all bathing waters are at least ‘sufficient’. They shall take such realistic and proportionate measures as they consider appropriate with a view to increasing the number of bathing waters classified as ‘excellent’ or ‘good’.
   4.   However, notwithstanding the general requirement of paragraph 3, bathing waters may temporarily be classified as ‘poor’ and still remain in compliance with this Directive. In such cases, Member States shall ensure that the following conditions are satisfied:

               (a)

               in respect of each bathing water classified as ‘poor’, the following measures shall be taken with effect from the bathing season that follows its classification:

                           (i)

                           adequate management measures, including a bathing prohibition or advice against bathing, with a view to preventing bathers' exposure to pollution;

                           (ii)

                           identification of the causes and reasons for the failure to achieve ‘sufficient’ quality status;

                           (iii)

                           adequate measures to prevent, reduce or eliminate the causes of pollution; and

                           (iv)

                           in accordance with Article 12, alerting the public by a clear and simple warning sign and informing them of the causes of the pollution and measures taken, on the basis of the bathing water profile.

               (b)

               If a bathing water is classified as ‘poor’ for five consecutive years, a permanent bathing prohibition or permanent advice against bathing shall be introduced. However, a Member State may introduce a permanent bathing prohibition or permanent advice against bathing before the end of the five‐year period if it considers that the achievement of ‘sufficient’ quality would be infeasible or disproportionately expensive.

         Article 6
   Bathing water profiles
   1.   Member States shall ensure that bathing water profiles are established in accordance with Annex III. Each bathing water profile may cover a single bathing water or more than one contiguous bathing waters. Bathing water profiles shall be established for the first time by 24 March 2011.
   2.   Bathing water profiles shall be reviewed and updated as provided for in Annex III.
   3.   When establishing, reviewing and updating bathing water profiles, adequate use shall be made of data obtained from monitoring and assessments carried out pursuant to Directive 2000/60/EC that are relevant for this Directive.
   Article 7
   Management measures in exceptional circumstances
   Member States shall ensure that timely and adequate management measures are taken when they are aware of unexpected situations that have, or could reasonably be expected to have, an adverse impact on bathing water quality and on bathers' health. Such measures shall include information to the public and, if necessary, a temporary bathing prohibition.
   Article 8
   Cyanobacterial risks
   1.   When the bathing water profile indicates a potential for cyanobacterial proliferation, appropriate monitoring shall be carried out to enable timely identification of health risks.
   2.   When cyanobacterial proliferation occurs and a health risk has been identified or presumed, adequate management measures shall be taken immediately to prevent exposure, including information to the public.
   Article 9
   Other parameters
   1.   When the bathing water profile indicates a tendency for proliferation of macro-algae and/or marine phytoplankton, investigations shall be undertaken to determine their acceptability and health risks and adequate management measures shall be taken, including information to the public.
   2.   Bathing waters shall be inspected visually for pollution such as tarry residues, glass, plastic, rubber or any other waste. When such pollution is found, adequate management measures shall be taken, including, if necessary, information to the public.
   Article 10
   Cooperation on transboundary waters
   Wherever a river basin gives rise to transboundary impacts on bathing water quality, the Member States involved shall cooperate as appropriate in implementing this Directive, including through the appropriate exchange of information and joint action to control those impacts.
   CHAPTER III
   EXCHANGE OF INFORMATION
   Article 11
   Public participation
   Member States shall encourage public participation in the implementation of this Directive and shall ensure the provision of opportunities for the public concerned:

               —

               to find out how to participate, and

               —

               to formulate suggestions, remarks or complaints.

         This shall relate, in particular, to the establishment, review and updating of lists of bathing waters in accordance with Article 3(1). Competent authorities shall take due account of any information obtained.
   Article 12
   Information to the public
   1.   Member States shall ensure that the following information is actively disseminated and promptly made available during the bathing season in an easily accessible place in the near vicinity of each bathing water:

               (a)

               the current bathing water classification and any bathing prohibition or advice against bathing referred to in this Article by means of a clear and simple sign or symbol;

               (b)

               a general description of the bathing water, in non-technical language, based on the bathing water profile established in accordance with Annex III;

               (c)

               in the case of bathing waters subject to short-term pollution:

                           —

                           notification that the bathing water is subject to short-term pollution,

                           —

                           an indication of the number of days on which bathing was prohibited or advised against during the preceding bathing season because of such pollution, and

                           —

                           a warning whenever such pollution is predicted or present,

               (d)

               information on the nature and expected duration of abnormal situations during such events;

               (e)

               whenever bathing is prohibited or advised against, a notice advising the public and giving reasons;

               (f)

               whenever a permanent bathing prohibition or permanent advice against bathing is introduced, the fact that the area concerned is no longer a bathing water and the reasons for its declassification; and

               (g)

               an indication of sources of more complete information in accordance with paragraph 2.

         2.   Member States shall use appropriate media and technologies, including the Internet, to disseminate actively and promptly the information concerning bathing waters referred to in paragraph 1 and also the following information in several languages, when appropriate:

               (a)

               a list of bathing waters;

               (b)

               the classification of each bathing water over the last three years and its bathing water profile, including the results of monitoring carried out in accordance with this Directive since the last classification;

               (c)

               in the case of bathing waters classified as being ‘poor’, information on the causes of pollution and measures taken with a view to preventing bathers' exposure to pollution and to tackle its causes as referred to in Article 5(4); and

               (d)

               in the case of bathing waters subject to short-term pollution, general information on:

                           —

                           conditions likely to lead to short-term pollution,

                           —

                           the likelihood of such pollution and its likely duration,

                           —

                           the causes of the pollution and measures taken with a view to preventing bathers' exposure to pollution and to tackle its causes.

         The list referred to in point (a) shall be available each year before the start of the bathing season. The results of the monitoring referred to in point (b) shall be made available on the Internet upon completion of the analysis.
   3.   The information referred to in paragraphs 1 and 2 shall be disseminated as soon as it is available and with effect from the start of the fifth bathing season after 24 March 2008.
   4.   Member States and the Commission shall, wherever possible, provide information to the public using geo-referenced technology and present it in a clear and coherent manner, in particular through the use of signs and symbols.
   Article 13
   Reports
   1.   Member States shall provide the Commission with the results of the monitoring and with the bathing water quality assessment for each bathing water, as well as with a description of significant management measures taken. Member States shall provide this information annually by 31 December in relation to the preceding bathing season. They shall begin providing it once the first bathing water quality assessment has been carried out in accordance with Article 4.
   2.   Member States shall notify the Commission annually before the start of the bathing season of all waters identified as bathing waters, including the reason for any change compared to the preceding year. They shall do so for the first time before the start of the first bathing season after 24 March 2008.
   3.   When monitoring of bathing water has started under this Directive, annual reporting to the Commission in accordance with paragraph 1 shall continue to take place pursuant to Directive 76/160/EEC until a first assessment can be made under this Directive. During that period, parameter 1 of the Annex to Directive 76/160/EEC shall not be taken into account in the annual report, and parameters 2 and 3 of the Annex to Directive 76/160/EEC shall be assumed to be equivalent to parameters 2 and 1 of column A of Annex I to this Directive.
   4.   The Commission shall publish an annual summary report on bathing water quality in the Community, including bathing water classifications, conformity with this Directive and significant management measures undertaken. The Commission shall publish this report by 30 April every year, including via the Internet. When establishing the report the Commission shall, wherever possible, make best use of data collection, assessment and presentation systems under related Community legislation, in particular Directive 2000/60/EC.
   CHAPTER IV
   FINAL PROVISIONS
   Article 14
   Report and review
   1.   The Commission shall, by 2008, submit a report to the European Parliament and to the Council. The report shall have particular regard to:

               (a)

               the results of an appropriate European epidemiological study conducted by the Commission in collaboration with Member States;

               (b)

               other scientific, analytical and epidemiological developments relevant to the parameters for bathing water quality, including in relation to viruses; and

               (c)

               World Health Organisation recommendations.

         2.   Member States shall, by the end of 2014, submit written observations to the Commission on that report including on the need for any further research or assessments which may be required to assist the Commission in its review of this Directive under paragraph 3.
   3.   In the light of the report, the Member States' written observations and an extended impact assessment and bearing in mind experience gained from implementing this Directive, the Commission shall, no later than 2020, review this Directive with particular regard to the parameters for bathing water quality, including whether it would be appropriate to phase out the ‘sufficient’ classification or modify the applicable standards, and shall present if necessary appropriate legislative proposals in accordance with Article 251 of the Treaty.
   Article 15
   Technical adaptations and implementing measures
   1.   It shall be decided in accordance with the procedure referred to in Article 16(2):

               (a)

               to specify the EN/ISO standard on the equivalence of microbiological methods for the purposes of Article 3(9);

               (b)

               to lay down detailed rules for the implementation of Articles 8(1), 12(1)(a) and 12(4);

               (c)

               to adapt the methods of analysis for the parameters set out in Annex I in the light of scientific and technical progress;

               (d)

               to adapt Annex V in the light of scientific and technical progress;

               (e)

               to lay down guidelines for a common method for the assessment of single samples.

         2.   The Commission shall present a draft of the measures to be taken in accordance with paragraph 1(b) with respect to Article 12(1)(a) by 24 March 2010. Before doing so, it shall consult representatives of Member States, regional and local authorities, relevant tourist and consumer organisations and other interested parties. After the adoption of relevant rules, it shall publicise them via the Internet.
   Article 16
   Committee procedure
   1.   The Commission shall be assisted by a committee.
   2.   Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
   3.   The Committee shall adopt its rules of procedure.
   Article 17
   Repeal
   1.   Directive 76/160/EEC is hereby repealed with effect from 31 December 2014. Subject to paragraph 2, this repeal shall be without prejudice to Member States' obligations concerning the time limits for transposition and application set out in the repealed Directive.
   2.   As soon as a Member State has taken all necessary legal, administrative and practical measures to comply with this Directive, this Directive will be applicable, replacing Directive 76/160/EEC.
   3.   References to the repealed Directive 76/160/EEC shall be construed as being made to this Directive.
   Article 18
   Implementation
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 24 March 2008. 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 a 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 main provisions of national law that they adopt in the field covered by this Directive.
   Article 19
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

   Article 20
   Addressees
   This Directive is addressed to Member States.

      Done at Strasbourg, 15 February 2006.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         H. WINKLER

      (1)  OJ C 45 E, 25.2.2003, p. 127.

      (2)  OJ C 220, 16.9.2003, p. 39.

      (3)  OJ C 244, 10.10.2003, p. 31.

      (4)  Opinion of the European Parliament of 21 October 2003 (OJ C 82 E, 1.4.2004, p. 115). Council Common Position of 20 December 2004 (OJ C 111 E, 11.5.2005, p. 1) and Position of the European Parliament of 10 May 2005 (not yet published in the Official Journal). European Parliament Legislative Resolution of 18 January 2006 (not yet published in the Official Journal) and Council Decision of 20 December 2005.

      (5)  OJ L 242, 10.9.2002, p. 1.

      (6)  OJ L 31, 5.2.1976, p. 1. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

      (7)  OJ L 135, 30.5.1991, p. 40. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (8)  OJ L 375, 31.12.1991, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

      (9)  OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1).

      (10)  OJ L 41, 14.2.2003, p. 26.

      (11)  OJ L 156, 25.6.2003, p. 17.

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

      (13)  OJ L 175, 5.7.1985, p. 40. Directive as last amended by Directive 2003/35/EC of the European Parliament and of the Council (OJ L 156, 25.6.2003, p. 17).

      ANNEX I
      For inland waters

                  A

                  B

                  C

                  D

                  E

                  Parameter

                  Excellent quality

                  Good quality

                  Sufficient

                  Reference methods of analysis

                  1

                  Intestinal enterococci (cfu/100 ml)

                  200 (1)

                  400 (1)

                  330 (2)

                  ISO 7899-1 or ISO 7899-2

                  2

                  Escherichia coli (cfu/100 ml)

                  500 (1)

                  1 000 (1)

                  900 (2)

                  ISO 9308-3 or ISO 9308-1

            For coastal waters and transitional waters

                  A

                  B

                  C

                  D

                  E

                  Parameter

                  Excellent quality

                  Good quality

                  Sufficient

                  Reference methods of analysis

                  1

                  Intestinal enterococci (cfu/100 ml)

                  100 (3)

                  200 (3)

                  185 (4)

                  ISO 7899-1 or ISO 7899-2

                  2

                  Escherichia coli (cfu/100 ml)

                  250 (3)

                  500 (3)

                  500 (4)

                  ISO 9308-3 or ISO 9308-1

         (1)  Based upon a 95‐percentile evaluation. See Annex II.

         (2)  Based upon a 90‐percentile evaluation. See Annex II.

         (3)  Based upon a 95‐percentile evaluation. See Annex II.

         (4)  Based upon a 90‐percentile evaluation. See Annex II.

