2002L0072—EN—30.03.2004—002.001—1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B ►C1 COMMISSION DIRECTIVE 2002/72/EC
of 6 August 2002
relating to plastic materials and articles intended to come into contact with foodstuffs
(Text with EEA relevance) ◄
(OJL220,15.8.2002,p.18)
Amendedby:
OfficialJournal
No page date
►M1CommissionDirective2004/1/ECof6January2004 L7 45 13.1.2004
►M2CommissionDirective2004/19/ECof1March2004 L71 8 10.3.2004
Correctedby:
►C1Corrigendum,OJL39,13.2.2003,p.1(2002/72/EC)
▼B
COMMISSION DIRECTIVE 2002/72/EC
of 6 August 2002
relating to plastic materials and articles intended to come into
contact with foodstuffs
(Text with EEA relevance)
THECOMMISSIONOFTHEEUROPEANCOMMUNITIES,
HavingregardtotheTreatyestablishingtheEuropeanCommunity,
HavingregardtoCouncilDirective89/109/EECof21December1988
on the approximation of the laws of the Member States relating tomaterialsandarticlesintendedtocomeintocontactwithfoodstuffs(
1),
andinparticularArticle3thereof,
AfterconsultingtheScientificCommitteeonFood,Whereas:
(1)CommissionDirective90/128/EECof23February1990relating
to plastic materials and articles intended to come into contactwithfoodstuffs(
2),aslastamendedbyDirective2002/17/EC(3),
has been frequently and substantially amended; for reasons of
clarityandrationality,itshouldthereforebeconsolidated.
(2)Article2ofDirective 89/109/EEClaysdownthatmaterials and
articles, in their finished state, must not transfer their constitu-ents to foodstuffs in quantities which could endanger humanhealthorbringaboutanunacceptablechangeinthecompositionofthefoodstuffs.
(3)Inordertoachievethisobjectiveinthecaseofplasticmaterialsand articles, a suitable instrument is a specific Directive withinthe meaning of Article 3 of Directive 89/109/EEC, the generalprovisionsofwhicharealsoapplicabletothecaseinquestion.
(4)The scope of this Directive must coincide with that of Council
Directive82/711/EEC(4).
(5)Since the rules established in this Directive are not suitable for
ion-exchangeresins,thesematerialsandarticleswillbecoveredbyasubsequentspecificDirective.
(6)Siliconesshouldberegardedaselastomericmaterialsratherthan
plasticmaterialsandthereforeshouldbeexcludedfromthedefi-
nitionofplastic.
(7)Theestablishmentofalistofapprovedsubstancesaccompaniedby a limit on overall migration and, where necessary, by otherspecific restrictions will be sufficient to achieve the objectivelaiddowninArticle2ofDirective89/109/EEC.
(8)Besidesthemonomersandotherstartingsubstancesfullyevalu-ated and authorised at Community level, there are alsomonomers and starting substances evaluated and authorised inat least one Member State which may continue to be usedpending their evaluation by the Scientific Committee on Food
and the decision on their inclusion in the Community list; this
Directive will accordingly be extended in due course to thesubstancesandsectorsprovisionallyexcluded.
(9)Thecurrentlistofadditivesisanincomplete listinasmuchasitdoesnotcontainallthesubstanceswhicharecurrentlyacceptedin one or more Member States; accordingly, these substances2002L0072—EN—30.03.2004—002.001—2
(1) OJL40,11.2.1989,p.38.
(2) OJL75,21.3.1990,correctedbyOJL349,13.12.1990,p.26.
(3) OJL58,28.2.2002,p.19.
(4) OJL297,23.10.1982,p.26.DirectiveaslastamendedbyDirective97/48/
EC(OJL222,12.8.1997,p.10).▼C1
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continuetoberegulatedbynationallawspendingadecisionon
inclusionintheCommunitylist.
(10)This Directive establishes specifications for only a fewsubstances. The other substances, which may require specifica-tions,thereforeremainregulatedinthisrespectbynationallawspendingadecisionatCommunitylevel.
(11)ForcertainadditivestherestrictionsestablishedinthisDirectivecannotyetbeappliedinallsituationspendingthecollectionand
evaluation of all the data needed for a better estimation of the
exposureofthe consumer insomespecific situations; therefore,these additives appear in a list other than that of the additivesfullyregulatedatCommunitylevel.
(12)Directive 82/711/EEC lays down the basic rules necessary for
testingmigrationoftheconstituentsofplasticmaterialsandarti-
clesandCouncilDirective85/572/EEC(1)establishesthelistof
simulantstobeusedinthemigrationtests.
(13)The determination of a quantity of a substance in a finishedmaterial or article is simpler than the determination of its
specificmigration level.Theverification ofcompliance through
thedeterminationofquantityratherthanspecificmigrationlevelshouldthereforebepermittedundercertainconditions.
(14)For certain types of plastics the availability of generally recog-nised diffusion models based on experimental data allows theestimation of the migration level of a substance under certain
conditions, therefore avoiding complex, costly and time-
consumingtesting.
(15)The overall migration limit is a measure of the inertness of thematerialandpreventsanunacceptablechangeinthecompositionof the foodstuffs, and, moreover, reduces the need for a large
number of specific migration limits or other restrictions, thus
givingeffectivecontrol.
(16)CouncilDirective78/142/EEC(2)laysdownlimitsforthequan-
tity of vinyl chloride present in plastic materials and articlesprepared with this substance and for the quantity of vinyl
chloride released by these materials and articles, and Commis-
sion Directives 80/766/EEC(
3) and 81/432/EEC(4) establish the
Communitymethodsofanalysisforcontrollingtheselimits.
