Avis juridique important

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31984L0386

Tenth Council Directive 84/386/EEC of 31 July 1984 on the harmonization of the laws of the Member States relating to turnover taxes, amending Directive 77/388/EEC - Application of value added tax to the hiring out of movable tangible property

Official Journal L 208 , 03/08/1984 P. 0058 - 0058 Finnish special edition: Chapter 9 Volume 1 P. 0122  Spanish special edition: Chapter 09 Volume 1 P. 0170  Swedish special edition: Chapter 9 Volume 1 P. 0122  Portuguese special edition Chapter 09 Volume 1 P. 0170

*****TENTH  COUNCIL DIRECTIVE  of 31 July 1984  on the harmonization of the laws of the Member States relating to turnover taxes, amending Directive 77/388/EEC - Application of value added tax to the hiring out of movable tangible property  (84/386/EEC)  THE COUNCIL OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Articles 99 and 100 thereof,  Having regard to the Sixth Council Directive 77/388/EEC of 17 May 1977 on the harmonization of the laws of the Member States relating to turnover taxes - Common system of value added tax: uniform basis of assessment (1),  Having regard to the proposal from the Commission (2),  Having regard to the opinion of the European Parliament (3),  Having regard to the opinion of the Economic and Social Committee (4),  Whereas, pursuant to Article 4 (2) of the aforementioned Directive, the hiring out of movable tangible property may constitute an economic activity subject to value added tax;  Whereas application of Article 9 (1) of the aforementioned Directive to the hiring out of movable tangible property may lead to substantial distortions of competition where the lessor and the lessee are established in different Member States and the rates of taxation in those States differ;  Whereas it is therefore necessary to establish that the place where a service is supplied is the place where the customer has established his business or has a fixed establishment for which the service has been supplied or, in the absence thereof, the place where he has his permanent address or usually resides;  Whereas, however, as regards the hiring out of forms of transport, Article 9 (1) should, for reasons of control, be strictly applied, the place where the supplier has established his business being treated as the place of supply of such services,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 77/388/EEC is hereby amended as follows:  1. Article 9 (2) (d) is deleted;  2. in Article 9 (2) (e) the following indent is added:  '- the hiring out of movable tangible property, with the exception of all forms of transport.';  3. in Article 9 (3), 'and the hiring out of movable tangible property' is replaced by 'and the hiring out of forms of transport'.  Article 2  1. Member States shall bring into force the measures necessary to comply with this Directive by 1 July 1985.  2. Member States shall inform the Commission of the provisions which they adopt for the purpose of applying this Directive. The Commission shall inform the other Member States thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 31 July 1984.  For the Council  The President  J. O'KEEFFE  (1) OJ No L 145, 13. 6. 1977, p. 1.  (2) OJ No C 116, 9. 5. 1979, p. 4.  (3) OJ No C 4, 7. 1. 1980, p. 63.  (4) OJ No C 297, 28. 11. 1979, p. 16.


Avis juridique important

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31984L0414

Commission Directive 84/414/EEC of 18 July 1984 adapting to technical progress Directive 76/764/EEC on the approximation of the laws of the Member States relating to clinical mercury-in-glass maximum-reading thermometers

Official Journal L 228 , 25/08/1984 P. 0025 - 0030 Spanish special edition: Chapter 13 Volume 16 P. 0036  Portuguese special edition Chapter 13 Volume 16 P. 0036