      ANNEX II
      Bathing water assessment and classification
      1.   Poor quality
      Bathing waters are to be classified as ‘poor’ if, in the set of bathing water quality data for the last assessment period (1), the percentile values (2) for microbiological enumerations are worse (3) than the ‘sufficient’ values set out in Annex I, column D.
      2.   Sufficient quality
      Bathing waters are to be classified as ‘sufficient’:

                  1.

                  if, in the set of bathing water quality data for the last assessment period, the percentile values for microbiological enumerations are equal to or better (4) than the ‘sufficient’ values set out in Annex I, column D; and

                  2.

                  if the bathing water is subject to short-term pollution, on condition that:

                              (i)

                              adequate management measures are being taken, including surveillance, early warning systems and monitoring, with a view to preventing bathers' exposure by means of a warning or, where necessary, a bathing prohibition;

                              (ii)

                              adequate management measures are being taken to prevent, reduce or eliminate the causes of pollution; and

                              (iii)

                              the number of samples disregarded in accordance with Article 3(6) because of short‐term pollution during the last assessment period represented no more than 15 % of the total number of samples provided for in the monitoring calendars established for that period, or no more than one sample per bathing season, whichever is the greater.

            3.   Good quality
      Bathing waters are to be classified as ‘good’:

                  1.

                  if, in the set of bathing water quality data for the last assessment period, the percentile values for microbiological enumerations are equal to or better (4) than the ‘good quality’ values set out in Annex I, column C; and

                  2.

                  if the bathing water is subject to short-term pollution, on condition that:

                              (i)

                              adequate management measures are being taken, including surveillance, early warning systems and monitoring, with a view to preventing bathers' exposure, by means of a warning or, where necessary, a bathing prohibition;

                              (ii)

                              adequate management measures are being taken to prevent, reduce or eliminate the causes of pollution; and

                              (iii)

                              the number of samples disregarded in accordance with Article 3(6) because of short‐term pollution during the last assessment period represented no more than 15 % of the total number of samples provided for in the monitoring calendars established for that period, or no more than one sample per bathing season, whichever is the greater.

            4.   Excellent quality
      Bathing waters are to be classified as ‘excellent’:

                  1.

                  if, in the set of bathing water quality data for the last assessment period, the percentile values for microbiological enumerations are equal to or better than the ‘excellent quality’ values set out in Annex I, column B; and

                  2.

                  if the bathing water is subject to short-term pollution, on condition that:

                              (i)

                              adequate management measures are being taken, including surveillance, early warning systems and monitoring, with a view to preventing bathers' exposure, by means of a warning or, where necessary, a bathing prohibition;

                              (ii)

                              adequate management measures are being taken to prevent, reduce or eliminate the causes of pollution; and

                              (iii)

                              the number of samples disregarded in accordance with Article 3(6) because of short‐term pollution during the last assessment period represented no more than 15 % of the total number of samples provided for in the monitoring calendars established for that period, or no more than one sample per bathing season, whichever is the greater.

            NOTES

         (1)  ‘Last assessment period’ means the last four bathing seasons or, when applicable, the period specified in Article 4(2) or (4).

         (2)  Based upon percentile evaluation of the log10 normal probability density function of microbiological data acquired from the particular bathing water, the percentile value is derived as follows:

                  (i)

                  Take the log10 value of all bacterial enumerations in the data sequence to be evaluated. (If a zero value is obtained, take the log10 value of the minimum detection limit of the analytical method used instead.)

                  (ii)

                  Calculate the arithmetic mean of the log10 values (μ).

                  (iii)

                  Calculate the standard deviation of the log10 values (σ).

            The upper 90‐percentile point of the data probability density function is derived from the following equation: upper 90‐percentile = antilog (μ + 1,282 σ).
      The upper 95‐percentile point of the data probability density function is derived from the following equation: upper 95‐percentile = antilog (μ + 1,65 σ).

         (3)  ‘Worse’ means with higher concentration values expressed in cfu/100 ml.

         (4)  ‘Better’ means with lower concentration values expressed in cfu/100 ml.

      ANNEX III
      The bathing water profile

                  1.

                  The bathing water profile referred to in Article 6 is to consist of:

                              (a)

                              a description of the physical, geographical and hydrological characteristics of the bathing water, and of other surface waters in the catchment area of the bathing water concerned, that could be a source of pollution, which are relevant to the purpose of this Directive and as provided for in Directive 2000/60/EC;

                              (b)

                              an identification and assessment of causes of pollution that might affect bathing waters and impair bathers' health;

                              (c)

                              an assessment of the potential for proliferation of cyanobacteria;

                              (d)

                              an assessment of the potential for proliferation of macro-algae and/or phytoplankton;

                              (e)

                              if the assessment under point (b) shows that there is a risk of short-term pollution, the following information:

                                          —

                                          the anticipated nature, frequency and duration of expected short-term pollution,

                                          —

                                          details of any remaining causes of pollution, including management measures taken and the time schedule for their elimination,

                                          —

                                          management measures taken during short-term pollution and the identity and contact details of bodies responsible for taking such action,

                              (f)

                              the location of the monitoring point.

                  2.

                  In the case of bathing waters classified as ‘good’, ‘sufficient’ or ‘poor’, the bathing water profile is to be reviewed regularly to assess whether any of the aspects listed in paragraph 1 have changed. If necessary, it is to be updated. The frequency and scope of reviews is to be determined on the basis of the nature and severity of the pollution. However, they are to comply with at least the provisions and to take place with at least the frequency specified in the following table.

                              Bathing water classification

                              ‘Good’

                              ‘Sufficient’

                              ‘Poor’

                              Reviews are to take place at least every

                              four years

                              three years

                              two years

                              Aspects to be reviewed (points of paragraph 1)

                              (a) to (f)

                              (a) to (f)

                              (a) to (f)

                        In the case of bathing waters previously classified as ‘excellent’, the bathing water profiles need be reviewed and, if necessary, updated only if the classification changes to ‘good’, ‘sufficient’ or ‘poor’. The review is to cover all aspects mentioned in paragraph 1.

                  3.

                  In the event of significant construction works or significant changes in the infrastructure in or in the vicinity of the bathing water, the bathing water profile is to be updated before the start of the next bathing season.

                  4.

                  The information referred to in paragraph 1(a) and (b) is to be provided on a detailed map whenever practicable.

                  5.

                  Other relevant information may be attached or included if the competent authority considers it appropriate.

      ANNEX IV
      Bathing water monitoring

                  1.

                  One sample is to be taken shortly before the start of each bathing season. Taking account of this extra sample and subject to paragraph 2, no fewer than four samples are to be taken and analysed per bathing season.

                  2.

                  However, only three samples need be taken and analysed per bathing season in the case of a bathing water that either:

                              (a)

                              has a bathing season not exceeding eight weeks; or

                              (b)

                              is situated in a region subject to special geographical constraints.

                  3.

                  Sampling dates are to be distributed throughout the bathing season, with the interval between sampling dates never exceeding one month.

                  4.

                  In the event of short-term pollution, one additional sample is to be taken to confirm that the incident has ended. This sample is not to be part of the set of bathing water quality data. If necessary to replace a disregarded sample, an additional sample is to be taken seven days after the end of the short-term pollution.

