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32001L0062

Commission Directive 2001/62/EC of 9 August 2001 amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)

Official Journal L 221 , 17/08/2001 P. 0018 - 0036

Commission Directive 2001/62/ECof 9 August 2001amending Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs(1), and in particular Article 3 thereof,After consulting the Scientific Committee on Food,Whereas:(1) Silicones should be regarded as elastomeric materials rather than plastic materials and therefore should be deleted from the definition of plastics.(2) The determination of a quantity of a substance in a finished material or article is simpler than the determination of its specific migration level. The verification of compliance through the determination of quantity rather than specific migration level should therefore be permitted under certain conditions.(3) For certain types of plastics, the availability of generally recognised diffusion models based on experimental data allows the estimation of the migration level of a substance under certain conditions, therefore avoiding complex, costly and time-consuming testing.(4) Recent collaborative tests indicate that there is greater variability in the results of analysis for the determination of overall migration of substances used in plastics when aqueous food simulants as well as volatile media such as isooctane, ethanol and other similar solutions are used.(5) Besides the monomers and other starting substances fully evaluated and authorised at Community level, there are also monomers and starting substances evaluated and authorised in at least one Member State, use of which may be continued pending their evaluation by the Scientific Committee on Food and the decision on their inclusion in the Community list.(6) On the basis of the new information available to the Scientific Committee on Food, certain monomers provisionally admitted at national level as well as other monomers requested for use following the adoption of Commission Directive 90/128/EEC of 23 February 1990 relating to plastic materials and articles intended to come into contact with foodstuffs(2), as last amended by Directive 1999/91/EC(3), may be included in the Community list of approved substances.(7) For certain substances, the restrictions already established at Community level should be amended on the basis of the information available.(8) The current total list of additives is an incomplete list inasmuch as it does not contain all the substances which are currently accepted in one or more Member States. Accordingly, these substances continue to be regulated by national laws only pending a decision on inclusion in the Community list.(9) This Directive establishes specifications for only a few substances, and therefore the other substances, which may require specifications remain regulated in this respect by national laws only pending a decision at Community level.(10) For certain additives the restrictions established in this Directive cannot yet be applied in all situations pending the collection and evaluation of all the data needed for a better estimation of the exposure of the consumer in some specific situations. Therefore, these additives appear in a list other than that of the additives fully regulated at Community level.(11) In accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of ensuring the free movement of plastic materials and articles intended to come into contact with foodstuffs, to lay down rules on the definition of plastics and admitted substances. This Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 5 of the Treaty.(12) Directive 90/128/EEC should therefore be amended accordingly.(13) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 90/128/EEC is amended as follows:1. In Article 1, paragraph 3 is replaced by the following: "3. For the purposes of this Directive, 'plastics' shall mean the organic macromolecular compounds obtained by polymerisation, polycondensation, polyaddition or any other similar process from molecules with a lower molecular weight or by chemical alteration of natural macromoles. Other substances or matter may be added to such macromolecular compounds.However, the following shall not be regarded as 'plastics':(i) varnished or unvarnished regenerated cellulose film, covered by Commission Directive 93/10/EEC(4);(ii) elastomers and natural and synthetic rubber;(iii) paper and paperboard, whether modified or not by the addition of plastics;(iv) surface coatings obtained from:- paraffin waxes, including synthetic paraffin waxes, and/or micro-crystalline waxes,- mixtures of the waxes listed in the first indent with each other and/or with plastics;(v) ion-exchange resins;(vi) silicones."2. In Article 3, paragraphs 4 and 5 are replaced by the following: "4. Only those monomers and other starting substances listed in Annex II, Section A, shall be used for the manufacture of plastic materials and articles, subject to the restrictions specified therein.By way of derogation from the first subparagraph, the monomers and other starting substances listed in Annex II, Section B, may continue to be used until 31 December 2004 at the latest, pending their evaluation by the Scientific Committee on Food.5. The lists appearing in Annex II, Sections A and B, do not yet include monomers and other starting substances used only in the manufacture of:- surface coatings obtained from resinous or polymerised products in liquid, powder or dispersion form, such as varnishes, lacquers, paints, etc.,- epoxy resins,- adhesives and adhesion promoters,- printing inks."3. Article 3a is replaced by the following: "Article 3aAn incomplete list of additives which may be used for the manufacture of plastic materials and articles, together with restrictions and/or specifications on their use, is set out in Annex III, Sections A and B.For the substances in Annex III, Section B, the specific migration limits are applied as from 1 January 2004 when the verification of compliance is carried out in simulant D or in test media of substitute tests as laid down in Directives 82/711/EEC and 85/572/EEC."4. In Article 3c, paragraph 1 is replaced by the following: "1. General specifications related to plastics materials and articles are laid down in Annex V, part A. Other specifications related to some substances appearing in Annexes II, III and IV are laid down in Annex V, part B."5. In Article 5, the following paragraph 4 is added: "4. The verification of compliance with the specific migration limits provided for in paragraph 1 may be ensured by the determination of the quantity of a substance in the finished material or article provided that a relationship between that quantity and the value of the specific migration of the substance has been established either by an adequate experimentation or by the application of generally recognised diffusion models based on scientific evidence. To demonstrate the non-compliance of a material or article, confirmation of the estimated migration value by experimental testing is obligatory."6. Annexes I, II, III, V and VI are amended as set out in Annexes I to V to this Directive.Article 2The requirements introduced by this Directive shall not apply to materials and articles containing the substances regulated by the Directive which have been put into free circulation in the Community before 1 December 2002.Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 November 2002 at latest. They shall forthwith inform the Commission thereof.When Member States adopt these 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.Article 4This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 9 August 2001.For the CommissionDavid ByrneMember of the Commission(1) OJ L 40, 11.2.1989, p. 38.(2) OJ L 75, 21.3.1990, p. 19.(3) OJ L 310, 4.12.1999, p. 41.(4) OJ L 93, 17.4.1993, p. 27.ANNEX IIn Annex I, paragraph 7, the second indent is replaced by the following: "- 12 mg/kg or 2 mg/dm2 in migration tests using the other simulants referred to in Directives 82/711/EEC and 85/572/EEC."ANNEX IIAnnex II is amended as follows:1. Section A is amended as follows:(a) The following monomers and other starting substances are inserted: ">TABLE>"(b) For the following monomers and other starting substances, the content of the column "Restrictions and/or specifications" is replaced by the following: ">TABLE>"(c) The following monomers and other starting substances are transferred from section B to section A: ">TABLE>"2. Section B is replaced by the following: "SECTION BList of monomers and other starting substances which may continue to be used pending a decision on inclusion in Section A>TABLE>"ANNEX IIIAnnex III is amended as follows:1. The table "Incomplete list of additives" is amended as follows:(a) The title is replaced by the following: "SECTION AIncomplete list of additives fully harmonised at Community level"(b) The following additives are inserted: ">TABLE>"(c) For the following additives, the content of column "Restriction and/or specifications" is replaced by the following: ">TABLE>"(d) The following additives are deleted: ">TABLE>"2. The following Section B is added: "SECTION BIncomplete list of additives referred to in Article 3a, second paragraph>TABLE>"ANNEX IVAnnex V is amended as follows:1. Part A of Annex V is replaced by the following: "Part A: General specificationsThe material and article manufactured by using aromatic isocyanates or colorants prepared by diazo-coupling, shall not release primary aromatic amines (expressed as aniline) in a detectable quantity (DL 0,02 mg/kg of food or food simulant, analytical tolerance included). However the migration value of the primary aromatic amines listed in this Directive are excluded from this restriction."2. The following specifications are inserted in the table of Part B of Annex V: ">TABLE>"ANNEX VAnnex VI is replaced by the following text: "ANNEX VINOTES RELATED TO THE COLUMN "RESTRICTIONS AND/OR SPECIFICATIONS"(1) Warning: there is a risk that the SML could be exceeded in fatty food simulants.(2) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 10060 and 23920.(3) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 15760, 16990, 47680, 53650 and 89440.(4) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 19540, 19960 and 64800.(5) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 14200, 14230 and 41840.(6) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration of the following substances mentioned as PM/REF Nos: 66560 and 66580.(7) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 30080, 42320, 45195, 45200, 53610, 81760, 89200 and 92030.(8) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 42400, 64320, 73040, 85760, 85840, 85920 and 95725.(9) Warning: there is a risk that the migration of the substance deteriorates the organoleptic characteristics of the food in contact and then, that the finished product does not comply with the second indent of Article 2 of Directive 89/109/EEC.(10) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 30180, 40980, 63200, 65120, 65200, 65280, 65360, 65440 and 73120.(11) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 45200, 64320, 81680 and 86800.(12) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 36720, 36800 and 92000.(13) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 39090 and 39120.(14) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 44960, 68078, 82020 and 89170.(15) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 15970, 48640, 48720, 48880, 61280, 61360 and 61600.(16) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 49600, 67520 and 83599.(17) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 50160, 50240, 50320, 50360, 50400, 50480, 50560, 50640, 50720, 50800, 50880, 50960, 51040 and 51120.(18) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 67600, 67680 and 67760.(19) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 60400, 60480 and 61440.(20) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 66400 and 66480.(21) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 93120 and 93280.(22) SML(T) in this specific case means that the restriction shall not be exceeded by the sum of the migration levels of the following substances mentioned as PM/REF Nos: 17260 and 18670."