*****COMMISSION  DIRECTIVE  of 18 July 1984  adapting to technical progress Directive 76/764/EEC on the approximation of the laws of the Member States relating to clinical mercury-in-glass maximum-reading thermometers  (84/414/EEC)  THE COMMISSION OF THE EUROPEAN  COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 71/316/EEC of 26 July 1971 on the approximation of the laws of the Member States relating to common provisions for both measuring instruments and methods of metrological control (1), as last amended by Directive 83/575/EEC (2), and in particular Article 17 thereof,  Whereas, since the adoption of Directive 76/764/EEC on the approximation of the laws of the Member States on clinical mercury-in-glass maximum-reading thermometers (3), as amended by Directive 83/128/EEC (4), new techniques have been developed in this field; whereas these techniques have made it necessary to conduct additional tests in order to establish the quality of the glass employed; whereas the Annexes to that Directive must, therefore, now be amended and modified in several points; whereas in the interests of clarity it is therefore appropriate to adopt a consolidated text for those Annexes;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the Adaptation to Technical Progress of Directives on the Removal of Technical Barriers to Trade in Measuring Instruments,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Annexes I and II to Directive 76/764/EEC are hereby replaced by the Annexes to this Directive.  Article 2  Member States shall bring into force laws, regulations and administrative provisions necessary to comply with this Directive on 1 January 1986. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 18 July 1984.  For the Commission  Karl-Heinz NARJES  Member of the Commission  (1) OJ No L 202, 6. 9. 1971, p. 1.  (2) OJ No L 332, 28. 11. 1983, p. 43.  (3) OJ No L 262, 27. 9. 1976, p. 139.  (4) OJ No L 91, 9. 4. 1983, p. 29.  ANNEX  I  1.2 // 1.  // UNIT OF TEMPERATURE  //   // The unit of temperature employed for thermometer graduation shall be the degree Celsius.  // 2.  // SCALE RANGE AND GRADUATION  //  // The thermometers shall have a scale range of at least 35,5 to 42,0 °C, the value of the scale divisions being 0,1 of a degree Celsius.  // 3.  // TYPES  // 3.1.  // Thermometers may be of the solid-stem or enclosed-scale type.  // 3.1.1.  // In the case of solid-stem thermometers, the scale shall be marked on the solid-stem.  // 3.1.2.  // In the case of enclosed-scale thermometers, the scale shall be marked on a scale panel fixed logitudinally behind the capillary tube; the capillary tube and the scale panel shall be enclosed in a transparent tube impermeably fixed to the bulb and forming a protective sheath.  // 3.2.  // Thermometers shall be provided with a maximum-reading device which prevents the mercury column from retracting when the thermometer cools.  // 4.  // MATERIALS  // 4.1.  // Thermometer bulbs shall be made of a type of glass which satisfies the conditions set out in Annex II. This glass shall be clearly and indelibly identified by either:  // 4.1.1.  // an integral mark introduced by the glass manufacturer in such a way as to be clearly recognizable in the bulb after manufacture of the thermometer,  // 4.1.2.  // or a mark chosen by the glass manufacturer and affixed by the thermometer manufacturer and clearly indicating the type of glass employed. The conformity of this glass with that approved in accordance with item 11.1.1 shall be confirmed by a certificate of conformity issued by the glass manufacturer.  // 4.2.  // The glass used for the maximum-reading device and capillary tube shall have a hydrolytic strength as specified in item 1 of Annex II.  // 4.3.  // The scale panels of enclosed-scale thermometers shall be of opaline, metal or a material of equivalent dimensional stability.  // 4.4.  // The sheaths of enclosed-scale thermometers shall be of glass.  // 5.  // DESIGN  // 5.1.  // The thermometer shall be free of any fault which could prevent normal functioning or result in user error.  // 5.2.  // The ends of the thermometer shall be so formed as to preclude any risk of accident during use.  // 5.3.  // The capillary tube shall be such that the entire length of the mercury column and the meniscus are clearly visible from one angle. It shall be prismatic in form and have a magnifying effect, or be so designed as to ensure equal ease of reading.  // 5.4.  // The mercury shall be sufficiently pure and dry.  //   // In order to ensure that the thermometer functions correctly, the bulb, capillary tube and mercury shall be free of gas, glass fragments and foreign bodies.  // 5.5.  // The mercury column shall rise uniformly, without appreciable surges, when the thermometer is heated slowly. It shall fall below the lowest numbered scale line when the mercury is subjected to an acceleration of 600 m/s2 at the bottom of the bulb after the thermometer has been brought to a temperature of not less than 37 °C and then cooled to a temperature below the minimum scale value.  // 5.6.  // In enclosed-scale thermometers, the scale panel shall be in direct contact with the capillary tube and fixed sufficiently firmly in the sheath to prevent any displacement with respect to the tube. The panel shall be so positioned as to ensure that any displacement thereof with respect to the capillary tube can be easily detected by means of an indelible mark on the sheath, level with a numbered scale mark, or by some equivalent means.  // 5.7.  // The sheaths of enclosed-scale thermometers shall be free of moisture, mercury, glass fragments and foreign bodies.  // 6.  // GRADUATION AND NUMBERING  // 6.1.  // The scale divisions shall be clearly and uniformly marked. The scale lines and numbering shall be engraved or printed clearly and indelibly.  // 6.2.  // The length of the scale divisions shall be not less than 0,5 mm in the case of solid-stem thermometers and not less than 0,6 mm in that of enclosed-scale thermometers.  // 6.3.  // The scale lines shall be perpendicular to the axis of the thermometers and their thickness shall not exceed one-fifth of the length of a scale division plus 0,05 mm in enclosed-scale thermometers, or one-quarter of the length of a scale division plus 0,05 mm in solid-stem thermometers.  // 6.4.  // Scale lines representing whole degrees and half-degrees shall be longer than the other scale lines.  // 6.4.  // Scale lines representing whole degrees shall be numbered. Numbering of the line corresponding to 37 °C shall be optional in the case of solid-stem thermometers and may take the form specified in item 6.5.  // 6.5.  // The line representing the temperature of 37 °C may be rendered conspicuous by means of a colour different from that used for the numbering and/or by an additional mark.  // 6.6.  // Scale lines and figures shall be so located as to be visible at the same times as the mercury column.  // 7.  // MARKS  // 7.1.  // The stem of solid-stem thermometers and the scale panel of enclosed-scale thermometers shall bear the following indelible marks:  // 7.1.1.  // The unit-of-temperature symbol '°C'.  // 7.1.2.  // The EEC pattern-approval sign in accordance with item 3.5 of Annex I to Directive 71/316/EEC; by way of derogation from the general rule set out in item 3.1 of that Annex, the EEC pattern-approval sign may be composed of the undermentioned marks in the following order:  //   // - the stylized letter 'e ',  //   // - the letter or letters denoting the Member State which granted EEC pattern approval,  //   // - the year of approval,  //   // - a mark to be determined by the metrological service which granted EEC pattern approval, clearly separated from the year.  // 7.1.3.  // The manufacturer's trade mark or business name.  // 7.1.4.  // Where applicable, the mark provided for in item 4.1.2.  // 7.2.  // Other inscriptions may be added, provided that they are not likely to mislead the user or give rise to difficulty in reading the thermometer.  //   // No indication of the measuring period shall appear on the instruments.  // 8.  // MAXIMUM PERMISSIBLE ERROR  //   // The maximum permissible error is + 0,10 to - 0,15 of a degree Celsius. These limits apply to stabilized thermometer readings.  //   // A stabilized reading is that given by a thermometer which after attaining thermal equilibrium with a water bath at a temperature within the thermometer scale range, has been cooled to a temperature of between 15 and 30 °C.  // 9.  // INFLUENCE OF IMMERSION TIME  //   // If a thermometer at the temperature t1 (15 °C µ t1 µ 30 °C) is suddenly immersed in a vigorously stirred water bath at a constant temperature t2 (35,5 °C µ t2 µ 42 °C) and withdrawn after 20 seconds, the thermometer reading shall satisfy the following conditions after cooling to ambient temperature (15 to 30 °C):  //   // 1. it must lie within the limits of the maximum permissible error;  //   // 2. it must not differ by more than 0,005 (t2 - t1) from the stabilized reading for temperature t2.  // 10.  // POSITION OF THE EEC INITIAL VERIFICATION MARK  // 10.1.  // A space for the EEC initial verification mark shall be reserved on the stem of solid-stem thermometers and on the sheath of enclosed-scale thermometers.  // 10.2.  // In accordance with item 3.1.1 of Annex II to Directive 71/316/EEC and notwithstanding the general rule specified in item 3 of that Annex, the verification mark may consist of the undermentioned marks in the following order:  //   // - the small letter 'e',  //   // - the letter or letters denoting the Member State in which initial verification took place,  //  // - the year of initial verification,  //   // - where necessary, the distinguishing number of the verifying office, separated clearly from the year.  // 10.3.  // In the case of sandblasted marks, the letters and figures shall be broken at appropriate points in such a way as to avoid impairing their legibility.  // 11.  // EEC PATTERN APPROVAL AND INITIAL VERIFICATION  // 11.1.  // EEC pattern approval  // 11.1.1.  // At the time of EEC pattern approval, thermometers shall be examined for the purpose of checking their conformity with the technical and metrological requirements set out in this Annex. In addition, the tests in Annex II shall be performed.  // 11.1.2.  // All manufacturers of thermometers using for the manufacture of the bulb a glass not marked by the glass manufacturer shall communicate to the competent department the mark referred to in item 4.1.2 and the chemical composition of the glass as guaranteed by the glass manufacturer.  // 11.2.  // EEC initial verification  //   // The EEC initial verification examination shall be conducted in order to establish the conformity of thermometers with the approved pattern.  // 11.2.1.  // In order to check that thermometers satisfy the requirements set out in items 8 and 9 of this Annex, the following test shall be performed:  //   // The thermometers shall be checked in vigorously stirred water baths against standard thermometers. This check shall be performed at at least two temperatures differing by at least four degrees Celsius between 35,5 and 42,0 °C.  //   // During this check, the thermometers shall be immersed for 20 seconds at one temperature and 40 seconds at the other, the temperatures or immersion periods being alternated at regular intervals.  //  // The thermometers shall be kept in the vertical position and, in each instance, readings shall be taken after removal from the bath and after return to ambient temperature.  //  // The accuracy with which the error is determined shall be equal to or better than 0,03 of a degree Celsius. This examination shall be carried out not less than 15 days after reception of the thermometers.  // 11.2.2.  // Where thermometer bulbs are manufactured from a glass which has not been identified by the glass manufacturer, the following conditions shall be met:  //   // (a) the certificate mentioned in item 4.1.2. relating to thermometers presented for EEC initial verification shall be kept at the disposal of the competent department;  //   // (b) an analysis to determine the chemical composition of the glass used in the bulbs of thermometers presented for EEC initial verification shall be carried out periodically, on the initiative of the competent department, in order to check its conformity with the approved glass.  ANNEX  II  CONDITIONS TO BE SATISFIED BY THE GLASS USED IN THE MANUFACTURE OF THE BULBS  1.2 // 1.  // HYDROLYTIC STRENGTH  //   // During the analysis of the glass in accordance with ISO Standard 719-1981 (determination of the hydrolytic strength of granulated glass at 98 °C), the quality of alkali dissolved for 1 g of glass shall not exceed 263,5 mg of Na2O.  // 2.  // AVERAGE ZERO POINT DEPRESSION  //   // Zero point depression shall be determined with special test thermometers without a maximum-reading device, made from the glass to be tested and in accordance with requirements laid down by the competent department.  // 2.1.  // The average zero point depression, as determined by the method described below, shall not exceed 0,05 of a degree Celsius.  // 2.2.  // The test thermometers shall satisfy the following conditions:  // 2.2.1.  // Minimum scale range: - 3,0 to + 3,0 °C.  // 2.2.2.  // Value of the scale divisions: 0,02, 0,05 or 0,1 of a degree Celsius.  // 2.2.3.  // The length of the scale division shall be not less than 0,7 mm in the case of enclosed-scale thermometers and not less than 1,0 mm in the case of solid-stem thermometers.  // 2.2.4.  // The expansion chamber shall be sufficiently large to allow the thermometer to be heated to a temperature of 400 °C without damage.  // 2.3.  // Each test thermometer shall be checked for correct stabilization in accordance with the following provisions:  // 2.3.1.  // The thermometer shall be heated in a temperature-controlled enclosure (liquid bath or furnace) from ambient temperature to 350 ± 10 °C and held at that temperature for not less than five minutes. It shall then be cooled to 50 °C in the temperature-controlled enclosure, the enclosure temperature decreasing at a rate of 10 to 15 degrees Celsius per hour.  // 2.3.2.  // When the thermometer has reached a temperature of 50 °C, it shall be removed from the temperature-controlled enclosure and the correction to 0 °C determined (value K1).  // 2.3.3.  // The thermometer shall then be heated to 350 ± 10 °C for a second time in a temperature-controlled enclosure and kept at that temperature for 24 hours. It shall then be cooled to 50 °C as described in item 2.3.1.  // 2.3.4.  // When the thermometer has reached a temperature of 50 °C, it shall be removed from the temperature-controlled enclosure and the correction to 0 °C shall again be determined (value K2).  // 2.3.5.  // The absolute value of the difference between K2 and K1 shall not exceed 0,15 of a degree Celsius. Thermometers which do not meet this requirement cannot be used for the determination of zero point depression.  // 2.4.  // Test procedure  // 2.4.1.  // Use shall be made of at least three thermometers which have satisfied the requirements of the stabilization test provided for in item 2.3 and which have not been heated above ambient temperature after the determination of K2.  // 2.4.2.  // Each of these thermometers shall be checked at least three times in accordance with the provisions of items 2.4.2.1 to 2.4.2.3.  // 2.4.2.1.  // The thermometer shall be kept for a week at a temperature between 20 and 25 °C. At the end of the week the correction to 0 °C (value K3) shall be determined.  // 2.4.2.2.  // The thermometer shall then be immersed in a test bath at a temperature of 100 ± 1 °C for 30 minutes, after which it shall be withdrawn and allowed to cool in air. Its bulb must not be in contact with other objects during cooling to ambient temperature.  // 2.4.2.3.  // The correction to 0 °C shall be determined within 15 minutes after the thermometer has been withdrawn from the test bath. The value of the correction obtained is designated K4.  // 2.4.3.  // The procedures described in items 2.4.2.1 to 2.4.2.3 shall be repeated in order to obtain a series of n differences, K4 - K3, K6 - K5, . . ., K2n+2 - K2n+1, which are the thermometer zero point depression values obtained during the first, second and nth series of measurements respectively.  // 2.4.4.  // When n series of measurements have been performed with m test thermometers, the average zero point depression of these thermometers is given by the expression:  1.2.3.4.5.6 //   // 1 m ; n  // m S  i = 1  //  [  // (K4 (i) - K3 (i) ) + (K6 (i) - K5 (i) ) + . . . + (K2 n + 2 (i) - K2 n + 1 (i) )  //  ] 1.2 //   // In accordance with items 2.4.1 and 2.4.2, the conditions m3 and n3 must be fulfilled in respect of m and n.  //   // The standard deviation of the average zero point depression determined in accordance with the preceding requirements shall not exceed 0,01 of a degree Celsius.