(17)In view of potential liability, there is a need for the writtendeclaration provided for in Article 6(5) of Directive 89/109/EECwheneverprofessionaluseismadeofplasticmaterialsand
articles which are not by their nature clearly intended for food
use.
(18)Commission Directive 80/590/EEC(5) determines the symbol
that may accompany any material and article intended to comeintocontactwithfoodstuffs.
(19)In accordance with the principle of proportionality, it is neces-sary and appropriate for the achievement of the basic objectiveof ensuring the free movement of plastic materials and articlesintendedtocomeintocontactwithfoodstuffs,tolaydownruleson the definition of plastics and permitted substances. This
Directiveconfinesitselftowhatisnecessaryinordertoachieve
theobjectivespursuedinaccordancewiththethirdparagraphofArticle5oftheTreaty.
(20)In accordance with Article 3 of Directive 89/109/EEC, theScientific Committee onFood has been consulted on the provi-sionsliabletoaffectpublichealth.2002L0072—EN—30.03.2004—002.001—3
(1) OJL372,31.12.1985,p.14.
(2) OJL44,15.2.1978,p.15.
(3) OJL213,16.8.1980,p.42.
(4) OJL167,24.6.1981,p.6.
(5) OJL151,19.6.1980,p.21.
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(21)The measures provided for in this Directive are in accordance
withtheopinion ofthe Standing Committee ontheFoodChain
andAnimalHealth.
(22)This Directive should be without prejudice to the deadlines set
out in Annex VII, Part B within which the Member States are
tocomplywithDirective90/128/EEC,andtheactsamendingit,
HASADOPTEDTHISDIRECTIVE:
Article 1
1. This Directive is a specific Directive within the meaning of
Article3ofDirective89/109/EEC.
2. This Directive shall apply to plastic materials and articles and
partsthereof:
(a) consistingexclusivelyofplastics;or
(b) composed of two or more layers of materials, each consisting
exclusively of plastics, which are bound together by means ofadhesivesorbyanyothermeans,
which,inthefinishedproductstate,areintended tocomeintocontact
or are brought into contact with foodstuffs and are intended for thatpurpose.
3. For the purposes of this Directive, ‘plastics’ shall mean the
organic macromolecular compounds obtained bypolymerisation, poly-
condensation,polyadditionoranyothersimilarprocessfrommolecules
with a lower molecular weight or by chemical alteration of naturalmacromolecules. Other substances or matter may be added to suchmacromolecularcompounds.
However,thefollowingshallnotberegardedas‘plastics’:
(a) varnished or unvarnished regenerated cellulose film, covered by
CommissionDirective93/10/EEC(
1);
(b) elastomersandnaturalandsyntheticrubber;
(c) paper and paperboard, whether modified or not by the addition of
plastics;
(d) surfacecoatingsobtainedfrom:
— paraffin waxes, including synthetic paraffin waxes, and/or
micro-crystallinewaxes,
— mixtures ofthe waxeslisted inthefirstindent witheach other
and/orwithplastics,
(e) ion-exchangeresins;
(f) silicones.
4. This Directive shall not apply, until further action by the
Commission,tomaterialsandarticlescomposedoftwoormorelayers,
one ormore ofwhich doesnot consist exclusively ofplastics, even ifthe one intended to come into direct contact with foodstuffs doesconsistexclusivelyofplastics.
Article 2
Plastic materials and articles shall not transfer their constituents to
foodstuffs in quantities exceeding 10 milligrams per square decimetreofsurfaceareaofmaterialorarticle(mg/dm
2)(overallmigrationlimit).2002L0072—EN—30.03.2004—002.001—4
(1) OJL93,17.4.1993,p.27.DirectiveamendedbyDirective93/111/EC(OJL
310,14.12.1993,p.41).
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However,thislimit shallbe60milligrams oftheconstituentsreleased
perkilogramoffoodstuff(mg/kg)inthefollowingcases:
(a) articles which are containers or are comparable to containers or
whichcanbefilled,withacapacityofnotlessthan500millilitres
(ml)andnotmorethan10litres(l);
(b) articleswhichcanbefilledandforwhichitisimpracticabletoesti-
matethesurfaceareaincontactwithfoodstuffs;
(c) caps,gaskets,stoppersorsimilardevicesforsealing.
Article 3
1. Only those monomers and other starting substances listed in
AnnexII,sectionAmaybeusedforthemanufacture ofplastic mate-rialsandarticlessubjecttotherestrictionssetouttherein.
2. Bywayofderogationfromparagraph1,themonomersandother
starting substances listed in Annex II, section B may continue to be
useduntil31December2004atthelatest,pendingtheirevaluationbythe European Food Safety Authority (hereinafter referred to as theAuthority).
3. ThelistinAnnexII,SectionA,maybeamended:
— eitherbyaddingsubstanceslistedinAnnexII,SectionB,according
tothecriteriainAnnexIIofDirective89/109/EEC,or
— by including ‘new substances’, i.e. substances which are listed
neither in Section A nor in Section B of Annex II, according toArticle3ofDirective89/109/EEC.
4. No Member State shall authorise any new substance for use
withinitsterritoryexceptundertheprocedureinArticle4ofDirective
89/109/EEC.