title: Directive 2007/45/EC Of the European Parliament and of the Council of 5 September 2007 laying down rules on nominal quantities for prepacked products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC

text:
               21.9.2007

               EN

               Official Journal of the European Union

               L 247/17

      DIRECTIVE 2007/45/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 5 September 2007
   laying down rules on nominal quantities for prepacked products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Council Directives 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids (3) and 80/232/EEC of 15 January 1980 on the approximation of the laws of the Member States relating to the ranges of nominal quantities and nominal capacities permitted for certain prepackaged products (4) set out nominal quantities for a number of liquid and non-liquid prepacked products, the purpose of this being to ensure the free movement of products complying with the requirements of those Directives. For most products, national nominal quantities are allowed to exist alongside Community nominal quantities. For some products, however, Community nominal quantities are fixed to the exclusion of any national nominal quantities.

               (2)

               Changes in consumer preferences and innovations in prepacking and retailing at Community and national levels have made it necessary to assess whether existing legislation is still appropriate.

               (3)

               The Court of Justice held in its judgment of 12 October 2000 in Case C-3/99 Cidrerie Ruwet (5) that Member States are precluded from prohibiting the marketing of a prepackage having a nominal volume not included in the Community range, which is lawfully manufactured and marketed in another Member State, unless such a prohibition is designed to meet an overriding requirement relating to consumer protection, applies without distinction to national and imported products alike, is necessary in order to meet the requirement in question and is proportionate to the objective pursued, and that objective cannot be achieved by measures which are less restrictive of intra-Community trade.

               (4)

               Consumer protection is facilitated by legislation adopted after Directives 75/106/EEC and 80/232/EEC, notably Directive 98/6/EC of the European Parliament and of the Council of 16 February 1998 on consumer protection in the indication of the prices of products offered to consumers (6). Member States which have not already done so should consider whether to implement Directive 98/6/EC in relation to certain small retail businesses.

               (5)

               An impact assessment, including a wide consultation of all interested stakeholders, has indicated that, in many sectors, free nominal quantities increase the freedom of producers to provide goods according to consumer tastes and enhance competition as regards quality and price on the internal market. In other sectors, however, it is more appropriate, in the interests of consumers and business, to retain mandatory nominal quantities for the time being.

               (6)

               Implementation of this Directive should be accompanied by more information for consumers and industry to enhance understanding of unit pricing.

               (7)

               Consequently, nominal quantities should generally not be subject to regulation at Community or national level and it should be possible to place prepacked goods on the market in any nominal quantity.

               (8)

               However, in certain sectors such deregulation could result in disproportionately high extra costs, especially for small and medium sized enterprises. For those sectors, therefore, existing Community legislation should be adapted in the light of experience, in particular to ensure that Community nominal quantities are fixed at least in the case of those products most sold to consumers.

               (9)

               Since the maintenance of mandatory nominal quantities should be regarded as a derogation, except in the wine and spirits sector, which has specific features, it should be periodically reassessed in the light of experience and in order to meet the needs of consumers and producers. For sectors in which mandatory nominal quantities might be maintained, when the Commission ascertains a disturbance of market conditions or a destabilisation of consumer behaviour, particularly that of the most vulnerable consumers, it should consider whether Member States should be authorised to maintain transitional periods and in particular to maintain the most-sold mandatory range sizes.

               (10)

               In Member States where prepacked bread forms a high proportion of regular consumption, there is a strong correlation between pack size and bread weight. As with other prepacked products, existing package sizes for prepacked bread traditionally in use will not be affected by this Directive and can continue to be used.

               (11)

               In order to promote transparency, all nominal quantities for prepacked products should be set out in a single legislative act, and consequently Directives 75/106/EEC and 80/232/EEC should be repealed.

               (12)

               In order to increase consumer protection, in particular for vulnerable consumers such as the disabled and the elderly, proper attention should be paid to ensuring that weight and volume indications on consumer product labelling are more easily legible and visible on the prepackage under normal conditions of presentation.

               (13)

               For certain liquid products, Directive 75/106/EEC sets out metrological requirements identical to those set out in Council Directive 76/211/EEC of 20 January 1976 on the approximation of the laws of the Member States relating to the making-up by weight or by volume of certain prepackaged products (7). Directive 76/211/EEC should therefore be amended to include in its scope the products currently covered by Directive 75/106/EEC.

               (14)

               In accordance with point 34 of the Interinstitutional Agreement on better law-making (8), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public.

               (15)

               Since the objectives of this Directive cannot be sufficiently achieved by the Member States and can therefore, by reason of the repeal of Community ranges and the establishment of uniform Community nominal quantities where needed, 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,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER I
   GENERAL PROVISIONS
   Article 1
   Subject matter and scope
   1.   This Directive lays down rules on the nominal quantities for products put up in prepackages. It shall apply to prepacked products and prepackages, as defined in Article 2 of Directive 76/211/EEC.
   2.   This Directive shall not apply to the products listed in the Annex which are sold in duty-free shops for consumption outside the European Union.
   Article 2
   Free movement of goods
   1.   Save as otherwise provided for in Articles 3 and 4, Member States may not, on grounds relating to the nominal quantities of the package, refuse, prohibit or restrict the placing on the market of prepacked products.
   2.   While respecting the principles stated in the Treaty and, in particular, the free movement of goods, Member States which currently prescribe mandatory nominal quantities for milk, butter, dried pasta and coffee may continue to do so until 11 October 2012.
   Member States which currently prescribe mandatory nominal quantities for white sugar may continue to do so until 11 October 2013.
   CHAPTER II
   SPECIFIC PROVISIONS
   Article 3
   Placing on the market and free movement of certain products
   Member States shall ensure that the products listed in section 2 of the Annex and put up in prepackages in the intervals listed in section 1 of the Annex are placed on the market only if they are prepacked in the nominal quantities listed in section 1 of the Annex.
   Article 4
   Aerosol dispensers
   1.   Aerosol dispensers shall indicate the nominal total capacity of the container. The indication shall be such as not to create confusion with the nominal volume of the contents.
   2.   By way of derogation from Article 8(1)(e) of Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers (9), products which are sold in aerosol dispensers need not be marked with the nominal weight of their contents.
   Article 5
   Multipacks and prepackages made up of individual packages which are not intended to be sold individually
   1.   For the purposes of Article 3, where two or more individual prepackages make up a multipack, the nominal quantities listed in section 1 of the Annex shall apply to each individual prepackage.
   2.   Where a prepackage is made up of two or more individual packages which are not intended to be sold individually, the nominal quantities listed in section 1 of the Annex shall apply to the prepackage.
   CHAPTER III
   REPEALS, AMENDMENT AND FINAL PROVISIONS
   Article 6
   Repeals
   Directives 75/106/EEC and 80/232/EEC shall be repealed.
   Article 7
   Amendment to Directive 76/211/EEC
   In Article 1 of Directive 76/211/EEC, the words ‘with the exception of those referred to in the Council Directive 75/106/EEC of 19 December 1974 on the approximation of the laws of the Member States relating to the making-up by volume of certain prepackaged liquids, and’ shall be deleted.
   Article 8
   Transposition
   1.   Member States shall, by 11 October 2008, adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.
   They shall apply those measures from 11 April 2009.
   When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be determined by the Member States.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 9
   Reporting, communication of derogations and monitoring
   1.   The Commission shall submit a report on the application and effects of this Directive to the European Parliament, the Council and the European Economic and Social Committee by 11 October 2015, and every 10 years thereafter. Where necessary, those reports shall be accompanied by proposals for revision of this Directive.
   2.   By 11 April 2009, the Member States referred to in Article 2(2) shall communicate to the Commission the sectors subject to the derogation referred to in that paragraph, the period of that derogation, the range of mandatory nominal quantities applied and the interval concerned.
   3.   The Commission shall monitor the application of Article 2(2) based on its own findings and on the reports from the Member States concerned. More particularly, the Commission shall observe market developments after transposition of this Directive, and shall consider, in the light of the results of that observation, applying follow-up measures to this Directive by maintaining mandatory nominal quantities for the goods referred to in Article 2(2).
   Article 10
   Entry into force
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Articles 2, 6 and 7 shall apply from 11 April 2009.
   Article 11
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 5 September 2007.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         M. LOBO ANTUNES