title: Commission Directive 2004/87/EC of 7 September 2004 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress Text with EEA relevance

text:
               8.9.2004

               EN

               Official Journal of the European Union

               L 287/4

      COMMISSION DIRECTIVE 2004/87/EC
   of 7 September 2004
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (1), and in particular Article 8(2) thereof,
   After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers,
   Whereas:

               (1)

               In April 2002, the Commission included in part 2 of Annex III to Directive 76/768/EEC 60 hair dyes under the reference numbers 1 to 60. Since more information on the safety of those hair dyes was needed in order for the Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) to finish the risk assessment of those substances, those hair dyes have been provisionally allowed to be employed in cosmetic products until 30 September 2004.

               (2)

               In December 2002, the SCCNFP set the basic requirements to carry out a modern risk assessment of hair dyes. Following the process of consultation with the Member States and stakeholders it was agreed in December 2003 that the date of July 2005 was appropriate for the presentation to the SCCNFP of the additional information on hair dyes meeting the new requirements. Therefore, the period for which those hair dyes have been included in part 2 of Annex III to Directive 76/768/EEC has to be extended.

               (3)

               Directive 76/768/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 Cosmetic Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In part 2 of Annex III to Directive 76/768/EEC, the date ‘30.9.2004’ in column g for reference numbers 1 to 60 is replaced by ‘31.12.2005’.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 October 2004 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 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 that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 7 September 2004.

            For the Commission

         Olli REHN

            Member of the Commission

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2003/83/EC (OJ L 238, 25.9.2003, p. 23).


title: Commission Directive 2008/66/EC of 30 June 2008 amending Council Directive 91/414/EEC to include bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine as active substances (Text with EEA relevance)

text:
               1.7.2008

               EN

               Official Journal of the European Union

               L 171/9

      COMMISSION DIRECTIVE 2008/66/EC
   of 30 June 2008
   amending Council Directive 91/414/EEC to include bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   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 includes bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine.

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For bifenox the rapporteur Member State was Belgium and all relevant information was submitted on 4 July 2005. For diflufenican the rapporteur Member State was the United Kingdom and all relevant information was submitted on 1 August 2005. For fenoxaprop-P the rapporteur Member State was Austria and all relevant information was submitted on 2 May 2005. For fenpropidin and quinoclamine the rapporteur Member State was Sweden and all relevant information was submitted on 24 June 2005 and 15 June 2005 respectively.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 14 November 2007 for quinoclamine, on 29 November 2007 for bifenox and fenoxaprop-P and on 17 December 2007 for diflufenican and fenpropidin in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 14 March 2008 in the format of the Commission review reports for bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine.

               (4)

               It has appeared from the various examinations made that plant protection products containing bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine 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 were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore it is appropriate to require that bifenox should be subjected to further testing for confirmation of the risk assessment for consumers and the long-term risk to herbivorous mammals and that fenpropidin should be subjected to further testing for confirmation of the risk assessment for the long-term risk to herbivorous and insectivorous birds and such studies should be presented by the notifiers.