5. The lists appearing in Annex II, Sections A and B, do not yet
includemonomersandotherstartingsubstancesusedonlyinthemanu-factureof:
— surfacecoatingsobtainedfromresinousorpolymerisedproductsin
liquid, powder or dispersion form, such as varnishes, lacquers,
paints,etc.,
— epoxyresins,
— adhesivesandadhesionpromoters,
— printinginks.
Article 4
1. A list of additives which may be used for the manufacture of
plastic materials and articles, together with the restrictions and/or
specificationsontheiruse,issetoutinAnnexIII.
Thatlistofadditivesshallbeconsideredtobeanincompletelistuntil
the Commission decides, in accordance with Article 4a, that it shallbecomeapositiveCommunitylistofauthorisedadditives,totheexclu-sionofallothers.
TheCommissionshallestablish,by31December2007atthelatest,the
datewhenthatlistshallbecomeapositivelist.
2. FortheadditiveslistedinAnnexIII,sectionB,theverificationof
compliance with the specific migration limits in simulant D or in testmedia ofsubstitutetestsaslaiddowninArticle 3(1),secondsubpara-graphofDirective82/711/EECandArticle1ofDirective85/572/EECshallapplyfrom1July2006.2002L0072—EN—30.03.2004—002.001—5
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3. The lists in Annex III, sections A and B do not yet include the
followingadditives:
(a) additivesusedonlyinthemanufactureof:
— surface coatings obtained fromresinous or polym erised
products in liquid, powder or dispersion form, such as
varnishes,lacquers,paints,
— epoxyresins,
— adhesivesandadhesionpromoters,— printinginks;
(b) colorants;
(c) solvents.
Article 4a
1. A new additive may always be added to the list of substances
referred to in Article 4(1) following an evaluation of its safety by theAuthority.
2. Member States shall provide that any person interested in the
inclusioninthelistreferredtoinArticle4(1)ofanadditive, whichisalready placed on the market in one or more of the Member States,shall submit data for the evaluation of its safety by the Authority by
31December2006atthelatest.
Forthesubmissionoftherequireddata,theapplicantshallconsultthe
‘GuidelinesoftheEuropeanFoodSafetyAuthorityforthepresentation
of an application for safety assessment of a substance to be used infoodcontactmaterialspriortoitsauthorisation’.
3. If during the examination of the data referred to in paragraph 2,
the Authority calls for supplementary information, the additive maycontinue to be used subject to national law until the Authority hasissued an opinion, provided that the information is submitted within
thetimelimitsspecifiedbytheAuthority.
4. The Commission shall establish, by 31 December 2007 at the
latest, a provisional list of additives which may continue to be used
after 31 December 2007 subject to national law until the Authorityhasevaluatedthem.
5. The inclusion of an additive in the provisional list is subject to
thefollowingconditions:
(a) the additive must be permitted in one or more of the Member
Statesnolaterthan31December2006;
(b) the data referred to in paragraph 2 concerning that additive must
have been supplied in accordance with the Authority requirements
nolaterthan31December2006.
Article 4b
Without prejudice to Article 4 of Directive 89/109/EEC, Member
Statesmaynotauthoriseafter31December2006additivesreferredtoinArticle4(1)whichwereneverevaluatedbytheScientificCommittee
onFoodortheAuthority.
Article 5
Onlytheproductsobtainedbymeansofbacterialfermentationlistedin
AnnexIVmaybeusedincontactwithfoodstuffs.2002L0072—EN—30.03.2004—002.001—6
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Article 5a
5. Additives referred to in Article 4, which are authorised as food
additives by Council Directive 89/107/EEC(1) or flavourings by
CouncilDirective88/388/EEC(2)shallnotmigrateinto:
(a) foodstuffsinquantitieshavingatechnologicalfunctioninthefinal
foodstuffs;
(b) foodstuffs for which their use is authorised as food additives or
flavourings,inquantitiesexceeding therestrictionsprovidedforin
Directive 89/107/EEC or in Directive 88/388/EEC or in Article 4ofthisDirective,whicheveristhelower;
(c) foodstuffsforwhichtheiruseisnotauthorisedasfoodadditivesor
flavourings, in quantities exceeding the restrictions set out in
Article4ofthisDirective.
2. Atthemarketingstagesotherthantheretailstages,plasticmate-
rials and articles which are intended to be placed in contact withfoodstuffsandwhichcontainadditivesreferredtoinparagraph1shallbe accompanied by a written declaration containing the information
referredtoinArticle9(1)(b).
3. By way of derogation fromparagraph 1, when the substances
referred to in point (a) of paragraph 1 are used as active componentsof active food contact materials and articles, they may be subject tonationalprovisionspendingtheadoptionofCommunityprovisions.
Article 6
1. Generalspecifications relatedtoplasticmaterials andarticles are
laid down in Annex V, Part A. Other specifications related to somesubstancesappearinginAnnexesII,IIIandIVarelaiddowninAnnexV,PartB.
2. The meaning of the numbers between brackets appearing in the
column‘Restrictionsand/orspecifications’isexplainedinAnnexVI.
Article 7
The specific migration limits in the list set out in Annexes II and III
are expressed in mg/kg. However, such limits are expressed in mg/dm
2inthefollowingcases:
(a) articles which are containers or are comparable to containers or
which can be filled, with a capacity of less than 500 ml or more
than10l;
(b) sheet, filmor other m aterial or articles which cannot be filled or
for which it is impracticable to estimate the relationship betweenthe surface area of such material or article and the quantity of
foodincontacttherewith.
In those cases, the limits set out in Annexes II and III, expressed in
mg/kg shall be divided by the conventional conversion factor of 6 inordertoexpresstheminmg/dm
2.