      (1)  OJ C 255, 14.10.2005, p. 36.

      (2)  Opinion of the European Parliament of 2 February 2006 (OJ C 288 E, 25.11.2006, p. 52), Council Common Position of 4 December 2006 (OJ C 311 E, 19.12.2006, p. 21), Position of the European Parliament of 10 May 2007 (not yet published in the Official Journal) and Council Decision of 16 July 2007.

      (3)  OJ L 42, 15.2.1975, p. 1. Directive as last amended by the 2003 Act of Accession.

      (4)  OJ L 51, 25.2.1980, p. 1. Directive as last amended by Directive 87/356/EEC (OJ L 192, 11.7.1987, p. 48).

      (5)  [2000] ECR I-8749.

      (6)  OJ L 80, 18.3.1998, p. 27.

      (7)  OJ L 46, 21.2.1976, p. 1. Directive as amended by Commission Directive 78/891/EEC (OJ L 311, 4.11.1978, p. 21).

      (8)  OJ C 321, 31.12.2003, p. 1.

      (9)  OJ L 147, 9.6.1975, p. 40. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

      ANNEX
      RANGE OF NOMINAL QUANTITIES OF CONTENTS OF PREPACKAGES
      1.   Products sold by volume (quantity in ml)

                  Still wine

                  On the interval from 100 ml to 1 500 ml only the following 8 nominal quantities:
                  ml: 100 — 187 — 250 — 375 — 500 — 750 — 1 000 — 1 500

                  Yellow wine

                  On the interval from 100 ml to 1 500 ml only the following nominal quantity:
                  ml: 620

                  Sparkling wine

                  On the interval from 125 ml to 1 500 ml only the following 5 nominal quantities:
                  ml: 125 — 200 — 375 — 750 — 1 500

                  Liqueur wine

                  On the interval from 100 ml to 1 500 ml only the following 7 nominal quantities:
                  ml: 100 — 200 — 375 — 500 — 750 — 1 000 — 1 500

                  Aromatised wine

                  On the interval from 100 ml to 1 500 ml only the following 7 nominal quantities:
                  ml: 100 — 200 — 375 — 500 — 750 — 1 000 — 1 500

                  Spirit drinks

                  On the interval from 100 ml to 2 000 ml only the following 9 nominal quantities:
                  ml: 100 — 200 — 350 — 500 — 700 — 1 000 — 1 500 — 1 750 — 2 000

            2.   Product definitions

                  Still wine

                  Wine as defined in Article 1(2)(b) of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (1) (CN code ex 2204).

                  Yellow wine

                  Wine as defined in Article 1(2)(b) of Regulation (EC) No 1493/1999 (CN code ex 2204) with the designation of origin: ‘Côtes du Jura’, ‘Arbois’, ‘L'Etoile’ and ‘Château-Chalon’ in bottles as defined in Annex I, point 3 of Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine sector products (2).

                  Sparkling wine

                  Wine as defined in Article 1(2)(b) and in Annex I, points 15, 16, 17 and 18 of Regulation (EC) No 1493/1999 (CN code 2204 10).

                  Liqueur wine

                  Wine as defined in Article 1(2)(b) and in Annex I, point 14 of Regulation (EC) No 1493/1999 (CN code 2204 21 — 2204 29).

                  Aromatised wine

                  Aromatised wine as defined in Article 2(1)(a) of Council Regulation (EEC) No 1601/91 of 10 June 1991 laying down general rules on the definition, description and presentation of aromatised wines, aromatised wine-based drinks and aromatised wine-product cocktails (3) (CN code 2205).

                  Spirit drinks

                  Spirit drinks as defined in Article 1(2) of Council Regulation (EEC) No l576/89 of 29 May 1989 laying down general rules on the definition, description and presentation of spirit drinks (4) (CN code 2208).

         (1)  OJ L 179, 14.7.1999, p. 1. Regulation as last amended by Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1).

         (2)  OJ L 118, 4.5.2002, p. 1. Regulation as last amended by Regulation (EC) No 382/2007 (OJ L 95, 5.4.2007, p. 12).

         (3)  OJ L 149, 14.6.1991, p. 1. Regulation as last amended by the 2005 Act of Accession.

         (4)  OJ L 160, 12.6.1989, p. 1. Regulation as last amended by the 2005 Act of Accession.


Avis juridique important

|

31978L0687

Council Directive 78/687/EEC of 25 July 1978 concerning the coordination of provisions laid down by Law, Regulation or Administrative Action in respect of the activities of dental practitioners

Official Journal L 233 , 24/08/1978 P. 0010 - 0014 Finnish special edition: Chapter 6 Volume 2 P. 0006  Greek special edition: Chapter 05 Volume 3 P. 0021  Swedish special edition: Chapter 6 Volume 2 P. 0006  Spanish special edition: Chapter 06 Volume 2 P. 0040  Portuguese special edition Chapter 06 Volume 2 P. 0040