      ANNEX V
      Rules on the handling of samples for microbiological analyses
      1.   Sampling point
      Where possible, samples are to be taken 30 centimetres below the water's surface and in water that is at least one metre deep.
      2.   Sterilisation of sample bottles
      Sample bottles are:

                  —

                  to undergo sterilisation in an autoclave for at least 15 minutes at 121 oC, or

                  —

                  to undergo dry sterilisation at between 160 oC and 170 oC for at least one hour, or

                  —

                  to be irradiated sample containers obtained directly from manufacturer.

            3.   Sampling
      The volume of the sampling bottle/container is to depend on the quantity of water needed for each parameter to be tested. The minimum content is generally 250 ml.
      Sample containers are to be of transparent and non-coloured material (glass, polyethene or polypropylene).
      In order to prevent accidental contamination of the sample, the sampler is to employ an aseptic technique to maintain the sterility of the sample bottles. There is no further need for sterile equipment (such as sterile surgical gloves or tongs or sample pole) if this is done properly.
      The sample is to be clearly identified in indelible ink on the sample and on the sampling form.
      4.   Storage and transport of samples before analysis
      Water samples are to be protected at all stages of transport from exposure to light, in particular direct sunlight.
      The sample is to be conserved at a temperature of around 4 oC, in a cool box or refrigerator (depending on climate) until arrival at the laboratory. If the transport to the laboratory is likely to take more than four hours, then transport in a refrigerator is required.
      The time between sampling and analysis is to be kept as short as possible. It is recommended that samples be analysed on the same working day. If this is not possible for practical reasons, then the samples shall be processed within no more than 24 hours. In the meantime, they shall be stored in the dark and at a temperature of 4 oC ± 3 oC.


Avis juridique important

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31999L0029

Council Directive 1999/29/EC of 22 April 1999 on the undesirable substances and products in animal nutrition

