Avis juridique important

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32002L0011

Council Directive 2002/11/EC of 14 February 2002 amending Directive 68/193/EEC on the marketing of material for the vegetative propagation of the vine and repealing Directive 74/649/EEC

Official Journal L 053 , 23/02/2002 P. 0020 - 0027

Council Directive 2002/11/ECof 14 February 2002amending Directive 68/193/EEC on the marketing of material for the vegetative propagation of the vine and repealing Directive 74/649/EECTHE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the European Parliament(2),Having regard to the opinion of the Economic and Social Committee(3),Whereas:(1) In the context of consolidating the internal market and in the light of experience, various provisions of Directive 68/193/EEC(4) should be amended or repealed to remove all barriers to trade likely to prevent the free movement of vinepropagating material in the Community. To that end, any possibility for Member States to make unilateral derogations from the Directive should be removed.(2) It should be made possible, on certain conditions, to market propagating material produced by new production methods.(3) The Commission, assisted by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry, should be able to lay down the conditions under which Member States may authorise the marketing of propagating material for trials, scientific purposes or selection work.(4) In the light of the experience gained in other sectors regarding the marketing of seed and propagating material, temporary trials should be organised, subject to certain conditions, to find better alternatives to certain provisions of the Directive.(5) As a result of scientific and technical progress, it is now possible to modify vine varieties genetically. It is therefore important that genetically modified vine varieties are not accepted unless all the appropriate measures have been taken to avoid any risk to human health or the environment.(6) A specific environmental risk assessment should be carried out equivalent to that provided for in Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(5) where vine variety propagating material is composed of genetically modified organisms. The Commission should submit to the European Parliament and the Council a proposal for a Regulation ensuring the equivalence of risk assessment and other relevant requirements, in particular those regarding risk management, labelling, any monitoring required, public information and a safeguard clause with those established by Directive 2001/18/EC. Pending the entry into force of that Regulation, the provisions of Directive 2001/18/EC should remain applicable.(7) Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients(6) includes provisions on genetically modified food and food ingredients. In determining whether a genetically modified vine variety can be accepted on the market and in order to protect public health, it is necessary to ensure that novel foods and novel food ingredients were subject to a safety assessment.(8) To ensure that the movement of vine-propagating material is adequately monitored, it is appropriate that Member States should be able to require a document to accompany each lot.(9) It is desirable to ensure that genetic diversity is preserved. Appropriate biodiversity conservation measures to guarantee the conservation of existing varieties must be taken. The Commission should take into account not only the concept of variety but also that of genotype and of clone.(10) The measures necessary for the implementation of Directive 68/193/EEC should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(7).(11) Council Directive 74/649/EEC of 9 December 1974 on the marketing of material for the vegetative propagation of the vine produced in third countries(8) should be repealed,HAS ADOPTED THIS DIRECTIVE:Article 1Directive 68/193/EEC is hereby amended as follows:1. Article 2(1) shall be replaced by the following: "1. For the purposes of this Directive, the following definitions shall apply:(A) Vines: plants of the genus Vitis (L.) intended for the production of grapes or for use as propagation material for such plants.AA. Variety: a plant grouping within a single botanical tax on of the lowest known rank, which can be:(a) defined by the expression of the characters resulting from a given genotype or combination of genotypes;(b) distinguished from any other plant grouping by the expression of at least one of the said characters; and(c) considered as an entity in view of its ability to be propagated unchanged.AB. Clone: a clone is the vegetative progeny of a variety which is true to a vine stock chosen on account of varietal identity, its phenotypic characters and its state of health.(B) Propagating material(i) Young vine plants(a) rooted cuttings: ungrafted pieces of rooted vine shoot or herbaceous shoot, intended for planting ungrafted or for use as rootstocks;(b) rooted grafts: pieces of vine shoot or herbaceous shoot joined by grafting, the underground part of which is rooted.(ii) Parts of young vine plants(a) vine shoots: one-year shoots;(b) herbaceous shoots: unlignified shoots;(c) graftable rootstock cuttings: pieces of vine shoot or herbaceous shoot intended to form the underground part when preparing rooted grafts;(d) top-graft cuttings: pieces of vine shoot or herbaceous shoot intended to form the part above ground when preparing rooted grafts or when grafting plants in situ;(e) nursery cuttings: pieces of vine shoot or herbaceous shoot intended for the production of rooted cuttings.(C) Stock nurseries: nurseries for the production of rootstock cuttings for grafting, nursery cuttings or top-graft cuttings.(D) Cutting nurseries: nurseries for the cultivation of rooted cuttings or rooted grafts.DA. Initial propagating material: propagating material(a) which has been produced under the responsibility of the grower according to accepted practices for the maintenance of the identity of the variety and, where applicable, of the clone, and for the prevention of diseases;(b) which is intended for the production of basic propagating material or certified propagating material;(c) which satisfies the conditions laid down in Annexes I and II for basic propagating material. These Annexes may be amended in accordance with the procedure laid down in Article 17(2) in order to set additional or more stringent conditions for the certification of initial propagating material;(d) which has been found by official examination to satisfy the above conditions.(E) Basic propagating material: propagating material(a) which has been produced under the responsibility of the grower according to accepted practices for the maintenance of the identity of the variety and, where applicable, of the clone, and for the prevention of diseases and which is obtained by vegetative propagation directly from initial propagating material;(b) which is intended for the production of certified propagating material;(c) which satisfies the conditions laid down in Annexes I and II for basic propagating material; and(d) which has been found by official examination to satisfy the above conditions.(F) Certified material: propagation material(a) which is obtained directly from basic propagating material or initial propagating material;(b) which is intended for:- the production of young plants or parts of plants for use in the production of grapes, or- the production of grapes;(c) which satisfies the conditions laid down in Annexes I and II for certified material; and(d) which has been found by official examination to satisfy the abovementioned conditions.(G) Standard material: propagation material(a) which has varietal identity and purity;(b) which is intended for:- the production of young plants or parts of plants for use in the production of grapes, or- the production of grapes;(c) which satisfies the conditions laid down in Annexes I and II for standard material; and(d) which has been found by official examination to satisfy the abovementioned conditions.(H) Official measures: measures taken(a) by State authorities; or(b) by any legal person whether governed by public or by private law, acting under the responsibility of the State; or(c) in the case of ancillary activities which are also subject to State control, by any natural person duly sworn for that purpose,provided that the persons mentioned under (b) and (c) derive no private gain from such measures.