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31989L0530

Council Directive 89/530/EEC of 18 September 1989 supplementing and amending Directive 76/116/EEC in respect of the trace elements boron, cobalt, copper, iron, manganese, molybdenum and zinc contained in fertilizers

Official Journal L 281 , 30/09/1989 P. 0116 - 0124 Finnish special edition: Chapter 13 Volume 19 P. 0109  Swedish special edition: Chapter 13 Volume 19 P. 0109

*****COUNCIL  DIRECTIVE  of 18 September 1989  supplementing and amending Directive 76/116/EEC in respect of the trace elements boron, cobalt, copper, iron, manganese, molybdenum and zinc contained in fertilizers  (89/530/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community and in particular Article 100a thereof,  Having regard to the proposal from the Commission (1),  In cooperation with the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas it is necessary to adopt measures with the aim of progressively establishing the internal market over a period expiring on 31 December 1992; whereas the internal market comprises an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;  Whereas Council Directive 76/116/EEC of 18 December 1975 on the approximation of the laws of the Member States relating to fertilizers (1), as last amended by Directive 89/284/EEC (2), lays down rules on the marketing of EEC-type fertilizers; whereas it has proved necessary to extend this Directive to cover the seven trace elements (boron, cobalt, copper, iron, manganese, molybdenum and zinc) contained in these fertilizers;  Whereas Directive 76/116/EEC should henceforth apply to soluble fertilizers or fluids containing one or more trace elements marketed individually and mixtures thereof and to certain chelated trace elements;  Whereas the Directives on fertilizers should be continually developed and updated as regards the adaptation to scientific and technical progress of the products listed in the Annexes to those Directives; whereas for this purpose it is considered necessary to extend the functions of the Committee provided for in Directive 76/116/EEC,  HAS ADOPTED THIS DIRECTIVE:  Article 1  1. Solid or fluid fertilizers listed in Chapter A of the Annex, containing only one of the following trace elements: boron, cobalt, copper, iron, manganese, molybdenum or zinc and meeting the requirements of the said Chapter A, may be marked 'EEC FERTILIZER'.  2. Mixtures of two or more of the fertilizers referred to in paragraph 1 containing at least two different trace elements may be marked 'EEC FERTILIZER' if they meet the requirements of Chapter B of the Annex.  Article 2  EEC fertilizers complying with the provisions of Article 1 shall be packaged.  Article 3  1. The content of one or more of the following trace elements: boron, cobalt, copper, iron, manganese, molybdenum or zinc in the EEC fertilizers listed in Annex I to Directive 76/116/EEC shall be declared where the following two conditions are fulfilled:  (a) the trace elements are added and present at least in the minimum quantities specified in Chapters C and D of the Annex to this Directive;  (b) the EEC fertilizers must continue to satisfy the requirements of Annex I to Directive 76/116/EEC.  2. Where the trace elements are the normal ingredients of the raw materials intended to supply major and secondary elements, their declaration shall be optional, provided that these trace elements are present at least in the minimum quantities specified in Chapters C and D of the Annex to this Directive.  Article 4  The compulsory markings for the identification of the fertilizers covered by this Directive shall be as follows:  (a) 'EEC FERTILIZER' in capital letters,  (b) the designation of the type of fertilizer:  - either in accordance with Chapter A of the Annex,  - or as the type designation 'Mixture of trace elements', followed by the names of the trace elements present or their chemical symbols,  - or in accordance with Annex I to Directive 76/116/EEC, by adding to the type designation either:  'with trace elements',  or  'with' followed by the name or names of the trace elements present or by their chemical symbols.  Only the numbers stating the contents of the major and secondary elements covered by Directive 76/116/EEC shall follow the type designation.  Where several trace elements are present they shall be listed in the alphabetical of their chemical symbols: B, Co, Cu, Fe, Mn, Mo, Zn;  (c) the guaranteed content in respect of each nutrient and the guaranteed content expressed as forms and/or solubilities where these are specified in the Annexes to Directive 76/116/EEC and, for each trace element present, as required by Article 6;  (d) where all or part of the trace element is chemically linked with an organic molecule, the name of that element is then followed by one of the following qualifiers:  - 'chelated by . . .' (name of chelating agent or its abbreviation as set out in Chapter E (1) of the Annex),  - 'complexed by . . .' (name of complexing agent as set out in Chapter E (2) of the Annex).  The trace-element content shall be expressed as a percentage by weight, in whole numbers or where necessary to one decimal place for fertilizers containing only one trace element (Chapter A of the Annex). Where fertilizers contain several trace elements the number of decimal places may, for a given element, be as set out in Chapters B, C and D of the Annex.  Trace-element content shall be expressed both in words and by the appropriate chemical symbols.  The following shall be entered on the label or accompanying papers, with regard to the products appearing in Chapters A and B of the Annex below the obligatory or optional declarations:  'To be used only where there is a recognized need. Do not exceed the appropriate dose rates.'  Article 5  Member States may require on their territory without impeding trade and on the responsiblity of the person in charge of marketing that an indication be given of the dose rates and conditions of use suitable for the soil and crop conditions under which the fertilizer is used. This information must be clearly separated from the obligatory declarations provided for in Article 4.  