               (6)

               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.

               (7)

               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 six months after inclusion to review existing authorisations of plant protection products containing bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine 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 way of 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.

               (8)

               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 (5) 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.

               (9)

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

               (10)

               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
   Member States shall adopt and publish by 30 June 2009 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 July 2009.
   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 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine as active substances by 30 June 2009.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine 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 bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine 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 December 2008 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 bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine respectively. 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 bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2012 at the latest; or

               (b)

               in the case of a product containing bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2012 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 4
   This Directive shall enter into force on 1 January 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 30 June 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2008/45/EC (OJ L 94, 5.4.2008, p. 21).

      (2)  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

      (3)  OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regulation (EC) No 1095/2007 (OJ L 246, 21.9.2007, p. 19).

      (4)  EFSA Scientific Report (2007) 119, 1-84, Conclusion regarding the peer review of the pesticide risk assessment of the active substance bifenox (finalised 29 November 2007).

      EFSA Scientific Report (2007) 122, 1-84, Conclusion regarding the peer review of the pesticide risk assessment of the active substance diflufenican (finalised 17 December 2007).

      EFSA Scientific Report (2007) 121, 1-76, Conclusion regarding the peer review of the pesticide risk assessment of the active substance fenoxaprop-P (finalised 29 November 2007).

      EFSA Scientific Report (2007) 124, 1-84, Conclusion regarding the peer review of the pesticide risk assessment of the active substance fenpropidin (finalised 17 December, revision of 29 January 2008 with corrections of miscalculations in the aquatic risk assessment).

      EFSA Scientific Report (2007) 117, 1-70, Conclusion regarding the peer review of the pesticide risk assessment of the active substance quinoclamine (finalised on 14 November 2007).

      (5)  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 416/2008 (OJ L 125, 9.5.2008, p. 25).

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

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘186

                     Bifenox
                     CAS No 42576-02-3
                     CIPAC No 413

                        Methyl 5-(2,4-dichlorophenoxy)-2-nitrobenzoate

                     ≥ 970 g/kg impurities:

                                 max. 3 g/kg 2,4-dichlorophenol

                                 max. 6 g/kg 2,4-dichloroanisole

                     1 January 2009

                     31 December 2018

                     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 bifenox, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where,

                                 —

                                 the dietary exposure of consumers to bifenox residues in products of animal origin and in succeeding rotational crops.

                           The Member States concerned shall request the submission of:

                                 —

                                 information on residues of bifenox and its metabolite hydroxy bifenox acid in food of animal origin and on residues of bifenox in rotational crops,

                                 —

                                 information to further address the long-term risk to herbivorous mammals arising from the use of bifenox.

                           They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.

                     187

                     Diflufenican
                     CAS No 83164-33-4
                     CIPAC No 462

                        2′,4′-difluoro-2-(α,α,α-trifluoro-m-tolyloxy) nicotinanilide

                     ≥ 970 g/kg

                     1 January 2009

                     31 December 2018

                     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 diflufenican, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of aquatic organisms. Risk mitigation measures such as buffer zones shall be applied, where appropriate,

                                 —

                                 the protection of non-target plants. Risk mitigation measures such as an in-field no spray buffer zones shall be applied, where appropriate.

                     188

                     Fenoxaprop-P
                     CAS No 113158-40-0
                     CIPAC No 484

                        (R)-2[4-[(6-chloro-2-benzoxazolyl)oxy]-phenoxy]-propanoic acid

                     ≥ 920 g/kg

                     1 January 2009

                     31 December 2018

                     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 fenoxaprop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

                                 —

                                 the protection of non target plants,

                                 —

                                 the presence of the safener mefenpyr-diethyl in formulated products as regards operator, worker and bystander exposure,

                                 —

                                 the persistence of the substance and of some of its degradation products in colder zones and areas where anaerobic conditions may occur.

                           Conditions of authorisation should include risk mitigation measures, where appropriate.

                     189

                     Fenpropidin
                     CAS No 67306-00-7
                     CIPAC No 520

                        (R,S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine

                     ≥ 960 g/kg (racemate)

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenpropidin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

                                 —

                                 the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zone.

                           The Member States concerned shall request the submission of:

                                 —

                                 information to further address the long-term risk to herbivorous and insectivorous birds arising from the use of fenpropidin.

