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31985L0520

Commission Directive 85/520/EEC of 11 November 1985 amending Commission Directive 85/429/EEC, amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs

Official Journal L 323 , 04/12/1985 P. 0012 - 0016 Spanish special edition: Chapter 03 Volume 39 P. 0088  Portuguese special edition Chapter 03 Volume 39 P. 0088  Finnish special edition: Chapter 3 Volume 19 P. 0223  Swedish special edition: Chapter 3 Volume 19 P. 0223

*****COMMISSCOMMISSION  DIRECTIVE  of 11 November 1985  amending Commission Directive 85/429/EEC, amending the Annexes to Council Directive 70/524/EEC concerning additives in feedingstuffs  (85/520/EEC)  THETHE 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 Commission Directive 85/429/EEC (2), and in particular Article 7 thereof,  Whereas Directive 70/524/EEC provides for regular adaptation of the content of its Annexes to the evolution of scientific and technical knowledge;  Whereas certain additives of the antibiotics, coccidiostats, emulsifers or preservatives groups, hitherto authorized for certain uses at national level, have been widely tested, whereas the studies carried out and experience gained indicate that these additives may be authorized throughout the Community for the uses specified;  Whereas Directive 70/524/EEC authorizes, under certain conditions, the use of copper in feedingstuffs and fixes, in particular, maximum levels for copper for different types of feedingstuffs for pigs;  Whereas there is evidence that pig slurry could contain certain risks for the environment in Member States with very intensive pig rearing and little surface for the spreading of slurry; whereas the copper contribution by slurry could lead to a not negligible increase of the copper level in soils and cause phytotoxic effects in more or less long terms;  Whereas taking account of the particular situation of these Member States, it is therefore appropriate beyond a specific threshold of total number of pigs to provide for the fixing of maximum levels for copper lower than those actually fixed by Directive 70/524/EEC for fattening pigs; it is also indicated to adapt the levels intended for other categories or species of animals to their real physiological need (requirements);  Whereas the investigation of various additives currently listed in Annex II and therefore authorizable at national level has not yet been completed; whereas, therefore, the period of authorization of these substances should be extended for a specific period;  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 of Directive 70/524/EEC shall be amended as set out in the Annex hereto.  Article 2  Member States shall, by 3 December 1986, bring into force the laws, regulations or administrative provisions necessary to comply with Article 1, and shall immedialety inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 11 November 1985.  For the Commission  Frans ANDRIESSEN  Vice-President  ((1) OJ No L 270, 14. 12. 1970, p. 1.  (2) OJ No L 245, 12. 9. 1985, p. 1.  ANNEX  1. In Annex I  (a) under part A 'Antibiotics' item EEC No E 715 is completed as follows:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 //  //  //  / / Calves    // 6 months   // 15   // 40   // -  //  //  //  // Cattle for fattening  // -   // 15   // 30  // Indicate in the instructions for use:   //   //   //   //  //   //   //   // '- for supplementary feedingstuffs, the maximum dose in the daily ration must not exceed:   //   //  //   //   //   //   //   // - for 100 kg bodyweight: 110 mg;  //   //   //   //   //   //   //   // - above 100 kg: add 5 mg for each additional 10 kg bodyweight'   //    //   //   //  //   //   //   //  (b) under part D 'Coccidiostats and other medicinal substances', the item EEC No E 761 'Meticlorpindol/methylbenzoquate: (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate)' is completed as follows:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 //  //  //  / / Turkeys    // 12 weeks   // 110   // 110   // Use prohibited at least 5 days before slaughter'   //    //   //   //   //  //   //   //  (c) under part E 'Emulsifiers, stabilizers, thickeners and gelling agents', the following item is added:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 // E 498  // Partial polyglycerol esters of polycondensed fatty acids of castor oil   // -   // Dogs  // -   // -   // -   // All feedingstuffs'   //    //   //   //   //   //   //   //  (d) under part G 'Preservatives'  aa) the following item is added:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 // E 250  // Sodium nitrite   // NaNO2  // Dogs, cats  // -   // -  // 100   // Canned feedingstuffs only'   //    //   //   //  //   //   //   //  bb) item EEC No E 490 'Propane-1,2-diol' is completed as follows:  1.2.3.4.5.6.7.8 //  //  //  //  //  //  //  //  // 'EEC No  // Additive  // Chemical formula, description  // Species or category of animal  // Maximum age  // Minimum content  // Maximum content   // Other provisions 1.2.3.4.5.6,7.8 //  //  //  //  //  //  //  //  //  //  //  //  / / mg/kg   of complete feedingstuff  //  //  //  //  //  //  //  //  // 1.2.3.4.5.6.7.8 //  //  //  / / Cats     // -   // -   // 75 000   // All feedingstuffs'  //    //   //   //   //   //   //   //  (e) under part I 'Trace elements' the text of item EEC No E 4 'Copper-Cu' is replaced by the following:  1.2.3.4.5,6 //  //  //  //  //  // 'EEC No  // Element  // Additive  // Chemical formula  // Maximum content of the element in mg/kg of the complete feedingstuff  // 1.2.3.4.5.6 //  //  //  //  //  //  // E4   // Copper-Cu  // Cupric acetate, monohydrate Cupric methionate  // Cu(CH3COO)2.H2O Cu(C5H10NO2S)2   // Pigs for fattening: - up to 16 weeks: 175 (total) - from 17th week up to slaughter: 35 (total)   // In Member States where the mean density of the porcine population is equal to or higher than 175 pigs per 100 ha of utilizable agricultural land   //   //   // Basic cupric carbonate, monohydrate Cupric chloride, dihydrate Cupric oxide Cupric sulphate, pentahydrate   // CuCO3.Cu(OH)2.H2O CuC12.2H2O CuO CuSO4.5H2O   // Pigs for fattening: - up to 16 weeks: 175 (total) - from 17th week up to 6 months: 100 (total) - over 6 months up to slaughter: 35 (total) Breeding pigs: 35 (total) Calves: - milk replacers: 30 (total) - other complete feedingstuffs: 50 (total) Ovines: 20 (total) Other species or categories of animals: 35 (total)   // In Member States where the mean density of the porcine population is lower than 175 pigs per 100 ha of utilizable agricultural land'   //    //  //   //   //   //   2. In Annex II:  (a) under part A 'Antibiotics'  aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:  No 21 Virginiamycin  No 22 Avoparcin  No 25 Nosiheptide;  bb) under item No 22 'Avoparcin'  aaa) in the column 'Maximum content' the figure 45 is replaced by the figure 30 with respect to cattle for fattening;  bbb) in the column 'Other provisions'  - first indent: the figure 155 is replaced by the figure 110;  - second indent: the figure 6,5 is replaced by the figure 5;  (b) under part D 'Coccidiostats and other medicinal substances'  aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:  No 6 Nicarbazine  No 16 Meticlorpindol/methylbenzoquate (mixture of 100 parts of (a) meticlorpindol and 8,35 parts of (b) methylbenzoquate)  No 19 Nifursol;  bb) under item No 6 'Nicarbazine' the term '7 days' in the column headed 'Other provisions' is replaced by the term '9 days';  cc) under item No 19 'Nifursol', the indications in the column headed 'Other provisions' are completed as follows: 'Indicate in the instructions for use: "Avoid inhalation and contact with the skin" ';  (c) under part E 'Emulsifiers, stabilizers, thickeners and gelling agents'  aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:  No 8 Partial polyglycerol ersters of polycondensed fatty acids of castor oil  No 12 Polyoxyethylene (20) sorbitan monolaurate  No 13 Polyoxyethylene (20) sorbitan monopalmitate  No 14 Polyoxyethylene (20) sorbitan monostearate  No 15 Polyoxyethylene (20) sorbitan tristearate  No 16 Polyoxyethylene (20) sorbitan mono-oleate  No 29 Polyoxyethylene (20) sorbitan trioleate (synonym: polysorbate 85);  bb) under item No 8 'Partial polyglycerol esters of polycondensed fatty accids of castor oil' the word 'Dogs' is added in the column headed 'Species or category of animal';  (d) under part F 'Colouring matters including pigments' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1985 for item No 2 'Canthaxanthin';  (e) under part G 'Preservatives'  aa) the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:  No 3 Hydrochloric acid  No 4 Sulphuric acid  No 5 Formaldehyde  No 16 Sodium nitrite (E 250)  No 19 Propane-1,2-diol;  bb) under item No 16 'Sodium nitrite (E 250)' in the column headed 'Other provisions' the words 'except canned feedingstuffs' are added after 'All feedingstuffs'; (f) under part J 'Growth promoters' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:  No 1 Nitrovin  No 2 Carbadox  No 3 Olaquindox;  (g) under part L 'Binders, anti-caking agents and coagulants' the date 30. 11. 1985 in the column headed 'Period of authorization' is replaced by 3. 12. 1986 for the following items:  No 1 Bentonite and montmorillonite  No 4 Natural mixtures of steatite and chlorite free of asbestos, other than the mixture E 560  No 5 Perlite.