Article 6  Member States shall require that the trace-element content of EEC fertilizers placed on the market must be stated in the form of elements (B, Co, Cu, Fe, Mn, Mo, Zn).  The trace-element content of a fertilizer shall be declared in the following manner:  (a) for the fertilizers referred to in Article 1 (1): in accordance with the requirements set out in Chapter A (column 6) of the Annex;  (b) for the fertilizers referred to in Article 1 (2) and Article 3 by indicating:  - the total content, expressed as a percentage by weight of the fertilizer, and  - the water-soluble content, expressed as a percentage by weight of the fertilizer, where that solubility is at least half of the total content.  Where a trace-element is totally water-soluble, only the water-soluble content shall be declared.  The trace-element content of a fertilizer shall be determined under the conditions laid down in the methods of analysis provided for in Article 8 of Directive 76/116/EEC. Where a trace element is chemically linked with an organic molecule the content present in the fertilizer shall be declared immediately following the water-soluble content as a percentage by weight of the product, followed by one of the terms: 'chelated by' or 'complexed by' with the name of the organic molecule as set out in Chapter E of the Annex. The name of the organic molecule may be replaced by its initials.  Article 7  The tolerance allowed in respect of the declared trace-element content shall be:  - 0,4 % in absolute terms for a content of more than 2 %,  - one-fifth of the declared value for a content not exceeding 2 %.  Article 8  Article 9 (1) of Directive 76/116/EEC is replaced by the following:  'Amendments required to adapt the Annexes to technical progress shall be adopted in accordance with the procedure laid down in Article 11.  Where such amendments are made, a fertilizer shall be included only if:  (a) it does not adversely affect human or animal health or the environment;  (b) it provides nutrients in an effective manner according to the needs of a particular crop or according to growing conditions of particular crops.'  Article 9  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within eighteen months of its notification. They shall forthwith inform the Commission thereof.  2. Member States shall communicate to the Commission the provisions of national law which they adopt in the field governed by this Directive.  Article 10  This Directive is addressed to the Member States.  Done at Brussels, 18 September 1989.  For the Council  The President  E. CRESSON  (1) OJ No C 304, 29. 11. 1988, p. 8.  (2) OJ No C 47, 20. 2. 1989, p. 75 and Decision of 15 September 1989 (not yet published in the Official Journal).  (3) OJ No C 102, 24. 4. 1989, p. 9.  (4) OJ No L 24, 30. 1. 1976, p. 21.  (5) OJ No L 111, 22. 4. 1989, p. 34.  ANNEX  CHAPTER A  FERTILIZERS CONTAINING ONLY ONE TRACE ELEMENT  Note 1: A chelating agent may be designated by means of its initials as set out in Chapter E.  Note 2: If the product leaves no solid residue after being dissolved in water, it may be described as 'for dissolution'.  Note 3: Where a trace element is present in a chelated form, the pH range guaranteeing acceptable stability of the chelated fraction shall be stated.  1.2.3.4.5.6 //  //  //  //  //  //  // No   // Type designation  // Data on method of production and essential ingredients  // Minimum trace-element content (percentage by weight) Data on the expression of nutrients. Other requirements  // Other data or type designation  // Trace-element content to be declared. Solubilities. Other criteria  //  //  //  //  //  //  // 1   // 2  // 3  // 4  // 5  // 6  //  //  //  //  //  // 1,6 //  // BORON  1.2.3.4.5.6 //  //  //  //  //  //  // 1a   // Boric acid  // Product obtained by the action of an acid on a borate  // 14 % water-soluble B   // Usual trade names may be added  // Water-soluble boron B   //    //   //   //   //   //  // 1b   // Sodium borate   // Product obtained chemically and having as its essential ingredient a sodium borate   // 10 % water-soluble B   // Usual trade names may be added  // Water-soluble boron B   //    //   //   //   //   //  // 1c   // Calcium borate   // Product obtained partly from colemanite or pandermite, and having as its essential ingredient calcium borates   // 7 % total B Particle size: at least 98 % passing through a 0,063 mm sieve   // Usual trade names may be added   // Total boron (B)   //    //   //   //  //   //   // 1d   // Boron ethanol amine   // Product obtained from the reaction of boric acid with an ethanol amine   // 8 % water-soluble B   //   // Water-soluble boron (B)   //    //  //   //   //   //   // 1e   // Borated fertilizer in solution or suspension   // Product obtained by dissolution or suspension in water of types 1a, 1b, 1d   // 2 % water-soluble B   //   // Water-soluble boron (B)   //    //   //   //   //  //  //  //  //  //  //  //  // 1   // 2  // 3  // 4  // 5  // 6  //  //  //  //  //  // 1,6 // 1,6 // COBALT  1.2.3.4.5.6 //  //  //  //  //  //  // 2a   // Cobalt salt  // Product obtained chemically and having as its essential ingredient a mineral salt of cobalt   // 19 % water-soluble Co  // The designation must include the name of the combined mineral anion   // Water-soluble cobalt (Co)   //    //   //  //   //   //   // 2b   // Cobalt chelate   // Product obtained by combining cobalt chemically with a chelating agent   // 2 % water-soluble Co, at least 8/10 of which has been chelated  // Nature of the chelating agent   // Water-soluble cobalt (Co). Chelated cobalt (Co)   //    //   //   //   //   //  // 2c   // Solution of cobalt fertilizer   // Product obtained by dissolving types 2a and/or 2b in water   // 2 % water-soluble Co   // The designation must include the name of the mineral anion and/or the nature of the chelating agent  // Water-soluble cobalt (Co). Chelated cobalt (Co)   //    //  //   //   //   //  1,6 // COPPER  1.2.3.4.5.6 //  //  //  //  //  //  // 3a   // Copper salt  // Product obtained chemically and