Article 8
1. Verification of compliance with the migration limits shall be
carried out in accordance with the rules laid down in Directives 82/
711/EEC and85/572/EEC andthefurther provisionsset outinAnnexI.2002L0072—EN—30.03.2004—002.001—7
(1) OJL40,11.2.1989,p.27.
(2) OJL184,15.7.1988,p.61.▼C1
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2. The verification ofcompliance withthe specific migration limits
provided for in paragraph 1 shall not be compulsory, if the value ofoverall migration determination implies that the specific migration
limitsreferredtointhatparagrapharenotexceeded.
3. The verification ofcompliance withthe specific migration limits
providedforinparagraph1shallnotbecompulsory,ifitcanbeestab-lished that, by assuming complete migration of the residual substancein the material orarticle, it cannot exceed the specific limit ofmigra-
tion.
4. The verification ofcompliance withthe specific migration limits
providedforinparagraph1maybeensuredbythedeterminationofthequantityofasubstanceinthefinishedmaterialorarticleprovidedthata relationship between that quantity and the value of the specificmigration of the substance has been established either by an adequate
experimentationorbytheapplicationofgenerallyrecogniseddiffusion
models based on scientific evidence. To demonstrate the non-compli-ance of a material or article, confirmation of the estimated migrationvaluebyexperimentaltestingisobligatory.
Article 9
1. Atthemarketingstagesotherthantheretailstages,plasticmate-
rials and articles which are intended to be placed in contact withfoodstuffsshallbeaccompaniedbyawrittendeclaration,whichshall:
(a) beinaccordancewithArticle6(5)ofDirective89/109/EEC;
(b) provide, for substances which are subject to a restriction in food,
adequate information obtained by experimental data or theoreticalcalculation about the level of their specific migration and, whereappropriate, purity criteria in accordance with Commission Direc-
tives 95/31/EC(
1), 95/45/EC(2) and 2002/82/EC(3) to enable the
user of these materials and articles to comply with the relevantCommunityprovisionsor,intheirabsence,withnationalprovisionsapplicabletofood.
Article 10
1. Directive 90/128/EEC, as amended by the Directives set out in
AnnexVII,PartA,isherebyrepealedwithoutprejudicetotheobliga-
tionsoftheMemberStatesinrespectofthedeadlinesfortranspositionandapplicationlaiddowninAnnexVII,PartB.
2. ReferencestotherepealedDirectivesshallbeconstruedasrefer-
ences to this Directive and be read in accordance with the correlationtablesetoutinAnnexVIII.
Article 11
ThisDirective shall enterinto forceonthe 20thdayfollowingthat of
itspublicationinthe Official Journal of the European Communities .
Article 12
ThisDirectiveisaddressedtotheMemberStates.2002L0072—EN—30.03.2004—002.001—8
(1) OJL178,28.7.1995,p.1.
(2) OJL226,22.9.1995,p.1.
(3) OJL292,28.10.2002,p.1.▼C1
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ANNEX I
FURTHER PROVISIONS APPLICABLE WHEN CHECKING COMPLI-
ANCE WITH THE MIGRATION LIMITS
General provisions
1. WhencomparingtheresultsofthemigrationtestsspecifiedintheAnnexto
Directive 82/711/EEC, the specific gravity of all the simulants should
conventionally be assumed to be 1. Milligrams of substance(s) released per
litre of simulant (mg/l) will thus correspond numerically to milligrams of
substance(s) released per kilogramof sim ulant and, taking into account the
provisionslaiddowninDirective85/572/EEC,tomilligramsofsubstance(s)
releasedperkilogramoffoodstuff.
2. Wherethemigrationtestsarecarriedoutonsamplestakenfromthematerial
orarticle oronsamplesmanufactured forthepurpose,andthe quantities of
foodstuff or simulant placed in contact with the sample differ from those
employed in the actual conditions under which the material or article is
used, the results obtained should be corrected by applying the following
formula:
M¼m/C1a2
a1/C1q/C11000
Where:
M isthemigrationinmg/kg;
m isthemassinmgofsubstancereleasedbythesampleasdeterminedby
themigrationtest;
a1isthesurfaceareaindm2ofthesampleincontactwiththefoodstuffor
simulantduringthemigrationtest;
a2isthesurfaceareaindm2ofthematerialorarticleinrealconditionsof
use;
q is the quantity in grams of foodstuff in contact with the material or
articleinrealconditionsofuse.
3. Thedeterminationofmigrationiscarriedoutonthematerialorarticleor,if
that is impracticable, using either specimens taken from the material or
article or, where appropriate, specimens representative of this material or
article.
The sample shall be placed in contact with the foodstuff or simulant in a
manner representing the contact conditions in actual use. For this purpose,
thetestshallbeperformedinsuchawaythatonlythosepartsofthesample
intendedtocomeintocontactwithfoodstuffsinactualusewillbeincontact
withthefoodstufforsimulant.Thisconditionisparticularlyimportantinthe
caseofmaterialsandarticlescomprisingseverallayers,forclosures,etc.
Themigrationtestingofcaps,gaskets,stoppersorsimilardevicesforsealing
mustbe carried out onthese articles byapplying them to thecontainers for
whichtheyareintendedinamannerwhichcorrespondstotheconditionsof
closinginnormalorforeseeableuse.
Itshallinallcasesbepermissibletodemonstratecompliancewithmigration
limitsbytheuseofamoreseveretest.
