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31978L0522

Twenty-second Commission Directive 78/522/EEC of 30 May 1978 amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 159 , 17/06/1978 P. 0043 - 0044 Greek special edition: Chapter 03 Volume 21 P. 0154

****( 1 ) OJ NO L 270 , 14 . 12 . 1970 , P . 1 .  ( 2 ) OJ NO L 40 , 10 . 2 . 1978 , P . 19 .    TWENTY-SECOND COMMISSION DIRECTIVE   OF 30 MAY 1978   AMENDING THE ANNEXES TO COUNCIL DIRECTIVE 70/524/EEC CONCERNING ADDITIVES IN FEEDINGSTUFFS  ( 78/522/EEC )   THE COMMISSION OF THE EUROPEAN COMMUNITIES ,   HAVING REGARD TO THE TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY ,   HAVING REGARD TO COUNCIL DIRECTIVE 70/524/EEC OF 23 NOVEMBER 1970 CONCERNING ADDITIVES IN FEEDINGSTUFFS ( 1 ), AS LAST AMENDED BY THE TWENTY-FIRST COMMISSION DIRECTIVE 78/117/EEC ( 2 ), AND IN PARTICULAR ARTICLE 6 THEREOF ,   WHEREAS THE ABOVEMENTIONED DIRECTIVE PROVIDES FOR THE CONTENT OF THE ANNEXES TO BE SUBJECT TO CONSTANT REVISION IN THE LIGHT OF THE DEVELOPMENT OF SCIENTIFIC AND TECHNICAL KNOWLEDGE ;   WHEREAS , FOLLOWING WIDE EXPERIMENTATION , RONIDAZOLE AND IPRONIDAZOLE , BOTH HITHERTO ENTERED UNDER ANNEX II , CAN BE AUTHORIZED , UNDER CERTAIN CONDITIONS , FOR USE AT COMMUNITY LEVEL IN TURKEY FEEDINGSTUFFS ; WHEREAS FURTHERMORE IT IS NECESSARY TO ADJUST THE CONDITIONS OF USE SHOWN IN ANNEX I FOR DIMETRIDAZOLE ;   WHEREAS IT APPEARS THAT THE USE OF DIMETRIDAZOLE , AND RONIDAZOLE ALLOWED UNDER ANNEX II FOR CERTAIN SPECIES , REQUIRES FURTHER TESTING ; WHEREAS THE PERIOD DURING WHICH THE MEMBER STATES MAY AUTHORIZE THEIR USE FOR THESE SPECIES SHOULD THEREFORE BE EXTENDED ;   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 ANNEXES TO COUNCIL DIRECTIVE 70/524/EEC ARE HEREBY AMENDED AS FOLLOWS :   1 . IN ANNEX I , PART D ' COCCIDIOSTATS AND OTHER MEDICINAL SUBSTANCES ' ,  ( A ) ITEM NO E 754 ' DIMETRIZADOLE '  IS AMENDED TO READ AS FOLLOWS :    //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES  //  CHEMICAL NAME , DESCRIPTION  //  ANIMAL SPECIES  //  MAXIMUM AGE //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS  //  // E 754 //  DIMETRI- DAZOLE //  1,2-DIMETHYL-5- NITROIMIDAZOLE //  TURKEYS GUINEA FOWL //  //  100 125 //  200 150 //  USE PROHIBITED FROM LAYING AGE ONWARDS AND AT LEAST SIX DAYS BEFORE SLAUGHTER RESPECTIVELY //  ( B ) THE FOLLOWING ITEMS ARE ADDED :    //   //  //  //  //  //  //  MINIMUM CONTENT //  MAXIMUM CONTENT //   // EEC NO  //  ADDITIVES  //  CHEMICAL NAME , DESCRIPTION  //  ANIMAL SPECIES  //  MAXIMUM AGE //  PPM OF COMPLETE FEEDINGSTUFF //  OTHER PROVISIONS  //  // E 759 //  RONIDAZOLE //  ( 1-METHYL-5-NITRO- IMIDAZOL-2-YL)- METHYL- CARBAMATE //  TURKEYS //  //  60 //  90 //  USE PROHIBITED FROM LAYING AGE ONWARDS AND AT LEAST SIX DAYS BEFORE SLAUGHTER RESPECTIVELY // E 760 //  IPRONIDAZOLE //  1-METHYL-2-ISO- PROPYL-5-NITRO- IMIDAZOLE //  TURKEYS //  //  50 //  85 //  USE PROHIBITED FROM LAYING AGE ONWARDS AND AT LEAST SIX DAYS BEFORE SLAUGHTER RESPECTIVELY //   2 . IN ANNEX II , PART B ' COCCIDIOSTATS AND OTHER MEDICINAL SUBSTANCES ' , THE DATE ' 30 JUNE 1978 '  SHOWN IN THE ' PERIOD OF AUTHORIZATION '  COLUMN SHALL READ ' 31 DECEMBER 1978 '  FOR THE FOLLOWING ITEMS :   NO 2 DIMETRIDAZOLE ,   NO 12 RONIDAZOLE ( IN THE CASE OF PIGS ONLY ).   ARTICLE 2   MEMBER STATES SHALL BRING INTO FORCE THE LAWS , REGULATIONS OR ADMINISTRATIVE PROVISIONS NECESSARY TO COMPLY WITH ARTICLE 1 ( 1 ) WITH EFFECT FROM 1 JULY 1978 AND SHALL IMMEDIATELY INFORM THE COMMISSION THEREOF .   ARTICLE 3   THIS DIRECTIVE IS ADDRESSED TO THE MEMBER STATES .   DONE AT BRUSSELS , 30 MAY 1978 .   FOR THE COMMISSION   FINN GUNDELACH   VICE-PRESIDENT


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31993L0026

Commission Directive 93/26/EEC of 4 June 1993 amending Council Directive 82/471/EEC concerning certain products used in animal nutrition

Official Journal L 179 , 22/07/1993 P. 0002 - 0004 Finnish special edition: Chapter 3 Volume 51 P. 0022  Swedish special edition: Chapter 3 Volume 51 P. 0022

COMMISSION DIRECTIVE 93/26/EEC of 4 June 1993 amending Council Directive 82/471/EEC concerning certain products used in animal nutritionTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 82/471/EEC of 30 June 1992 concerning certain products used in animal nutrition (1), as last amended by Council Directive 90/654/EEC (2), and in particular Article 6 thereof,  Whereas Directive 82/471/EEC provides for regular amendment of the content of the Annex thereto as a result of developments in scientific or technical knowledge;  Whereas it has been found necessary to alter provisions concerning the declaration on the label of compound feedingstuffs of products in the Annex belonging to the group 'hydroxyanalogues of amino acids';  Whereas a new technique enables to protect amino acids in order to avoid their degradation in the rumen of dairy cows and therefore to increase the availability of these nutriments in the intestine; whereas the use of protected amino acids appeared  particular benefic for the dairy cow, the use of these products in animal nutrition should, therefore, be permitted;  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 Annex to Directive 82/471/EEC is amended as set out in the Annex hereto.  Article 2  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 1 not later than 31 March 1994. They shall immediately inform the Commission thereof.  When Member States adopt these measures, 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 is addressed to the Member States.  Done at Brussels, 4 June 1993.  For the Commission René STEICHEN Member of the Commission (1) OJ No L 213, 21. 7. 1982, p. 8.  (2) OJ No L 353, 17. 12. 1990, p. 48.    ANNEX  1. In the group 3 'Amino acids and their salts':  (a) In point 3.1 'Methionine' the following product is added:   /* Tables: see OJ */        /* Tables: see OJ */        /* Tables: see OJ */


title: Directive 2009/54/EC of the European Parliament and of the Council of 18 June 2009 on the exploitation and marketing of natural mineral waters (Recast) (Text with EEA relevance)

text:
               26.6.2009

               EN

               Official Journal of the European Union

               L 164/45

      DIRECTIVE 2009/54/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 18 June 2009
   on the exploitation and marketing of natural mineral waters
   (Recast)
   (Text with EEA relevance)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with procedure laid down in Article 251 of the Treaty (2),
   Whereas:

               (1)

               Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity.

               (2)

               The laws of the Member States define natural mineral waters. Those laws lay down the terms on which natural mineral waters are recognised as such and govern the conditions for exploiting springs. They furthermore prescribe specific rules for marketing the waters in question.

               (3)

               The differences between those laws hinder the free movement of natural mineral waters, creating disparate competitive situations, and consequently directly affect the functioning of the internal market.

               (4)

               In this particular case, the elimination of these barriers may be achieved both by an obligation on each Member State to allow the marketing in its territory of the natural mineral waters recognised as such by each of the other Member States and by laying down common rules concerning in particular the microbiological requirements to be fulfilled and the conditions in which specific names must be used for certain of the mineral waters.

               (5)

               The primary purposes of any rules on natural mineral waters should be to protect the health of consumers, to prevent consumers from being misled and to ensure fair trading.

               (6)

               Pending the conclusion of agreements on mutual recognition of natural mineral waters between the Community and third countries, the terms should be laid down on which, until implementation of those agreements, similar products imported from third countries may be allowed to enter the Community as natural mineral waters.

               (7)

               Care should be taken to ensure that natural mineral waters retain at the marketing stage those characteristics which enabled them to be recognised as such. Therefore, the containers used for packaging them should have suitable closures.

               (8)

               In respect of labelling, natural mineral waters are subject to the general rules laid down by Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (5). Accordingly, this Directive may be limited to laying down the additions and derogations which should be made to those general rules.

               (9)

               The inclusion of the statement of the analytical composition of a natural mineral water should be compulsory in order to ensure that consumers are informed.

               (10)

               The measures necessary for the implementation of this Directive should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (6).

               (11)

               In particular, the Commission should be empowered to adopt limits for the concentrations of constituents of natural mineral waters, any necessary provisions for the indication on the labelling of high levels of certain constituents, the conditions of use of ozone-enriched air for the treatment of natural mineral water, information on the treatments of natural mineral water, methods of analysis to determine the absence of pollution of natural mineral waters, and the sampling procedures and methods of analysis necessary for checking the microbiological characteristics of natural mineral waters. Since those measures are of general scope and are designed to amend non-essential elements of this Directive, inter alia, by supplementing it, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

               (12)

               When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of amendments to this Directive necessary in order to ensure the protection of public health.

               (13)

               The new elements introduced into this Directive only concern the committee procedures. They therefore do not need to be transposed by the Member States.

               (14)

               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 IV, Part B,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   1.   This Directive concerns waters extracted from the ground of a Member State and recognised by the responsible authority of that Member State as natural mineral waters satisfying the provisions of Annex I, Section I.
   2.   This Directive also concerns waters extracted from the ground of a third country, imported into the Community and recognised as natural mineral waters by the responsible authority of a Member State.
   The waters referred to in the first subparagraph may be so recognised only if the responsible authority in the country of extraction has certified that they satisfy the provisions of Annex I, Section I, and that regular checks are made on the application of the provisions of Annex II, point 2.
   The validity of the certification referred to in the second subparagraph may not exceed a period of five years. It shall not be necessary to repeat the recognition procedure referred to in the first subparagraph if the certification is renewed before the end of that period.
   3.   This Directive shall not apply to:

               (a)

               waters which are medicinal products within the meaning of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (7);

               (b)

               natural mineral waters used at source for curative purposes in thermal or hydromineral establishments.

         4.   The grounds for granting the recognition referred to in paragraphs 1 and 2 shall be stated in due form by the responsible authority of the Member State and shall be officially published.
   5.   Each Member State shall inform the Commission of the cases where the recognition referred to in paragraphs 1 and 2 has been granted or withdrawn. The list of natural mineral waters so recognised shall be published in the Official Journal of the European Union.
   Article 2
   Member States shall take the measures necessary to ensure that only the waters referred to in Article 1 which comply with the provisions of this Directive may be marketed as natural mineral waters.
   Article 3
   Natural mineral water springs may be exploited and their waters bottled only in accordance with Annex II.
   Article 4
   1.   Natural mineral water, in its state at source, may not be the subject of any treatment other than:

               (a)

               the separation of its unstable elements, such as iron and sulphur compounds, by filtration or decanting, possibly preceded by oxygenation, in so far as this treatment does not alter the composition of the water as regards the essential constituents which give it its properties;

               (b)

               the separation of iron, manganese and sulphur compounds and arsenic from certain natural mineral waters by treatment with ozone-enriched air in so far as such treatment does not alter the composition of the water as regards the essential constituents which give it its properties, and provided that:

                           (i)

                           the treatment complies with the conditions for use to be laid down by the Commission following consultation of the European Food Safety Authority, established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (8);

                           (ii)

                           the treatment is notified to, and specifically controlled by, the competent authorities;

               (c)

               the separation of undesirable constituents other than those specified in points (a) or (b), in so far as this treatment does not alter the composition of the water as regards the essential constituents which give it its properties, and provided that:

                           (i)

                           the treatment complies with the conditions for use to be laid down by the Commission following consultation of the European Food Safety Authority;

                           (ii)

                           the treatment is notified to, and specifically controlled by, the competent authorities;

               (d)

               the total or partial elimination of free carbon dioxide by exclusively physical methods.

         The measures referred to in points (b)(i) and (c)(i), designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(2).
   The first subparagraph shall not constitute a bar to the utilisation of natural mineral waters and spring waters in the manufacture of soft drinks.
   2.   Natural mineral water, in its state at source, may not be the subject of any addition other than the introduction or the reintroduction of carbon dioxide under the conditions laid down in Annex I, Section III.
   3.   Any disinfection treatment by whatever means and, subject to paragraph 2, the addition of bacteriostatic elements or any other treatment likely to change the viable colony count of the natural mineral water, shall be prohibited.
   Article 5
   1.   The revivable total colony count of a natural mineral water at source shall conform to its normal viable colony count and give satisfactory evidence of the protection of the source against all contamination. This total colony count shall be determined under the conditions laid down in Annex I, Section II, point 1.3.3.
   After bottling, the total colony count at source may not exceed 100 per millilitre at 20 to 22 °C in 72 hours on agar-agar or an agar-gelatine mixture and 20 per millilitre at 37 °C in 24 hours on agar-agar. The total colony count shall be measured within the 12 hours following bottling, the water being maintained at 4 °C ± 1 °C during this 12-hour period.
   At source, those values must not normally exceed 20 per millilitre at 20 to 22 °C in 72 hours and 5 per millilitre at 37 °C in 24 hours respectively, on the understanding that they shall be considered as guide figures and not as maximum permitted concentrations.
   2.   At source and during its marketing, a natural mineral water shall be free from:

               (a)

               parasites and pathogenic micro-organisms;

               (b)

                  Escherichia coli and other coliforms and faecal streptococci in any 250 ml sample examined;

               (c)

               sporulated sulphite-reducing anaerobes in any 50 ml sample examined;

               (d)

                  Pseudomonas aeruginosa in any 250 ml sample examined.

         3.   Without prejudice to paragraphs 1 and 2 and the conditions of exploitation laid down in Annex II, at the marketing stage:

               (a)

               the revivable total colony count of a natural mineral water may only be that resulting from the normal increase in the bacterial count which it had at source;

               (b)

               the natural mineral water may not contain any organoleptic defects.

         Article 6
   Any containers used for packaging natural mineral waters shall be fitted with closures designed to avoid any possibility of adulteration or contamination.
   Article 7
   1.   The sales description of natural mineral waters shall be ‘natural mineral water’ or, in the case of an effervescent natural mineral water as defined in Annex I, Section III, as appropriate, ‘naturally carbonated natural mineral water’, ‘natural mineral water fortified with gas from the spring’ or ‘carbonated natural mineral water’.
   The sales description of natural mineral waters which have undergone any of the treatments referred to in point (d) of the first subparagraph of Article 4(1) shall have added to it, as appropriate, the indication ‘fully de-carbonated’ or ‘partially de-carbonated’.
   2.   Labels on natural mineral waters shall also give the following mandatory information:

               (a)

               a statement of the analytical composition, giving its characteristic constituents;

               (b)

               the place where the spring is exploited and the name of the spring;

               (c)

               information on any treatments referred to in points (b) and (c) of the first subparagraph of Article 4(1).

         3.   In the absence of Community provisions on information on any treatments referred to in paragraph 2(c), Member States may maintain their national provisions.
   Article 8
   1.   The name of a locality, hamlet or place may occur in the wording of a trade description provided that it refers to a natural mineral water the spring of which is exploited at the place indicated by that description and provided that it is not misleading as regards the place of exploitation of the spring.
   2.   It shall be prohibited to market natural mineral water from one and the same spring under more than one trade description.
   3.   When the labels or inscriptions on the containers in which the natural mineral waters are offered for sale include a trade description different from the name of the spring or the place of its exploitation, that place of exploitation or the name of the spring shall be indicated in letters at least one and a half times the height and width of the largest of the letters used for that trade description.
   The first subparagraph shall apply, mutatis mutandis and with the same intention as regards the importance attributed to the name of the spring or the place of its exploitation, with regard to the trade description used in advertising, in whatsoever form, relating to natural mineral waters.
   Article 9
   1.   It shall be prohibited, both on packaging or labels and in advertising in any form whatsoever, to use indications, designations, trade marks, brand names, pictures or other signs, whether figurative or not, which:

               (a)

               in the case of a natural mineral water, suggest a characteristic which the water does not possess, in particular as regards its origin, the date of the authorisation to exploit it, the results of analyses or any similar references to guarantees of authenticity;

               (b)

               in the case of drinking water packaged in containers, which does not satisfy the provisions of Annex I, Section I, are liable to cause confusion with a natural mineral water, in particular the description ‘mineral water’.

         2.   All indications attributing to a natural mineral water properties relating to the prevention, treatment or cure of a human illness shall be prohibited.
   However, the indications listed in Annex III shall be authorised if they meet the relevant criteria laid down in that Annex or, in the absence thereof, criteria laid down in national provisions and provided that they have been drawn up on the basis of physico-chemical analyses and, where necessary, pharmacological, physiological and clinical examinations carried out according to recognised scientific methods, in accordance with Annex I, Section I, point 2.
   Member States may authorise the indications ‘stimulates digestion’, ‘may facilitate the hepato-biliary functions’ or similar indications. They may also authorise the inclusion of other indications, provided that the latter do not conflict with the principles provided for in the first subparagraph and are compatible with those provided for in the second subparagraph.
   3.   Member States may adopt special provisions regarding indications — both on packaging or labels and in advertising — concerning the suitability of a natural mineral water for the feeding of infants. Such provisions may also concern the properties of the water which determine the use of those indications.
   Member States which intend taking such measures shall inform the other Member States and the Commission of them beforehand.
   4.   The term ‘spring water’ shall be reserved for a water which is intended for human consumption in its natural state, and bottled at source, which:

               (a)

               satisfies the conditions of exploitation laid down in Annex II, points 2 and 3, which shall be fully applicable to spring waters;

               (b)

               satisfies the microbiological requirements laid down in Article 5;

               (c)

               satisfies the labelling requirements of Article 7(2), points (b) and (c), and Article 8;

               (d)

               has not undergone any treatment other than those referred to in Article 4. Other treatments may be authorised by the Commission.