having as its essential ingredient a mineral salt of copper   // 20 % water-soluble Cu  // The designation must include the name of the combined anion   // Water-soluble copper (Cu)   //    //   //   //   //   //  // 3b   // Copper oxide   // Product obtained chemically and having as its essential ingredient copper oxide   // 70 % total Cu Particle size: at least 98 % passing through a 0,063 mm sieve   //   // Total copper (Cu)   //    //   //   //   //  //   // 3c   // Copper hydroxide   // Product obtained chemically and having as its essential ingredient copper hydroxide   // 45 % total Cu Particle size: at least 98 % passing through a 0,063 mm sieve   //   // Total copper (Cu)  //    //   //   //   //   //   // 3d   // Copper chelate  // Product obtained by combining copper chemically with a chelating agent   // 9 % water-soluble Cu of which at least 8/10 has been chelated   // Nature of the chelating agent  // Water-soluble copper (Cu). Chelated copper (Cu)   //    //  //   //   //   //   // 3e   // Copper-based fertilizer  // Product obtained by mixing types 3a, 3b, 3c or 3d and, if required, filler that is neither nutrient   // 5 % total Cu Particle size: at least 98 % passing through a 0,063 mm sieve  // Nature of the chelating agent   // Total copper (Cu) Water-soluble copper (Cu) if this accounts for at least one-quarter of the total copper. Chelated copper (Cu)   //  //   //   //   //   //   // 3f   // Copper fertilizer solution   // Product obtained by dissolving types 3a and/or 3d in water   // 3 % water-soluble Cu   // Nature of the chelating agent  // Water-soluble copper (Cu), a proportion of which is chelated copper (Cu)   //    //   //   //   //   //  //  //  //  //  //  //  // 1   // 2  // 3  // 4  // 5  // 6  //  //  //  //  //  // 1,6 // 1,6 // IRON  1.2.3.4.5.6 //  //  //  //  //  //  // 4a   // Iron salt  // Product obtained chemically and having as its essential ingredient a ferrous salt (Fe II)   // 12 % water-soluble Fe  // The designation must include the name of the combined anion   // Water-soluble iron (Fe)   //    //   //   //   //   //  // 4b   // Iron chelate   // Product obtained by combining iron chemically with a chelating agent   // 5 % water-soluble Fe, of which at least 8/10 has been chelated   // Nature of the chelating agent   // Water-soluble iron (Fe). Chelated iron (Fe)   //    //   //   //   //   //   // 4c   // Iron fertilizer solution   // Product obtained by dissolving types 4a and/or 4b in water   // 2 % water-soluble Fe   // Nature of the chelating agent   // Water-soluble iron (Fe). Chelated iron (Fe)   //    //   //   //   //   //  1,6 // MANGANESE  1.2.3.4.5.6 //  //  //  //  //  //  // 5a   // Manganese salt   // Product obtained chemically and having as its essential ingredient a mineral salt of manganese (II)   // 17 % water-soluble Mn   // The designation must include the name of the combined anion   // Water-soluble manganese (Mn)   //  //   //   //   //   //   // 5b   // Manganese chelate  // Product obtained by combining manganese chemically with a chelating agent   // 5 % water-soluble Mn, of which at least 8/10 has been chelated   // Nature of the chelating agent  // Water-soluble manganese (Mn). Chelated manganese (Mn)   //   //   //   //   //   //   // 5c   // Manganese oxide  // Product obtained chemically and having as its essential ingredients manganese oxides   // 40 % total Mn Particle size: at least 80 % passing through a 0,063 mm sieve   //   // Total manganese (Mn)   //    //   //   //   //   //   // 5d  // Manganese-based fertilizer   // Product obtained by mixing types 5a and 5c   // 17 % total Mn   //   // Total manganese (Mn) Water-soluble manganese (Mn) if this accounts for at least one-quarter of the total manganese   //    //   //   //   //  //   // 5e   // Fertilizer in manganese-based solution  // Product obtained by dissolving types 5a and/or 5b in water  // 3 % water-soluble Mn   // Nature of the chelating agent  // Water-soluble manganese (Mn). Chelated manganese (Mn)   //   //   //   //   //   //  1,6 // MOLYBDENUM  1.2.3.4.5.6 //  //  //  //  //  //  // 6a   // Sodium molybdate   // Product obtained chemically and having as its essential ingredient sodium molybdate   // 35 % water-soluble Mo   //   // Water-soluble molybdenum (Mo)   //    //   //  //   //   //   // 6b   // Ammonium molybdate   // Product obtained chemically and having as its essential ingredient ammonium molybdate   // 50 % water-soluble Mo   //  // Water-soluble molybdenum (Mo)   //    //   //   //   //  //   // 6c   // Molybdenum-based fertilizer   // Product obtained by mixing types 6a and 6b   // 35 % water-soluble Mo  //   // Water-soluble molybdenum (Mo)   //    //   //   //  //   //   // 6d   // Molybdenum fertilizer in solution  // Product obtained by dissolving types 6a and/or 6b in water  // 3 % water-soluble Mo   //   // Water-soluble molybdenum (Mo)   //    //   //   //   //   //  //  //  //  //  //  //  // 1   // 2  // 3  // 4  // 5  // 6  //  //  //  //  //  // 1,6 // 1,6 // ZINC  1.2.3.4.5.6 //  //  //  //  //  //  // 7a   // Zinc salt  // Product obtained chemically and having as its essential ingredient a mineral salt of zinc   // 15 % water-soluble Zn  // The designation must include the name of the combined anion   // Water-soluble zinc (Zn)   //    //   //   //   //   //  // 7b   // Zinc chelate   // Product obtained by combining zinc chemically with a chelating agent   // 5 % water-soluble Zn   // Nature of the chelating agent   // Water-soluble zinc (Zn). Chelated Zinc (Zn)   //    //   //   //   //   //   // 7c   // Zinc oxide   // Product obtained chemically and having as its essential ingredient zinc oxide   // 70 % total Zn   //  // Total zinc (Zn)   //    //   //   //   //   //   // 7d  // Zinc-based fertilizer   // Product derived from types 7a and 7b   // 30 % total Zn   //   // Total zinc (Zn) Water-soluble zinc (Zn) if this accounts for at least one-quarter of the total zinc (Zn)   //    //   //   //   //  //   // 7e   // Zinc-based solution   // Product obtained by dissolving types 7a and 7b in water   // 3 % water-soluble Zn  // Nature of the chelating agent   // Water-soluble zinc (Zn). Chelated zinc (Zn)   //    //   //   //   //   //  MINIMUM TRACE-ELEENT CONTENT, PERCENTAGE WEIGHT OF FERTILIZER  CHAPTER B  SOLID OR FLUID MIXTURES OF TRACE ELEMENTS  1.2,3 //  //  //  // Where the trace element is present in a form that is:  // 1.2.3 //  // exclusively mineral  // chelated or complexed   //    //   //   // For a trace element:   //   //   // Boron (B)   // 0,2   // 0,2   // Cobalt (Co)   // 0,02   // 0,02   // Copper (Cu)   // 0,5   // 0,1  // Iron (Fe)   // 2,0   // 0,3   // Manganese (Mn)   // 0,5  // 0,1   // Molybdenum (Mo)   // 0,02   // -   // Zinc (Zn)  // 0,5   // 0,1   //    //   //  Minimum total of trace elements in a solid mixture: 5 % by mass of the fertilizer.  Minimum total of trace elements in a fluid mixture: 2 % by mass of the fertilizer.  CHAPTER C  EEC FERTILIZERS CONTAINING MAJOR AND/OR SECONDARY ELEMENTS WITH TRACE ELEMENTS APPLIED TO THE SOIL  1.2.3 //  //  //  //  // For crops or grassland   // For horticultural use   //    //   //   // Boron (B)   // 0,01  // 0,01   // Cobalt (Co)   // 0,002   // -   // Copper (Cu)  // 0,01   // 0,002   // Iron (Fe)   // 0,5   // 0,02  // Manganese (Mn)   // 0,1   // 0,01   // Molybdenum (Mo)  // 0,001   // 0,001   // Zinc (Zn)   // 0,01   // 0,002   //  //   //  CHAPTER D  EEC FERTILIZERS CONTAINING MAJOR AND/OR SECONDARY ELEMENTS WITH TRACE ELEMENTS FOR LEAF SPRAYS  Boron (B) 0,01  Cobalt (Co) 0,002  Copper (Cu) 0,002  Iron (Fe) 0,02  Manganese (Mn) 0,01  Molybdenum (Mo) 0,001  Zinc (Zn) 0,002 CHAPTER E  LIST OF AUTHORIZED ORGANIC COMPLEXING AGENTS FOR TRACE ELEMENTS  Definition of complexed trace elements:  Within the meaning of this Directive complexed trace elements are defined as combinations where the metal is present in the form of:  - a chelated product  - a complexed product  Authorized products:  1. Chelating agents:  Sodium, potassium or ammonium acid or salts of:  1.2.3 // ethylene diamine tetraacetic acid:   // EDTA  // C10H16O8N2   // diethylene triamine pentaacetic acid:  // DPTA   // C14H23O10N3   // ethylene diamine - di (O-hydroxyphenyl acetic) acid:   // EDDHA   // C18H20O6N2  // hydroxy-2 ethylene diamine triacetic acid:   // HEEDTA  // C10H18O7N2   // ethyldiamine-di (O-hydroxy P-methyl phenyl) acetic acid:   // EDDHMA   // C20H24N2O6   // ethylene diamine di (5-carboxy-2-hydroxyphenyl) acetic acid:   // EDDCHA  // C20H20O10N2  2. Complexing agents (*)  (*) List to be drawn up.50 % WATER-SOLUBLE MO   //  WATER-SOLUBLE MOLYBDENUM ( MO )   //   //  //  //  //  //  6C  MOLYBDENUM-BASED FERTILIZER  PRODUCT OBTAINED BY MIXING TYPES 6A AND 6B  35 % WATER-SOLUBLE MO   //  WATER-SOLUBLE MOLYBDENUM ( MO )   //   //  //  //  //  //  6D  MOLYBDENUM FERTILIZER IN SOLUTION  PRODUCT OBTAINED BY DISSOLVING TYPES 6A AND/OR 6B IN WATER  3 % WATER-SOLUBLE MO   //  WATER-SOLUBLE MOLYBDENUM ( MO )   //   //  //  //  //  //  1  2  3  4  5  6  1,61,6ZINC  1.2.3.4.5.67A  ZINC SALT  PRODUCT OBTAINED CHEMICALLY AND HAVING AS ITS ESSENTIAL INGREDIENT A MINERAL SALT OF ZINC  15 % WATER-SOLUBLE ZN  THE DESIGNATION MUST INCLUDE THE NAME OF THE COMBINED ANION  WATER-SOLUBLE ZINC ( ZN )   //   //  //  //  //  //  7B  ZINC CHELATE  PRODUCT OBTAINED BY COMBINING ZINC CHEMICALLY WITH A CHELATING AGENT  5 % WATER-SOLUBLE ZN  NATURE OF THE CHELATING AGENT  WATER-SOLUBLE ZINC ( ZN ). CHELATED ZINC ( ZN )   //   //  //  //  //  //  7C  ZINC OXIDE  PRODUCT OBTAINED CHEMICALLY AND HAVING AS ITS ESSENTIAL INGREDIENT ZINC OXIDE  70 % TOTAL ZN   //  TOTAL ZINC ( ZN )   //   //  //  //  //  //  7D  ZINC-BASED FERTILIZER  PRODUCT DERIVED FROM TYPES 7A AND 7B  30 % TOTAL ZN   //  TOTAL ZINC ( ZN ) WATER-SOLUBLE ZINC ( ZN ) IF THIS ACCOUNTS FOR AT LEAST ONE-QUARTER OF THE TOTAL ZINC ( ZN )   //   //  //  //  //  //  7E  ZINC-BASED SOLUTION  PRODUCT OBTAINED BY DISSOLVING TYPES 7A AND 7B IN WATER  3 % WATER-SOLUBLE ZN  NATURE OF THE CHELATING AGENT  WATER-SOLUBLE ZINC ( ZN ). CHELATED ZINC ( ZN )   //   //  //  //  //  //  MINIMUM TRACE-ELEENT CONTENT, PERCENTAGE WEIGHT OF FERTILIZER  CHAPTER B  SOLID OR FLUID MIXTURES OF TRACE ELEMENTS  1.2,3WHERE THE TRACE ELEMENT IS PRESENT IN A FORM THAT IS :  1.2.3EXCLUSIVELY MINERAL  CHELATED OR COMPLEXED   //   //  //  FOR A TRACE ELEMENT :   //  //  BORON ( B )  0,2  0,2  COBALT ( CO )  0,02  0,02  COPPER ( CU )  0,5  0,1  IRON ( FE )  2,0  0,3  MANGANESE ( MN )  0,5  0,1  MOLYBDENUM ( MO )  0,02  _  ZINC ( ZN )  0,5  0,1   //   //  //  MINIMUM TOTAL OF TRACE ELEMENTS IN A SOLID MIXTURE : 5 % BY MASS OF THE FERTILIZER .  MINIMUM TOTAL OF TRACE ELEMENTS IN A FLUID MIXTURE : 2 % BY MASS OF THE FERTILIZER .  CHAPTER C  EEC FERTILIZERS CONTAINING MAJOR AND/OR SECONDARY ELEMENTS WITH TRACE ELEMENTS APPLIED TO THE SOIL  1.2.3FOR CROPS OR GRASSLAND  FOR HORTICULTURAL USE   //   //  //  BORON ( B )  0,01  0,01  COBALT ( CO )  0,002  _  COPPER ( CU )  0,01  0,002  IRON ( FE )  0,5  0,02  MANGANESE ( MN )  0,1  0,01  MOLYBDENUM ( MO )  0,001  0,001  ZINC ( ZN )  0,01  0,002   //   //  //  CHAPTER D  EEC FERTILIZERS CONTAINING MAJOR AND/OR SECONDARY ELEMENTS WITH TRACE ELEMENTS FOR LEAF SPRAYS  BORON ( B ) 0,01  COBALT ( CO ) 0,002  COPPER ( CU ) 0,002  IRON ( FE ) 0,02  MANGANESE ( MN ) 0,01  MOLYBDENUM ( MO ) 0,001  ZINC ( ZN ) 0,002  CHAPTER E  LIST OF AUTHORIZED ORGANIC COMPLEXING AGENTS FOR TRACE ELEMENTS  DEFINITION OF COMPLEXED TRACE ELEMENTS :  WITHIN THE MEANING OF THIS DIRECTIVE COMPLEXED TRACE ELEMENTS ARE DEFINED AS COMBINATIONS WHERE THE METAL IS PRESENT IN THE FORM OF :  _ A CHELATED PRODUCT  _ A COMPLEXED PRODUCT  AUTHORIZED PRODUCTS :  1 . CHELATING AGENTS :  SODIUM, POTASSIUM OR AMMONIUM ACID OR SALTS OF :  1.2.3ETHYLENE DIAMINE TETRAACETIC ACID :  EDTA  C10H16O8N2  DIETHYLENE TRIAMINE PENTAACETIC ACID :  DPTA  C14H23O10N3  ETHYLENE DIAMINE _ DI ( O-HYDROXYPHENYL ACETIC ) ACID :  EDDHA  C18H20O6N2  HYDROXY-2 ETHYLENE DIAMINE TRIACETIC ACID :  HEEDTA  C10H18O7N2  ETHYLDIAMINE-DI ( O-HYDROXY P-METHYL PHENYL ) ACETIC ACID :  EDDHMA  C20H24N2O6  ETHYLENE DIAMINE DI ( 5-CARBOXY-2-HYDROXYPHENYL ) ACETIC ACID :  EDDCHA  C20H20O10N2  2 . COMPLEXING AGENTS (*)  (*) LIST TO BE DRAWN UP .