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31976L0628

Council Directive 76/628/EEC of 20 July 1976 amending for the fourth time Directive 73/241/EEC on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption

Official Journal L 223 , 16/08/1976 P. 0001 - 0002 Finnish special edition: Chapter 13 Volume 5 P. 0028  Greek special edition: Chapter 03 Volume 16 P. 0086  Swedish special edition: Chapter 13 Volume 5 P. 0028  Spanish special edition: Chapter 13 Volume 5 P. 0032  Portuguese special edition Chapter 13 Volume 5 P. 0032

COUNCIL DIRECTIVE  of 20 July 1976  amending for the fourth time Directive 73/241/EEC on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption  (76/628/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission,  Having regard to the opinion of the European Parliament (1),  Having regard to the opinion of the Economic and Social Committee (2),  Whereas Article 6 (2) of Council Directive 73/241/EEC of 24 July 1973 on the approximation of the laws of the Member States relating to cocoa and chocolate products intended for human consumption (3), as last amended by Directive 75/155/EEC (4), provides that the individual weights for marketing cocoa powder products shall be fixed at a later date;  Whereas a scale of weights should be fixed to ensure the transparency of the market and as far as possible reduce the risk that consumers may be misled by weights which are too close to one another,  HAS ADOPTED THIS DIRECTIVE:    Article 1 Article 6 (2) of Directive 73/241/EEC shall be replaced by the following:  "2. The cocoa powder products referred to in Annex I, headings 1.8 to 1.13, when packaged in units having an individual net weight equal to or more than 50 g and not exceeding 1 kg, shall be marketed in the following individual net weights only : 50 g, 75 g, 125 g, 250 g, 500 g, 750 g and 1 kg".   Article 2 Within one year from the date of notification of this Directive, Member States shall, if necessary, amend  (1)OJ No C 280, 8.12.1975, p. 69. (2)OJ No C 15, 22.1.1976, p. 7. (3)OJ No L 228, 16.8.1973, p. 23. (4)OJ No L 64, 11.3.1975, p. 21.   their laws in accordance with this Directive and shall forthwith inform the Commission thereof.  The laws thus amended shall be applied so as to:    - permit the marketing of products conforming to this Directive within two years from the date of notification,       - ban the marketing of products not conforming to this Directive not later than seven years from the date of notification.          Article 3 This Directive is addressed to the Member States.     Done at Brussels, 20 July 1976.  For the Council  The President  A.P.L.M.M. van der STEE


title: Commission Directive 2009/89/EC of 30 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include nitrogen as an active substance in Annex I thereto (Text with EEA relevance)

text:
               31.7.2009

               EN

               Official Journal of the European Union

               L 199/19

      COMMISSION DIRECTIVE 2009/89/EC
   of 30 July 2009
   amending Directive 98/8/EC of the European Parliament and of the Council to include nitrogen as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes nitrogen.

               (2)

               Pursuant to Regulation (EC) No 1451/2007, nitrogen has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, as defined in Annex V to Directive 98/8/EC.

               (3)

               Ireland was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 13 November 2007 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 28 November 2008, in an assessment report.

               (5)

               It appears from the examinations made that biocidal products used as insecticides and containing nitrogen may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include nitrogen in Annex I, in order to ensure that in all Member States authorisations for biocidal products used as insecticides and containing nitrogen can be granted, modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.

               (6)

               Not all potential uses have been evaluated at the Community level. It is therefore appropriate that Member States assess those risks to the compartments and populations that have not been representatively addressed in the Community level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks to acceptable levels.

               (7)

               In the light of the findings of the assessment report, it is appropriate to require that specific risk mitigation measures are applied at product authorisation level to products containing nitrogen and used as insecticides. In particular, products should only be sold to and used by trained professionals with safe working practices and safe systems of work in place to ensure minimum risk.

               (8)

               It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance nitrogen and also to facilitate the proper operation of the biocidal products market in general.

               (9)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

               (10)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel authorisations of biocidal products in product-type 18 containing nitrogen to ensure that they comply with Directive 98/8/EC.

               (11)

               Directive 98/8/EC should therefore be amended accordingly.

               (12)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 August 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 September 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 30 July 2009.

            For the Commission

         Stavros DIMAS

            Member of the Commission

      (1)  OJ L 123, 24.4.1998, p. 1.

      (2)  OJ L 325, 11.12.2007, p. 3.

      ANNEX
      The following entry ‘No 27’ is inserted in Annex I to Directive 98/8/EC:

                     No

                     Common name

                     IUPAC name
                     Identification numbers

                     Minimum purity of the active substance in the biocidal product as placed on the market

                     Date of inclusion

                     Deadline for compliance with Article 16(3)
                     (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘27

                     Nitrogen

                     Nitrogen
                     EC No: 231-783-9
                     CAS No: 7727-37-9

                     999 g/kg

                     1 September 2011

                     31 August 2013

                     31 August 2021

                     18

                     When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, the populations that may be exposed to the product and the use or exposure scenarios that have not been representatively addressed at the Community level risk assessment.
                     When granting product authorisation, Member States shall assess the risks and subsequently ensure that appropriate measures are taken or specific conditions imposed in order to mitigate the identified risks.
                     Product authorisation can only be granted where the application demonstrates that risks can be reduced to acceptable levels.
                     Member States shall ensure that authorisations are subject to the following conditions:

                                 1.

                                 Products may only be sold to and used by professionals trained to use them.

                                 2.

                                 Safe working practices and safe systems of work must be in place to ensure minimum risk, including the availability of personal protective equipment if necessary.’

         (1)  For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm