欧盟添加剂的标准.pdf

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1、This 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 JournalNopageda

2、teM1Directive 96/85/EC of the European Parliament and of the Council of19 December 1996L 86428.3.1997M2Directive 98/72/EC of the European Parliament and of the Council of15 October 1998L 295184.11.1998M3Directive 2001/5/EC of the European Parliament and of the Council of12 February 2001L 555924.2.20

3、01M4Directive 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 Coun-cil of 22 December 200

4、3L 245829.1.2004M7Directive 2006/52/EC of the European Parliament and of the Council of5 July 2006L 2041026.7.2006Corrected by:C1Corrigendum,OJ L 248,14.10.1995,p.60(2/1995)1995L0002 EN 15.08.2006 006.001 1BEUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE No95/2/ECof 20 February 1995on food additives other

5、 than colours and sweetenersTHE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEANUNION,Having regard to the Treaty establishing the European Community,andin particular Article 100a thereof,Having regard to the proposal from the Commission(1),Having regard to the opinion of the Economic and Social

6、Committee(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

7、),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 a

8、ny 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 toxicologicalin

9、formation 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 food addi-tives in infant formulae,follow-on formulae and weaning foods,asreferred to in Council Directive 89/

10、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 pr

11、ovisions pursuant to Council Directive91/414/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,inc

12、luding 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 15.08.2006 006.001 2(1)OJ No C 206,13.8.1992,p.12,and OJ No

13、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

14、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 ha

15、s been consulted for thosesubstances which are not yet the subject of a Community provision;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 a parti-

16、cular foodstuff belongs to a certain category of foods,the consultationof the Standing Committee for Foodstuffs procedure is followed;Whereas modifications of existing purity criteria for food additives otherthan colours and sweeteners and new specifications for those where nopurity criteria exist w

17、ill be adopted in accordance with the procedurelaid down in Article 11 of Directive 89/107/EEC;Whereas the Scientific Committee for Food has not yet given an opinionon flour treatment agents;whereas those agents will be the subject of aseparate Directive;Whereas this Directive replaces Directives 64

18、/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 1M21.This Directive is a specific Directive forming a part of the compre-hensive Directive,within the meaning of Article 3 of Directive 89/107/EEC,and applies to ad

19、ditives other than colours and sweeteners.It doesnot apply to enzymes other than those mentioned in the Annexes,B2.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

20、 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-stuffs by protecting them against deterioration caused by oxidation,such as fat rancidity and colour changes;M7(c)carrie

21、rs,includingcarriersolvents,aresubstancesusedtodissolve,dilute,disperse or otherwise physically modify a foodadditive or flavouring without altering its function(and withoutexerting any technological effect themselves)in order to facilitateits handling,application or use;B(d)acids are substances whi

22、ch increase the acidity of a foodstuff and/or impart a sour taste to it;(e)acidity regulators are substances which alter or control the acidityor 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

23、)anti-foaming agents are substances which prevent or reducefoaming;(h)bulking agents are substances which contribute to the volume of afoodstuff without contributing significantly to its available energyvalue;1995L0002 EN 15.08.2006 006.001 3(1)OJ No 12,27.1.1964,p.161/64.(2)OJ No L 157,18.7.1970,p.

24、31.(3)OJ No L 189,12.7.1974,p.1.(4)OJ No L 255,15.9.1983,p.1.B(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)emulsifying salts are substances which convert proteins containedin chees

25、e into a dispersed form and thereby bring about homoge-nous 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

26、 enhance the existing tasteand/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(i

27、ncluding lubricants)are substances which,whenapplied to the external surface of a foodstuff,impart a shiny appear-ance 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 p

28、romote 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,

29、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 substances whichliberate gas and thereby increase the volume of a dough or

30、 a batter;(u)sequestrants are substances which form chemical complexes withmetallic ions;M6(v)stabilisers are substances which make it possible to maintain thephysico-chemical state of a foodstuff;stabilisers include substanceswhich enable the maintenance of a homogenous dispersion of twoor more imm

31、iscible substances in a foodstuff,substances whichstabilise,retain or intensify an existing colour of a foodstuff andsubstances which increase the binding capacity of the food,including the formation of cross-links between proteins enablingthe binding of food pieces into re-constituted food;B(w)thic

32、keners are substances which increase the viscosity of a food-stuff.4.Flour treatment agents other than emulsifiers are substances whichare added to flour or dough to improve its baking quality.5.For the purposes of this Directive the following are not consideredas food additives:(a)substances used f

33、or treatment of drinking water as provided for inDirective 80/778/EEC(1);(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);1

34、995L0002 EN 15.08.2006 006.001 4(1)OJ No L 229,30.8.1980,p.11.Directive as last amended by Directive91/692/EEC(OJ No L 377,31.12.1991,p.48).B(c)chewing gum bases;(d)white or yellow dextrin,roasted or dextrinated starch,starch modi-fied by acid or alkali treatment,bleached starch,physically modifieds

35、tarch 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)case

36、inates and casein;(i)inulin.Article 2M21.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

37、the excep-tion of those foodstuffs listed in Annex II,following the quantum satisprinciple,B3.Except where specifically provided for,paragraph 2 does not applyto:(a)unprocessed foodstuffs,honey as defined in Directive 74/409/EEC(1)non-emulsified oils and fats of animal or vegetable origin,butter,M2

38、pasteurised and sterilised(including UHT)milk(including plain,skimmed and semi-skimmed)and plain pasteurised cream,B unflavoured,live fermented milk products,natural mineral water as defined in Directive 80/777/EEC(2)andspring water,coffee(excluding flavoured instant coffee)and coffee extracts,unfla

39、voured leaf tea,sugars as defined in Directive 73/437/EEC(3),M2 dry pasta,excluding gluten-free and/or pasta intended for hypo-proteic diets,in accordance with Directive 89/398/EEC,B natural unflavoured buttermilk(excluding sterilized buttermilk).Within the meaning of this Directive,the term unproce

40、ssed meansnot having undergone any treatment resulting in a substantial changein the original state of the foodstuffs;however,the foodstuffs mayhave been,for example,divided,parted,severed,boned,minced,skinned,pared,peeled,ground,cut,cleaned,trimmed,deep-frozenor frozen,chilled,milled or husked,pack

41、ed or unpacked;(b)foods for infants and young children as referred to in Directive89/398/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

42、to in that Annex and those additives referred to inAnnexes III and IV under the conditions specified therein.1995L0002 EN 15.08.2006 006.001 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.B4.Additives listed in Annexes III and IV may only be used in thefoo

43、dstuffs 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 conditionsspecified therein.6.The provisions of this Directive shall also apply to the co

44、rre-sponding foodstuffs intended for particular nutritional uses in accor-dance 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,

45、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 do notmislead the consumer.Article 3M61.The presence of a food additive is permissible:(a)in a compound foodstuff other than one menti

46、oned 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 compliancewith this Directive and has been carri

47、ed over to the foodstuff via theflavouring,provided the food additive has no technological functionin 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 thi

48、s Directive.B2.Paragraph 1 does not apply to infant formulae,follow-on formulaeand M7 processed cereal-based foods and baby foods,as referredto in Directive 89/398/EEC,except where specially provided for.M63.The level of additives in flavourings shall be limited to theminimum necessary to guarantee

49、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 consequence ofadding flavourings,has a technological function in t

50、he foodstuff,it shallbe considered as an additive of the foodstuff and not as an additive ofthe flavouring.BArticle 4This Directive shall apply without prejudice to specific Directivespermitting additives listed in the Annexes to be used as sweeteners orcolours.Article 5Where necessary,it may be dec