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31999L0011

Commission Directive 1999/11/EC of 8 March 1999 adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (Text with EEA relevance)

Official Journal L 077 , 23/03/1999 P. 0008 - 0021

COMMISSION DIRECTIVE 1999/11/EC of 8 March 1999 adapting to technical progress the principles of good laboratory practice as specified in Council Directive 87/18/EEC on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 87/18/EEC of 18 December 1986 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (1), and in particular Article 4 thereof,Whereas the principles of good laboratory practice (GLP) referred to in Directive 87/18/EEC have been modified by OECD Council Decision [C(97)186(Final)];Whereas it is necessary to adapt the reference to the principles of GLP as specified in Directive 87/18/EEC so as to take account of these modifications, and, by publishing the full text of the revised principles of GLP, to facilitate the uniform interpretation and application thereof;Whereas the measures provided for in this Directive are in accordance with the opinion of the Committee for the adaptation to technical progress of the Directives concerning the elimination of technical barriers to trade in dangerous substances and preparations,HAS ADOPTED THIS DIRECTIVE:Article 1 Article 1(1) of Directive 87/18/EEC is replaced by the following:'1. Member States shall take all measures necessary to ensure that laboratories carrying out tests on chemical products, in accordance with Directive 67/548/EEC, comply with the principles of good laboratory practice as laid down in the Annex to this Directive.`Article 2 The Annex hereto is added as Annex to Directive 87/18/EEC.Article 3 1. Member States shall adopt the laws, regulations and administrative provisions necessary in order to comply with this Directive not later than 30 September 1999 and shall forthwith inform the Commission thereof.2. 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 a reference shall be adopted by Member States.Article 4 This Directive is addressed to the Member States.Done at Brussels, 8 March 1999.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 15, 17. 1. 1987, p. 29.ANNEX THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP) Contents Section I INTRODUCTION Preface1. Scope2. Definitions of terms2.1. Good laboratory practice2.2. Terms concerning the organisation of a test facility2.3. Terms concerning the non-clinical health and environmental safety study2.4. Terms concerning the test itemSection II GOOD LABORATORY PRACTICE PRINCIPLES 1. Test facility organisation and personnel1.1. Test facility management's responsibilities1.2. Study director's responsibilities1.3. Principal investigator's responsibilities1.4. Study personnel's responsibilities2. Quality assurance programme2.1. General2.2. Responsibilities of the quality assurance personnel3. Facilities3.1. General3.2. Test system facilities3.3. Facilities for handling test and reference items3.4. Archive facilities3.5. Waste disposal4. Apparatus, material, and reagents5. Test systems5.1. Physical/chemical5.2. Biological6. Test and reference items6.1. Receipt, handling, sampling and storage6.2. Characterisation7. Standard operating procedures8. Performance of the study8.1. Study plan8.2. Content of the study plan8.3. Conduct of the study9. Reporting of study results9.1. General9.2. Content of the final report10. Storage and retention of records and materialsSection I INTRODUCTION Preface Government and industry are concerned about the quality of non-clinical health and environmental safety studies upon which hazard assessments are based. As a consequence, OECD Member countries have established criteria for the performance of these studies.To avoid different schemes of implementation that could impede international trade in chemicals, OECD Member countries have pursued international harmonisation of test methods and good laboratory practice. In 1979 and 1980 an international group of experts, established under the special programme on the control of chemicals, developed the 'OECD principles of good laboratory practice` (GLP), utilising common managerial and scientific practices and experience from various national and international sources. These principles of GLP were adopted by the OECD Council in 1981, as an Annex to the Council Decision on the mutual acceptance of data in the assessment of chemicals. [C(81)30(Final)].In 1995 and 1996, a new group of experts was formed to revise and update the principles. The current document is the result of the consensus reached by that group. It cancels and replaces the original principles adopted in 1981.The purpose of these principles of good laboratory practice is to promote the development of quality test data. Comparable quality of test data forms the basis for the mutual acceptance of data among countries. If individual countries can confidently rely on test data developed in other countries, duplicative testing can be avoided, thereby saving time and resources. The application of these principles should help to avoid the creation of technical barriers to trade, and further improve the protection of human health and the environment.1. Scope These principles of good laboratory practice should be applied to the non-clinical safety testing of test items contained in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals. These test items are frequently synthetic chemicals, but may be of natural or biological origin and, in some circumstances, may be living organisms. The purpose of testing these test items is to obtain data on their properties and/or their safety with respect to human health and/or the environment.Non-clinical health and environmental safety studies covered by the principles of good laboratory practice include work conducted in the laboratory, in greenhouses, and in the field.Unless specifically exempted by national legislation, these principles of good laboratory practice apply to all non-clinical health and environmental safety studies required by regulation for the purpose of registering or licensing pharmaceuticals, pesticides, food and feed additives, cosmetic products, veterinary drug products and similar products, and for the regulation of industrial chemicals.2. Definition of terms 2.1. Good laboratory practice Good laboratory practice (GLP) is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.2.2. Terms concerning the organisation of a test facility 1. Test facility means the persons, premises and operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study. For multisite studies, those which are conducted at more than one site, the test facility comprises the site at which the study director is located and all individual test sites, which individually or collectively can be considered to be test facilities.2. Test site means the location(s) at which a phase(s) of a study is conducted.3. Test facility management means the person(s) who has the authority and formal responsibility for the organisation and functioning of the test facility according to these principles of good laboratory practice.4. Test site management (if appointed) means the person(s) responsible for ensuring that the phase(s) of the study, for which he is responsible, are conducted according to these principles of good laboratory practice.5. Sponsor means an entity which commissions, supports and/or submits a non-clinical health and environmental safety study.6. Study director means the individual responsible for the overall conduct of the non-clinical health and environmental safety study.7. Principal investigator means an individual who, for a multisite study, acts on behalf of the study director and has defined responsibility for delegated phases of the study. The study director's responsibility for the overall conduct of the study cannot be delegated to the principal investigator(s); this includes approval of the study plan and its amendments, approval of the final report, and ensuring that all applicable principles of good laboratory practice are followed.8. Quality assurance programme: means a defined system, including personnel, which is independent of study conduct and is designed to assure test facility management of compliance with these principles of good laboratory practice.9. Standard operating procedures (SOPs) means documented procedures which describe how to perform tests or activities normally not specified in detail in study plans or test guidelines.10. Master schedule means a compilation of information to assist in the assessment of workload and for the tracking of studies at a test facility.2.3. Terms concerning the non-clinical health and environmental safety study 1. Non-clinical health and environmental safety study, henceforth referred to simply as 'study`, means an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities.2. Short-term study means a study of short duration with widely used, routine techniques.3. Study plan means a document which defines the objectives and experimental design for the conduct of the study, and includes any amendments.4. Study plan amendment means an intended change to the study plan after the study initiation date.5. Study plan deviation means an unintended departure from the study plan after the study initiation date.6. Test system means any biological, chemical or physical system or a combination thereof used in a study.7. Raw data means all original test facility records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study. Raw data also may include, for example, photographs, microfilm or microfiche copies, computer readable media, dictated observations, recorded data from automated instruments, or any other data storage medium that has been recognised as capable of providing secure storage of information for a time period as stated in section 10 below.8. Specimen means any material derived from a test system for examination, analysis, or retention.9. Experimental starting date means the date on which the first study specific data are collected.10. Experimental completion date means the last date on which data are collected from the study.11. Study initiation date means the date the study director signs the study plan.12. Study completion date means the date the study director signs the final report.2.4. Terms concerning the test item 1. Test item means an article that is the subject of a study.2. Reference item ('control item`) means any article used to provide a basis for comparison with the test item.3. Batch means a specific quantity or lot of a test item or reference item produced during a defined cycle of manufacture in such a way that it could be expected to be of a uniform character and should be designated as such.4. Vehicle means any agent which serves as a carrier used to mix, disperse, or solubilise the test item or reference item to facilitate the administration/application to the test system.Section II GOOD LABORATORY PRACTICE PRINCIPLES 1. Test facility organisation and personnel 1.1. Test facility management's responsibilities 1. Each test facility management should ensure that these principles of good laboratory practice are complied with, in its test facility.2. At a minimum it should:(a) ensure that a statement exists which identifies the individual(s) within a test facility who fulfil the responsibilities of management as defined by these principles of good laboratory practice;(b) ensure that a sufficient number of qualified personnel, appropriate facilities, equipment, and materials are available for the timely and proper conduct of the study;(c) ensure the maintenance of a record of the qualifications, training, experience and job description for each professional and technical individual;(d) ensure that personnel clearly understand the functions they are to perform and, where necessary, provide training for these functions;(e) ensure that appropriate and technically valid standard operating procedures are established and followed, and approve all original and revised standard operating procedures;(f) ensure that there is a quality assurance programme with designated personnel and assure that the quality assurance responsibility is being performed in accordance with these principles of good laboratory practice;(g) ensure that for each study an individual with the appropriate qualifications, training, and experience is designated by the management as the study director before the study is initiated. Replacement of a study director should be done according to established procedures, and should be documented;(h) ensure, in the event of a multisite study, that, if needed, a principal investigator is designated, who is appropriately trained, qualified and experienced to supervise the delegated phase(s) of the study. Replacement of a principal investigator should be done according to established procedures, and should be documented;(i) ensure documented approval of the study plan by the study director;(j) ensure that the study director has made the approval study plan available to the quality assurance personnel;(k) ensure the maintenance of a historical file of all standard operating procedures;(l) ensure that an individual is identified as responsible for the management of the archive(s);(m) ensure the maintenance of a master schedule;(n) ensure that test facility supplies meet requirements appropriate to their use in a study;(o) ensure for a multisite study that clear lines of communication exist between the study director, principal investigator(s), the quality assurance programme(s) and study personnel;(p) ensure that test and reference items are appropriately characterised;(q) establish procedures to ensure that computerised systems are suitable for their intended purpose, and are validated, operated and maintained in accordance with these principles of good laboratory practice.3. When a phase(s) of a study is conducted at a test site, test site management (if appointed) will have the responsibilities as defined above with the following exceptions: 1.1.2(g), (i), (j) and (o).1.2. Study director's responsibilities1. The study director is the single point of study control and has the responsibility for the overall conduct of the study and for its final report.2. These responsibilities should include, but not be limited to, the following functions. The study director should:(a) approve the study plan and any amendments to the study plan by dated signature;(b) ensure that the quality assurance personnel have a copy of the study plan and any amendments in a timely manner and communicate effectively with the quality assurance personnel as required during the conduct of the study;(c) ensure that study plans and amendments and standard operating procedures are available to study personnel;(d) ensure that the study plan and the final report for a multisite study identify and define the role of any principal investigator(s) and any test facilities and test sites involved in the conduct of the study;(e) ensure that the procedures specified in the study plan are followed, and assess and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from standard operating procedures during the conduct of the study;(f) ensure that all raw data generated are fully documented and recorded;(g) ensure that computerised systems used in the study have been validated;(h) sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with these principles of good laboratory practice;(i) ensure that after completion (including termination) of the study, the study plan, the final report, raw data and supporting material are archived.1.3. Principal investigator's responsibilities The principal investigator will ensure that the delegated phases of the study are conducted in accordance with the applicable principles of good laboratory practice.1.4. Study personnel's responsibilities 1. All personnel involved in the conduct of the study must be knowledgeable in those parts of the principles of good laboratory practice which are applicable to their involvement in the study.2. Study personnel will have access to the study plan and appropriate standard operating procedures applicable to their involvement in the study. It is their responsibility to comply with the instructions given in these documents. Any deviation from these instructions should be documented and communicated directly to the study director, and/or if appropriate, the principal investigator(s).3. All study personnel are responsible for recording raw data promptly and accurately and in compliance with these principles of good laboratory practice, and are responsible for the quality of their data.4. Study personnel should exercise health precautions to minimise risk to themselves and to ensure the integrity of the study. They should communicate to the appropriate person any relevant known health or medical condition in order that they can be excluded from operations that may affect the study.2. Quality assurance programme 2.1. General 1. The test facility should have a documented quality assurance programme to assure that studies performed are in compliance with these principles of good laboratory practice.2. The quality assurance programme should be carried out by an individual or by individuals designated by and directly responsible to management and who are familiar with the test procedures.3. This individual(s) should not be involved in the conduct of the study being assured.2.2. Responsibilities of the quality assurance personnel The responsibilities of the quality assurance personnel include, but are not limited to, the following functions. They should:(a) maintain copies of all approved study plans and standard operating procedures in use in the test facility and have access to an up-to-date copy of the master schedule;(b) verify that the study plan contains the information required for compliance with these principles of good laboratory practice. This verification should be documented;(c) conduct inspections to determine if all studies are conducted in accordance with these principles of good laboratory practice. Inspections should also determine that study plans and standard operating procedures have been made available to study personnel and are being followed.Inspections can be of three types as specified by quality assurance programme standard operating procedures:- study-based inspections,- facility-based inspections,- process-based inspections.Records of such inspections should be retained;(d) inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately and completely reflect the raw data of the studies;(e) promptly report any inspection results in writing to management and to the study director, and to the principal investigator(s) and the respective management, when applicable;(f) prepare and sign a statement, to be included with the final report, which specifies types of inspections and their dates, including the phase(s) of the study inspected, and the dates inspection results were reported to management and the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.3. Facilities 3.1. General 1. The test facility should be of suitable size, construction and location to meet the requirements of the study and to minimise disturbance that would interfere with the validity of the study.2. The design of the test facility should provide an adequate degree of separation of the different activities to assure the proper conduct of each study.3.2. Test system facilities 1. The test facility should have a sufficient number of rooms or areas to assure the isolation of test systems and the isolation of individual projects, involving substances or organisms known to be or suspected of being biohazardous.2. Suitable rooms or areas should be available for the diagnosis, treatment and control of diseases, in order to ensure that there is no unacceptable degree of deterioration of test systems.3. There should be storage rooms or areas as needed for supplies and equipment. Storage rooms or areas should be separated from rooms or areas housing the test systems and should provide adequate protection against infestation, contamination, and/or deterioration.3.3. Facilities for handling test and reference items 1. To prevent contamination or mix-ups, there should be separate rooms or areas for receipt and storage of the test and reference items, and mixing of the test items with a vehicle.2. Storage rooms or areas for the test items should be separate from rooms or areas containing the test systems. They should be adequate to preserve identity, concentration, purity, and stability, and ensure safe storage for hazardous substances.3.4. Archive facilities Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.3.5. Waste disposal Handling and disposal of wastes should be carried out in such a way as not to jeopardise the integrity of studies. This includes provision for appropriate collection, storage and disposal facilities, and decontamination and transportation procedures.4. Apparatus, material, and reagents 1. Apparatus, including validated computerised systems, used for the generation, storage and retrieval of data, and for controlling environmental factors relevant to the study should be suitably located and of appropriate design and adequate capacity.2. Apparatus used in a study should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to national or international standards of measurement.3. Apparatus and materials used in a study should not interfere adversely with the test systems.4. Chemicals, reagents, and solutions should be labelled to indicate identity (with concentration if appropriate), expiry date and specific storage instructions. Information concerning source, preparation date and stability should be available. The expiry date may be extended on the basis of documented evaluation or analysis.5. Test systems 5.1. Physical/chemical 1. Apparatus used for the generation of physical/chemical data should be suitably located and of appropriate design and adequate capacity.2. The integrity of the physical/chemical test systems should be ensured.5.2. Biological 1. Proper conditions should be established and maintained for the storage, housing, handling and care of biological test systems, in order to ensure the quality of the data.2. Newly received animal and plant test systems should be isolated until their health status has been evaluated. If any unusual mortality or morbidity occurs, this lot should not be used in studies and, when appropriate, should be humanely destroyed. At the experimental starting date of a study, test systems should be free of any disease or condition that might interfere with the purpose or conduct of the