4. In accordance with the provisions set out in Article 8 of the present Direc-
tive, the sample of the material or article is placed in contact with the
foodstuff or appropriate simulant for a period and at a temperature which
arechosenbyreferencetothecontactconditionsinactualuse,inaccordance
with the rules laid down in Directives 82/711/EEC and 85/572/EEC. At the
endoftheprescribedtime, theanalytical determination ofthetotalquantity
ofsubstances(overallmigration)and/orthespecificquantityofoneormore
substances (specific migration) released by the sample is carried out on the
foodstufforsimulant.
5. Where a material or article is intended to come into repeated contact with
foodstuffs, the migration test(s) shall be carried out three times on a single
sample in accordance with the conditions laid down in Directive 82/711/
EEC using another sample of the food or simulant(s) on each occasion. Its
complianceshallbecheckedonthebasisofthelevelofthemigrationfound
in the third test. However, if there is conclusive proof that the level of the
migrationdoesnotincreaseinthesecondandthirdtestsandifthemigration
limit(s)is(are)notexceededonthefirsttest,nofurthertestisnecessary.2002L0072—EN—30.03.2004—002.001—9
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Special provisions relating to overall migration
6. IftheaqueoussimulantsspecifiedinDirectives82/711/EECand85/572/EEC
are used, the analytical determination of the total quantity of substances
released by the sample may be carried out by evaporation of the simulant
andweighingoftheresidue.
If rectified olive oil or any of its substitutes is used, the procedure given
belowmaybefollowed.
Thesampleofthematerialorarticleisweighedbeforeandaftercontactwith
the simulant. The simulant absorbed by the sample is extracted and deter-
mined quantitatively. The quantity of simulant found is subtracted from the
weight of the sample measured after contact with the simulant. The differ-
ence between the initial and corrected final weights represents the overall
migrationofthesampleexamined.
Where a material or article is intended to come into repeated contact with
foodstuffs and it is technically impossible to carry out the test described in
paragraph 5, modifications to that test are acceptable, provided that they
enablethelevelofmigrationoccurringduringthethirdtesttobedetermined.
Oneofthesepossiblemodificationsisdescribedbelow.
The test is carried out on three identical samples of the material or article.
Oneoftheseshallbesubjectedtotheappropriatetestandtheoverallmigra-
tiondetermined(M1).Thesecondandthirdsamplesshallbesubjectedtothe
same conditions of temperature but the period of contact shall be two and
threetimesthatspecifiedandoverallmigrationdeterminedineachcase(M2andM3,respectively).
The material or article shall be deemed to be in compliance provided that
eitherM1orM3-M2doesnotexceedtheoverallmigrationlimit.
7. A material or article that exceeds the overall migration limit by an amount
not greater than the analytical tolerance mentioned below should therefore
bedeemedtobeincompliancewiththisDirective.
Thefollowinganalyticaltoleranceshavebeenobserved:
— 20 mg/kg or 3 mg/dm2in migration tests using rectified olive oil or
substitutes,
— 12 mg/kg or 2 mg/dm2in migration tests using the other simulants
referredtoinDirectives82/711/EECand85/572/EEC.
8. WithoutprejudicetotheprovisionsofArticle3(2)ofDirective82/711/EEC,
migrationtestsusingrectifiedoliveoilorsubstitutesshallnotbecarriedout
tocheckcompliancewiththeoverallmigrationlimitincaseswherethereis
conclusive proof that the specified analytical method is inadequate from a
technicalstandpoint.
In any such case, for substances exempt from specific migration limits or
otherrestrictionsinthelistprovidedinAnnexII,agenericspecificmigration
limitof60mg/kgor10mg/dm2,accordingtothecase,isapplied.However,
the sum of all specific migrations determined shall not exceed the overall
migrationlimit.2002L0072—EN—30.03.2004—002.001—10
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ANNEX II
LIST OF MONOMERS AND OTHER STARTING SUBSTANCES
WHICH MAY BE USED IN THE MANUFACTURE OF PLASTIC MATE-
RIALS AND ARTICLES
GENERALINTRODUCTION
1. This Annex contains the list of monomers or other starting substances. The
listincludes:
— substances undergoing polymerisation, which includes polycondensation,
polyaddition or any other similar process, to manufacture macromole-
cules,
— natural or synthetic macromolecular substances used in the manufacture
of modified macromolecules, if the monomers or the other starting
substancesrequiredtosynthesisethemarenotincludedinthelist,
— substances used to modify existing natural or synthetic macromolecular
substances.
2. The list does not include the salts (including double salts and acid salts) of
aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and
zinc of the authorised acids, phenols or alcohols which are also authorised.
However,namescontaining‘…acid(s),salts’appearinthelistsifthecorre-
spondingfreeacid(s)is(are)notmentioned.Ineachcasethemeaningofthe
term ‘salts’ is ‘salts of aluminium, ammonium, calcium, iron, magnesium,
potassium,sodiumandzinc’.
3. Thelistalsodoesnotincludethefollowingsubstancesalthoughtheymaybe
present:
(a) substanceswhichcouldbepresentinthefinishedproductas:
— impuritiesinthesubstancesused,
— reactionintermediates,
— decompositionproducts;
(b) oligomersandnaturalorsyntheticmacromolecularsubstancesaswellas
theirmixtures,ifthemonomersorstartingsubstancesrequiredtosynthe-
sisethemareincludedinthelist;
(c) mixturesoftheauthorisedsubstances.