Official Journal L 115 , 04/05/1999 P. 0032 - 0046

COUNCIL DIRECTIVE 1999/29/ECof 22 April 1999on the undesirable substances and products in animal nutritionTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 43 thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Parliament(1),Having regard to the opinion of the Economic and Social Committee(2),(1) Whereas Council Directive 74/63/EEC of 17 December 1973 on the undesirable substances in animal nutrition(3) has been frequently and substantially amended; whereas for reasons of clarity and rationality the said Directive should be consolidated;(2) Whereas livestock production occupies a very important place in the agriculture of the Community; whereas satisfactory results depend to a large extent on the use of appropriate good-quality feedingstuffs;(3) Whereas the existence of rules concerning feedingstuffs is essential to an increase in agricultural productivity;(4) Whereas feedingstuffs often contain undesirable substances or products which can endanger animal health or, because of their presence in livestock products, human health;(5) Whereas it is impossible to exclude totally the presence of the substances and products in question; whereas it is important that their content in feedingstuffs should be reduced in order to prevent undesirable and harmful effects; whereas it is at present impossible to fix this content below the levels detectable by methods of analysis to be defined for the Community;(6) Whereas undesirable substances and products may be present in feedingstuffs only in accordance with the conditions laid down in this Directive and may not be used in any other way for the purposes of animal feeding; whereas this Directive should therefore apply without prejudice to other Community provisions on feedingstuffs, and particularly the rules applicable to compound feedingstuffs;(7) Whereas Member States should, however, retain the power to allow, under certain conditions, feedingstuffs having levels of undesirable substances and products higher than those provided for in Annex I;(8) Whereas this Directive must apply to feed materials and feedingstuffs from the date of their introduction into the Community; whereas it should therefore be stipulated that the maximum levels of undesirable substances or products set apply in general from the date on which the feed materials and feedingstuffs are put into circulation, including all stages of marketing, and in particular from the date of their importation;(9) Whereas it is advisable to establish the principle that raw materials used in animal nutrition must be sound, genuine and of merchantable quality; whereas, therefore, it is necessary to prohibit the use or putting into circulation of feed materials which, because they contain too high a level of undesirable substances or products, result in the maximum levels for compound feedingstuffs laid down in Annex I being exceeded;(10) Whereas it is proper to limit the presence of certain undesirable substances or products in complementary feedingstuffs by fixing appropriate maximum levels;(11) Whereas Member States should retain the power, if animal or human health is endangered, to reduce temporarily the fixed maximum permissible levels or to fix maximum levels for other substances or products or to prohibit the presence of such substances or products in feedingstuffs; whereas in order that a Member State should not abuse that power, possible amendments to Annexes I and II based on supporting documents should be decided on by emergency Community procedure;(12) Whereas feedingstuffs satisfying the requirements of this Directive should not be subject, with regard to their level of undesirable substances and products, to restrictions on their entry into circulation other than those provided for in this Directive;(13) Whereas, in order to ensure that the requirements laid down in respect of undesirable substances and products are satisfied during marketing of feedingstuffs, Member States must make appropriate control arrangements;(14) Whereas, as part of the information system introduced by this Directive within the official control departments, Member States should also be informed by operators of cases where the provisions of this Directive are not complied with; whereas, in such cases, Member States are required to take all measures to enable the use in animal nutrition of undesirable substances and products to be excluded; whereas Member States are, where appropriate, obliged to ensure that consignments of feed materials or feedingstuffs are destroyed, if this has been decided by its owner;(15) Whereas an appropriate Community procedure is essential to adjust the technical provisions laid down in Annexes I and II, to developments in scientific and technical knowledge;(16) Whereas, in order to facilitate implementation of the proposed measures, a procedure should be laid down to establish close cooperation between Member States and the Commission within the Standing Committee on Feedingstuffs set up by Decision 70/372/EEC(4);(17) Whereas this Directive should not affect the obligations of the Member States concerning the deadlines for transposition of the Directives set out in Annex III, part B,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive deals with undesirable substances and products in animal nutrition.2. This Directive shall apply without prejudice to the provisions on:(a) additives in feedingstuffs;(b) the marketing of feedingstuffs;(c) the fixing of maximum permitted levels for pesticide residues on and in products intended for animal feeding, where these residues are not listed in Section B of Annex I;(d) micro-organisms in feedingsstuffs;(e) certain products used in animal nutrition;(f) feedingstuffs for particular nutritional purposes.Article 2For the purposes of this Directive, the following definitions shall apply:(a) feedingstuffs: products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding;(b) feed materials: various products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing additives, which are intended for use in oral animal feeding, either directly as such or after processing, in the preparation of compound feedingstuffs or as carriers of premixtures;(c) complete feedingstuffs: mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration;(d) complementary feedingstuffs: mixtures of feedingstuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily ration only if they are used in combination with other feedingstuffs;(e) compound feedingstuffs: mixtures of feed materials, whether or not containing additives, which are intended for oral animal feeding as complete or complementary feedingstuffs;(f) daily ration: the average total quantity of feedingstuffs, calculated on a moisture content of 12 %, required daily by an animal of a given species, age category and yield, to satisfy all its needs;(g) animals: animals belonging to species normally nourished and kept or consumed by man as well as animals living freely in the wild in cases where they are nourished with feedingstuffs;(h) pet animals: animals belonging to species normally nourished and kept but not consumed by man, except animals bred for fur production.Article 31. Member States shall prescribe that feed materials may only be put into circulation in the Community if they are sound, genuine and of merchantable quality.2. In particular, and subject to the provisions in Part A of Annex II, feed materials cannot be considered as sound, genuine and of merchantable quality if the level of undesirable substances or products is so high as to make it impossible to respect the maximum levels fixed for compound feedingstuffs in Annex I.Article 41. Member States shall prescribe that the substances and products listed in Annex I shall be tolerated in feedingstuffs only under the conditions therein set out.2. Member States may authorise the maximum permitted levels provided for in Annex I in respect of feedingstuffs to be exceeded in the case of fodder which is produced and used in the same state on the same agricultural holding, where this is necessary for particular local reasons. The Member States concerned shall ensure that neither animal nor human health can suffer harm thereby.Article 51. Member States shall prescribe that the feed materials listed in Annex II, part (A) may be put into circulation only if their content of the undesirable substance or product mentioned in column 1 of the said Annex does not exceed the maximum level laid down in column 3 of that Annex.2. Where the content of the undesirable substance or product listed in column 1 of Annex II, part (A) exceeds the level laid down in column 3 of Annex I in respect of feed materials, the feed materials listed in column 2 of Annex II, part (A) may, without prejudice to paragraph 1, be put into circulation only if:(a) it is intended for use by establishments which meet the conditions of Council Directive 95/69/EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector(5),and(b) it is accompanied by a document stating:- that the feed materials are intended for manufacturers of compound feedingstuffs who fulfil the conditions laid down in paragraph (a),- that the feed materials may not be fed unprocessed to livestock,- the amount of the undesirable substance or product contained in the feed material.3. Member States shall prescribe that paragraph 2(a) and (b) shall also apply to the feed materials and undesirable substances or products listed in Annex II, part (B) the maximum level of which is not restricted in Annex II, part (A), if the level of the undesirable substance or product present in the feed materials exceeds that laid down in column 3 of Annex I for the corresponding feed materials.Article 6Member States may restrict the application of Article 5(2)(a) to those manufacturers of compound feedingstuffs who use the materials in question for the production and the putting into circulation of compound feedingstuffs.Article 7Member States shall prescribe that a consignment of a feed material detailed in part A of Annex II with a content of an undesirable substance or product higher than the maximum level fixed in column 3 of the abovementioned Annex must not be mixed with other consignments of feed materials or with consignments of feedingstuffs.Article 8Member States shall prescribe that in so far as there are no special provisions for complementary feedingstuffs, these may not, allowing for the dilutions prescribed for their use, contain levels of the substances and products listed in Annex I in excess of those fixed for complete feedingstuffs.Article 91. Where a Member State, as a result of new information or of a reassessment of existing information made since the provisions in question were adopted, has detailed grounds for establishing that a maximum content fixed in Annex I or II or a substance or product not listed therein constitutes a danger to animal or human health or the environment, that Member State may provisionally reduce that content, fix a maximum content or prohibit the presence of that substance or product in feedingstuffs or feed materials. It shall immediately inform the other Member States and the Commission thereof, giving reasons for its decision.2. In accordance with the procedure laid down in Article 14, an immediate decision shall be made as to whether the Annexes should be modified. So long as no decision has been made by either the Council or the Commission the Member State may maintain the measures it has implemented.Article 10In accordance with the procedure laid down in Article 13 and in the light of developments in scientific and technical knowledge:(a) the amendments to be made to the Annexes shall be adopted;(b) a consolidated version of the Annexes shall be drawn up periodically incorporating the successive amendments made pursuant to (a);(c) criteria for the acceptability of feed materials which have undergone certain decontamination processes may be defined.Article 11Member States shall ensure that feedingstuffs and feed materials which conform to this Directive are not subject to any other restrictions on their circulation as regards the presence of undesirable substances and products.Article 121. Member States shall take all necessary measures to ensure that feedingstuffs and feed materials are officially controlled, at least by random sampling, to verify whether the conditions laid down in this Directive are satisfied.2. Member States shall inform the other Member States and the Commission of the name of the departments appointed to carry out this control.3. Member States shall prescribe that where an operator (importer, producer, etc.) or a person who, by virtue of his professional activities, possesses, or has possessed, or has had direct contact with a consignment of feed materials or of feedingstuffs and has knowledge to the effect that:- the consignment of feed materials is unsuitable for any use in animal feedingstuffs because of contamination by an undesirable substance or product listed in Annexes I and II, and therefore does not meet the provisions of Article 3(1) and consequently constitutes a serious risk for animal and public health,- the consignment of feedingstuffs does not meet the provisions of Annex I, and therefore constitutes a serious risk for animal and public health,such a person or operator shall immediately inform the official authorities even if the destruction of the consignment is envisaged.After verifying the information received, Member States shall ensure that, in the case of a contaminated consignment, the measures necessary are taken to ensure that the consignment is not used in animal nutrition.Member States shall ensure that the final destination of the contaminated consignment, including possible destruction, cannot have harmful effects on public or animal health or on the environment.4. If a consignment of feed materials or a consignment of feedingstuffs is likely to be sent to a Member State after it has been judged not to comply with the provisions of this Directive on account of an excessive content of undesirable substances or products in another Member State, the latter Member State shall immediately give the other Member States and the Commission any useful information concerning that consignment.Article 131. Where the procedure laid down in this Article is to be followed, matters shall be referred without delay by the Chairman, either on his own initiative or at the request of a Member State, to the Standing Committee on Feedingstuffs, hereinafter called the "Committee".2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.If the Council has not adopted any measures within three months of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.Article 141. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee without delay by the Chairman, either on his own initiative or at the request of a Member State.2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion within two days. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.The Commission shall adopt the measures and implement them forthwith where they are in accordance with the opinion of the Committee. Where they are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall adopt the measures by a qualified majority.If the Council has not adopted any measures within 15 days of the proposal being submitted to it, the Commission shall adopt the proposed measures and implement them forthwith, except where the Council has voted by a simple majority against such measures.Article 151. The Member States shall apply at least the provisions of this Directive to feedingstuffs intended for export to third countries.2. Paragraph 1 does not affect the right of Member States to allow the re-exportation to the exporting third country of consignments of feedingstuffs which do not fulfil the requirements of this Directives.Article 161. The Directives listed in Annex III, part A, are hereby repealed, without prejudice to the obligations of the Member States concerning the deadlines for transposition of those Directives, as set out in Annex III, part B.2. References to the repealed Directives shall be construed as references to this Directive and should be read in accordance with the correlation table in Annex IV.Article 17This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 18This Directive is addressed to the Member States.Done at Luxembourg, 22 April 1999.For the CouncilThe PresidentW. MÜLLER(1) Opinion delivered on 9 February 1999 (not yet published in the Official Journal).(2) OJ C 153, 28.5.1996, p. 49.(3) OJ L 38, 11.2.1974, p. 31. Directive as last amended by Commission Directive 98/60/EC (OJ L 209, 25.7.1998, p. 50).(4) OJ L 170, 3.8.1970, p. 1.(5) OJ L 332, 30.12.1995, p. 15. Directive as amended by Directive 98/92/EC (OJ L 346, 22.12.1998, p. 49).ANNEX I(Article 3(2), Article 4, Article 5(2) and (3), Article 8, Article 12(3))>TABLE>ANNEX IIPART A(Article 3(2), Article 5, Article 7)>TABLE>PART B(Article 5(3))>TABLE>ANNEX IIIPART ARepealed Directives(referred to by Article 16)>TABLE>PART BDeadlines for transposition into national law(referred to by Article 16)>TABLE>ANNEX IVCORRELATION TABLE>TABLE>


