欧盟《食品添加剂标准》.pdf

ENConsolidated TEXTproduced by theCONSLEGsystemof the Office for Official Publications of the European CommunitiesCONSLEG:1995L0002 29/01/2004Number of pages:53Office for Official Publications of the European Communities1995L0002 EN 29.01.2004 005.001 1This document is meant purely as a documentation tool and the institutions do not assume any liability for its contentsBEUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No 95/2/ECof 20 February 1995on food additives other than colours and sweeteners(OJ L 61,18.3.1995,p.1)Amended by:Official JournalNopagedateM1Directive 96/85/EC of the European Parliament and of the Council of 19December 1996L 86428.3.1997M2Directive 98/72/EC of the European Parliament and of the Council of 15October 1998L 295184.11.1998M3Directive 2001/5/EC of the European Parliament and of the Council of12 February 2001L 555924.2.2001M4Directive 2003/52/EC of the European Parliament and of the Council of18 June 2003L 1782317.7.2003M5Regulation(EC)No 1882/2003 of the European Parliament and of theCouncil of 29 September 2003L 284131.10.2003M6Directive 2003/114/EC of the European Parliament and of the Council of22 December 2003L 245829.1.2004Corrected by:C1Corrigendum,OJ L 248,14.10.1995,p.60(95/2/EC)BEUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No 95/2/ECof 20 February 1995on food additives other than colours and sweetenersTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THEEUROPEAN UNION,Having regard to the Treaty establishing the European Community,andin particular Article 100a thereof,Having regard to the proposal from the Commission(1),HavingregardtotheopinionoftheEconomicandSocialCommittee(2),Acting in accordance with the procedure laid down in Article 189b ofthe Treaty(3),HavingregardtotheCouncilDirective89/107/EECof21 December 1988 on the approximation of the laws of the MemberStates concerning food additives authorized for use in foodstuffsintended for human consumption(4),and in particular Article 3(2)thereof,Whereas differences between national laws relating to preservatives,antioxidants and other additives and their conditions of use hinder thefree movement of foodstuffs;whereas this may create conditions ofunfair competition;Whereas the prime consideration for any rules on these food additivesand their conditions of use should be the need to protect the consumer;Whereas it is generally recognized that unprocessed foodstuffs andcertain other foodstuffs should be free from food additives;Whereas,having regard to the most recent scientific and toxicologicalinformation on these substances,some of them are to be permitted onlyfor certain foodstuffs and under certain conditions of use;Whereas it is necessary to lay down strict rules for the use of foodadditives in infant formulae,follow-on formulae and weaning foods,as referred to in Council Directive 89/398/EEC of 3 May 1989 on theapproximation of the laws of the Member States relating to foodstuffsintended for particular nutritional uses(5),and in particular Article 4(1)(e)thereof;Whereas this Directive is not intended to affect rules relating to sweet-eners and colours;Whereas,pending specific provisions pursuant to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protectionproducts on the market(6),and pursuant to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesti-cide residues in and on certain products of plant origin,including fruitand vegetables(7),certain substances belonging to this category areprovisionally covered by this Directive;Whereas the Commission is to adapt Community provisions to accordwith the rules laid down in this Directive;1995L0002 EN 29.01.2004 005.001 2(1)OJ No C 206,13.8.1992,p.12,and OJ No C 189,13.7.1993,p.11.(2)OJ No C 108,19.4.1993,p.26.(3)Opinion of the European Parliament of 26 May 1993(OJ No C 176,28.6.1993,p.117),confirmed on 2 December 1993(OJ No C 342,20.12.1993),common position of the Council of 10 March 1994(OJ No C 172,24.6.1994,p.4)and decision of the European Parliament of 16 November 1994(OJ No C 341,5.12.1994)(4)OJ No L 40,11.2.1989,p.27.(5)OJ No L 186,30.6.1989,p.27.(6)OJ No L 230,19.8.1991,p.1.Directive as last amended by CommissionRegulation(EEC)No 3600/92(OJ No L 366,15.12.1992,p.10).(7)OJ No L 350,14.12.1990,p.71.BWhereas the Scientific Committee for Food has been consulted forthose substances which are not yet the subject of a Community provi-sion;Whereas it is necessary to include in this Directive specific provisionsconcerning additives referred to in other Community provisions;Whereas it is desirable that when a decision is taken on whether aparticular foodstuff belongs to a certain category of foods,the consulta-tion of the Standing Committee for Foodstuffs procedure is followed;Whereas modifications of existing purity criteria for food additivesother than colours and sweeteners and new specifications for thosewhere no purity criteria exist will be adopted in accordance with theprocedure laid down in Article 11 of Directive 89/107/EEC;Whereas the Scientific Committee for Food has not yet given anopinion on flour treatment agents;whereas those agents will be thesubject of a separate Directive;Whereas this Directive replaces Directives 64/54/EEC(1),70/357/EEC(2),74/329/EEC(3)and 83/463/EEC(4);whereas those Directivesare hereby repealed,HAVE ADOPTED THIS DIRECTIVE:Article 11.This Directive is a specific Directive forming a part of thecomprehensive Directive,within the meaning of Article 3 of Directive89/107/EEC,and applies to additives other than colours and sweet-eners.It does not apply to enzymes other than those mentioned in theAnnexes,2.Only additives which satisfy the requirements laid down by theScientific Committee for Food may be used in foodstuffs.3.For the purpose of this Directive:(a)preservatives are substances which prolong the shelf-life of food-stuffs by protecting them against deterioration caused by micro-organisms;(b)antioxidants are substances which prolong the shelf-life of food-stuffsbyprotectingthemagainstdeteriorationcausedbyoxidation,such as fat rancidity and colour changes;(c)carriers,including carrier solvents,are substances used todissolve,dilute,disperse or otherwise physically modify a foodadditive without altering its technological function(and withoutexerting any technological effect themselves)in order to facilitateits handling,application or use;(d)acids are substances which increase the acidity of a foodstuffand/or impart a sour taste to it;(e)acidity regulators are substances which alter or control theacidity or alkalinity of a foodstuff;(f)anti-caking agents are substances which reduce the tendency ofindividual particles of a foodstuff to adhere to one another;(g)anti-foaming agents are substances which prevent or reducefoaming;(h)bulking agents are substances which contribute to the volume ofa foodstuff without contributing significantly to its availableenergy value;1995L0002 EN 29.01.2004 005.001 3(1)OJ No 12,27.1.1964,p.161/64.(2)OJ No L 157,18.7.1970,p.31.(3)OJ No L 189,12.7.1974,p.1.(4)OJ No L 255,15.9.1983,p.1.M2BB(i)emulsifiers are substances which make it possible to form ormaintain a homogenous mixture of two or more immiscible phasessuch as oil and water in a foodstuff;(j)emulsifyingsaltsaresubstanceswhichconvertproteinscontained in cheese into a dispersed form and thereby bring abouthomogenous distribution of fat and other components;(k)firming agents are substances which make or keep tissues of fruitor vegetables firm or crisp,or interact with gelling agents toproduce or strengthen a gel;(l)flavour enhancers are substances which enhance the existingtaste and/or odour of a foodstuff;(m)foaming agents are substances which make it possible to form ahomogenous dispersion of a gaseous phase in a liquid or solidfoodstuff;(n)gelling agents are substances which give a foodstuff texturethrough formation of a gel;(o)glazing agents(including lubricants)are substances which,whenapplied to the external surface of a foodstuff,impart a shinyappearance or provide a protective coating;(p)humectants are substances which prevent foodstuffs from dryingout by counteracting the effect of an atmosphere having a lowdegree of humidity,or promote the dissolution of a powder in anaqueous medium;(q)modified starches are substances obtained by one or morechemical treatments of edible starches,which may have undergonea physical or enzymatic treatment,and may be acid or alkalithinned or bleached;(r)packaging gases are gases other than air,introduced into acontainer before,during or after the placing of a foodstuff in thatcontainer;(s)propellants are gases other than air which expel a foodstuff froma container;(t)raising agents are substances or combinations of substanceswhich liberate gas and thereby increase the volume of a dough ora batter;(u)sequestrants are substances which form chemical complexes withmetallic ions;(v)stabilisers are substances which make it possible to maintain thephysico-chemicalstateofafoodstuff;stabilisersincludesubstances which enable the maintenance of a homogenous disper-sion of two or more immiscible substances in a foodstuff,substances which stabilise,retain or intensify an existing colourof a foodstuff and substances which increase the binding capacityof the food,including the formation of cross-links betweenproteins enabling the binding of food pieces into re-constitutedfood;(w)thickeners are substances which increase the viscosity of a food-stuff.4.Flour treatment agents other than emulsifiers are substanceswhich are added to flour or dough to improve its baking quality.5.For the purposes of this Directive the following are not consid-ered as food additives:(a)substances used for treatment of drinking water as provided for inDirective 80/778/EEC(1);1995L0002 EN 29.01.2004 005.001 4(1)OJ No L 229,30.8.1980,p.11.Directive as last amended by Directive 91/692/EEC(OJ No L 377,31.12.1991,p.48).M6BB(b)products containing pectin and derived from dried apple pomace orpeel of citrus fruits,or