         The measures referred to in point (d), designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(2).
   In addition, spring waters shall comply with the provisions of Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (9).
   5.   In the absence of Community provisions on the treatment for spring waters referred to in point (d) of the first subparagraph of paragraph 4, Member States may maintain their national provisions on the treatments.
   Article 10
   Member States shall adopt the measures necessary to ensure that trade in natural mineral waters which comply with the definitions and rules laid down in this Directive cannot be impeded by the application of non-harmonised national provisions governing the properties, composition, conditions of exploitation, packaging, labelling or advertising of natural mineral waters or foodstuffs in general.
   Article 11
   1.   Where a Member State has detailed grounds for considering that a natural mineral water does not comply with the provisions laid down in this Directive, or endangers public health, albeit freely circulating in one or more Member States, that Member State may temporarily restrict or suspend trade in that product within its territory. It shall immediately inform the Commission and the other Member States thereof and give reasons for its decision.
   2.   At the request of any Member State or the Commission, the Member State which has recognised that water shall provide all relevant information concerning recognition of that water, together with the results of the regular checks.
   3.   The Commission shall examine as soon as possible the grounds adduced by the Member State referred to in paragraph 1 within the Standing Committee referred to in Article 14(1), and shall deliver its opinion forthwith and take appropriate measures.
   4.   If the Commission considers that amendments to this Directive are necessary in order to ensure the protection of public health, it shall adopt those amendments.
   Those measures, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(2). On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 14(3).
   The Member State which has adopted safeguard measures may, in that event, retain them until the amendments have been adopted.
   Article 12
   The following measures shall be adopted by the Commission:

               (a)

               limits for the concentrations of constituents of natural mineral waters;

               (b)

               any necessary provisions for the indication on the labelling of high levels of certain constituents;

               (c)

               the conditions of use of ozone-enriched air referred to in point (b) of the first subparagraph of Article 4(1);

               (d)

               the information on the treatments referred to in Article 7(2)(c);

               (e)

               methods of analysis, including limits of detection, to verify the absence of pollution of natural mineral waters;

               (f)

               the sampling procedures and the methods of analysis necessary for checking the microbiological characteristics of natural mineral waters.

         Those measures, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(2).
   Article 13
   Any decision likely to have an effect on public health shall be adopted by the Commission following consultation of the European Food Safety Authority.
   Article 14
   1.   The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002.
   2.   Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   3.   Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
   Article 15
   This Directive shall not apply to natural mineral waters intended for export to third countries.
   Article 16
   Directive 80/777/EEC, as amended by the acts listed in Annex IV, Part A, is hereby 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 IV, 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 V.
   Article 17
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 18
   This Directive is addressed to the Member States.

      Done at Brussels, 18 June 2009.

            For the European Parliament

            The President

         H.-G. PÖTTERING

            For the Council

            The President

         Š. FÜLE

      (1)  OJ C 162, 25.6.2008, p. 87.

      (2)  Opinion of the European Parliament of 23 September 2008 (not yet published in the Official Journal) and Council Decision of 28 May 2009.

      (3)  OJ L 229, 30.8.1980, p. 1.

      (4)  See Annex IV, Part A.

      (5)  OJ L 109, 6.5.2000, p. 29.

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

      (7)  OJ L 311, 28.11.2001, p. 67.

      (8)  OJ L 31, 1.2.2002, p. 1.

      (9)  OJ L 330, 5.12.1998, p. 32.

      ANNEX I
      I.   DEFINITION

                  1.

                  ‘Natural mineral water’ means microbiologically wholesome water, within the meaning of Article 5, originating in an underground water table or deposit and emerging from a spring tapped at one or more natural or bore exits.
                  Natural mineral water can be clearly distinguished from ordinary drinking water:

                              (a)

                              by its nature, which is characterised by its mineral content, trace elements or other constituents and, where appropriate, by certain effects;

                              (b)

                              by its original purity,

                        both characteristics having been preserved intact because of the underground origin of such water, which has been protected from all risk of pollution.

                  2.

                  The characteristics referred to in point 1, which may give natural mineral water properties favourable to health, shall have been assessed:

                              (a)

                              from the following points of view:

                                          (i)

                                          geological and hydrological;

                                          (ii)

                                          physical, chemical and physico-chemical;

                                          (iii)

                                          microbiological;

                                          (iv)

                                          if necessary, pharmacological, physiological and clinical;

                              (b)

                              according to the criteria listed in Section II;

                              (c)

                              according to scientific methods approved by the responsible authority.

                        The analyses referred to in point (a)(iv) of the first subparagraph may be optional where the water presents the compositional characteristics on the strength of which it was considered a natural mineral water in the Member State of origin prior to 17 July 1980. This is the case in particular when the water in question contains, per kg, both at source and after bottling, a minimum of 1 000 mg of total solids in solution or a minimum of 250 mg of free carbon dioxide.

                  3.

                  The composition, temperature and other essential characteristics of natural mineral water shall remain stable within the limits of natural fluctuation; in particular, they shall not be affected by possible variations in the rate of flow.
                  Within the meaning of Article 5(1), the normal viable colony count of natural mineral water means the reasonably constant total colony count at source before any treatment, the qualitative and quantitative composition of which, as taken into account in the recognition of that water, is checked by periodic analysis.

            II.   REQUIREMENTS AND CRITERIA FOR APPLYING THE DEFINITION

      1.1.   Requirements for geological and hydrological surveys

      There shall be a requirement to supply the following particulars:

                  1.1.1.

                  the exact site of the catchment with indication of its altitude, on a map with a scale of not more than 1:1 000;

                  1.1.2.

                  a detailed geological report on the origin and nature of the terrain;

                  1.1.3.

                  the stratigraphy of the hydrogeological layer;

                  1.1.4.

                  a description of the catchment operations;

                  1.1.5.

                  the demarcation of the area or details of other measures protecting the spring against pollution.

            1.2.   Requirements for physical, chemical and physico-chemical surveys

      These surveys shall establish:

                  1.2.1.

                  the rate of flow of the spring;

                  1.2.2.

                  the temperature of the water at source and the ambient temperature;

                  1.2.3.

                  the relationship between the nature of the terrain and the nature and type of minerals in the water;

                  1.2.4.

                  the dry residues at 180 °C and 260 °C;

                  1.2.5.

                  the electrical conductivity or resistivity, with the measurement temperature having to be specified;

                  1.2.6.

                  the hydrogen ion concentration (pH);

                  1.2.7.

                  the anions and cations;

                  1.2.8.

                  the non-ionised elements;

                  1.2.9.

                  the trace elements;

                  1.2.10.

                  the radio-actinological properties at source;

                  1.2.11.

                  where appropriate, the relative isotope levels of the constituent elements of water, oxygen (16O — 18O) and hydrogen (protium, deuterium, tritium);

                  1.2.12.

                  the toxicity of certain constituent elements of the water, taking account of the limits laid down for each of them.

            1.3.   Criteria for microbiological analyses at source

      These analyses shall include:

                  1.3.1.

                  a demonstration of the absence of parasites and pathogenic micro-organisms;

                  1.3.2.

                  a quantitative determination of the revivable colony count indicative of faecal contamination:

                              (a)

                              absence of Escherichia coli and other coliforms in 250 ml at 37 °C and 44,5 °C;

                              (b)

                              absence of faecal streptococci in 250 ml;

                              (c)

                              absence of sporulated sulphite-reducing anaerobes in 50 ml;

                              (d)

                              absence of Pseudomonas aeruginosa in 250 ml;

                  1.3.3.

                  determination of the revivable total colony count per ml of water:

                              (a)

                              at 20 to 22 °C in 72 hours on agar-agar or an agar-gelatine mixture;

                              (b)

                              at 37 °C in 24 hours on agar-agar.

            1.4.   Requirements for clinical and pharmacological analyses

                  1.4.1.

                  The analyses, which shall be carried out in accordance with scientifically recognised methods, shall be suited to the particular characteristics of the natural mineral water and its effects on the human organism, such as diuresis, gastric and intestinal functions, compensation for mineral deficiencies.

                  1.4.2.

                  The establishment of the consistency and concordance of a substantial number of clinical observations may, if appropriate, take the place of the analyses referred to in point 1.4.1. Clinical analyses may, in appropriate cases, take the place of the analyses referred to in point 1.4.1 provided that the consistency and concordance of a substantial number of observations enable the same results to be obtained.

            III.   SUPPLEMENTARY QUALIFICATIONS RELATING TO EFFERVESCENT NATURAL MINERAL WATERS

      At source or after bottling, effervescent natural mineral waters give off carbon dioxide spontaneously and in a clearly visible manner under normal conditions of temperature and pressure. They fall into three categories to which the following reserved designations respectively shall apply:

                  (a)

                  ‘naturally carbonated natural mineral water’ means water the carbon dioxide content of which from the spring after decanting, if any, and bottling is the same as at source, taking into account where appropriate the reintroduction of a quantity of carbon dioxide from the same water table or deposit equivalent to that released in the course of those operations and subject to the usual technical tolerances;

                  (b)

                  ‘natural mineral water fortified with gas from the spring’ means water the carbon dioxide content of which from the same water table or the same deposit after decanting, if any, and bottling is greater than that established at source;

                  (c)

                  ‘carbonated natural mineral water’ means water to which has been added carbon dioxide of an origin other than the water table or deposit from which the water comes.

