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31996L0005

Commission Directive 96/5/EC, Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (Text with EEA relevance)

Official Journal L 049 , 28/02/1996 P. 0017 - 0028

COMMISSION DIRECTIVE 96/5/EC of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4 thereof,Whereas the Community measures envisaged by this Directive do not exceed what is necessary for the attainment of the objectives already provided for by Directive 89/398/EEC;Whereas processed cereal-based foods and baby foods for infants and young children are used as part of a diversified diet and do not constitute the sole source of nourishment of infants and young children;Whereas there is a great variety of the products in question reflecting the widely varied diet of infants being weaned and young children owing to social and cultural circumstances existing in the Community;Whereas the essential composition of the products in question must be appropriate for the nutritional requirements of infants and young children in good health as established by generally accepted scientific data, account being taken of the abovementioned factors;Whereas the essential nutritional requirements for the composition of the two broad categories of these products, namely processed cereal-based foods and baby foods should be laid down;Whereas although, because of the nature of such products, a number of mandatory requirements and other restrictions as to the level of vitamins, minerals and other nutrients should be imposed, such nutrients may be added voluntarily by manufacturers provided that they use exclusively the substances listed in Annex IV to this Directive;Whereas the use of the products to which such nutrients have been voluntarily added at levels currently observed in the Community do not appear to result in excessive intakes of those nutrients by infants and young children; whereas attention will be paid to any future developments of the situation, and if necessary, appropriate measures will be taken;Whereas the provisions relating to the use of additives in the manufacture of processed cereal-based foods and baby foods will be laid down in a Council Directive;Whereas the use of novel food ingredients will be dealt with horizontally for all foodstuffs in a separate measure;Whereas this Directive reflects current knowledge about these products; whereas any amendment, to allow for innovation based on scientific and technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC;Whereas, in view of the persons for whom the products are intended, the necessary microbiological criteria and maximum levels for contaminants should be laid down without delay;Whereas pursuant to Article 7 of Directive 89/398/EEC the products covered by this Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (2), as last amended by Commission Directive 93/102/EC (3);Whereas in this Directive the additions and exceptions to those general rules are adopted and expanded upon, where appropriate;Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling showing the energy value and principal nutrients they contain; whereas, on the other hand, the method of use should be specified in accordance with point 8 of Article 3 (1) and Article 10 of Directive 79/112/EEC, in order to prevent inappropriate uses liable to harm the health of infants;Whereas, whilst claims not specifically prohibited may generally be made for the products in question in conformity with the rules applicable for all foodstuffs, such claims should, where appropriate, take into account the compositional criteria specified in this Directive;Whereas the Scientific Committee for Food has, in accordance with Article 4 of Directive 89/398/EEC, been consulted on the provisions liable to affect public health;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 1. This Directive is a 'specific Directive` within the meaning of Article 4 of Directive 89/398/EEC.2. This Directive covers foodstuffs for particular nutritional use fulfilling the particular requirements of infants and young children in good health in the Community and are intended for use by infants while they are being weaned, and by young children as a supplement to their diet and/or for their progressive adaptation to ordinary food. They comprise:(a) 'Processed cereal-based foods` which are divided into the following four categories:(i) simple cereals which are or have to be reconstituted with milk or other appropriate nutritious liquids;(ii) cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid;(iii) pastas which are to be used after cooking in boiling water or other appropriate liquids;(iv) rusks and biscuits which are to be used either directly or, after pulverization, with the addition of water, milk or other suitable liquids.(b) 'Baby foods` other than processed cereal-based foods.3. This Directive does not apply to milks intended for young children.4. For the purpose of this Directive:- 'infants` shall mean children under the age of twelve months,- 'young children` shall mean children aged between 1 and 3 years.Article 2 Member States shall ensure that the products referred to in Article 1 are marketed within the Community only if they conform to the rules laid down in this Directive.Article 3 Processed cereal-based foods and baby foods shall be manufactured from ingredients whose suitability for particular nutritional use by infants and young children has been established by generally accepted scientific data.Article 4 1. Processed cereal-based foods shall comply with the compositional criteria specified in Annex I.2. Baby foods which are described in Annex II shall comply with the compositional criteria specified therein.Article 5 Only the nutritional substances listed in Annex IV may be added in the manufacture of processed cereal-based foods and baby foods. Within 12 months of the entry into force of this Directive maximum levels, in addition to those already stipulated, shall be laid down where necessary.The purity criteria for those substances shall be laid down at a later stage.Article 6 Processed cereal-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children. Necessary maximum levels shall be established without delay.Microbiological criteria shall also be established as necessary.Article 7 1. The labelling of the products concerned shall bear in addition to the particulars provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars:(a) A statement as to the appropriate age from which the product may be used, regard being had to its composition, texture or other particular properties. The stated age shall not be less than four months for any product. Products recommended for use from the age of four months may indicate that they are suitable from that age unless independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, advise otherwise.(b) Information as to the presence or absence of gluten if the indicated age from which the product may be used is below six months.(c) The available energy value expressed in kJ and kcal, and the protein, carbohydrate and lipid content, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption;(d) The average quantity of each mineral substance and of each vitamin governed by a specific level in Annex I and Annex II respectively, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption;(e) Instructions for appropriate preparation, when necessary, and a statement as to the importance of following those instructions.2. The labelling may bear:(a) the average quantity of the nutrients set out in Annex IV when such declaration is not covered by the provisions of point (d) of paragraph 1, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption;(b) in addition to numerical information, information on vitamins and minerals shown in Annex V, expressed as a percentage of the reference values given therein, per 100 g or 100 ml of the product as sold, and where appropriate, per specified quantity of the product as proposed for consumption, provided that the quantities present are at least equal to 15 % of the reference values.Article 8 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 30 September 1997. They shall forthwith inform the Commission thereof.Those laws, regulations and administrative provisions shall be applied in such a way as to:- permit trade in products complying with this Directive, by 1 October 1997,- prohibit trade in products which do not comply with this Directive, with effect from 31 March 1999.When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 9 This Directive shall enter into force on the twentieth day following its publication in the Official Journal of the European Communities.Article 10 This Directive is addressed to the Member States.Done at Brussels, 16 February 1996.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ No L 186, 30. 6. 1989, p. 27.(2) OJ No L 33, 8. 2. 1979, p. 1.(3) OJ No L 291, 25. 11. 1993, p. 14.ANNEX I ESSENTIAL COMPOSITION OF PROCESSED CEREAL-BASED FOODS FOR INFANTS AND YOUNG CHILDREN The requirements concerning nutrients refer to the products ready for use marketed as such or reconstituted as instructed by the manufacturer.1. Cereal content Processed cereal-based foods are prepared primarily from one or more milled cereals and/or starchy root products.The amount of cereal and/or starchy root shall not be less than 25 % of the final mixture on a dry weight for weight basis.2. Protein 2.1. For products mentioned in points (a) (ii) and (a) (iv) of Article 1 (2), the protein content shall not exceed 1,3 g/100 kJ (5,5 g/100 kcal).2.2. For products mentioned in point (a) (ii) of Article 1 (2), the added protein shall not be less than 0,48 g/100 kJ (2 g/100 kcal).2.3. For biscuits mentioned in point (a) (iv) of Article 1 (2), made with the addition of a high protein food, and presented as such, the added protein shall not be less than 0,36 g/100 kJ (1,5/100 kcal).2.4. The chemical index of the added protein shall be equal to at least 80 % of that of the reference protein (casein as defined in Annex III), or the protein energy ratio (PER) of the protein in the mixture shall be equal to at least 70 % of that of the reference protein. In all cases, the addition of amino acids is permitted solely for the purpose of improving the nutritional value of the protein mixture, and only in the proportions necessary for that purpose.3. Carbohydrates 3.1. If sucrose, fructose, glucose, glucose syrups or honey are added to products mentioned in points (a) (i) and (a) (iv) of Article 1 (2):- the amount of added carbohydrates from these sources shall not exceed 1,8 g/100 kJ (7,5 g/100 kcal),- the amount of added fructose shall not exceed 0,9 g/100 kJ (3,75 g/100 kcal).3.2. If sucrose, fructose, glucose syrups or honey are added to products mentioned in point (a) (ii) of Article 1 (2),- the amount of added carbohydrates from these sources shall not exceed 1,2 g/100 kJ (5 g/100 kcal),- the amount of added fructose shall not exceed 0,6 g/100 kJ (2,5 g/100 kcal).4. Lipids 4.1. For products mentioned in points (a) (i) and (a) (iv) of Article 1 (2) the lipid content shall not exceed 0,8 g/100 kJ (3,3 g/100 kcal).4.2. For products mentioned in point (a) (ii) of Article 1 (2), the lipid content shall not exceed 1,1 g/100 kJ (4,5 g/100 kcal). If the lipid content exceeds 0,8 g/100 kJ (3,3 g/100 kcal):(a) the amount of lauric acid shall not exceed 15 % of the total lipid content;(b) the amount of myristic acid shall not exceed 15 % of the total lipid content;(c) the amount of linoleic acid (in the form of glycerides = linoleates) shall not be less than 70 mg/100 kJ (300 mg/100 kcal) and shall not exceed 285 mg/100 kJ (1 200 mg/100 kcal).5. Minerals 5.1. Sodium- sodium salts may only be added to processed cereal-based foods for technological purposes,- the sodium content of processed cereal-based foods shall not exceed 25 mg/100 kJ (100 mg/100 kcal).5.2. Calcium5.2.1. For products mentioned in point (a) (ii) of Article 1 (2), the amount of calcium shall not be less than 20 mg/100 kJ (80 mg/100 kcal).5.2.2. For products mentioned in point (a) (iv) of Article 1 (2), manufactured with the addition of milk (milk biscuits) and presented as such, the amount of calcium shall not be less than 12 mg/100 kJ (50 mg/100 kcal).6. Vitamins6.1. For processed cereal-based foods the amount of thiamin shall not be less than 25 ìg/100 kJ (100 ìg/100 kcal).6.2. For products mentioned in point (a) (ii) of Articled 1 (2):>TABLE>These limits are also applicable if vitamins A and D are added to other processed cereal-based foods.ANNEX II ESSENTIAL COMPOSITION OF BABY FOODS FOR INFANTS AND YOUNG CHILDREN The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer.1. Protein 1.1. If meat, poultry, fish, offal or other traditional source of protein are the only ingredients mentioned in the name of the product, then:- the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 40 % by weight of the total product,- each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 %, by weight, of total named protein sources,- the total protein from the named sources shall not be less than 1,7 g/100 kJ (7 g/100 kcal).1.2. If meat, poultry, fish, offal or other traditional source of protein, singularly or in combination, are mentioned first in the name of the product, whether or not the product is presented as a meal, then:- the named poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 10 % by weight of the total product,- each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 % by weight, of total named protein sources,- the protein from the named sources shall not be less than 1 g/100 kJ (4 g/100 kcal).1.3. If meat, poultry, fish, offal or other traditional source of protein, singularly or in combination are mentioned, but not first, in the name of the product, whether or not the product is presented as a meal, then:- the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 8 % by weight of the total product,- each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25 %, by weight, of total named protein sources,- the protein from the named sources shall not be less than 0,5 g/100 kJ (2,2 g/100 kcal),- the total protein in the product from all sources shall not be less than 0,7 g/100 kJ (3 g/100 kcal).1.4. If the product is designated on the label as a meal, but does not mention meat, poultry, fish, offal or other traditional source of protein in the name of the product, then:- the total protein in the product from all sources shall not be less than 0,7 g/100 kJ (3 g/100kcal).1.5. The addition of amino acids is permitted solely for the purpose of improving the nutritional value of the protein present, and only in the proportions necessary for that purpose.2. Carbohydrates The quantities of total carbohydrates present in fruit and vegetable juices and nectars, fruit-only dishes, and desserts or puddings shall not exceed:- 10 g/100 ml for vegetable juices and drinks based on them,- 15 g/100 ml for fruit juices and nectars and drinks based on them,- 20 g/100 g for fruit-only dishes,- 25 g/100 g for desserts and puddings,- 5 g/100 g for other non-milk-based drinks.3. Fat 3.1. For products referred to in point 1.1 of this Annex:If meat or cheese are the only ingredients or are mentioned first in the name of a product, then:- the total fat in the product from all sources should not exceed 1,4 g/100 kJ (6 g/100 kcal).3.2. For all other products:the total fat in the product from all sources should not exceed 1,1 g/100 kJ (4,5 g/100 kcal).4. Sodium 4.1. The final sodium content in the product should be either not more than 48 mg/100 kJ (200 mg/100 kcal) or not more than 200 mg per 100 g. However if cheese is the only ingredient mentioned in the name of the product, the final sodium content in the product should not be more than 70 mg/100 kJ (300 mg/100 kcal).4.2. Sodium salts may not be added to products based on fruit, nor to desserts, puddings except for technological purposes.5. Vitamins Vitamin CIn a fruit juice, nectar, or vegetable juice the final content of vitamin C in the product should be either not less than 6 mg/100 kJ (25 mg/100 kcal) or not less than 25 mg per 100 g.Vitamin AIn vegetable juices, the final content of vitamin A in the product should be not less than 25 ìg RE/100 kJ (100 ìg RE/100 kcal) (1).Vitamin A shall not be added to other baby foods.Vitamin D.Vitamin D shall not be added to baby foods.(1) RE = all trans retinol equivalents.ANNEX III AMINO ACID COMPOSITION OF CASEIN >TABLE>ANNEX IV NUTRITIONAL SUBSTANCES 1. Vitamins Vitamin ARetinolRetinyl acetateRetinyl palmitatebeta caroteneVitamin DVitamin D2 (= ergocalciferol)Vitamin D3 (= cholecalciferol)Vitamin B1Thiamin hydrochlorideThiamin mononitrateVitamin B2RiboflavinRiboflavin-5'-phosphte, sodiumNiacinNicotinamideNicotinic acidVitamin B6Pyridoxine hydrochloridePyridoxine-5-phosphatePyridoxine dipalmitatePantothenic AcidD-pantothenate, calciumD-pantothenate, sodiumDexpanthenolFolateFolic acidVitamin B12CyanocobalaminHydroxocobalaminBiotinD-biotinVitamin CL-Ascorbic acidSodium L-ascorbateCalcium L-ascorbate6-Palmityl-L-ascorbic acid (ascorbyl palmitate)potassium ascorbateVitamin KPhylloquinone (Phytomenadione)Vitamin ED-alpha tocopherolDL-alpha tocopherolD-alpha tocopherol acetateDL-alpha tocopherol acetate2. Amino acids >TABLE>3. Others CholineCholine chlorideCholine citrateCholine bitartrateInositolL-CarnitineL-carnitine hydrochloride4. Salts of minerals and trace elements CalciumCalcium carbonateCalcium chlorideCalcium salts of citric acidCalcium gluconateCalcium glycerophosphateCalcium lactateCalcium oxideCalcium hydroxideCalcium salts of orthophosphoric acidMagnesiumMagnesium carbonateMagnesium chlorideMagnesium salts of citric acidMagnesium gluconateMagnesium oxideMagnesium hydroxideMagnesium salts of orthophosphoric acidMagnesium sulphateMagnesium lactateMagnesium glycerophosphatePotassiumPotassium chloridePotassium salts of citric acidPotassium gluconatePotassium lactatePotassium glycerophosphateIronFerrous citrateFerric ammonium citrateFerrous gluconateFerrous lactateFerrous sulphateFerous fumarateFerric diphosphate (Ferric pyrophosphate)Elemental iron (carbonyl + electrolytic + hydrogen-reduced)Ferric saccharateSodium ferric diphosphateFerrous carbonateCopperCopper-lysine complexCupric carbonateCupric citrateCupric gluconateCupric sulphateZincZinc acetateZinc acetateZinc citrateZinc lactateZinc sulphateZinc oxideZinc gluconateManganeseManganese carbonateManganese chlorideManganese citrateManganese gluconateManganese sulphateManganese glycerophosphateIodineSodium iodidePotassium iodidePotassium iodateSodium iodate.ANNEX V REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN >TABLE>


