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31982L0532

Council Directive 82/532/EEC of 19 July 1982 amending Directive 71/118/EEC on health problems affecting trade in fresh poultrymeat

Official Journal L 234 , 09/08/1982 P. 0012 - 0013 Finnish special edition: Chapter 3 Volume 15 P. 0136  Swedish special edition: Chapter 3 Volume 15 P. 0136

COUNCIL DIRECTIVE of 19 July 1982 amending Directive 71/118/EEC on health problems affecting trade in fresh poultrymeat (82/532/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 43 and 100 thereof,  Having regard to the proposals from the Commission (1),  Having regard to the opinions of the European Parliament (2),  Having regard to the opinions of the Economic and Social Committee (3),  Whereas a Commission proposal was forwarded to the Council on 19 March 1981 in order to amend certain provisions of Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (4), as last amended by Directive 81/578/EEC (5) ; whereas the object of this proposal is in particular to amend and clarify the inspection rules, to settle the problem of the financing of inspection costs and to postpone the date of expiry of the derogation mentioned in the third indent of Article 16a(a) concerning the slaughtering and evisceration of poultry, in order to extend this derogation from 15 August 1981 to 15 August 1986, in view of the fact that in certain Member States the production of partially eviscerated poultrymeat is still considerable;  Whereas Directive 71/118/EEC limited in particular use of the chilling of fresh poultrymeat by means of immersion in water, carried out in accordance with the said Directive, to poultry carcases which, once chilled, are immediately frozen or deep-frozen ; whereas that Directive afforded Member States the option of granting derogations from this provision ; whereas the derogations granted expire on 15 August 1982;  Whereas, moreover, a Commission proposal was forwarded to the Council on 14 February 1979 aimed at extending the use of the chilling process to carcases intended for marketing in a chilled state;  Whereas, having regard to the progress made on these various proposals it is necessary to postpone, as a precaution, the date of expiry of the abovementioned derogations until the adoption of Community rules on inspection costs arising from Directive 71/118/EEC, on the determination of the specific conditions of hygiene under which the so-called "counter-flow" chilling process may be applied to fresh poultrymeat which is not immediately frozen or deep-frozen, and on the production and inspection of partially eviscerated poultry, it being understood that this date may not be later than 31 March 1984,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Directive 71/118/EEC is hereby amended as follows:  1. In Article 14 (2) the last sentence of the first subparagraph shall be replaced by the following:  "These derogations shall apply until the entry into force of Community rules on the inspection costs arising from this Directive and the determination of the specific conditions of hygiene under which the process which complies with the conditions laid down in points 28a and 28b of Annex I, Chapter V, may be applied to carcases which are neither immediately frozen or deep-frozen. The derogations may not apply beyond 31 March 1984".   2. In Article 16a point (a), the third indent shall be replaced by the following:  "- a further time limit in order to comply with the provisions on slaughtering and evisceration laid down in Chapter IV of Annex I. This time limit may be extended not later than the entry into force of Community rules on the inspection costs arising from this Directive, and on the production and inspection of  (1) OJ No C 65, 9.3.1979, p. 5 and OJ No C 97, 29.4.1981, p. 12. (2) OJ No C 140, 5.6.1979, p. 180, OJ No C 234, 14.9.1981, p. 99 and OJ No C 87, 5.4.1982, p. 116. (3) OJ No C 247, 1.10.1979, p. 16, OJ No C 230, 19.9.1981, p. 24 and OJ No C 252, 2.10.1981, p. 11. (4) OJ No L 55, 8.3.1971, p. 23. (5) OJ No L 209, 29.7.1981, p. 35.  partially eviscerated poultry. It may not be extended beyond 31 March 1984."      Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 15 August 1982. They shall forthwith inform the Commission thereof.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 19 July 1982.  For the Council  The President  B. WESTH


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31984L0318

Commission Directive 84/318/EEC of 23 May 1984 laying down provisions for the application of Articles 13 and 14 of Directive 69/73/EEC as regards release for free circulation of compensating products under inward processing

Official Journal L 166 , 26/06/1984 P. 0019 - 0022 Spanish special edition: Chapter 02 Volume 11 P. 0011  Portuguese special edition Chapter 02 Volume 11 P. 0011

*****COMMISSION  DIRECTIVE  of 23 May 1984  laying down provisions for the application of Articles 13 and 14 of Directive 69/73/EEC as regards release for free circulation of compensating products under inward processing  (84/318/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 69/73/EEC 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 Directive 83/89/EEC (2), and in particular Article 28 thereof,  Whereas Commission Directive 73/95/EEC (3), as amended by Directive 75/681/EEC (4), laid down certain implementing measures in respect of Articles 13 and 14 of Directive 69/73/EEC, in particular setting out the provisions for administrative cooperation between the Member States necessary to ensure the collection of customs duties, charges having equivalent effect, agricultural levies and other charges provided for in the framework of the common agricultural policy or under specific arrangements applicable by virtue of Article 235 of the Treaty to certain goods resulting from the processing of agricultural products, where the authorized entry for free circulation of the compensating products, intermediate products or goods in the unaltered state takes place in a Member State other than that where the authorization was granted;  Whereas, in accordance with Article 10 (1) of the Treaty, entry for free circulation implies not only the collection of customs duties and charges having equivalent effect, where there is no drawback, either partial or total of these duties and charges, but equally that the import formalities have been complied with including the application of any specific commercial policy measure in force;  Whereas these specific measures do not apply where the imported goods are placed under the inward processing arrangements on condition that they are later re-exported; whereas the measures should be applicable when the goods enter into free circulation, either in the unaltered state or after processing; whereas it should be specified that the measures are intended to apply to goods placed under the inward processing arrangements which are in force at the time of their entry for free circulation;  Whereas where entry for free circulation is granted by the competent authorities of a Member State, other than that in which the inward processing arrangements were authorized because the products or goods are situated in that Member State, an exchange of information between the administrative authorities concerned in relation to the collection of customs duties and other import charges is already provided for in Directive 73/95/EEC; whereas, on the other hand, those rules do not provide for an adequate exchange of information where entry for free circulation also  involves the application of specific measures of commercial policy as regards goods imported under inward processing arrangements, so that therefore it is necessary to increase the range of information which may be exchanged by means of the INF 1 information sheet;  Whereas authorization for entry for free circulation, which may be granted by the competent authorities of the Member State where the goods or products are situated, is subject to the application of specific commercial policy measures in the Member State where the inward processing arrangements were authorized;  Whereas, for reasons of clarity, it is desirable to incorporate the provisions of Directive 73/95/EEC, amended as appropriate, and the new provisions in a single text;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for Customs Processing Arrangements,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. This Directive lays down certain provisions for the application of Articles 13 and 14 of Directive 69/73/EEC, hereinafter referred to as 'the basic Directive', where the circumstances justify the entry for free circulation of compensating products, intermediate products or goods in the unaltered state in a Member State other than that in which the said arrangements were authorized.  2. For the purposes of this Directive:  - 'specific measures of commercial policy' means non-tariff measures established in the framework of the common commercial policy by Community provisions regarding arrangements applicable to the importation of goods, such as protective measures, quantitative restrictions or limits and import prohibitions,  - 'import duties' means any customs duties and charges having equivalent effect as well as agricultural levies and other charges on importation provided for within the framework of the common agricultural policy or specific arrangements applicable by virtue of Article 235 of the Treaty to certain goods resulting from the processing of agricultural products.  Article 2  1. Where compensating products, intermediate products or goods in the unaltered state are placed, for the purpose of their subsequent exportation, under the Community external transit procedure, the box reserved for the description of goods on the Community transit document must contain one of the following endorsements:  - 'I.P. goods'  - 'A.F.-varer'  - 'A.V.-Waren'  - 'Emporévmata T.E.'  - 'Marchandises P.A.'  - 'Merci P.A.'  - 'A.V.-goederen'  2. Where goods placed under the inward processing arrangements are the subject of specific measures of commercial policy, in cases where such measures continue to be applicable at the time when these goods are placed under the Community external transit procedure, whether in the unaltered state or in the form of compensating or intermediate products, the endorsement mentioned in paragraph 1 must be supplemented by one of the following endorsements:  - 'Commercial policy'  - 'Handelspolitik'  - 'Handelspolitik'  - 'Emporikí Politikí'  - 'Politique commerciale'  - 'Politica commerciale'  - 'Handelspolitiek'  Article 3  The provisions of Article 2 shall also apply where the products and goods which are referred to therein are placed under one of the other international transit arrangements provided for in first subparagraph of Article 7 (1) of Council Regulation (EEC) No 222/77 (1).  In such cases, the endorsements provided for in Article 2 shall be entered on the transit document in question.  Article 4  In cases where the products or goods referred to in Article 2 are placed under a customs arrangement or in a free zone subsequent to the Community external transit procedure, the competent authorities shall reproduce the endorsements provided for in Article 2 which are contained in one of the transit documents provided for in Articles 2 and 3 on the documents proper to the customs arrangements or used in the free zone.  Article 5  The authorization for entry for free circulation of the products or goods referred to in Article 2 (2), to be carried out in a Member State other than that in which the inward processing arrangements were authorized, shall be subject to the application, in the Member  State where the said arrangements were authorized, of specific measures of commercial policy in force in that State for goods placed under inward processing arrangements.  Article 6  1. Where entry for free circulation of the products or goods referred to in Article 2 is requested in a Member State other than that in which the inward processing arrangements were authorized, the information sheet referred to in paragraph 2 shall be used.  2. The information sheet, hereinafter referred to as 'the INF 1 sheet', shall comprise an original and one copy on a form which must conform with the model and the provisions set out in the Annex.  Article 7  1. Where partial or total entry for free circulation of compensating products, intermediate products or goods in the unaltered state referred to in Article 2 is requested in accordance with Articles 14 (b) and 15 of the basic Directive, the competent authorities responsible for permitting entry for free circulation may, by means of an INF 1 sheet, request the competent authorities of the Member State where the inward processing arrangements were authorized, to indicate the import duties to be levied pursuant to Article 16 of the basic Directive.  However, without prejudice to the provisions of paragraph 5, such information must be requested in the event of application of Article 14 (a) of the basic Directive.  2. Where the request for entry for free circulation concerns products or goods as referred to in Article 2 (2), the competent authorities responsible for permitting entry for free circulation shall, by means of the INF 1 sheet countersigned by them, request the competent authorities of the Member State where the inward processing arrangements were authorized to indicate whether the specific measures of commercial policy in force in that State for goods placed under the inward processing arrangements have been applied.  3. The original of the INF 1 sheet shall be transmitted to the competent authorities who authorized the inward processing arrangements, and the copy shall be kept by the competent authorities who countersigned the INF 1 sheet.  Where the INF 1 sheet is used for the application of specific measures of commercial policy, the authorities who receive the INF 1 sheet shall notify the holder of the authorization of the request referred to in paragraph 2.  4. The competent authorities of the Member State to whom the INF 1 sheet is addressed shall supply the information requested and shall return the original. However, the competent authorities shall no longer be obliged to supply such information after the period for the keeping of records has expired.  5. In the event of application of the second subparagraph of paragraph 1, the INF 1 sheet shall also be countersigned by the competent authorities who authorized the inward processing arrangements when the holder of the authorization so requests. In this case, they shall give the original to the holder and keep the copy.  Article 8  Member States shall take the measures necessary to comply with this Directive by 30 September 1984, at which date Directive 73/95/EEC shall be repealed.  Article 9  Member States shall communicate to the Commission provisions which they adopt in implementation of this Directive. The Commission shall inform the other Member States thereof.  Article 10  This Directive is addressed to the Member States.  Done at Brussels, 23 May 1984.  For the Commission  Karl-Heinz NARJES  Member of the Commission  (1) OJ No L 58, 8. 3. 1969, p. 1.  (2) OJ No L 59, 5. 3. 1983, p. 1.  (3) OJ No L 120, 7. 5. 1973, p. 17.  (4) OJ No L 301, 20. 11. 1975, p. 1.  (1) OJ No L 38, 9. 2. 1977, p. 1.  ANNEX  PROVISIONS REGARDING INFORMATION SHEET INF 1  1. The form on which the INF 1 information sheet is to be drawn up shall be printed on white paper free of mechanical pulp, dressed for writing purposes and shall weigh between 40 and 65 g/m2.  2. The size of the form shall be 210 × 297 mm.  3. Member States shall be responsible for having the form printed. The form shall bear an individual serial number.  4. The form shall be printed in one of the official languages of the European Communities designated by the competent authorities of the Member State issuing the sheet. The part of the sheet where the request for information is entered shall be filled in in one of the official languages of the European Communities designated by the competent authorities of the Member State issuing the sheet. The competent authorities of the Member State which is to supply the information or make use of it may request that the information contained in the form submitted to them be translated into the official language, or one of the official languages, of that Member State.  EUROPEAN  COMMUNITY  1 Holder of authorization for inward processing  3 Application to be made to  4 Information to be supplied to  5 Document covering transport of products or goods (1)  £ T1 £ Carnet TIR £ Rhine manifest £ CIM valid as T1  £ T1Ex valid as T1 £ Community transfer note valid as T1  £ other (3)  1.2.3.4.5 //   //   //   //   //   // of  //   //   //  // No  //   //   //   //   //   //   // Day  // Month  // Year  //  Office:  Original  No A 000000  INWARD PROCESSING  INFORMATION SHEET  2 APPLICATION (1)  1.2 // £  // The undersigned, holder of the authorization for inward processing.  // £  // The responsible office shown in box 4 requests the amount of import duties (2) applicable to the goods placed under the inward processing arrangements to be determined and indicated in the case of the authorized entry for free circulation of the products or goods described below.  // £  // The responsible office shown in box 4 requests it to be stated whether the specific measures of commercial policy to which the said goods are liable have been applied.  Place:  1.2.3.4.5 //   //   //   //   //   // Date:  //   //   //  // Official stamp  //   //   //   //   //   //   // Day  // Month  // Year  //  Signature  6 Marks and numbers - Number and kind of packages - Description of products or goods  7 Net quantity  A  6 Marks and numbers - Number and kind of packages - Description of products or goods  7 Net quantity  B  8 INFORMATION SUPPLIED BY THE COMPETENT AUTHORITIES  9 Boxes  10 Amounts determined as  11 Currency  12 Customs duties  13 Charges having equivalent effect  14 Other charges (4)  A  B  15 Application of specific measures of commercial policy  16 Remarks  A  £ YES  £ NO, for following reasons:  B  £ YES  £ NO, for following reasons:  17 Place:  1.2.3.4.5 //   //   //   //   //   // Date:  //   //   //  // Official stamp  //   //   //   //   //   //   // Day  // Month  // Year  //  Signature  (1) The appropriate box to be indicated like this £ × .  (2) Customs duties, charges having equivalent effect, agricultural levies and other charges provided for under the common agricultural policy or specific arrangements applicable to certain goods resulting from processed agricultural products.  (3) Specify as appropriate, for example, ship's manifest.  (4) Specify as appropriate in box 16, for example, agricultural levy.  Consult notes overleaf before completing this form  Reverse  of original  18 REQUEST FOR VERIFICATION  The responsible office shown below requests that the authenticity of this information sheet and the accuracy of the information it contains be verified.  Place:  1.2.3.4.5 //   //   //   //   //   // Date:  //   //   //  // Official stamp  //   //   //   //   //   //   // Day  // Month  // Year  //  Signature  Responsible office  19 RESULT OF VERIFICATION  The control carried out by the responsible office shown below confirms that this information  sheet (1) £ has been correctly stamped by the competent authorities indicated and that the information it contains is accurate;  £ gives rise to the remarks annexed hereto.  Place:  1.2.3.4.5 //   //   //   //   //   // Date:  //   //   //  // Official stamp  //   //   //   //   //   //   // Day  // Month  // Year  //  Signature  Responsible office  (1) The appropriate box to be indicated like this £ ×    NOTES  A. General notes  1. The part of the sheet requesting information (boxes 1 to 7) shall be filled in either by the holder of the authorization for inward processing or by the office requesting the information.  2. The form must be filled in so that it is legible and indelible, preferably using a typewriter. It shall not contain any erasures or overwritten words. Corrections should be made by crossing out the wrong words and adding further particulars, if necessary. Corrections must be approved by the person filling in the sheet and endorsed by the competent authorities.  3. Where the INF 1 information sheet is used solely to indicate the amount of import duties, box 15 must be crossed through.  B. Special notes referring to the relevant box numbers  1. Give the full name and address including the postal code, if any, and the name of the Member State. This item is left blank when the application is made by the competent authorities of the Member State requesting the information.  3. Give the full name and address including the postal code, if any, and the name of the Member State, of the competent authority.  4. Give the full name and address including postal code, if any, and the name of the Member State of the competent authority requesting the information. This item is left blank when the application is made by the holder of the authorization for inward processing.  6. Give the number, kind, marks and numbers of packages. In the case of unpackaged goods or products, give the number of objects, or if appropriate, insert 'bulk'.  Give the usual trade description of the products or goods or their tariff description. The description must correspond to that used in the documents indicated in item 5. The quantity must be expressed in units of the metric system: kg net, litres, m2, etc.  10. The amounts shall be entered in national currency, one figure per small box, the last two boxes being reserved for fractions of a unit, if any.  11. National currencies shall be indicated by the following signs:  1.2 // - FB  // for Belgian francs,  // - DM  // for German marks,  // - FF  // for French francs,  // - LI  // for Italian lire,  // - LF  // for Luxembourg francs,  // - FL  // for Dutch guilders,  // - KR  // for Danish kroner,  // - I£  // for Irish pounds,  // - £  // for pounds sterling,  // - DR  // for Greek drachmas.