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31997L0065

Commission Directive 97/65/EC of 26 November 1997 adapting, for the third time, to technical progress Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work (Text with EEA relevance)

Official Journal L 335 , 06/12/1997 P. 0017 - 0018

COMMISSION DIRECTIVE 97/65/EC of 26 November 1997 adapting, for the third time, to technical progress Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (1), and in particular Article 17 thereof,Having regard to Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) (2), as last amended by Commission Directive 97/59/EC (3) and in particular Article 19 thereof,Having regard to the opinion of the Advisory Committee on Safety, Hygiene and Health Protection at Work,Whereas the provisions laid down in Directive 90/679/EEC must be regarded as an important element in the overall approach towards protecting the health of workers at the workplace;Whereas the aim of Council Directive 93/88/EEC (4) establishing a first list of biological agents on the basis of the definitions given in Article 2 (d) (2), (3) and (4) of Directive 90/679/EEC is to harmonize conditions in this field while maintaining the progress made;Whereas the list and classification of the biological agents must be regularly examined and revised on the basis of new scientific data; whereas, in particular, in the light of new scientific evidence concerning the transmissibility to humans of the bovine spongiform encephalopathy (BSE) agent, it is necessary to adjust the classification of the BSE agent and make reference to variant Creutzfeldt-Jakob disease;Whereas, it is necessary to protect workers against possible occupational transmission of human and animal transmissible spongiform encephalopathies (TSEs);Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee set up pursuant to Article 17 of Directive 89/391/EEC,HAS ADOPTED THIS DIRECTIVE:Article 1 Annex III to Directive 90/679/EEC is amended in accordance with the Annex hereto.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 June 1998. They shall immediately inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.2. Member States shall communicate to the Commission the text of the provisions of national law which they adopt in the field covered by this Directive.Article 3 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 26 November 1997.For the CommissionPádraig FLYNNMember of the Commission(1) OJ L 183, 29. 6. 1989, p. 1.(2) OJ L 374, 31. 12. 1990, p. 1.(3) OJ L 282, 15. 10. 1997, p. 33.(4) OJ L 268, 29. 10. 1993, p. 71.ANNEX Annex III to Directive 90/679/EEC is amended as follows:1. Under the heading 'Virus`:- the wording: 'Unconventional agents associated with (i)` is replaced by: 'Unconventional agents associated with the transmissible spongiform encephalopathies (TSEs)`;- the following agents are added under 'Unconventional agents associated with the transmissible spongiform encephalopathies (TSEs)`, and are classified as follows after the entry for Creutzfeldt-Jakob disease:- 'variant Creutzfeldt-Jakob disease`, classified as group 3 (**), with the notes 'D (d)`.- 'Bovine spongiform encephalopathy (BSE) and other related animal TSEs (i)`, classified as group 3 (**), with the notes 'D (d)`.2. The wording of footnote '(i)` which follows the list of viruses is replaced by the following:'There is no evidence in humans of infections caused by the agents responsible for other animal TSEs. Nevertheless, the containment measures for agents categorised in risk group 3 (**) are recommended as a precaution for laboratory work, except for laboratory work relating to an identified agent of scrapie where containment level 2 is sufficient.`


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31987L0054

Council Directive 87/54/EEC of 16 December 1986 on the legal protection of topographies of semiconductor products

Official Journal L 024 , 27/01/1987 P. 0036 - 0040 Finnish special edition: Chapter 13 Volume 16 P. 0095  Swedish special edition: Chapter 13 Volume 16 P. 0095