(I) Marketing:the sale, holding with a view to sale, offer for sale and any disposal, supply or transfer aimed at commercial exploitation of propagating material to third parties, whether or not for a consideration.Trade in propagating material not aimed at commercial exploitation of the variety, such as the following operations, shall not be regarded as marketing:(a) the supply of propagating material to official testing and inspection bodies;(b) the supply of propagating material to providers of services for processing or packaging, provided that the provider of services does not acquire title to propagating material thus supplied.The rules for the application of these provisions shall be adopted in accordance with the procedure laid down in Article 17(3).";2. Article 3 shall be replaced by the following: "Article 31. The Member States shall require that vine propagating material may not be placed on the market unless:(a) it has been officially certified as 'initial propagating material', 'basic propagating material' or 'certified propagating material' or, in the case of propagating material not intended for use as rootstocks, it is officially checked standard material, and(b) it satisfies the conditions laid down in Annex II.2. By derogation from paragraph 1, Member States may, as a transitional measure until 1 January 2005, allow the marketing in their own territory of standard material intended for use as rootstocks and taken from parent plants in existence on 23 February 2002.3. Notwithstanding paragraph 1, Member States may authorise producers on their own territory to place on the market appropriate quantities of propagating material:(a) intended for trials or for scientific purposes;(b) for selection work;(c) intended to help preserve genetic diversity.The conditions under which Member States may grant such authorisation may be determined in accordance with the procedure laid down in Article 17(2).In the case of genetically modified material, such authorisation may be granted only if all appropriate measures have been taken to avoid risks to human health and the environment. For the environmental risk assessment and other checks to be carried out in this respect, Article 5ba shall apply accordingly.4. In the case of propagating material produced by means of in vitro propagation techniques, the following provisions may be adopted in accordance with the procedure laid down in Article 17(2):(a) derogation from specific provisions of this Directive;(b) conditions applicable to such propagating material;(c) designations that may be used for such propagating material;(d) conditions to guarantee that the varietal authenticity has first been verified.5. The Commission, acting in accordance with the procedure laid down in Article 17(3), may require that, after specified dates, propagating material other than for use as rootstocks may be placed on the market only if it has been officially certified as 'initial propagating material', 'basic propagating material' or 'certified propagating material':(a) throughout the Community, in the case of certain vine varieties for which the Community's needs can be covered, taking into account their genetic diversity, if necessary under an established programme, by propagating material officially certified as 'initial propagating material', 'basic propagating material' or 'certified propagating material', and(b) in the case of propagating material of varieties other than those referred to in (a), if intended for use in the territory of Member States which have already required, in accordance with this Directive, that 'standard material' may no longer be marketed.";3. the following subparagraph shall be added to Article 4: "This provision shall not apply, in the case of grafting, to propagating material produced in another Member State or in a third country recognised as equivalent in accordance with Article 15(2).";4. Article 5 shall be replaced by the following: "Article 51. Each Member State shall establish a catalogue of the vine varieties officially accepted for certification and for checking as standard propagating material in its territory. The catalogue shall be open to public inspection. The catalogue shall determine the principal morphological and physiological characters by which the varieties can be distinguished from one another. For those varieties already accepted as at 31 December 1971, reference may be made to the description in the official ampelographic publications.2. Member States shall ensure that varieties and clones accepted into the catalogues of the other Member States are also accepted for certification and for the checking of standard propagating material in their own territory, without prejudice to Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine(9), with regard to the rules for the classification of vine varieties.3. Each Member State shall also establish, if appropriate, a list of clones officially accepted for certification in its territory.Member States shall ensure that clones accepted for certification in another Member State are also accepted for certification in their own territory.";5. Article 5b shall be replaced by the following: "Article 5b1. A variety shall be deemed to be distinct if it is clearly distinguishable, by reference to the expression of the characteristics resulting from a particular genotype or combination of genotypes, from any other variety whose existence is a matter of common knowledge in the Community.A variety shall be deemed to be a matter of common knowledge in the Community if, on the date on which application is duly made for its acceptance, it either is entered in the catalogue of the Member State in question or of another Member State or is the subject of an application for acceptance in the Member State in question or in another Member State, unless the conditions referred to in the first sentence of this paragraph are no longer met in all the Member States concerned before a decision is made regarding the application for acceptance of the new variety being assessed.2. A variety shall be deemed to be stable if the expression of the characters which are included in the examination for distinctness, as well as any others used for the variety description, remains unchanged after repeated propagation.3. A variety shall be deemed to be uniform if, subject to the variation that may be expected from the particular features of its propagation, it is sufficiently uniform in the expression of those characters which are included in the examination for distinctness, as well as any others used for describing the variety.";6. the following Article shall be inserted: "Article 5ba1. In the case of a genetically modified variety within the meaning of points 1 and 2 of Article 2 of Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(10), the variety shall be accepted only if all appropriate measures have been taken to avoid adverse effects on human health and the environment.2. With regard to genetically modified varieties within the meaning of paragraph 1:(a) a specific environmental risk assessment equivalent to the assessment provided for in Directive 2001/18/EC and in accordance with the principles set out in Annex II and on the basis of the information specified in Annex III of that Directive shall be carried out;(b) the procedures intended to ensure the equivalence of the specific risk assessment and other relevant requirements, in particular those regarding risk management, labelling, and any monitoring required, public information and a safeguard clause with those established by Directive 2001/18/EC shall be introduced, on a proposal from the Commission, by a Regulation of the European Parliament and of the Council. Pending the entry into force of that Regulation, genetically modified varieties shall be accepted for inclusion in a national catalogue only when they have been accepted for marketing in accordance with Directive 2001/18/EC;(c) Articles 13 to 24 of Directive 2001/18/EC shall no longer apply to genetically modified varieties of vine authorised in conformity with the Regulation referred to in point (b).3. Where products derived from vine propagating material are intended to be used as a food or food ingredient falling within the scope of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients(11), it must be ensured prior to the acceptance of genetically modified varieties of vine that the foods or food ingredients derived therefrom do not:(a) present a danger for the consumer;(b) mislead the consumer;(c) differ from the foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.Where products derived from one of the varieties referred to in this Directive is intended for use as a food or food ingredient covered by Regulation (EC) No 258/97, the variety shall be accepted only if the food or food ingredient has already been authorised in accordance with that Regulation.";7. Article 5c shall be replaced by the following: "Article 5cMember States shall ensure that varieties and, where applicable, clones coming from other Member States are subject to the same requirements as those which apply to domestic varieties or clones, in particular as regards the acceptance procedure.";8. Article 5e(2) shall be replaced by the following: "2. All applications or withdrawals of applications for acceptance of a variety, entries in a catalogue of varieties and amendments made to it shall immediately be communicated to the other Member States and to the Commission. On the basis of the notifications from the Member States, the Commission shall publish a common catalogue of varieties.";9. the following Article shall be inserted: "Article 5fMember States shall ensure that genetically modified varieties which have been accepted are clearly indicated as such in the catalogue of varieties. They shall further ensure that any person marketing such a variety clearly indicates in their vine sales catalogue that the variety is genetically modified and states the purpose of the modification.";10. the following Article shall be inserted: "Article 5g1. Member States shall require that varieties and, where applicable, clones accepted into the catalogue are maintained by selection for conservation.2. Maintenance must always be verifiable on the basis of records made by those responsible for maintenance of a variety and, where applicable, of a clone.3. Samples may be requested from those responsible for maintenance of a variety. Where necessary, samples may be taken officially.4. Where maintenance is carried out in a Member State other than that in which the variety was accepted, the Member States in question shall assist each other administratively as regards control.";11. Article 7 shall be replaced by the following: "Article 7Member States shall provide that, while growing and during lifting, or removal from the parent vine, packaging, storage and transportation, propagation material be kept in separate batches and be marked with the variety and, where applicable, in the case of original propagating materials, basic material and certified material, with the clone.";12. Article 8(2) shall be replaced by the following: "2. By way of derogation from paragraph 1 as regards packaging, sealing and marking, the Commission shall determine, in accordance with the procedure laid down in Article 17(2), the