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31974L0181

Sixth Commission Directive 74/181/EEC of 26 February 1974 amending the Annexes of the Council Directive of 23 November 1970 concerning additives in feedingstuffs

Official Journal L 094 , 04/04/1974 P. 0016 - 0017

++++SIXTH COMMISSION DIRECTIVE  OF 26 FEBRUARY 1974  AMENDING THE ANNEXES OF THE COUNCIL DIRECTIVE OF 23 NOVEMBER 1970 CONCERNING ADDITIVES IN FEEDINGSTUFFS   ( 74/181/EEC )  THE COMMISSION OF THE EUROPEAN COMMUNITIES ,  HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ;  HAVING REGARD TO THE COUNCIL DIRECTIVE OF 23 NOVEMBER 1970 ( 1 ) , CONCERNING ADDITIVES IN FEEDINGSTUFFS AS LAST AMENDED BY THE FIFTH COMMISSION DIRECTIVE OF 26 FEBRUARY 1974 AND PARTICULARLY ARTICLE 6 ( 1 ) ( A ) THEREOF ;  WHEREAS THE PROVISIONS OF THE ABOVEMENTIONED DIRECTIVE PROVIDE FOR THE CONTENT OF THE ANNEXES TO BE CONSTANTLY AMENDED DUE TO THE DEVELOPMENT OF SCIENTIFIC AND TECHNICAL KNOWLEDGE ;  WHEREAS COMMUNITY PROVISIONS PROHIBIT , TO A LARGE EXTENT , THE COLOURATION OF FEEDINGSTUFFS ; WHEREAS IN ANY CASE COLOURING AGENTS TOLERATED IN FEEDINGSTUFFS DUE TO THE NECESSITY TO DENATURE CERTAIN BASIC COMPONENTS SHOULD NOT HAVE AN UNFAVOURABLE EFFECT ON THE ANIMAL PRODUCTS RESULTING THEREFROM ;  WHEREAS , FURTHERMORE , THERE IS NO REASON TO OPPOSE THE PRESENCE OF COLOURING AGENTS IN FEEDINGSTUFFS INTENDED FOR DOGS AND CATS IN THE CASE OF ADDITIVES AUTHORIZED FOR THE COLOURATION OF FOODSTUFFS UNDER COMMUNITY RULES ;  WHEREAS THE MEASURES PROVIDED FOR IN THIS DIRECTIVE ARE IN ACCORDANCE WITH THE OPINION OF THE STANDING COMMITTEE FOR FEEDINGSTUFFS ,  HAS ADOPTED THIS DIRECTIVE :  ARTICLE 1  THE FOLLOWING TEXT SHALL BE SUBSTITUTED FOR THE TEXT OF ANNEX I PART F POINT 2 OF THE COUNCIL DIRECTIVE OF 23 NOVEMBER 1970 , CONCERNING ADDITIVES IN FEEDINGSTUFFS :  EEC NO*ADDITIVES*CHEMICAL FORMULA , DESCRIPTION*SPECIES OF ANIMAL*MAXIMUM AGE*PPM OF COMPLETE FEEDINGSTUFFS*OTHER PROVISIONS*  *****MINIMUM CONTENT*MAXIMUM CONTENT**  *2 . ALL OTHER SUBSTANCES AUTHORIZED FOR COLOURING FOODSTUFFS BY COMMUNITY RULES**A ) ALL SPECIES OF ANIMALS WITH THE EXCEPTION OF DOGS AND CATS* - * - * - *PERMITTED IN ANIMAL FEEDINGSTUFF ONLY : *  *******A ) IN THE PROCESSED PRODUCTS OF*  *******I ) WASTE PRODUCTS OF FOODSTUFFS ; *  *******II ) CEREALS OR MANIOC FLOUR DENATURED BY MEANS OF PERMITTED AND APPROPRIATE COLOURING AGENTS ; OR*  *******III ) OTHER BASE SUBSTANCES DENATURED BY MEANS OF PERMITTED AND APPROPRIATE AGENTS OR COLOURED DURING TECHNICAL PREPARATION TO ENSURE THE NECESSARY IDENTIFICATION DURING MANUFACTURE ; AND*  *******B ) IN COMPLIANCE WITH THE CONDITIONS LAID DOWN IN RESPECT OF THESE SUBSTANCES BY COMMUNITY RULES . *  ***B ) DOGS AND CATS* - * - * - *COMPLIANCE WITH THE CONDITIONS LAID DOWN IN RESPECT OF THESE SUBSTANCES BY COMMUNITY RULES*  ARTICLE 2  MEMBER STATES SHALL , NOT LATER THAN 1 JUNE 1974 , BRING INTO FORCE THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH THIS DIRECTIVE . THEY SHALL FORTHWITH INFORM THE COMMISSION THEREOF .  ARTICLE 3  THIS DIRECTIVE IS ADDRESSED TO ALL MEMBER STATES .  DONE AT BRUSSELS , 26 FEBRUARY 1974 .  FOR THE COMMISSION  THE PRESIDENT  FRANCOIS-XAVIER ORTOLI  ( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .


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31998L0066

Commission Directive 98/66/EC of 4 September 1998 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (Text with EEA relevance)

Official Journal L 257 , 19/09/1998 P. 0035 - 0036

COMMISSION DIRECTIVE 98/66/EC of 4 September 1998 amending Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), as amended by European Parliament and Council Directive 94/34/EC (2), and in particular Article 3(3)(a) thereof,After consulting the Scientific Committee on Food,Whereas European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (3), as amended by Directive 96/83/EC (4), lists those substances which may be used as sweeteners in foodstuffs;Whereas Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (5) sets out the purity criteria for the sweeteners mentioned in Directive 94/35/EC;Whereas it is necessary, in the light of technical progress, to amend the purity criteria set out in Directive 95/31/EC for isomalt (E 953); whereas it is consequently necessary to adapt that Directive;Whereas it is necessary to take into account the specifications and analytical techniques for sweeteners as set out in the Codex Alimentarius by the Joint FAO/WHO Expert Committee on Food Additives (JECFA);Whereas food additives, prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or different from those mentioned in this Directive, shall be submitted for evaluation by the Scientific Committee on Food with a view to full evaluation with emphasis on the purity criteria;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 In the Annex to Directive 95/31/EC, the text concerning E 953 - isomalt is replaced by the text in the Annex to this Directive.Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the Directive before 1 July 1999. They shall immediately inform the Commission thereof.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 4 September 1998.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 40, 11. 2. 1989, p. 27.(2) OJ L 237, 10. 9. 1994, p. 1.(3) OJ L 237, 10. 9. 1994, p. 3.(4) OJ L 48, 19. 2. 1997, p. 16.(5) OJ L 178, 28. 7. 1995, p. 1.ANNEX >TABLE>


title: Commission Directive 2008/64/EC of 27 June 2008 amending Annexes I to IV to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community

text:
               28.6.2008

               EN

               Official Journal of the European Union

               L 168/31

      COMMISSION DIRECTIVE 2008/64/EC
   of 27 June 2008
   amending Annexes I to IV to Council Directive 2000/29/EC on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard 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 (1), and in particular points (c) and (d) of the second paragraph of Article 14 thereof,
   After consulting the Member States concerned,
   Whereas:

               (1)

               Directive 2000/29/EC provides for certain measures against the introduction into the Member States from other Member States or third countries of organisms which are harmful to plants or plant products. It also provides for certain zones to be recognised as protected zones.

               (2)

               From information supplied by Member States, it has been determined that only certain plants for planting of Dendranthema (DC.) Des Moul, Dianthus L., Pelargonium l'Hérit. ex Ait. and Solanaceae present a risk of spreading of Heliothis armigera (Hübner). Since the risk of spreading of that organism is limited to those plants, that organism should be deleted from Annex I to Directive 2000/29/EC, which imposes a general ban, and included instead in Annex II to that Directive, which imposes a ban only with respect to specific plants presenting a risk. Furthermore, the name of Heliothis armigera (Hübner) should be changed to Helicoverpa armigera (Hübner), in line with its recent revised scientific denomination.

               (3)

               From information supplied by Member States, it has become apparent that Colletotrichum acutatum (Simmonds) is widespread within the Community. Therefore, that organism should no longer be listed as a harmful organism under Directive 2000/29/EC and no further protective measures under that Directive should be taken with respect to that organism. Annex II to Directive 2000/29/EC should therefore be amended accordingly.

               (4)

               From information supplied by Portugal, it appears that Citrus tristeza virus (European isolates) is now established in Madeira. This part of the Portuguese territory should therefore no longer be recognised as a protected zone in respect of that harmful organism and Annexes II and IV to Directive 2000/29/EC should be amended accordingly.

               (5)

               From information supplied by Spain, it appears that Thaumetopoea pityocampa (Den. and Schiff.) is now established in Ibiza. This part of the Spanish territory should therefore no longer be recognised as a protected zone in respect of that harmful organism and Annexes II and IV to Directive 2000/29/EC should be amended accordingly.

               (6)

               From information supplied by Slovenia, it appears that Erwinia amylovora (Burr.) Winsl. et al. is now established in the Koroška and Notranjska regions. These regions should therefore no longer be recognised as a protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. and Annexes II, III and IV to Directive 2000/29/EC should be amended accordingly.

               (7)

               Information supplied by Italy shows that Erwinia amylovora (Burr.) Winsl. et al. is now established in some parts of its regions of Emilia-Romagna, Lombardy and Veneto. Those parts of the Italian territory should therefore no longer be recognised as a protected zone in respect of Erwinia amylovora (Burr.) Winsl. et al. and Annexes II, III and IV to Directive 2000/29/EC should be amended accordingly.

               (8)

               From the Swiss legislation on plant protection, it appears that the Cantons of Berne and Grisons are no longer recognised as a protected zone for Erwinia amylovora (Burr.) Winsl. et al. in Switzerland. The derogation allowing certain imports from those regions into certain protected zones under special requirements should therefore be deleted and Part B of Annex IV to Directive 2000/29/EC should be amended accordingly.

               (9)

               Annexes I to IV to Directive 2000/29/EC should therefore be amended accordingly.

               (10)

               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
   Annexes I to IV to Directive 2000/29/EC are amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 August 2008 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 September 2008.
   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 a reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the third day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 27 June 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 169, 10.7.2000, p. 1. Directive as last amended by Commission Directive 2007/41/EC (OJ L 169, 29.6.2007, p. 51).

      ANNEX
      Annexes I to IV to Directive 2000/29/EC are amended as follows:

                  1.

                  in point (a) of Section II of Part A of Annex I, point 3 is deleted;

                  2.

                  Annex II is amended as follows:

                              (a)

                              Section II of Part A is amended as follows:

                                          (i)

                                          in heading (a), the following point 6.2 is inserted after point 6.1:

                                                                  ‘6.2.

                                                                     Helicoverpa armigera (Hübner)

                                                      Plants of Dendranthema (DC.) Des Moul, Dianthus L., Pelargonium l'Hérit. ex Ait. and of the family Solanaceae, intended for planting, other than seeds’

                                          (ii)

                                          in heading (c), point 2 is deleted.

                              (b)

                              Part B is amended as follows:

                                          (i)

                                          in heading (a), point 10 is deleted;

                                          (ii)

                                          in point 2 of heading (b), the text in the third column, protected zone(s), is replaced by the following:
                                          ‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza); Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the province of Rovigo, the communes Castelbaldo, Barbona, Piacenza d’Adige, Vescovana, S. Urbano, Boara Pisani, Masi in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna), P, SI (except the regions Gorenjska, Koroška, Notranjska and Maribor), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Veľké Ripňany (Topoľčany County), Málinec (Poltár County), Hrhov (Rožňava County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;

                                          (iii)

                                          in point 1 of heading (d), the text in the third column, protected zone(s), is replaced by the following:
                                          ‘EL, F (Corsica), M, P (except Madeira)’;

                  3.