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31978L0170

Council Directive 78/170/EEC of 13 February 1978 on the performance of heat generators for space heating and the production of hot water in new or existing non- industrial buildings and on the insulation of heat and domestic hot-water distribution in new non-industrial buildings

Official Journal L 052 , 23/02/1978 P. 0032 - 0033 Greek special edition: Chapter 10 Volume 1 P. 0161  Spanish special edition: Chapter 12 Volume 3 P. 0082  Portuguese special edition Chapter 12 Volume 3 P. 0082  Finnish special edition: Chapter 12 Volume 2 P. 0003  Swedish special edition: Chapter 12 Volume 2 P. 0003

COUNCIL DIRECTIVE  of 13 February 1978  on the performance of heat generators for space heating and the production of hot water in new or existing non-industrial buildings and on the insulation of heat and domestic hot-water distribution in new non-industrial buildings  (78/170/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 103 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, in its resolution of 17 September 1974 concerning a new energy policy strategy for the Community (3), the Council adopted the objective of a reduction of the rate of growth of internal consumption by measures for using energy rationally and economically without jeopardizing social and economic growth objectives;  Whereas, in its resolution of 17 December 1974 on a Community action programme on the rational utilization of energy (4), the Council noted that, in its communications to the Council entitled "Rational utilization of energy", the Commission had drawn up a Community action programme in this field;  Whereas any improvement in the rational use of energy is generally beneficial to the environment;  Whereas the sector concerned with heating systems in buildings lends itself to such measures;  Whereas recommendation 76/493/EEC (5), related to the heating systems of existing buildings;  Whereas in the case of new heating systems it is necessary to achieve energy savings as soon as possible which will have an influence on total energy consumption as and when the systems are installed;  Whereas, to this end, a Directive should be adopted to provide a general framework within which the Member States would jointly explore energy saving methods designed to lessen the impact of the supply difficulties referred to in Article 103 (4) of the Treaty;  Whereas heat generators for space heating and the production of domestic hot water in new or existing non-industrial buildings should be inspected at the stage of manufacture or at the time of installation;  Whereas it should be made compulsory in new non-industrial buildings to provide, in economically justifiable conditions, thermal insulation both for generators and for the system whereby the heated fluids are distributed;  Whereas the Commission should receive regular information on the implementing measures adopted and the results obtained or anticipated;  Whereas the implementing measures adopted for this Directive should incorporate the measures adopted for the approximation of the laws of the Member States in the fields concerned by this Directive and should be directed towards facilitating the harmonization and standardization work in progress or to be undertaken in these fields both at Community and international level,  HAS ADOPTED THIS DIRECTIVE:    Article 1 1. Member States shall take all necessary measures to ensure that all new heat generators for space heating and/or the production of hot water in new or existing non-industrial buildings comply with minimum performance requirements.  In the case of generators capable of using various forms of energy, the minimum performance requirements must relate to each form of energy used.  (1)OJ No C 266, 7.11.1977, p. 55. (2)OJ No C 287, 30.11.1977, p. 9. (3)OJ No C 153, 9.7.1975, p. 1. (4)OJ No C 153, 9.7.1975, p. 5. (5)OJ No L 140, 28.5.1976, p. 12.    The term heat generator shall, in particular, mean hot-water boilers, steam boilers, air heaters, including components and especially the associated firing equipment appropriate to the type of fossil fuel used. Combined electricity/heat generators used in buildings shall also be regarded as heat generators ; for these, the minimum performance requirements must relate to the full energy output.  Electric heat generators with resistances and connections to a remote heating network shall be excluded.  Those appliances for which type-testing is not practicable will be the subject of a subsequent proposal after appropriate technical study.  2. Member States shall ensure that compliance with the minimum performance requirements is assured by an inspection carried out either at the stage of manufacture of the generator or at the time of installation.  3. Heat generators subject to inspection at the time of manufacture cannot be offered for sale unless they comply with the minimum performance requirements ; compliance with the relevant rules shall be certified by means of a data plate giving the following minimum details:    - manufacturer's identity,       - type of heat generator and its year of manufacture,       - heat rating in kW for every type of energy foreseen,       - type and characteristics of the energy or energies used,       - maximum temperature of the heating fluid,       - confirmation of inspection and identification of the body which carried it out,       - consumption of each heat generator when working to rated capacity.         The term "heat rating" refers to the highest output that can be continuously supplied by the heat generator.  When a heat generator of a type subject to inspection at the time of manufacture is installed, the user shall be provided with written operating and maintenance instructions to enable him to obtain optimum efficiency. These instructions must have been inspected in the same way as the generator and include the main details of the findings of the inspection.  4. In the case of heat generators subject to inspection at the time of installation, energy losses must not exceed the levels laid down by the Member States.   Article 2 Member States shall take all necessary measures to ensure that economically justifiable insulation of the distribution and storage system is made compulsory in new non-industrial buildings, both as regards heating fluid and domestic hot water.  These provisions shall also apply to systems connected to a remote-heating network.  They shall also apply to new heat generators, including electric systems for heating water, in all new or existing non-industrial buildings.   Article 3 The date from which a heat generator may no longer be installed, unless it complies with the minimum performance requirements in accordance with Article 1, shall be 1 January 1981.  The measures referred to in Article 2 shall apply from 1 July 1980.   Article 4 The Member States shall duly inform the Commission of measures taken within the scope of this Directive and of the results obtained or anticipated from such measures.   Article 5 This Directive shall in no way prejudge measures based on Article 100 of the Treaty.   Article 6 This Directive is addressed to the Member States.     Done at Brussels, 13 February 1978.  For the Council  The President  P. DALSAGER


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31973L0239

First Council Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance

Official Journal L 228 , 16/08/1973 P. 0003 - 0019 Finnish special edition: Chapter 6 Volume 1 P. 0146  Greek special edition: Chapter 06 Volume 1 P. 0157  Swedish special edition: Chapter 6 Volume 1 P. 0146  Spanish special edition: Chapter 06 Volume 1 P. 0143  Portuguese special edition Chapter 06 Volume 1 P. 0143