*****COUNCIL  DIRECTIVE  of 16 December 1986  on the legal protection of topographies of semiconductor products  (87/54/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community and in particular Article 100 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 semiconductor products are playing an increasingly important role in a broad range of industries and semiconductor technology can accordingly be considered as being of fundamental importance for the Community's industrial development;  Whereas the functions of semiconductor products depend in large part on the topographies of such products and whereas the development of such topographies requires the investment of considerable resources, human, technical and financial, while topographies of such products can be copied at a fraction of the cost needed to develop them independently;  Whereas topographies of semiconductor products are at present not clearly protected in all Member States by existing legislation and such protection, where it exists, has different attributes;  Whereas certain existing differences in the legal protection of semiconductor products offered by the laws of the Member States have direct and negative effects on the functioning of the common market as regards semiconductor products and such differences could well become greater as Member States introduce new legislation on this subject;  Whereas existing differences having such effects need to be removed and new ones having a negative effect on the common market prevented from arising;  Whereas, in relation to extension of protection to persons outside the Community, Member States should be free to act on their own behalf in so far as Community decisions have not been taken within a limited period of time;  Whereas the Community's legal framework on the protection of topographies of semiconductor products can, in the first instance, be limited to certain basic principles by provisions specifying whom and what should be protected, the exclusive rights on which protected persons should be able to rely to authorize or prohibit certain acts, exceptions to these rights and for how long the protection should last;  Whereas other matters can for the time being be decided in accordance with national law, in particular, whether registration or deposit is required as a condition for protection and, subject to an exclusion of licences granted for the sole reason that a certain period of time has elapsed, whether and on what conditions non-voluntary licences may be granted in respect of protected topographies;  Whereas protection of topographies of semiconductor products in accordance with this Directive should be without prejudice to the application of some other forms of protection;  Whereas further measures concerning the legal protection of topographies of semiconductor products in the Community can be considered at a later stage, if necessary, while the application of common basic principles by all Member States in accordance with the provisions of this Directive is an urgent necessity,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER 1  Definitions  Article 1  1. For the purposes of this Directive:  (a) a 'semiconductor product' shall mean the final or an intermediate form of any product:  (i) consisting of a body of material which includes a layer of semiconducting material; and  (ii) having one or more other layers composed of conducting, insulating or semiconducting material, the layers being arranged in accordance with a predetermined three-dimensional pattern; and  (iii) intended to perform, exclusively or together with other functions, an electronic function;  (b) the 'topography' of a semiconductor product shall mean a series of related images, however fixed or encoded;  (i) representing the three-dimensional pattern of the layers of which a semiconductor product is composed; and  (ii) in which series, each image has the pattern or part of the pattern of a surface of the semiconductor product at any stage of its manufacture;  (c) 'commercial exploitation' means the sale, rental, leasing or any other method of commercial distribution, or an offer for these purposes. However, for the purposes of Articles 3 (4), 4 (1), 7 (1), (3) and (4) 'commercial exploitation' shall not include exploitation under conditions of confidentiality to the extent that no further distribution to third parties occurs, except where exploitation of a topography takes place under conditions of confidentiality required by a measure taken in conformity with Article 223 (1) (b) of the Treaty.  2. The Council acting by qualified majority on a proposal from the Commission, may amend paragraph 1 (a) (i) and (ii) in order to adapt these provisions in the light of technical progress.  CHAPTER 2  Protection of topographies of semiconductor products  Article 2  1. Member States shall protect the topographies of semiconductor products by adopting legislative provisions conferring exclusive rights in accordance with the provisions of the Directive.  2. The topography of a semiconductor product shall be protected in so far as it satisfies the conditions that it is the result of its creator's own intellectual effort and is not commonplace in the semiconductor industry. Where the topography of a semiconductor product consists of elements that are commonplace in the semiconductor industry, it shall be protected only to the extent that the combination of such elements, taken as a whole, fulfils the abovementioned conditions.  Article 3  1. Subject to paragraphs 2 to 5, the right to protection shall apply in favour of persons who are the creators of the topographies of semiconductor products.  2. Member States may provide that,  (a) where a topography is created in the course of the creator's employment, the right to protection shall apply in favour of the creator's employer unless the terms of employment provide to the contrary;  (b) where a topography is created under a contract other than a contract of employment, the right to protection shall apply in favour of a party to the contract by whom the topography has been commissioned, unless the contract provides to the contrary.  3. (a) As regards the persons referred to in paragraph 1, the right to protection shall apply in favour of natural persons who are nationals of a Member State or who have their habitual residence on the territory of a Member State.  (b) Where Member States make provision in accordance with paragraph 2, the right to protection shall apply in favour of:  (i) natural persons who are nationals of a Member State or who have their habitual residence on the territory of a Member State;  (ii) companies or other legal persons which have a real and effective industrial or commercial establishment on the territory of a Member State.  4. Where no right to protection exists in accordance with other provisions of this Article, the right to protection shall also apply in favour of the persons referred to in paragraph 3 (b) (i) and (ii) who:  (a) first commercially exploit within a Member State a topography which has not yet been exploited commercially anywhere in the world; and  (b) have been exclusively authorized to exploit commercially the topography throughout the Community by the person entitled to dispose of it.  5. The right to protection shall also apply in favour of the successors in title of the persons mentioned in paragraphs 1 to 4.  6. Subject to paragraph 7, Member States may negotiate and conclude agreements or understandings with third States and multilateral Conventions concerning the legal protection of topographies of semiconductor products whilst respecting Community law and in particular the rules laid down in this Directive.  7. Member States may enter into negotiations which third States with a view to extending the right to protection to persons who do not benefit from the right to protection according to the provisions of this Directive. Member States who enter into such negotiations shall inform the Commission thereof.  When a Member State wishes to extend protection to persons who otherwise do not benefit from the right to protection according to the provisions of this Directive or to conclude an agreement or understanding on the extension of protection with a non-Member State it shall notify the Commission. The Commission shall inform the other Member States thereof. The Member State shall hold the extension of protection or the conclusion of the agreement or understanding in abeyance for one month from the date on which it notifies the Commission. However, if within that period the Commission notifies the Member State concerned of its intention to submit a proposal to the Council for all Member States to extend protection in respect of the persons or non-Member State concerned, the Member State shall hold the extension of protection or the conclusion of the agreement or undestanding in abeyance for a period of two months from the date of the notification by the Member State.  Where, before the end of this two-month period, the Commission submits such a proposal to the Council, the Member State shall hold the extension of protection or the conclusion of the agreement or understanding in abeyance for a further period of four months from the date on which the proposal was submitted.  In the absence of a Commission notification or proposal or a Council decision within the time limits prescribed above, the Member State may extend protection or conclude the agreement or understanding.  A proposal by the Commission to extend protection, whether or not it is made following a notification by a Member State in accordance with the preceding paragraphs shall be adopted by the Council acting by qualified majority.  A Decision of the Council on the basis of a Commission proposal shall not prevent a Member State from extending protection to persons, in addition to those to benefit from protection in all Member States, who were included in the envisaged extension, agreement or understanding as notified, unless the Council acting by qualified majority has decided otherwise.  8. Commission proposals and Council decisions pursuant to paragraph 7 shall be published for information in the Official Journal of the European Communities.  Article 4  1. Member States may provide that the exclusive rights conferred in conformity with Article 2 shall not come into existence or shall no longer apply to the topography of a semiconductor product unless an application for registration in due form has been filed with a public authority within two years of its first commercial exploitation. Member States may require in addition to such registration that material identifying or exemplifying the topography or any combination thereof has been deposited with a public authority, as well as a statement as to the date of first commercial exploitation of the topography where it precedes the date of the applciation for registration.  2. Member States shall ensure that material deposited in conformity with paragraph 1 is not made available to the public where it is a trade secret. This provision shall be without prejudice to the disclosure of such material pursuant to an order of a court or other competent authority to persons involved in litigation concerning the validity or infringement of the excusive rights referred to in Article 2.  3. Member States may require that transfers of rights in protected topographies be registered.  4. Member States may subject registration and deposit in accordance with paragraphs 1 and 3 to the payment of fees not exceeding their administrative costs.  5. Conditions prescribing the fulfilment of additional formalities for obtaining or maintaining protection shall not be admitted.  6. Member States which require registration shall provide for legal remedies in favour of a person having the right to protection in accordance with the provisions of this Directive who can prove that another person has applied for or obtained the registration of a topography without his authorization.  Article 5  1. The exclusive rights referred to in Article 2 shall include the rights to authorize or prohibit any of the following acts:  (a) reproduction of a topography in so far as it is protected under Article 2 (2);  (b) commercial exploitation or the importation for that purpose of a topography or of a semiconductor product manufactured by using the topography.  2. Notwithstanding paragraph 1, a Member State pay permit the reproduction of a topography privately for non commercial aims.  3. The exclusive rights referred to in paragraph 1 (a) shall not apply to reproduction for the purpose of analyzing, evaluating or teaching the concepts, processes, systems or techniques embodied in the topography or the topography itself.  4. The exclusive rights referred to in paragraph 1 shall not extend to any such act in relation to a topography meeting the requirements of Article 2 (2) and created on the basis of an analysis and evaluation of another topography, carried out in conformity with paragraph 3.  5. The exclusive rights to authorize or prohibit the acts specified in paragraph 1 (b) shall not apply to any such act committed after the topography or the semiconductor product has been put on the market in a Member State by the person entitled to authorize its marketing or with his consent. 6. A person who, when he acquires a semiconductor product, does not know, or has no reasonable grounds to believe, that the product is protected by an exclusive right conferred by a Member State in conformity with this Directive shall not be prevented from commercially exploiting that product.  However, for acts committed after that person knows, or has reasonable grounds to believe, that the semiconductor product is so protected, Member States shall ensure that on the demand of the rightholder a tribunal may require, in accordance with the provisions of the national law applicable, the payment of adequate remuneration.  7. The provisions of paragraph 6 shall apply to the successors in title of the person referred to in the first sentence of that paragraph.  Article 6  Member States shall not subject the exclusive rights referred to in Article 2 to licences granted, for the sole reason that a certain period of time has elapsed, automatically, and by operation of law.  Article 7  1. Member States shall provide that the exclusive rights referred to in Article 2 shall come into existence:  (a) where registration is the condition for the coming into existence of the exclusive rights in accordance with Article 4, on the earlier of the following dates:  (i) the date when the topography is first commercially exploited anywhere in the world;  (ii) the date when an application or registration has been filed in due form; or  (b) when the topography is first commercially exploited anywhere in the world; or  (c) when the topography is first fixed or encoded.  2. Where the exclusive rights come into existence in accordance with paragraph 1 (a) or (b), the Member States shall provide, for the period prior to those rights coming into existence, legal remedies in favour of a person having the right to protection in accordance with the provisions of this Directive who can prove that another person has fraudulently reproduced or commercially exploited or imported for that purpose a topography. This paragraph shall be without prejudice to legal remedies made available to enforce the exclusive rights conferred in conformity with Article 2.  3. The exclusive rights shall come to an end 10 years from the end of the calendar year in which the topography is first commercially exploited anywhere in the world or, where registration is a condition for the coming into existence or continuing application of the exclusive rights, 10 years from the earlier of the following dates:  (a) the end of the calendar year in which the topography is first commercially exploited anywhere in the world;  (b) the end of the calendar year in which the application for registration has been filed in due form.  4. Where a topography has not been commercially exploited anywhere in the world within a period of 15 years from its first fixation or encoding, any exclusive rights in existence pursuant to paragraph 1 shall come to an end and no new exclusive rights shall come into existence unless an application for registration in due form has been filed within that period in those Member States where registration is a condition for the coming into existence or continuing application of the exclusive rights.  Article 8  The protection granted to the topographies of semiconductor products in accordance with Article 2 shall not extend to any concept, process, system, technique or encoded information embodied in the topography other than the topography itself.  Article 9  Where the legislation of Member States provides that semiconductor products manufactured using protected topographies may carry an indication, the indication to be used shall be a capital T as follows: T, 'T ', [ T ] , T  , T * or T  .  CHAPTER 3  Continued application of other legal provisions  Article 10  1. The provisions of this Directive shall be without prejudice to legal provisions concerning patent and utility model rights.  2. The provisions of this Directive shall be without prejudice:  (a) to rights conferred by the Member States in fulfilment of their obligations under international agreements, including provisions extending such rights to nationals of, or residents in, the territory of the Member State concerned;  (b) to the law of copyright in Member States, restricting the reproduction of drawing or other artistic representations of topographies by copying them in two dimensions.  3. Protection granted by national law to topographies of semiconductor products fixed or encoded before the entry into force of the national provisions enacting the Directive, but no later than the date set out in Article 11 (1), shall not be affected by the provisions of this Directive. CHAPTER 4  Final provisions  Article 11  1. Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive by 7 November 1987.  2. Member States shall ensure that they communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.  Article 12  This Directive is addressed to the Member States.  Done at Brussels, 16 December 1986.  For the Council  The President  G. HOWE  (1) OJ No C 360, 31. 12. 1985, p. 14.  (2) OJ No C 255, 13. 10. 1986, p. 249.  (3) OJ No C 189, 28. 7. 1986, p. 5.