                           They shall ensure that the notifier provides such confirmatory data and information to the Commission within two years from the entry into force of this Directive.

                     190

                     Quinoclamine
                     CAS No 2797-51-5
                     CIPAC No 648

                        2-amino-3-chloro-1,4-naphthoquinone

                     ≥ 965 g/kg impurity:
                     dichlone (2,3-dichloro-1,4-naphthoquinone) max. 15 g/kg

                     1 January 2009

                     31 December 2018

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing quinoclamine for uses other than ornamentals or nursery plants, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on quinoclamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 March 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator, worker and bystander safety and ensure that conditions of use prescribe the application of adequate personal protective equipment,

                                 —

                                 the protection of aquatic organisms,

                                 —

                                 the protection of birds and small mammals.

                           Conditions of use shall include adequate risk mitigation measures, where appropriate.

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


title: Commission Directive 2008/100/EC of 28 October 2008 amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions (Text with EEA relevance)

text:
               29.10.2008

               EN

               Official Journal of the European Union

               L 285/9

      COMMISSION DIRECTIVE 2008/100/EC
   of 28 October 2008
   amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs (1), and in particular Article 1(4)(a) and (j) and Article 5(2) thereof,
   After consulting the European Food Safety Authority,
   Whereas:

               (1)

               Directive 90/496/EEC specifies that fibre should be defined.

               (2)

               Conditions for nutrition claims such as ‘source of fibre’ or ‘high fibre’ are laid down in the Annex to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (2).

               (3)

               For reasons of clarity and coherence with other Community legislation that refers to that notion, it is necessary to provide a definition of ‘fibre’.

               (4)

               The definition of fibre should take into account relevant work by the Codex Alimentarius and the statement related to dietary fibre, expressed on the 6 July 2007, by the European Food Safety Authority Scientific Panel on Dietetic Products, Nutrition and Allergies.

               (5)

               Fibre has been traditionally consumed as plant material and has one or more beneficial physiological effects such as: decrease intestinal transit time, increase stool bulk, is fermentable by colonic microflora, reduce blood total cholesterol, reduce blood LDL cholesterol levels, reduce post-prandial blood glucose, or reduce blood insulin levels. Recent scientific evidence has shown that similar beneficial physiological effects may be obtained from other carbohydrate polymers that are not digestible and not naturally occurring in the food as consumed. Therefore it is appropriate that the definition of fibre should include carbohydrate polymers with one or more beneficial physiological effects.

               (6)

               The carbohydrate polymers of plant origin that meet the definition of fibre may be closely associated in the plant with lignin or other non-carbohydrate components such as phenolic compounds, waxes, saponins, phytates, cutin, phytosterols. These substances when closely associated with carbohydrate polymers of plant origin and extracted with the carbohydrate polymers for analysis of fibre may be considered as fibre. However, when separated from the carbohydrate polymers and added to a food these substances should not be considered as fibre.

               (7)

               In order to take account of new scientific and technological developments, there is a need to amend the list of energy conversion factors.

               (8)

               The FAO report of a technical workshop on food energy — methods of analysis and conversion factors indicates that 70 percent of the fibre in traditional foods is assumed to be fermentable. Therefore, it is appropriate that the average energy value for fibre should be 8 kJ/g (2 kcal/g).

               (9)

               Erythritol can be used in a wide variety of foods and its use is, among others, as a replacement for nutrients such as sugar where lower energy value is desired.

               (10)

               Erythritol is a polyol, and according to the current rules as provided for in Article 5(1) of Directive 90/496/EEC, its energy would be calculated using the conversion factor for polyols, namely 10 kJ/g (2,4 kcal/g). Using this energy conversion factor would not fully inform the consumer about the reduced energy value of a product achieved by the use of erythritol in its manufacture. The Scientific Committee on Food in its opinion on erythritol, expressed on 5 March 2003, noted that the energy provided by erythritol was less than 0,9 kJ/g (less than 0,2 kcal/g). Therefore it is appropriate to adopt a suitable energy conversion factor for erythritol.

               (11)

               The Annex to Directive 90/496/EEC lists the vitamins and minerals which may be declared as part of the nutrition labelling, specifies their recommended daily allowances (RDAs) and defines a rule of what constitutes a significant amount. The purpose of this RDA list is to provide values for nutrition labelling and the calculation of what constitutes a significant amount.