COUNCIL DIRECTIVE  of 25 July 1978  concerning the coordination of provisions laid down by law, regulation or administrative action in respect of the activities of dental practitioners  (78/687/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 49, 57, 66 and 235 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),  Whereas, with a view to achieving the mutual recognition of diplomas, certificates and other evidence of the formal qualifications in dentistry, laid down by Council Directive 78/686/EEC of 25 July 1978 concerning the mutual recognition of diplomas, certificates and other evidence of the formal qualifications of practitioners of dentistry, including measures to facilitate the effective exercise of the right of establishment and freedom to provide services (3), the comparable nature of training courses in the Member States enables coordination in this field to be confined to the requirement that minimum standards be observed, which then leaves the Member States freedom of organization as regards teaching;  Whereas, with a view to mutual recognition of diplomas, certificates and other evidence of formal qualifications of a practitioner of specialized dentistry and in order to put all members of the profession who are nationals of the Member States on an equal footing within the Community, some coordination of the requirements for training as a practitioner of specialized dentistry is necessary ; whereas certain minimum criteria should be laid down for this purpose concerning the right to take up specialized training, the minimum training period, the method by which such training is given and the place where it is to be carried out, as well as the supervision to which it should be subject ; whereas these criteria only concern the specializations common to several Member States;  Whereas it is necessary for reasons of public health to move within the Community towards a common definition of the field of activity of the professional persons concerned ; whereas this Directive does not at this stage enable complete coordination to be achieved as regards the field of activity of dental practitioners in the various Member States;  Whereas Member States will ensure that, as from the implementation of this Directive, the training of dental practitioners will provide them with the skills necessary for carrying out all activities involving the prevention, diagnosis and treatment of anomalies and diseases of the teeth, mouth, jaws and associated tissues;  Whereas coordination of the conditions for the pursuit of these activities, as provided for under this Directive, does not exclude any subsequent coordination;  Whereas the coordination envisaged by this Directive covers the professional training of dental practitioners ; whereas, as far as training is concerned, most Member States do not at present distinguish between dental practioners who pursue their activities as employed persons and those who are self-employed ; whereas for this reason and in order to encourage as far as possible the free movement of professional persons within the Community, it appears necessary to extend the application of this Directive to dental practitioners pursuing their activities as employed persons;  Whereas, at the time of notification of this Directive, dentistry is practised in Italy solely by doctors, whether or not specializing in odontostomatology ; whereas, under this Directive, Italy is obliged to create a new category of professional persons entitled to practise dentistry under a title other than that of doctor ; whereas in creating a new profession Italy must not only introduce a specific system of training complying with the criteria laid down in this Directive, but also set up structures proper to this new profession, such as a Council, for example ; whereas, therefore, in view of the extent of the measures to be taken, Italy should be granted an additional period to allow it to comply with this Directive,  (1)OJ No C 101, 4.8.1970, p. 19. (2)OJ No C 36, 28.3.1970, p. 19. (3)See page 1 of this Official Journal.   HAS ADOPTED THIS DIRECTIVE:    CHAPTER I TRAINING REQUIREMENTS  Article 1 1. The Member States shall require persons wishing to take up and pursue a dental profession under the titles referred to in Article 1 of Directive 78/686/EEC to hold a diploma, certificate or other evidence of formal qualifications referred to in Article 3 of the same Directive which guarantees that during his complete training period the person concerned has acquired:    (a) adequate knowledge of the sciences on which dentistry is based and a good understanding of scientific methods, including the principles of measuring biological functions, the evaluation of scientifically established facts and the analysis of data;       (b) adequate knowledge of the constitution, physiology and behaviour of healthy and sick persons as well as the influence of the natural and social environment on the state of health of the human being, in so far as these factors affect dentistry;       (c) adequate knowledge of the structure and function of the teeth, mouth, jaws and associated tissues, both healthy and diseased, and their relationship to the general state of health and to the physical and social well-being of the patient;       (d) adequate knowledge of clinical disciplines and methods, providing the dentist with a coherent picture of anomalies, lesions and diseases of the teeth, mouth, jaws and associated tissues and of preventive, diagnostic and therapeutic dentistry;       (e) suitable clinical experience under appropriate supervision.        This training shall provide him with the skills necessary for carrying out all activities involving the prevention, diagnosis and treatment of anomalies and diseases of the teeth, mouth, jaws and associated tissues.   2. A complete period of dental training of this kind shall comprise at least a five-year full time course of theoretical and practical instruction given in a university, in a higher-education institution recognized as having equivalent status or under the supervision of a university and shall include the subjects listed in the Annex.  3. In order to be accepted for such training, the candidate must have a diploma or a certificate which entitles him to be admitted for the course of study concerned to the universities of a Member State or to the higher education institutions recognized as having equivalent status.  4. Nothing in this Directive shall prejudice any facility which may be granted in accordance with their own rules by Member States in respect of their own territory to authorize holders of diplomas, certificates or other evidence of formal qualifications which have not been obtained in a Member State to take up and pursue the activities of a dental practitioner.   Article 2 1. Member States shall ensure that the training leading to a diploma, certificate or other evidence of formal qualifications as a practitioner of specialized dentistry meets the following requirements at least:    (a) it shall entail the completion and validation of a five-year full-time course of theoretical and practical instruction within the framework of the training referred to in Article 1, or possession of the documents referred to in Article 7 (1) of Directive 78/686/EEC.       (b) it shall comprise theoretical and practical instruction;       (c) it shall be a full-time course of a minimum of three years' duration supervised by the competent authorities or bodies;       (d) it shall be in a university centre, in a treatment, teaching and research centre or, where appropriate, in a health establishment approved for this purpose by the competent authorities or bodies;       (e) it shall involve the personal participation of the dental practitioner training to be a specialist in the activity and in the responsibilities of the establishments concerned.         2. Member States shall make the award of a diploma, certificate or other evidence of formal qualifications as a practitioner of specialized dentistry subject to the possession of one of the diplomas, certificates or other evidence of formal qualifications in dentistry referred to in Article 1, or to the possession of the documents referred to in Article 7 (1) of Directive 78/686/EEC.  3. Within the time limit laid down in Article 8 Member States shall designate the authorities or bodies competent to issue the diplomas, certificates or other evidence of formal qualifications referred to in paragraph 1.  4. Member States may derogate from paragraph 1 (a). Persons in respect of whom such derogation is made shall not be entitled to avail themselves of Article 4 of Directive 78/686/EEC.    Article 3 1. Without prejudice to the principle of full-time training as set out in Article 2 (1) (c), and until such time as the Council takes a decision in accordance with paragraph 3, Member States may permit part-time specialist training, under conditions approved by the competent national authorities, when training on a full-time basis would not be practicable for well-founded reasons.  2. The total period of specialized training may not be shortened by virtue of paragraph 1. The standard of the training may not be impaired, either by its part-time nature or by the practice of private, remunerated professional activity.  3. Four years at the latest after notification of this Directive and in the light of a review of the situation, acting on a proposal from the Commission, and bearing in mind that the possibility of part-time training should continue to exist in certain circumstances to be examined separately for each specialization, the Council shall decide whether the provisions of paragraphs 1 and 2 should be retained or amended.   Article 4 As a transitional measure and notwithstanding Articles 2 (1) (c) and 3, Member States whose provisions laid down by law, regulation or administrative action permit a method of part-time specialist training at the time of notification of this Directive may continue to apply these provisions to candidates who have begun their training as specialists no later than four years after the notification of this Directive. This period may be extended if the Council has not taken a decision in accordance with Article 3 (3).   CHAPTER II FIELD OF ACTIVITY  Article 5 Member States shall ensure that dental surgeons shall generally be entitled to take up and pursue activities involving the prevention, diagnosis and treatment of anomalies and diseases of the teeth, mouth, jaws and associated tissues in accordance with the regulatory provisions and the rules of professional conduct governing the profession at the time of notification of this Directive.  Those Member States which do not have such provisions or rules may define or limit the pursuit of certain activities referred to in the first subparagraph to an extent which is comparable to that existing in the other Member States.   CHAPTER III FINAL PROVISIONS  Article 6 Persons covered by Article 19 of Directive 78/686/EEC shall be regarded as fulfilling the requirements laid down in Article 2 (1) (a).  For the purposes of applying Article 2 (2), persons covered by Article 19 of Directive 78/686/EEC shall be treated in the same way as those holding one of the diplomas, certificates or other evidence of formal qualifications in dentistry referred to in Article 1.   Article 7 This Directive shall also apply to nationals of Member States who, in accordance with Council Regulation (EEC) No 1612/68 of 15 October 1968 on freedom of movement for workers within the Community (1), are or will be pursuing, as employed persons, any of the activities referred to in Article 1 of Directive 78/686/EEC.   Article 8 1. Member States shall take the measures necessary to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof. However, Italy shall take these measures within a maximum of six years.  2. Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.   Article 9 Where a Member State encounters major difficulties in certain fields when applying this Directive, the Commission shall examine these difficulties in conjunction with that State and shall request the opinion of the Committee of Senior Officials on Public Health set up  (1)OJ No L 257, 19.10.1968, p. 2.   by Decision 75/365/EEC (1), as last amended by Decision 78/689/EEC (2).  Where necessary, the Commission shall submit appropriate proposals to the Council.   Article 10 This Directive is addressed to the Member States.     Done at Brussels, 25 July 1978.  For the Council  The President  K. von DOHNANYI  (1)OJ No L 167, 30.6.1975, p. 19. (2)See page 17 of this Official Journal.     ANNEX Study programme for dental practitioners  The programme of studies leading to a diploma, certificate or other evidence of formal qualifications in dentistry shall include at least the following subjects. One or more of these subjects may be taught in the context of the other disciplines or in conjunction therewith.    (a) Basic subjects  chemistry,  physics,  biology.       (b) Medico-biological subjects and general medical subjects  anatomy,  embryology,  histology, including cytology,  physiology,  biochemistry (or physiological chemistry),  pathological anatomy,  general pathology,  pharmacology,  microbiology,  hygiene,  preventive medicine and epidemiology,  radiology,  physiotherapy,  general surgery,  general medicine, including paediatrics,  oto-rhino-laryngology,  dermato-venereology,  general psychology - psychopathology - neuropathology,  anaesthetics.       (c) Subjects directly related to dentistry  prosthodontics,  dental materials and equipment,  conservative dentistry,  preventive dentistry,  anaesthetics and sedation in dentistry,  special surgery,  special pathology,  clinical practice,  paedodontics,  orthodontics,  periodontics,  dental radiology,  dental occlusion and function of the jaw,  professional organization, ethics and legislation,  social aspects of dental practice.