provisions applicable to the sale of small quantities to final consumers and also to market vines in pots, crates or boxes.";13. Article 9 shall be replaced by the following: "Article 9Member States shall require packages and bundles of propagating material to be sealed officially or under official supervision in such a manner that they cannot be opened without damaging the seal or without the official label referred to in Article 10(1) or, in the case of packaging, the packaging showing signs of tampering. To ensure proper sealing, the sealing device must comprise at least either the official label or an official seal. A decision may be taken in accordance with the procedure laid down in Article 17(2) as to whether a specific sealing device meets the requirements of this Article. Further sealing may take place only officially or under official supervision.";14. Article 10 shall be replaced by the following: "Article 101. The Member States shall require that an official label in one of the official languages of the Community, conforming to the specification in Annex IV, be affixed on the outside of packages and bundles of propagating material by means of the sealing device. The colour of the label shall be white with a diagonal violet stripe for initial material, white for basic material, blue for certified material and dark yellow for standard material.2. However, Member States may authorise producers in their territory to market more than one package or bundle of grafted or rooted vines with the same characteristics, using a single label conforming to the specification in Annex IV. In such cases, the packages or bundles shall be attached together in such a way that the attachment is damaged on separation and can no longer be put back. The label shall be affixed by means of the attachment. No resealing shall be authorised.3. Without prejudice to Article 23(2) of Regulation (EC) No 1493/1999, Member States may require that each delivery of material produced within their territories also be accompanied by a uniform document featuring the following particulars inter alia: the nature of the goods, the variety and, where applicable, the clone, the category, quantity, consignor and recipient. The conditions to be set regarding this accompanying document shall be established according to the procedure provided for under Article 17(3) of this Directive.4. The official label provided for under paragraph 1 may also include the phytosanitary accompanying documents, provided for in Commission Directive 92/105/EEC(12), which establishes a degree of standardisation for plant passports. However, all of the conditions applicable to the official labelling and plant passports are defined and must be recognised as equivalent.5. Member States shall prescribe that the official labels must be preserved by the recipient of the material for the vegetative propagation of the vine for at least one year and made available to the official control authority.6. By 23 February 2004, the Commission shall draw up a report, together with proposals, if appropriate, on the movement of material for the propagation of the vine and in particular on the use of official labels and the accompanying documents introduced by the Member States.";15. the following Article shall be inserted: "Article 10aIn the case of propagating material of a variety which has been genetically modified, any label and document, official or otherwise, which is affixed to or accompanies the batch of material under this Directive shall clearly indicate that the variety has been genetically modified and shall name the genetically modified organisms.";16. Article 11(2) shall be replaced by the following: "2. Without prejudice to the free movement of material within the Community, Member States shall take all necessary measures to ensure that the competent authorities are supplied with the following particulars during the marketing of propagating material imported from a third country:(a) species (botanical name);(b) variety and, where applicable, clone; in the case of rooted grafts, such information shall apply both to the rootstock and to the top-graft cutting;(c) category;(d) nature of propagating material:(e) country of production and official control authority;(f) country of despatch, if different from the country of production;(g) importer;(h) quantity of material.The manner in which these particulars are to be presented may be determined in accordance with the procedure laid down in Article 17(2).";17. Article 12 shall be replaced by the following: "Article 12Member States shall ensure that propagating material marketed in accordance with this Directive, under either compulsory or optional rules, is not subjected to any marketing restrictions as regards its characteristics, examination arrangements, marking and sealing other than those laid down in this Directive.";18. Article 12a shall be replaced by the following: "Article 12aMember States shall ensure that propagating material of vine varieties and, where applicable, clones, which have been officially accepted in one of the Member States for certification and for checking as standard propagating material in accordance with this Directive, are not subjected to any marketing restrictions in their territory based on variety, and, where applicable, clone, without prejudice to Regulation (EC) No 1493/1999.";19. Article 14(1) shall be replaced by the following: "1. In order to eliminate any temporary difficulties in the supply of propagating material in the Community that cannot be overcome in any other way, a decision may be taken in accordance with the procedure laid down in Article 17(2) that Member States should authorise, for a specified period, the marketing throughout the Community's territory of such quantity of propagating material of a category satisfying less stringent requirements as is needed to overcome the difficulties.";20. the following Article shall be inserted: "Article 14aFor the purpose of seeking better alternatives to certain provisions of this Directive, it may be decided, in accordance with the procedure laid down in Article 17(3), to organise temporary experiments under specified conditions at Community level.";21. Article 15(2) shall be replaced by the following: "2. (a) On a Commission proposal the Council, acting by qualified majority, shall determine whether material for the vegetative propagation of the vine produced in a third country offers, as regards the conditions for its acceptance and the measures taken to ensure its production with a view to its marketing, the same guarantees as material produced in the Community and meets the requirements of this Directive.(b) Furthermore, the Council shall determine the types of material and the categories of material for the vegetative propagation of the vine that may be admitted to marketing within the territory of the Community under point (a).(c) Until the Council has taken a decision pursuant to point (a) and without prejudice to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community(13), the Member States may be authorised to take such decisions in accordance with the procedure laid down in Article 17(2). When doing so, they shall ensure that the material to be imported offers guarantees equivalent in every respect to those offered by material for the vegetative propagation of the vine produced in the Community in accordance with this Directive. Such imported material shall in particular be accompanied by a document setting out the particulars prescribed in Article 11(2).";22. the following Articles shall be inserted: "Article 16aThe measures necessary for the implementation of this Directive with regard to the matters contained in the provisions referred to below shall be adopted in accordance with the management procedure laid down in Article 17(2):- Article 2(1)(DA)(c), Article 3(3), Article 8(2), Article 9, Article 11(2), Article 14(1) and Article 15(2)(c).Article 16bThe measures necessary for the implementation of this Directive with regard to the matters contained in the provisions referred to below shall be adopted in accordance with the regulatory procedure laid down in Article 17(3):- Article 2(1)(I), Article 3(5), Article 10(3) and Article 14a.";23. Article 17 shall be replaced by the following: "Article 171. The Commission shall be assisted by the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry (hereinafter referred to as the 'committee').2. Where reference is made to this paragraph, Articles 4 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(14) shall apply.The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply.The period laid down in Article 5(6) of Decision 1999/468/EC shall be two months.4. The committee shall adopt its rules of procedure.";24. References to Article 17 appearing in Article 5d(2), Article 14(3), Article 16, Article 17a and Article 18a shall be deemed to be references to Article 17(2).Article 2Directive 74/649/EEC shall be repealed.Article 3Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 23 February 2003. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field governed by this Directive.Article 4This Directive shall enter into force on the day of its publication in the Official Journal of the European Communities.Article 5This Directive is addressed to the Member States.Done at Brussels, 14 February 2002.For the CouncilThe PresidentP. del Castillo(1) OJ C 177 E, 27.6.2000, p. 77.(2) OJ C 197, 12.7.2001, p. 24.(3) OJ C 268, 19.9.2000, p. 42.(4) OJ L 93, 17.4.1968, p. 15. Directive as last amended by the 1994 Act of Accession.(5) OJ L 106, 17.4.2001, p. 1.(6) OJ L 43, 14.2.1997, p. 1.(7) OJ L 184, 17.7.1999, p. 23.(8) OJ L 352, 28.12.1974, p. 45.(9) OJ L 179, 17.7.1999, p. 1.(10) OJ L 106, 17.4.2001, p. 1.(11) OJ L 43, 14.2.1997, p. 1.(12) OJ L 4, 8.1.1993, p. 22.(13) OJ L 169, 10.7.2000, p. 1.(14) OJ L 184, 17.7.1999, p. 23.