                  Part B of Annex III is amended as follows:

                              (a)

                              in point 1, the text in the second column, protected zone(s), is replaced by the following:
                              ‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the province of Rovigo, the communes Castelbaldo, Barbona, Piacenza d’Adige, Vescovana, S. Urbano, Boara Pisani, Masi in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna), P, SI (except the regions Gorenjska, Koroška, Notranjska and Maribor), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Veľké Ripňany (Topoľčany County), Málinec (Poltár County), Hrhov (Rožňava County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;

                              (b)

                              in point 2, the text in the second column, protected zone(s), is replaced by the following:
                              ‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the province of Rovigo, the communes Castelbaldo, Barbona, Piacenza d’Adige, Vescovana, S. Urbano, Boara Pisani, Masi in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna), P, SI (except the regions Gorenjska, Koroška, Notranjska and Maribor), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Veľké Ripňany (Topoľčany County), Málinec (Poltár County), Hrhov (Rožňava County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;

                  4.

                  Annex IV is amended as follows:

                              (a)

                              Part A is amended as follows:

                                          (i)

                                          in point 27.1 of Section I, in the second column, special requirements, the words ‘Heliothis armigera Hübner’ are replaced by ‘Helicoverpa armigera (Hübner)’;

                                          (ii)

                                          in point 20 of Section II, in the second column, special requirements, the words ‘Heliothis armigera Hübner’ are replaced by ‘Helicoverpa armigera (Hübner)’;

                              (b)

                              Part B is amended as follows:

                                          (i)

                                          Point 17 is deleted;

                                          (ii)

                                          Point 21 is amended as follows:

                                                      —

                                                      in the second column, special requirements, point (c) is replaced by the following:

                                                                  ‘(c)

                                                                  the plants originate in one of the following Cantons of Switzerland: Fribourg, Vaud, Valais, or’,

                                                      —

                                                      the text in the third column, protected zone(s), is replaced by the following:

                                                         ‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the province of Rovigo, the communes Castelbaldo, Barbona, Piacenza d’Adige, Vescovana, S. Urbano, Boara Pisani, Masi in the province of Padova and the area situated to the south of highway A4 in the province of Verona)), LV, LT, A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna), P, SI (except the regions Gorenjska, Koroška, Notranjska and Maribor), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Veľké Ripňany (Topoľčany County), Málinec (Poltár County), Hrhov (Rožňava County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’

                                          (iii)

                                          Point 21.3 is amended as follows:

                                                      —

                                                      in the second column, special requirements, point (b) is replaced by the following:

                                                                  ‘(b)

                                                                  originate in one of the following Cantons of Switzerland: Fribourg, Vaud, Valais, or’,

                                                      —

                                                      The text in the third column, protected zone(s), is replaced by the following:

                                                         ‘E, EE, F (Corsica), IRL, I (Abruzzo, Apúlia, Basilicata, Calabria, Campania, Emilia-Romagna (the provinces of Parma and Piacenza), Friuli-Venezia Giulia, Lazio, Liguria, Lombardy (except the province of Mantua), Marche, Molise, Piedmont, Sardinia, Sicily, Tuscany, Umbria, Valle d'Aosta, Veneto (except the province of Rovigo, the communes Castelbaldo, Barbona, Piacenza d’Adige, Vescovana, S. Urbano, Boara Pisani, Masi in the province of Padova and the area situated to the South of highway A4 in the province of Verona)), LV, LT, A (Burgenland, Carinthia, Lower Austria, Tirol (administrative district Lienz), Styria and Vienna), P, SI (except the regions Gorenjska, Koroška, Notranjska and Maribor), SK (except the communes of Blahová, Horné Mýto and Okoč (Dunajská Streda County), Hronovce and Hronské Kľačany (Levice County), Veľké Ripňany (Topoľčany County), Málinec (Poltár County), Hrhov (Rožňava County), Kazimír, Luhyňa, Malý Horeš, Svätuše and Zatín (Trebišov County)), FI, UK (Northern Ireland, Isle of Man and Channel Islands).’;

                                          (iv)

                                          Point 31 is amended as follows:

                                                      —

                                                      the text in the third column, protected zone(s), is replaced by the following:

                                                         ‘EL, F (Corsica), M, P (except Madeira)’.


title: Commission Directive 2006/47/EC of  23 May 2006  laying down special conditions concerning the presence of  Avena fatua  in cereal seed (Codified version)   (Text with EEA relevance)

text:
               24.5.2006

               EN

               Official Journal of the European Union

               L 136/18

         COMMISSION DIRECTIVE 2006/47/EC
   of 23 May 2006
   laying down special conditions concerning the presence of Avena fatua in cereal seed
   (Codified version)
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), and in particular Article 11(2) thereof,
   Whereas:

               (1)

               Commission Directive 74/268/EEC of 2 May 1974 laying down special conditions concerning the presence of Avena fatua in fodder plant and cereal seed (2) has been substantially amended (3). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               Directive 66/402/EEC has laid down tolerances in respect of the presence of Avena fatua in cereal seed.

               (3)

               Those tolerances appear too high with regard to certain requirements. Consequently, Directive 66/402/EEC, provides for an additional marking in the case of seed complying with special conditions concerning the presence of Avena fatua.

               (4)

               The special conditions laid down in that connection are such as to satisfy such requirements while also taking account of the possibilities for the production and control of seed.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture, and Forestry.

               (6)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Member States shall issue on request the official certificate provided for in Article 11 of Directive 66/402/EEC;

               (a)

               if the crop is free of Avena fatua at the time of the field inspection officially carried out in conformity with the provisions of Annex I to that Directive and if a sample of a least 1 kg, drawn in accordance with the provisions of Article 7 of that Directive, is free of Avena fatua at the time of official examination; or

               (b)

               if a sample of at least 3 kg, drawn in accordance with the provisions of Article 7 of that Directive, is free of Avena fatua at the time of official examination.

         Article 2
   Member States may prescribe that the official certificate is issued only in one of the two cases provided for in Article 1.
   Article 3
   Directive 74/268/EEC, as amended by the Directive listed in Annex I, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex I, Part B.
   References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex II.
   Article 4
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 23 May 2006.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ 125, 11.7.1966, p. 2309. Directive as last amended by Directive 2004/117/EC (OJ L 14, 18.1.2005, p. 18).

      (2)  OJ L 141, 24.5.1974, p. 19. Directive as amended by Directive 78/511/EEC (OJ L 157, 15.6.1978, p. 34).

      (3)  See Annex I, Part A.