title: Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (Text with EEA relevance)

text:
               17.9.2015

               EN

               Official Journal of the European Union

               L 241/1

         DIRECTIVE (EU) 2015/1535 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 9 September 2015
   laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (codification)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 114, 337 and 43 thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   Having regard to the opinions of the European Economic and Social Committee (1),
   Acting in accordance with the ordinary legislative procedure (2),
   Whereas:

               (1)

               Directive 98/34/EC of the European Parliament and of the Council (3) has been substantially amended several times (4). In the interests of clarity and rationality, that Directive should be codified.

               (2)

               The internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured. Therefore, the prohibition of quantitative restrictions on the movement of goods and of measures having an equivalent effect is one of the basic principles of the Union.

               (3)

               In order to promote the smooth functioning of the internal market, as much transparency as possible should be ensured as regards national initiatives for the establishment of technical regulations.

               (4)

               Barriers to trade resulting from technical regulations relating to products may be allowed only where they are necessary in order to meet essential requirements and have an objective in the public interest of which they constitute the main guarantee.

               (5)

               It is essential for the Commission to have the necessary information at its disposal before the adoption of technical provisions. Consequently, the Member States, which are required to facilitate the achievement of its task pursuant to Article 4(3) of the Treaty on European Union (TEU), must notify it of their projects in the field of technical regulations.

               (6)

               All the Member States must also be informed of the technical regulations envisaged by any one Member State.

               (7)

               The aim of the internal market is to create an environment that is conducive to the competitiveness of undertakings. Increased provision of information is one way of helping undertakings to make more of the advantages inherent in this market. It is therefore necessary to enable economic operators to give their assessment of the impact of the national technical regulations proposed by other Member States, by providing for the regular publication of the titles of notified drafts and by means of the provisions relating to the confidentiality of such drafts.

               (8)

               It is appropriate, in the interests of legal certainty, that Member States publicly announce that a national technical regulation has been adopted in accordance with the formalities laid down in this Directive.

               (9)

               As far as technical regulations for products are concerned, the measures designed to ensure the proper functioning or the continued development of the market include greater transparency of national intentions and a broadening of the criteria and conditions for assessing the potential effect of the proposed regulations on the market.

               (10)

               It is therefore necessary to assess all the requirements laid down in respect of a product and to take account of developments in national practices for the regulation of products.

               (11)

               Requirements, other than technical specifications, referring to the life cycle of a product after it has been placed on the market are liable to affect the free movement of that product or to create obstacles to the proper functioning of the internal market.

               (12)

               It is necessary to clarify the concept of a de facto technical regulation. In particular, the provisions by which the public authority refers to technical specifications or other requirements, or encourages the observance thereof, and the provisions referring to products with which the public authority is associated, in the public interest, have the effect of conferring on such requirements or specifications a more binding value than they would otherwise have by virtue of their private origin.

               (13)

               The Commission and the Member States must also be allowed sufficient time in which to propose amendments to an envisaged measure, in order to remove or reduce any barriers which it might create to the free movement of goods.

               (14)

               The Member State concerned must take account of those amendments when formulating the definitive text of the measure envisaged.

               (15)

               It is inherent in the internal market that, in particular where the principle of mutual recognition cannot be implemented by the Member States, the Commission adopts or proposes the adoption of binding acts. A specific temporary standstill period has been established in order to prevent the introduction of national measures from compromising the adoption of binding acts by the European Parliament and the Council or by the Commission in the same field.

               (16)

               The Member State concerned is to, pursuant to the general obligations laid down in Article 4(3) TEU, defer implementation of the envisaged measure for a period sufficient to allow either a joint examination of the proposed amendments or the preparation of a proposal for a legislative act or the adoption of a binding act of the Commission.

               (17)

               With a view to facilitating the adoption of measures by the European Parliament and the Council, Member States should refrain from adopting technical regulations once the Council has adopted a position at first reading on a Commission proposal concerning that sector.

               (18)

               It is necessary to provide for a Standing Committee, the members of which are appointed by the Member States, with the task of cooperating in the efforts of the Commission to lessen any adverse effects on the free movement of goods.

               (19)

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

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   1.   For the purposes of this Directive, the following definitions apply:

               (a)

               ‘product’ means any industrially manufactured product and any agricultural product, including fish products;

               (b)

               ‘service’ means any Information Society service, that is to say, any service normally provided for remuneration, at a distance, by electronic means and at the individual request of a recipient of services.
               For the purposes of this definition:

                           (i)

                           ‘at a distance’ means that the service is provided without the parties being simultaneously present;

                           (ii)

                           ‘by electronic means’ means that the service is sent initially and received at its destination by means of electronic equipment for the processing (including digital compression) and storage of data, and entirely transmitted, conveyed and received by wire, by radio, by optical means or by other electromagnetic means;

                           (iii)

                           ‘at the individual request of a recipient of services’ means that the service is provided through the transmission of data on individual request.

                     An indicative list of services not covered by this definition is set out in Annex I;

               (c)

               ‘technical specification’ means a specification contained in a document which lays down the characteristics required of a product such as levels of quality, performance, safety or dimensions, including the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures.
               The term ‘technical specification’ also covers production methods and processes used in respect of agricultural products, as referred to in the second subparagraph of Article 38(1) of the Treaty on the Functioning of the European Union (TFEU), products intended for human and animal consumption, and medicinal products as defined in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council (5), as well as production methods and processes relating to other products, where these have an effect on their characteristics;

               (d)

               ‘other requirements’ means a requirement, other than a technical specification, imposed on a product for the purpose of protecting, in particular, consumers or the environment, and which affects its life cycle after it has been placed on the market, such as conditions of use, recycling, reuse or disposal, where such conditions can significantly influence the composition or nature of the product or its marketing;

               (e)

               ‘rule on services’ means a requirement of a general nature relating to the taking-up and pursuit of service activities within the meaning of point (b), in particular provisions concerning the service provider, the services and the recipient of services, excluding any rules which are not specifically aimed at the services defined in that point.
               For the purposes of this definition:

                           (i)

                           a rule shall be considered to be specifically aimed at Information Society services where, having regard to its statement of reasons and its operative part, the specific aim and object of all or some of its individual provisions is to regulate such services in an explicit and targeted manner;

                           (ii)

                           a rule shall not be considered to be specifically aimed at Information Society services if it affects such services only in an implicit or incidental manner;

               (f)

               ‘technical regulation’ means technical specifications and other requirements or rules on services, including the relevant administrative provisions, the observance of which is compulsory, de jure or de facto, in the case of marketing, provision of a service, establishment of a service operator or use in a Member State or a major part thereof, as well as laws, regulations or administrative provisions of Member States, except those provided for in Article 7, prohibiting the manufacture, importation, marketing or use of a product or prohibiting the provision or use of a service, or establishment as a service provider.
               De facto technical regulations shall include:

                           (i)

                           laws, regulations or administrative provisions of a Member State which refer either to technical specifications or to other requirements or to rules on services, or to professional codes or codes of practice which in turn refer to technical specifications or to other requirements or to rules on services, compliance with which confers a presumption of conformity with the obligations imposed by the aforementioned laws, regulations or administrative provisions;

                           (ii)

                           voluntary agreements to which a public authority is a contracting party and which provide, in the general interest, for compliance with technical specifications or other requirements or rules on services, excluding public procurement tender specifications;

                           (iii)

                           technical specifications or other requirements or rules on services which are linked to fiscal or financial measures affecting the consumption of products or services by encouraging compliance with such technical specifications or other requirements or rules on services; technical specifications or other requirements or rules on services linked to national social security systems are not included.