title: Commission Directive 2011/27/EU of 4 March 2011 amending Council Directive 91/414/EEC to include oryzalin as active substance and amending Decision 2008/934/EC  Text with EEA relevance

text:
               5.3.2011

               EN

               Official Journal of the European Union

               L 60/12

         COMMISSION DIRECTIVE 2011/27/EU
   of 4 March 2011
   amending Council Directive 91/414/EEC to include oryzalin as active substance and amending Decision 2008/934/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included oryzalin.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of oryzalin.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (4)

               The application was submitted to France, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               France evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 17 August 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on oryzalin to the Commission on 6 August 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 January 2011 in the format of the Commission review report for oryzalin.

               (6)

               It has appeared from the various examinations made that plant protection products containing oryzalin may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which have been examined and detailed in the Commission review report. It is therefore appropriate to include oryzalin in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.

               (7)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is necessary that the specification of the technical material, as commercially manufactured, be confirmed by appropriate analytical data, including information on the relevance of the impurities, which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12. The relevance of the test material used in the toxicity dossiers should be confirmed in view of the specification of the technical material and information confirming the risk assessment for aquatic organisms should be requested. Provided that oryzalin becomes classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information confirming the relevance of the metabolites OR13 (8) and OR15 (9), and the corresponding groundwater risk assessment.

               (8)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing oryzalin to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (10)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (10) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (11)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (12)

               Decision 2008/934/EC provides for the non-inclusion of oryzalin and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning oryzalin in the Annex to that Decision.

               (13)

               It is therefore appropriate to amend Decision 2008/934/EC accordingly.

               (14)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   The line concerning oryzalin in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing oryzalin as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to oryzalin are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing oryzalin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning oryzalin. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing oryzalin as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing oryzalin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 4 March 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  OJ L 333, 11.12.2008, p. 11.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance oryzalin. EFSA Journal 2010; 8(9):1707. [59 pp.]. doi:10.2903/j.efsa.2010.1707. Available online: www.efsa.europa.eu

      (7)  OJ L 353, 31.12.2008, p. 1.

      (8)  2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide.

      (9)  2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide.

      (10)  OJ L 366, 15.12.1992, p. 10.

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘334

                     Oryzalin
                     CAS No: 19044-88-3

                     CIPAC No: 537

                        3,5-dinitro-N4,N4-dipropylsulfanilamide

                     ≥ 960 g/kg
                     N-nitrosodipropylamine:
                     ≤ 0,1 mg/kg
                     Toluene: ≤ 4 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI the conclusions of the review report on oryzalin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 January 2011, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 1.

                                 the operator safety and ensure that conditions of use include the application of adequate personal protective equipment;

                                 2.

                                 the protection of aquatic organisms and non-target plants;

                                 3.

                                 the protection of groundwater, where the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 4.

                                 the risk to herbivorous birds and mammals;

                                 5.

                                 the risk to bees, in the flowering season.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolites OR13 (2-ethyl-7-nitro-1-propyl-1H-benzimidazole-5-sulfonamide) and OR15 (2-ethyl-7-nitro-1H-benzimidazole-5-sulfonamide) in vulnerable zones, where appropriate. The Member States concerned shall request the submission of confirmatory information as regards:

                                 1.

                                 the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities which for confidentiality reasons are referred to as impurities 2, 6, 7, 9, 10, 11, 12;

                                 2.

                                 the relevance of the test material used in the toxicity dossiers in view of the specification of the technical material;

                                 3.

                                 the risk assessment for aquatic organisms;

                                 4.

                                 the relevance of the metabolites OR13 and OR15, and the corresponding groundwater risk assessment, provided that oryzalin becomes classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (OJ L 353, 31.12.2008, p. 1) as “suspected of causing cancer”.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points 1 and 2 by 1 December 2011, and the information set out in point 3 by 31 May 2013. The information set out in point 4 shall be submitted within 6 months of notification of a decision classifying oryzalin.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Directive 2013/26/EU of 8 February 2013 adapting certain directives in the field of food safety, veterinary and phytosanitary policy, by reason of the accession of Croatia

text:
               10.6.2013

               EN

               Official Journal of the European Union

               L 158/376

         COMMISSION DIRECTIVE 2013/26/EU
   of 8 February 2013
   adapting certain directives in the field of food safety, veterinary and phytosanitary policy, by reason of the accession of Croatia
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty of Accession of the Republic of Croatia, and in particular Article 3(4) thereof,
   Having regard to the Act of Accession of the Republic of Croatia, and in particular Article 50 thereof,
   Whereas:

               (1)

               Pursuant to Article 50 of the Act of Accession, where acts of the institutions adopted prior to accession require adaptation by reason of accession, and the necessary adaptations have not been provided for in the Act of Accession or its Annexes, the Commission, if the original act was adopted by the Commission, shall, to this end, adopt the necessary acts.

               (2)

               The Final Act of the Conference which drew up the Treaty of Accession indicated that the High Contracting Parties had reached political agreement on a set of adaptations to acts adopted by the institutions required by reason of accession and invited the Council and the Commission to adopt these adaptations before accession, completed and updated where necessary to take account of the evolution of the law of the Union.

               (3)

               Commission Directives 1999/21/EC (1) and 2006/141/EC (2) should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directives 1999/21/EC and 2006/141/EC are amended as set out in the Annex.
   Article 2
   1.   Member States shall adopt and publish, by the date of accession of the Republic of Croatia to the European Union at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from the date of accession of the Republic of Croatia to the European Union.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force subject to, and as from the date of the entry into force of the Treaty of Accession of the Republic of Croatia.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 8 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 91, 7.4.1999, p. 29.

      (2)  OJ L 401, 30.12.2006, p. 1.

      ANNEX

         FOOD SAFETY, VETERINARY AND PHYTOSANITARY POLICY

      FOOD SAFETY LEGISLATION

                  1.