FIRST COUNCIL DIRECTIVE  of 24 July 1973  on the coordination of laws, Regulations and administrative provisions relating to the taking-up and pursuit of the business of direct insurance other than life assurance  (73/239/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 57 (2) thereof;  Having regard to the General Programme (1) for the abolition of restrictions on freedom of establishment, and in particular Title IV C thereof;  Having regard to the proposal from the Commission;  Having regard to the Opinion of the European Parliament (2);  Having regard to the Opinion of the Economic and Social Committee (3);  Whereas by virtue of the General Programme the removal of restrictions on the establishment of agencies and branches is, in the case of the direct insurance business, dependent on the coordination of the conditions for the taking-up and pursuit of this business ; whereas such coodination should be effected in the first place in respect of direct insurance other than life assurance;  Whereas in order to facilitate the taking-up and pursuit of the business of insurance, it is essential to eliminate certain divergencies which exist between national supervisory legislation ; whereas in order to achieve this objective, and at the same time ensure adequate protection for insured and third parties in all the Member States, it is desirable to coordinate, in particular, the provisions relating to the financial guarantees required of insurance undertakings;  Whereas a classification of risks in the different classes of insurance is necessary in order to determine, in particular, the activities subject to a compulsory authorization and the amount of the minimum guarantee fund fixed for the class of insurance concerned;  Whereas it is desirable to exclude from the application of this Directive mutual associations which, by virtue of their legal status, fulfil appropriate conditions as to security and financial guarantees ; whereas it is further desirable to exclude certain institutions in several Member States whose business covers a very limited sector only and is restricted by law to a specified territory or to specified persons;  Whereas the various laws contain different rules as to the simultaneous undertaking of health insurance, credit and suretyship insurance and insurance in respect of recourse against third parties and legal defence, whether with one another or with other classes of insurance ; whereas continuance of this divergence after the abolition of restrictions on the right of establishment in classes other than life assurance would mean that obstacles to establishment would continue to exist ; whereas a solution to this problem must be provided in subsequent coordination to be effected within a relatively short period of time;  Whereas it is necessary to extend supervision in each Member State to all the classes of insurance to which this Directive applies ; whereas such supervision is not possible unless the undertaking of such classes of insurance is subject to an official authorization ; whereas it is therefore necessary to define the conditions for the granting or withdrawal of such authorization ; whereas provision must be made for a right to apply to the courts should an authorization be refused or withdrawn;  Whereas it is desirable to bring the classes of insurance known as transport classes bearing Nos 4, 5, 6, 7 and 12 in Paragraph A of the Annex, and the credit insurance classes bearing Nos 14 and 15 in paragraph A of the Annex, under more flexible rules in view of the continual fluctuations in conditions affecting goods and credit;  Whereas the search for a common method of calculating technical reserves is at present the subject of studies at Community level ; whereas it therefore appears to be desirable to reserve the attainment of coordination in this matter, as well as questions relating to the determination of categories of investments and the valuation of assets, for subsequent Directives;  (1)OJ No 2, 15.1.1962, p. 36/62. (2)OJ No C 27, 28.3.1968, p. 15. (3)OJ No 158, 18.7.1967, p. 1.   Whereas it is necessary that insurance undertakings should possess, over and above technical reserves of sufficient amount to meet their underwriting liabilities, a supplementary reserve, to be known as the solvency margin, and represented by free assets, in order to provide against business fluctuations ; whereas in order to ensure that the requirements imposed for such purposes are determined according to objective criteria, whereby undertakings of the same size are placed on an equal footing as regards competition, it is desirable to provide that such margin shall be related to the overall volume of business of the undertaking and be determined by reference to two indices of security, one based on premiums and the other on claims;  Whereas it is desirable to require a minimum guarantee fund related to the size of the risk in the classes undertaken, in order to ensure that undertakings possess adequate resources when they are set up and that in the subsequent course of business the solvency margin shall in no event fall below a minimum of security;  Whereas it is necessary to make provision for the case where the financial condition of the undertaking becomes such that it is difficult for it to meet its underwriting liabilities;  Whereas the coordinated rules concerning the taking-up and pursuit of the business or direct insurance within the Community should, in principle, apply to all undertakings entering the market and, consequently, also to agencies and branches where the head office of the undertaking is situated outside the Community ; whereas it is, nevertheless, desirable as regards the methods of supervision to make special provision with respect to such agencies or branches in view of the fact that the assets of the undertakings to which they belong are situated outside the Community;  Whereas it is, however, desirable to permit the relaxation of such special conditions, while observing the principle that such agencies and branches should not obtain more favourable treatment than undertakings within the Community;  Whereas certain transitional provisions are required in order, in particular, to permit small and medium-sized undertakings already in existence to adapt themselves to the requirements which must be imposed by the Member States in pursuance of this Directive, subject to the application of Article 53 of the Treaty;  Whereas it is important to guarantee the uniform application of coordinated rules and to provide, in this respect, for close collaboration between the Commission and the Member States in this field;  HAS ADOPTED THIS DIRECTIVE:    Title I - General provisions   Article 1  This Directive concerns the taking-up and pursuit of the self-employed activity of direct insurance carried on by insurance undertakings which are established in a Member State or which wish to become established there in the classes of insurance defined in the Annex to this Directive.  Article 2 This Directive does not apply to:    1. The following kinds of insurance:      (a) Life assurance, that is to say, the branch of insurance which comprises, in particular, assurance on survival to a stipulated age only, assurance on death only, assurance on survival to a stipulated age or an earlier death, life assurance with return of premiums, tontines, marriage assurance, and birth assurance;           (b) Annuities;           (c) Supplementary insurance carried on by life-assurance undertakings, that is to say, insurance against personal injury including incapacity for employment, insurance against death resulting from an accident, and insurance against disability resulting from an accident or sickness, where these various kinds of insurance are underwritten in addition to life assurance;           (d) Insurance forming part of a statutory system of social security;           (e) The type of insurance existing in Ireland and the United Kingdom known as "permanent health insurance not subject to cancellation".                  2. The following operations:     (a) Capital redemption operations, as defined by the law in each Member State;       (b) Operations of provident and mutual benefit institutions whose benefits vary according to the resources available and in which the contributions of the members are determined on a flat-rate basis;       (c) Operations carried out by organizations not having a legal personality with the purpose of providing mutual cover for their members without there being any payment of premiums or constitution of technical reserves;        (d) Pending further coordination, which shall be implemented within four years of notification of this Directive, export credit insurance operations for the account of or with the support of the State.                Article 3 1. This Directive does not apply to mutual associations in so far as they fulfil all the following conditions:    - the articles of association must contain provisions for calling up additional contributions or reducing their benefits,       - their business does not cover liability risks - unless the latter constitute ancillary cover within the meaning of subparagraph (c) of the Annex - or credit and suretyship risks,       - the annual contribution income for the activities covered by this Directive must not exceed one million units of account,  and       - at least half of the contribution income from the activities covered by this Directive must come from persons who are members of the mutual association.         2. This Directive shall not, moreover, apply to mutual associations which have concluded with other associations of this nature an agreement which provides for the full reinsurance of the insurance policies issued by them or under which the concessionary undertaking is to meet the liabilities arising under such policies in the place of the ceding undertaking.  In such a case the concessionary undertaking shall be subject to the rules of this Directive.   Article 4 This Directive shall not apply to the following institutions unless their statutes or the law are amended as regards capacity:    (a) In Germany  The following institutions under public law enjoying a monopoly (Monopolanstalten):      1. Badische Gebäudeversicherungsanstalt, Karlsruhe,           2. Bayerische Landesbrandversicherungsanstalt, Munich,           3. Bayerische Landestierversicherungsanstalt, Schlachtviehversicherung, Munich,           4. Braunschweigische Landesbrandversicherungsanstalt, Brunswick,           5. Hamburger Feuerkasse, Hamburg,           6. Hessische Brandversicherungsanstalt (Hessische Brandversicherungskammer), Darmstadt,           7. Hessische Brandversicherungsanstalt, Kassel,           8. Hohenzollernsche Feuerversicherungsanstalt, Sigmaringen,           9. Lippische Landesbrandversicherungsanstalt, Detmold,           10. Nassauische Brandversicherungsanstalt, Wiesbaden,           11. Oldenburgische Landesbrandkasse, Oldenburg,           12. Ostfriesische Landschaftliche Brandkasse, Aurich,           13. Feuersozietät Berlin, Berlin,           14. Württembergische Gebäudebrandversicherungsanstalt, Stuttgart.             However, territorial capacity shall not be regarded as modified in the case of a merger between such institutions which has the effect of maintaining for the benefit of the new institution the territorial capacity of the institutions which have merged, nor shall capacity as to the classes of insurance be regarded as modified if one of these institutions takes over in respect of the same territory one or more of the classes of another such institution.  The following semi-public institutions:      1. Postbeamtenkrankenkasse,           2. Krankenversorgung der Bundesbahnbeamten;                  (b) In France  The following institutions:      1. Caisse départementale des incendiés des Ardennes,           2. Caisse départementale des incendiés de la Côte-d'Or,           3. Caisse départementale des incendiés de la Marne,           4. Caisse départementale des incendiés de la Meuse,            5. Caisse départementale des incendiés de la Somme,           6. Caisse départementale grêle du Gers,           7. Caisse départementale grêle de l'Hérault;                  (c) In Ireland  Voluntary Health Insurance Board;       (d) In Italy,  The Cassa di Previdenza per l'assicurazione degli sportivi (Sportass);       (e) In the United Kingdom  The Crown Agents.          Article 5 For the purposes of this Directive:    (a) "Unit of account" means that unit which is defined in Article 4 of the Statute of the European Investment Bank;       (b) "Matching assets" means the representation of underwriting liabilities expressed in a particular currency by assets expressed or realizable in the same currency;       (c) "Localization of assets" means the existence of assets, whether movable of immovable, within a Member State but shall not be construed as involving a requirement that movable property be deposited or that immovable property be subjected to restrictive measures such as the registration of mortgages. Assets represented by claims against debtors shall be regarded as situated in the Member State where they are to be liquidated.          Title II - Rules applicable to undertakings whose head offices are situated within the Community  Section A : Conditions of admission  Article 6 1. Each Member State shall make the taking-up of the business of direct insurance in its territory subject to an official authorization.  2. Such authorization shall be sought from the competent authority of the Member State in question by:    (a) Any undertaking which establishes its head office in the territory of such state;       (b) Any undertaking whose head office is situated in another Member State and which opens a branch or agency in the territory of the Member State in question;       (c) Any undertaking which, having received the authorization required under (a) or (b) above, extends its business in the territory of such State to other classes;       (d) Any undertaking which, having obtained in accordance with Article 7 (1) an authorization for a part of the national territory, extends its business beyond such part.         3. Member States shall not make an authorization subject to the lodging of a deposit or the provision of security.   Article 7 1. An authorization shall be valid for the entire national territory unless, and in so far as the national legislation permits, the applicant seeks permission to carry out his business only in a part of the national territory.  2. An authorization shall be given for a particular class of insurance. It shall cover the entire class, unless the applicant desires to cover only part of the risks pertaining to such class, as listed in point A of the Annex.  However:    (a) It shall be open to any Member State to grant an authorization for any group of classes indicated in point B of the Annex, provided that it attaches to such authorization the appropriate denomination specified therein;       (b) An authorization given for one class or a group of classes shall also be valid for the purpose of covering ancillary risks included in another class if the conditions specified in point C of the Annex are fulfilled;       (c) Pending further coordination, which must be implemented within four years of notification of this Directive, the Federal Republic of Germany may maintain the provision prohibiting the simultaneous undertaking in its territory of health insurance, credit and suretyship insurance or insurance in respect of recourse against third parties and legal defence, either with one another or with other classes.          Article 8 1. Each Member State shall require that any undertaking set up in its territory for which an authorization is sought shall:     (a) Adopt one of the following forms:  - in the case of the Kingdom of Belgium:  "société anonyme/naamloze vennootschap", "société en commandite par actions/vennootschap bij wijze van geldschieting op aandelen", "association d'assurance mutuelle/onderlinge verzekeringsmaatschappij", "société coopérative/cooperative vennootschap", - in the case of Denmark:  "Aktieselskaber" (joint stock companies), "gensidige selskaber" (mutuals),  - in the case of the Federal Republic of Germany:  "Aktiengesellschaft", "Versicherungsverein auf Gegenseitigkeit", "Öffentlich-rechtliches Wettbewerbs-Versicherungsunternehmen",  - in the case of the French Republic:  "société anonyme", "société à forme mutuelle", "mutuelle", "union de mutuelles",  - in the case of the Republic of Ireland:  "incorporated companies limited by shares or by guarantee or unlimited",  - in the case of the Italian Republic:  "società per azioni", "società cooperativa", "mutua di assicurazione",  - in the case of the Grand Duchy of Luxembourg:  "société anonyme", "société en commandite par actions", "association d'assurances mutuelles", "société coopérative",  - in the case of the Kingdom of the Netherlands:  "naamloze vennootschap", "onderlinge waarborgmaatschappij", "coöperative vereniging",  - in the case of the United Kingdom:  "incorporated companies limited by shares or by guarantee or unlimited", "societies registered under the Industrial and Provident Societies Acts", "societies registered under the Friendly Societies Act" Lloyd's underwriters.  Furthermore, Member States may set up, where appropriate, undertakings under any form of known public law provided that such institutions have as their object insurance operations in conditions equivalent to those undertakings under private law;       (b) Limit its business activities to the business of insurance and operations directly arising therefrom to the exclusion of all other commercial business;       (c) Submit a scheme of operations in accordance with the provisions of Article 9;       (d) Possess the minimum guarantee fund provided for in Article 17 (2).         2. An undertaking seeking an authorization to extend its business to other classes or, in the case referred to in Article 6 (2) (d), to another part of the territory, shall be required to submit a scheme of operations in accordance with the provisions of Article 9 as regards such other classes or other part of the territory.  It shall, furthermore, be required to show proof that it possesses the solvency margin provided for in Article 16 and, if, with regard to such other classes, the provisions of Article 17 (2) require a higher minimum guarantee fund than previously, that it possesses such minimum.  3. These coordinating measures do not prevent Member States from applying provisions requiring directors and managers to have technical qualifications or from requiring the memorandum or articles of association, general and special policy conditions, tariffs and any other documents necessary for the normal exercise of supervision to be approved.  4. The abovementioned provisions may not require that any application for an authorization shall be dealt with in the light of the economic requirements of the market.   Article 9 The scheme of operations referred to in Article 8 (1) (c) shall contain the following particulars or proof concerning:    (a) The nature of the risks which the undertaking proposes to cover ; the general and special policy conditions which it proposes to use;       (b) The tariffs which it is proposed to apply for each category of business;       (c) The guiding principles as to reinsurance;        (d) The items constituting the minimum guarantee fund;       (e) Estimates relating to the expenses of installing the administrative services and the organization for securing business ; the financial resources intended to cover them;  and in addition, for the first three financial years:    (f) Estimates relating to expenses of management other than costs of installation, and in particular current general expenses and Commissions;       (g) Estimates relating to premiums or contributions and to claims;       (h) A forecast balance sheet;       (i) Estimates relating to the financial resources intended to cover underwriting liabilities and the solvency margin.         However, the particulars referred to in (a) and (b) above shall not be required with regard to the risks classified under Nos 4, 5, 6, 7 and 12 of point A of the Annex, nor shall those referred to in (b) above be required with regard to risks classified under Nos 14 and 15 of point A of the Annex. The particulars referred to in (a) and (b) need not be required in the case of risks classified under No 11 of the same point.   Article 10 1. Each Member State shall require that an undertaking having its head office in the territory of another Member State and seeking an authorization to open an agency or branch shall:    (a) Submit its statutes and a list of its directors and managers;       (b) Produce a certificate issued by the competent authorities of the head office country, attesting the classes of insurance which the undertaking is entitled to carry on and that it possesses the minimum guarantee fund or, if higher, the minimum solvency margin calculated in accordance with Article 16 (3), and stating the risks which it actually covers and the financial resources referred to in Article 11 (1) (e);       (c) Submit a scheme of operations in accordance with Article 11;       (d) Designate an authorized agent having his permanent residence and abode in the host country, and possessing sufficient powers to bind the undertaking in relation to third parties and to represent it in relations with the authorities and courts of the host country ; if the agent has a legal personality, it must have its head office in the host country and it must in its turn designate an individual to represent it who complies with the above conditions. The designated agent shall not be refused by the Member State except on grounds relating to repute or technical qualifications such as apply to directors of undertakings whose head offices are situated in the territory of the State in question.   With regard to Lloyd's, in the event of any litigation in the host country resulting from underwritten commitments, assured persons must not be more unfavourably treated than if the litigation had been brought against businesses of a more conventional type. The authorized agent must, therefore, possess sufficient powers to enable proceedings to be instituted against him and must in that capacity be able to bind the Lloyd's underwriters concerned.       2. Each Member State shall require that for the purpose of extending the business of the agency or branch, either to other classes or to other parts of the national territory in the case provided for in Article 6 (2) (d), the applicant for the authorization shall submit a scheme of operations in accordance with Article 11 and comply with the conditions contained in (1) (b) above.  3. These coordinating measures do not prevent Member States from enforcing provisions requiring, for all insurance undertakings, approval of the general and special policy conditions, tariffs and any other document necessary for the normal exercise of supervision.  4. The abovementioned provisions may not require that any application for an authorization shall be examined in the light of the economic requirements of the market.   Article 11 1. The scheme of operations of the agency or branch referred to in Article 10 (1) (c) shall contain the following particulars or proofs concerning:    (a) The nature of the risks which the undertaking proposes to cover in the host country ; the general and special policy conditions which it proposes to use;       (b) The tariffs which the undertaking proposes to apply for each category of business;        (c) The guiding principles as to reinsurance;       (d) The state of the solvency margin of the undertaking, referred to in Articles 16 and 17;       (e) Estimates relating to the expenses of installing the administrative services and the organization for securing business ; the financial resources intended to cover them;  and in addition, for the first three financial years:    (f) Estimates relating to expenses of management;       (g) Estimates relating to premiums or contributions and to claims in respect of the new business;       (h) A forecast balance sheet for the agency or branch.         However, the particulars referred to in (a) and (b) above shall not be required with regard to the risks classified under Nos 4, 5, 6, 7 and 12 of point A of the Annex, nor shall those referred to in (b) above be required with regard to the risks classified under Nos 14 and 15 of point A of the Annex. The particulars referred to in (a) and (b) need not be required in the case of risks classified under No 11 of the same point.  2. The scheme of operations shall be accompanied by the balance sheet and profit and loss account of the undertaking for each of the past three financial years. If, however, it has not yet been in business for three financial years it shall be required to furnish them only for the financial years completed.  With regard to Lloyd's, the publication of the balance sheet and the profit and loss account shall be replaced by the compulsory presentation of annual trading accounts covering the insurance operations, and accompanied by an affidavit certifying that auditors'certificates have been supplied in respect of each insurer and showing that the responsibilities incurred as a result of these operations are wholly covered by the assets. These documents must allow authorities to form a view of the state of solvency of the Association.  3. The scheme of operations, together with the observations of the authorities competent to issue authorizations, shall be forwarded to the competent authorities of the head office country. The latter authorities shall communicate their Opinion to the former within three months from the receipt of the documents ; if their Opinion has not been communicated upon the expiry of this time, it shall he deemed to he favourable.   Article 12 Any decision to refuse an authorization shall be accompanied by the precise grounds for doing so and notified to the undertaking in question.  Each Member State shall make provision for a right to apply to the courts should there be any refusal.  Such provision shall also be made with regard to cases where to competent authorities have not dealt with an application for an authorization upon the expiry of a period of six months from the date of its receipt.  Section B : Conditions for exercise of business   Article 13 Member States shall collaborate closely with one another in supervising the financial position of authorized undertakings.   Article 14 The supervisory authority of the Member State in whose territory the head office of the undertaking is situated must verify the state of solvency of the undertaking with respect to its entire business. The supervisory authorities of the other Member States shall provide the former with all the information necessary to enable such verification to be effected.   Article 15 1. Each Member State in whose territory business is carried on shall require the undertaking to establish sufficient technical reserves.  The amount of such reserves shall be determined according to the rules fixed by the State, or, in the absence of such rules, according to the established practices in such State.  2. Technical reserves shall be required to be covered by equivalent and matching assets localized in each country where business is carried on. Member States may, however, permit relaxations in the rules as to matching assets and the localization of assets.  Having regard to its special position, the Grand Duchy of Luxembourg may, pending coordination of legislation on the winding-up of undertakings, retain the system of guarantees for technical reserves existing at the time of entry into force of this Directive.   The regulations of the country where the business is is carried on shall determine the nature of such assets and, where appropriate, the extent to which they may be used for the purpose of covering the technical reserves and shall also determine the rules for valuing such assets.  3. If a Member State allows any technical reserves to be covered by claims against reinsurers, it shall fix the percentage so allowed. In such case, it may not require the assets representing such claims to be localized in its territory, notwithstanding the provisions of paragraph 2.  4. The supervisory authority of the Member State in whose territory the head office of an undertaking is situated shall verify that its balance sheet shows in respect of the technical reserves assets equivalent to the underwriting liabilities assumed in all the countries where it undertakes business.   Article 16 1. Each Member State shall require every undertaking whose head office is situated in its territory to establish an adequate solvency margin in respect of its entire business.  The solvency margin shall correspond to the assets of the undertaking, free of all foreseeable liabilities, less any intangible items. In particular the following shall be considered:    - the paid up share capital or, in the case of a mutual concern, the effective initial fund,       - one-half of the share capital or the initial fund which is not yet paid up, once the paid-up part reaches 25 % of this capital or fund,       - reserves (statutory reserves and free reserves) not corresponding to underwriting liabilities,       - any carry-forward of profits,       - in the case of a mutual or mutual-type association with variable contributions, any claim which it has against its members by way of a call for supplementary contribution, within the financial year, up to one-half of the difference between the maximum contributions and the contributions actually called in, and subject to an over-riding limit of 50 % of the margin,       - at the request of, and upon proof being shown by the undertaking, and with the agreement of the supervisory authorities of each other Member State where it carries on its business, any hidden reserves resulting from under-estimation of assets or over-estimation of liabilities in the balance sheet, in so far as such hidden reserves are not of an exceptional nature.         Over-estimation of technical reserves shall be determined in relation to their amount calculated by the undertaking in conformity to national regulations ; however, pending further coordination of technical reserves, an amount equivalent to 75 % of the difference between the amount of the reserve for outstanding risks calculated at a flat rate by the undertaking by application of a minimum percentage in relation to premiums and the amount that would have been obtained by calculating the reserve contract by contract where the national law gives an option between the two methods, can be taken into account in the solvency margin up to 20 %.  2. The solvency margin shall be determined on the basis either of the annual amount of premiums or contributions, or of the average burden of claims for the past three financial years. In the case, however, of undertakings which essentially underwrite only one or more of the risks of storm, hail, frost, the last seven years shall be taken as the period of reference for the average burden of claims.  3. Subject to the provisions of Article 17, the amount of the solvency margin shall be equal to the higher of the following two results:  first result (premium basis):    - the premiums or contributions (inclusive of charges ancillary to premiums or contributions) due in respect of all direct business in the last financial year for all financial years, shall be aggregated,       - to this aggregate there shall be added the amount of premiums accepted for all reinsurance in the last financial year,       - from this sum there shall then be deducted the total amount of premiums or contributions cancelled in the last financial year, as well as the total amount of taxes and levies pertaining to the premiums or contributions entering into the aggregate.         The amount so obtained shall be divided into two portions, the first portion extending up to 10 million units of account, the second comprising the excess ; 18 % and 16 % of these portions respectively shall be calculated and added together.  The first result shall be obtained by multiplying the sum so calculated by the ratio existing in respect of the last financial year between the amount of claims remaining to be borne by the undertaking after deduction of transfers for reinsurance and the gross amount of claims ; this ratio may in no case be less than 50 %.   Second result (claims basis):    - the amounts of claims paid in respect of direct business (without any deduction of claims borne by reinsurers and retrocessionaires) in the periods specified in (2) shall be aggregated,       - to this aggregate there shall be added the amount of claims paid in respect of reinsurances or retrocessions accepted during the same periods,       - to this sum there shall be added the amount of provisions or reserves for outstanding claims established at the end of the last financial year both for direct business and for reinsurance acceptances,       - from this sum there shall be deducted the amount of claims paid during the periods specified in (2),       - from the sum then remaining, there shall be deducted the amount of provisions or reserves for outstanding claims established at the commencement of the second financial year preceding the last financial year for which there are accounts, both for direct business and for reinsurance acceptances.         One-third, or one-seventh, of the amount so obtained, according to the period of reference established in (2), shall be divided into two portions, the first extending up to seven million units of account and the second comprising the excess ; 26 % and 23 % of these portions respectively shall be calculated and added together.  The second result shall be obtained by multiplying the sum so obtained by the ratio existing in respect of the last financial year between the amount of claims remaining to be borne by the business after transfers for reinsurance and the gross amount of claims ; this ratio may in no case be less than 50 %.  4. The fractions applicable to the portions referred to in (3) shall each be reduced to a third in the case of health insurance practised on a similar technical basis to that of life assurance, if    - the premiums paid are calculated on the basis of sickness tables according to the mathematical method applied in insurance, - a reserve is set up for increasing age,       - an additional premium is collected in order to set up a safety margin of an appropriate amount,       - the insurer may only cancel the contract before the end of the third year of insurance at the latest,       - the contract provides for the possibility of increasing premiums or reducing payments even for current contracts.         5. In the case of Lloyd's, the calculation of the first result in respect of premiums, referred to in paragraph 3, shall be made on the basis of net premiums, which shall be multiplied by a flat-rate percentage fixed annually by the internal auditor. This flat-rate percentage must be calculated on the basis of the most recent statistical data on Commissions paid.  The details, together with the relevant calculations shall be sent to the authorities of the countries where Lloyd's is established.   Article 17 1. One-third of the solvency margin shall constitute the guarantee fund.  2.    (a) The guarantee fund may not, however, be less than:      - 400 000 units of account in the case where all or some of the risks included in one of the classes listed in point A of the Annex under Nos 10, 11, 12, 13, 14 and 15 are covered,           - 300 000 units of account in the case where all or some of the risks included in one of the classes listed in point A of the Annex under Nos 1, 2, 3, 4, 5, 6, 7, 8, and 16 are covered,           - 200 000 units of account in the case where all or some of the risks included in one of the classes listed in point A of the Annex under Nos 9 and 17 are covered;                  (b) If the business carried on by the undertaking covers several classes or several risks, only that class or risk for which the highest amount is required shall be taken into account;       (c) Any Member State may provide for a one-fourth reduction of the minimum guarantee fund in the case of mutual associations and mutual-type associations.         Article 18 1. Member States shall not prescribe any rules as to the choice of the assets in excess of those representing the technical reserves referred to in Article 15.   2. Subject to the provisions of Article 15 (2), Article 20 (1) and (3) and Article 22 (1) last subparagraph, Member States shall not restrain the free disposal of the assets, whether movable or immovable property, forming part of the assets of authorized businesses.  The Federal Republic of Germany may, however, pending further coordination of the conditions for the taking up and pursuit of the business of life assurance maintain, with respect to health insurance within the meaning of Article 16 (4), the restrictions imposed on the free disposal of assets in so far as the free disposal of assets which cover mathematical reserves is subject to the agreement of a "Treuhänder".  Until further measures of coordination have been taken, the Kingdom of Denmark may however retain in force its legislation restricting the free disposal of assets built up by insurance undertakings to cover pensions payable under compulsory insurance against industrial accidents.  3. These provisions shall not preclude any measures which Member States, while observing the rules prevailing in the country where the business is carried on, as required under Article 15 (2), and while safeguarding the interests of the insured, are entitled to take as owners or members or associates of the undertakings in question.   Article 19 1. Each Member State shall require every undertaking whose head office is situated in its territory to produce an annual account covering all types of operation, of its financial situation and solvency.  2. Member States shall require undertakings operating in their territory to render periodically the returns, together with statistical documents, which are necessary for the purposes of supervision. The competent supervisory authorities shall furnish each other with the documents and information necessary for exercising supervision.   Article 20 1. If an undertaking does not comply with the provisions of Article 15, the supervisory authority of the country where it carries on its business may prohibit the free disposal of assets in that country after having informed the supervisory authorities of the country where the head office is situated of its intention.  2. For the purposes of restoring the financial situation of an undertaking whose solvency margin has fallen below the minimum required under Article 16 (3), the supervisory authority of the head-office country shall require a plan for the restoration of a sound financial position to be submitted for its approval.  3. If the solvency margin falls below the guarantee fund as defined in Article 17, the supervisory authority of the head-office country shall require the undertaking to submit a short-term finance scheme for its approval.  It may also restrict or prohibit the free disposal of the assets of the undertaking. It shall inform the authorities of other Member States in whose territories the undertaking is authorized of any measures and the latter shall, at the request of the former, take the same measures.  4. The competent supervisory authorities may further take all measures necessary to safeguard the interests of the insured in the cases provided for in (1) and (3).  5. The supervisory authorities of other Member States in whose territory the undertaking in question has also been authorized shall collaborate for the purpose of implementing the provisions referred to in (1) to (4).   Article 21 1. Each Member State shall make it possible for an undertaking to assign all or part of its portfolio of policies if the assignees possess the necessary solvency margin, due account being taken of the assignment.  The supervisory authorities concerned shall consult each other before approving such assignment.  2. Once approved by the competent supervisory authority, such assignment shall affect directly the policy-holders or insured concerned.  Section C : Withdrawal of authorization   Article 22 1. The authorization granted by the competent authority of the Member State in whose territory the head office is situated may be withdrawn by such authority if the undertaking:    (a) No longer fulfils the conditions of admission;        (b) Has been unable, within the time allowed, to take the measures contained in the restoration plan or finance scheme referred to in Article 20;       (c) Fails seriously in its obligations under the national regulations.         In the event of the withdrawal of the authorization, the supervisory authority of the head-office country shall notify such withdrawal to the supervisory authorities of other Member States which have issued an authorization to the undertaking ; they shall, thereupon, also withdraw their authorizations. The supervisory authority of the head-office country shall, in conjunction with such other authorities, take all necessary measures to safeguard the interests of the insured and, in particular, shall restrict the free disposal of the assets of the undertaking if such restriction has not been already imposed in accordance with the provisions of Article 20 (1) and (3), subparagraph 2.  2. An authorization granted to an agency or branch of an undertaking whose head office is situated in another Member State may be withdrawn if the agency or branch:    (a) No longer fulfils the conditions for admission;       (b) Fails seriously in its obligations under the regulations of the country where it carries on its business, with respect in particular to the establishment of technical reserves as defined in Article 15.         Before withdrawing the authorization the supervisory authorities of the country where business is carried on shall consult the supervisory authority of the country where the head office is situated. If they deem it necessary to suspend the business of such agency or branch before consultation is concluded, they shall immediately advise the supervisory authority of the country where the head office is situated.  3. Any decision to withdraw an authorization or suspend business shall be supported by precise reasons and notified to the undertaking in question.  Each Member State shall make provision for a right to apply to the courts against such a decision.   Title III - Rules applicable to agencies or branches established within the Community and belonging to undertakings whose head offices are outside the Community   Article 23   1. Each Member State shall make access to the business referred to in Article 1 by any undertaking whose head office is outside the Community subject to an official authorization.   2. A Member State may grant an authorization if the undertaking fulfils at least the following conditions:      (a) It is entitled to undertake insurance business under its national law;           (b) It establishes an agency or branch in the territory of such Member State;           (c) It undertakes to establish at the place of management of the agency or branch accounts specific to the business which it undertakes there, and to keep there all the records relating to the business transacted;           (d) It designates an authorized agent, to be approved by the competent authorities;           (e) It possesses in the country where it carries on its business assets of an amount equal to at least one-half of the minimum amount prescribed in Article 17 (2), in respect of the guarantee fund, and deposits one-fourth of the minimum amount as security;           (f) It undertakes to keep a margin of solvency in accordance with the requirements referred to in Article 25;           (g) It submits a scheme of operations in accordance with the provisions of Article 11 (1) and (2).             Article 24 Member States shall require undertakings to establish adequate technical reserves to cover the underwriting liabilities assumed in their territories. Member States shall see that the agency or branch covers such technical reserves by means of assets which are equivalent to such reserves and are, to the extent fixed by the State in question, matching assets.  The law of the Member States shall be applicable to the calculation of technical reserves, the determination of categories of investments, and the valuation of assets.  The Member State in question shall require that the assets representing the technical reserves shall be localized in its territory. Article 15 (3) shall, however, be applicable.   Article 25 1. Each Member State shall require for agencies or branches established in its territory a solvency margin consisting of assets free of all foreseeable liabilities, less any intangible items. The solvency margin shall be calculated in accordance with the provisions of Article 16 (3). However, for the purpose of calculating this margin, account shall be taken only  of the premiums or contributions and claims pertaining to the business effected by the agency or branch concerned.  2. One-third of the solvency margin shall constitute the guarantee fund. The guarantee fund may not be less than one-half of the minimum required under Article 17 (2). The initial deposit lodged in accordance with Article 23 (2) (e) shall be counted towards such guarantee fund.  3. The assets representing the solvency margin must be kept within the country where the business is carried on up to the amount of the guarantee fund and the excess, within the Community.   Article 26 1. Any undertaking which, having obtained an authorization from one Member State, obtains an authorization from one or more other Member States to establish other agencies or branches therein may apply for one or more of the following advantages:      (a) That the solvency margin referred to in Article 25 be calculated in relation to the entire business which it undertakes within the Community ; in such case, account shall be taken of the premiums or contributions and claims pertaining to the business effected by all the agencies or branches established within the Community;           (b) That it be dispensed from lodging the deposit required under Article 23 (2) (e), in such States also;           (c) That the assets representing the guarantee fund be kept in any one of the Member States in which it carries out business.             2. Should at least two of the Member States in question approve the application in whole or in part, the competent authority of the Member State in whose territory the oldest establishment of the applicant is situated shall verify the state of solvency of the undertaking with respect to the entire business carried on by it within the Member States which approve the application. However, at the request of the undertaking and with the unanimous approval of the Member States concerned, such verification may be carried out by the competent authority of another Member State. The authority carrying out the verification shall obtain from the other Member States the necessary information regarding the agencies or branches established in their territories.  3. The advantages conferred by this Article may be withdrawn upon the initiative of one or more of the Member States concerned.   Article 27 The provisions of Articles 19 and 20 shall also apply in relation to agencies and branches of undertakings to which this Title applies.  As regards the application of Article 20, the supervisory authority of the oldest establishment or the one that carries out in its place the verification of the overall solvency of branches or agencies shall be assimilated to the authority of the State in which the head office of a Community undertaking is situated.   Article 28 In the case of a withdrawal of authorization by the authority referred to in Article 26 (2), this authority shall notify the authorities of the other Member States where the undertaking operates and the latter supervisory authorities shall take the appropriate measures. If the reason for the withdrawal of the authorization is the inadequacy of the overall state of solvency as fixed by the Member States which agreed to the request referred to in Article 26, the Member States which gave their approval shall also withdraw their authorizations.   Article 29 The Community may, by means of agreements concluded pursuant to the Treaty with one or more third countries, agree to the application of provisions different to those provided for in this Title, for the purpose of ensuring, under conditions of reciprocity, adequate protection for insured persons in the Member States.   Title IV - Transitional and other provisions   Article 30   1. Member States shall allow undertakings referred to in Title II which at the entry into force of the implementing measures to this Directive provide insurance in their territories in one or more of the classes referred to in Article 1 a period of five years, commencing with the date of notification of this Directive, in order to comply with the requirements of Articles 16 and 17.   2. Furthermore, Member States may:      (a) allow any undertakings referred to in (1), which upon the expiry of the five-year period have not fully established the margin of solvency, a further period not exceeding two years in which to do so  provided that such undertakings have, in accordance with Article 20, submitted for the approval of the supervisory authority the measures which they propose to take for such purpose;           (b) exempt undertakings referred to in (1) whose annual premium or contribution income upon the expiry of the period of five years falls short of six times the amount of the minimum guarantee fund required under Article 17 (2) from the requirement to establish such minimum guarantee fund before the end of the financial year in respect of which the premium or contribution income is as much as six times such minimum guarantee fund. After considering the results of the examination provided for under Article 33, the Council shall unanimously decide, on a proposal from the Commission, when this exemption is to be abolished by Member States.             3. Undertakings desiring to extend their operations within the meaning of Article 8 (2) or Article 10 may not do so unless they comply immediately with the rules of this Directive. However, the undertakings referred to in paragraph (2) (b) which within the national territory extend their business to other classes of insurance or to other parts of such territory may be exempted for a period of ten years from the date of notification of the Directive from the requirement to constitute the minimum guarantee fund referred to in Article 17 (2).  4. An undertaking having a structure different from any of those listed in Article 8 may continue, for a period of three years from the notification of the Directive, to carry on their present business in the legal form in which they are constituted at the time of such notification. Undertakings set up in the United Kingdom "by Royal Charter" or "by private Act" or "by special public Act" may continue to carry on their business in their present form for an unlimited period.  Undertakings in Belgium which, in accordance with their objects, carry on the business of intervention mortgage loans or savings operations in accordance with No 4 of Article 15 of the provisions relating to the supervision of private savings banks, coordinated by the "arrête royal" of 23 June 1967, may continue to undertake such business for a period of three years from the date of notification of this Directive.  The Member States in question shall draw up a list of such undertakings and communicate it to the other Member States and the Commission.  5. At the request of undertakings which comply with the requirements of Articles 15, 16 and 17, Member States shall cease to apply restrictive measures such as those relating to mortgages, deposits and securities established under present regulations.  Article 31 Member States shall allow agencies or branches referred to in Title III which, at the entry into force of the implementing measures to this Directive, are undertaking one or more classes referred to in Article 1 and do not extend their business within the meaning of Article 10 (2) a maximum period of five years, from the date of notification of this Directive, in order to comply with the conditions of Article 25.   Article 32 During a period which terminates at the time of the entry into force of an agreement concluded with a third country pursuant to Article 29 and at the latest upon the expiry of a period of four years after the notification of the Directive, each Member State may retain in favour of undertakings of that country established in its territory the rules applied to them on 1 January 1973 in respect of matching assets and the localization of technical reserves, provided that notification is given to the other Member States and the Commission and that the limits of relaxations granted pursuant to Article 15 (2) in favour of the undertakings of Member States established in its territory are not exceeded.     Title V - Final provisions   Article 33  The Commission and the competent authorities of the Member States shall collaborate closely for the purpose of facilitating the supervision of direct insurance within the Community and of examining any difficulties which may arise in the application of this Directive.  Article 34 1. The Commission shall submit to the Council, within six years from the date of notification of this Directive, a report on the effects of the financial requirements imposed by this Directive on the situation on the insurance markets of the Member States.  2. The Commission shall, as and when necessary, submit interim reports to the Council before the end of the transitional period provided for in Article 30 (1).   Article 35 Member States shall amend their national provisions to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.  The provisions thus amended shall, subject to Articles 30, 31 and 32, be applied within 30 months from the date of notification.    Article 36 Upon notification of this Directive, Member States shall ensure that the texts of the main provisions of a legislative, regulatory or administrative nature which they adopt in the field covered by this Directive are communicated to the Commission.   Article 37 The Annex shall form an integral part of this Directive.   Article 38 This Directive is addressed to the Member States.     Done at Brussels, 24 July 1973.  For the Council  The President  I. NØRGAARD     ANNEX    A. Classification of risks according to classes of insurance      1. Accident (including industrial injury and occupational diseases)        - fixed pecuniary benefits               - benefits in the nature of indemnity               - combinations of the two               - injury to passengers                          2. Sickness        - fixed pecuniary benefits               - benefits in the nature of indemnity               - combinations of the two                          3. Land vehicles (other than railway rolling stock)  All damage to or loss of        - land motor vehicles               - land vehicles other than motor vehicles                          4. Railway rolling stock  All damage to or loss of railway rolling stock           5. Aircraft  All damage to or loss of aircraft           6. Ships (sea, lake and river and canal vessels)  All damage to or loss of        - river and canal vessels               - lake vessels               - sea vessels                          7. Goods in transit (including merchandise, baggage, and all other goods)  All damage to or loss of goods in transit or baggage, irrespective of the form of transport           8. Fire and natural forces  All damage to or loss of property (other than property included in classes 3, 4, 5, 6 and 7) due to        - fire               - explosion               - storm               - natural forces other than storm               - nuclear energy               - land subsidence                           9. Other damage to property  All damage to or loss of property (other than property included in classes 3, 4, 5, 6 and 7) due to hail or frost, and any event such as theft, other than those mentioned under 8           10. Motor vehicle liability  All liability arising out of the use of motor vehicles operating on the land (including carrier's liability)           11. Aircraft liability  All liability arising out of the use of aircraft (including carrier's liability)           12. Liability for ships (sea, lake and river and canal vessels)  All liability arising out of the use of ships, vessels or boats on the sea, lakes, rivers or canals (including carrier's liability)           13. General liability  All liability other than those forms mentioned under Nos 10, 11 and 12           14. Credit        - insolvency (general)               - export credit               - instalment credit               - mortgages               - agricultural credit                          15. Suretyship        - suretyship (direct)               - suretyship (indirect)                          16. Miscellaneous financial loss        - employment risks               - insufficiency of income (general)               - bad weather               - loss of benefits               - continuing general expenses               - unforeseen trading expenses               - loss of market value               - loss of rent or revenue               - indirect trading losses other than those mentioned above               - other financial loss (non-trading)               - other forms of financial loss                          17. Legal expenses  Legal expenses and costs of litigation  The risks included in a class may not be included in any other class except in the cases referred to in point C.        B. Description of authorizations granted for more than one class of insurance  Where the authorization simultaneously covers:      (a) Classes Nos 1 and 2, it shall be named "Accident and Health Insurance";           (b) Classes Nos 1 (fourth indent), 3, 7 and 10, it shall be named "Motor Insurance";           (c) Classes Nos 1 (fourth indent), 4, 6, 7 and 12, it shall be named "Marine and Transport Insurance";           (d) Classes Nos 1 (fourth indent), 5, 7 and 11, it shall be named "Aviation Insurance";           (e) Classes Nos 8 and 9, it shall be named "Insurance against Fire and other Damage to Property";           (f) Classes Nos 10, 11, 12 and 13, it shall be named "Liability Insurance";           (g) Classes Nos 14 and 15, it shall be named "Credit and Suretyship Insurance";           (h) All classes, it shall be named at the choice of the Member State in question, which shall notifiy the other Member States and the Commission of its choice.                  C. Ancillary risks  An undertaking obtaining an authorization for a principal risk belonging to one class or a group of classes may also insure risks included in another class without an authorization being necessary for them if they:      - are connected with the principal risk,           - concern the object which is covered against the principal risk, and           - are covered by the contract insuring the principal risk.             However, the risks included in classes 14 and 15 in point A of this Annex may not be regarded as risks ancillary to other classes.


Avis juridique important

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32000L0068

Commission Directive 2000/68/EC of 23 October 2000 including an active substance (bentazone) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market

Official Journal L 276 , 28/10/2000 P. 0041 - 0043

Commission Directive 2000/68/ECof 23 October 2000including an active substance (bentazone) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the marketTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2000/10/EC(2), and in particular Article 6(1) and the fourth subparagraph of Article 8(2) thereof,Whereas:(1) Commission Regulation (EEC) No 3600/92(3), as last amended by Regulation (EC) No 2266/2000(4), laid down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC (hereinafter referred to as "the Directive"). Pursuant to that Regulation, Commission Regulation (EC) No 933/94(5), as last amended by Regulation (EC) No 2230/95(6), laid down the list of active substances of plant protection products to be assessed, with a view to their possible inclusion in Annex I to the Directive.(2) In accordance with Article 5(1) of the Directive, an active substance should be included in Annex I if it may be expected that neither the use of, nor residues from, plant protection products containing that active substance will have any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment.(3) Such an active substance may be included in Annex I for a period not exceeding 10 years.(4) For bentazone the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulation (EEC) No 3600/92 for a number of uses proposed by the notifiers. Germany was designated as rapporteur Member State under Regulation (EC) No 933/94 laying down the active substances of plant protection products and designating the rapporteur Member State for the implementation of Regulation (EEC) No 3600/92. It submitted the relevant assessment report and recommendation to the Commission on 13 November 1996, in accordance with Article 7(1)(c) of Regulation (EEC) No 3600/92.(5) The assessment report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health. This review was finalised on 13 July 2000 in the format of the Commission review report for bentazone.(6) The dossier and the information from the review have also been submitted to the Scientific Committee for Plants for consultation. The Scientific Committee for Plants in its opinion(7) confirmed that the substance can be used without unacceptable risk but noted that Member States should assess the leaching potential to groundwater in particularly vulnerable locations and in rice cultures.(7) It has appeared from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a) and (b) of the Directive, in particular with regard to the uses which were examined. It is appropriate therefore to include the active substance concerned in Annex I, in order to ensure that in all Member States the granting, varying or withdrawing, as appropriate, of the authorisations of plant protection products containing bentazone can be undertaken in accordance with the provisions of the Directive.(8) Article 8(2) of the Directive provides that after inclusion of an active substance in its Annex I, Member States shall, within a prescribed period, grant, vary or withdraw, as appropriate, the authorisations of the plant protection products containing the active substance. In particular, Articles 4(1) and 13(1) of the Directive require that plant protection products are not authorised unless account is taken of the conditions associated with the inclusion of the active substance in Annex I and the uniform principles laid down in Annex VI on the basis of a dossier satisfying the data requirements laid down in its Article 13.(9) Before inclusion, a reasonable deadline is necessary to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. Moreover, after inclusion, a reasonable period is necessary for the Member States to implement the Directive and in particular to vary or withdraw, as appropriate, existing authorisations or grant new authorisations in accordance with the provisions of Directive 91/414/EEC. A longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product in accordance with the uniform principles laid down in Annex VI to the Directive. For plant protection products containing several active substances, the complete evaluation on the basis of the uniform principles can only be carried out when all the active substances concerned have been included in Annex I to the Directive.(10) It is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties.(11) The review report is required for the proper implementation by the Member States of several sections of the uniform principles laid down in Annex VI to the Directive, where these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive.(12) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1Bentazone is hereby designated as an active substance in Annex I to Directive 91/414/EEC, as set out in the Annex hereto.Article 21. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 31 January 2002, and shall immediately inform the Commission thereof. In particular they shall, in accordance with the provisions of Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing bentazone as an active substance within such period.2. However, with regard to evaluation and decision-making pursuant to the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto, the period laid down in the first paragraph is extended:- for plant protection products containing bentazone as the only active substance, to four years from the entry into force of this Directive,- for plant protection products containing bentazone together with another active substance which is in Annex I to Directive 91/414/EEC, to four years from the entry into force of such Directive as shall include the last of those substances in Annex I.3. Member States shall keep available the review report (except for confidential information within the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.4. When Member States adopt the provisions referred to in paragraph 1, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3This Directive shall enter into force on 1 August 2001.Article 4This Directive is addressed to the Member States.Done at Brussels, 23 October 2000.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 57, 2.3.2000, p. 28.(3) OJ L 366, 15.12.1992, p. 10.(4) OJ L 259, 13.10.2000, p. 27.(5) OJ L 107, 28.4.1994, p. 8.(6) OJ L 225, 22.9.1995, p. 1.(7) Opinion of the Scientific Committee on Plants regarding the inclusion of bentazone in Annex I to Directive 91/414/EEC concerning the placing of plant protection products on the market (opinion expressed by the Scientific Committee on Plants on 2 December 1999).ANNEXBentazone1.>TABLE>2. Particular conditions to be fulfilled:2.1. The active substance as manufactured shall have a purity of 960 g/kg.2.2. Only uses as herbicide may be authorised.2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on bentazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 13 July 2000 shall be taken into account. In this overall assessment Member States:- must pay particular attention to the protection of groundwater.3. Expiry date of the inclusion: 31 July 2011.