                     This comprises technical regulations imposed by the authorities designated by the Member States and appearing on a list drawn up and updated, where appropriate, by the Commission, in the framework of the Committee referred to in Article 2.
               The same procedure shall be used for amending this list;

               (g)

               ‘draft technical regulation’ means the text of a technical specification or other requirement or of a rule on services, including administrative provisions, formulated with the aim of enacting it or of ultimately having it enacted as a technical regulation, the text being at a stage of preparation at which substantial amendments can still be made.

         2.   This Directive shall not apply to:

               (a)

               radio broadcasting services;

               (b)

               television broadcasting services covered by point (e) of Article 1(1) of Directive 2010/13/EU of the European Parliament and of the Council (6).

         3.   This Directive shall not apply to rules relating to matters which are covered by Union legislation in the field of telecommunications services, as covered by Directive 2002/21/EC of the European Parliament and of the Council (7).
   4.   This Directive shall not apply to rules relating to matters which are covered by Union legislation in the field of financial services, as listed non-exhaustively in Annex II to this Directive.
   5.   With the exception of Article 5(3), this Directive shall not apply to rules enacted by or for regulated markets within the meaning of Directive 2004/39/EC of the European Parliament and of the Council (8) or by or for other markets or bodies carrying out clearing or settlement functions for those markets.
   6.   This Directive shall not apply to those measures Member States consider necessary under the Treaties for the protection of persons, in particular workers, when products are used, provided that such measures do not affect the products.
   Article 2
   A Standing Committee shall be set up consisting of representatives appointed by the Member States who may call on the assistance of experts or advisers; its chairman shall be a representative of the Commission.
   The Committee shall draw up its own rules of procedure.
   Article 3
   1.   The Committee shall meet at least twice a year.
   The Committee shall meet in a specific composition to examine questions concerning Information Society services.
   2.   The Commission shall submit to the Committee a report on the implementation and application of the procedures set out in this Directive, and shall present proposals aimed at eliminating existing or foreseeable barriers to trade.
   3.   The Committee shall express its opinion on the communications and proposals referred to in paragraph 2 and may, in that regard, propose, in particular, that the Commission:

               (a)

               ensure where necessary, in order to avoid the risk of barriers to trade, that initially the Member States concerned decide amongst themselves on appropriate measures;

               (b)

               take all appropriate measures;

               (c)

               identify the areas where harmonisation appears necessary, and, should the case arise, undertake appropriate harmonisation in a given sector.

         4.   The Committee must be consulted by the Commission:

               (a)

               when deciding on the actual system through which the exchange of information provided for in this Directive is to be effected and on any change to it;

               (b)

               when reviewing the operation of the system provided for in this Directive.

         5.   The Committee may be consulted by the Commission on any preliminary draft technical regulation received by the latter.
   6.   Any question regarding the implementation of this Directive may be submitted to the Committee at the request of its chairman or of a Member State.
   7.   The proceedings of the Committee and the information to be submitted to it shall be confidential.
   However, the Committee and the national authorities may, provided that the necessary precautions are taken, consult, for an expert opinion, natural or legal persons, including persons in the private sector.
   8.   With respect to rules on services, the Commission and the Committee may consult natural or legal persons from industry or academia, and where possible representative bodies, capable of delivering an expert opinion on the social and societal aims and consequences of any draft rule on services, and take note of their advice whenever requested to do so.
   Article 4
   Member States shall communicate to the Commission, in accordance with Article 5(1), all requests made to standards institutions to draw up technical specifications or a standard for specific products for the purpose of enacting a technical regulation for such products in the form of draft technical regulations, and shall state the grounds for their enactment.
   Article 5
   1.   Subject to Article 7, Member States shall immediately communicate to the Commission any draft technical regulation, except where it merely transposes the full text of an international or European standard, in which case information regarding the relevant standard shall suffice; they shall also let the Commission have a statement of the grounds which make the enactment of such a technical regulation necessary, where those grounds have not already been made clear in the draft.
   Where appropriate, and unless it has already been sent with a prior communication, Member States shall simultaneously communicate the text of the basic legislative or regulatory provisions principally and directly concerned to the Commission, should knowledge of such text be necessary to assess the implications of the draft technical regulation.
   Member States shall communicate the draft technical regulation again to the Commission under the conditions set out in the first and second subparagraphs of this paragraph if they make changes to the draft that have the effect of significantly altering its scope, shortening the timetable originally envisaged for implementation, adding specifications or requirements, or making the latter more restrictive.
   Where, in particular, the draft technical regulation seeks to limit the marketing or use of a chemical substance, preparation or product on grounds of public health or of the protection of consumers or the environment, Member States shall also forward either a summary or the references of all relevant data relating to the substance, preparation or product concerned and to known and available substitutes, where such information may be available, and communicate the anticipated effects of the measure on public health and the protection of the consumer and the environment, together with an analysis of the risk carried out as appropriate in accordance with the principles provided for in the relevant part of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (9).
   The Commission shall immediately notify the other Member States of the draft technical regulation and all documents which have been forwarded to it; it may also refer this draft, for an opinion, to the Committee referred to in Article 2 of this Directive and, where appropriate, to the committee responsible for the field in question.
   With respect to the technical specifications or other requirements or rules on services referred to in point (iii) of the second subparagraph of point (f) of Article 1(1) of this Directive, the comments or detailed opinions of the Commission or Member States may concern only aspects which may hinder trade or, in respect of rules on services, the free movement of services or the freedom of establishment of service operators and not the fiscal or financial aspects of the measure.
   2.   The Commission and the Member States may make comments to the Member State which has forwarded a draft technical regulation; that Member State shall take such comments into account as far as possible in the subsequent preparation of the technical regulation.
   3.   Member States shall communicate the definitive text of a technical regulation to the Commission without delay.
   4.   Information supplied under this Article shall not be confidential except at the express request of the notifying Member State. Any such request shall be supported by reasons.
   In cases of that kind, if the necessary precautions are taken, the Committee referred to in Article 2 and the national authorities may seek expert advice from physical or legal persons in the private sector.
   5.   When draft technical regulations form part of measures which are required to be communicated to the Commission at the draft stage under another Union act, Member States may make a communication within the meaning of paragraph 1 under that other act, provided that they formally indicate that the said communication also constitutes a communication for the purposes of this Directive.
   The absence of a reaction from the Commission under this Directive to a draft technical regulation shall not prejudice any decision which might be taken under other Union acts.
   Article 6
   1.   Member States shall postpone the adoption of a draft technical regulation for three months from the date of receipt by the Commission of the communication referred to in Article 5(1).
   2.   Member States shall postpone:

               —

               for four months the adoption of a draft technical regulation in the form of a voluntary agreement within the meaning of point (ii) of the second subparagraph of point (f) of Article 1(1),

               —

               without prejudice to paragraphs 3, 4 and 5 of this article, for six months the adoption of any other draft technical regulation except for draft rules on services,

         from the date of receipt by the Commission of the communication referred to in Article 5(1), if the Commission or another Member State delivers a detailed opinion, within three months of that date, to the effect that the measure envisaged may create obstacles to the free movement of goods within the internal market,

               —

               without prejudice to paragraphs 4 and 5, for four months the adoption of any draft rule on services, from the date of receipt by the Commission of the communication referred to in Article 5(1), if the Commission or another Member State delivers a detailed opinion, within three months of that date, to the effect that the measure envisaged may create obstacles to the free movement of services or to the freedom of establishment of service operators within the internal market.