                  31999 L 0021: Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (OJ L 91, 7.4.1999, p. 29):
                  in Article 4(1) the list starting with ‘in Bulgarian’ and ending with ‘medicinska ändamål’, is replaced by the following list:

                              ‘—

                              in Bulgarian:
                              “Диетични храни за специални медицински цели”

                              —

                              in Spanish:
                              “Alimento dietético para usos médicos especiales”

                              —

                              in Czech:
                              “Dietní potravina určená pro zvláštní lékařské účely”

                              —

                              in Danish:
                              “Levnedsmiddel/Levnedsmidler til særlige medicinske formål”

                              —

                              in German:
                              “Diätetisches/Diätetische Lebensmittel für besondere medizinische
                              Zwecke (Bilanzierte Diäten)”

                              —

                              in Estonian:
                              “Toit meditsiinilisel näidustusel kasutamiseks”

                              —

                              in Greek:
                              “Διαιτητικά τρόφιμα για ειδικούς ιατρικούς σκοπούς”

                              —

                              in English:
                              “Food(s) for special medical purposes”

                              —

                              in French:
                              “Aliment(s) diététique(s) destiné(s) a des fins médicales spéciales”

                              —

                              in Croatian:
                              “Hrana za posebne medicinske potrebe”

                              —

                              in Italian:
                              “Alimento dietetico destinato a fini medici speciali”

                              —

                              in Latvian:
                              “Diētiskā pārtika cilvēkiem ar veselības traucējumiem”

                              —

                              in Lithuanian:
                              “Specialios medicininės paskirties maisto produktai”

                              —

                              in Hungarian:
                              “Speciális – gyógyászati célra szánt – tápszer”

                              —

                              in Maltese:
                              “Ikel dijetetiku għal skopijiet mediċi speċifiċi”

                              —

                              in Dutch:
                              “Dieetvoeding voor medisch gebruik”

                              —

                              in Polish:
                              “Dietetyczne środki spożywcze specjalnego przeznaczenia medycznego”

                              —

                              in Portuguese:
                              “Produto dietético de uso clínico”

                              —

                              in Romanian:
                              “Alimente dietetice pentru scopuri medicale speciale”

                              —

                              in Slovak:
                              “dietetická potravina na osobitné lekárske účely”

                              —

                              in Slovenian:
                              “Dietno (dietetično) živilo za posebne zdravstvene namene”

                              —

                              in Finnish:
                              “Kliininen ravintovalmiste/kliinisiä ravintovalmisteita”

                              —

                              in Swedish:
                              “Livsmedel för speciella medicinska ändamål”.’

                  2.

                  32006 L 0141: Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ L 401, 30.12.2006, p. 1):

                              (a)

                              in Article 11 in the list starting with ‘— in Bulgarian’ and ending with ‘Tillskottsnäring’, the following entry is inserted after the entry for French:

                                          ‘—

                                             in Croatian: “početna hrana za dojenčad” and “prijelazna hrana za dojenčad”,’;

                              (b)

                              in Article 12 in the list starting with ‘— in Bulgarian’ and ending with ‘Tillskottsnäring uteslutande baserad på mjölk’ the following entry is inserted after the entry for French:

                                          ‘—

                                             in Croatian: “početna mliječna hrana za dojenčad” and “prijelazna mliječna hrana za dojenčad”,’.


title: Directive 2008/22/EC of the European Parliament and of the Council of 11 March 2008 amending Directive 2004/109/EC on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market, as regards the implementing powers conferred on the Commission

text:
               19.3.2008

               EN

               Official Journal of the European Union

               L 76/50

      DIRECTIVE 2008/22/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 11 March 2008
   amending Directive 2004/109/EC on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market, as regards the implementing powers conferred on the Commission
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Articles 44 and 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Having regard to the opinion of the European Central Bank (2),
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (3),
   Whereas:

               (1)

               Directive 2004/109/EC (4) of the European Parliament and of the Council provides that certain measures are to be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (5).

               (2)

               Decision 1999/468/EC has been amended by Decision 2006/512/EC which introduced the regulatory procedure with scrutiny for the adoption of measures of general scope and designed to amend non-essential elements of a basic instrument adopted in accordance with the procedure referred to in Article 251 of the Treaty, inter alia, by deleting some of those elements or by supplementing the instrument with new non-essential elements.

               (3)

               In accordance with the statement by the European Parliament, the Council and the Commission (6) concerning Decision 2006/512/EC, for the regulatory procedure with scrutiny to be applicable to instruments adopted in accordance with the procedure referred to in Article 251 of the Treaty which are already in force, those instruments must be adjusted in accordance with the applicable procedures.

               (4)

               The Commission should be empowered to adopt the measures necessary for the implementation of Directive 2004/109/EC in order to clarify the technical aspects of some of the definitions provided under that Directive, notably the maximum length of the usual short settlement cycle, the calendar of trading days, the circumstances under which a person should have learnt of the acquisition or disposal of voting rights, the conditions of independence to be respected by market makers and management companies; take account of technical developments in financial markets; clarify the nature of the auditor’s review, to define the minimum content of the condensed set of solo financial statements; elaborate further the procedures for the notification and disclosure of major holdings as well as the procedures for filing regulated information with the competent authority of the issuer’s home Member State; and define minimum standards for the dissemination of regulated information and for the setting up of storage mechanisms. Since those measures are of general scope and are designed to amend non-essential elements of Directive 2004/109/EC, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (5)

               Directive 2004/109/EC provides for a time restriction concerning the implementing powers conferred on the Commission. In their statement concerning Decision 2006/512/EC, the European Parliament, the Council and the Commission stated that Decision 2006/512/EC provides a horizontal and satisfactory solution to the European Parliament’s wish to scrutinise the implementation of instruments adopted under the co-decision procedure and that, accordingly, implementing powers should be conferred on the Commission without time limit. The European Parliament and the Council also declared that they would ensure that the proposals aimed at repealing the provisions in the instruments that provide for a time limit on the delegation of implementing powers to the Commission are adopted as rapidly as possible. Following the introduction of the regulatory procedure with scrutiny, the provision establishing that time restriction in Directive 2004/109/EC should be deleted.

               (6)

               The Commission should, at regular intervals, evaluate the functioning of the provisions concerning the implementing powers conferred on it in order to allow the European Parliament and the Council to determine whether the extent of those powers and the procedural requirements imposed on the Commission are appropriate and ensure both efficiency and democratic accountability.

               (7)

               Directive 2004/109/EC should therefore be amended accordingly.

               (8)

               Since the amendments made to Directive 2004/109/EC by this Directive are technical in nature and concern committee procedure only, they do not need to be transposed by the Member States. It is therefore not necessary to lay down provisions to that effect,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments
   Directive 2004/109/EC is hereby amended as follows:

               1.

               Article 2(3) shall be replaced by the following:
               ‘3.   In order to take account of technical developments on financial markets and to ensure the uniform application of paragraph 1, the Commission shall, in accordance with the procedures referred to in Article 27(2) and (2a), adopt implementing measures concerning the definitions set out in paragraph 1.
               The Commission shall, in particular:

                           (a)

                           establish, for the purposes of paragraph 1(i)(ii), the procedural arrangements in accordance with which an issuer may make the choice of the home Member State;

                           (b)

                           adjust, where appropriate for the purposes of the choice of the home Member State referred to in paragraph 1(i)(ii), the three-year period in relation to the issuer’s track record in the light of any new requirement under Community law concerning admission to trading on a regulated market; and

                           (c)

                           establish, for the purposes of paragraph 1(l), an indicative list of means which are not to be considered as electronic means, thereby taking into account Annex V to 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 (7) in accordance with the regulatory procedure referred to in Article 27(2).

                     The measures referred to in points (a) and (b) of the second subparagraph, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).

               2.

               Article 5(6) shall be amended as follows:

                           (a)

                           in the first subparagraph, the words ‘, in accordance with the procedure referred to in Article 27(2),’ shall be deleted;

                           (b)

                           the third subparagraph shall be replaced by the following:
                           ‘The measures referred to in point (a) shall be adopted in accordance with the regulatory procedure referred to in Article 27(2). The measures referred to in points (b) and (c), designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).
                           Where appropriate, the Commission may also adapt the five-year period referred to in paragraph 1. That measure, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               3.

