Avis juridique important

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31991L0321

Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae

Official Journal L 175 , 04/07/1991 P. 0035 - 0049 Finnish special edition: Chapter 15 Volume 10 P. 0107  Swedish special edition: Chapter 15 Volume 10 P. 0107

COMMISSION DIRECTIVE  of 14 May 1991  on infant formulae and follow-on formulae  (91/321/EEC) THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic 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 for particular nutritional uses (1), and in particular Article 4 thereof,  Whereas the essential composition of the products in question must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data;  Whereas on the basis of these data the essential composition of infant formulae and follow-on formulae manufactured from cows' milk proteins and soya proteins alone or in a mixture can already be defined; whereas the same is not true for preparations  based wholly or partly on other sources of protein; whereas for this reason specific rules for such products, if necessary, will therefore have to be adopted at a later date;  Whereas this Directive reflects current knowledge about these products; whereas any modification, to allow innovation based on scientific and technical progress, will be decided by the procedure laid down in Article 13 of Directive 89/398/EEC;  Whereas because of the persons for which these products are intended it will be necessary to lay down microbiological criteria and maximum levels for contaminants; whereas given the complexity of the subject these will have to be adopted at a later  stage;  Whereas infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first four to six months of life; whereas in order to safeguard the health of such infants it is necessary to ensure that  the only products marketed as suitable for such use during the period would be infant formulae;  Whereas pursuant to Article 7 (1) 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 for sale to the ultimate consumer (2), as last amended by Directive 89/395/EEC (3); whereas this Directive adopts and expands upon the additions and exceptions to those general rules,  where it is appropriate, in order to promote and protect breast-feeding;  Whereas, in particular, the nature and destination of the products covered by this Directive require nutritional labelling for the energy value and principal nutrients they contain; whereas, on the other hand, the method of use must be specified in  conformity with Article 3 (1) (8) and Article 10 (2) of Directive 79/112/EEC, in order to prevent inappropriate uses likely to be detrimental to the health of infants;  Whereas, pursuant to Article 2 (2) of Directive 79/112/EEC, and in order to supply objective and scientifically verified information, it is necessary to define the conditions under which claims about the particular composition of an infant formula are  authorized;  Whereas, in an effort to provide better protection for the health of infants, the rules of composition, labelling and advertising laid down in this Directive should be in conformity with the principles and the aims of the International Code of Marketing  of Breast-Milk Substitutes adopted by the 34th World Health Assembly, bearing in mind the particular legal and factual situations existing in the Community;  Whereas given the important role which information on infant feeding plays in choosing, by pregnant women and mothers of infants, the type of nourishment provided to their children, it is necessary for Member States to take appropriate measures in order  that this information ensures an adequate use of the products in question and is not counter to the promotion of breast-feeding;  Whereas this Directive does not concern the conditions of sale of publications specializing in baby care and of scientific publications;  Whereas the Scientific Committee for Food, in accordance with Article 4 of Directive 89/398/EEC, has been consulted on the provisions liable to affect public health;  Whereas issues relating to products intended for export to third countries should be dealt with in a coherent and homogeneous manner in a separate measure;  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 and lays down compositional and labelling requirements for infant formulae and follow-on formulae intended for use by infants in good health in  the Community. It also provides for Member States to give effect to principles and aims of the International Code of Marketing of Breast-Milk Substitutes dealing with marketing, information and responsibilities of health authorities.  2. For the purposes of this Directive,  (a) 'infants' means children under the age of 12 months;  (b) 'young children' means children aged between one and three years;  (c) 'infant formulae' means foodstuffs intended for particular nutritional use by infants during the first four to six months of life and satisfying by themselves the nutritional requirements of this category of persons;  (d) 'follow-on formulae' means foodstuffs intended for particular nutritional use by infants aged over four months and constituting the principal liquid element in a progressively diversified diet of this category of persons.  Article 2  Member States shall ensure that the products referred to in Article 1 (2) (c) and (d) may be marketed within the Community only if they conform to the definitions and rules laid down in this Directive. No product other than infant formula may  be marketed or otherwise represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life.  Article 3  1. Infant formulae shall be manufactured from protein sources defined in the Annexes and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally  accepted scientific data.  2. Follow-on formulae shall be manufactured from protein sources defined in the Annexes and other food ingredients as the case may be whose suitability for particular nutritional use by infants aged over four months has been established by generally  accepted scientific data.  3. The prohibitions and limitations on the use of food ingredients laid down in Annexes I and II shall be observed.  Article 4  1. Infant formulae must comply with the compositional criteria specified in Annex I.  2. Follow-on formulae must comply with the compositional criteria specified in Annex II.  3. In order to make infant formulae and follow-on formulae ready for use, nothing more shall be required, as the case may be, than the addition of water.  Article 5  1. Only the substances listed in Annex III may be used in the manufacture of infant formulae and follow-on formulae in order to satisfy the requirements on:  - mineral substances,  - vitamins,  - amino acids and other nitrogen compounds,  - other substances having a particular nutritional purpose.  The purity criteria for these substances shall be stipulated at a later stage.  2. The provisions relating to the use of additives in the manufacture of infant formulae and follow-on formulae shall be laid down in a Council directive.   Article 6  1. Infant formulae and follow-on formulae shall not contain any substance in such quantity as to endanger the health of infants. Where necessary the maximum levels of any such substance shall be stipulated at a later date.  2. Microbiological criteria shall be established at a later date.  Article 7  1. The name under which the products covered by Article 1 (2) are sold shall be, respectively:  - in English:  'infant formula' and 'follow-on formula',  - in Danish:  'Modermaelkserstatning' and 'Tilskudsblanding',  - in German:  'Saeuglingsanfangsnahrung' and 'Folgenahrung',  - in Greek:  'Ðáñáóêaaýáóìá ãéá âñÝoeç » and 'Ðáñáóêaaýáóìá aeaaýôaañçò âñaaoeéêÞò çëéêssáò »,  - in Spanish:  'Preparado para lactentes' and 'Preparado de continuación',  - in French:  'Préparation pour nourrissons' and 'Préparation de suite',  - in Italian:  'Alimento per lattanti' and 'Alimento di proseguimento',  - in Dutch:  'Volledige zuigelingenvoeding' and 'Opvolgzuigelingenvoeding',  - in Portuguese:  'Fórmula para lactentes' and 'Fórmula de transiçao'.  However, the name of products manufactured entirely from cows' milk proteins, shall be respectively:  - in English:  'Infant milk' and 'follow-on milk',  - in Danish:  'Modermaelkserstatning udelukkende baseret paa maelk' and 'Tilskudsblanding udelukkende baseret paa maelk',  - in German:  'Saeuglingsmilchnahrung' and 'Folgemilch',  - in Greek:  'ÃUEëá ãéá âñÝoeç » and 'ÃUEëá aeaaýôaañçò âñaaoeéêÞò çëéêssáò »,  - in Spanish:  'Leche para lactentes' and 'Leche de continuación',  - in French:  'Lait pour nourrissons' and 'Lait de suite',  - in Italian:  'Latte per lattanti' and 'Latte di proseguimento',  - in Dutch:  'Volledige zuigelingenvoeding op basis van melk' or 'Zuigelingenmelk' and 'Opvolgmelk',  - in Portuguese:  'Leite para lactentes' and 'Leite de transiçao'.  2. The labelling shall bear, in addition to those provided for in Article 3 of Directive 79/112/EEC, the following mandatory particulars:  (a) in the case of infant formulae, a statement to the effect that the product is suitable for particular nutritional use by infants from birth when they are not breast-fed;  (b) in the case of infant formulae that do not contain added iron, a statement to the effect that, when the product is given to infants over the age of four months, their total iron requirements must be met from other additional sources;  (c) in the case of follow-on formulae, a statement to the effect that the product is suitable only for particular nutritional use by infants over the age of four months, that it should form only part of a diversified diet and that it is not to be used  as a substitute for breast milk during the first four months of life;  (d) in the case of infant formulae and follow-on formulae, the available energy value, expressed in kJ and kcal, and the content of proteins, lipids and carbohydrates per 100 ml of the product ready for use;  (e) in the case of infant formulae and follow-on formulae, the average quantity of each mineral substance and of each vitamin mentioned in Annexes I and II respectively, and where applicable of choline, inositol and carnitine, per 100 ml of the product  ready for use;  (f) in the case of infant formulae and follow-on formulae, instructions for appropriate preparation of the product and a warning against the health hazards of inappropriate preparation.  3. The labelling of infant formulae and follow-on formulae shall be designed to provide the necessary information about the appropriate use of the products so as not to discourage breast-feeding. The use of the terms 'humanized', 'maternalized', or  similar terms shall be prohibited. The term 'adapted' may only be used in conformity with paragraph 6 and Annex IV, point 1.  4. The labelling of infant formulae shall in addition bear the following mandatory particulars, preceded by the words 'Important Notice' or their equivalent:  (a) a statement concerning the superiority of breast-feeding;  (b) a statement recommending that the product be used only on the advice of independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care;  5. The labelling of infant formulae shall not include pictures of infants, nor shall it include other pictures or text which may idealize the use of the product. It may, however, have graphic representations for easy identification of the product and  for illustrating methods of preparation.  6. The labelling may bear claims concerning the special composition of an infant formula only in the cases listed in Annex IV and in accordance with the conditions laid down therein.  7. The requirements, prohibitions and restrictions referred to in paragraphs 3 to 6 shall also apply to:  (a) the presentation of the products concerned, in particular their shape, appearance or packaging, the packaging materials used, the way in which they are arranged and the setting in which they are displayed;  (b) advertising.  Article 8  1. Advertising of infant formulae shall be restricted to publications specializing in baby care and scientific publications. Member States may further restrict or prohibit such advertising. Such advertisements for infant formulae shall be  subject to the conditions laid down in Article 7 (3), (4), (5), (6) and (7) (b) and contain only information of a scientific and factual nature. Such information shall not imply or create a belief that bottle-feeding is equivalent or superior to  breast-feeding.  2. There shall be no point-of-sale advertising, giving of samples or any other promotional device to induce sales of infant formula directly to the consumer at the retail level, such as special displays, discount coupons, premiums, special sales,  loss-leaders and tie-in sales.  3. Manufacturers and distributors of infant formulae shall not provide, to the general public or to pregnant women, mothers or members of their families, free or low-priced products, samples or any other promotional gifts, either directly or indirectly  via the health care system or health workers.  Article 9  1. Member States shall ensure that objective and consistent information is provided on infant and young child feeding for use by families and those involved in the field of infant and young child nutrition covering the planning, provision,  design and dissemination of information and their control.  2. Member States shall ensure that informational and educational materials, whether written or audiovisual, dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children, shall include clear  information on all the following points:  (a) the benefits and superiority of breast-feeding;  (b) maternal nutrition and the preparation for and maintenance of breast-feeding;  (c) the possible negative effect on breast-feeding of introducing partial bottle-feeding;  (d) the difficulty of reversing the decision not to breast-feed;  (e) where needed, the proper use of infant formulae, whether manufactured industrially or home-prepared.  When such materials contain information about the use of infant formulae, they shall include the social and financial implications of its use; the health hazards of inappropriate foods or feeding methods, and, in particular, the health hazards of  improper use of infant formulae. Such material shall not use any pictures which may idealize the use of infant formulae.  3. Member States shall ensure that donations of informational or educational equipment or materials by manufacturers or distributors shall be made only on request and with the written approval of the appropriate national authority or within guidelines  given by that authority for this purpose. Such equipment or materials may bear the donating company's name or logo, but shall not refer to a proprietary brand of infant formulae and shall be distributed only through the health care system.  4. Member States shall ensure that donations or low-price sales of supplies of infant formulae to institutions or organizations, whether for use in the institutions or for distribution outside them, shall only be used by or distributed for infants who  have to be fed on infant formulae and only for as long as required by such infants.  Article 10  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof. Those provisions shall be applied in such a way as to:  - permit trade in products complying with this Directive, by 1 December 1992,  - prohibit trade in products which do not comply with this Directive, with effect from 1 June 1994.  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 11  This Directive is addressed to the Member States. Done at Brussels, 14 May 1991. For the Commission  Martin BANGEMANN  Vice-President  (1) OJ No L 186, 30. 6. 1989, p. 27. (2) OJ No L 33, 8. 2. 1979, p. 1. (3) OJ No L 186, 30. 6. 1989, p. 17.    ANNEX I ESSENTIAL COMPOSITION OF INFANT FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER  NB: The values refer to the product ready for use    1.  Energy    Minimum  Maximum   250 kJ  315 kJ   (60 kcal/100 ml)  (75 kcal/100 ml)  2.  Proteins   (Protein content = nitrogen content × 6,38) for cows' milk proteins.   (Protein content = nitrogen content × 6,25) for soya protein isolates.  2.1.   Formulae manufactured from unmodified cows' milk proteins   Minimum  Maximum   0,56 g/100 kJ  0,7 g/100 kJ   (2,25 g/100 kcal)  (3 g/100 kcal)   The chemical index of the proteins present shall be equal to at least 80 % of that of the reference protein  (breast milk, as defined in Annex VI); nevertheless, for calculation purposes, the concentrations of methionine and cystine may be added together.   The 'chemical index' shall mean the lowest of the ratios between the quantity of each essential amino  acid of the test protein and the quantity of each corresponding amino acid of the reference protein.  2.2  Formulae manufactured from modified cows' milk proteins (alteration of the casein/whey protein ratio)   Minimum  Maximum   0,45 g/100 kJ  0,7  g/100 kJ   (1,8 g/100 kcal)  (3 g/100 kcal)   For an equal energy value, the formula must contain an available quantity of each essential and semi-essential amino acid at least equal to that contained in the reference protein (breast milk, as defined in  Annex V).  2.3.  Formulae manufactured from soya protein isolates, alone or in a mixture with cows' milk proteins   Minimum  Maximum   0,56 g/100 kJ  0,7 g/100 kJ   (2,56 g/100 kcal)  (3 g/100 kcal)   Only soya protein isolates must be used in  manufacturing these formulae.   The chemical index shall be equal to at least 80 % of that of the reference protein (breast milk, as defined in Annex VI).   For an equal energy value the formula must contain an available quantity of methionine at least  equal to that contained in the reference protein (breast milk, as defined in Annex V).   The L-carnitine content shall be at least equal to 1,8 ìmoles/100 kJ (7,5 ìmoles/100 kcal).  2.4.  In all cases, the addition of amino  acids is permitted solely for the purpose of improving the nutritional value of the proteins, and only in the proportions necessary for that purpose.  3.  Lipids   Minimum  Maximum   0,8 g/100 kJ  1,5 g/100 kJ   (3,3 g/100 kcal)  (6,5 g/100 kcal)  3.1.   The use of the following substances is prohibited:   - sesame seed oil,   - cotton seed oil,   - fats containing more than 8 % trans isomers of fatty acids.  3.2.  Lauric acid   Minimum  Maximum   -  15 % of the total fat content  3.3.  Myristic acid     Minimum  Maximum   -  15 % of the total fat content  3.4.  Linoleic acid (in the form of glycerides = linoleates)   Minimum  Maximum   70 mg/100 kJ  285 mg/100 kJ   (300 mg/100 kcal)  (1 200 mg/100 kcal)  4.  Carbohydrates    Minimum  Maximum   1,7  g/100 kJ  3,4 g/100 kJ   (7 g/100 kcal)  (14 g/100 kcal)  4.1.  Only the following carbohydrates may be used:   - lactose,   - maltose,   - sucrose,   - malto-dextrins,   - glucose syrup or dried glucose syrup,   - pre-cooked starch   - gelatinized  starch naturally free of gluten  4.2.  Lactose   Minimum  Maximum   0,85 g/100 kJ  -   (3,5 g/100 kcal)  -   This provision does not apply to formulae in which soya proteins represent more than 50 % of the total protein content.  4.3.  Sucrose   Minimum   Maximum   -  20 % of the total carbohydrate content  4.4  Pre-cooked starch and/or gelatinied starch   Minimum  Maximum   -  2 g/100 ml, and 30 % of the total carbohydrate content  5.  Mineral substances  5.1.  Formulae manufactured from cows' milk  proteins       Per 100 kJ   Per 100 kcal     Minimum  Maximum  Minimum  Maximum        Sodium (mg)  5  14  20  60  Potassium (mg)  15  35  60  145  Chloride (mg)  12  29  50  125  Calcium (mg)  12  -  50  -  Phosphorus (mg)  6  22  25  90  Magnesium  (mg)  1,2  3,6  5  15  Iron (mg) (1)  0,12  0,36  0,5  1,5  Zinc (mg)  0,12  0,36  0,5  1,5  Copper (ìg)  4,8  19  20  80  Iodine (ìg)  1,2  -  5  -       (1) Limit applicable to formulae with added iron.      The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0.  5.2.  Formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins   All requirements of paragraph 5.1 are applicables except those concerning  iron and zinc, which are as follows:       Per 100 kJ   Per 100 kcal     Minimum  Maximum  Minimum  Maximum        Iron (mg)  0,25  0,5  1  2  Zinc (mg)  0,18  0,6  0,75  2,4        6.  Vitamins       Per 100 kJ   Per 100 kcal     Minimum  Maximum   Minimum  Maximum        Vitamin A (ìg-RE) (1)  14  43  60  180  Vitamin D (ìg) (2)  0,25  0,65  1  2,5  Thiamin (ìg)  10  -  40  -  Riboflavin (ìg)  14  -  60  -  Nicotinamide (ìg-EN) (3)   60  -  250  -  Pantothenic acid (ìg)  70  -  300  -  Vitamin B6 (ìg)  9  -  35  -  Biotin (ìg)  0,4  -  1,5  -  Folic acid (ìg)  1  -  4  -  Vitamin B12 (ìg)  0,025  -  0,1  -  Vitamin C  (ìg)  1,9  -  8  -  Vitamin K (ìg)  1  -  4  -  Vitamin E (mg á-TE) (4)  0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ  -  0,5/g of  polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  -       (1) RE = all trans retinol equivalent.  (2) In the form of cholecalciferol, of which 10 ìg = 400 i.u. of vitamin D.  (3) NE = Niacin equivalent = mg nicotinic acid + mg tryptophan/60.  (4) á-TE = d-á-tocopherol equivalent.   ANNEX II ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER  NB: The values refer to the product ready for use    1.  Energy    Minimum  Maximum   250 kJ/100 ml  335 KJ/100 ml   (60 kcal/100 ml)  (80 kcal/100 ml)  2.  Proteins   (Protein content = nitrogen content × 6,38) for cows' milk proteins.   (Protein content = nitrogen content × 6,25) for soya protein  isolates.   Minimum  Maximum   0,5 g/100 kJ  1 g/100 kJ   (2,25 g/100 kcal)  (4,5 g/100 kcal)   The chemical index of the proteins present shall be at least equal to 80 % of that of the reference protein (casein as defined in Annex VI).   The 'chemical  index' shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein.   For follow-on forumulae manufactured from soya proteins, alone  or in a mixture with cows' milk proteins, only protein isolates from soya may be used.   Amino acids may be added to follow-on formulae for the purpose of improving the nutritional value of the proteins, in the proportions necessary for that purpose.   3.  Lipids    Minimum  Maximum   0,8 g/100 kJ  1,5 g/100 kJ   (3,3 g/100 kcal)  (6,5 g/100 kcal)  3.1.  The use of the following substances is prohibited:   - sesame seed oil,   - cotton seed oil,   - fats containing more than 8 % trans isomers of  fatty acids.  3.2.  Lauric acid    Minimum  Maximum   -  15 % of the total fat content  3.3.  Myristic acid    Minimum  Maximum   -  15 % of the total fat content  3.4.  Linoleic acid (in the form of glycerides = linoleates)   Minimum  Maximum   70  mg/100 kJ  -   (300 mg/100 kcal):    this limit applies only to follow-on formulae containing vegetable oils   4.  Carbohydrates    Minimum  Maximum   1,7 g/100 kJ  3,4 g/100 kJ   (7 g/100 kcal)  (14 g/100 kcal)  4.1.  The use of ingredients containing  gluten is prohibited.  4.2.  Lactose   Minimum  Maximum   0,45 g/100 kJ  -   (1,8 g/100 kcal)    This provision does not apply to follow-on formulae in which soya protein isolates represent more than 50 % of the total protein content.  4.3.  Sucrose,  fructose, honey   Minimum  Maximum   -  separately or as a whole:    20 % of the total carbohydrate content  5.  Mineral substances  5.1.        Per 100 kJ   Per 100 kcal     Minimum  Maximum  Minimum  Maximum             Iron (mg)  0,25  0,5  1  2   Iodine (ìg)  1,2  -  5  -        5.2.  Zinc   5.2.1.  Follow-on formulae manufactured entirely from cows' milk   Minimum  Maximum   0,12 mg/100 kJ  -   (0,5 mg/100 kcal)   5.2.2.  Follow-on formulae containing soya protein isolates, or  mixed with cows' milk   Minimum  Maximum   0,18 mg/100 kJ  -   (0,75 mg/100 kcal)   5.3.  Other mineral substances:   The concentrations are at least equal to those normally found in cows' milk, reduced, where appropriate, in the same ratio as the  protein concentration of the follow-on formulae to that of cows' milk. The typical composition of cows' milk is given, for guidance, in Annex VIII.  5.4.  The calcium/phosphorus ratio shall not exceed 2,0.  6.  Vitamins       Per 100 kJ   Per 100 kcal      Minimum  Maximum  Minimum  Maximum             Vitamin A (ìg-ER) (1)  14  43  60  180  Vitamin D (ìg) (2)  0,25  0,75  1  3  Vitamin C (ìg)  1,9  -  8  -  Vitamin E (mg á-TE) (3)  0,5/g  polyunsaturated fatty acids expressed al linoleic acid but in no case less than 0,1 mg per 100 available kJ  -  0,5/g polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  -       (1) RE =  all trans retinol equivalent.  (2) In the form of cholecalciferol, of which 10 ìg = 400 u.i. of vitamin D.  (3) á-TE = d-á-tocopherol equivalent.   ANNEX III NUTRITIONAL SUBSTANCES  1. Vitamins   Vitamin  Vitamin formulation     Vitamin A  Retinyl acetate   Retinyl palmitate   Beta-carotene   Retinol  Vitamin D  Vitamin D2 (ergocalciferol)   Vitamin D3 (cholecalciferol)  Vitamin B1  Thalmin hydrochloride   Thalmin mononitrate  Vitamin B2   Riboflavin   Riboflavin-5-phosphate, sodium  Niacin  Nictotinamide   Nicotinic acid  Vitamin B6  Pyridoxine hydrochloride   Pyridoxine-5-phosphate  Folate  Folic acid  Pantothenic acid  D-pantothenate, calcium   D-pantothenate, sodium   Dexpanthenol   Vitamin B12  Cyanocobalamin   Hydroxocobalamin  Biotin  D-biotin  Vitamin C  L-ascorbic acid   Sodium L-ascorbate   Calcium L-ascorbate   6-palmityl-L-ascorbic acid (ascorbyl palmitate)   Potassium ascorbate  Vitamin E  D-alpha tocopherol   DL-alpha  tocopherol   D-alpha tocopherol acetate   DL-alpha tocopherol acetate  Vitamin K  Phylloquinone (Phytomenadione)    2. Mineral substances   Mineral substances  Permitted salts       Calcium (Ca)  Calcium carbonate   Calcium chloride   Calcium salts of citric acid   Calcium gluconate   Calcium glycerophosphate   Calcium lactate   Calcium salts of orthophosphoric acid   Calcium  hydroxide  Magnesium (Mg)  Magnesium carbonate   Magnesium chloride   Magnesium oxide   Magnesium salts of orthophosphoric acid   Magnesium sulphate   Magnesium gluconate   Magnesium hydroxide   Magnesium salts of citric acid  Iron (Fe)  Ferrous citrate    Ferrous gluconate   Ferrous lactate   Ferrous sulphate   Ferric ammonium citrate   Ferrous fumarate   Ferric diphosphate (Ferric pyrophosphate)  Copper (Cu)  Cupric citrate   Cupric gluconate   Cupric sulphate   Copper-lysine complex   Cupric  carbonate  Iodine (I)  Potassium iodide   Sodium iodide   Potassium iodate  Zinc (Zn)  Zinc acetate   Zinc chloride   Zinc lactate   Zinc sulphate   Zinc citrate   Zinc gluconate   Zinc oxide  Manganese (Mn)  Manganese carbonate   Manganese chloride    Manganese citrate   Manganese sulphate   Manganese gluconate  Sodium (Na)  Sodium bicarbonate   Sodium chloride   Sodium citrate   Sodium gluconate   Sodium carbonate   Sodium lactate   Sodium salts of orthophosphoric acid   Sodium hydroxide   Potassium (K)  Potassium bicarbonate   Potassium carbonate   Potassium chloride   Potassium salts of citric acid   Potassium gluconate   Potassium lactate   Potassium salts of orthophosphoric acid   Potassium hydroxide    3. Amino acids and other  nitrogen compounds  L-arginine and its hydrochloride  L-cystine and its hydrochloride  L-histidine and its hydrochloride  L-isoleucine and its hydrochloride  L-leucine and its hydrochloride  L-cysteine and its hydrochloride  L-cysteine and its hydrochloride  L-methionine  L-phenylalanine  L-threonine  L-tryptophan  L-tyrosine  L-valine  L-carnitine and its hydrochloride  Taurine  4. Others  Choline  Choline chloride  Choline citrate  Choline bitartrate  Inositol   ANNEX IV COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM   Claim related to  Conditions warranting the claim     1. Adapted protein  The protein content is lower than 0,6 g/100 kJ (2,5 g/100 kcal) and the whey protein/casein ratio is not less than 1,0.  2. Low sodium  The sodium content is lower than 9  mg/100 kJ (39 mg/100 kcal).  3. Sucrose free  No sucrose is present.  4. Lactose only  Lactose is the only carbohydrate present.  5. Lactose free  No lactose is present (1).  6. Iron enriched  Iron is added.    (1) When determined by a method the  detection limits of which will be established at a later stage.   ANNEX V ESSENTIAL AND SEMI-ESSENTIAL AMINO ACIDS IN BREAST MILK  For the purpose of this report, the essential and semi-essential amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:    Per 100 kJ (1)  Per 100 kcal      Arginine  16  69  Cystine  6  24  Histidine  11  45  Isoleucine  17  72  Leucine  37  156  Lysine  29  122  Methionine  7  29  Phenylalanine  15  62  Threonine  19  80  Tryptophan  7  30  Tyrosine  14  59  Valine   19  80     (1) 1 kJ = 0,239 kcal.   ANNEX VI Amino acid composition of casein and breast milk protein  The amino acid composition of casein and breast milk protein:  (g/100 g of protein)    Casein (1)  Breast milk (1)      Arginine  3,7  3,8  Cystine  0,3  1,3  Histidine  2,9  2,5  Isoleucine  5,4  4,0  Leucine  9,5  8,5  Lysine  8,1  6,7  Methionine  2,8  1,6  Phenylalanine  5,2  3,4  Threonine  4,7  4,4  Tryptophan  1,6  1,7   Tyrosine  5,8  3,2  Valine  6,7  4,5     (1) Amino acid content of foods and biological data on protein. FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383.   ANNEX VII The mineral elements in cows' milk  As a reference, the contents of mineral elements in cows' milk expressed per 100 g of solids-non-fat and per g of proteins are the following:    Per 100 g SNF (1)  Per g of proteins      Sodium (mg)  550  15  Potassium (mg)  1 680  43  Chloride (mg)  1 050  28  Calcium (mg)  1 350  35  Phosphorus (mg)  1 070  28  Magnesium (mg)  135  3,5  Copper (ìg)  225  6  Iodine  NS (2)   NS     (1) SNF: 'solids-no fats'.  (2) NS: non-specified, varies widely according to season and stock farming conditions._  1.2,3 //  This provision does not apply to formulae in which soya proteins represent more than 50 % of the total protein content .  4.3 .  Sucrose  1.2.3 //  Minimum  Maximum   //  _  20 % of the total carbohydrate content  1.2,34.4  Pre-cooked starch and/or gelatinied starch  1.2.3 //  Minimum  Maximum   //  _  2 g/100 ml, and 30 % of the total carbohydrate content  1.2,35 .  Mineral substances  5.1 .  Formulae manufactured from cows' milk proteins  1.2,3.4,5 //   //  //  //  Per 100 kJ  Per 100 kcal  1.2.3.4.5Minimum  Maximum  Minimum  Maximum   //   //  //  //  //  Sodium ( mg )  5  14  20  60  Potassium ( mg )  15  35  60  145  Chloride ( mg )  12  29  50  125  Calcium ( mg )  12  _  50  _  Phosphorus ( mg )  6  22  25  90  Magnesium ( mg )  1,2  3,6  5  15  Iron ( mg ) ( 1 )  0,12  0,36  0,5  1,5  Zinc ( mg )  0,12  0,36  0,5  1,5  Copper (* g )  4,8  19  20  80  Iodine (* g )  1,2  _  5  _   //   //  //  //  //  ( 1 ) Limit applicable to formulae with added iron .  1.2The calcium/phosphorus ratio shall not be less than 1,2 nor greater than 2,0 .  5.2 .  Formulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins   //  All requirements of paragraph 5.1 are applicables except those concerning iron and zinc, which are as follows :  1.2,3.4,5 //   //  //  //  Per 100 kJ  Per 100 kcal  1.2.3.4.5Minimum  Maximum  Minimum  Maximum   //   //  //  //  //  Iron ( mg )  0,25  0,5  1  2  Zinc ( mg )  0,18  0,6  0,75  2,4   //   //  //  //  //  1.26 .  Vitamins  1.2,3.4,5 //   //  //  //  Per 100 kJ  Per 100 kcal  1.2.3.4.5Minimum  Maximum  Minimum  Maximum   //   //  //  //  //  Vitamin A (* g-RE ) ( 1 )  14  43  60  180  Vitamin D (* g ) ( 2 )  0,25  0,65  1  2,5  Thiamin (* g )  10  _  40  _  Riboflavin (* g )  14  _  60  _  Nicotinamide (* g-EN ) ( 3 )  60  _  250  _  Pantothenic acid (* g )  70  _  300  _  Vitamin B6 (* g )  9  _  35  _  Biotin (* g )  0,4  _  1,5  _  Folic acid (* g )  1  _  4  _  Vitamin B12 (* g )  0,025  _  0,1  _  Vitamin C (* g )  1,9  _  8  _  Vitamin K (* g )  1  _  4  _  Vitamin E ( mg *-TE ) ( 4 )  0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,1 mg per 100 available kJ  _  0,5/g of polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  _   //   //  //  //  //  ( 1 ) RE = all trans retinol equivalent .  ( 2 ) In the form of cholecalciferol, of which 10 *g = 400 i.u . of vitamin D .  ( 3 ) NE = Niacin equivalent = mg nicotinic acid + mg tryptophan/60 .  ( 4 ) *-TE = d-*-tocopherol equivalent .  ANNEX II  ESSENTIAL COMPOSITION OF FOLLOW-ON FORMULAE WHEN RECONSTITUTED AS INSTRUCTED BY THE MANUFACTURER  NB : The values refer to the product ready for use  1.2.31 .  Energy   //  //  Minimum  Maximum   //  250 kJ/100 ml  335 KJ/100 ml   //  ( 60 kcal/100 ml )  ( 80 kcal/100 ml )  1.2,32 .  Proteins   //  ( Protein content = nitrogen content x 6,38 ) for cows' milk proteins .   //  ( Protein content = nitrogen content x 6,25 ) for soya protein isolates .  1.2.3 //  Minimum  Maximum   //  0,5 g/100 kJ  1 g/100 kJ   //  ( 2,25 g/100 kcal )  ( 4,5 g/100 kcal )  1.2,3 //  The chemical index of the proteins present shall be at least equal to 80 % of that of the reference protein ( casein as defined in Annex VI ).   //  The "chemical index' shall mean the lowest of the ratios between the quantity of each essential amino acid of the test protein and the quantity of each corresponding amino acid of the reference protein .   //  For follow-on forumulae manufactured from soya proteins, alone or in a mixture with cows' milk proteins, only protein isolates from soya may be used .   //  Amino acids may be added to follow-on formulae for the purpose of improving the nutritional value of the proteins, in the proportions necessary for that purpose .  1.2.33 .  Lipids   //  //  Minimum  Maximum   //  0,8 g/100 kJ  1,5 g/100 kJ   //  ( 3,3 g/100 kcal )  ( 6,5 g/100 kcal )  1.2,33.1 .  The use of the following substances is prohibited :   //  _ sesame seed oil,   //  _ cotton seed oil,   //  _ fats containing more than 8 % trans isomers of fatty acids .  1.2.33.2 .  Lauric acid   //  //  Minimum  Maximum   //  _  15 % of the total fat content  3.3 .  Myristic acid   //  //  Minimum  Maximum   //  _  15 % of the total fat content  1.2,33.4 .  Linoleic acid ( in the form of glycerides = linoleates )  1.2.3 //  Minimum  Maximum   //  70 mg/100 kJ  _   //  ( 300 mg/100 kcal ):   //  //  this limit applies only to follow-on formulae containing vegetable oils   //  4 .  Carbohydrates   //  //  Minimum  Maximum   //  1,7 g/100 kJ  3,4 g/100 kJ   //  ( 7 g/100 kcal )  ( 14 g/100 kcal )  1.2,34.1 .  The use of ingredients containing gluten is prohibited .  4.2 .  Lactose  1.2.3 //Minimum  Maximum   //  0,45 g/100 kJ  _   //  ( 1,8 g/100 kcal )   //  1.2,3 //  This provision does not apply to follow-on formulae in which soya protein isolates represent more than 50 % of the total protein content .  4.3 .  Sucrose, fructose, honey  1.2.3 //  Minimum  Maximum   //  _  separately or as a whole :   //  //  20 % of the total carbohydrate content  1.2,35 .  Mineral substances  5.1 .   //  1.2,3.4,5 //   //  //  //  Per 100 kJ  Per 100 kcal  1.2.3.4.5Minimum  Maximum  Minimum  Maximum   //   //  //  //  //  //  //  //  //  //  Iron ( mg )  0,25  0,5  1  2  Iodine (* g )  1,2  _  5  _   //   //  //  //  //  1.2.35.2 .  Zinc   //  1.2,35.2.1 .  Follow-on formulae manufactured entirely from cows' milk  1.2.3Minimum  Maximum   //  0,12 mg/100 kJ  _   //  ( 0,5 mg/100 kcal )   //  1.2,35.2.2 .  Follow-on formulae containing soya protein isolates, or mixed with cows' milk  1.2.3Minimum  Maximum   //  0,18 mg/100 kJ  _   //  ( 0,75 mg/100 kcal )   //  1.2,35.3 .  Other mineral substances :   //  The concentrations are at least equal to those normally found in cows' milk, reduced, where appropriate, in the same ratio as the protein concentration of the follow-on formulae to that of cows' milk . The typical composition of cows' milk is given, for guidance, in Annex VIII .  5.4 .  The calcium/phosphorus ratio shall not exceed 2,0 .  6 .  Vitamins  1.2,3.4,5 //   //  //  //  Per 100 kJ  Per 100 kcal  1.2.3.4.5Minimum  Maximum  Minimum  Maximum   //   //  //  //  //  //  //  //  //  //  Vitamin A (* g-ER ) ( 1 )  14  43  60  180  Vitamin D (* g ) ( 2 )  0,25  0,75  1  3  Vitamin C (* g )  1,9  _  8  _  Vitamin E ( mg *-TE ) ( 3 )  0,5/g polyunsaturated fatty acids expressed al linoleic acid but in no case less than 0,1 mg per 100 available kJ  _  0,5/g polyunsaturated fatty acids expressed as linoleic acid but in no case less than 0,5 mg per 100 available kcal  _   //   //  //  //  //  ( 1 ) RE = all trans retinol equivalent .  ( 2 ) In the form of cholecalciferol, of which 10 *g = 400 u.i . of vitamin D .  ( 3 ) *-TE = d-*-tocopherol equivalent .  ANNEX III  NUTRITIONAL SUBSTANCES  1 . Vitamins  1.2Vitamin  Vitamin formulation  Vitamin A  Retinyl acetate   //  Retinyl palmitate   //  Beta-carotene   //  Retinol  Vitamin D  Vitamin D2 ( ergocalciferol )   //  Vitamin D3 ( cholecalciferol )  Vitamin B1  Thalmin hydrochloride   //  Thalmin mononitrate  Vitamin B2  Riboflavin   //  Riboflavin-5-phosphate, sodium  Niacin  Nictotinamide   //  Nicotinic acid  Vitamin B6  Pyridoxine hydrochloride   //  Pyridoxine-5-phosphate  Folate  Folic acid  Pantothenic acid  D-pantothenate, calcium   //  D-pantothenate, sodium   //  Dexpanthenol  Vitamin B12  Cyanocobalamin   //  Hydroxocobalamin  Biotin  D-biotin  Vitamin C  L-ascorbic acid   //  Sodium L-ascorbate   //  Calcium L-ascorbate   //  6-palmityl-L-ascorbic acid ( ascorbyl palmitate )   //  Potassium ascorbate  Vitamin E  D-alpha tocopherol   //  DL-alpha tocopherol   //  D-alpha tocopherol acetate   //  DL-alpha tocopherol acetate  Vitamin K  Phylloquinone ( Phytomenadione )   //   //  2 . Mineral substances  1.2Mineral substances  Permitted salts  Calcium ( Ca )  Calcium carbonate   //  Calcium chloride   //  Calcium salts of citric acid   //  Calcium gluconate   //  Calcium glycerophosphate   //  Calcium lactate   //  Calcium salts of orthophosphoric acid   //  Calcium hydroxide  Mineral substances  Permitted salts  Magnesium ( Mg )  Magnesium carbonate   //  Magnesium chloride   //  Magnesium oxide   //  Magnesium salts of orthophosphoric acid   //  Magnesium sulphate   //  Magnesium gluconate   //  Magnesium hydroxide   //  Magnesium salts of citric acid  Iron ( Fe )  Ferrous citrate   //  Ferrous gluconate   //  Ferrous lactate   //  Ferrous sulphate   //  Ferric ammonium citrate   //  Ferrous fumarate   //  Ferric diphosphate ( Ferric pyrophosphate )  Copper ( Cu )  Cupric citrate   //  Cupric gluconate   //  Cupric sulphate   //  Copper-lysine complex   //  Cupric carbonate  Iodine ( I )  Potassium iodide   //  Sodium iodide   //  Potassium iodate  Zinc ( Zn )  Zinc acetate   //  Zinc chloride   //  Zinc lactate   //  Zinc sulphate   //  Zinc citrate   //  Zinc gluconate   //  Zinc oxide  Manganese ( Mn )  Manganese carbonate   //  Manganese chloride   //  Manganese citrate   //  Manganese sulphate   //  Manganese gluconate  Sodium ( Na )  Sodium bicarbonate   //  Sodium chloride   //  Sodium citrate   //  Sodium gluconate   //  Sodium carbonate   //  Sodium lactate   //  Sodium salts of orthophosphoric acid   //  Sodium hydroxide  Potassium ( K )  Potassium bicarbonate   //  Potassium carbonate   //  Potassium chloride   //  Potassium salts of citric acid   //  Potassium gluconate   //  Potassium lactate   //  Potassium salts of orthophosphoric acid   //  Potassium hydroxide   //   //  3 . Amino acids and other nitrogen compounds  L-arginine and its hydrochloride  L-cystine and its hydrochloride  L-histidine and its hydrochloride  L-isoleucine and its hydrochloride  L-leucine and its hydrochloride  L-cysteine and its hydrochloride  L-cysteine and its hydrochloride  L-methionine  L-phenylalanine  L-threonine  L-tryptophan  L-tyrosine  L-valine  L-carnitine and its hydrochloride  Taurine  4 . Others  Choline  Choline chloride  Choline citrate  Choline bitartrate  Inositol  ANNEX IV  COMPOSITIONAL CRITERIA FOR INFANT FORMULAE, WARRANTING A CORRESPONDING CLAIM  1.2Claim related to  Conditions warranting the claim  1 . Adapted protein  The protein content is lower than 0,6 g/100 kJ ( 2,5 g/100 kcal ) and the whey protein/casein ratio is not less than 1,0 .  2 . Low sodium  The sodium content is lower than 9 mg/100 kJ ( 39 mg/100 kcal ).  3 . Sucrose free  No sucrose is present .  4 . Lactose only  Lactose is the only carbohydrate present .  5 . Lactose free  No lactose is present ( 1 ).  6 . Iron enriched  Iron is added .   //   //  ( 1 ) When determined by a method the detection limits of which will be established at a later stage .  ANNEX V  ESSENTIAL AND SEMI-ESSENTIAL AMINO ACIDS IN BREAST MILK  For the purpose of this report, the essential and semi-essential amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following :1.2.3Per 100 kJ ( 1 )  Per 100 kcal   //   //  //  Arginine  16  69  Cystine  6  24  Histidine  11  45  Isoleucine  17  72  Leucine  37  156  Lysine  29  122  Methionine  7  29  Phenylalanine  15  62  Threonine  19  80  Tryptophan  7  30  Tyrosine  14  59  Valine  19  80   //   //  //  ( 1 ) 1 kJ = 0,239 kcal .  ANNEX VI  Amino acid composition of casein and breast milk protein  The amino acid composition of casein and breast milk protein :  ( g/100 g of protein )  1.2.3Casein ( 1 )  Breast milk ( 1 )   //   //  //  Arginine  3,7  3,8  Cystine  0,3  1,3  Histidine  2,9  2,5  Isoleucine  5,4  4,0  Leucine  9,5  8,5  Lysine  8,1  6,7  Methionine  2,8  1,6  Phenylalanine  5,2  3,4  Threonine  4,7  4,4  Tryptophan  1,6  1,7  Tyrosine  5,8  3,2  Valine  6,7  4,5   //   //  //  ( 1 ) Amino acid content of foods and biological data on protein . FAO Nutritional Studies, No 24, Rome 1970, items 375 and 383 .  ANNEX VII  The mineral elements in cows' milk  As a reference, the contents of mineral elements in cows' milk expressed per 100 g of solids-non-fat and per g of proteins are the following :  1.2.3Per 100 g SNF ( 1 )  Per g of proteins   //   //  //  Sodium ( mg )  550  15  Potassium ( mg )  1 680  43  Chloride ( mg )  1 050  28  Calcium ( mg )  1 350  35  Phosphorus ( mg )  1 070  28  Magnesium ( mg )  135  3,5  Copper (* g )  225  6  Iodine  NS ( 2 )  NS   //   //  //  ( 1 ) SNF : "solids-no fats '.  ( 2 ) NS : non-specified, varies widely according to season and stock farming conditions .


Avis juridique important

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31991L0494

Council Directive 91/494/EEC of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat

Official Journal L 268 , 24/09/1991 P. 0035 - 0040 Finnish special edition: Chapter 3 Volume 39 P. 0024  Swedish special edition: Chapter 3 Volume 39 P. 0024

COUNCIL DIRECTIVE of 26 June 1991 on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (91/494/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 43 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas poultrymeat is included in the list of products in Annex II to the Treaty; whereas the breeding and rearing of poultry is included in the farming sector and constitutes a source of income for part of the farming population;  Whereas disparities between Member States should be removed by laying down rules regarding the animal health aspects of intra-Community trade in fresh poultrymeat in order to ensure the rational development of that sector and improve productivity by  encouraging intra-Community trade, with a view to the completion of the internal market;  Whereas, in particular, to improve information concerning the state of health of the poultry from which fresh meat for consignment to another Member State comes, it should be stipulated that the poultry must either have been reared on the territory of  the Community or have been imported from third countries in accordance with Chapter III of Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade and imports from third countries of poultry and  hatching eggs (4);  Whereas, in order to prevent it from propagating epizootic diseases, fresh meat coming from a holding or area which, in accordance with Community rules, has been placed under health restrictions or from an area infected by avian influenza or Newcastle  disease should be excluded from intraCommunity trade;  Whereas care should be taken that fresh poultrymeat that does not comply with Community rules should not be given the health mark provided for in Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat (5), as last amended by Directive 90/484/EEC (6); whereas, such meat may, however, be put to other uses provided  that it has undergone treatment designed to destroy the germs of diseases, in which case it will bear a special mark to that effect;  Whereas, in respect of the organization of and the follow-up to the checks being carried out by the Member State of destination and the safeguard measures to be implemented, reference should be made to the general rules laid down in Council Directive  89/662/EEC of 11 December 1989 concerning veterinary checks in intra-Community trade with a view to the completion of the internal market (7);  Whereas provision should be made so that inspections may be carried out by the Commission;  Whereas, in the interests of the harmonious development of intra-Community trade; Community arrangements should be defined in respect of imports from third countries;  Whereas defining the said arrangements requires in particular that a list be drawn up of third countries or parts of third countries from which fresh poultrymeat may be imported and that a certificate be produced;  Whereas the Commission's veterinary experts should be instructed to carry out checks in third countries in order to determine whether the Community rules are complied with;  Whereas the rules and general principles governing checks on fresh poultrymeat will be determined later as part of the measures to be taken to bring about the internal market;  Whereas Directive 90/539/EEC should be amended in order to take into account the contents of this Directive, with a view in particular to ensure parallelism with regard to the date on which Member States must comply with the new health rules;  Whereas the provisions of this Directive will have to be reviewed in the context of the completion of the internal market;  Whereas provision should be made for a procedure establishing close cooperation between the Commission and the Member States within the Standing Veterinary Committee;  Whereas it is advisable to allow time to introduce harmonized rules concerning Newcastle disease,  HAS ADOPTED THIS DIRECTIVE:  CHAPTER I General provisions   Article 1  This Directive lays down animal health requirements governing intra-Community trade in and imports from third countries of fresh poultrymeat.  Article 2  For the purposes of this Directive, the definitions, and especially those for poultry, set out in Article 2 of Directive 90/539/EEC shall also apply.  Moreover:  (a)  'meat' means any parts of poultry which are fit for human consumption;  (b)  'fresh meat' means any meat, including meat vacuum-wrapped or wrapped in a controlled atmosphere, which has not undergone any treatment other than cold treatment to ensure its preservation.   CHAPTER II Rules governing intra-community trade   Article 3  A.  In order to be traded within the Community fresh meat must have been obtained from poultry which:  1.  has been held in Community territory since hatching or has been imported from third countries in accordance with the requirements of Chapter III of Directive 90/539/EEC.  Until 31 December 1992 poultrymeat intended for Member States or regions of Member States the status of which has been recognized in accordance with Article 12 (2) of that Directive must come from poultry which has not been vaccinated against Newcastle  disease using an attenuated live vaccine during the 30 days preceding slaughter.  Acting before 1 January 1992 by a qualified majority on a proposal from the Commission based on a report on the risks of transmission of Newcastle disease, the Council shall adopt the rules applicable as from 1 January 1993;  2.  comes from a holding:  - which has not been placed under animal health restrictions in connection with a poultry disease,  - which is not situated in an area which has been declared an avian influenza or Newcastle disease infection area;  3.  during transport to the slaughterhouse did not come into contact with poultry suffering from avian influenza or Newcastle disease; such transport through an area which has been declared an avian influenza or Newcastle disease infection area shall be  prohibited unless major road or rail links are used;  4.  comes from slaughterhouses in which, at the time of slaughter, no case of avian influenza or Newcastle disease had been recorded.  Any fresh meat which is suspected of having been contaminated at the slaughterhouse, cutting plant or storage depot or in the course of transport must be excluded from trade;  5.  is marked in accordance with Articles 4 and 5;  6.  is accompanied by the health certificate provided for in Annex IV to Directive 71/118/EEC, amended in accordance with the Annex to this Directive.  B.  Exempted from this chapter are national controls governing meat:  - contained in the personal luggage of travellers and intended for their personal consumption,  - in small consignments to private individuals, provided that the said consignments are not of a commercial nature,  - for consumption by the crew and passengers on board means of transport operating internationally.  Article 4  Fresh poultrymeat covered by this Directive shall be given the health mark specified in Article 3 (1) A (e) of Directive 71/118/EEC, provided that it meets the requirements laid down in Article 3 (A) of this Directive and that it comes from poultry  slaughtered in accordance with the hygiene requirements laid down in Directive 71/118/EEC.  Article 5  1.  Notwithstanding Article 4, and insofar as it is not intended for intra-Community trade in fresh meat, fresh poultrymeat which does not satisfy the requirements laid down in Article 3 (A) (2) (3) and the first subparagraph of (4) may carry a mark in accordance with Article 3 (1) A (e) of Directive 71/118/EEC, provided that this mark is immediately:  (a)  either overstamped in such a way that the health mark defined in point 44.1 (a) and (b) of Chapter X of Annex I to Directive 71/118/EEC is covered by a diagonal cross consisting of two straight lines crossing at right angles, with the point of intersection in the centre of the stamp and the information thereon remaining legible;  (b)  or replaced by a single special mark consisting of the health mark defined in point 44 (a) and (b) of Chapter X of Annex I to Directive 71/118/EEC, overstamped in accordance with point (a) of this paragraph.  The provisions of point 43 of Chapter X of Annex I to Directive 71/118/EEC shall apply mutatis mutandis to the keeping and use of marking instruments.  2.  The meat referred to in paragraph 1 must be obtained, cut, transported and stored separately from, or not at the same time as, meat intended for intra-Community trade in fresh meat and must be used in such a way as to avoid it being introduced into  meat products intended for intraCommunity trade unless they have undergone the treatment specified in Article 4 (1) of Directive 80/215/EEC (8) as last amended by Directive 89/662/EEC.  Article 6  The rules laid down in Directive 89/662/EEC shall apply, in particular as regards the organization of and the follow-up to the checks carried out by the Member State of destination and the safeguard measures to be applied.  Article 7  Commission veterinary experts may, to the extent necessary to ensure uniform application of this Directive, and in conjunction with the competent national authorities, carry out on-the spot inspections. The Commission shall inform the Member States of  the outcome of such inspections.  Member States in whose territory an inspection is carried out shall give the experts all the assistance necessary for the performance of their tasks.  General rules for the application of this Article shall be adopted in accordance with the procedure laid down in Article 18. The rules to be followed for the inspections provided for in this Article shall be adopted in accordance with the same  procedure.  CHAPTER III Rules applicable to imports from third countries   Article 8  1.  Fresh poultrymeat imported into the Community must satisfy the requirements laid down in Articles 9 to 12.  2.  However, this Chapter shall not apply to:  (a)  poultrymeat forming part of travellers' personal luggage and intended for their personal consumption, provided that the quantity transported does not exceed one kilogram per person and that it comes from a third country or part thereof appearing on  the list drawn up in accordance with Article 9 and from which importation is not prohibited under Article 14;  (b) poultrymeat sent as small consignments to private individuals, provided that such meat is not imported by way of trade, that the quantity does not exceed one kilogram and that it comes from a third country or part thereof appearing on the list drawn up  in accordance with Article 9 and from which importation is not prohibited under Article 14;  (c) meat for consumption by the crew and passengers on board means of transport operating internationally.  Where such meat or the resulting kitchen waste is unloaded, it must be destroyed. It is not, however, necessary to destroy meat when it is transferred, directly or after being placed provisionally under customs supervision, from one means of transport  to another.  Article 9  1.  Fresh poultrymeat must come from a third country or part of a third country appearing on a list drawn up by the Commission in accordance with the procedure laid down in Article 18. The list may be supplemented or amended in accordance with the  procedure laid down in Article 17.  2.  In deciding whether a third country or part thereof may be included in the list referred to in paragraph 1, particular account shall be taken of:  (a)  the state of health of the poultry, other domestic animals and wildlife in the third country, particular attention being paid to exotic animal diseases, and the environmental health situation in that country, where either are liable to endanger  public and animal health in the Member States;  (b) the regularity and rapidity of the supply of information by the third country relating to the existence of contagious animal diseases in its territory, in particular the diseases appearing on lists A and B of the International Office of Epizootics;  (c) that country's rules on animal disease prevention and control;  (d) the structure of the veterinary services in the country and their powers;  (e) the organization and implementation of measures to prevent and control contagious animal diseases;  (f) that country's legislation on the use of banned substances, in particular legislation concerning the prohibition or authorization of substances, their distribution, placing on the market and the rules on administering and controlling them;  (g) the guarantees which the third country can give with regard to rules laid down by this Directive.  3.  The list referred to in paragraph 1 and any amendments thereto shall be published in the Official Journal of the European Communities.  Article 10  1.  Fresh poultrymeat must come from third countries free from avian influenza and Newcastle disease.  2.  The general criteria for classifying third countries in terms of the diseases referred to in paragraph 1 shall be adopted in accordance with the procedure laid down in Article 17. These criteria must in no case be more favourable than those adopted  for the Member States pursuant to Directive 90/539/EEC.  3.  The Commission may, in accordance with the procedure laid down in Article 18, decide that paragraph 1 shall apply only to a part of the territory of a third country.  Article 11  1.  Fresh poultrymeat must:  (a)  satisfy animal health requirements adopted in accordance with the procedure laid down in Article 17. These requirements may differ according to the species of bird;  (b) come from flocks which, prior to consignment, have, without interruption, been held in the third country or part thereof for a period to be defined in accordance with the procedure laid down in Article 17.  2.  The animal health conditions shall be determined on the basis of the rules laid down in Chapter II and the corresponding Annexes to Directive 90/539/EEC. In accordance with the procedure laid down in Article 18, derogations may be granted on a  case-by-case basis, if the third country concerned offers similar animal health guarantees which are at least of an equivalent standard.  Article 12  1.  Fresh poultrymeat must be accompanied by a certificate drawn up by an official veterinarian of the exporting third country.  The certificate must:  (a)  be issued on the day of loading for consignment to the country of destination;  (b) be drawn up in the official language or languages of the country of shipment, of the country of destination, and in one of the official languages of the country in which the import checks are to be carried out;  (c) accompany the consignment in the original;  (d) attest that the fresh meat satisfies the requirements of this Directive and those adopted pursuant to this Directive with regard to importation from third countries;  (e) consist of a single sheet of paper;  (f) be made out for a single consignee.  2.  The certificate must conform with a model established in accordance with the procedure laid down in Article 18.  Article 13  On-the-spot inspections shall be carried out by veterinary experts of the Member States and the Commission to ensure that all the provisions of this Directive are effectively applied.  Member States' experts responsible for these inspections shall be designated by the Commission on proposals from the Member States.  The inspections shall be carried out on behalf of the Community, which shall bear the expenditure incurred.  The frequency of the inspections and the inspection procedure shall be determined in accordance with the procedure laid down in Article 18.  Article 14  1.  The Commission may, in accordance with the procedure laid down in Article 17, decide that imports from a third country or part thereof are to be confined to fresh poultrymeat of particular species.  2.  The Commission may decide, in accordance with the procedure laid down in Article 17, to apply animal health restrictions, as required, after importation.  Article 15  The rules and general principles applicable during inspections in third countries or during inspections of imported poultrymeat from third countries and the safeguard measures to be implemented shall be those set out in Directive 90/675/EEC (9).  Article 16  1.  Pending the implementation of Community health rules concerning imports of poultrymeat from third countries, Member States shall apply to such imports provisions which shall not be more favourable than those governing intra-Community trade in accordance with Directive 71/118/EEC and shall make trade in poultrymeat subject to the requirements laid down in the second subparagraph of Article 6 (1) (b) of Directive 89/662/EEC.  2.  To ensure uniform application of these provisions, inspections may be carried out on-the-spot in third countries by veterinary experts of the Member States and the Commission.  Member States' experts responsible for these inspections shall be designated by the Commission on a proposal from the Member States.  The inspections shall be carried out on behalf of the Community, which shall bear the expenditure incurred.  However, Member States shall be entitled to continue to make inspections under national arrangements of any third country establishments which have not been inspected under the Community procedure.  A list of establishments meeting the conditions referred to Annex 1 to Directive 71/118/EEC shall be drawn up in accordance with the procedure laid down in Article 18.  3.  The health certificate which accompanies products on import, and the form and nature of the health mark which the products shall bear, shall correspond to a model to be determined in accordance with the procedure laid down in Article 18.   CHAPTER IV Common provisions   Article 17  Where the procedure laid down in this Article is to be used, the Standing Veterinary Committee (hereinafter referred to as 'the Committee'), set up by Decision 68/361/EEC ($), shall discuss the matter in accordance with the rules laid down in Article 12  of Directive 71/118/EEC.  Article 18  Where the procedure laid down in this Article is to be used, the Committee shall discuss the matter in accordance with the rules laid down in Article 12 a of Directive 71/118/EEC.  Article 19  1.  Annex A to Directive 89/662/EEC shall be supplemented by the following text:  '- Council Directive 91/494/EEC of 26 June 1991, on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat (OJ No L 268, 24. 9. 1991, p. 35).' 2.  Directive 90/539/EEC shall be amended as follows:  (a)  In Article 12 (2), first subparagraph, the phrase 'at the latest six months before the date on which the Member States must conform to this Directive' shall be deleted.  (b) In Article 36, the date '1 January 1992' shall be replaced by '1 May 1992'.  Article 20  In connection with the proposals for completing the internal market the Council shall review the provisions of this Directive before 31 December 1992, acting by a qualified majority on a proposal from the Commission.  Article 21  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive no later than 1 May 1992. They shall forthwith inform the Commission thereof.  When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such a reference shall be laid down by the Member  States.  Article 22  This Directive is addressed to the Member States.  Done at Luxembourg, 26 June 1991.  For the Council The President R. STEICHEN (1) OJ No C 327, 30. 12. 1989, p. 72.(2) OJ No C 183, 15. 7. 1991.(3) OJ No C 124, 21. 5. 1990, p. 12.(4) OJ No L 303, 31. 10. 1990, p. 6.(5) OJ No L 55, 8. 3. 1971, p. 23.(6) OJ No L 267, 29. 9. 1990, p. 45.(7) OJ No L 395, 31. 12. 1989, p.  13.(8) OJ No L 47, 21. 2. 1980, p. 4.(9) OJ No L 373, 31. 12. 1990, p. 1.(10) OJ No L 255, 18. 10. 1968, p. 23.   ANNEX   Amendments to be made to the health certificate set out in annex IV to Directive 71/118/EEC  1.  The title should be supplemented as follows:  'ANIMAL-HEALTH AND HEALTH CERTIFICATE' 2.  Point IV should be replaced by the following:  'IV.  Attestation I, the undersigned, official veterinarian, certify that:  (a)  the poultrymeat described above (;) satisfies the requirements of Directive 90/494/EEC on animal health conditions governing intra-Community trade in and imports from third countries of fresh poultrymeat and also the requirements of the second  subparagraph of Article 3 (1) of that Directive, if such meat is destined for a Member State or region of a Member State that is recognised as being free of Newcastle disease;  (b) - the poultrymeat described above (%),  - the packaging of the meat described above (%),  bear a mark proving that:  - the meat comes from animals slaughtered in approved slaughterhouses (%),  - the meat was cut in approved cutting premises (%);  (c) this meat has been passed as fit for human consumption following a veterinary inspection carried out in accordance with Council Directive 71/118/EEC of 15 February 1971 on health problems affecting trade in fresh poultrymeat;  (d) the transport vehicles or containers and the loading conditions of this consignment meet the hygiene requirements laid down in Directive 71/118/EEC.' 3.  Footnote 1 should be replaced by the following:  '(;) fresh poultrymeat: fresh meat from the following species: live domestic hens, turkeys, guinea fowls, ducks, geese, quail, pigeons, pheasants and partridges which have not been treated to ensure their preservation'.


title: Directive 2006/115/EC of the European Parliament and of the Council of 12 December 2006 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (codified version)

text:
               27.12.2006

               EN

               Official Journal of the European Union

               L 376/28

      DIRECTIVE 2006/115/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

   of 12 December 2006
   on rental right and lending right and on certain rights related to copyright in the field of intellectual property
   (codified version)
   THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty establishing the European Community, and in particular Articles 47(2), 55 and 95 thereof,
   Having regard to the proposal from the Commission,
   Having regard to the opinion of the European Economic and Social Committee,
   Acting in accordance with the procedure laid down in Article 251 of the Treaty (1),
   Whereas:

               (1)

               Council Directive 92/100/EEC of 19 November 1992 on rental right and lending right and on certain rights related to copyright in the field of intellectual property (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.

               (2)

               Rental and lending of copyright works and the subject matter of related rights protection is playing an increasingly important role in particular for authors, performers and producers of phonograms and films. Piracy is becoming an increasing threat.

               (3)

               The adequate protection of copyright works and subject matter of related rights protection by rental and lending rights as well as the protection of the subject matter of related rights protection by the fixation right, distribution right, right to broadcast and communication to the public can accordingly be considered as being of fundamental importance for the economic and cultural development of the Community.

               (4)

               Copyright and related rights protection must adapt to new economic developments such as new forms of exploitation.

               (5)

               The creative and artistic work of authors and performers necessitates an adequate income as a basis for further creative and artistic work, and the investments required particularly for the production of phonograms and films are especially high and risky. The possibility of securing that income and recouping that investment can be effectively guaranteed only through adequate legal protection of the rightholders concerned.

               (6)

               These creative, artistic and entrepreneurial activities are, to a large extent, activities of self-employed persons. The pursuit of such activities should be made easier by providing a harmonised legal protection within the Community. To the extent that these activities principally constitute services, their provision should equally be facilitated by a harmonised legal framework in the Community.

               (7)

               The legislation of the Member States should be approximated in such a way as not to conflict with the international conventions on which the copyright and related rights laws of many Member States are based.

               (8)

               The legal framework of the Community on the rental right and lending right and on certain rights related to copyright can be limited to establishing that Member States provide rights with respect to rental and lending for certain groups of rightholders and further to establishing the rights of fixation, distribution, broadcasting and communication to the public for certain groups of rightholders in the field of related rights protection.

               (9)

               It is necessary to define the concepts of rental and lending for the purposes of this Directive.

               (10)

               It is desirable, with a view to clarity, to exclude from rental and lending within the meaning of this Directive certain forms of making available, as for instance making available phonograms or films for the purpose of public performance or broadcasting, making available for the purpose of exhibition, or making available for on-the-spot reference use. Lending within the meaning of this Directive should not include making available between establishments which are accessible to the public.

               (11)

               Where lending by an establishment accessible to the public gives rise to a payment the amount of which does not go beyond what is necessary to cover the operating costs of the establishment, there is no direct or indirect economic or commercial advantage within the meaning of this Directive.

               (12)

               It is necessary to introduce arrangements ensuring that an unwaivable equitable remuneration is obtained by authors and performers who must remain able to entrust the administration of this right to collecting societies representing them.

               (13)

               The equitable remuneration may be paid on the basis of one or several payments at any time on or after the conclusion of the contract. It should take account of the importance of the contribution of the authors and performers concerned to the phonogram or film.

               (14)

               It is also necessary to protect the rights at least of authors as regards public lending by providing for specific arrangements. However, any measures taken by way of derogation from the exclusive public lending right should comply in particular with Article 12 of the Treaty.

               (15)

               The provisions laid down in this Directive as to rights related to copyright should not prevent Member States from extending to those exclusive rights the presumption provided for in this Directive with regard to contracts concerning film production concluded individually or collectively by performers with a film producer. Furthermore, those provisions should not prevent Member States from providing for a rebuttable presumption of the authorisation of exploitation in respect of the exclusive rights of performers provided for in the relevant provisions of this Directive, in so far as such presumption is compatible with the International Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organisations (hereinafter referred to as the Rome Convention).

               (16)

               Member States should be able to provide for more far-reaching protection for owners of rights related to copyright than that required by the provisions laid down in this Directive in respect of broadcasting and communication to the public.

               (17)

               The harmonised rental and lending rights and the harmonised protection in the field of rights related to copyright should not be exercised in a way which constitutes a disguised restriction on trade between Member States or in a way which is contrary to the rule of media exploitation chronology, as recognised in the judgment handed down in Société Cinéthèque v. FNCF
                   (4).

               (18)

               This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives as set out in Part B of Annex I,

         HAVE ADOPTED THIS DIRECTIVE:
   CHAPTER I
   RENTAL AND LENDING RIGHT
   Article 1
   Object of harmonisation
   1.   In accordance with the provisions of this Chapter, Member States shall provide, subject to Article 6, a right to authorise or prohibit the rental and lending of originals and copies of copyright works, and other subject matter as set out in Article 3(1).
   2.   The rights referred to in paragraph 1 shall not be exhausted by any sale or other act of distribution of originals and copies of copyright works and other subject matter as set out in Article 3(1).
   Article 2
   Definitions
   1.   For the purposes of this Directive the following definitions shall apply:

               (a)

               ‘rental’ means making available for use, for a limited period of time and for direct or indirect economic or commercial advantage;

               (b)

               ‘lending’ means making available for use, for a limited period of time and not for direct or indirect economic or commercial advantage, when it is made through establishments which are accessible to the public;

               (c)

               ‘film’ means a cinematographic or audiovisual work or moving images, whether or not accompanied by sound.

         2.   The principal director of a cinematographic or audiovisual work shall be considered as its author or one of its authors. Member States may provide for others to be considered as its co-authors.
   Article 3
   Rightholders and subject matter of rental and lending right
   1.   The exclusive right to authorise or prohibit rental and lending shall belong to the following:

               (a)

               the author in respect of the original and copies of his work;

               (b)

               the performer in respect of fixations of his performance;

               (c)

               the phonogram producer in respect of his phonograms;

               (d)

               the producer of the first fixation of a film in respect of the original and copies of his film.

         2.   This Directive shall not cover rental and lending rights in relation to buildings and to works of applied art.
   3.   The rights referred to in paragraph 1 may be transferred, assigned or subject to the granting of contractual licences.
   4.   Without prejudice to paragraph 6, when a contract concerning film production is concluded, individually or collectively, by performers with a film producer, the performer covered by this contract shall be presumed, subject to contractual clauses to the contrary, to have transferred his rental right, subject to Article 5.
   5.   Member States may provide for a similar presumption as set out in paragraph 4 with respect to authors.
   6.   Member States may provide that the signing of a contract concluded between a performer and a film producer concerning the production of a film has the effect of authorising rental, provided that such contract provides for an equitable remuneration within the meaning of Article 5. Member States may also provide that this paragraph shall apply mutatis mutandis to the rights included in Chapter II.
   Article 4
   Rental of computer programs
   This Directive shall be without prejudice to Article 4(c) of Council Directive 91/250/EEC of 14 May 1991 on the legal protection of computer programs (5).
   Article 5
   Unwaivable right to equitable remuneration
   1.   Where an author or performer has transferred or assigned his rental right concerning a phonogram or an original or copy of a film to a phonogram or film producer, that author or performer shall retain the right to obtain an equitable remuneration for the rental.
   2.   The right to obtain an equitable remuneration for rental cannot be waived by authors or performers.
   3.   The administration of this right to obtain an equitable remuneration may be entrusted to collecting societies representing authors or performers.
   4.   Member States may regulate whether and to what extent administration by collecting societies of the right to obtain an equitable remuneration may be imposed, as well as the question from whom this remuneration may be claimed or collected.
   Article 6
   Derogation from the exclusive public lending right
   1.   Member States may derogate from the exclusive right provided for in Article 1 in respect of public lending, provided that at least authors obtain a remuneration for such lending. Member States shall be free to determine this remuneration taking account of their cultural promotion objectives.
   2.   Where Member States do not apply the exclusive lending right provided for in Article 1 as regards phonograms, films and computer programs, they shall introduce, at least for authors, a remuneration.
   3.   Member States may exempt certain categories of establishments from the payment of the remuneration referred to in paragraphs 1 and 2.
   CHAPTER II
   RIGHTS RELATED TO COPYRIGHT
   Article 7
   Fixation right
   1.   Member States shall provide for performers the exclusive right to authorise or prohibit the fixation of their performances.
   2.   Member States shall provide for broadcasting organisations the exclusive right to authorise or prohibit the fixation of their broadcasts, whether these broadcasts are transmitted by wire or over the air, including by cable or satellite.
   3.   A cable distributor shall not have the right provided for in paragraph 2 where it merely retransmits by cable the broadcasts of broadcasting organisations.
   Article 8
   Broadcasting and communication to the public
   1.   Member States shall provide for performers the exclusive right to authorise or prohibit the broadcasting by wireless means and the communication to the public of their performances, except where the performance is itself already a broadcast performance or is made from a fixation.
   2.   Member States shall provide a right in order to ensure that a single equitable remuneration is paid by the user, if a phonogram published for commercial purposes, or a reproduction of such phonogram, is used for broadcasting by wireless means or for any communication to the public, and to ensure that this remuneration is shared between the relevant performers and phonogram producers. Member States may, in the absence of agreement between the performers and phonogram producers, lay down the conditions as to the sharing of this remuneration between them.
   3.   Member States shall provide for broadcasting organisations the exclusive right to authorise or prohibit the rebroadcasting of their broadcasts by wireless means, as well as the communication to the public of their broadcasts if such communication is made in places accessible to the public against payment of an entrance fee.
   Article 9
   Distribution right
   1.   Member States shall provide the exclusive right to make available to the public, by sale or otherwise, the objects indicated in points (a) to (d), including copies thereof, hereinafter ‘the distribution right’:

               (a)

               for performers, in respect of fixations of their performances;

               (b)

               for phonogram producers, in respect of their phonograms;

               (c)

               for producers of the first fixations of films, in respect of the original and copies of their films;

               (d)

               for broadcasting organisations, in respect of fixations of their broadcasts as set out in Article 7(2).

         2.   The distribution right shall not be exhausted within the Community in respect of an object as referred to in paragraph 1, except where the first sale in the Community of that object is made by the rightholder or with his consent.
   3.   The distribution right shall be without prejudice to the specific provisions of Chapter I, in particular Article 1(2).
   4.   The distribution right may be transferred, assigned or subject to the granting of contractual licences.
   Article 10
   Limitations to rights
   1.   Member States may provide for limitations to the rights referred to in this Chapter in respect of:

               (a)

               private use;

               (b)

               use of short excerpts in connection with the reporting of current events;

               (c)

               ephemeral fixation by a broadcasting organisation by means of its own facilities and for its own broadcasts;

               (d)

               use solely for the purposes of teaching or scientific research.

         2.   Irrespective of paragraph 1, any Member State may provide for the same kinds of limitations with regard to the protection of performers, producers of phonograms, broadcasting organisations and of producers of the first fixations of films, as it provides for in connection with the protection of copyright in literary and artistic works.
   However, compulsory licences may be provided for only to the extent to which they are compatible with the Rome Convention.
   3.   The limitations referred to in paragraphs 1 and 2 shall be applied only in certain special cases which do not conflict with a normal exploitation of the subject matter and do not unreasonably prejudice the legitimate interests of the rightholder.
   CHAPTER III
   COMMON PROVISIONS
   Article 11
   Application in time
   1.   This Directive shall apply in respect of all copyright works, performances, phonograms, broadcasts and first fixations of films referred to in this Directive which were, on 1 July 1994, still protected by the legislation of the Member States in the field of copyright and related rights or which met the criteria for protection under this Directive on that date.
   2.   This Directive shall apply without prejudice to any acts of exploitation performed before 1 July 1994.
   3.   Member States may provide that the rightholders are deemed to have given their authorisation to the rental or lending of an object referred to in points (a) to (d) of Article 3(1) which is proven to have been made available to third parties for this purpose or to have been acquired before 1 July 1994.
   However, in particular where such an object is a digital recording, Member States may provide that rightholders shall have a right to obtain an adequate remuneration for the rental or lending of that object.
   4.   Member States need not apply the provisions of Article 2(2) to cinematographic or audiovisual works created before 1 July 1994.
   5.   This Directive shall, without prejudice to paragraph 3 and subject to paragraph 7, not affect any contracts concluded before 19 November 1992.
   6.   Member States may provide, subject to the provisions of paragraph 7, that when rightholders who acquire new rights under the national provisions adopted in implementation of this Directive have, before 1 July 1994, given their consent for exploitation, they shall be presumed to have transferred the new exclusive rights.
   7.   For contracts concluded before 1 July 1994, the unwaivable right to an equitable remuneration provided for in Article 5 shall apply only where authors or performers or those representing them have submitted a request to that effect before 1 January 1997. In the absence of agreement between rightholders concerning the level of remuneration, Member States may fix the level of equitable remuneration.
   Article 12
   Relation between copyright and related rights
   Protection of copyright-related rights under this Directive shall leave intact and shall in no way affect the protection of copyright.
   Article 13
   Communication
   Member States shall communicate to the Commission the main provisions of national law adopted in the field covered by this Directive.
   Article 14
   Repeal
   Directive 92/100/EEC is hereby repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives as set out in Part B of Annex I.
   References made to the repealed Directive shall be construed as being made to this Directive and should be read in accordance with the correlation table in Annex II.
   Article 15
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 16
   Addressees
   This Directive is addressed to the Member States.

      Done at Strasbourg, 12 December 2006.

            For the European Parliament

            The President

         J. BORRELL FONTELLES

            For the Council

            The President

         M. PEKKARINEN

      (1)  Opinion of the European Parliament delivered on 12 October 2006 (not yet published in the Official Journal).

      (2)  OJ L 346, 27.11.1992, p. 61. Directive as last amended by Directive 2001/29/EC of the European Parliament and of the Council (OJ L 167, 22.6.2001, p. 10).

      (3)  See Annex I, Part A.

      (4)  Joined Cases 60/84 and 61/84 [1985] ECR 2 605.

      (5)  OJ L 122, 17.5.1991, p. 42. Directive as amended by Directive 93/98/EEC (OJ L 290, 24.11.1993, p. 9).

      ANNEX I
      PART A
      Repealed Directive with its successive amendments

                  Council Directive 92/100/EEC
                  (OJ L 346, 27.11.1992, p. 61)

                  Council Directive 93/98/EEC
                  (OJ L 290, 24.11.1993, p. 9)

                  Article 11(2) only

                  Directive 2001/29/EC of the European Parliament and of the Council
                  (OJ L 167, 22.6.2001, p. 10)

                  Article 11(1) only

            PART B
      List of time-limits for transposition into national law

         (referred to in Article 14)

                  Directive

                  Time-limit for transposition

                  92/100/EEC

                  1 July 1994

                  93/98/EEC

                  30 June 1995

                  2001/29/EC

                  21 December 2002

      ANNEX II
      CORRELATION TABLE

                  Directive 92/100/EEC

                  This Directive

                  Article 1(1)

                  Article 1(1)

                  Article 1(2)

                  Article 2(1), introductory words and point (a)

                  Article 1(3)

                  Article 2(1), point (b)

                  Article 1(4)

                  Article 1(2)

                  Article 2(1), introductory words

                  Article 3(1), introductory words

                  Article 2(1), first indent

                  Article 3(1)(a)

                  Article 2(1), second indent

                  Article 3(1)(b)

                  Article 2(1), third indent

                  Article 3(1)(c)

                  Article 2(1), fourth indent, first sentence

                  Article 3(1)(d)

                  Article 2(1), fourth indent, second sentence

                  Article 2(1), point (c)

                  Article 2(2)

                  Article 2 (2)

                  Article 2(3)

                  Article 3(2)

                  Article 2(4)

                  Article 3(3)

                  Article 2(5)

                  Article 3(4)

                  Article 2(6)

                  Article 3(5)

                  Article 2(7)

                  Article 3(6)

                  Article 3

                  Article 4

                  Article 4

                  Article 5

                  Article 5(1) to (3)

                  Article 6(1) to (3)

                  Article 5(4)

                  —

                  Article 6

                  Article 7

                  Article 8

                  Article 8

                  Article 9(1), introductory words and final words

                  Article 9(1), introductory words

                  Article 9(1), first indent

                  Article 9(1)(a)

                  Article 9(1), second indent

                  Article 9(1)(b)

                  Article 9(1), third indent

                  Article 9(1)(c)

                  Article 9(1), fourth indent

                  Article 9(1)(d)

                  Article 9(2), (3) and (4)

                  Article 9(2), (3) and (4)

                  Article 10(1)

                  Article 10(1)

                  Article 10(2), first sentence

                  Article 10(2), first subparagraph

                  Article 10(2), second sentence

                  Article 10(2), second subparagraph

                  Article 10(3)

                  Article 10(3)

                  Article 13(1) and (2)

                  Article 11(1) and (2)

                  Article 13(3), first sentence

                  Article 11(3), first subparagraph

                  Article 13(3), second sentence

                  Article 11(3), second subparagraph

                  Article 13(4)

                  Article 11(4)

                  Article 13(5)

                  —

                  Article 13(6)

                  Article 11(5)

                  Article 13(7)

                  Article 11(6)

                  Article 13(8)

                  —

                  Article 13(9)

                  Article 11(7)

                  Article 14

                  Article 12

                  Article 15(1)

                  —

                  Article 15(2)

                  Article 13

                  —

                  Article 14

                  —

                  Article 15

                  Article 16

                  Article 16

                  —

                  Annex I

                  —

                  Annex II


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31998L0036

Commission Directive 98/36/EC of 2 June 1998 amending Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children (Text with EEA relevance)

Official Journal L 167 , 12/06/1998 P. 0023 - 0024

COMMISSION DIRECTIVE 98/36/EC of 2 June 1998 amending Directive 96/5/EC 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), as amended by Directive 96/84/EC of the European Parliament and of the Council (2), and in particular Article 4(1) thereof,After consulting the Scientific Committee for Food on the provisions liable to affect public health;Whereas the essential compositional criteria for processed cereal-based foods and baby foods are specified in Annexes I and II respectively to Commission Directive 96/5/EC (3);Whereas, because of the particular nutrient composition and chemical, physical and organoleptic properties of cheese, if products made of cheese and other ingredients were made to meet the protein requirements laid down in Annex II to Directive 96/5/EC, they would have too high a fat content and be unpalatable to infants and young children;Whereas therefore the protein requirement for those products should be redefined;Whereas the diverse culinary habits in the Community have resulted in the marketing of sauces used as accompaniment to a meal which are organoleptically important but not significant in nutrient contribution; whereas therefore these sauces should be exempt from the protein requirements in Annex II;Whereas maximum levels for some substances added for nutritional purposes are laid down in the Annexes to Directive 96/5/EC; whereas Article 5 of Directive 96/5/EC provides that maximum levels, in addition to those already stipulated, should be laid down where necessary;Whereas Directive 96/5/EC should be amended accordingly;Whereas the measures provided in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,HAS ADOPTED THIS DIRECTIVE:Article 1 The Annexes to Directive 96/5/EC are amended as shown in the Annex to this Directive.Article 2 Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 31 December 1998. 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 conforming to this Directive no later than 1 January 1999,- prohibit trade in products which do not comply with this Directive with effect from 1 January 2000.When Member States adopt these provisions, they shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.Article 3 This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities.Article 4 This Directive is addressed to the Member States.Done at Brussels, 2 June 1998.For the CommissionMartin BANGEMANNMember of the Commission(1) OJ L 186, 30. 6. 1989, p. 27.(2) OJ L 48, 19. 2. 1997, p. 20.(3) OJ L 49, 28. 2. 1996, p. 17.ANNEX The Annexes to the Directive 96/5/EC are amended as follows:1. In Annex II, section 1, the following shall be inserted:'1.3a. If cheese is mentioned together with other ingredients in the name of a savoury product, whether or not the product is presented as a meal, then:- the protein from the dairy 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).`'1.4a. Sauces presented as an accompaniment to a meal are exempt from the requirements of sections 1.1 to 1.4 inclusive.1.4b. Sweet dishes that mention dairy products as the first or only ingredient in the name shall contain not less than 2,2 g dairy protein/100 kcal. All other sweet dishes are exempt from the requirements in 1.1 to 1.4.`2. The following Annex VI is added:'ANNEX VIMaximum limits for vitamins, minerals and trace elements, if added, in processed cereal-based foods and baby foods intended for infants and young childrenThe requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer, except for potassium and calcium for which the requirements refer to the product as sold.>TABLE>