      ANNEX I
      PART A
      Repealed Directive with its amendment
      (referred to in Article 3)

                  Commission Directive 74/268/EEC

                  (OJ L 141, 24.5.1974, p. 19)

                  Commission Directive 78/511/EEC

                  (OJ L 157, 15.6.1978, p. 34)

            PART B
      List of time-limits for transposition into national law
      (referred to in Article 3)

                  Directive

                  Time-limit for transposition

                  74/268/EEC

                  1 July 1974

                  78/511/EEC

                  1 July 1980

      ANNEX II
      CORRELATION TABLE

                  Directive 74/268/EEC

                  This Directive

                  Article 2(1), introductory wording

                  Article 1, introductory wording

                  Article 2(1), first indent

                  Article 1, point (a)

                  Article 2(1), second indent

                  Article 1, point (b)

                  Article 3

                  Article 2

                  Article 4

                  —

                  —

                  Article 3

                  —

                  Article 4

                  Article 5

                  Article 5

                  —

                  Annexes I-II


Avis juridique important

|

31993L0054

Council Directive 93/54/EEC of 24 June 1993 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and products

Official Journal L 175 , 19/07/1993 P. 0034 - 0037 Finnish special edition: Chapter 3 Volume 51 P. 0011  Swedish special edition: Chapter 3 Volume 51 P. 0011

COUNCIL DIRECTIVE 93/54/EEC of 24 June 1993 amending Directive 91/67/EEC concerning the animal health conditions governing the placing on the market of aquaculture animals and productsTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 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, in accordance with Article 28 of Council Directive 91/67/EEC of 28 January 1991 concerning the animal health conditions governing the placing on the market of aquaculture animals and products (4), it is necessary to review the list of diseases  set out in Annex A to the said Directive; whereas this review must take into account both the Commission report on the experience gained and the opinion of the Scientific Veterinary Committee;  Whereas, following the opinion of the Scientific Veterinary Committee, the list of diseases must be amended in order to take account of the latest epidemiological findings and of the experience gained;  Whereas the situation with regard do diseases which are exotic to the Community needs to be reviewed and whereas current epidemiological data indicate that the susceptibility of certain species to certain diseases which are endemic to the Community and  the classification of those diseases in lists II or III of Annex A to Directive 91/67/EEC must be reconsidered;  Whereas it is necessary to clarify certain requirements laid down in Directive 91/67/EEC, in particular those concerning the procedure for the approval of zones and concerning the conditions governing the placing on the market of aquaculture animals not  belonging to the susceptible species,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 91/67/EEC is hereby amended as follows:  1. in Article 3 (a) paragraph 1 (c) shall be replaced by the following:  '(c) they must not come from a farm which is subject to a prohibition for animal health reasons and must not have been in contact with animals from such a farm, and in particular from a farm which is subject to control measures in the context of  Commission Directive 93/53/EEC of 24 June 1993 introducing minimum Community measures for the control of certain fish diseases (*);  (*) OJ No L 175, 19. 7. 1993, p. 23.' (b) the following paragraph shall be added:  '4. This Article shall apply without prejudice to the provisions of Directive 93/53/EEC with regard to the control of certain fish diseases, in particular the diseases in list I';  2. in Article 5 (1), the introductory words shall be replaced by the following:  '1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved zone, Member States shall submit to the Commission:';  3. Article 5 (2) shall be replaced by the following:  '2. The Commission shall scrutinize the information referred to in paragraph 1. The Commission shall use such information as a basis for approving zones in accordance with the procedure laid down in Article 26. If, in accordance with Annex B under  I.D.5, II.D or III.D.5, the approval of a zone is withdrawn by the official service, the Commission shall revoke the decision concerning its approval. Re-approval of the zone concerned shall occur in accordance with the procedure laid down in Article  26.';  4. in Article 6 (1), the introductory words shall be replaced by the following:  '1. In order to obtain, for one or more of the diseases referred to in Annex A, column 1, list II, the status of approved farm situated in a non-approved zone, Member States shall submit to the Commission:';  5. in Article 7 (1), the introductory words shall be replaced by the following:  '1. The placing on the market of live fish belonging to the susceptible species referred to in Annex A, column 2, list II, their eggs or gametes, shall be subject to the following additional guarantees:';  6. in Article 8 (1), the introductory words shall be replaced by the following:  '1. The placing on the market of live molluscs referred to in Annex A, column 2, list II, shall be subject to the following additional guarantees:';  7. in Article 9, the first sentence of point 1 shall be replaced by the following:  '1. Fish susceptible to the diseases referred to in Annex A, column 1, list II, must be slaughtered and eviscerated prior to dispatch.';  8. in Article 9, the first sentence of point 2 shall be replaced by the following:  '2. Live molluscs susceptible to the diseases referred to in Annex A, column 1, list II, must be delivered either for direct human consumption or to the preserving industry; they shall not be relaid unless:';  9. Article 14 shall be replaced by the following:  'Article 14 1. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III, established in accordance with Articles 12 and 13, the placing on the market of live farmed fish not belonging to the susceptible species referred to in  Annex A, column 2, list II, as well as their eggs and gametes shall be subject to the following additional requirements:  (a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying  that they come from a zone of the same health status, from an approved farm in a non-approved zone or from a farm which may be situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred  to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters.  However, pending the outcome of the review provided for in Article 28, Member States may, under the procedure laid down in Article 26, request a derogation from the preceding subparagraph, in particular so as to prohibit the introduction into an  approved zone of fish referred to in this paragraph originating in an approved farm situated in a non-approved zone on condition that such a farm contains no fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not  connected with a watercourse or with coastal or estuarial waters. In order to ensure uniform compliance with that provision, appropriate conditions and measures shall be fixed under the same procedure. Pending those decisions, the relevant national  rules shall continue to apply subject to compliance with the general provisions of the Treaty;  (b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn  up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone, from a farm of the same health status or from a farm which may be situated in a non-approved zone on condition that such a farm contains no  fish belonging to the susceptible species referred to in Annex A, column 2, list II, and is not connected with a watercourse or with coastal or estuarial waters.  2. The requirements laid down in paragraph 1 shall apply to the placing on the market of farmed molluscs not belonging to the susceptible species referred to in Annex A, column 2, list II.  3. Without prejudice to the requirements for diseases referred to in Annex A, column 1, list III established in accordance with Articles 12 and 13, the placing on the market of wild fish, molluscs or crustaceans, their eggs or gametes, shall be subject  to the following additional requirements:  (a) where they are to be introduced into an approved zone, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn up in accordance with the procedure laid down in Article 26, certifying  that they come from a zone of the same health status;  (b) where they are to be introduced into a farm which, although situated in a non-approved zone, fulfils the conditions of Annex C, they must, in accordance with Article 11, be accompanied by a movement document, corresponding to the model to be drawn  up in accordance with the procedure laid down in Article 26, certifying that they come from an approved zone;  (c) where such animals are fished in the deep sea and are to be used for breeding in approved zones and approved farms, they must be placed in quarantine under the supervision of the official service in suitable facilities and under appropriate  conditions to be determined in accordance with the procedure laid down in Article 26.  4. The requirements laid down in paragraphs 1, 2 and 3 shall not apply where practical experience and/or scientific evidence has shown that there is no passive transmission of the disease when acquacultre animals, their eggs and gametes, not belonging  to the susceptible species referred to in Annex A, column 2, list II, are moved from a non-approved zone to an approved zone.  In accordance with the procedure laid down in Article 26, the Commission shall establish the list of aquaculture animals to which the derogation referred to in the first subparagraph shall apply and, where necessary, shall amend that list in the light  of scientific and technological developments. The special conditions for placing such animals on the market, including the model of the accompanying document required, shall be established and amended according to the same procedure.  5. This Article shall not apply to ornamental tropical fish kept permanently in aquariums.';  10. the following paragraph shall be added to Article 19:  '4. If by 1 January 1994 no decision has been taken with regard to the drawing up of the list referred to in paragraph 1, the requisite transitional measures may be adopted, in accordance with the procedure laid down in Article 26, for a period of three  years.';  11. the following paragraph shall be added to Article 20:  '3. Pending establishment of the import conditions provided for in this Directive, Member States shall ensure that imports of aquaculture animals and products from third countries are subject to conditions at least equivalent to those applying to the  production and placing on the market of Community products.';  12. Article 24 shall be replaced by the following:  'Article 24 If an infectious or contagious disease of aquaculture animals, likely to endanger the health of livestock in a Member State breaks out or spreads in a third country or if any other animal health reason so justifies, the rules, procedures and measures  laid down in Article 19 of Directive 90/675/EEC shall apply as regards aquaculture products and those laid down in Article 18 of Directive 91/496/EEC shall apply as regards aquaculture animals.';  13. Annex A shall be replaced by the following:  'ANNEX A LIESTED DISEASES/PATHOGENS OF FISH, MOLLUSCS AND CRUSTACEA 1 2 Disease/pathogen Susceptible species LIST I Fish Infectious salmon aneamia (ISA) Atlantic salmon (Salmo salar) LIST II Fish Viral haemorrhagic septicaemia (VHS) Salmonid species, Grayling (Thymallus thymallus); Whitefish (Coregonus spp.); Pike (Esox  lucius); Turbot (Scophthalmus maximus); Infectious haematopoietic necrosis (IHN) Salmonid species Pike fry (Esox lucius) Molluscs Bonamia ostreae Flat oyster (Ostrea edulis) Marteilla refringens Flat oyster (Ostrea edulis) 1 2 Disease/pathogen  Susceptible species LIST III Fish Infectious pancreatic necrosis (IPN) Spring viraemia of carp (SVC) Bacterial kidney disease (BKD) (Renibacterium salmonidarum) Furunculosis (Aeromonas salmonicida) (Enteric redmouth disease) (ERM) (Yersinia ruckeri)  Gyrodactylus salaris To be specified in the programme referred to in Articles 12 and 13'Crustaceans Crayfish plague (Aphanomyces astaci)' 14. References to 'list I' of Annex A shall be deleted from Annexes B, C and D.  Article 2  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1994; they shall notify 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 a reference shall be laid down by the Member  States.  2. 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 3  This Directive is addressed to the Member States.  Done at Luxembourg, 24 June 1993.  For the Council The President B. WESTH (1) OJ No C 324, 10. 12. 1992, p. 16.(2) OJ No C 150, 31. 5. 1993.(3) OJ No C 129, 10. 5. 1993, p. 6.(4) OJ No L 46, 19. 2. 1991, p. 1