               Article 9(7) shall be replaced by the following:
               ‘7.   The Commission shall adopt implementing measures in order to take account of technical developments on financial markets and to ensure the uniform application of paragraphs 2, 4 and 5. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).
               The Commission shall specify the maximum length of the ‘short settlement cycle’ referred to in paragraph 4 of this Article, as well as the appropriate control mechanisms by the competent authority of the home Member State. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).
               In addition, the Commission may draw up a list of the events referred to in paragraph 2 of this Article, in accordance with the regulatory procedure referred to in Article 27(2).’;

               4.

               Article 12(8) shall be amended as follows:

                           (a)

                           the words ‘, in accordance with the procedure referred to in Article 27(2),’ shall be deleted;

                           (b)

                           the following subparagraph shall be added:
                           ‘Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               5.

               Article 13(2) shall be amended as follows:

                           (a)

                           the words ‘, in accordance with the procedure referred to in Article 27(2),’ shall be deleted;

                           (b)

                           the following subparagraph shall be added:
                           ‘Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               6.

               Articles 14(2), 17(4) and 18(5) shall each be amended as follows:

                           (a)

                           the words ‘, in accordance with the procedure referred to in Article 27(2),’ shall be deleted;

                           (b)

                           the following sentence shall be added:
                           ‘Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               7.

               Article 19(4) shall be amended as follows:

                           (a)

                           in the first subparagraph, the words ‘, in accordance with the procedure referred to in Article 27(2),’ shall be deleted;

                           (b)

                           the following subparagraph shall be added:
                           ‘The measures referred to in the first and second subparagraphs, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               8.

               Article 21(4) shall be amended as follows:

                           (a)

                           in the first subparagraph, the words ‘in accordance with the procedure referred to in Article 27(2)’ shall be deleted;

                           (b)

                           the following subparagraph shall be added:
                           ‘The measures referred to in the first, second and third subparagraphs, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               9.

               Article 23 shall be amended as follows:

                           (a)

                           paragraph 4 shall be amended as follows:

                                       (i)

                                       the following subparagraph shall be inserted after the first subparagraph:
                                       ‘In the context of point (ii) of the first subparagraph, the Commission shall also adopt implementing measures concerning the assessment of standards relevant to the issuers of more than one country. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

                                       (ii)

                                       the following subparagraph shall be added:
                                       ‘In the context of the previous subparagraph, the Commission shall also adopt implementing measures aimed at establishing general equivalence criteria regarding accounting standards relevant to issuers of more than one country. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

                           (b)

                           paragraph 5 shall be amended as follows:

                                       (i)

                                       the words ‘, in accordance with the procedure referred to in Article 27(2),’ shall be deleted;

                                       (ii)

                                       the following sentence shall be added:
                                       ‘Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

                           (c)

                           in paragraph 7, the following subparagraph shall be added:
                           ‘The Commission shall also adopt implementing measures aimed at establishing general equivalence criteria for the purpose of the first subparagraph. Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 27(2a).’;

               10.

               Article 27 shall be amended as follows:

                           (a)

                           the following paragraph shall be inserted:
                           ‘2a.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.’;

                           (b)

                           paragraphs 3 and 4 shall be replaced by the following:
                           ‘3.   By 31 December 2010, and, thereafter, at least every three years, the Commission shall review the provisions concerning its implementing powers and present a report to the European Parliament and to the Council on the functioning of those powers. The report shall examine, in particular, the need for the Commission to propose amendments to this Directive in order to ensure the appropriate scope of the implementing powers conferred on the Commission. The conclusion as to whether or not amendment is necessary shall be accompanied by a detailed statement of reasons. If necessary, the report shall be accompanied by a legislative proposal to amend the provisions conferring implementing powers on the Commission’.

         Article 2
   Entry into force
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 3
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 11 March 2008.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         J. LENARČIČ

      (1)  OJ C 161, 13.7.2007, p. 45.

      (2)  OJ C 39, 23.2.2007, p. 1.

      (3)  Opinion of the European Parliament of 14 November 2007 (not yet published in the Official Journal) and Council Decision of 3 March 2008.

      (4)  OJ L 390, 31.12.2004, p. 38.

      (5)  OJ L 184, 17.7.1999, p. 23. Decision as amended by Decision 2006/512/EC (OJ L 200, 22.7.2006, p. 11).

      (6)  OJ C 255, 21.10.2006, p. 1.

      (7)  OJ L 204, 21.7.1998, p. 37. Directive as last amended by Council Directive 2006/96/EC (OJ L 363, 20.12.2006, p. 81).’;


Avis juridique important

|

31976L0681

Commission Directive 76/681/EEC of 22 July 1976 amending the Directive of 1 February 1972 fixing the standard rates of yield for certain inward processing operations

Official Journal L 231 , 21/08/1976 P. 0015 - 0018

+++++( 1 ) OJ NO L 58 , 8 . 3 . 1969 , P . 1 .  ( 2 ) OJ NO L 24 , 30 . 1 . 1976 , P . 58 .  ( 3 ) OJ NO L 45 , 21 . 2 . 1972 , P . 10 .  ( 4 ) OJ NO L 306 , 26 . 11 . 1975 , P . 3 .  COUNCIL DIRECTIVE OF 22 JULY 1976 AMENDING THE DIRECTIVE OF 1 FEBRUARY 1972 FIXING STANDARD RATES OF YIELD FOR CERTAIN INWARD PROCESSING OPERATIONS ( 76/681/EEC )  THE COMMISSION OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,  HAVING REGARD TO THE COUNCIL DIRECTIVE OF 4 MARCH 1969 ON THE HARMONIZATION OF PROVISIONS LAID DOWN BY LAW , REGULATION OR ADMINISTRATIVE ACTION IN RESPECT OF INWARD PROCESSING ( 1 ) , AS LAST AMENDED BY THE DIECTIVE OF 18 DECEMBER 1975 ( 2 ) , AND IN PARTICULAR ARTICLE 12 THEREOF ,  WHEREAS ANNEX I TO THE COMMISSION DIRECTIVE OF 1 FEBRUARY 1972 FIXING STANDARD RATES OF YIELD FOR CERTAIN INWARD PROCESSING OPERATIONS ( 3 ) , FIXES , IN PARTICULAR , STANDARD RATES OF YIELD FOR THE PROCESSING OF CERTAIN AGRICULTURAL PRODUCTS INTO SORBITOL AS PART OF THE INWARD ARRANGEMENTS ;  WHEREAS CERTAIN VARIETIES OF SORBITOL HAVE BEEN EXCLUDED FROM SUBHEADING 29.04 C III OF THE COMMON CUSTOMS TARIFF AND HAVE BEEN CLASSIFIED UNDER SUBHEADING 38.19 T BY COUNCIL REGULATION NO 3058/75 OF 24 NOVEMBER 1975 AMENDING REGULATIONS ( EEC ) NO 1059/69 , ( EEC ) NO 1060/69 , ( EEC ) NO 2682/72 , ( EEC ) NO 2727/75 , ( EEC ) NO 3330/74 , ( EEC ) NO 765/68 AND ( EEC ) NO 950/68 AS REGARDS THE CLASSIFICATION IN THE COMMON CUSTOMS TARIFF OF CERTAIN TYPES OF SORBITOL ( 4 ) ;  WHEREAS SUBHEADING 38.19 T SHOULD BE INCLUDED IN ANNEX I TO THE DIRECTIVE OF 1 FEBRUARY 1972 , WHILE MAINTAINING THE STANDARD RATES OF YIELD WHICH HAVE APPLIED SO FAR TO THESE GOODS ;  WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE COMMITTEE FOR CUSTOMS PROCESSING SYSTEMS ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  ANNEX I TO THE COMMISSION DIRECTIVE OF 1 FEBRUARY 1972 IS HEREBY REPLACED BY THE ANNEX HERETO .  ARTICLE 2  1 . MEMBER STATES SHALL BRING INTO FORCE THE MEASURES REQUIRED TO COMPLY WITH THIS DIRECTIVE NOT LATER THAN 30 SEPTEMBER 1976 AND SHALL NOTIFY THE COMMISSION THEREOF IMMEDIATELY .  2 . THE COMMISSION SHALL COMMUNICATE THE INFORMATION TO THE OTHER MEMBER STATES .  ARTICLE 3  THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .  DONE AT BRUSSELS , 22 JULY 1976 .  FOR THE COMMISSION  FINN GUNDELACH  MEMBER OF THE COMMISSION  ANNEXES SEE OJ NO L 231 OF 21 . 8 . 1976 .