study. Test systems that become diseased or injured during the course of a study should be isolated and treated, if necessary to maintain the integrity of the study. Any diagnosis and treatment of any disease before or during a study should be recorded.3. Records of source, date of arrival, and arrival condition of test systems should be maintained.4. Biological test systems should be acclimatised to the test environment for an adequate period before the first administration/application of the test or reference item.5. All information needed to properly identify the test systems should appear on their housing or containers. Individual test systems that are to be removed from their housing or containers during the conduct of the study should bear appropriate identification, wherever possible.6. During use, housing or containers for test systems should be cleaned and sanitised at appropriate intervals. Any material that comes into contact with the test system should be free of contaminants at levels that would interfere with the study. Bedding for animals should be changed as required by sound husbandry practice. Use of pest control agents should be documented.7. Test systems used in field studies should be located so as to avoid interference in the study from spray drift and from past usage of pesticides.6. Test and reference items 6.1. Receipt, handling, sampling and storage 1. Records including test item and reference item characterisation, date of receipt, expiry date, quantities received and used in studies should be maintained.2. Handling, sampling, and storage procedures should be identified in order that the homogeneity and stability are assured to the degree possible and contamination or mix-up are precluded.3. Storage container(s) should carry identification information, expiry date, and specific storage instructions.6.2. Characterisation 1. Each test and reference item should be appropriately identified (e.g. code, chemical abstracts service registry number (CAS number), name, biological parameters).2. For each study, the identity, including batch number, purity, composition, concentrations, or other characteristics to appropriately define each batch of the test or reference items should be known.3. In cases where the test item is supplied by the sponsor, there should be a mechanism, developed in cooperation between the sponsor and the test facility, to verify the identity of the test item subject to the study.4. The stability of test and reference items under storage and test conditions should be known for all studies.5. If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For test items used in field studies (e.g. tank mixes), these may be determined through separate laboratory experiments.6. A sample for analytical purposes from each batch of test item should be retained for all studies except short-term studies.7. Standard operating procedures 1. A test facility should have written standard operating procedures approved by test facility management that are intended to ensure the quality and integrity of the data generated by that test facility. Revisions to standard operating procedures should be approved by test facility management.2. Each separate test facility unit or area should have immediately available current standard operating procedures relevant to the activities being performed therein. Published text books, analytical methods, articles and manuals may be used as supplements to these standard operating procedures.3. Deviations from standard operating procedures related to the study should be documented and should be acknowledged by the study director and the principal investigator(s), as applicable.4. Standard operating procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples.1. Test and reference itemsReceipt, identification, labelling, handling, sampling and storage.2. Apparatus, materials and reagents(a) Apparatus:use, maintenance, cleaning and calibration.(b) Computerised systems:validation, operation, maintenance, security, change control and back-up.(c) Materials, reagents and solutions:preparation and labelling.3. Record keeping, reporting, storage, and retrievalCoding of studies, data collection, preparation of reports, indexing systems, handling of data, including the use of computerised systems.4. Test system (where appropriate)(a) Room preparation and environmental room conditions for the test system.(b) Procedures for receipt, transfer, proper placement, characterisation, identification and care of the test system.(c) Test system preparation, observations and examinations, before, during and at the conclusion of the study.(d) Handling of test system individuals found moribund or dead during the study.(e) Collection, identification and handling of specimens including necropsy and histopathology.(f) Siting and placement of test systems in test plots.5. Quality assurance proceduresOperation of Quality Assurance personnel in planning, scheduling, performing, documenting and reporting inspections.8. Performance of the study 8.1. Study plan 1. For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the study director and verified for GLP compliance by quality assurance personnel as specified in 2.2(b) of Section II. The study plan should also be appproved by the test facility management and the sponsor, if required by national regulation or legislation in the country where the study is being performed.2. (a) Amendments to the study plan should be justified and approved by dated signature of the study director and maintained with the study plan.(b) Deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the study director and/or principal investigator(s) and maintained with the study raw data.3. For short-term studies, a general study plan accompanied by a study specific supplement may be used.8.2. Content of the study plan The study plan should contain, but not be limited to the following information:1. Identification of the study, the test item and reference item:(a) a descriptive title;(b) a statement which reveals the nature and purpose of the study;(c) identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.);(d) the reference item to be used.2. Information concerning the sponsor and the test facility:(a) name and address of the sponsor;(b) name and address of any test facilities and test sites involved;(c) name and address of the study director;(d) name and address of the principal investigator(s), and the phase(s) of the study delegated by the study director and under the responsibility of the principal investigator(s).3. Dates:(a) the date of approval of the study plan by signature of the study director. The date of approval of the study plan by signature of the test facility management and sponsor if required by national regulation or legislation in the country where the study is being performed;(b) the proposed experimental starting and completion dates.4. Test methods:Reference to the OECD test guideline or other test guideline or method to be used.5. Issues (where applicable):(a) the justification for selection of the test system;(b) characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information;(c) the method of administration and the reason for its choice;(d) the dose levels and/or concentration(s), frequency, and duration of administration/application;(e) detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed, and statistical methods to be used (if any).6. Records:a list of records to be retained.8.3. Conduct of the study 1. A unique identification should be given to each study. All items concerning this study should carry this identification. Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study.2. The study should be conducted in accordance with the study plan.3. All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated.4. Any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change.5. Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given.9. Reporting of study results 9.1. General 1. A final report should be prepared for each study. In the case of short-term studies, a standardised final report accompanied by a study specific extension may be prepared.2. Reports of principal investigators or scientists involved in the study should be signed and dated by them.3. The final report should be signed and dated by the study director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these principles of good laboratory practice should be indicated.4. Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the study director.5. Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report.9.2. Content of the final report The final report should include, but not be limited to, the following information:1. Identification of the study, the test item and reference item:(a) a descriptive title;(b) identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.);(c) identification of the reference item by name;(d) characterisation of the test item including purity, stability and homogeneity.2. Information concerning the sponsor and the test facility:(a) name and address of the sponsor;(b) name and address of any test facilities and test sites involved;(c) name and address of the study director;(d) name and address of the principal investigator(s) and the phase(s) of the study delegated, if applicable;(e) name and address of scientists having contributed reports to the final report.3. Dates:experimental starting and completion dates.4. Statement:a quality assurance programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.5. Description of materials and test methods:(a) description of methods and materials used;(b) reference to OECD test guideline or other test guideline or method.6. Results:(a) a summary of results;(b) all information and data required by the study plan;(c) a presentation of the results, including calculations and determinations of statistical significance;(d) an evaluation and discussion of the results and, where appropriate, conclusions.7. Storage:the location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.10. Storage and retention of records and materials 10.1. The following should be retained in the archives for the period specified by the appropriate authorities:(a) the study plan, raw data, samples of test and reference items, specimens, and the final report of each study;(b) Records of all inspections performed by the quality assurance programme, as well as master schedules;(c) records of qualifications, training, experience and job descriptions of personnel;(d) records and reports of the maintenance and calibration of apparatus;(e) validation documentation for computerised systems;(f) the historical file of all standard operating procedures;(g) environmental monitoring records.In the absence of a required retention period, the final disposition of any study materials should be documented. When samples of test and reference items and specimens are disposed of before the expiry of the required retention period for any reason, this should be justified and documented. Samples of test and reference items and specimens should be retained only as long as the quality of the preparation permits evaluation.10.2. Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval.10.3. Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded.10.4. If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).