         With regard to draft rules on services, detailed opinions from the Commission or Member States may not affect any cultural policy measures, in particular in the audiovisual sphere, which Member States might adopt in accordance with the law of the Union, taking account of their linguistic diversity, their specific national and regional characteristics and their cultural heritage.
   The Member State concerned shall report to the Commission on the action it proposes to take on such detailed opinions. The Commission shall comment on this reaction.
   With respect to rules on services, the Member State concerned shall indicate, where appropriate, the reasons why the detailed opinions cannot be taken into account.
   3.   With the exclusion of draft rules relating to services, Member States shall postpone the adoption of a draft technical regulation for 12 months from the date of receipt by the Commission of the communication referred to in Article 5(1) of this Directive, if, within three months of that date, the Commission announces its intention to propose or adopt a directive, regulation or decision on the matter in accordance with Article 288 TFEU.
   4.   Member States shall postpone the adoption of a draft technical regulation for 12 months from the date of receipt by the Commission of the communication referred to in Article 5(1) of this Directive, if, within the three months following that date, the Commission announces its finding that the draft technical regulation concerns a matter which is covered by a proposal for a directive, regulation or decision presented to the European Parliament and the Council in accordance with Article 288 TFEU.
   5.   If the Council adopts a position at first reading during the standstill period referred to in paragraphs 3 and 4, that period shall, subject to paragraph 6, be extended to 18 months.
   6.   The obligations referred to in paragraphs 3, 4 and 5 shall lapse:

               (a)

               when the Commission informs the Member States that it no longer intends to propose or adopt a binding act;

               (b)

               when the Commission informs the Member States of the withdrawal of its draft or proposal;

               (c)

               when a binding act has been adopted by the European Parliament and the Council or by the Commission.

         7.   Paragraphs 1 to 5 shall not apply in cases where:

               (a)

               for urgent reasons, occasioned by serious and unforeseeable circumstances relating to the protection of public health or safety, the protection of animals or the preservation of plants, and for rules on services, also for public policy, in particular the protection of minors, a Member State is obliged to prepare technical regulations in a very short space of time in order to enact and introduce them immediately without any consultations being possible; or

               (b)

               for urgent reasons occasioned by serious circumstances relating to the protection of the security and the integrity of the financial system, in particular the protection of depositors, investors and insured persons, a Member State is obliged to enact and implement rules on financial services immediately.

         In the communication referred to in Article 5, the Member State shall give reasons for the urgency of the measures taken. The Commission shall give its views on the communication as soon as possible. It shall take appropriate action in cases where improper use is made of this procedure. The European Parliament shall be kept informed by the Commission.
   Article 7
   1.   Articles 5 and 6 shall not apply to those laws, regulations and administrative provisions of the Member States or voluntary agreements by means of which Member States:

               (a)

               comply with binding Union acts which result in the adoption of technical specifications or rules on services;

               (b)

               fulfil the obligations arising out of international agreements which result in the adoption of common technical specifications or rules on services in the Union;

               (c)

               make use of safeguard clauses provided for in binding Union acts;

               (d)

               apply Article 12(1) of Directive 2001/95/EC of the European Parliament and of the Council (10);

               (e)

               restrict themselves to implementing a judgment of the Court of Justice of the European Union;

               (f)

               restrict themselves to amending a technical regulation within the meaning of point (f) of Article 1(1), in accordance with a Commission request, with a view to removing a barrier to trade or, in the case of rules on services, to the free movement of services or the freedom of establishment of service operators.

         2.   Article 6 shall not apply to the laws, regulations and administrative provisions of the Member States prohibiting manufacture in so far as they do not impede the free movement of products.
   3.   Paragraphs 3 to 6 of Article 6 shall not apply to the voluntary agreements referred to in point (ii) of the second subparagraph of point (f) of Article 1(1).
   4.   Article 6 shall not apply to the technical specifications or other requirements or the rules on services referred to in point (iii) of the second subparagraph of point (f) of Article 1(1).
   Article 8
   The Commission shall report every two years to the European Parliament, the Council and the European Economic and Social Committee on the results of the application of this Directive.
   The Commission shall publish annual statistics on the notifications received in the Official Journal of the European Union.
   Article 9
   When Member States adopt a technical regulation, it shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of its official publication. The methods of making such reference shall be laid down by Member States.
   Article 10
   Directive 98/34/EC, as amended by the acts listed in Part A of Annex III to this Directive, is repealed, without prejudice to the obligations of the Member States relating to the time limits for the transposition into national law of the Directives set out in Part B of Annex III to the repealed Directive and in Part B of Annex III to this Directive.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.
   Article 11
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 12
   This Directive is addressed to the Member States.

      Done at Strasbourg, 9 September 2015.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         N. SCHMIT

      (1)  Opinion of 14 July 2010 (OJ C 44, 11.2.2011, p. 142) and opinion of 26 February 2014 (OJ C 214, 8.7.2014, p. 55).

      (2)  Position of the European Parliament of 15 April 2014 (not yet published in the Official Journal) and decision of the Council of 13 July 2015.

      (3)  Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998, p. 37). The original title was ‘Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations’. It was amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 amending Directive 98/34/EC laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 217, 5.8.1998, p. 18).

      (4)  See Annex III, Part A.

      (5)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

      (6)  Directive 2010/13/EU of the European Parliament and of the Council of 10 March 2010 on the coordination of certain provisions laid down by law, regulation or administrative action in Member States concerning the provision of audiovisual media services (Audiovisual Media Services Directive) (OJ L 95, 15.4.2010, p. 1).

      (7)  Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, p. 33).

      (8)  Directive 2004/39/EC of the European Parliament and of the Council of 21 April 2004 on markets in financial instruments amending Council Directives 85/611/EEC and 93/6/EEC and Directive 2000/12/EC of the European Parliament and of the Council and repealing Council Directive 93/22/EEC (OJ L 145, 30.4.2004, p. 1).

      (9)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

      (10)  Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (OJ L 11, 15.1.2002, p. 4).

      ANNEX I

         Indicative list of services not covered by the second subparagraph of point (b) of Article 1(1)

      1.   Services not provided ‘at a distance’

      Services provided in the physical presence of the provider and the recipient, even if they involve the use of electronic devices:

                  (a)

                  medical examinations or treatment at a doctor's surgery using electronic equipment where the patient is physically present;

                  (b)

                  consultation of an electronic catalogue in a shop with the customer on site;

                  (c)

                  plane ticket reservation at a travel agency in the physical presence of the customer by means of a network of computers;

                  (d)

                  electronic games made available in a video arcade where the customer is physically present.

            2.   Services not provided ‘by electronic means’

                  —

                  services having material content even though provided via electronic devices:

                              (a)

                              automatic cash or ticket dispensing machines (banknotes, rail tickets);

                              (b)

                              access to road networks, car parks, etc., charging for use, even if there are electronic devices at the entrance/exit controlling access and/or ensuring correct payment is made,

                  —

                  offline services: distribution of CD-ROMs or software on diskettes,

                  —

                  services which are not provided via electronic processing/inventory systems:

                              (a)

                              voice telephony services;

                              (b)

                              telefax/telex services;

                              (c)

                              services provided via voice telephony or fax;

                              (d)

                              telephone/telefax consultation of a doctor;

                              (e)

                              telephone/telefax consultation of a lawyer;

                              (f)

                              telephone/telefax direct marketing.

            3.   Services not supplied ‘at the individual request of a recipient of services’

      Services provided by transmitting data without individual demand for simultaneous reception by an unlimited number of individual receivers (point to multipoint transmission):

                  (a)

                  television broadcasting services (including near-video on-demand services), covered by point (e) of Article 1(1) of Directive 2010/13/EU;

                  (b)

                  radio broadcasting services;

                  (c)

                  (televised) teletext.

      ANNEX II

         Indicative list of the financial services covered by Article 1(4)

                  —

                  Investment services,

                  —

                  insurance and reinsurance operations,

                  —

                  banking services,

                  —

                  operations relating to pension funds,

                  —

                  services relating to dealings in futures or options.

            Such services include in particular:

                  (a)

                  investment services referred to in the Annex to Directive 2004/39/EC; services of collective investment undertakings;

                  (b)

                  services covered by the activities subject to mutual recognition referred to in Annex I to Directive 2013/36/EU of the European Parliament and of the Council (1);

                  (c)

                  operations covered by the insurance and reinsurance activities referred to in Directive 2009/138/EC of the European Parliament and of the Council (2).

         (1)  Directive 2013/36/EU of the European Parliament and of the Council of 26 June 2013 on access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms, amending Directive 2002/87/EC and repealing Directives 2006/48/EC and 2006/49/EC (OJ L 176, 27.6.2013, p. 338).

         (2)  Directive 2009/138/EC of the European Parliament and of the Council of 25 November 2009 on the taking-up and pursuit of the business of Insurance and Reinsurance (Solvency II) (OJ L 335, 17.12.2009, p. 1).

      ANNEX III
      PART A

         Repealed Directive with list of the successive amendments thereto

      (referred to in Article 10)

                  Directive 98/34/EC of the European Parliament and of the Council
                  (OJ L 204, 21.7.1998, p. 37)

                  Directive 98/48/EC of the European Parliament and of the Council
                  (OJ L 217, 5.8.1998, p. 18)

                  Part 1, Title H of Annex II to Act of Accession 2004
                  (OJ L 236, 23.9.2003, p. 68)

                  Only as regards the reference, in point 2, to Directive 98/34/EC

                  Council Directive 2006/96/EC
                  (OJ L 363, 20.12.2006, p. 81)

                  Only as regards the reference, in Article 1, to Directive 98/34/EC

                  Regulation (EU) No 1025/2012 of the European Parliament and of the Council
                  (OJ L 316, 14.11.2012, p. 12)

                  Only Article 26(2)

            PART B

         Time-limits for transposition into national law

      (referred to in Article 10)

                  Directive

                  Time-limit for transposition

                  98/34/EC

                  —

                  98/48/EC

                  5 August 1999

                  2006/96/EC

                  1 January 2007

      ANNEX IV

         Correlation Table

                  Directive 98/34/EC

                  This Directive

                  Article 1, first paragraph, introductory wording

                  Article 1(1), introductory wording

                  Article 1, first paragraph, point (1)

                  Article 1(1), point (a)

                  Article 1, first paragraph, point (2), first subparagraph

                  Article 1(1), point (b), first subparagraph

                  Article 1, first paragraph, point (2), second subparagraph, first indent

                  Article 1(1), point (b), second subparagraph, point (i)

                  Article 1, first paragraph, point (2), second subparagraph, second indent

                  Article 1(1), point (b), second subparagraph, point (ii)

                  Article 1, first paragraph, point (2), second subparagraph, third indent

                  Article 1(1), point (b), second subparagraph, point (iii)

                  Article 1, first paragraph, point (2), third subparagraph

                  Article 1(1), point (b), third subparagraph

                  Article 1, first paragraph, point (2), fourth subparagraph, introductory wording

                  Article 1(2), introductory wording

                  Article 1, first paragraph, point (2), fourth subparagraph, first indent

                  Article 1(2), point (a)

                  Article 1, first paragraph, point (2), fourth subparagraph, second indent

                  Article 1(2), point (b)

                  Article 1, first paragraph, point (3)

                  Article 1(1), point (c)

                  Article 1, first paragraph, point (4)

                  Article 1(1), point (d)

                  Article 1, first paragraph, point (5), first subparagraph

                  Article 1(1), point (e), first subparagraph

                  Article 1, first paragraph, point (5), second subparagraph

                  Article 1(3)

                  Article 1, first paragraph, point (5), third subparagraph

                  Article 1(4)

                  Article 1, first paragraph, point (5), fourth subparagraph

                  Article 1(5)

                  Article 1, first paragraph, point (5), fifth subparagraph, introductory sentence

                  Article 1(1), point (e), second subparagraph, introductory sentence

                  Article 1, first paragraph, point (5), fifth subparagraph, first indent

                  Article 1(1), point (e), second subparagraph, point (i)

                  Article 1, first paragraph, point (5), fifth subparagraph, second indent

                  Article 1(1), point (e), second subparagraph, point (ii)

                  Article 1, first paragraph, point (11), first subparagraph

                  Article 1(1), point (f), first subparagraph

                  Article 1, first paragraph, point (11), second subparagraph, introductory sentence

                  Article 1(1), point (f), second subparagraph, introductory sentence

                  Article 1, first paragraph, point (11) second subparagraph, first indent

                  Article 1(1), point (f), second subparagraph, point (i)

                  Article 1, first paragraph, point (11), second subparagraph, second indent

                  Article 1(1), point (f), second subparagraph, point (ii)

                  Article 1, first paragraph, point (11), second subparagraph, third indent

                  Article 1(1), point (f), second subparagraph, point (iii)

                  Article 1, first paragraph, point (11), third subparagraph

                  Article 1(1), point (f), third subparagraph

                  Article 1, first paragraph, point (11), fourth subparagraph

                  Article 1(1), point (f), fourth subparagraph

                  Article 1, first paragraph, point (12)

                  Article 1(1), point (g)

                  Article 1, second paragraph

                  Article 1(6)

                  Article 5

                  Article 2

                  Article 6(1) and (2)

                  Article 3(1) and (2)

                  Article 6(3), introductory wording

                  Article 3(3), introductory wording

                  Article 6(3), second indent

                  Article 3(3), point (a)

                  Article 6(3), third indent

                  Article 3(3), point (b)

                  Article 6(3), fourth indent

                  Article 3(3), point (c)

                  Article 6(4), introductory wording

                  Article 3(4), introductory wording

                  Article 6(4), point (c)

                  Article 3(4), point (a)

                  Article 6(4), point (d)

                  Article 3(4), point (b)

                  Article 6(5) to (8)

                  Article 3(5) to (8)

                  Article 7

                  Article 4

                  Article 8

                  Article 5

                  Article 9(1) to (5)

                  Article 6(1) to (5)

                  Article 9(6), introductory wording

                  Article 6(6), introductory wording

                  Article 9(6), first indent

                  Article 6(6), point (a)

                  Article 9(6), second indent

                  Article 6(6), point (b)

                  Article 9(6), third indent

                  Article 6(6), point (c)

                  Article 9(7), first subparagraph, introductory wording

                  Article 6(7), first subparagraph, introductory wording

                  Article 9(7), first subparagraph, first indent

                  Article 6(7), first subparagraph, point (a)

                  Article 9(7), first subparagraph, second indent

                  Article 6(7), first subparagraph, point (b)

                  Article 9(7), second subparagraph

                  Article 6(7), second subparagraph

                  Article 10(1), introductory wording

                  Article 7(1), introductory wording

                  Article 10(1), first indent

                  Article 7(1), point (a)

                  Article 10(1), second indent

                  Article 7(1), point (b)

                  Article 10(1), third indent

                  Article 7(1), point (c)

                  Article 10(1), fourth indent

                  Article 7(1), point (d)

                  Article 10(1), fifth indent

                  Article 7(1), point (e)

                  Article 10(1), sixth indent

                  Article 7(1), point (f)

                  Article 10(2), (3) and (4)

                  Article 7(2), (3) and (4)

                  Article 11, first sentence

                  Article 8, first paragraph

                  Article 11, second sentence

                  Article 8, second paragraph

                  Article 12

                  Article 9

                  Article 13

                  —

                  —

                  Article 10

                  Article 14

                  Article 11

                  Article 15

                  Article 12

                  Annex III

                  —

                  Annex IV

                  —

                  Annex V

                  Annex I

                  Annex VI

                  Annex II

                  —

                  Annex III

                  —

                  Annex IV