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31989L0394

Council Directive 89/394/EEC of 14 June 1989 amending for the third time Directive 75/726/EEC on the approximation of the laws of the Member States concerning fruit juices and certain similar products

Official Journal L 186 , 30/06/1989 P. 0014 - 0016

COUNCIL DIRECTIVE of 14 June 1989 amending for the third time Directive 75/726/EEC on the approximation of the laws of the Member States concerning fruit juices and certain similar products (89/394/EEC) THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Directive 75/726/EEC (4), as last amended by the Act of Accession of Spain and Portugal, makes no provision for the possibility of producing fruit nectars without the addition of sugar; whereas in view of changes in eating habits the existence  of such products should be envisaged;  Whereas it is not possible to extract the juice of certain tropical fruits without the pulp; whereas it therefore appears necessary to provide for the possible use of fruit purée in the manufacture of certain fruit juices;  Whereas the option of replacing all sugars by honey within the limits laid down should be extended to all fruit nectars, and the option of using sugars and honey together in certain nectars should be removed;  Whereas the sweetening of certain concentrated fruit juices should be authorized only if they are intended for direct sale to the consumer, since the sweetening may not exceed the permitted limits at the final stage,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 75/726/EEC is hereby amended as follows:   1.  Article 1 (7) shall be replaced by the following:  '7.  Fruit nectar:  (a)  The unfermented but fermentable product obtained by the addition of water and sugars to  fruit juice, concentrated fruit juice, fruit purée, concentrated fruit purée or to a mixture of these products which also conforms with the Annex.  (b)  However, it may be decided under the procedure in Article 14 that, in the case of certain fruits whose juice has a high natural sugar content, nectar may be produced from them without the addition of sugars.'  2.  Article 4 (1) (a) shall be replaced by the following:  '(a)  the mixing of one or more kinds of fruit juices and/or fruit purées (as defined in Article 1 (2) and (5));'.   3.  Article 7 (2) (c) and (d) shall be replaced by the following:  '(c)  the total replacement of sugars with honey, within the 20 % limit specified in (a);  '(d)  in the case of the production of the fruit nectars referred to in Article 3 (2) (c) which are obtained from apples, pears or peaches or a mixture of these fruits, the addition of citric acid in a quantity not greater than five grams per litre of  finished product; the citric acid may, however, be replaced totally or partially by an equivalent quantity of lemon juice.'  4.  Article 7 (3) and (4) shall be deleted.   5.  Article 8 (a) shall be replaced by the following:  '(a)  the treatments and processes listed in Article 4 with the exception of the provisions in paragraph 2 (a). However, the addition of sugars provided for in that point (a) shall be authorized only for prepackaged concentrated fruit juices intended  for the ultimate consumer and provided that the sweetening is indicated in the description; in that case the total quantity of sugars added expressed in relation to the volume of the juice "obtained from concentrated . . ." may not exceed the limit  authorized in Article 4 (2) (a) (i) and (ii).  For a period of 10 years from 14 June 1989, sugar may be added to concentrated orange juice not intended for the ultimate consumer up to a maximum quantity expressed as dry matter of 15 grams per litre for the purpose of correcting it.  In the case referred to in the second subparagraph the processor must be informed of the addition of sugar, in accordance with trade practices.  On expiry of the period referred to in the second subparagraph, the Council shall decide, acting on a proposal from the Commission, whether to continue the exception in the said subparagraph;'.   6.  The following Article shall be inserted:  'Article 11b The amendments necessary to adapt Articles 4, 7, 8 and 9 and the Annex to technical progress shall be adopted in accordance with the procedure laid down in Article 14, with the exception of those concerning additives.'  7.  Article 13 shall be replaced by the following:  'Article 13 The identity and purity criteria for the additives and treatment agents referred to in Articles 4 and 7 shall be determined where necessary in accordance with the procedure laid down in Article 14.'  8.  Article 14 shall be replaced by the following:  'Article 14 1.  Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter to the Standing Committee for Foodstuffs, either on his own initiative or at the request of the representative of a Member State.  2.  The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter.  The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the  Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.  3.  (a)  The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.  (b)  If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a  qualified majority.  If, on the expiry of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.'  9.  Article 15 shall be deleted.  10.  Article 16 (1) (f) shall be deleted.  11.  Article 16 (2) shall be replaced by the following:  '2.  The derogations regarding additives provided for in paragraph 1 (c), (d), (e), (g) and (h) shall cease to apply once the relevant rules become applicable at Community level.' 12.  The Annex shall be replaced by the Annex hereto.  Article 2 The Member States shall take the necessary measures to comply with this Directive. They shall forthwith inform the Commission thereof.  These measures shall be applied so as to:  - permit trade in products complying with this Directive not later than 14 June 1990,  - prohibit trade in products not complying with this Directive not later than 14 June 1991.  Article 3 This Directive is addressed to the Member States.   Done at Luxembourg, 14 June 1989.  For the Council The President P. SOLBES  (1) OJ No C 24, 31. 1. 1987, p. 12. (2) OJ No C 122, 9. 5. 1988, p. 78, and OJ No C 120, 16. 5. 1989. (3) OJ No C 150, 2. 6. 1987, p. 16. (4) OJ No L 311, 1. 12. 1975, p. 40.   ANNEX    SPECIAL PROVISIONS RELATING TO FRUIT NECTARS   III.  Fruit nectars made from Minimum total acid content expressed as tartaric acid (g/l of finished product) Minimum juice and/or purée content (% by weight of finished product) III.  Fruits with acid juice unpalatable in the natural state   Passion fruit (Passiflora edulis) 8 (¹) 25 Quito naranjillos (Solanum quitoense) 5 (¹) 25 Blackcurrants 8 (¹) 25 Whitecurrants 8 (¹) 25 Redcurrants 8 (¹) 25 Gooseberries 9 (¹) 30 Sallow-thorn berries (Hippophaë) 9 (¹) 25 Sloes 8 (¹) 30 Plums 6 (¹) 30 Quetsches 6 (¹) 30 Rowanberries 8 (¹) 30 Rose hips (fruits of Rosa sp.) 8 (¹) 40 Sour cherries 8 (¹) 35 Other cherries 6 (¹) 40 Bilberries 4 (¹) 40 Elderberries 7 (¹) 50 Raspberries 7 (¹) 40 Apricots 3 (¹) 40 Strawberries 5 (¹) 40 Mulberries/blackberries 6 (¹) 40 Cranberries 9 (¹) 30 Quinces 7 (¹) 50 Lemons and limes -(¹)  25 Other fruits belonging to this category -(¹)  25 III.  Low-acid, pulpy or highly flavoured fruits with juice unpalatable in the natural state   Mangoes -(¹)  35 Bananas -(¹)  25 Guavas -(¹)  25 Papayas -(¹)  25 Lychees -(¹)  25 Azeroles (Neapolitan medlars) -(¹)  25 Soursop (Annona muricata) -(¹)  25 Bullock's heart or custard apple (Annona reticulata) -(¹)  25 Sugar apples -(¹)  25 Pomegranates -(¹)  25 Cashew fruits -(¹)  25 Spanish plums (Spondia purpurea) -(¹)  25 Umbu (Spondias tuberosa aroda) -(¹)  30 Other fruits belonging to this category -(¹)  25 III.  Fruits with juice palatable in the natural state   Apples 3 (¹) 50 Pears 3 (¹) 50 Peaches 3 (¹) 45 Citrus fruits except lemons and limes 5 (¹) 50 Pineapples 4 (¹) 50 Other fruits belonging to this category -(¹)  50 (¹) Limit not applicable in the case of the product referred to in Article 3 (2) (c).