from a mixture of both,by the action ofdilute acid followed by partial neutralization with sodium or potas-sium salts(liquid pectin);(c)chewing gum bases;(d)white or yellow dextrin,roasted or dextrinated starch,starch modi-fied by acid or alkali treatment,bleached starch,physicallymodified starch and starch treated by amylolitic enzymes;(e)ammonium chloride;(f)blood plasma,edible gelatin,protein hydrolysates and their salts,milk protein and gluten;(g)amino acids and their salts other than glutamic acid,glycine,cysteine and cystine and their salts and having no additive function;(h)caseinates and casein;(i)inulin.Article 21.Only substances listed in Annexes I,III,IV and V may be used infoodstuffs for the purposes mentioned in Article 1(3)and Article 1(4),2.Food additives listed in Annex I are permitted in foodstuffs,forthe purposes mentioned in Article 1(3)and Article 1(4),with theexception of those foodstuffs listed in Annex II,following thequantum satis principle,3.Except where specifically provided for,paragraph 2 does notapply to:(a)unprocessed foodstuffs,honey as defined in Directive 74/409/EEC(1)non-emulsified oils and fats of animal or vegetable origin,butter,pasteurised and sterilised(including UHT)milk(includingplain,skimmed and semi-skimmed)and plain pasteurisedcream,unflavoured,live fermented milk products,natural mineral water as defined in Directive 80/777/EEC(2)and spring water,coffee(excluding flavoured instant coffee)and coffee extracts,unflavoured leaf tea,sugars as defined in Directive 73/437/EEC(3),dry pasta,excluding gluten-free and/or pasta intended for hypo-proteic diets,in accordance with Directive 89/398/EEC,natural unflavoured buttermilk(excluding sterilized buttermilk).Within the meaning of this Directive,the term unprocessed meansnot having undergone any treatment resulting in a substantialchange in the original state of the foodstuffs;however,the food-stuffs may have been,for example,divided,parted,severed,boned,minced,skinned,pared,peeled,ground,cut,cleaned,trimmed,deep-frozen or frozen,chilled,milled or husked,packedor unpacked;1995L0002 EN 29.01.2004 005.001 5(1)OJ No L 211,12.8.1974,p.10.(2)OJ No L 229,30.8.1980,p.1.(3)OJ No L 356,27.12.1973,p.71.M2BM2BM2BB(b)foods for infants and young children as referred to in Directive 89/398/EEC,including foods for infants and young children not ingood health;these foodstuffs are subject to the provisions of AnnexVI;(c)the foodstuffs listed in Annex II,which may contain only thoseadditives referred to in that Annex and those additives referred toin Annexes III and IV under the conditions specified therein.4.Additives listed in Annexes III and IV may only be used in thefoodstuffs referred to in those Annexes and under the conditions speci-fied therein.5.Only those additives listed in Annex V may be used as carriers orcarrier solvents for food additives and must be used under the condi-tions specified therein.6.The provisions of this Directive shall also apply to the corre-spondingfoodstuffsintendedforparticularnutritionalusesinaccordance with Directive 89/398/EEC.7.Maximum levels indicated in the Annexes refer to foodstuffs asmarketed,unless otherwise stated.8.In the Annexes to this Directive,quantum satis means that nomaximum level is specified.However,additives shall be used in accor-dance with good manufacturing practice,at a level not higher than isnecessary to achieve the intended purpose and provided that they donot mislead the consumer.Article 31.The presence of a food additive is permissible:(a)in a compound foodstuff other than one mentioned in Article 2(3),to the extent to which the food additive is permitted in one of theingredients of the compound foodstuff;(b)in a foodstuff where a flavouring has been added,to the extent towhich the food additive is permitted in the flavouring in compli-ance with this Directive and has been carried over to the foodstuffvia the flavouring,provided the food additive has no technologicalfunction in the final foodstuff;or(c)if the foodstuff is destined to be used solely in the preparation of acompound foodstuff and to an extent such that the compound food-stuff conforms to the provisions of this Directive.2.Paragraph 1 does not apply to infant formulae,follow-onformulae and weaning foods,as referred to in Directive 89/398/EEC,except where specially provided for.3.The level of additives in flavourings shall be limited to theminimum necessary to guarantee the safety and quality of flavouringsand to facilitate their storage.Furthermore,the presence of additives inflavourings must not mislead consumers or present a hazard to theirhealth.If the presence of an additive in a foodstuff,as a consequenceof adding flavourings,has a technological function in the foodstuff,itshall be considered as an additive of the foodstuff and not as an addi-tive of the flavouring.Article 4This Directive shall apply without prejudice to specific Directivespermitting additives listed in the Annexes to be used as sweeteners o