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31992L0039

Commission Directive 92/39/EEC of 14 May 1992 amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffs

Official Journal L 168 , 23/06/1992 P. 0021 - 0029 Finnish special edition: Chapter 13 Volume 23 P. 0067  Swedish special edition: Chapter 13 Volume 23 P. 0067

COMMISSION DIRECTIVE 92/39/EEC  of 14 May 1992  amending Directive 90/128/EEC relating to plastics materials and articles intended to come into contact with foodstuffsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular Article 3 thereof,  Whereas Commission Directive 90/128/EEC (2) of 23 February 1990, and in particular Article 3 (4), provides for the revision of Annex II and particularly section B;  Whereas, on the basis of the available information, certain substances provisionally admitted at national level may be included in the Community list, while others must be definitively prohibited;  Whereas certain substances provisionally admitted at national level may continue to be permitted for a further specified period since the data requested by the Scientific Committee for Food are not yet available but the required studies are ongoing or  are planned;  Whereas other substances have been requested for use following the adoption of the Directive, and the technical data supplied permit their inclusion in the Community list;  Whereas, for certain substances, the restrictions already set out should be amended according to the available information;  Whereas it is necessary to permit the continued use of certain well-defined substances contained in those groups of substances which are not well-defined and are now deleted, pending a decision on their inclusion in the Community list;  Whereas the Scientific Committee for Food has been consulted;  Whereas the measures laid down by this Directive comply with the opinion of the Standing Committee on Foodstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  Directive 90/128/EEC is hereby amended as follows:  1. Article 3 (4) is replaced by the following:  '4. As from 1 January 1997, only those monomers and other starting substances listed in Annex II, Section A, shall be used for the manufacture of plastic materials and articles, subject to the restrictions specified therein. However, the substances  listed in Annex II, Section B may be deleted before the abovementioned date if the data requested for inclusion in Section A are not supplied in time to permit their evaluation by the Scientific Committee for Food. Moreover, before 1 January 1996 it may  be decided that, in some justified cases, for certain substances listed in Annex II, Section B, this time-limit will be postponed.'  2. Annex II of Directive 90/128/EEC is amended as follows:  (a) Section A:  - the substances appearing in Annex I to this Directive are added;  - the content of the column 'Restrictions' for the substances appearing in Annex II of this Directive is modified as indicated therein.  (b) Section B:  - the substances appearing in Annex III to this Directive are added, as a replacement for those groups of substances which are not well-defined and which are deleted by this Directive;  - the substances appearing in Annex IV to this Directive are deleted;  - the content of the column 'Restrictions' for the substance appearing in Annex V to this Directive is modified as indicated therein.  (c) The substances appearing in Annex VI to this Directive are transferred from Section B to A and are now subject to the restrictions, if any, specified.  (d) Point 8 is hereby amended as follows:  - the following text is inserted after 'NCO = isocyanate moiety;'  'ND = not detectable.  For the purpose of this Directive "not detectable" means that the substance should not be detected by a validated method of analysis which should detect it at the detection limit (DL) specified.  If such a method does not currently exist, an analytical method with appropriate performance characteristics at the detection limit may be used, pending the development of a validated method.'  - the following text is inserted after 'SML = specific migration limit in food or in food stimulant, unless it is specified otherwise.'  'For the purpose of this Directive "SML" means that the specific migration of the substance should be determined by a validated method of analysis at the specified limit. If such a method does not currently exist, an analytical method with appropriate  performance characteristics at the specified limit may be used, pending the development of a validated method.'  Article 2  1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 1992. They shall immediately inform the Commission thereof.  Member States should:  - permit trade in and use of plastic materials and articles complying with this Directive by 31 March 1994;  - prohibit trade in and use of plastic materials and articles intended to come into contact with foodstuffs and which do not comply with this Directive with effect from 1 April 1995.  2. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 14 May 1992. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 40, 11. 2. 1989, p. 38. (2) OJ No L 75, 21. 3. 1990, p. 19, rectified by OJ No L 349, 13. 12. 1990, p. 26.    ANNEX I LIST OF MONOMERS AND OTHER STARTING SUBSTANCES ADDED TO SECTION A        PM/Ref No  CAS No  Name  Restrictions       (1)  (2)  (3)  (4)    12788  002432-99-7  11-Aminoundecanoic acid  SML = ND (DL = 0,01 mg/kg)  13530  038103-06-9  2,2-Bis(4-hydroxyphenyl)propane bis(phtalic anhydride)  SML = 0,05 mg/kg  13614  038103-06-9  Bisphenol A bis(phtalic anhydride)  See 13530  19470   000143-07-7  Lauric acid   22350  000544-63-8  Myristic acid   22763  000112-80-1  Oleic acid   24270  000069-72-7  Salicylic acid   24887  006362-79-4  5-Sulphoisophthalic acid, monosodium salt  SML = 0,05 mg/kg  25910  024800-44-0  Tripropyleneglycol          ANNEX II LIST OF MONOMERS AND OTHER STARTING SUBSTANCES IN SECTION A FOR WHICH THE CONTENT OF THE COLUMN 'RESTRICTIONS' IS MODIFIED        PM/Ref No  CAS No  Name  Restrictions       (1)  (2)  (3)  (4)    17005  000151-56-4  Ethyleneimine  SML = ND (DL = 0,01 mg/kg)  18670  000100-97-0  Hexamethylenetetramine  SML (T) = 15 mg/kg (expressed as formaldehyde)  22150  000691-37-2  4-Methyl-1-pentene  SML = 0,02 mg/kg        ANNEX III LIST OF MONOMERS AND OTHER STARTING SUBSTANCES ADDED TO SECTION B        PM/Ref No  CAS No  Name  Restrictions    (1)  (2)  (3)  (4)        10160  002206-94-2  alpha-Acetoxystyrene   10162  010521-96-7  beta-Acetoxystyrene   10599/70   Acids, fatty, unsaturated (C 18)   10599/90  061788-89-4  Acids, fatty, unsaturated (C18), dimers   10599/92  068783-41-5  Acids, fatty,  unsaturated (C18), dimers, hydrogenated   10775  084100-23-2  Acrylic acid, 4-tert-butylcyclohexyl ester   11000  050976-02-8  Acrylic acid, dicyclopentadienyl ester   11005  012542-30-2  Acrylic acid, dicyclopentenyl ester   11010  024447-78-7  Acrylic  acid, diester with 2,2-bis(4-hydroxyphenyl)propane bis(2-hydroxyethyl) ether   11180  017831-71-9  Acrylic acid, diester with tetraethyleneglycol   11195  068901-05-3  Acrylic acid, diester with tripropyleneglycol   11245  002156-97-0  Acrylic acid,  dodecyl ester   11520  002918-23-2  Acrylic acid, 2-hydroxyisopropyl ester (= acrylic acid, 2-hydroxy-1-methylethyl ester)   11532  002761-08-2  Acrylic acid, 3-hydroxypropyl ester   11695  003121-61-7  Acrylic acid, 2-methoxyethyl ester   11875   004813-57-4  Acrylic acid, octadecyl ester   12055  094160-26-6  Acrylic acid, triester with glycerol tris(2-hydroxypropyl) ether   12062  075577-70-7  Acrylic acid, triester with 1,1,1-trimethylolpropane tris (2-hydroxyethyl) ether   12265   004074-90-2  Adipic acid, divinyl ester   13328  000104-38-1  Bis(2-hydroxyethyl) ether of hydroquinone   13932  000598-32-3  3-Buten-2-ol   14008  000098-52-2  4-tert-Butylcyclohexanol   14035  001746-23-2  4-tert-Butylstyrene   14833  000623-43-8   Crotonic acid, methyl ester   15020  002182-05-0  Cyclohexyl vinyl ether   15030  000931-88-4  Cyclooctene   15060  000142-29-0  Cyclopentene   15095  000334-48-5  Decanoic acid   15260  000646-25-3  1,10-Diaminodecane   15270  002783-17-7   1,12-Diaminododecane   15295  000373-44-4  1,8-Diaminooctane   16252  000110-03-2  2,5-Dimethyl-2,5-hexanediol   16697  000693-23-2  Dodecanedioic acid   16719  003813-52-3  Endomethylenetetrahydrophthalic acid   17040  000149-57-5  2-Ethylhexanoic  acid   17116  005877-42-9  4-Ethyl-1-octyn-3-ol   17150  000078-27-3  1-Ethynylcyclohexanol   17305  000141-02-6  Fumaric acid, bis(2-ethylhexyl) ester   17398  007283-68-3  Fumaric acid, dioctadecyl ester   18436  001687-30-5  Hexahydrophthalic acid    18441  000085-42-7  Hexahydrophthalic anhydride   18865  003031-66-1  3-Hexyn-2,5-diol   18905  002628-17-3  4-Hydroxystyrene   19130  026896-18-4  Isononanoic acid   19490  000947-04-6  Laurolactam   19915  000925-21-3  Maleic acid, monobutyl ester    19936  007423-42-9  Maleic acid, mono(2-ethylhexyl) ester   20095  046729-07-1  Methacrylic acid, 4-tert-butylcyclohexyl ester   20455  006606-59-3  Methacrylic acid, diester with 1,6-hexanediol   20945  004664-49-7  Methacrylic acid,  2-hydroxyisopropyl ester (= methacrylic acid, 2-hydroxy-1-methylethyl ester)   20965  002761-09-3  Methacrylic acid, 3-hydroxypropyl ester   21115  000816-74-0  Methacrylic acid, methallyl ester   21170  000997-46-6  Methacrylic acid, monoester with  1,4-butanediol   21733  000115-19-5  2-Methyl-3-butyn-2-ol   21736  002549-61-3  alpha-Methyl-epsilon-caprolactone   21739  002549-60-2  beta-Methyl-epsilon-caprolactone   21742  002549-58-8  delta-Methyl-epsilon-caprolactone   21745  002549-59-9   epsilon-Methyl-epsilon-caprolactone   21748  002549-42-0  gamma-Methyl-epsilon-caprolactone   21837  001116-90-1  4-Methyl-1,4-hexadiene  SML = ND (DL = 0,05 mg/kg)  22428  051000-52-3  Neodecanoic acid, vinyl ester   22465  000112-05-0  Nonanoic acid    22585  003710-30-3  1,7-Octadiene   22811  000591-93-5  1,4-Pentadiene   22842  002590-16-1  Pentaerythritol diallyl ether   22858  005343-92-0  1,2-Pentanediol   22861  000111-29-5  1,5-Pentanediol   22901  000109-68-2  2-Pentene   22932  001187-93-5   Perfluoromethyl perfluorovinyl ether   22935  003823-94-7  Perfluoromethyl vinyl ether   22937  001623-05-8  Perfluoropropyl perfluorovinyl ether   22940  006996-01-6  Perfluoropropyl vinyl ether   24560  000111-63-7  Stearic acid, vinyl ester   25158   000088-98-2  1,2,3,6-Tetrahydrophalic acid   25161  000085-43-8  1,2,3,6-Tetrahydrophalic anhydride   25380   Trialkyl (C5-C15) acetic acid, vinyl ester (= vinyl versatate)   25645  000682-09-7  1,1,1-Trimethylolpropane diallyl ether         ANNEX IV LIST OF MONOMERS AND OTHER STARTING SUBSTANCES DELETED       PM/Ref No  CAS No  Name      (1)  (2)  (3)         10180  000556-08-1  p-(Acetylamino)benzoic acid  10240   Acids, aliphatic, dicarboxylic, esters with alcohols, aliphatic, monohydric  10270   Acids, aliphatic, dicarboxylic (C3-C12), esters  with alcohols, unsaturated (C3-C18)  10300   Acids, aliphatic, dicarboxylic, saturated (C4-C18)  10330   Acids, aliphatic, dicarboxylic, unsaturated (C4-C12)  10360   Acids, aliphatic, dicarboxylic, unsaturated, esters with polyethyleneglycol  10390    Acids, aliphatic, dicarboxylic, unsaturated, esters with polypropyleneglycol  10420   Acids, aliphatic, mono- and dicarboxylic (C2-C20), vinyl esters  10450   Acids, aliphatic, monocarboxylic (C3-C12), esters with alcohols, unsaturated (C3-C18)  10540    Acids, aliphatic, monocarboxylic, unsaturated (C3-C8), esters with alcohols, aliphatic, monohydric, saturated (C2-C12)  10570   Acids, aliphatic, monocarboxylic, unsaturated, esters with polypropyleneglycol  10870  002206-89-5  Acrylic acid,  2-chloroethyl ester  10900   Acrylic acid, cyclohexylaminoethyl ester  10960  016868-13-6  Acrylic acid, cyclopentyl ester  11290   Acrylic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21)  11320   Acrylic acid, esters with  alcohols, aliphatic, monohydric, unsaturated (C4-C18)  11350   Acrylic acid, esters with alcohols, aliphatic, polyhydric (C2-C21)  11380   Acrylic acid, esters with etheralcohols  11410   Acrylic acid, esters with glycolethers obtained from mono- and/or  digylcols with alcohols, aliphatic, monohydric (C1-C18)  11440  044992-01-0  Acrylic acid, ester with trimethylethanolammonium chloride  11920  005048-82-8  Acrylic acid, phenylaminoethyl ester  11950  000937-41-7  Acrylic acid, phenyl ester  12070   002177-18-6  Acrylic acid, vinyl ester  12400   Alcohols, aliphatic, monohydric, unsaturated (up to C18)  12430   Alcohols, aliphatic, polyhydric (up to C18)  12460   Alcohols, cycloaliphatic, mono- and/or polyhydric, substituted (up to C18)  12490    Aldehydes (C4)  12520   Alkadienes  12550   n-Alkenes (up to C16)  12580   p-Alkyl(C4-C9) phenols  12730  000060-32-2  6-Aminocaproic acid  12760   omega-Aminocarboxylic acids, alphatic, linear (C6-C12)  12880  000123-98-8  Azelaic acid dichloride   12940  004080-88-0  Azelaic acid, diphenyl ester  13030  000539-48-0  1,4-Benzenedimethanamine  13120  000769-78-8  Benzoic acid, vinyl ester  13180  000498-66-8  Bicyclo[2.2.1]hept-2-ene  13240  003377-24-0  2,2-Bis(4-aminocyclohexyl)propane  13300   038050-97-4  1,4-Bis(4,4"-dihydroxytriphenylmethyl)benzene  13330   Bis(2-hydroxyethyl) ether of hydroquinone and its condensation products with propylene oxide  13360  001620-68-4  2,6-Bis(2-hydroxy-5-methylbenzyl)-4-methylphenol  13420  000843-55-0   1,1-Bis(4-hydroxyphenyl)cyclohexane  13450  000125-13-3  3,3-Bis(4-hydroxyphenyl)-2-indolinone  13570  000141-07-1  1,3-Bis(methoxymethyl)urea  13930  006117-91-5  2-Buten-1-ol  13990  005153-77-5  N-(Butoxymethyl)methacrylamide  14050  000111-34-2   Butyl vinyl ether  14080  000926-02-3  tert-Butyl vinyl ether  14290   Caprolactone, substituted  14440  064147-40-6  Castor oil, dehydrated  14470  008001-78-3  Castor oil, hydrogenated  14590  000615-67-8  Chlorohydroquinone  14620  057981-99-4   Chlorohydroquinone diacetate  14830   Crotonic acid, esters with alcohols, mono- and polyhydric  14860   Cycloalkenes  14920  002842-38-8  2-(Cyclohexylamino)ethanol  15010  001131-60-8  p-Cyclohexylphenol  15040  000542-92-7  1,3-Cyclopentadiene   15160  000765-05-9  Decyl vinyl ether  15190   Diamines, aliphatic, linear (C2-C12)  15430  003749-77-7  4,4-Dicarboxydiphenoxybutane  15460  003753-05-7  4,4-Dicarboxydiphenoxyethane  15520  004919-48-6  4,4-Dicarboxydiphenyl sulphide  15550   002449-35-6  4,4-Dicarboxydiphenyl sulphone  15640  000156-59-2  cis-1,2-Dichloroethylene  15670  000156-60-5  trans-1,2-Dichloroethylene  16030  001965-09-9  4,4-Dihydroxydiphenyl ether  16060  002664-63-3  4,4-Dihydroxydiphenyl sulphide  16420   000123-91-1  Dioxane  16720  000826-62-0  Endomethylenetetrahydrophthalic anhydride  16810   Ether alcohols  16840   Ethers of N-methylolacrylamide  16870   Ethers of N-methylolmethacrylamide  16930  000075-00-3  Ethyl chloride  17080  000103-44-6   2-Ethylhexyl vinyl ether  17140  000109-92-2  Ethyl vinyl ether  17410   Fumaric acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18)  17440   Fumaric acid, esters with alcohols, aliphatic, monohydric, unsaturated (C3-C18)  17470    Fumaric acid, esters with alcohols, polyhydric  17500  000098-01-0  Furfural  17560   Glucosides obtained from glucose and 1,3-butanediol  17590   Glucosides obtained from glucose and 1,4-butanediol  17620   Glucosides obtained from glucose and  diethyleneglycol  17650   Glucosides obtained from glucose and 2,2-dimethyl-1,3-propanediol  17680   Glucosides obtained from glucose and ethyleneglycol  17710   Glucosides obtained from glucose and glycerol  17740   Glucosides obtained from glucose and  1,6-hexanediol  17770   Glucosides obtained from glucose and 1,2,6-hexanetriol  17890   Glucosides obtained from glucose and propanediol  17920   Glucosides obtained from glucose and sorbitol  17950   Glucosides obtained from glucose and sucrose  17980    Glucosides obtained from glucose and 1,1,1-trimethylolpropane  18040  029733-18-4  Glutaric acid, diisodecyl ester  18130  004371-64-6  1,1-Heptadecanedicarboxylic acid  18160  025339-56-4  Heptene  18190  000592-76-7  1-Heptene  18340  000822-28-6   Hexadecyl vinyl ether  18520  038775-37-0  Hexamethylenediamine azelate  18550   Hexamethylenediamine dodecanedicarboxylate  18580   Hexamethylenediamine heptadecanedicarboxylate  18730  002935-44-6  2,5-Hexanediol  18760  000106-69-4   1,2,6-Hexanetriol  18790  025264-93-1  Hexene  18910  000288-32-4  Imidazole  18940  000095-13-6  Indene  19240  000744-45-6  Isophthalic acid, diphenyl ester  19300  002155-60-4  Itaconic acid, dibutyl ester  19330  007748-43-8  Itaconic acid,  2,3-epoxypropyl diester  19360   Itaconic acid, 2,3-epoxypropyl monoester  19390   Itaconic acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C18)  19420   Itaconic acid, esters with alcohols, polyhydric  19450   Lactams of  omega-aminocarboxylic acids, aliphatic, linear (C7-C12)  19630  071550-61-3  Maleic acid, diester with 1,2-propanediol  19780  002915-53-9  Maleic acid, dioctyl ester  19810   Maleic acid, esters with alcohols, aliphatic, saturated (C1-C18)  19840    Maleic acid, esters with alcohols, polyhydric  19870   Maleic acid, ester with 1,3-butanediol  19900  002424-58-0  Maleic acid, monoallyl ester  19930   Maleic acid, monoesters with alcohols, aliphatic, monohydric, unsaturated (C3-C18)  20230    Methacrylic acid, cyclohexylaminoethyl ester  20290  016868-14-7  Methacrylic acid, cyclopentyl ester  20350   Methacrylic acid, (di-tert-butylamino)ethyl ester  20500  000105-16-8  Methacrylic acid, 2-(diethylamino)ethyl ester  20620   Methacrylic  acid, esters with alcohols, aliphatic, monohydric, saturated (C1-C21)  20650   Methacrylic acid, esters with alcohols, aliphatic, monohydric, unsaturated (C4-C18)  20680   Methacrylic acid, esters with alcohols, polyhydric (C2-C21)  20710   Methacrylic  acid, esters with etheralcohols  20770   Methacrylic acid, esters with glycolethers obtained from mono- and/or diglycols with alcohols, aliphatic, monohydric (C1-C18)  20800  024493-59-2  Methacrylic acid, ester with methoxytriethyleneglycol  20860    Methacrylic acid, ester with trimethylethanolammonium chloride  21160   Methacrylic acid, monoester with 1,3-butanediol  21310  003683-12-3  Methacrylic acid, phenylethyl ester  21580  003644-11-9  N-(Methoxymethyl)acrylamide  21610  003644-12-0   N-(Methoxymethyl)methacrylamide  21700  000513-35-9  2-Methyl-2-butene  21790  000110-26-9  Methylenebiscarylamide  21820  013093-19-1  Methylenebiscaprolactam  21910  000814-78-8  Methyl isopropenyl ketone  22000  001118-58-7  2-Methyl-1,3-pentadiene   22030  001115-08-8  3-Methyl-1,4-pentadiene  22060  000926-56-7  4-Methyl-1,3-pentadiene  22090  000763-29-1  2-Methyl-1-pentene  22120  000760-20-3  3-Methyl-1-pentene  22180  004461-48-7  4-Methyl-2-pentene  22300  000078-94-4  Methyl vinyl ketone   22330  001822-74-8  Methyl vinyl thioether  22510  027215-95-8  Nonene  22580  000930-02-9  Octadecyl vinyl ether  22630  025377-83-7  Octene (except 1-octene)  22750  000929-62-4  Octyl vinyl ether  22810  000504-60-9  1,3-Pentadiene  22930    Perfluoroalkyl(C1-C3)vinyl ethers  22990   Phenols, mono- and dihydric, alkoxylated or hydrogenated  23020  028994-41-4  alpha-Phenyl-o-cresol  23080  001079-21-6  Phenylhydroquinone  23110  058244-28-3  Phenylhydroquinone diacetate  23260   000088-95-9  o-Phthalic acid dichloride  23290   Phthalic acids, halogenated derivatives  23320   Phthalic acids, hydrogenated  23350   Phthalic acids, hydrogenated, substituted, endosubstituted, and their halogenated derivatives  23410   Phthalic  anhydride, hydrogenated  23440  000111-16-0  Pimelic acid  23560   Polyethers based on ethylene oxide, propylene oxide and/or tetrahydrofuran, containing free hydroxyl groups  23620   Polyols derived from phenols and bisphenols, hydrogenated and/or  condensed with epoxyalkanes and/or arylepoxyalkanes possibly halogenated, alkoxylated, aryloxylated  23680  009002-89-5  Polyvinylalcohols  23710  063148-65-2  Polyvinylbutyrals  24040  000764-47-6  Propyl vinyl ether  24220  009006-03-5  Rubber,  chlorinated  24310  000111-19-3  Sebacic acid, dichloride  24340  002432-89-5  Sebacic acid, didecyl ester  24400  002918-18-5  Sebacic acid, diphenyl ester  24640   Styrene, substituted by alkyl groups (alpha)  24670   Styrene, substituted in the  benzene ring  24700   Styrene, substituted by halogens (alpha or beta)  24730   Styrene, substituted in the vinyl group  24790  000505-48-6  Suberic acid  25000  001539-04-4  Terephthalic acid, diphenyl ester  25060  000632-58-6  Tetrachlorophthalic  acid  25330  000070-55-3  P-Toluenesulphonamide  25570  000067-48-1  Trimethylethanolammonium chloride  25660  019727-16-3  1,1,1-Trimethylolpropane dimethacrylate  25690   1,1,1-Trimethylolpropane maleates  25720  007024-08-0  1,1,1-Trimethylolpropane  monoacrylate  25750  007024-09-1  1,1,1-Trimethylolpropane monomethacrylate  25870  000107-39-1  2,4,4-Trimethyl-1-pentene  25990  000689-97-4  Vinylacetylene  26020  001484-13-5  N-Vinylcarbazole  26080   Vinyl ethers of alcohols, aliphatic,  monohydric, saturated (C2-C18)       ANNEX V LIST OF MONOMERS AND OTHER STARTING SUBSTANCES IN SECTION B FOR WHICH THE CONTENT OF THE COLUMN 'RESTRICTIONS' IS MODIFIED        PM/Ref No  CAS No  Name  Restrictions    (1)  (2)  (3)  (4)        26140  000075-38-7  Vinylidene fluoride  SML = ND (DL = 0,05 mg/kg)        ANNEX VI LIST OF MONOMERS AND OTHER STARTING SUBSTANCES TRANSFERRED TO SECTION A        PM/Ref No  CAS No  Name  Restrictions    (1)  (2)  (3)  (4)        10630  000079-06-1  Acrylamide  SML = ND (DL = 0,01 mg/kg)  12280  002035-75-8  Adipic anhydride   12670  002855-13-2  1-Amino-3-aminomethyl-3,5,5-trimethylcyclohexane  SML = 6 mg/kg  12970  004196-95-6  Azelaic anhydride   15250  000110-60-1   1,4-Diaminobutane   18070  000108-55-4  Glutaric anhydride   18250  000115-28-6  Hexachloroendomethylenetetrahydrophthalic acid  SML = ND (DL = 0,01 mg/kg)  18280  000115-27-5  Hexachloroendomethylenetetrahydrophthalic anhydride  SML = ND (DL = 0,01  mg/kg)  18430  000116-15-4  Hexafluoropropylene  SML = ND (DL = 0,01 mg/kg)  21190  000868-77-9  Methacrylic acid, monoester with ethyleneglycol   21940  000924-42-5  N-Methylolacrylamide  SML = ND (DL = 0,01 mg/kg)  23200  000088-99-3  o-Phthalic acid    23230  000131-17-9  Phthalic acid, diallyl ester  SML = ND (DL = 0,01 mg/kg)  24430  002561-88-8  Sebacic anhydride   24850  000108-30-5  Succinic anhydride


Avis juridique important

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31987L0019

Council Directive 87/19/EEC of 22 December 1986 amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco- toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products

Official Journal L 015 , 17/01/1987 P. 0031 - 0033 Finnish special edition: Chapter 13 Volume 16 P. 0088  Swedish special edition: Chapter 13 Volume 16 P. 0088

*****COUNCIL  DIRECTIVE  of 22 December 1986  amending Directive 75/318/EEC on the approximation of the laws of the Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products  (87/19/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 100 thereof,  Having regard to the proposal from the Commission (1),  Having regard to the opinion of the European Parliament (2),  Having regard to the opinion of the Economic and Social Committee (3),  Whereas the testing of proprietary medicinal products must regularly be adapted to scientific and technical progress in order to ensure optimum protection of public health in the Community;  Whereas, in order to achieve such optimum protection of health, the resources allocated to pharmaceutical research must not be squandered on obsolete or repetitive tests resulting from divergences between the Member States in assessing the state of the art in science and technology;  Whereas, for ethical reasons, it is necessary to replace existing methods as soon as scientific and technical advances so allow by methods involving as few laboratory animals as possible;  Whereas, it is therefore necessary to introduce a rapid procedure for adapting to technical progress the requirements regarding the testing of proprietary medicinal products listed in the Annex to Directive 75/318/EEC (4), as amended by Directive 83/570/EEC (5), whilst ensuring close cooperation between the Commission and the Member States within a 'Committee for the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medical Products Sector';  Whereas the requirements relating to the testing of medicinal products must also be capable of rapid revision by the same procedure, having regard to the evolution of test methods and of good laboratory practices recognized by the Community or in international trade in proprietary medicinal products,  HAS ADOPTED THIS DECISION:  Article 1  Directive 75/318/EEC is hereby amended as follows:  1. The following Articles 2a, 2b and 2c shall be inserted:  'Article 2a  Any changes which are necessary in order to adapt the Annex to take account of technical progress shall be adopted in accordance with the procedure laid down in Article 2c.  If appropriate, the Commission shall propose to the Council that the procedure in Article 2c be reviewed in connection with the detailed rules set for the exercise of the powers of implementation granted to the Commission.  Article 2b  1. A Committee on the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade in the Proprietary Medicinal Products Sector, hereinafter called "the Committee", is hereby set up; it shall consist of representatives of the Member States with a representative of the Commission as chairman.  2. The Committee shall adopt its own rules of procedure.  Article 2c  1. Where the procedure laid down in this Article is to be followed, matters shall be referred to the Committee by the chairman either on his own initiative or at the request of the representative of a Member State.  2. The representative of the Commission shall submit to the Committee a draft of the measures to be adopted. The Committee shall deliver its opinion on the draft within a time limit set by the chairman, having regard to the urgency of the matter. It shall act by a qualified majority, the votes of the Member States being weighted as provided in Article 148 (2) of the Treaty. The chairman shall not vote.  3. (a) The Commission shall adopt the measures envisaged where they are in accordance with the opinion of the Committee.  (b) Where the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is adopted, the Commission shall without delay propose to the Council the measures to be adopted. The Council shall act by a qualified majority.  (c) If, within three months of the proposal being submitted to it, the Council has not acted, the proposed measures shall be adopted by the Commission.';  2. Part 1 of the Annex, 'Physico-Chemical, Biological or Microbiological Tests of Proprietary Medicinal Products', shall be amended as follows:  (a) In (A), the following section shall be inserted:  '4. An explanation should be provided with regard to the choice of composition, constituents and container, supported by scientific data on development pharmaceutics. The overage, with justification thereof, should be stated.';  (b) In (B) the following fifth indent shall be inserted:  '- experimental studies validating the manufacturing process, where a non-standard method of manufacture is used or where it is critical for the product.';  (c) In (C) (2), subparagraph (b) shall be replaced by the following:  '(b) the description of the substance, set down in a form similar to that used in a descriptive item in the European Pharmacopoeia, shall be accompanied by any necessary explanatory evidence, especially concerning the molecular structure where appropriate; it must be accompanied by an appropriate description of the method of synthetic preparation. Where substances can only be described by their method of preparation, the description should be sufficiently detailed to characterize a substance which is constant both in its composition and in its effects;'  3. Part 2 of the Annex, 'Toxicological and Pharmacological Tests', is hereby amended as follows:  (a) The following paragraph shall be inserted after the introductory paragraph:  'Member States shall ensure that the safety tests are executed in conformity with the principles of good laboratory practice recognized by Community law in the field of tests on dangerous substances, or in the absence thereof, with those recommended by the Organization for Economic Cooperation and Development.';  (b) In Chapter 1 (B), the text of paragraph 1 shall be replaced by the following:  '1. Single dose toxicity  An acute test infers a qualitative and quantitative study of the toxic reactions which may result from a single administration of the active substance or substances contained in the proprietary medicinal product, in the proportions and physico-chemical state in which they are present in the actual product.  The acute toxicity test must be carried out in two or more mammalian species of known strain unless a single species can be justified. At least two different routes of administration shall normally be used, one being identical with or similar to that proposed for use in human beings and the other ensuring systemic absorption of the substance.  This study will cover the signs observed, including local reactions. The period during which the test animals are observed shall be fixed by the investigator as being adequate to reveal tissue or organ damage or recovery, usually for a period of 14 days but not less than seven days, but without exposing the animals to prolonged suffering. Animals dying during the observation period should be subject to autopsy as also should all animals surviving to the end of the observation period. Histopathological examinations should be considered on any organ showing macroscopic changes at autopsy. The maximum amount of information should be obtained from the animals used in the study. The single dose toxicity tests should be conducted in such a way that signs of acute toxicity are revealed and the mode of death assessed as far as reasonably possible. In suitable species a quantitative evaluation of the approximate lethal dose and information on the dose effect relationship should be obtained, but a high level of precision is not required.  These studies may give some indication of the likely effects of acute overdosage in man and may be useful for the design of toxicity studies requiring repeated dosing on the suitable animal species. In the case of active substances in combination, the study must be carried out in such a way as to check whether or not there is enhancement of toxicity or if novel toxic effects occur.'  Article 2  Member States shall take the measures necessary in order to comply with this Directive no later than 1 July 1987. They shall forthwith inform the Commission thereof.  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 22 December 1986.  For the Council  The President  G. SHAW  (1) OJ No C 293, 5. 11. 1984, p. 4.  (2) OJ No C 36, 17. 2. 1986, p. 152.  (3) OJ No C 160, 1. 7. 1985, p. 18.  (4) OJ No L 147, 9. 6. 1975, p. 1.  (5) OJ No L 332, 28. 11. 1983, p. 1.


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31980L0590

Commission Directive 80/590/EEC of 9 June 1980 determining the symbol that may accompany materials and articles intended to come into contact with foodstuffs

Official Journal L 151 , 19/06/1980 P. 0021 - 0022 Finnish special edition: Chapter 13 Volume 10 P. 0203  Greek special edition: Chapter 13 Volume 9 P. 0125  Swedish special edition: Chapter 13 Volume 10 P. 0203  Spanish special edition: Chapter 13 Volume 11 P. 0024  Portuguese special edition Chapter 13 Volume 11 P. 0024

COMMISSION DIRECTIVE  of 9 June 1980  determining the symbol that may accompany materials and articles intended to come into contact with foodstuffs  (80/590/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in particular the last indent of Article 7 (1) (a) thereof,  Whereas the last indent of Article 7 (1) (a) of Directive 76/893/EEC provides for the determination of a symbol that may accompany materials and articles instead of the particulars "for food use" or a specific indication as to the use of such materials and articles;  Whereas such symbol must be easy to understand ; whereas in addition it must be possible to reproduce it on materials and articles or on other media under the best possible technical conditions;  Whereas the symbol reproduced in the Annex hereto meets these criteria;  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 The symbol referred to in the last indent of Article 7 (1) (a) of Directive 76/893/EEC shall be that reproduced in the Annex hereto.   Article 2 The Member States shall take the measures necessary to authorize with effect from 1 January 1981 the use of the symbol referred to in Article 1.   Article 3 This Directive is addressed to the Member States.     Done at Brussels, 9 June 1980.  For the Commission  Étienne DAVIGNON  Member of the Commission  (1)OJ No L 340, 9.12.1976, p. 19.     BILAG - ANHANG - ANNEX - ANNEXE - ALLEGATO - BIJLAGE >PIC FILE= "T0013289">


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31973L0210

Council Directive of 24 July 1973 extending the time limits for implementation of the Directive of 17 April 1972 on the reform of agricultural structures

Official Journal L 207 , 28/07/1973 P. 0048 - 0048 Spanish special edition: Chapter 03 Volume 7 P. 0061  Portuguese special edition Chapter 03 Volume 7 P. 0061

COUNCIL DIRECTIVE  of 24 July 1973  extending the time limits for implementation of the Directive of 17 April 1972 on the reform of agricultural structures  (73/210/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;  Having regard to the Opinion of the European Parliament;  Whereas, under the terms of Article 25 of Council Directive of 17 April 1972 (1) on the modernization of farms, Article 17 of Council Directive of 17 April 1972 (2) concerning measures to encourage the cessation of farming and the reallocation of utilized agricultural areas for the purposes of structural improvement and Article 18 of Council Directive of 17 April 1972 (3) concerning the provision of socio-economic guidance for, and the acquisition of, occupational skills by persons engaged in agriculture, the Member States are to put into effect the measures necessary to comply with the Directives in question within one year following the date of notification thereof, and whereas this time limit expires on 20 April 1973;  Whereas it is necessary in view of the difficulties encountered by Member States in bringing into effect the provisions required for the implementation of the Directives aforesaid to extend the abovementioned time limit until 31 December 1973;  HAS ADOPTED THIS DIRECTIVE:    Article 1 Article 25 of Council Directive of 17 April 1972 on the modernization of farms, Article 17 of Council Directive of 17 April 1972 concerning measures to encourage the cessation of farming and the reallocation of utilized agricultural area for the purposes of structural improvement, and Article 18 of Council Directive of 17 April 1972 concerning the provision of socio-economic guidance for, and the acquisition of, occupational skills by persons engaged in agriculture, shall be replaced by the following:  "The Member States shall bring into force the measures necessary to comply herewith not later than 31 December 1973."   Article 2 This Directive is addressed to the Member States.     Done at Brussels, 24 July 1973.  For the Council  The President  I. NØRGAARD  (1)OJ No L 96, 23.4.1972, p. 1. (2)OJ No L 96, 23.4.1972, p. 9. (3)OJ No L 96, 23.4.1972, p. 15.


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31992L0004

Commission Directive 92/4/EEC of 10 February 1992 amending Council Directive 78/663/EEC laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs

Official Journal L 055 , 29/02/1992 P. 0096 - 0097 Finnish special edition: Chapter 13 Volume 22 P. 0004  Swedish special edition: Chapter 13 Volume 22 P. 0004

COMMISSION DIRECTIVE 92/4/EEC  of 10 February 1992  amending Council Directive 78/663/EEC laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffsTHE COMMISSION OF THE  EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), and in particular Article 3 (3)  thereof,  Whereas taking into account the specifications as adopted by the Codex Alimentarius and to take into account new production techniques, it is necessary to amend Council Directive 78/663/EEC (2), as last amended by Commission Directive 90/612/EEC (3);  Whereas, in pursuance of Article 6 of Directive 89/107/EEC, the Scientific Committee of Foodstuffs was consulted on the provisions likely to affect public health;  Whereas, the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The Annex to Directive 78/663/EEC is hereby amended as set out 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 by 1 June 1993, at the latest, and shall forthwith inform the Commission thereof.  When Member States adopt these provisions, these shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The procedure for such reference shall be laid down by Member States.  Article 3  This Directive is addressed to the Member States. Done at Brussels, 10 February 1992. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 40, 11. 2. 1989, p. 27. (2) OJ No L 223, 14. 8. 1978, p. 7. (3) OJ No L 326, 24. 11. 1990, p. 58.    ANNEX  The Annex to Directive 78/663/EEC is amended as follows:  Under E 473 - Sucrose esters:  (a) the final sentence in the item on the chemical description is replaced by the following sentence:  'No organic solvent other than dimethylsulphoxide, diméthylformamide, ethyl acetate, isopropanol, isobutanol and methylethylketon may be used in their preparation.'  (b) below the point concerning the isobutanol content, the following point is added:  'Methylethylketon content / not more than 10 mg/kg.'


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31992L0001

Commission Directive 92/1/EEC of 13 January 1992 on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumption

Official Journal L 034 , 11/02/1992 P. 0028 - 0029 Finnish special edition: Chapter 15 Volume 11 P. 0005  Swedish special edition: Chapter 15 Volume 11 P. 0005

COMMISSION DIRECTIVE 92/1/EEC  of 13 January 1992  on the monitoring of temperatures in the means of transport, warehousing and storage of quick-frozen foodstuffs intended for human consumptionTHE COMMISSION OF THE EUROPEAN COMMUNITIES,   Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 89/108/EEC of 21 December 1988 on the approximation of the laws of the Member States relating to quick-frozen foods intended for human consumption (1), and in particular Article 11 thereof,  Whereas the legal provisions must, in this case, be restricted solely to the requirements that are necessary in order to meet essential and imperative needs regarding the monitoring of temperatures in means of transport, warehousing and storage in such  a way as to ensure that the temperatures required by Article 5 of Directive 89/108/EEC are fully maintained;  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  This Directive concerns the monitoring of temperatures in the means of transport, warehousing and storage for quick-frozen foods.  Article 2  1. The means of transport, warehousing and storage must be fitted with suitable recording instruments to monitor, at frequent and regular intervals, the air temperatures to which quick-frozen foods intended for human consumption are  subjected.  In the case of transport, the measuring instruments must be approved by the competent authorities of the country in which means of transport is registered.  Temperature recordings obtained in this manner must be dated and stored by the operator for at least one year or longer according to the nature of food.  2. The air temperature during storage in retail display cabinets, and in the course of local distribution, shall be measured by at least one easily visible thermometer which, in the case of open retail display cabinets, shall indicate the temperature at  the air return side at the level of the clearly marked maximum load line.  3. Member States may permit a derogation from paragraph 1 in the case of cold chambers of less than 10 cubic metres for storing stock in retail outlets, so as to permit the air temperature to be measured by an easily visible thermometer.  Article 3  Member States shall bring into force the laws, regulations and administrative provisions needed in order to comply with this Directive by 31 July 1993, except for railways for which the date of implementation will be decided later.  They shall immediately inform the Commission thereof.  When Member States adopt these measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States.  Article 4  This Directive is addressed to the Member States. Done at Brussels, 13 January 1992. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 40, 11. 2. 1989, p. 34.


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31991L0071

Commission Directive 91/71/EEC of 16 January 1991 completing Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production

Official Journal L 042 , 15/02/1991 P. 0025 - 0026 Finnish special edition: Chapter 13 Volume 20 P. 0064  Swedish special edition: Chapter 13 Volume 20 P. 0064

COMMISSION DIRECTIVE  of 16 January 1991  completing Council Directive 88/388/EEC on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production  (91/71/EEC)  THE COMMISSION OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community,  Having regard to Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (1), and in particular Article 6 (4) thereof,   Whereas difference between the laws, regulations and administrative provisions of Member States on the labelling of flavourings intended for sale to the final consumer may impede the free circulation of these products and lead to unequal conditions of  competition;  Whereas the main objective of any provisions on the labelling of flavourings should be the need to inform and protect the consumer;  Whereas in accordance with the procedure laid down in Article 10 of Council Directive 88/388/EEC, a draft of the measures to be taken was submitted to the Standing Committee for Foodstuffs which was unable to express an opinion; whereas under the same  procedure, the Commission consequently submitted to the Council a proposal relating to the measures to be taken;  Whereas since the Council had not adopted any measures by the end of the three months it was given, the Commission must adopt the proposed measure,  HAS ADOPTED THIS DIRECTIVE:    Article 1  The following Article shall be added:  'Article 9a  1. Flavourings intended for sale to the final consumer may not be marketed unless their labels indicate the following obligatory information, which should be easily visible, clearly legible and indelible:  (a) either the word "flavouring" or a more specific name or description of the flavouring;  (b) either the words "for foodstuffs" or a more specific reference to the foodstuff for which the flavouring is intended;  (c) the date of minimum durability in conformity with Article 3 (1) No 4 and Article 9 of Council Directive 79/112/EEC (*);  (d) where necessary, the special conditions for storage and use;  (e) the instructions for use if omission thereof would prevent appropriate use of the flavouring;  (f) the net quantity expressed in units of mass or volume;  (g) the name or business name and address of the manufacturer or packer, or of a seller established within the Community;  (h) an indication or mark indentifying the batch in conformity with Council Directive 89/396/EEC (**);  (i) in the case of a mixture of flavouring(s) with other substances a list in descending order of weight in the mixture of:  - the flavouring or flavourings in question, in conformity with (a) above;  - the names of each of the other substances or materials or, where appropriate, their E numbers.  2. the word 'natural', or any other word having substantially the same meaning, may be used only for flavourings in which the flavouring component contains exclusively flavouring substances as defined in Article 1 (2) (b) (i) and/or flavouring  preparations as defined in Article 1 (2) (c). If the sales description of the flavourings contains a reference to a foodstuff or a flavouring source, the word 'natural' or any other word having substantially the same meaning, may not be used unless the  flavouring component has been isolated by appropriate physical processes, enzymatic or microbiological processes or traditional food-preparation processes solely or almost solely from the foodstuff or the flavouring source concerned.  3. The particulars required in this Article shall be given in a language easily understood by the purchaser unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such particulars from being  indicated in various languages.   (*) OJ No L 33, 8. 2. 1979, p. 1.  (**) OJ No L 186, 30. 6. 1989, p. 21.'  Article 2  1. Member States shall, where necessary, amend their laws, regulations and administrative provisions in such a way as to:  - permit trade in products complying with this Directive at the latest by 30 June 1992;  - prohibit trade in products not complying with this Directive with effect from1 January 1994.  They shall forthwith inform the Commission thereof.  2. All such provisions adopted by the Member States shall contain a reference to this Directive or shall be accompanied by such a reference at the time of official publication. The detailed rules on this reference shall be adopted by the Member States.  Article 3  This Directive is addressed to the Member States.   Done at Brussels, 16 January 1991. For the Commission  Martin BANGEMANN  Vice-President   (1) OJ No L 184, 15. 7. 1988, p. 61.


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31993L0010

Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs

Official Journal L 093 , 17/04/1993 P. 0027 - 0036 Finnish special edition: Chapter 13 Volume 24 P. 0027  Swedish special edition: Chapter 13 Volume 24 P. 0027

COMMISSION DIRECTIVE 93/10/EEC of 15 March 1993 relating to materials and articles made of  regenerated cellulose film intended to come into contact with foodstuffsTHE  COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Economic Community, Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws  of the Member States relating to materials and articles intended to come into contact with  foodstuffs  (1), and in particular Article 3 thereof, After consulting the Scientific Committee for Food, Whereas the number and nature of the changes that have had to be made and should now be made to  Council Directive 83/229/EEC of 25 April 1993 on the approximation of the laws of the Member States  relating to materials and articles made of regenerated cellulose film intended to come into contact  with foodstuffs  (2), as last amended by Commission Directive 92/15/EEC  (3), indicate the need for  the said Directive to be replaced; Whereas the Community measures envisaged by this Directive are not only necessary but also  indispensable for the attainment of the objectives of the internal market; whereas these objectives  cannot be achieved by Member States individually; whereas, furthermore, their attainment at  Community level is already provided for by Directive 89/109/EEC; Whereas Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished  state, must not transfer their constituents to foodstuffs in quantities which could endanger human  health or bring about an unacceptable change in the composition of the foodstuffs; Whereas, in order to achieve this objective in the case of regenerated cellulose film, the suitable  instrument is a specific directive within the meaning of Article 3 of Directive 89/109/EEC; Whereas synthetic casings of regenerated cellulose should be the subject of specific provisions; Whereas the method for determining the absence of migration of colouring matters should be  established at a later stage; Whereas, until criteria of purity and methods of analysis have been drawn up, national provisions  should remain in force; Whereas the establishment of a list of approved substances, accompanied by limits to the quantities  to be used, is sufficient in principle in this specific case to achieve the objective laid down in  Article 2 of Directive 89/109/EEC; Whereas, however, the bis(2-hydroxyethyl)ether (=  diethyleneglycol) and ethanediol (=   monoethyleneglycol), can migrate extensively to certain foodstuffs and therefore in order to avoid  this possibility, as a preventive measure, it is more appropriate to lay down definitively the  maximum authorized quantity of such substances in foodstuffs which have been in contact with  regenerated cellulose film; Whereas, to protect the health of the consumer, direct contact between foodstuffs and the printed  surfaces of regenerated cellulose film should be avoided; Whereas the written declaration referred to in Article 6 (5) of Directive 89/109/EEC should be provided for in the event of professional use of regenerated  cellulose film for materials and articles intended to come into contact with foodstuffs, except  those which are, by their nature, intended for this use; 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 3 of Directive 89/109/EEC. 2.  This Directive shall apply to regenerated cellulose film within the meaning of the description  given in Annex I which either: (a)  constitutes a finished product in itself; or (b)  forms part of a finished product containing other materials, and which is intended to come into contact with foodstuffs or which, by virtue of its purpose, does  come into such contact. 3.  This Directive does not apply to: (a)  regenerated cellulose film which, on the side intended to come into contact with foodstuffs or  which, by virtue of its purpose does come into such contact, has a coating exceeding 50 mg/dm2; (b)  synthetic casings of regenerated cellulose. Article 2 1.  Only those substances or groups of substances listed in Annex II may be used for  the manufacture of regenerated cellulose film and only under the conditions laid down therein. 2.  By way of derogation from paragraph 1, substances other than those listed in Annex II may be  used when these substances are employed as colouring matter (dyes and pigments) or as adhesives,  provided that there is no trace of migration of the substances into or onto foodstuffs, detectable  by a validated method. Article 3 Printed surfaces of regenerated cellulose film shall not come into contact with the  foodstuffs. Article 4 1.  At the marketing stages other than the retail stages, materials and articles made  of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by  a written declaration in accordance with Article 6 (5) of Directive 89/109/EEC. 2.  Paragraph 1 does not apply to materials and articles made of regenerated cellulose film which  by their nature are clearly intended to come into contact with foodstuffs. 3.  Where special conditions of use are indicated, the material or article made of regenerated  cellulose film shall be labelled accordingly. Article 5 1.  Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive as from 1 January 1994. They shall immediately  inform the Commission thereof. Member States shall: -  permit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is  intended to come into contact with foodstuffs complying with this Directive, -  prohibit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is  intended to come into contact with foodstuffs and which complies with neither this Directive nor  Directive 83/229/EEC, -  prohibit, as from 1 January 1995, the trade in and use of regenerated cellulose film which is  intended to come into contact with foodstuffs and which does not comply with this Directive but did  comply with Directive 83/229/EEC. 2.  When Member States adopt the measures referred to in paragraph 1, these shall contain a  reference to this Directive or shall be accompanied by such reference at the time of their official  publication. The procedure for such reference shall be adopted by Member States. Article 6 1.  Directive 83/229/EEC is hereby repealed as from 1 January 1994. 2.  References to Directive 83/229/EEC shall be construed as references to this Directive and  should be read in accordance with the correlation table appearing in Annex III. Article 7 This Directive is addressed to the Member States. Done at Brussels, 15 March 1993. For the Commission Martin BANGEMANN Member of the Commission  ANNEX I DESCRIPTION OF REGENERATED CELLULOSE FILM Regenerated cellulose film is a thin  sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet  technical requirements, suitable substances may be added either in the mass or on the surface.  Regenerated cellulose film may be coated on one or both sides.  ANNEX II LIST OF SUBSTANCES AUTHORIZED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM  NB -  The percentages in this Annex, first and second parts, are expressed in weight/weight (w/w) and  are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film. -  The usual technical denominations are given in square brackets. -  The substances used shall be of good technical quality as regards the purity criteria. FIRST PART UNCOATED REGENERATED CELLULOSE FILM >TABLE>SECOND PART COATED  REGENERATED CELLULOSE FILM >TABLE> ANNEX III CORRELATION TABLE >TABLE>


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31990L0496

Council Directive 90/496/EEC of 24 September 1990 on nutrition labelling for foodstuffs

Official Journal L 276 , 06/10/1990 P. 0040 - 0044 Finnish special edition: Chapter 15 Volume 10 P. 0007  Swedish special edition: Chapter 15 Volume 10 P. 0007

*****COUNCIL  DIRECTIVEof 24 September 1990on nutrition labelling for foodstuffs(90/496/EEC)THE COUNCIL OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,Having regard to the proposal from the Commission (1),In cooperation with the European Parliament (2),Having regard to the opinion of the Economic and Social Committee (3),Whereas it is important that measures should be adopted with a view to the progressive establishment of the internal market by 31 December 1992; whereas the internal market is an area without internal frontiers in which freedom of movement is ensured for goods, persons, services and capital;Whereas there is growing public interest in the relationship between diet and health and in the choice of an appropriate diet to suit individual needs;Whereas the Council and the Representatives of the Governments of the Member States meeting within the Council, in their resolution of 7 July 1986 on the European programme against cancer, considered the improvement of nutrition to be a priority;Whereas knowledge of the basic principles of nutrition and appropriate nutrition labelling of foodstuffs would contribute significantly towards enabling the consumer to make this choice;Whereas the provision of nutrition labelling should assist action in the area of nutrition education for the public;Whereas, for the benefit of the consumer on the one hand, and to avoid any possible technical barriers to trade on the other, nutrition labelling should be presented in a standardized form applying throughout the Community;Whereas foodstuffs bearing nutrition labelling should conform to the rules laid down in this Directive;Whereas all other forms of nutrition labelling should be prohibited but foodstuffs bearing no nutrition labelling should be able to circulate freely;Whereas, to appeal to the average consumer and to serve the purpose for which it is introduced, and given the current low level of knowledge on the subject of nutrition, the information provided should be simple and easily understood;Whereas application of this Directive for a certain length of time will enable valuable experience on the subject to be gained and consumer reaction to the way in which nutrition information is presented to be evaluated thus enabling the Commission to review the rules and propose any appropriate amendments;Whereas in order to encourage interested parties, especially small and medium-sized undertakings, to provide nutrition labelling for as many products as possible, measures to make information more complete and more balanced should be introduced gradually;Whereas the rules laid down in this Directive should also take into account the Codex Altimentarius guidelines on nutrition labelling;Whereas general labelling provisions and definitions are contained in 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 (4), as last amended by Directive 89/395/EEC (5); whereas this Directive can therefore be confined to those provisions pertaining to nutrition labelling,HAS ADOPTED THIS DIRECTIVE:Article 11. This Directive concerns nutrition labelling of foodstuffs to be delivered as such to the ultimate consumer. It shall also apply to foodstuffs intended for supply to restaurants, hospitals, canteens and other similar mass caterers (hereinafter referred to as 'mass caterers').2. This Directive shall not apply to:- natural mineral waters or other waters intended for human consumption,- diet integrators/food supplements.3. This Directive shall apply without prejudice to the labelling provisions of 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 (3) and specific Directives as referred to in Article 4 of that Directive.4. For the purposes of this Directive:(a) 'nutrition labelling' means any information appearing on labelling and relating to:(i) energy value;(ii) the following nutrients:- protein,- carbohydrate,- fat,- fibre,- sodium,- vitamins and minerals listed in the Annex and present in significant amounts as defined in that Annex.Changes to the list of vitamins, minerals and their recommended daily allowances shall be adopted in accordance with the procedure laid down in Article 10;(b) 'nutrition claim' means any representation and any advertising message which states, suggests or implies that a foodstuff has particular nutrition properties due to the energy (calorific value) it- provides,- provides at a reduced or increased rate or- does not provide,and/or due to the nutrients it- contains,- contains in reduced or increased proportions or- does not contain.A reference to qualities or quantities of a nutrient does not constitute a nutrition claim in so far as it is required by legislation.In accordance with the procedure laid down in Article 10, it may be decided in certain cases whether the conditions described in this point are satisfied;(c) 'protein' means the protein content calculated using the formula: protein = total Kjeldahl nitrogen × 6,25;(d) 'carbohydrate' means any carbohydrate which is metabolized in man, and includes polyols;(e) 'sugars' means all monosaccharides and disaccharides present in food, but excludes polyols;(f) 'fat' means total lipids, and includes phospholipids;(g) 'saturates' means fatty acids without double bond;(h) 'mono-unsaturates' means fatty acids with one cis double bond;(i) 'polyunsaturates' means fatty acids with cis, cis-methylene interrupted double bonds;(j) 'fibre' means the material to be defined in accordance with the procedure laid down in Article 10 and measured by the method of analysis to be determined in accordance with that procedure;(k) 'average value' means the value which best represents the amount of the nutrient which a given food contains, and reflects allowances for seasonal variability, patterns of consumption and other factors which may cause the actual value to vary.Article 21. Subject to paragraph 2, nutrition labelling shall be optional.2. Where a nutrition claim appears on labelling, in presentation or in advertising, with the exclusion of generic advertising, nutrition labelling shall be compulsory.Article 3The only nutrition claims permitted shall be those relating to energy, to the nutrients listed in Article 1 (4) (a) (ii) and to substances which belong to or which are components of a category of those nutrients. Provisions restricting or prohibiting nutrition claims within the meaning of this Article may be adopted by the procedure laid down in Article 10.Article 41. Where nutrition labelling is provided, the information to be given shall consist of either group 1 or group 2 in the following order:Group 1(a) energy value;(b) the amounts of protein, carbohydrate and fat.Group 2(a) energy value;(b) the amounts of protein, carbohydrate, sugars, fat, saturates, fibre and sodium.2. Where a nutrition claim is made for sugars, saturates, fibre or sodium, the information to be given shall consist of group 2.3. Nutrition labelling may also include the amounts of one or more of the following:- starch,- polyols,- mono-unsaturates,- polyunsaturates,- cholesterol,- any of the minerals or vitamins listed in the Annex and present in significant amounts as defined in that Annex.4. The declaration of substances which belong to or are components of one of the categories of nutrients referred to in paragraphs 1 and 3 shall be compulsory where a nutrition claim is made.In addition, where the amount of polyunsaturates and/or mono-unsaturates and/or the cholesterol rate is given, the amount of saturates shall also be given, the declaration of the latter not constituting - in this case - a nutrition claim within the meaning of paragraph 2.Article 51. The energy value to be declared shall be calculated using the following conversion factors:- carbohydrate (except polyols) 4 kcal/g - 17 kJ/g- polyols 2,4 kcal/g - 10 kJ/g- protein 4 kcal/g - 17 kJ/g- fat 9 kcal/g - 37 kJ/g- alcohol (ethanol) 7 kcal/g - 29 kJ/g- organic acid 3 kcal/g - 13 kJ/g2. Provisions concerning the following points shall be adopted in accordance with the procedure laid down in Article 10:- amendments to the conversion factors mentioned in paragraph 1,- the addition to the list in paragraph 1 of substances which belong to or are components of one of the categories of nutrients referred to in that paragraph and their conversion factors in order to calculate more precisely the energy value of foodstuffs.Article 61. The declaration of the energy value and of the proportion of nutrients or their components shall be numerical. The units to be used are the following:1.2 // - energy - kJ and kcal   //   // - protein   //   // - carbohydrate   //   // - fat   // grams (g)   // - fibre   //  // - sodium   //   // - cholesterol   // milligrams (mg)  // - vitamins and minerals   // the units specified in the Annex2. Information shall be expressed per 100 g or per 100 ml. In addition, this information may be given per serving as quantified on the label or per portion, provided that the number of portions contained in the package is stated.3. In accordance with the procedure laid down in Article 10 it may be decided that the information in paragraphs 1 and 2 may also be given in graphical form according to formats to be determined.4. The amounts mentioned shall be those of the food as sold. Where appropriate, this information may relate to the foodstuff after preparation, provided that sufficiently detailed preparation instructions are given and the information relates to the food as prepared for consumption.5. (a) Information on vitamins and minerals must also be expressed as a percentage of the recommended daily allowance (RDA) given in the Annex for the amounts as specified in paragraph 2.(b) The percentage of the recommended daily allowance (RDA) for vitamins and minerals may also be given in graphical form. Rules for implementing this subparagraph may be adopted in accordance with the procedure laid down in Article 10.6. Where sugars and/or polyols and/or starch are declared, this declaration shall immediately follow the declaration of the carbohydrate content in the following manner:1.2 // - carbohydrate   // g   // of which:   //   // - sugars   // g   // - polyols   // g   // - starch   // g7. Where the amount and/or type of fatty acid and/or the cholesterol rate is declared, this declaration shall immediately follow the declaration of total fats in the following manner:1.2 // - fat   // g   // of which:   //   // - saturates  // g   // - mono-unsaturates   // g   // - polyunsaturates  // g   // - cholesterol   // mg8. The declared values shall, according to the individual case, be average values based on:(a) the manufacturer's analysis of the food;(b) a calculation from the known or actual average values of the ingredients used; (c) a calculation from generally established and accepted data.The rules for implementing the first paragraph with regard in particular to the differences between the declared values and those established in the course of official checks shall be decided upon in accordance with the procedure laid down in Article 10.Article 71. The information covered by this Directive must be presented together in one place in tabular form, with the numbers aligned if space permits. Where space does not permit, the information shall be presented in linear form.It shall be printed in legible and indelible characters in a conspicuous place.2. Member States shall ensure that the information covered by this Directive appears in a language easily understood by purchasers, unless other measures have been taken to ensure that the purchaser is informed. This provision shall not prevent such information from being indicated in more than one language.3. Member States shall refrain from laying down requirements more detailed than those already contained in this Directive concerning nutrition labelling.Article 8In the case of non-prepackaged foodstuffs put up for sale to the ultimate consumer or to mass caterers and foodstuffs packed at the point of sale at the request of the purchaser or prepackaged with a view to immediate sale, the extent of the information referred to in Article 4 and the manner of its communication may be determined by national provisions until the eventual adoption of Community measures in accordance with the procedure laid down in Article 10.Article 9Any measures likely to have an effect on public health shall be adopted after consultation of the Scientific Committee for Food set up by Decision 74/234/EEC (1).Article 101. Where the procedure laid down in this Article is to be followed, the matter shall be referred to the Standing Committee for Foodstuffs set up by Decision 69/414/EEC (2) (hereinafter referred to as 'the Committee') by its chairman, either on his own initiative or at the request of the representative of a Member State.2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The chairman shall not vote.3. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.(b) Where the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.(c) If, on expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.Article 111. Member States shall take the measures necessary to comply with this Directive and shall forthwith inform the Commission thereof. Those measures shall be applied in such a way as to:- permit trade in products complying with this Directive by 1 April 1992,- prohibit trade in products which do not comply with this Directive with effect from 1 October 1993.2. Until . . . . (five years following notification of this Directive), the declaration in nutrition labelling, either on a voluntary basis or following a nutrition claim, of one or more of the following nutrients; sugars, saturates, fibre, sodium, shall not trigger the obligation set out in Article 4 (1) and (2) to declare all these nutrients.3. The Commission shall, by . . . . (eight years after notification of this Directive), submit to the European Parliament and the Council a report on the application ofthis Directive. At the same time, it shall submit to the Council any appropriate proposals for amendment.Article 12This Directive is addressed to the Member States.Done at Brussels, 24 September 1990.For the CouncilThe PresidentV. SACCOMANDI(1) OJ No C 282, 5. 11. 1988, p. 8 and OJ No C 296, 24. 11. 1989, p. 3.(2) OJ No C 158, 26. 6. 1989, p. 250 and OJ No C 175, 16. 7. 1990, p. 76.(3) OJ No C 159, 26. 6. 1989, p. 41.(4) OJ No L 33, 8. 2. 1979, p. 1.(5) OJ No L 186, 30. 6. 1989, p. 17.(1) OJ No L 186, 30. 6. 1989, p. 27.(1) OJ No L 136, 20. 5. 1974, p. 1.(2) OJ No L 291, 19. 11. 1969, p. 9.ANNEXVitamins and minerals which may be declared and their recommended daily allowances (RDAs)Vitamin A µg 800 Vitamin D µg 5 Vitamin E mg 10 Vitamin C mg 60 Thiamin mg 1,4 Riboflavin mg 1,6 Niacin mg 18 Vitamin B6 mg 2 Folacin µg 200 Vitamin B12 µg 1 Biotin mg 0,15 Pantothenic acid mg 6 Calcium mg 800 Phosphorus mg 800 Iron mg 14 Magnesium mg 300 Zinc mg 15 Iodine µg 150 As a rule, 15 % of the recommended allowance specified in ths Annex supplied by 100 g or 100 ml or per package if the package contains only a single portion should be taken into consideration in deciding what constitutes a significant amount.


title: Commission Directive 2012/14/EU of 8 May 2012 amending Directive 98/8/EC of the European Parliament and of the Council to include methyl nonyl ketone as an active substance in Annex I thereto  Text with EEA relevance

text:
               9.5.2012

               EN

               Official Journal of the European Union

               L 123/36

         COMMISSION DIRECTIVE 2012/14/EU
   of 8 May 2012
   amending Directive 98/8/EC of the European Parliament and of the Council to include methyl nonyl ketone as an active substance in Annex I thereto
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
   Whereas:

               (1)

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

               (2)

               Pursuant to Regulation (EC) No 1451/2007, methyl nonyl ketone has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 19, repellents and attractants, as defined in Annex V to that Directive.

               (3)

               Spain was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 8 April 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

               (4)

               The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 9 December 2011, in an assessment report.

               (5)

               It appears from the evaluations that biocidal products used as repellents and containing methyl nonyl ketone may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include methyl nonyl ketone in Annex I to that Directive.

               (6)

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

               (7)

               The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance methyl nonyl ketone and also to facilitate the proper operation of the biocidal products market in general.

               (8)

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

               (9)

               After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

               (10)

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

               (11)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 30 April 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
   They shall apply those provisions from 1 May 2014.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 8 May 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 123, 24.4.1998, p. 1.

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

      ANNEX
      In Annex I to Directive 98/8/EC, the following entry is added:

                     No

                     Common Name

                     IUPAC Name
                     Identification Numbers

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

                     Date of inclusion

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

                     Expiry date of inclusion

                     Product type

                     Specific provisions (1)

                     ‘54

                     methyl nonyl ketone

                     Undecan-2-one
                     CAS No: 112-12-9
                     EC No: 203-937-5

                     975 g/kg

                     1 May 2014

                     30 April 2016

                     30 April 2024

                     19

                     The Union level risk assessment was based on indoor use by non-professional users. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment.’

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


Avis juridique important

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31986L0566

Council Directive 86/566/EEC of 17 November 1986 amending the First Directive of 11 May 1960 for the implementation of Article 67 of the Treaty

Official Journal L 332 , 26/11/1986 P. 0022

*****COUNCIL  DIRECTIVE  of 17 November 1986  amending the First Directive of 11 May 1960 for the implementation of Article 67 of the Treaty  (86/566/EEC)  THE COUNCIL OF THE EUROPEAN COMMUNITIES,  Having regard to the Treaty establishing the European Economic Community, and in particular Article 69 thereof,  Having regard to the proposal from the Commission, submitted after consultation of the Monetary Committee (1),  Having regard to the opinion of the European Parliament (2),  Whereas the Directive of 11 May 1960 (3), as last amended by Directive 85/583/EEC (4), laid down the Member States' obligations in respect of the liberalization of capital movements; whereas the degree of liberalization differs according to the categories of capital movements in question;  Whereas if the objectives of the Treaty and, in particular, completion of the internal market and the Community's greater financial integration are to be attained, gradual progress must be made towards the liberalization of capital movements; whereas it is important that such progress be made jointly with that made towards the increased convergence of the economic policies of the Member States, greater monetary stability and the development of the European Monetary System (EMS);  Whereas the reclassification of the operations on List B of Annex I to the Directive of 11 May 1960 so that the liberalization rules applying to operations on List A of the same Annex apply to them also must not make the procedures for granting the requisite authorizations more difficult for such operations;  Whereas the Kingdom of Spain and the Portuguese Republic may, under the terms of Articles 61 to 66 and 222 to 232 respectively of the 1985 Act of Accession, postpone the liberalization of certain capital movements in derogation from the obligations of the Directive of 11 May 1960; whereas those two Member States should be able to postpone the application of the new liberalization obligations resulting from this Directive for periods similar to those laid down in the Act of Accession and for the same economic reasons,  HAS ADOPTED THIS DIRECTIVE:  Article 1  The Directive of 11 May 1960 is hereby amended as follows:  1. Article 2 is hereby repealed.  2. In Article 3 (1), 'List C of Annex I' is replaced by 'List B of Annex I'.  3. Article 5 (2) is replaced by the following:  '2. The Member States shall undertake not to render more difficult the autorization procedures required on the date of entry into force of this Directive. They shall simplify as far as possible the authorization and control formalities applicable to the conclusion and performance of transactions and transfers and shall where necessary consult one another with a view to such simplification.'  4. In The second subparagraph of Article 7, 'List D of Annex I' is replaced by 'List C of Annex I'.  5. In Article 10, 'Lists A, B, C and D contained in Annex I' is replaced by 'Lists A, B and C of Annex I'.  6. Annex I is replaced by the Annex to this Directive.  7. Annex II is hereby amended as follows:  '- The Nomenclature of Capital Movements is hereby amended as follows:  (a) The following heading is added to items III A 1, III A 2, III B 1 and III B 2:  units of collective investment undertakings';  (b) The following two headings are added to items IV A and IV C:  '5. Acquisition of units of collective investment undertakings,  6. Repatriation of the proceeds of the liquidation of units of collective investment undertakings';  (c) The following two headings are added to items IV B and IV D:  '5. Acquisition of units of collective investment undertakings,  6. Use of the proceeds of the liquidation of units of collective investment undertakings';  (d) The titles of items IV B and IV D are hereby amended as follows:  'B. Acquisition by residents of foreign securities dealt in on a stock exchange, or of domestic securities issued on a foreign market and dealt in on a stock exchange, and use of the proceeds of the liquidation thereof',  'D. Acquisition by residents of foreign securities not dealt in on a stock exchange, or of domestic securities issued on a foreign market but not dealt in on a stock exchange, and use of the proceeds of the liquidation thereof';  - The Explanatory Notes are hereby amended as follows:  (a) The definition of undertakings for collective investment in transferable securities (UCITS) is replaced by the following:  '- Collective investment undertakings  Undertakings:  - the object of which is the collective investment in transferable securities or other assets of the capital they raise and which operate on the principle of risk-spreading, and  - the units of which are, at the request of holders, under the legal, contractual or statutory conditions governing them, repurchased or redeemed, directly or indirectly, out of those undertakings' assets. Action taken by a collective investment undertaking to ensure that the stock exchange value of its units does not significantly vary from their net asset value shall be regarded as equivalent to such repurchase or redemption.  Such undertakings may be constituted according to law either under the law of contract (as common funds managed by management companies) or trust law (as unit trusts) or under statute (as investment companies).  For the purposes of this Directive ''common funds'' shall also include unit trusts.';  (b) The definition of the term 'bonds' is replaced by the following:  '- Bonds  Negotiable securities with a maturity of two years or more from issue for which the interest rate and the terms for the repayment of the principal and the payment of interest are determined at the time of issue. The bonds referred to in category IV of the Nomenclature are those issued by both public and private bodies.'  Article 2  1. The Member States shall take the measures necessary for them to comply with this Directive no later than 28 February 1987. They shall forthwith inform the Commission thereof.  2. Without prejudice to Articles 61 to 66 and 222 to 232 of the 1985 Act of Accession, the Kingdom of Spain and the Portuguese Republic may continue to apply Article 3 of the Directive of 11 May 1960 to the following operations referred to in the Nomenclature of Capital Movements:  A. until 1 October 1989 for the Kingdom of Spain and until 31 December 1990 for the Portuguese Republic:  - operations under headings IV B 5 and IV B 6 relating to the acquisition by residents of units in foreign undertakings for collective investment subject to Directive 85/611/EEC (1) and taking the form of common funds,  - operations under headings IV D 5 and IV D 6 relating to the acquisition by residents of units in foreign undertakings for collective investment subject to Directive 85/611/EEC,  and use of the proceeds of the liquidation thereof;  B. until 31 December 1990 for the Kingdom of Spain and until 31 December 1992 for the Portuguese Republic:  - operations under headings III A 1, III A 2, III B 1 and III B 2, (a) and (b), in List A annexed to this Directive,  - operations under heading IV B relating to the acquisition by residents of the following securities dealt in on a stock exchange, and to use of the proceeds of the liquidation thereof:  (a) units in foreign collective investment undertakings not subject to Directive 85/611/EEC and taking the form of common funds;  (b) foreign bonds issued on a foreign market and denominated in national currency;  (c) domestic securities issued on a foreign market,  - operations under heading IV C and IV D, other than those relating to units in collective investment undertakings subject to Directive 85/611/EEC, and  - operations under headings VII A 1 and VII B 1 (iii).  Article 3  This Directive is addressed to the Member States.  Done at Brussels, 17 November 1986.  For the Council  The President  N. LAWSON  (1) OJ No C 229, 10. 11. 1986, p. 3.  (2) OJ No C 297, 24. 11. 1986.  (3) OJ No 43, 12. 7. 1960, p. 921/60.  (4) OJ No L 372, 31. 12. 1985, p. 39.  (1) OJ No L 375, 31. 12. 1985, p. 3.  ANNEX  'ANNEX I  LIST A  Capital movements referred to in Article 1 of the Directive  1.2 //  //  //  // Heading  //  //  //  //  // Direct investments   // I   // excluding purely financial investments made with a view only to giving the persons providing the capital indirect access to the money or capital market of another country, through the creation of an undertaking or participation in an existing undertaking in that country   //  // Liquidation of direct investments   // II   // Admission of an undertaking's securities to the capital market - Shares and other securities of a participating nature, dealt in on or in the process of introduction to a stock exchange in a Member State   // III A 1 and 2 III B 1 and 2   // - Bonds dealt in on or in the process of introduction to a stock exchange in a Member State   //   // - Units of undertakings for collective investment in transferable securities covered by Directive 85/611/EEC (1), without prejudice to the provisions of that Directive relating to the marketing of UCITS units (Section VIII)   //   // Operations in securities   // IV   // - shares and other securities of a participating nature   //   // - bonds   //   // - units of collective investment undertakings  //   // - units of collective investment undertakings dealt in on a stock exchange   //   // - units not dealt in on a stock exchange   //   // - of undertakings for collective investment in transferable securities covered by Directive 85/611/EEC  //   // - of other collective investment undertakings the sole object of which is investment in transferable securities or other assets the acquisition of which has been liberalized  //   // Investments in real estate   // V   // Grant and repayment of credits in connection with commercial transactions or the provision of services in which a resident is participating   // VII 1 A and B   // Personal capital movements   //   // Gifts and endowments   // X B   // Dowries  // X C   // Inheritances   // X D   // Settlement of debts in their countries of origin by immigrants   // X E   // Transfers   // X F   // Transfers of capital belonging to emigrants returning to their countries of origin   // X G   // Transfers of workers' savings during their periods of stay   // X H  // Transfers by instalments of blocked funds belonging to non-residents by the holders of such funds in case of special hardship   // X I   // Annual transfers of blocked funds to another Member State by a non-resident account holder, up to an amount or proportion of the total assets, fixed uniformly by the Member States concerned for all applicants   // X L  // Transfers abroad of minor amounts   // X M   // Transfers in performance of insurance contracts   // XI   // as and when freedom of movement in respect of services is extended to those contracts in implementation of Articles 59 et seq. of the Treaty 1,2 // (1) Council Directive 85/611/EEC of 20 December 1985 on the coordination of laws, regulations and administrative provisions relating to undertakings for collective investment in transferable securities (UCITS). OJ No L 375, 31. 12. 1985, p. 3.  // 1.2 //  //  //  // Heading  //  //  //  // Sureties, other guarantees and rights of pledge and transfers connected with them relating to   //   // credits in connection with commercial transactions or the provision of services in which a resident is participating   // XII A and B in conjunction with VII 1 A and B   // long-term loans with a view to establishing or maintaining lasting economic links   // XII A and B in conjunction with I A 3 B 3   // Other capital movements   //  // Death duties   // XIV A   // Damages (where these can be considered as capital)   // XIV B   // Refunds in cases of the cancellation of contracts and refunds of uncalled-for payments (where these can be considered as capital)   // XIV C  // Authors' royalties   //   // Patents, designs, trade marks and inventions (assignment and transfers arising out of such assignments)   // XIV D   // Transfers of the moneys required for the provision of services   // XIV E   //    //  The use of the proceeds of the liquidation of assets abroad belonging to residents must be permitted at least within the limits of the obligations as regards liberalization accepted by Member States.  LIST B  Capital movements referred to in Article 3 of the Directive  1.2 //  //  //  // Heading  //  //  //  //  // Admission of an undertaking's securities to the capital market   // III A 1 and 2 III B 1 and 2   // Shares and other securities of a participating nature, not dealt in on or in the process of introduction to a stock exchange in a Member State   //  // Bonds not dealt in on or in the process of introduction to a stock exchange in a Member State   //   // Units of collective investment undertakings not covered by Directive 85/611/EEC   //   // Operations in securities   //   // Units, not dealt in on a stock exchange, of collective investment undertakings not covered by Directive 85/611/EEC, the sole object of which is not investment in transferable securities or other assets the acquisition of which has been liberalized  // IV   // Grant and repayment of medium- and long-term credits in connection with commercial transactions or the provision of services in which no resident is participating  // VII 2 A (ii) and (iii) B (ii) and (iii)   // Grant and repayment of medium- and long-term loans and credits not in connection with commercial transactions or the provision of services   // VIII A (ii) and (iii) B (ii) and (iii)  // Sureties, other guarantees and rights of pledge and transfers connected with them and relating to:   //  // medium- and long-term credits in connection with commercial transactions or the provision of services in which no resident is participating   // XII A and B in conjunction with VII 2 A (ii) and (iii) B (ii) and (iii)   // medium- and long-term loans and credits not in connection with commercial transactions or the provision of services   // XII A and B in conjunction with VIII A (ii) and (iii) B (ii) and (iii)   //  //  The use of the proceeds of the liquidation of assets abroad belonging to residents must be permitted at least within the limits of the obligations as regards liberalization accepted by Member States.  LIST C  Capital movements referred to in Article 4 of the Directive  1.2 //  //  //  // Heading  //  //  // Short-term investments in treasury bills and other securities normally dealt in on the money market   // VI   // Opening and placing of funds on current or deposit accounts, repatriation or use of balances on current or deposit accounts with credit institutions   // IX  // Grant and repayment of short-term credits in connection with commercial transactions or the provision of services in which no resident is participating   // VII 2 A (i) B (i)  // Grant and repayment of short-term loans and credits not in connection with commercial transactions or the provision of services   // VIII A (i) B (i)  // Personal capital movements  //   // loans   // XA   // Sureties, other guarantees and rights of pledge and transfers connected with them relating to  //   // short-term credits in connection with commercial transactions or the provision of services in which no resident is participating   // XII A and B in conjunction with VII 2 A (i) B (i)  // short-term loans and credits not in connection with commercial transactions or the provision of services  // XII A and B in conjunction with VIII A (i) B (i)  // private loans   // XII A and B in conjunction with XA  // Physical import and export of financial assets   // XIII  // Other capital movements: Miscellaneous   // XIV F'   //  //