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31996L0015

Commission Directive 96/15/EC of 14 March 1996 amending Directive 92/76/EEC recognizing protected zones exposed to particular plant health risks in the Community

Official Journal L 070 , 20/03/1996 P. 0035 - 0037

COMMISSION DIRECTIVE 96/15/EC of 14 March 1996 amending Directive 92/76/EEC recognizing protected zones exposed to particular plant health risks in the Community THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 77/93/EEC of 21 December 1976 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), as last amended by Commission Directive 95/66/EC (2), and in particular the first subparagraph of Article 2 (1) (h) thereof,Whereas under Commission Directive 92/76/EEC (3), as last amended by Directive 95/65/EC (4), certain zones in the Community were recognized as 'protected zones` in respect of certain harmful organisms for a period expiring on 1 April 1996;Whereas, based on recent new information provided by Greece, it appears that it is no longer appropriate to maintain the 'protected zone` recognized for Greece in respect of Ips typographus Heer, because this organism seems to be present locally;Whereas also from new information provided by Greece, Italy and Spain it appears that it is no longer appropriate to maintain the 'protected zones` recognized, for Greece in respect of Phytophthora cinnamomi Rands, for Italy in respect of Curtobacterium flaccumfaciens pv. flaccumfaciens (Hedges) Collins and Jones, and for Spain in respect of Dendroctonus micans Kugelan, Ips amitinus Eichhof, Ips cembrae Heer, Ips duplicatus Sahlberg and Ips typographus Heer to take account of the concern in relation to the production and distribution of the relevant host plants of these organisms; whereas, also the extent of the protected zones recognized for Spain in respect of Anthonomus grandis Boh. and for Spain and Portugal in respect of Sternochetus mangiferae Fabricius should be modified to take account of the concern in relation to the relevant production areas of Gossypium spp. and Mangifera spp. respectively;Whereas from new information supplied by France a protected zone should be recognized for France in respect of Beet necrotic yellow vein virus;Whereas, from information supplied by the United Kingdom and from the survey monitoring information gathered by Commission experts it appears that the provisional recognition of the protected zone for the United Kingdom in respect of Beet necrotic yellow vein virus should be extended for a further period to enable the responsible official bodies of the United Kingdom to complete the information on the distribution of Beet necrotic yellow vein virus and to complete their efforts for the eradication of this harmful organism in the East Anglian area of the United Kingdom;Whereas, furthermore, from information supplied by Ireland and Italy and from survey monitoring information gathered by Commission experts it appears that the provisional recognition of the protected zones for Ireland and Italy in respect of Erwinia amylovora (Burr.) Winsl. et al. should be extended for a further period to enable the responsible official bodies of Ireland and Italy to complete their efforts to eradicate the harmful organism in the area around Dublin and in the region of Apulia, respectively;Whereas it should be established that the extension of the recognition beyond the dates referred to in Article 1, and any amendment to the list of protected zones referred to in Article 1, shall be made in accordance with the procedure laid down in Article 16a of Directive 77/93/EEC, taking into account the results of appropriate surveys based on Community conditions and monitored by Commission experts;Whereas in absence of any extension of the recognition beyond the dates referred to in Article 1, the relevant protected zones cease on these dates, to be 'protected zones` within the meaning of Directive 77/93/EEC, including its Annexes;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1 Directive 92/76/EEC is hereby amended as follows:1. Article 1, first subparagraph shall be replaced as follows:'The zones in the Community listed in the Annex are hereby recognized as "protected zones" referred to in the first subparagraph of Article 2 (1) (h) of Directive 77/93/EEC, in respect of harmful organism(s) listed against their names in the Annex; in the case of points (a) 17, (b) 3, (c) 5 and (d) 3, the said zones are recognized for a period expiring on 1 April 1996; in the case of (b) 2 for Ireland and the region of Apulia in Italy the said zones are recognized until 31 December 1997; and in the case of point (d) 1, for the United Kingdom, the said zone is recognized until 1 November 1999, and for France, the zone is recognized until 31 December 1997.`2. In Article 2, the word 'date` shall be replaced by the word 'dates`.3. The Annex shall be amended as indicated in the Annex to this Directive.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive with effect from 1 April 1996. They shall immediately inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The procedure for such a reference shall be adopted by Member States.2. Member States shall immediately communicate to the Commission the essential provisions of domestic law which they adopt in the field governed by this Directive. The Commission shall inform the other Member States thereof.Article 3 This Directive shall enter into force on the day following its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 14 March 1996.For the CommissionFranz FISCHLERMember of the Commission(1) OJ No L 26, 31. 1. 1977, p. 20.(2) OJ No L 308, 21. 12. 1995, p. 77.(3) OJ No L 305, 21. 10. 1992, p. 12.(4) OJ No L 308, 21. 12. 1995, p. 75.ANNEX 1. In point (a) 1, in the right hand column 'Greece, Spain` is replaced by 'Greece, Spain (Andalucia, Catalonia, Extremadura, Murcia, Valencia)`.2. In point (a) 4, in the right hand column 'Spain` is deleted.3. In points (a) 7, 8 and 9, in the right hand column 'Spain` is deleted.4. In point (a) 11, in the right hand column 'Greece, Spain` is deleted.5. In point (a) 15, the right hand column is altered as follows:'Spain (Granada and Malaga), Portugal (Alentejo, Algarve and Madeira)`.6. In point (b) 1, in the right hand column 'Italy` is deleted.7. The point (c) 4 is deleted.8. In point (d) 1 the right hand column is replaced as follows:'Denmark, Finland, France (Brittany), Ireland, Portugal (Azores), Sweden, United Kingdom`.