      ANNEX II

         CONDITIONS FOR EXPLOITATION AND MARKETING OF NATURAL MINERAL WATER

                  1.

                  Exploitation of a natural mineral water spring shall be subject to permission from the responsible authority of the country where the water has been extracted, after it has been established that the water in question complies with the provisions laid down in Annex I, Section I.

                  2.

                  Equipment for exploiting the water shall be so installed as to avoid any possibility of contamination and to preserve the properties, corresponding to those ascribed to it, which the water possesses at source.
                  To that end, in particular:

                              (a)

                              the spring or outlet shall be protected against the risks of pollution;

                              (b)

                              the catchment, pipes and reservoirs shall be of materials suitable for water and so built as to prevent any chemical, physico-chemical or microbiological alteration of the water;

                              (c)

                              the conditions of exploitation, particularly the washing and bottling equipment, shall meet hygiene requirements; in particular, the containers shall be so treated or manufactured as to avoid adverse effects on the microbiological and chemical characteristics of the natural mineral water;

                              (d)

                              the transport of natural mineral water in containers other than those authorised for distribution to the ultimate consumer shall be prohibited.

                        However, point (d) need not be applied to mineral waters extracted, exploited and marketed in the territory of a Member State if, in that Member State on 17 July 1980, transport of the natural mineral water in tanks from the spring to the bottling plant was authorised.
                  Similarly, point (d) need not be applied to spring waters extracted, exploited and marketed in the territory of a Member State if, in that Member State on 13 December 1996, transport of the spring water in tanks from the spring to the bottling plant was authorised.

                  3.

                  Where it is found during exploitation that the natural mineral water is polluted and no longer presents the microbiological characteristics laid down in Article 5, the person exploiting the spring shall forthwith suspend all exploitation, particularly the bottling process, until the cause of pollution is eradicated and the water complies with the provisions of Article 5.

                  4.

                  The responsible authority in the country of origin shall carry out periodic checks to see whether:

                              (a)

                              the natural mineral water in respect of which exploitation of the spring has been authorised complies with the provisions of Annex I, Section I;

                              (b)

                              the provisions of points 2 and 3 are being applied by the person exploiting the spring.

      ANNEX III

         INDICATIONS AND CRITERIA LAID DOWN IN ARTICLE 9(2)

                  Indications

                  Criteria

                  Low mineral content

                  Mineral salt content, calculated as a fixed residue, not greater than 500 mg/l

                  Very low mineral content

                  Mineral salt content, calculated as a fixed residue, not greater than 50 mg/l

                  Rich in mineral salts

                  Mineral salt content, calculated as a fixed residue, greater than 1 500 mg/l

                  Contains bicarbonate

                  Bicarbonate content greater than 600 mg/l

                  Contains sulphate

                  Sulphate content greater than 200 mg/l

                  Contains chloride

                  Chloride content greater than 200 mg/l

                  Contains calcium

                  Calcium content greater than 150 mg/l

                  Contains magnesium

                  Magnesium content greater than 50 mg/l

                  Contains fluoride

                  Fluoride content greater than 1 mg/l

                  Contains iron

                  Bivalent iron content greater than 1 mg/l

                  Acidic

                  Free carbon dioxide content greater than 250 mg/l

                  Contains sodium

                  Sodium content greater than 200 mg/l

                  Suitable for the preparation of infant food

                  —

                  Suitable for a low-sodium diet

                  Sodium content less than 20 mg/l

                  May be laxative

                  —

                  May be diuretic

                  —

      ANNEX IV
      PART A

         Repealed Directive with list of its successive amendments

      (referred to in Article 16)

                  Council Directive 80/777/EEC
                  (OJ L 229, 30.8.1980, p. 1)

                  Council Directive 80/1276/EEC
                  (OJ L 375, 31.12.1980, p. 77).

                  Article 1, third indent only

                  Council Directive 85/7/EEC
                  (OJ L 2, 3.1.1985, p. 22).

                  Article 1, point 10 only

                  Point B.1.(o) of Annex I to the 1985 Act of Accession
                  (OJ L 302, 15.11.1985, p. 214).

                  Directive 96/70/EC of the European Parliament and of the Council
                  (OJ L 299, 23.11.1996, p. 26).

                  Regulation (EC) No 1882/2003 of the European Parliament and of the Council
                  (OJ L 284, 31.10.2003, p. 1).

                  Annex III, point 4 only

            PART B

         Time-limits for transposition into national law

      (referred to in Article 16)

                  Directive

                  Time-limit for transposition

                  Permission of trade in products complying with this Directive

                  Prohibition of trade in products not complying with this Directive

                  80/777/EEC

                  —

                  18 July 1982

                  18 July 1984

                  80/1276/EEC

                  —

                  —

                  —

                  85/7/EEC

                  —

                  —

                  —

                  96/70/EC

                  —

                  28 October 1997

                  28 October 1998 (1)

         (1)  However, trade in products placed on the market or labelled before the date and not conforming with this Directive may continue until stocks run out.

      ANNEX V

         CORRELATION TABLE

                  Directive 80/777/EEC

                  This Directive

                  Article 1(1)

                  Article 1(1)

                  Article 1(2)

                  Article 1(2)

                  Article 1(3), first and second indents

                  Article 1(3), points (a) and (b)

                  Article 1(4)

                  Article 1(4)

                  Article 1(5)

                  Article 1(5)

                  Article 2

                  Article 2

                  Article 3

                  Article 3

                  Article 4(1), point (a)

                  Article 4(1), first subparagraph, point (a)

                  Article 4(1), point (b), first and second indents

                  Article 4(1), first subparagraph, points (b)(i) and (ii)

                  Article 4(1), point (c), first and second indents

                  Article 4(1), first subparagraph, points (c)(i) and (ii)

                  Article 4(1), point (d)

                  Article 4(1), first subparagraph, point (d)

                  —

                  Article 4(1), second subparagraph

                  Article 4(2)

                  Article 4(2)

                  Article 4(3)

                  Article 4(3)

                  Article 4(4)

                  Article 4(1), third subparagraph

                  Article 5(1)

                  Article 5(1)

                  Article 5(2)

                  Article 5(2)

                  Article 5(3), first and second indents

                  Article 5(3), points (a) and (b)

                  Article 6

                  Article 6

                  Article 7(1)

                  Article 7(1)

                  Article 7(2)

                  Article 7(2)

                  Article 7(2a)

                  Article 7(3)

                  Article 8

                  Article 8

                  Article 9(1)

                  Article 9(1)

                  Article 9(2), points (a), (b) and (c)

                  Article 9(2), first, second and third subparagraphs

                  Article 9(3)

                  Article 9(3)

                  Article 9(4)

                  —

                  Article 9(4a), first subparagraph, first to fourth indents

                  Article 9(4), first subparagraph, points (a) to (d)

                  Article 9(4a), second subparagraph

                  Article 9(4), second subparagraph

                  Article 9(4b)

                  Article 9(5)

                  Article 10(1)

                  Article 10

                  Article 10a

                  Article 11

                  Article 11(1), first to fourth indents

                  Article 12, points (a) to (d)

                  Article 11(2), first and second indents

                  Article 12, points (e) and (f)

                  Article 11a

                  Article 13

                  Article 12(1)

                  Article 14(1)

                  Article 12(2)

                  Article 14(2) and (3)

                  Article 12(3)

                  —

                  Article 13

                  —

                  Article 14

                  Article 15

                  Article 15

                  —

                  Article 16

                  —

                  —

                  Article 16

                  —

                  Article 17

                  Article 17

                  Article 18

                  Annex I, part I, point 1

                  Annex I, part I, point 1

                  Annex I, part I, point 2, first paragraph, points (a)(1) to (4)

                  Annex I, part I, point 2, first paragraph, points (a)(i) to (iv)

                  Annex I, part I, point 2, first paragraph, point (b)

                  Annex I, part I, point 2, first paragraph, point (b)

                  Annex I, part I, point 2, first paragraph, point (c)

                  Annex I, part I, point 2, first paragraph, point (c)

                  Annex I, part I, point 2, second paragraph

                  Annex I, part I, point 2, second paragraph

                  Annex I, part I, point 3

                  Annex I, part I, point 3

                  Annex I, part II, point 1.1

                  Annex I, part II, point 1.1

                  Annex I, part II, point 1.2

                  Annex I, part II, point 1.2

                  Annex I, part II, point 1.3

                  Annex I, part II, point 1.3

                  Annex I, part II, point 1.3.1

                  Annex I, part II, point 1.3.1

                  Annex I, part II, point 1.3.2

                  Annex I, part II, point 1.3.2

                  Annex I, part II, point 1.3.3, points (i) and (ii)

                  Annex I, part II, point 1.3.3, points (a) and (b)

                  Annex I, part II, point 1.4

                  Annex I, part II, point 1.4

                  Annex I, part III

                  Annex I, part III

                  Annex II

                  Annex II

                  Annex III

                  Annex III

                  —

                  Annex IV

                  —

                  Annex V


title: Directive 2012/5/EU of the European Parliament and of the Council of 14 March 2012 amending Council Directive 2000/75/EC as regards vaccination against bluetongue

text:
               21.3.2012

               EN

               Official Journal of the European Union

               L 81/1

         DIRECTIVE 2012/5/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
   of 14 March 2012
   amending Council Directive 2000/75/EC as regards vaccination against bluetongue
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2) thereof,
   Having regard to the proposal from the European Commission,
   After transmission of the draft legislative act to the national parliaments,
   Having regard to the opinion of the European Economic and Social Committee (1),
   Acting in accordance with the ordinary legislative procedure (2),
   Whereas:

               (1)

               Council Directive 2000/75/EC of 20 November 2000 laying down specific provisions for the control and eradication of bluetongue (3) lays down control rules and measures to combat and eradicate bluetongue, including rules on the establishment of protection and surveillance zones and the use of vaccines against bluetongue.

               (2)

               In the past, only sporadic incursions of certain serotypes of the bluetongue virus were recorded in the Union. Those incursions mainly occurred in the southern parts of the Union. However, since the adoption of Directive 2000/75/EC, and particularly since the introduction into the Union of bluetongue virus serotypes 1 and 8 in the years 2006 and 2007, the bluetongue virus has become more widespread in the Union, with the potential to become endemic in certain areas. It has therefore become difficult to control the spread of that virus.

               (3)

               The rules on vaccination against bluetongue laid down in Directive 2000/75/EC are based on experience of the use of so-called ‘modified live vaccines’, or ‘live attenuated vaccines’, which were the only vaccines available when that Directive was adopted. The use of those vaccines may lead to an undesired local circulation of the vaccine virus in unvaccinated animals.

               (4)

               In recent years, as a result of new technology, ‘inactivated vaccines’ against bluetongue have become available which do not pose the risk of undesired local circulation of the vaccine virus to unvaccinated animals. The extensive use of such vaccines during the vaccination campaign in the years 2008 and 2009 has led to a significant improvement in the disease situation. It is now widely accepted that vaccination with inactivated vaccines is the preferred tool for the control of bluetongue and for the prevention of clinical disease in the Union.

               (5)

               In order to ensure better control of the spread of the bluetongue virus and to reduce the burden on the agricultural sector posed by that disease, it is appropriate to amend the current rules on vaccination laid down in Directive 2000/75/EC in order to take account of the recent technological developments in vaccine production.

               (6)

               In order to enable the vaccination season 2012 to benefit from the new rules, this Directive should enter into force on the day following its publication in the Official Journal of the European Union.

               (7)

               The amendments provided for in this Directive should make the rules on vaccination more flexible and also take into account the fact that inactivated vaccines that can also be successfully used outside areas subject to animal movement restrictions are now available.

               (8)

               In addition, and provided that appropriate precautionary measures are taken, the use of live attenuated vaccines should not be excluded, as their use might still be necessary under certain circumstances, such as following the introduction of a new bluetongue virus serotype against which inactivated vaccines may not be available.

               (9)

               Directive 2000/75/EC should therefore be amended accordingly,

         HAVE ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2000/75/EC is hereby amended as follows:

               (1)

               in Article 2, the following point is added:
               ‘(j)   “live attenuated vaccines”: vaccines which are produced by adapting bluetongue virus field isolates through serial passages in tissue culture or in embryonated hens’ eggs.’;

               (2)

               Article 5 is replaced by the following:
               ‘Article 5
               1.   The competent authority of a Member State may decide to allow the use of vaccines against bluetongue provided that:

                           (a)

                           such decision is based on the result of a specific risk assessment carried out by the competent authority;

                           (b)

                           the Commission is informed before such vaccination is carried out.

                     2.   Whenever live attenuated vaccines are used, Member States shall ensure that the competent authority demarcates:

                           (a)

                           a protection zone, consisting of at least the vaccination area;

                           (b)

                           a surveillance zone, consisting of a part of the Union territory with a depth of at least 50 kilometres extending beyond the limits of the protection zone.’;

               (3)

               in Article 6(1), point (d) is replaced by the following:

                           ‘(d)

                           implement the measures adopted in accordance with the procedure laid down in Article 20(2), in particular with regard to the introduction of any vaccination programme or other alternative measures;’;

               (4)

               in Article 8(2), point (b) is replaced by the following:

                           ‘(b)

                           The surveillance zone shall consist of a part of the Union territory with a depth of at least 50 kilometres extending beyond the limits of the protection zone and in which no vaccination against bluetongue with live attenuated vaccines has been carried out during the previous 12 months.’;

               (5)

               in Article 10, point 2 is replaced by the following:

                           ‘2.

                           any vaccination against bluetongue using live attenuated vaccines is prohibited in the surveillance zone.’.

         Article 2
   1.   Member States shall adopt and publish, by 23 September 2012 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate immediately to the Commission the text of those provisions.
   They shall apply those provisions from 24 September 2012 at the latest.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Strasbourg, 14 March 2012.

            For the European Parliament

            The President

         M. SCHULZ

            For the Council

            The President

         N. WAMMEN

      (1)  OJ C 132, 3.5.2011, p. 92.

      (2)  Position of the European Parliament of 7 April 2011 (not yet published in the Official Journal) and position of the Council at first reading of 15 December 2011 (OJ C 46 E, 17.2.2012, p. 15). Position of the European Parliament of 14 February 2012 (not yet published in the Official Journal).

      (3)  OJ L 327, 22.12.2000, p. 74.


Avis juridique important

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31993L0062

Commission Directive 93/62/EEC of 5 July 1993 setting out the implementing measures concerning the supervision and monitoring of suppliers and establishments pursuant to Council Directive 92/33/EEC on the marketing of vegetable propagating and planting material, other than seed

Official Journal L 250 , 07/10/1993 P. 0029 - 0030 Finnish special edition: Chapter 3 Volume 52 P. 0257  Swedish special edition: Chapter 3 Volume 52 P. 0257

COMMISSION DIRECTIVE 93/62/EEC of 5 July 1993 setting out the implementing measures concerning the supervision and monitoring of suppliers and establishments pursuant to Council Directive 92/33/EEC on the marketing of vegetable propagating and  planting material, other than seedTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 92/33/EEC of 28 April 1992 on the marketing of vegetable propagating and planting material, other than seed(1) , and in particular Article 6 (4) thereof,  Whereas it is appropriate so set out measures concerning the supervision and monitoring of all suppliers and their establishments, with the exception of those whose activity is confined to the placing on the market of vegetable propagating and planting  material;  Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Agricultural, Horticultural and Forestry Seeds and Plants,  HAS ADOPTED THIS DIRECTIVE:   Article 1  1.  This Directive lays down implementing measures concerning the supervision and monitoring of suppliers and their establishments, other than those whose activity is confined to the placing on the market of vegetable propagating and planting  material, pursuant to Article 6 (4) of Directive 92/33/EEC, in cases where the checks referred to in Article 5 (2) of the said Directive are carried out by the suppliers themselves or an accredited supplier.   Article 2  The responsible official body shall carry out regularly, at least once a year at an appropriate time, supervision and monitoring of suppliers and their establishments in order to ensure continued compliance with the requirements laid down in  Directive 92/33/EEC, and in particular with the principles set out in the first to fourth indents of Article 5 (2) thereof, account being taken of the particular nature of the activity or activities of the supplier.   Article 3  As far as the identification of critical points in the production process referred to in the first indent of Article 5 (2) of Directive 92/33/EEC and the keeping of records referred to in the fourth indent of Article 5 (2) thereof are  concerned, the responsible official body shall supervise and monitor the supplier to ensure that the supplier:  (a) continues to take into account the following critical points, where appropriate:  - the quality of the vegetable propagating and planting material utilized to start the production process;  - the sowing, pricking-out, potting-up, and planting of vegetable propagating and planting material,  - compliance with the conditions laid down in Articles 3, 4 and 5 of Council Directive 77/93/EEC(2) ,  - the cultivation plan and method,  - general crop care,  - the multiplication operations,  - the harvesting operations,  - hygiene,  - treatments,  - packaging,  - storage,  - transport,  - administration;  (b) keeps records, with a view to having complete information available for the said responsible official bodies, on:  (i) plants or other objects:  - purchased for storage or planting on the premises,  - under production,  or - dispatched to others;  and (ii) any chemical treatments which have been applied to the plants, and that he keeps related documents for at least one year;  (c) is available personally or designates another person technically experienced in plant production and related plant-health matters, to liaise with the said responsible official bodies;  (d) carries out visual inspections as necessary and at appropriate times in a manner accepted by the said responsible official bodies;  (e) allows access by persons entitled to act for the said responsible official bodies, in particular for inspection and/or sampling purposes, and allows access to the records and related documents referred to in point (b);  (f) otherwise cooperates with the said responsible official bodies.   Article 4  As fas as the establishment and implementation of methods for monitoring and checking the critical points as referred to in the second indent of Article 5 (2) of Directive 92/33/EEC are concerned, the responsible official body shall supervise  and monitor the supplier to ensure that, where apropriate, such methods continue to be carried out, giving particular attention to:  (a) the availability and actual use of methods for checking each of the critical points mentioned in Article 3;  (b) the reliability of those methods;  (c) their suitability for an assessment of the content of the production and marketing arrangements, including the administrative aspects; and (d) the competence of the supplier's staff to carry out the checks.   Article 5  As far as the taking of samples for analysis in an accredited laboratory as referred to in the third indent of Article 5 (2) of Directive 92/33/EEC is concerned, the responsible official body shall supervise and monitor the supplier to  ensure, where appropriate, that:  (a) samples are taken during the various stages of production at such intervals as are established by the responsible official body when the production methods were verified at the time of accreditation;  (b) samples are taken in a technically correct manner and using a statistically reliable procedure, regard being had to the kind of analysis to be carried out;  (c) the persons who take the samples are qualified to do so; and (d) the analysis of samples is carried out by a laboratory which is accredited for that purpose pursuant to Article 6 (2) of the said Directive.   Article 6  1.  Member States shall bring into force the laws, regulations or administrative provisions necessary to comply with this Directive not later than 30 June 1994. They shall forthwith inform the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  2.  Member States shall communicate to the Commission the text of the main provisions of domestic law which they adopt in the field covered by this Directive.   Article 7  This Directive is addressed to the Member States.  Done at Brussels, 5 July 1993.  For the CommissionRené STEICHENMember of the Commission  (1) OJ No L 157, 10. 6. 1992, p. 10.  (2) OJ No L 26, 31. 1. 1977, p. 20.