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Directive 2003/65/EC of the European Parliament and of the Council of 22 July 2003 amending Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (Text with EEA relevance)

Official Journal L 230 , 16/09/2003 P. 0032 - 0033

Directive 2003/65/EC of the European Parliament and of the Councilof 22 July 2003amending Council Directive 86/609/EEC on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes(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(1),Having regard to the opinion of the European Economic and Social Committee(2),Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),Whereas:(1) On 23 March 1998 the Council adopted Decision 1999/575/EC concerning the conclusion by the Community of the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes(4) (hereinafter referred to as the Convention).(2) Council Directive 86/609/EEC(5) is the implementing tool of the Convention incorporating the same objectives as the Convention.(3) Annex II to Directive 86/609/EEC containing guidelines for accommodation and care of animals takes over Appendix A to the Convention. The provisions contained in Appendix A to the Convention and the Annexes to the said Directive are of a technical nature.(4) It is necessary to ensure the consistency of the Annexes to Directive 86/609/EEC with the latest scientific and technical developments and results of research within the fields covered. Currently, changes to the Annexes can only be adopted by the long-drawn-out co-decision procedure with the consequence that their content is lagging behind the latest developments in the field.(5) 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).(6) Therefore Directive 86/609/EEC should be amended accordingly,HAVE ADOPTED THIS DIRECTIVE:Article 1In Directive 86/609/EEC the following Articles shall be inserted:"Article 24aThe measures necessary for the implementation of this Directive relating to the subject matters referred to below shall be adopted in accordance with the regulatory procedure set out in Article 24b(2):- Annexes to this Directive.Article 24b1. The Commission shall be assisted by a Committee.2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.3. The Committee shall adopt its rules of procedure."Article 2Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 16 September 2004. They shall forthwith inform the Commission thereof.When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States.Article 3This Directive shall enter into force on the day of its publication in the Official Journal of the European Union.Article 4This Directive is addressed to the Member States.Done at Brussels, 22 July 2003.For the European ParliamentThe PresidentP. CoxFor the CouncilThe PresidentG. Alemanno(1) OJ C 25 E, 29.1.2002, p. 536.(2) OJ C 94, 18.4.2002, p. 5.(3) Opinion of the European Parliament of 2 July 2002 (not yet published in the Official Journal), Council Common Position of 17 March 2003 (OJ C 113 E, 13.5.2003, p. 59) and Decision of the European Parliament of 19 June 2003 (not yet published in the Official Journal).(4) OJ L 222, 24.8.1999, p. 29.(5) OJ L 358, 18.12.1986, p. 1.(6) OJ L 184, 17.7.1999, p. 23.


Avis juridique important

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31984L0458

Council Directive 84/458/EEC of 18 September 1984 amending for the 22nd time Directive 64/54/EEC on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption

Official Journal L 256 , 26/09/1984 P. 0019 - 0019 Spanish special edition: Chapter 13 Volume 18 P. 0003  Portuguese special edition Chapter 13 Volume 18 P. 0003

*****COUNCIL  DIRECTIVE  of 18 September 1984  amending for the 22nd time Directive 64/54/EEC on the approximation of the laws of the Member States concerning the preservatives authorized for use in foodstuffs intended for human consumption  (84/458/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 (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas Directive 64/54/EEC (4), as last amended by Directive 84/261/EEC (5), sets out a list of preservatives the use of which is authorized for the protection of foodstuffs intended for human consumption against deterioration caused by micro-organisms;  Whereas the Commission proposal currently under review aims, on the one hand, to add to the list of authorized preservatives potassium bisulphite and natamycin and, on the other hand, to authorize thiabendazol for surface treatment of citrus fruit and bananas, without any time limit;  Whereas, pending a Council decision on the whole of this proposal and without prejudice to current discussions on this subject the authorization for thiabendazol should, as a precautionary measure, be extended on a transitional basis from 16 September 1984 to 15 March 1985, in order to avoid any interruption in the traditional trade flows concerning citrus fruit and bananas,  HAS ADOPTED THIS DIRECTIVE:  Article 1  In No E 233 (c) of section I of the Annex to Directive 64/54/EEC, '16 September 1984' is hereby replaced by '16 March 1985'.  Article 2  The Member States shall bring into force, with effect from 16 September 1984, the laws, regulations and administrative provisions necessary to comply with this Directive and shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 18 September 1984.  For the Council  The President  A. DEASY  (1) OJ No C 330, 17. 12. 1981, p. 7.  (2) OJ No C 125, 17. 5. 1982, p. 147.  (3) OJ No C 178, 15. 7. 1982, p. 4.  (4) OJ No 12, 27. 1. 1964, p. 161/64.  (8) OJ No L 129, 15. 5. 1984, p. 28.