The materials and articles which contain the substances indicated under
points(a),(b)and(c)shallcomplywiththerequirementsstatedinArticle2
ofDirective89/109/EEC.
4. Substancesshallbeofgoodtechnicalqualityasregardsthepuritycriteria.5. Thelistcontainsthefollowinginformation:
— column1(Ref.No):theEECpackagingmaterialreferencenumberofthe
substancesonthelist,
— column 2 (CAS No): the CAS (Chemical Abstracts Service) registry
number,
— column3(Name):thechemicalname,
— column4(Restrictionsand/orspecifications):Thesemayinclude:
— specificmigrationlimit(SML),
— maximumpermittedquantityofthesubstanceinthefinishedmaterial
orarticle(QM),
— maximumpermittedquantityofthesubstanceinthefinishedmaterial
or article expressed as mg per 6 dm
2of the surface in contact with
foodstuffs(QMA),
— anyotherrestrictionspecificallymentioned,
— anytypeofspecificationsrelatedtothesubstanceortothepolymer.
6. If a substance appearing on the list as an individual compound is also
covered by a generic term, the restrictions applying to this substance shall
bethoseindicatedfortheindividualcompound.
7. WherethereisanyinconsistencybetweentheCASnumberandthechemical
name, the chemical name shall take precedence over the CAS number. If
thereisaninconsistencybetweentheCASnumberreportedinEINECSand
theCASRegistry,theCASnumberintheCASRegistryshallapply.2002L0072—EN—30.03.2004—002.001—11
▼C1
8. Anumberofabbreviationsorexpressionsareusedincolumn4ofthetable,
themeaningsofwhichareasfollows:
DL = Detectionlimitofthemethodofanalysis;
FP = Finishedmaterialorarticle;NCO = Isocyanatemoiety;
ND = not detectable. For the purpose of this Directive ‘not detect-
able’ 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 perfor-
mance characteristics at the detection limit may be used,
pendingthedevelopmentofavalidatedmethod;
QM = Maximumpermittedquantityofthe‘residual’substanceinthe
material or article. Forthe purpose ofthis Directive the quan-
tity of the substance in the material or article shall be
determinedbyavalidatedmethodofanalysis.Ifsuchamethod
doesnotcurrentlyexist,ananalytical methodwithappropriate
performance characteristics atthespecifiedlimit maybeused,pendingthedevelopmentofavalidatedmethod;
QM(T) = Maximumpermittedquantityofthe‘residual’substanceinthe
material orarticle expressedastotal ofmoiety orsubstance(s)
indicated. ForthepurposeofthisDirective thequantityofthe
substance in the material or article should be determined by a
validated method of analysis. If such a method does not
currently exist, an analytical method with appropriate perfor-
mance characteristics at the specified limit may be used,
pendingthedevelopmentofavalidatedmethod;
QMA = Maximumpermittedquantityofthe‘residual’substanceinthe
finished material or article expressed as mg per 6 dm
2of the
surface in contact with foodstuffs. For the purpose of this
Directive the quantity of the substance in the surface of the
materialorarticleshouldbedeterminedbyavalidatedmethod
ofanalysis.Ifsuchamethoddoesnotcurrentlyexist,ananaly-
ticalmethodwithappropriateperformancecharacteristicsatthe
specifiedlimitmaybeused,pendingthedevelopmentofavali-
datedmethod;
QMA(T) = Maximumpermittedquantityofthe‘residual’substanceinthe
material or article expressed as mg of total of moiety or
substance(s)indicatedper6dm2ofthesurfaceincontactwith
foodstuffs.ForthepurposeofthisDirectivethequantityofthe
substance in the surface of the material or article should be
determinedbyavalidatedmethodofanalysis.Ifsuchamethod
doesnotcurrentlyexist,ananalytical methodwithappropriate
performance characteristics atthespecifiedlimit maybeused,
pendingthedevelopmentofavalidatedmethod;
SML = Specificmigrationlimitinfoodorinfoodsimulant,unlessitis
specified otherwise. For the purpose of this Directive the
specific migration of the substance should be determined by a
validated method of analysis. If such a method does not
currently exist, an analytical method with appropriate perfor-
mance characteristics at the specified limit may be used,
pendingthedevelopmentofavalidatedmethod;
SML(T) = Specific migration limit in food or in food simulant expressed
astotalofmoietyorsubstance(s)indicated.Forthepurposeof
this Directive the specific migration of the substances should
be determined by a validated method of analysis. If such a
method does not currently exist, an analytical method with
appropriate performance characteristics at the specified limit
maybeused,pendingthedevelopmentofavalidatedmethod.2002L0072—EN—30.03.2004—002.001—12
▼M2
▼C1
▼C1
Section A
List of authorised monomers and other starting substances
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
10030 000514-10-3 Abieticacid
10060 000075-07-0 Acetaldehyde SML(T)=6mg/kg(2)
10090 000064-19-7 Aceticacid
10120 000108-05-4 Aceticacid,vinylester SML=12mg/kg
10150 000108-24-7 Aceticanhydride
10210 000074-86-2 Acetylene
10599/
90A061788-89-4 Acids,fatty,unsaturated(C18),dimers,
distilledQMA(T)=0,05mg/6dm2
(27)
10599/
91061788-89-4 Acids,fatty,unsaturated(C18),dimers,non
distilledQMA(T)=0,05mg/6dm2
(27)
10599/
92A068783-41-5 Acids,fatty,unsaturated(C18),dimers,
hydrogenated,distilledQMA(T)=0,05mg/6dm2
(27)
10599/
93068783-41-5 Acids,fatty,unsaturated(C18),dimers,
hydrogenated,nondistilledQMA(T)=0,05mg/6dm2
(27)
10630 000079-06-1 Acrylamide SML=ND(DL=0,01mg/
kg)
10660 015214-89-8 2-Acrylamido-2-methylpropanesulphonic
acidSML=0,05mg/kg
10690 000079-10-7 Acrylicacid
10750 002495-35-4 Acrylicacid,benzylester
10780 000141-32-2 Acrylicacid,n-butylester10810 002998-08-5 Acrylicacid,sec-butylester
10840 001663-39-4 Acrylicacid,tert-butylester
11000 050976-02-8 Acrylicacid,dicyclopentadienylester QMA=0,05mg/6dm
2
11245 002156-97-0 Acrylicacid,dodecylester SML=0,05mg/kg(1)
11470 000140-88-5 Acrylicacid,ethylester11510 000818-61-1 Acrylicacid,hydroxyethylester See‘Acrylicacid,monoester
withethyleneglycol’
11530 ►
M200999-
61-1◄Acrylicacid,2-hydroxypropylester ►M2QMA=0,05mg/
6dm2forthesumofacrylic
acid,2-hydroxypropylester
andacrylicacid,2-hydroxyi-
sopropylesterandin
compliancewiththespecifi-
cationslaiddowninAnnex
V◄
11590 000106-63-8 Acrylicacid,isobutylester11680 000689-12-3 Acrylicacid,isopropylester2002L0072—EN—30.03.2004—002.001—13
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
11710 000096-33-3 Acrylicacid,methylester
11830 000818-61-1 Acrylicacid,monoesterwithethylene-
glycol
11890 002499-59-4 Acrylicacid,n-octylester
11980 000925-60-0 Acrylicacid,propylester12100 000107-13-1 Acrylonitrile SML=ND(DL=0,020mg/
kg,analyticaltolerance
included)
12130 000124-04-9 Adipicacid
12265 004074-90-2 Adipicacid,divinylester QM=5mg/kginFP.Oruse
onlyascomonomer
12280 002035-75-8 Adipicanhydride
12310 Albumin
12340 Albumin,coagulatedbyformaldehyde
12375 Alcohols,aliphatic,monohydric,saturated,
linear,primary(C
4-C22)
12670 002855-13-2 1-Amino-3-aminomethyl-3,5,5-trimethylcy-
clohexaneSML=6mg/kg
12761 000693-57-2 12-Aminododecanoicacid SML=0,05mg/kg
12763 000141-43-5 2-Aminoethanol SML=0,05mg/kg.Notfor
useinpolymerscontacting
foodsforwhichsimulantD
islaiddowninDirective85/
572/EECandforindirect
foodcontactonly,behindthe
PETlayer
12765 084434-12-8 N-(2-Aminoethyl)-beta-alanine,sodiumsalt SML=0,05mg/kg
12788 002432-99-7 11-Aminoundecanoicacid SML=5mg/kg
12789 007664-41-7 Ammonia12820 000123-99-9 Azelaicacid
12970 004196-95-6 Azelaicanhydride
13000 001477-55-0 1,3-Benzenedimethanamine SML=0,05mg/kg13060 004422-95-1 1,3,5-Benzenetricarboxylicacidtrichloride QMA=0,05mg/6dm
2
(measuredas1,3,5-Benzene-
tricarboxylicacid)
13075 000091-76-9 Benzoguanamine See‘2,4-Diamino-6-phenyl-
1,3,5-triazine’
13090 000065-85-0 Benzoicacid
13150 000100-51-6 Benzylalcohol13180 000498-66-8 Bicyclo[2.2.1]hept-2-ene(=Norbornene) SML=0,05mg/kg
13210 001761-71-3 Bis(4-aminocyclohexyl)methane SML=0,05mg/kg2002L0072—EN—30.03.2004—002.001—14
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
13323 000102-40-9 1,3-Bis(2-hydroxyethoxy)benzene SML=0,05mg/kg
13326 000111-46-6 Bis(2-hydroxyethyl)ether See‘Diethyleneglycol’
13380 000077-99-6 2,2-Bis(hydroxymethyl)-1-butanol See‘1,1,1-Trimethylolpro-
pane’
13390 000105-08-8 1,4-Bis(hydroxymethyl)cyclohexane13395 004767-03-7 2,2-Bis(hydroxymethyl)propionicacid QMA=0,05mg/6dm
2
13480 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane ►M2SML(T)=0,6mg/kg
(28)◄
13510 001675-54-3 2,2-Bis(4-hydroxyphenyl)propanebis(2,3-
epoxypropyl)ether(=BADGE)AccordingtoCommission
Directive2002/16/ECof20
February2002ontheuseof
certainepoxyderivativesin
materialsandarticles
intendedtocomeintocontact
withfoodstuffs(OJL51,
22.2.2002,p.27)
13530 038103-06-9 2,2-Bis(4-hydroxyphenyl)propane
bis(phthalicanhydride)SML=0,05mg/kg
13550 000110-98-5 Bis(hydroxypropyl)ether See‘Dipropyleneglycol’
13560 0005124-30-1 Bis(4-isocyanatocyclohexyl)methane See‘Dicyclohexylmethane-
4,4′-diisocyanate’
13600 047465-97-4 3,3-Bis(3-methyl-4-hydroxyphenyl)2-indo-
linoneSML=1,8mg/kg
13607 000080-05-7 BisphenolA See‘2,2-Bis(4-hydroxyphe-
nyl)propane’
13610 001675-54-3 BisphenolAbis(2,3-epoxypropyl)ether See‘2,2-Bis(4-hydroxyphe-
nyl)propanebis(2,3-epoxy-
propyl)ether’
13614 038103-06-9 BisphenolAbis(phthalicanhydride) See‘2,2-Bis(4-hydroxyphe-
nyl)propanebis(phthalic
anhydride)’
13617 000080-09-1 BisphenolS See‘4,4 ′-Dihydroxydiphenyl
sulphone’
13620 010043-35-3 Boricacid SML(T)=6mg/kg(23)
(expressedasBoron)without
prejudicetotheprovisionsof
Directive98/83/EConwater
forhumanconsumption(OJ
L330,5.12.1998,p.32).