Avis juridique important

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31992L0095

Commission Directive 92/95/EEC of 9 November 1992 amending the Annex to the Seventh Directive 76/372/EEC establishing Community methods of analysis for the official control of feedingstuffs

Official Journal L 327 , 13/11/1992 P. 0054 - 0062 Finnish special edition: Chapter 3 Volume 45 P. 0182  Swedish special edition: Chapter 3 Volume 45 P. 0182

COMMISSION DIRECTIVE 92/95/EEC  of 9 November 1992  amending the Annex to the Seventh Directive 76/372//EEC establishing Community methods of analysis for the official control of feedingstuffsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 70/373/EEC of 20 July 1970 on the introduction of Community methods of sampling and analysis for the official control of feedingstuffs (1), as last amended by the Acts of Accession of Spain and Portugal, and in  particular Article 2 thereof,  Whereas the Seventh Commission Directive 76/372/EEC of 1 March 1976 establishing Community methods of analysis for the official control of feedingstuffs (2), as amended by Directive 81/680/EEC (3), prescribes the methods to be used for the determination  of aflatoxin B1;  Whereas there are grounds for adapting these methods in the light of advances in scientific and technical knowledge; whereas it is advisable particularly to have available a method of controlling the very low limits for aflatoxin fixed by Council  Directive 74/63/EEC of 17 December 1973 on the fixing of maximum permitted levels for undesirable substances and products in animal nutrition (4), as last amended by Directive 91/132/EEC (5);  Whereas it is also advisable to have available a method of determining aflatoxin B1 in the presence of interfering substances, such as citrus pulp;  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 Annex to Directive 76/372/EEC is amended in accordance with the Annex to this Directive.  Article 2  Member States shall bring into force not later than 1 October 1993 the laws, regulations and administrative provisions necessary to comply with the provisions of this Directive. They shall fortwith inform the Commission thereof.  When Member States adopt these provisions, they 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 the Member States.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 9 November 1992. For the Commission  Ray MAC SHARRY  Member of the Commission   (1) OJ No L 170, 3. 8. 1970, p. 2. (2) OJ No L 102, 15. 4. 1976, p. 8. (3) OJ No L 246, 29. 8. 1981, p. 32. (4) OJ No L 38, 11. 2. 1974, p. 31. (5) OJ No L 66, 13. 3. 1991, p. 16.    ANNEX  I. Under Part A 'One-dimensional thin layer chromatographic method' the text at point 1 'Purpose and scope' is replaced by the following text:  '1. Purpose and scope  The method makes it possible to determine the level of aflatoxin B1 in raw materials and straight feedingstuffs. This method can not be applied in the presence of citrus pulp. The lower limit of determination is 0,01 mg/kg (10 ppb).  In the presence of interfering substances it is necessary to repeat the analysis using method B (high performance liquid chromatography).'  II. Under Part B 'Two-dimensional thin layer chromatographic method' the text is replaced by the following:  'B. DETERMINATION OF AFLATOXIN B1. HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD   1.  Purpose and scope   This method is for the determination of aflatoxin B1 in animal feedingstuffs including those containing citrus pulp. The lower limit of determination is 0,001 mg/kg (1 ppb).  2.  Principle   The sample is extracted with  chloroform. The extract is filtered and an aliquot portion is purified on a Florisil cartridge followed by a C18 cartridge. The final separation and determination is achieved by high performance liquid chromatography (HPLC) using a reversed phase C18  column, followed by post-column derivatization with iodine in water, and fluorescence detection.   Note:   mycotoxins are extremely toxic sustances. Manipulations should be performed in a designated fume cupboard. Special precautions should be taken  when toxins are in a dry form because of their electrostatic nature and resulting tendency to disperse in working areas.  3.  Reagents  3.1.  Chloroform, stabilized with 0,5 to 1,0 % of ethanol, by mass. See observation 10.2.  3.2.  Methanol, HPLC grade  for preatation of 3.6.  3.3.  Acetone.  3.4.  Acetonitril, HPLC grade.  3.5.  Eluting solvents: Prepare one day before use, or remove air in the solvents ultrasonically.  3.5.1.  Mixture of acetone (3.3) and water, 98+2 (v+v).  3.5.2.  Mixture of water  and methanol (3.2), 80+20 (v+v).  3.5.3.  Mixture of water and acetone (3.3), 85+15 (v+v).  3.6.  Mobile phase for HPLC   Mixture of water, methanol (3.2) and acetonitril (3.4), 130+70+40 (v+v+v).   NB The composition of the mobile phase solvent may  need to be adjusted, depending on the characteristics of the HPLC column used.  3.7.  Saturated iodine solution: add 2 g of iodine to 400 ml of water. Mix for at least 90 min and filter through a membrane filter (4.15). Protect the saturated solution  from light to prevent photodegradation.  3.8.  Acid washed Celite 545, or equivalent.  3.9.  Florisil cartridge (Waters SEP-PAK), or equivalent.  3.10.  C18 cartridge (Waters SEP-PAK), or equivalent.  3.11.  Inert gas e.g. nitrogen.  3.12.  Aflatoxin B1  standard solution in chloroform, concentration 10 mg/ml. Check the concentration of the solution as follows: determine the absorption spectrum of the solution between 330 and 370 nm by means of the spectrophotometer (4.23). Measure the absorbance (A) at  the maximum near 363 nm. Calculate the concentration of aflatoxin B1 in micrograms per millilitre of solution from the formula:  Concentration (mg/ml) =  312 × A × 1000   22 300  = 13,991 × A  3.12.1.  Aflatoxine B1 stock standard solution in chloroform.   Transfer quantitatively 2,5 ml of the aflatoxin B1 standard solution (3.12) to a 50 ml volumetric flask and adjust to the mark with chloroform (3.1). Store this  solution in a cool place (4 °C) in the dark, well sealed and wrapped in aluminium foil.  3.13.  Aflatoxin B1 calibraltion solutions HPLC.   NB Use alcid-washed glassware for preparation of these solutions (see 4, Apparatus).  3.13.1.  Calibration  solution 4ng/ml.   Allow the volumetric flask with stock standard solution (3.12.1) to warm up to room temperature in the aluminium foil (a few hours). Transfer 400 ml of the stock standard solution (200 ng aflatoxin B1) into a 50 ml volumetric flask,  and evaporate the solution to dryness in a current of inet gas (3.11).   Dissolve the residue obtained in approximately 20 ml of water/acetone mixture (3.5.3), make up to the mark with the water/acetone mixture and mix well.  3.13.2.  Calibration  solution 3 ng/ml.   Transfer quantitatively 7,5 ml of the calibration solution (3.13.1) into a 10 ml volumetric flask, make up to the mark with the water/acetone mixture (3.5.3), and mix well.  3.13.3.  Calibration solution, 2 ng/ml.   Transfer  quantitatively 25 ml of the calibration solution (3.13.1) to a 50 ml volumetric flask, make up to the mark with the water/acetone mixture (3.5.3) and mix well.   This solution is also referred to as the reference standard, to be used for repetitive  injection during HPLC (5.5).  3.13.4.  Calibration solution 1 ng/ml.   Transfer quantitatively 2,5 ml of the calibration solution (3.13.1) to a 10 ml volumetric flask, make up to the mark with the water/acetone mixture (3.5.3) and mix well.  3.14.   Ampoule containing a mixture of aflatoxins B1, B2, G1 and G2 concentrations approximately 1, 0,5, 1 and 0,5 mg/ml respectively, in 1 ml chloroform.  3.14.1.  Chromatographic test solution.   Transfer the content of the ampoule (3.14) into a  glass-stoppered test-tube or screw-capped vial. Transfer 40 ml of this solution into a glass-stoppered test-tube (acid-rinsed) (4.22). Evaporate the chloroform in a stream of inert gas (3.11) and redissolve into 10 ml of the water/acetone mixture  (3.5.3).  3.15.  Reagents for confirmatory test (6).  3.15.1.  Sodium chloride saturated solution.  3.15.2.  Sodium sulphate, anhydrous, granular.  4.  Apparatus   Caution: Use of non acid-washed glassware for aqueous aflatoxin solutions may cause  losses. Particular care should be taken with new glassware and disposable glassware such as autosampler vials and Pasteur pipettes. Therefore laboratory glassware coming into contact with aqueous solutions of aflatoxins should be soaked in dilute acid  (e.g. sulfuric acid = 2 mol/l) for several hours, then rinsed well with distilled water to remove all traces of acid (e.g. three times, check with pH-paper). In practice, this treatment is necessary for the round bottomed flask (4.4), the volumetric  flasks, measuring cylinders, vials or tubes used for calibration solutions and final extracts (particularly vials for autosamplers), and Pasteur pipettes, if these are used to transfer calibration solutions or extracts.  4.1.  Grinder-mixer.  4.2.   Sieve of aperture size 1,0 mm, (ISO R 565).  4.3.  Mechanical shaker.  4.4.  Rotary vacuum evaporator, equipped with a 150 to 250 ml round bottomed flask.  4.5.  High performance liquid chromatograph, injector with a loop suitable for the injection of  250 ml. See the manufacturers instructions for partial or complete loop filling.  4.6.  HPLC analytical column: 3 mm or 5 mm C18 packing.  4.7.  Pulse-free pump for delivery of the iodine post-column reagent.  4.8.  Valco zero dead volume Tee, stainless  steel (1/16" ×0,75 mm).  4.9.  Spiral reaction coil; Teflon or stainless steel. Dimensions of 3 000 × 0,5 mm to 5 000 × 0,5 mm have been found to be appropriate in combination with 5 mm or 3mm HPLC columns.  4.10.  Thermostatically controlled water-bath  adjusted to 60 °C, capable of temperature regulation to better than 0,1 °C.  4.11.  Fluorescence detector, with excitation at 365 nm and emission at 435 nm wavelenths. (For filter instrument: emission wavelength > 400 nm). Detection of at least 0,05 ng  aflatoxin B1 shall be possible. Some back pressure may be advisable (e.g. restrictor, Teflon or stainless steel coil connected to the outlet of the detector), to suppress air bubbles in the flow-cell.  4.12.  Strip chart recorder.  4.13.  Electronic  integrator (optional).  4.14.  Fluted filter paper diameter: 24 cm, Macherey-Nagel 617 1/4 or equivalent.  4.15.  Membrane filter with a pore size of 0,45 mm, Millipore HAWP 04700 or equivalent.  4.16.  500 ml glass stoppered conical flask.  4.17.   Glass column (internal diameter approximately 1 cm, length approximately 30 cm) equipped with a Luer tip.  4.18.  Luer chloroform-resistant stopcock (e.g. Bio-rad 7328017, Analytichem A1 6078, J.T. Baker 4514 or equivalent).  4.19.  Chemically  resistant syringe, 10 ml Luer connector.  4.20.  Syringe suitable for HPLC injection of 250 ml (see 4.5).  4.21.  100 ml microsyringe for preparation of calibration solutions (check that the accuracy is within 2 % by weighing).  4.22.  10 ml glass  stoppered calibrated tubes.  4.23.  Spectrophotometer, suitable for making measurements in the UV region of the spectrum.  4.24.  Equipment for confirmatory test (6).  4.24.1.  Acid-rinsed 100 ml separating funnel with Teflon stopcock.  4.24.2.  Heating  block, 40 to 50 °C.  5.  Procedure  5.1.  Preparation of the sample.   Grind the sample so that it passes through the sieve (4.2).  5.2.  Test portion.   Weigh 50 g of the prepared test sample into the conical flask (4.16).  5.3.  Extraction   Add 25 g  of Celite (3.8), 250 ml of chloroform (3.1) and 25 ml of water to the test portion (5.2). Stopper the flask, and shake for 30 minutes on a mechanical shaker (4.3). Filter through a fluted filter paper (4.14). Collect 50 ml of the filtrate. If necessary,  take an aliquot of the filtrate and dilute to 50 ml with chloroform so that the concentration of aflatoxin B1 is not greater than 4 ng/ml.  5.4.  Clean-up (the procedure should be carried out without significant interruptions).   