title: Commission Directive 2007/26/EC of 7 May 2007 amending Directive 2004/6/EC to extend its period of application (Text with EEA relevance)

text:
               8.5.2007

               EN

               Official Journal of the European Union

               L 118/5

      COMMISSION DIRECTIVE 2007/26/EC
   of 7 May 2007
   amending Directive 2004/6/EC to extend its period of application
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1) and in particular Article 4(2) thereof,
   Whereas:

               (1)

               Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (2) specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of foodstuffs for particular nutritional uses.

               (2)

               At the time of the adoption of Directive 2001/15/EC a number of chemical substances added for specific nutritional purposes to some foods for particular nutritional uses, which are marketed in some Member States, could not be included in the Annex to that Directive because they had not been evaluated by the Scientific Committee on Food.

               (3)

               Pending the completion of the evaluation of those substances by the European Food Safety Authority (EFSA), Commission Directive 2004/6/EC (3) provides that Member States may continue to allow in their territory trade in products containing the substances concerned, in so far as certain conditions are fulfilled regarding their safety, until 31 December 2006.

               (4)

               It was not possible to complete the evaluations and associated administrative actions prior to 31 December 2006. Therefore, with a view to avoiding unnecessary disruption in the trade of the foodstuffs concerned, the application of Directive 2004/6/EC should be extended.

               (5)

               To take into account the time needed for the completion of the evaluation of the substances by the EFSA and for the transposition of the associated measures into the national legislation it is appropriate to provide for an extension of the period of application of Directive 2004/6/EC to 31 December 2009.

               (6)

               The date of 31 December 2006 provided for in Article 1 of Directive 2004/6/EC makes it necessary that the present Directive should be transposed within a short deadline. In order to avoid difficulties with the trade in products containing the substances listed in Directive 2004/6/EC, it is appropriate for the present directive to apply from 1 January 2007.

               (7)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Article 1 of Directive 2004/6/EC, the date of ‘31 December 2006’ is replaced by ‘31 December 2009’.
   Article 2
   Transposition
   1.   Member States shall adopt and publish, by 8 July 2007 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 2007.
   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 day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 7 May 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 186, 30.6.1989, p. 27. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1).

      (2)  OJ L 52, 22.2.2001, p. 19. Directive as last amended by Directive 2006/34/EC (OJ L 83, 22.3.2006, p. 14).

      (3)  OJ L 15, 22.1.2004, p. 31.