title: Commission Directive 2006/55/EC of  12 June 2006  amending Annex III to Council Directive 66/402/EEC as regards the maximum weight of seed lots   (Text with EEA relevance)

text:
               13.6.2006

               EN

               Official Journal of the European Union

               L 159/13

         COMMISSION DIRECTIVE 2006/55/EC
   of 12 June 2006
   amending Annex III to Council Directive 66/402/EEC as regards the maximum weight of seed lots
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), and in particular Article 21a thereof,
   Whereas:

               (1)

               The international rules in respect of the maximum weights for seed lots of certain cereal species, in particular Triticum aestivum, Triticum durum, Triticum spelta, Secale cereale, Triticosecale and Oryza sativa, Avena sativa and Hordeum vulgare, have recently been revised.

               (2)

               It is appropriate to adapt the maximum weights for seed lots of those species laid down in Community law.

               (3)

               Directive 66/402/EEC should therefore be amended accordingly.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In column 2 of the table in Annex III to Directive 66/402/EEC, ‘25’ is replaced by ‘30’.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 12 June 2006.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ 125, 11.7.1966, p. 2309/66. Directive as last amended by Directive 2004/117/EC (OJ L 14, 18.1.2005, p. 18).


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31992L0027

Council Directive 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leaflets

Official Journal L 113 , 30/04/1992 P. 0008 - 0012 Finnish special edition: Chapter 13 Volume 22 P. 0035  Swedish special edition: Chapter 13 Volume 22 P. 0035

COUNCIL DIRECTIVE 92/27/EEC of 31 March 1992 on the labelling of medicinal products for human use and on package leafletsTHE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 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 measures aimed a progressively establishing the internal market over a period expiring on 31 December 1992 need to be taken; whereas the internal market is to comprise an area without internal frontiers in which the free movement of goods,  persons, services and capital is ensured;  Whereas Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulations or administrative action relating to medicinal products(4) , as last amended by Directive 89/343/EEC(5) , establishes a list of  particulars to be given on the immediate packaging and the outer packaging of medicinal products for human use; whereas this list should be supplemented and details given of how labelling is to be presented;  Whereas Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(6) , as last amended by Directive 89/381/EEC(7) , establishes  a non-exhaustive list of particulars to be included in package leaflets; whereas this list should be supplemented and details given of how such leaflets are to be presented;  Whereas the provisions on labelling and on package leaflets should be brought together in a single text;  Whereas the provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information;  Whereas the marketing of medicinal products whose labelling and package leaflets comply with this Directive should not be prohibited or impeded on grounds connected with the labelling or package leaflet,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I Scope and definitions   Article 1  1.  This Directive deals with the labelling of medicinal products for human use and leaflets inserted in packages of such products, to which Chapters II, III, IV and V of Directive 65/65/EEC apply.  2.  For the purposes of this Directive:  - name of the medicinal product means the name given to a medicinal product, which may be either an invented name or a common or scientific name, together with a trade mark or the name of the manufacturer; the invented name shall not be liable to  confusion with the common name,  - common name means the international non-proprietary name recommended by the World Health Organization, or, if one does not exist, the usual common name,  - strength of the medicinal product means the content of the active ingredient expressed quantitatively per dosage unit, per unit of volume or weight according to the dosage form,  - immediate packaging means the container or other form of packaging immediately in contact with the medicinal product,  - outer packaging means the packaging into which is placed the immediate packaging,  - labelling means information on the immediate or outer packaging,  - package leaflet means a leaflet containing information for the user which accompanies the medicinal product,  - manufacturer means the holder of the authorization referred to in Article 16 of Directive 75/319/EEC on behalf of whom the qualified person has performed the specific obligations laid down in Article 22 of that Directive.  CHAPTER II Labelling of medicinal products   Article 2  1.  The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:  (a) the name of the medicinal product followed by the common name where the product contains only one active ingredient and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths,  the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be include in the name of the medicinal product;  (b) a statement of the active ingredients expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;  (c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;  (d) a list of those excipients known to have a recognized action or effect and included in the guidelines published pursuant to Article 12. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;  (e) the method and, if necessary, the route of administration;  (f) a special warning that the medicinal product must be stored out of reach of children;  (g) a special warning, if this is necessary for the medicinal product concerned;  (h) the expiry date in clear terms (month/year);  (i) special storage procautions, if any;  (j) special precautions for disposal of unused medicinal products or waste materials derived from such products, if appropriate;  (k) the name and address of the holder of the authorization for placing the medicinal product on the market;  (l) the number of the authorization for placing the medicinal product on the market;  (m) the manufacturer's batch number;  (n) in the case of self-medication, instructions on the use of the medicinal products.  2.  The outer packaging may include symbols or pictograms designed to clarify certain information mentioned in paragraph 1 and other information compatible with the summary of the product characteristics which is useful for health education, to the  exclusion of any element of a promotional nature.  Article 3  1.  The particulars laid down in Article 2 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3.  2.  The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Article 2:  - the name of the medicinal product as laid down in Article 2 (a),  - the name of the holder of the authorization for placing the product on the market,  - the expiry date,  - the batch number.  3.  The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Article 2 cannot be displayed:  - the name of the medicinal product and, if necessary, the strength and the route of administration,  - the method of administration,  - the expiry date,  - the batch number,  - the contents by weight, by volume or by unit.  Article 4  1.  The particulars referred to in Articles 2 and 3 shall be easily legible, clearly comprehensible and indelible.  2.  The particulars listed in Article 2 shall appear in the official language or languages of the Member State where the product is placed on the market. This provision shall not prevent these particulars from being indicated in several languages,  provided that the same particulars appear in all the languages used.  Article 5  1.  Member States may not prohibit or impede the placing on the market of medicinal products within their territory on grounds connected with labelling where such labelling complies with the requirements of this Chapter.  2.  Notwithstanding paragraph 1, Member States may require the use of certain forms of labelling making it possible to indicate:  - the price of the medicinal product,  - the reimbursement conditions of social security organizations,  - the legal status for supply to the patient, in accordance with Directive 92/26/EEC(8) ,  - identification and authenticity.  CHAPTER III User package leaflet   Article 6  The inclusion in the packaging of all medicinal products of a package leaflet for the information of users shall be obligatory unless all the information required by Article 7 is directly conveyed on the outer packaging or on the immediate  packaging.  Article 7  1.  The package leaflet shall be drawn up in accordance with the summary of the product characteristics; it shall include, in the following order:  (a) for the identification of the medicinal product:  - the name of the medicinal product, followed by the common name if the product contains only one active ingredient and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the  pharmaceutical form and/or the strength (for example, baby, child, adult) must be included in the name of the medicinal product,  - a full statement of the active ingredients and excipients expressed qualitatively and a statement of the active ingredients expressed quantitatively, using their common names, in the case of each presentation of the product,  - the pharmaceutical form and the contents by weight, by volume or by number of doses of the product, in the case of each presentation of the product,  - the pharmaco-therapeutic group, or type of activity in terms easily comprehensible for the patient,  - the name and address of the holder of the authorization for placing the medicinal product on the market and of the manufacturer;  (b) the therapeutic indications;  (c) a list of information which is necessary before taking the medicinal product:  - contra-indications,  - appropriate precautions for use,  - forms of interaction with other medicinal products and other forms of interaction (for example, alcohol, tobacco, foodstuffs) which may affect the action of the medicinal product,  - special warnings.  this list must:  - take into account the particular condition of certain categories of users (e.g. children, pregnant or breastfeeding women, the elderly, persons with specific pathological conditions),  - mention, if appropriate, potential effects on the ability to drive vehicles or to operate machinery,  - detail those excipients, knowledge of which is important for the safe and effective use of the medicinal product and included in the guidelines published pursuant to Article 12;  (d) the necessary and usual instructions for proper use, in particular:  - the dosage,  - the method and, if necessary, route of administration,  - the frequency of administration, specifying if necessary the appropriate time at which the medicinal product may or must be administered,  and, as appropriate, depending on the nature of the product:   - the duration of treatment, where it should be limited,  - the action to be taken in the case of an overdose (for example, symptoms, emergency procedures),  - the course of action to take when one or more doses have not been taken,  - indication, if necessary, of the risk of withdrawal effects;  (e) a description of the undesirable effects which can occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case; the patient should be expressly invited to communicate any undesirable effect which is not  mentioned in the leaflet to his doctor or to his pharmacist;  (f) a reference to the expiry date indicated on the label, with:  - a warning against using the product after this date,  - where appropriate, special storage precautions,  - if necessary, a warning against certain visible signs of deterioration;  (g) the date on which the package leaflet was last revised.  2.  Notwithstanding paragraph 1 (b), the competent authorities may decide that certain therapeutic indications shall not be mentioned in the package leaflet, where the dissemination of such information might have serious disadvantages for the patient.  3.  The package leaflet may include symbols or pictograms designed to clarify certain information mentioned in paragraph 1 and other information compatible with the summary of the product characteristics which is useful for health education, to the  exclusion of any element of a promotional nature.  Article 8  The package leaflet must be written in clear and understandable terms for the patient and be clearly legible in the official language or languages of the Member State where the medicinal product is placed on the market. This provision does  not prevent the package leaflet being printed in several languages, provided that the same information is given in all the languages used.  Article 9  Member States shall not prohibit or impede the marketing or medicinal products within their territory on grounds relating to the package leaflet if the latter complies with the requirements of this Chapter.  CHAPTER IV General and final provisions   Article 10  1.  One or more specimens or mock-ups of the outer packaging and the immediate packaging of a medicinal product, together with the draft package leaflet, shall be submitted to the authorities competent for authorizing marketing when the  authorization for placing the medicinal product on the market is requested.  2.  The competent authorities shall refuse the authorization for placing the medicinal product on the market if the labelling or the package leaflet do not comply with the provisions of this Directive or if they are not in accordance with the  particulars listed in the summary of product characteristics referred to in Article 4b of Directive 65/65/EEC.  3.  All proposed changes to an aspect of the labelling or the package leaflet covered by this Directive and not connected with the summary of characteristics shall be submitted to the authorities competent for authorizing marketing. If the competent  authorities have not opposed a proposed change within 90 days following the introduction of the request, the applicant may put the change into effect.  4.  The fact that the competent authorities do not refuse an authorization to place the medicinal product on the market pursuant to paragraph 2 or a change to the labelling or the package leaflet pursuant to paragraph 3 does not alter the general legal  liability of the manufacturer or as appropriate the holder of the authorization to place the medicinal product on the market.  5.  The competent authorities may exempt labels and package leaflets for specific medicinal products from the obligation that certain particulars shall appear and that the leaflet must be in the official language or languages of the Member State where  the product is placed on the market, when the product is not intended to be delivered to the patient for self-administration.  Article 11  1.  Where the provisions of this Directive are not complied with, and a notice served on the person concerned has remained without effect, the competent authorities of the Member States may suspend the authorization to place the medicinal  product on the market, until the labelling and the package leaflet of the medicinal product in question have been made to comply with the requirements of this Directive.  2.  All decisions taken pursuant to paragraph 1 shall state in detail the reasons on which they are based. They shall be notified to the party concerned, who shall at the same time be informed of the remedies available to him under the laws in force and  of the time limit allowed for the exercise of such remedies.  Article 12  1.  As necessary, the Commission shall publish guidelines concerning in particular:  - the formulation of certain special warnings for certain categories of medicinal products,  - the particular information needs relating to self-medication,  - the legibility of particulars on the labelling and package leaflet,  - methods for the identification and authentication of medicinal products,  - the list of excipients which must feature on the labelling of medicinal products and the way these excipients must be indicated.  2.  These guidelines shall be adopted in the form of a Directive addressed to the Member States, in accordance with the procedure laid down in Article 2c of Directive 75/318/EEC.  Article 13  Articles 13 to 20 of Directive 65/65/EEC and Articles 6 and 7 of Directive 75/319/EEC are hereby repealed.  Article 14  Member States shall take the measures necessary to comply with this Directive before 1 January 1993. 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 a reference shall be laid down by the Member  States.  From 1 January 1994, Member States shall refuse an application for authorization to place a medicinal product on the market or for the renewal of an existing authorization, where the labelling and the package leaflet do not comply with the requirements  of this Directive.  Article 15  This Directive is addressed to the Member States.  Done at Brussels, 31 March 1992.  For the Council The President Vitor MARTINS    (1) OJ No C 58, 8. 3. 1990, p. 21.  (2) OJ No C 183, 15. 7. 1991, p. 213.  (3) OJ No C 225, 10. 9. 1990, p. 24.  (4) OJ No 22, 9. 2. 1965, p. 369/65.  (5) OJ No L 142, 25. 5. 1989, p. 14.  (6) OJ No L 147, 9. 6. 1975, p. 13.  (7) OJ No L 81, 28. 6. 1989, p. 44.  (8) See page 5 of this Official Journal.