               (12)

               The rule on significant amount as defined in the Annex to Directive 90/496/EEC constitutes a reference in other Community legislation, in particular in Article 8(3) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (3), in the Annex to Regulation (EC) No 1924/2006 and in Article 6(6) of Regulation (EC) No 1925/2006 of the European Parliament and the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (4).

               (13)

               The RDAs listed in the Annex to Directive 90/496/EEC are based on the recommendation of the FAO/WHO expert consultation meeting in Helsinki in 1988.

               (14)

               In order to ensure coherence with other Community legislation, the current list of vitamins and minerals and their RDAs should be updated in the light of scientific developments since 1988.

               (15)

               The Scientific Committee on Food in its opinion on the revision of reference values for nutrition labelling, expressed on 5 March 2003, included reference labelling values for adults. This opinion covers the vitamins and minerals listed in Annex I to Directive 2002/46/EC and in Annex I to Regulation (EC) No 1925/2006.

               (16)

               The Annex to Directive 90/496/EEC should therefore be amended accordingly.

               (17)

               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
   Directive 90/496/EEC is amended as follows:

               1.

               In Article 1(4)(j) the following sentence is added:
               ‘The definition of the material and if necessary the methods of analysis shall be included in Annex II;’;

               2.

               The following indents are added in Article 5(1):

                           ‘—

                           fibre 2 kcal/g — 8 kJ/g

                           —

                           erythritol 0 kcal/g — 0 kJ/g.’;

               3.

               The Annex is replaced by the text in Annex I to this Directive;

               4.

               The text in Annex II to this Directive is added.

         Article 2
   1.   Member States shall bring into force by 31 October 2009 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 in such a way as to prohibit, with effect from 31 October 2012, the trade in products which do not comply with Directive 90/496/EEC, as amended by 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 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 20th 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, 28 October 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 276, 6.10.1990, p. 40.

      (2)  OJ L 12, 18.1.2007, p. 3.

      (3)  OJ L 183, 12.7.2002, p. 51.

      (4)  OJ L 404, 30.12.2006, p. 26.

      ANNEX I
      The Annex to Directive 90/496/EEC is replaced by the following:

            ‘ANNEX I
            Vitamins and minerals which may be declared and their recommended daily allowances (RDAs)

                        Vitamin A (μg)

                        800

                        Vitamin D (μg)

                        5

                        Vitamin E (mg)

                        12

                        Vitamin K (μg)

                        75

                        Vitamin C (mg)

                        80

                        Thiamin (mg)

                        1,1

                        Riboflavin (mg)

                        1,4

                        Niacin (mg)

                        16

                        Vitamin B6 (mg)

                        1,4

                        Folic acid (μg)

                        200

                        Vitamin B12 (μg)

                        2,5

                        Biotin (μg)

                        50

                        Pantothenic acid (mg)

                        6

                        Potassium (mg)

                        2 000

                        Chloride (mg)

                        800

                        Calcium (mg)

                        800

                        Phosphorus (mg)

                        700

                        Magnesium (mg)

                        375

                        Iron (mg)

                        14

                        Zinc (mg)

                        10

                        Copper (mg)

                        1

                        Manganese (mg)

                        2

                        Fluoride (mg)

                        3,5

                        Selenium (μg)

                        55

                        Chromium (μg)

                        40

                        Molybdenum (μg)

                        50

                        Iodine (μg)

                        150

                  As a rule, 15 % of the recommended allowance specified in this Annex supplied by 100 g or 100 ml or per package if the package contains only a single portion should be taken into consideration in deciding what constitutes a significant amount.’

      ANNEX II
      The following Annex II is added to Directive 90/496/EEC:

            ‘ANNEX II
            Definition of the material constituting fibre and methods of analysis as referred to in Article 1(4)(j)
            Definition of the material constituting fibre
            For the purposes of this Directive “fibre” means carbohydrate polymers with three or more monomeric units, which are neither digested nor absorbed in the human small intestine and belong to the following categories:

                        —

                        edible carbohydrate polymers naturally occurring in the food as consumed;

                        —

                        edible carbohydrate polymers which have been obtained from food raw material by physical, enzymatic or chemical means and which have a beneficial physiological effect demonstrated by generally accepted scientific evidence;

                        —

                        edible synthetic carbohydrate polymers which have a beneficial physiological effect demonstrated by generally accepted scientific evidence.’