Caution:   - protect  the laboratory, where the analyses are done, adequately from daylight. This can be achieved effectively by using:  (1) Egmond, H.P. van, Heisterkamp, S.H. and Paulsch, W.E. (1991). Food Additives and Contaminants 8, 17-29.  (2) ISO 3534-1977.  (3) OJ No L 351, 2. 12. 1989, p. 39.     (i) UV absorbing foil on the windows in combination with subdued light (no direct sunlight);   (ii) Curtains or blinds in combination with artificial light (fluorescent tubes are acceptable);   - Aflatoxin containing solutions must be protected  from light as much as possible (keep in the dark, use aluminium foil).  5.4.1.  Florisil SEP-PAK purification  5.4.1.1.  Preparation of the column-cartridge assembly   Attach a stopcock (4.18) to the shorter stem of a Florisil cartridge (3.9) (see  figure 1). Wash the cartridge and remove aid by taking 10 ml chloroform (3.1) and passing 8 ml via the stopcock rapidly through the cartridge using a syringe (4.19). Attach the longer stem of the cartridge to a glass column (4.17) and pass the reamining  2 ml chloroform through the cartridge into the column. Close the stopcock. Remove the syringe.  5.4.1.2.  Purification   Add the filtrate collected in 5.3 to the column-cartridge assembly and drain by gravity. Rinse with 5 ml of chloroform (3.1),  followed by 20 ml of methanol (3.2). Discard the eluates. During these operations, ensure that the column-cartridge assembly does not run dry.   Elute aflatoxin B1 with 40 ml of the acetone-water mixture (3.5.1) and collect the whole of the eluate in  the round bottomed flask of the rotary evaporator (4.4). Concentrate the eluate on the rotary evaporator at 40 °C to 50 °C until no more acetone is distilled. (NB approximately 0,5 ml of liquid remains in the flask at this point. Experiments have shown  that further evaporation is not harmful and that when 0,5 ml of liquid remains, there is then no significant amount of acetone. Residues of acetone might lead to losses of aflatoxin B1 on the C18 cartridge) Add 1 ml of methanol (3.2), swirl the flask to  dissolve aflatoxin B1 on the sides of the flask, add 4 ml water, and mix. Disconnect and discard the cartridge. Rinse the glass column with water and retain for the C18 purification step.  5.4.2.  C18 SEP-PAK purification  5.4.2.1.  Preparation of the  column-cartridge assembly.   Attach a stopcock (4.18) to the shorter stem of a C18-cartridge (3.10) (see figure 1). Prime the cartridge and remove any air by passing 10 ml methanol (3.2) via the stopcock rapidly through the cartridge with a syringe  (4.19) (Air bubbles in the cartridge are visible as light spots on the otherwise greyish background). Take 10 ml water, and pass 8 ml through the cartridge (Avoid introduction of air into the cartridge, when switching from methanol to water). Attach the  longer stem of the cartridge to a glass column (4.17) and pass the remaining 2 ml water through the cartridge in the column. Close the stopcock. Remove the syringe.  5.4.2.2.  Purification   Transfer the extract collected in 5.4.1.2 quantitatively to  the glass column (4.17), rinsing the flask twice with 5 ml water/methanol mixture (3.5.2) and drain by gravity. During these operations, ensure that the column-cartridge assembly does not run dry. (When air bubbles develop in the constriction near the  cartridge, stop the flow and tap the top of the glass column, to remove the air bubbles. Then continue). Elute with 25 ml water/methanol mixture. Discard the eluate. Elute the aflatoxin B1 with 50 ml water/acetone mixture (3.5.3), and collect the whole  of the eluate in a 50 ml volumetric flask. Make up to the mark with water and mix: the resulting test solution is used for chromatography (5.5).   Caution: Filtration of the final extract prior to HPLC is normally not necessary. If considered necessary,  cellulose filters are not to be used, because they may lead to losses of aflatoxin B1. Teflon filters are acceptable.  5.5.  High performance liquid chromatography   (See Figure 2 for setting-up of the equipment). Allow sufficient time for conditioning  and stabilizing the instruments.   Note 1:   The flow-rates given for the mobile phase and the post-column reagent are indicative only. They may need to be adjusted depending on the characteristics of the HPLC column.   Note 2:   The detector response  to aflatoxin B1 depends on the temperature, therefore compensation should be made for drift (see Figure 3). By injecting a fixed amoung of aflatoxin B1 reference standard (3.13.3) at regular intervals (i.e. every third injection), the aflatoxin B1 peak  values between these reference standards can be corrected using the mean response, provided that the difference between responses of consecutive reference standards is very small (< 10 %). Therefore injections must be made without interruptions. If  interruption is necessary, the last injection before interruption and the first injection after interruption must be the reference standard (3.13.3). Because the calibration curve is linear and passes through the origin, the amounts of aflatoxin B1 in  the sample extracts are determined directly by reference to the adjacent standards.  5.5.1.  HPLC pump settings   Set the HPLC pump (4.5) to give a flow of 0,5 or 0,3 ml/min for a 5 mm or a 3 mm HPLC column (4.6) respectively using the mobile phase  (3.6).  5.5.2.  Post-column pump settings   Set the pump (4.7) to give a flow of 0,2 to 0,4 ml/min of the iodine-saturated water solution (3.7). As a rough guide: Flows of approximately 0,4 or 0,2 ml/min are advisable in combination with flows of 0,5  and 0,3 ml/min of the mobile phase (3.6) respectively.  5.5.3.  Fluorescence detector   Set the fluorescence detector (4,11) to exc. = 365 nm and em = 435 nm (filter instrument; > 400 nm). Adjust the detector attenuator to obtain approximately 80 % full  scale deflection of the recorder pen for 1 ng of aflatoxin B1.  5.5.4.  Injector   For all solutions, inject 250 ml amounts following the instructions of the manufacturer of the injector.  5.5.5.  Check of chromatographic separation    Inject the chromatographic test solution (3.14.1). Valleys should be less than 5 % of the sum of peak heights of the adjacent peaks.  5.5.6.  Check of the stability of the system   Before each series of analyses, respectively inject the reference  standard (3.13.3), until stable peak areas are achieved (NB Peak responses for aflatoxin B1 between consecutive injections should not differ by more than 6 %). Proceed without delay with the check of linearity (5.5.7).  5.5.7.  Check of linearity    Inject the aflatoxin B1 calibration solutions (3.13.1 to 3.13.4). Every third injection use the reference standard (3.13.3), for correction of drift in response (NB Peak responses for this reference standard must not differ by more than 10 % in 90  minutes). Correct for drift according to the formula in 7. The calibration graph should be linear and pass through the origin, within twice standard error of Y-estimate. Values found must not differ by more than 3 % from the nominal values. If these  requirements are fulfilled, continue without delay. If not, identify and correct the sources of the problem before continuing.  5.5.8.  Injection of sample extracts   Inject the purified sample extracts (5.4.2.2). After every two sample extracts repeat  the injection of the reference standard (3.13.3) according to the following sequence: reference standard, extract, extract, reference standard, extract, extract, reference standard etc.  6.  Confirmatory test  6.1.  Further treatment of the extract  (5.4.2.2)   Add 5 ml sodium chloride solution (3.15.1) to the final extract obtained at 5.4.2.2.. Extract three times each with 2 ml chloroform (3.1) for one minute, in the separating funnel (4.24.1). Pour the combined chloroform extracts over  approximately 1 g sodium sulphate (3.15.2) into a 10 ml test tube. A small funnel (diameter: 4 cm) can be used with a piece of cottonwool in the constriction, covered with a approximately 1 g sodium sulphate.   Wash the sodium sulphate layer with a few  ml of chloroform and collect the washing in the same test tube. Evaporate the chloroform extract to dryness in the same test-tube using the heating block (4.24.2) and redissolve in 1 ml of chloroform.  6.2.  Preparation of derivative and thin layer  chromatography:   See Annex to Council Directive 76/372/EEC method A, point 5.6.2.  7.  Calculation of results   Calculate the aflatoxin B1 content (mm/kg) present in the sample, using the formula:  aflatoxin B1 content in mg/kg =  m × Ve x t   Vm × M × Vf  Vc  where:   m =  amount of aflatoxin B1 in ng represented by the B1 peak of the sample, calculated as follows:    m =  P (sample)   P (st1) + P (st2)  × 2 r (st)  P (sample) =  peak area of aflatoxin B1 for the sample  P (st1) =  peak area of aflatoxin B1 resulting from the preceeding injection of reference standard (3.13.3)  P (st2) =  peak area of aflatoxin B1 resulting from the  following injection of reference standard (3.13.3)  r (st) =  injected amount of aflatoxin B1 in the reference standard (3.13.3) in ng  Vm =  volume of the injected sample extract in ml  Ve x t =  final volume of sample extract in ml, allowing for any  dilution that was made (5.3)  M =  mass of sample in g  Vf =  volume of filtrate transferred to Florisil cartridge (5.4.1.2) in ml  Vc =  volume of chloroform, used for the extraction of the sample in ml   If the procedure is followed as in this  protocol, the formula reduces to:   aflatoxin B1 content in mg/kg = 20 × m.  7.1.  Calculations of the results may also be done by peak height measurement.  8.  Repeatability:   see under 10.1  9.  Reproducibility:   see under 10.1  10.  Observations   10.1.  Precision   A collaborative study (1), carried out at the international level on mixed feeding stuffs gave the results for repeatability and reproducibility indicated in Table 1. The term repeatability (r) used here is defined as the largest  ratio which is not significant at the 95 % probability level for comparison of two readings of the same sample in the same laboratory under similar conditions. The term reproducibility (R) is similarly defined for comparing two different laboratories.  In accordance to ISO 3534 - 1977, 2.35 (2) and Commission Decision 89/610/EEC (3) r and R are also given in Table 1 in terms of coefficients of variation.   Table 1   Repeatability (r) and reproducibility (R) expressed as ratios and corresponding  coefficients of variation   (15 laboratories)        Level  r  R  CVr (*)  CVR        (mg/kg)    (%)  (%)        8 &  14  1,4  1,7  11  18         (*) CV = coefficient of variation   10.2.  Stabilization of chloroform (3.1)   The adsorption  characteristics of the florisil cartridge may be changed if stabilizers other than ethanol are used. This should be verified in accordance with 10.3 when the chloroform described is not available.  10.3.  Accuracy   The correct applications of the  method shall be verified by making replicate measurements on certified reference materials. If these are not available, the performance of the method should be verified by recovery experiments made on the fortified blank samples. The deviation of the  mean from the actual value, expressed as a percentage of the actual value, shall not lie outside the limits  20 to +10 %.   Figure 1: Column-cartridge assembly    1. Mobile phase  2. Pump  3. Injection valve  4. Guard column  5. HPLC analytical column  6. Saturated iodine solution  7. Reagent pump  8. T-joint  9. Thermostatically controlled bath  10. Spiral reaction coil  11. Fluorescence detector  12. Restrictor  13. Waste  14. Strip chart recorder/integrator   Figure 2: Flow diagram of the LC system with iodine post-column derivatization   response     mean of adjacent  reference standards        time  reference standard  extract (or calibrant)  extract (or calibrant)  reference standard  extract (or calibrant)   Figure 3: Compensation for drift in aflatoxin B1 response by injecting reference standard (3.13.3) at  regular intervals'


title: Commission Directive 2007/22/EC of 17 April 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress (Text with EEA relevance)

text:
               18.4.2007

               EN

               Official Journal of the European Union

               L 101/11

         COMMISSION DIRECTIVE 2007/22/EC
   of 17 April 2007
   amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI 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 Consumer Products,
   Whereas:

               (1)

               The Scientific Committee on Cosmetic and Non-Food Products intended for consumers, replaced by the Scientific Committee on Consumer Products, (SCCP), by Commission Decision 2004/210/EC (2), delivered an opinion regarding the safe use of the preservative iodopropynyl butylcarbamate (IPBC) in cosmetic products concluding that the daily bioavailable intake of iodine from cosmetic products should not exceed 20 % of the recommended daily intake of 150 μg and that IPBC should not be used in oral hygiene and lip care products.

               (2)

               Considering that the list of preservatives authorised in cosmetic products should not be too limited, but that the exposure to iodine from IPBC should not be too high, the existing entry 56 to Annex VI should be amended accordingly.

               (3)

               Sodium iodate and colorant CI 45425 contain iodine and are currently respectively listed under Annex VI as authorised preservative and under Annex IV as authorised colorant. In view of the absence of interest from stakeholders to defend the use of these substances and the opinion of the SCCP regarding the necessity to reduce the exposure to iodine from cosmetic products, the authorisations should be withdrawn.

               (4)

               Directive 76/768/EEC should therefore be amended accordingly.

               (5)

               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
   Annexes IV and VI to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   Member States shall take all necessary measures to ensure that from 18 October 2008 no cosmetic products which fail to comply with this Directive are placed on the market by Community manufacturers or by importers established within the Community.
   Member States shall take all necessary measures to ensure that those products are not sold or disposed of to the final consumer after 18 April 2009.
   Article 3
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 18 January 2008 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 4
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 17 April 2007.

            For the Commission

         Günter VERHEUGEN

            Vice-President

      (1)  OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2007/17/EC (OJ L 82, 23.3.2007, p. 27).

      (2)  OJ L 66, 4.3.2004, p. 45.
   ANNEX
   Directive 76/768/EEC is amended as follows:

               (1)

               In part 1 of Annex IV, colouring agent CI 45425 is deleted.

               (2)

               Part 1 of Annex VI is amended as follows:

                           (a)

                           reference number 10 is deleted;

                           (b)

                           reference number 56 is replaced by the following:

                                       Reference number

                                       Substance

                                       Maximum authorised concentration

                                       Limitations and requirements

                                       Conditions of use and warnings which must be printed on the label

                                       a

                                       b

                                       c

                                       d

                                       e

                                       ‘56

                                       iodopropynyl butylcarbamate
                                       (IPBC)
                                       3-iodo-2-propynylbutylcarbamate
                                       CAS No: 55406-53-6

                                                   (a)

                                                   rinse-off products: 0,02 %

                                                   (b)

                                                   leave-on products: 0,01 %, except in deodorants/antiperspirants: 0,0075 %

                                       Not to be used in oral hygiene and lip care products

                                                   (a)

                                                   Not to be used in preparations for children under three years of age, except in bath products/shower gels and shampoo

                                                   (b)

                                                               —

                                                               Not to be used in body lotion and body cream (1)

                                                               —

                                                               Not to be used in preparations for children under three years of age

                                                   (a)

                                                   “Not to be used for children under three years of age” (2)

                                                   (b)

                                                   “Not to be used for children under three years of age” (3)

      (1)  Concerns any products aimed to be applied on a large part of the body.

      (2)  Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years of age.

      (3)  Solely for products which might be used for children under three years of age.’