13630 000106-99-0 Butadiene QM=1mg/kginFPor
SML=notdetectable
(DL=0,020mg/kg,analy-
ticaltoleranceincluded)
13690 000107-88-0 1,3-Butanediol13720 000110-63-4 1,4-Butanediol SML(T)=0,05mg/kg(
24)2002L0072—EN—30.03.2004—002.001—15
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
13780 002425-79-8 1,4-Butanediolbis(2,3-epoxypropyl)ether QM=1mg/kginFP
(expressedasEpoxygroup,
Mw=43)
13810 000505-65-7 1,4-Butanediolformal QMA=0,05mg/6dm2
13840 000071-36-3 1-Butanol13870 000106-98-9 1-Butene
13900 000107-01-7 2-Butene
13932 000598-32-3 3-Buten-2-ol QMA=ND(DL=0,02mg/
6dm
2)Tobeusedonlyasa
comonomerfortheprepara-
tionofpolymericadditive
14020 000098-54-4 4-tert-Butylphenol SML=0,05mg/kg
14110 000123-72-8 Butyraldehyde
14140 000107-92-6 Butyricacid14170 000106-31-0 Butyricanhydride
14200 000105-60-2 CaprolactamSML(T)=15m g/kg(
5)
14230 002123-24-2 Caprolactam,sodiumsalt SML(T)=15mg/kg(5)
(expressedasCaprolactam)
14320 000124-07-2 Caprylicacid
14350 000630-08-0 Carbonmonoxide
14380 000075-44-5 Carbonylchloride QM=1mg/kginFP
14411 008001-79-4 Castoroil
14500 009004-34-6 Cellulose
14530 007782-50-5 Chlorine
14570 000106-89-8 1-Chloro-2,3-epoxypropane See‘Epichlorohydrin’14650 000079-38-9 Chlorotrifluoroethylene QMA=0,5mg/6dm
2
14680 000077-92-9 Citricacid14710 000108-39-4 m-Cresol
14740 000095-48-7 o-Cresol
14770 000106-44-5 p-Cresol
14800 003724-65-0 Crotonicacid QMA(T)=0,05mg/6dm
2
(33)
14841 000599-64-4 4-Cumylphenol SML=0,05mg/kg
14880 000105-08-8 1,4-Cyclohexanedimethanol See‘1,4-Bis(hydroxy-
methyl)cyclohexane’2002L0072—EN—30.03.2004—002.001—16
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
14950 003173-53-3 Cyclohexylisocyanate ►M2QM(T)=1mg/kgin
FP(expressedasNCO)
(26)◄
15030 000931-88-4 Cyclooctene SML=0,05mg/kg.Foruse
onlyinpolymerscontacting
foodsforwhichsimulantA
islaiddowninDirective85/
572/EEC
15070 001647-16-1 1,9-Decadiene SML=0,05mg/kg15095 000334-48-5 Decanoicacid
15100 000112-30-1 1-Decanol
15130 000872-05-9 1-Decene SML=0,05mg/kg15250 000110-60-1 1,4-Diaminobutane
15272 000107-15-3 1,2-Diaminoethane See‘Ethylenediamine’
15274 000124-09-4 1,6-Diaminohexane See‘Hexamethylenediamine’
15310 000091-76-9 2,4-Diamino-6-phenyl-1,3,5-triazine QMA=5mg/6dm
2
15565 000106-46-7 1,4-Dichlorobenzene SML=12mg/kg15610 000080-07-9 4,4 ′-Dichlorodiphenylsulphone SML=0,05mg/kg
15700 005124-30-1 Dicyclohexylmethane-4,4 ′-diisocyanate QM(T)=1mg/kg(expressed
asNCO(
26)
15760 000111-46-6 Diethyleneglycol SML(T)=30mg/kg(3)
15790 000111-40-0 Diethylenetriamine SML=5mg/kg
15820 000345-92-6 4,4 ′-Difluorobenzophenone SML=0,05mg/kg
15880 000120-80-9 1,2-Dihydroxybenzene SML=6mg/kg15910 000108-46-3 1,3-Dihydroxybenzene SML=2,4mg/kg
15940 000123-31-9 1,4-Dihydroxybenzene SML=0,6mg/kg
15970 000611-99-4 4,4 ′-Dihydroxybenzophenone SML(T)=6mg/kg(
15)
16000 000092-88-6 4,4 ′-Dihydroxybiphenyl SML=6mg/kg
16090 000080-09-1 4,4 ′-Dihydroxydiphenylsulphone SML=0,05mg/kg
16150 000108-01-0 Dimethylaminoethanol SML=18mg/kg
16210 006864-37-5 3,3'-Dimethyl-4,4'-diaminodicyclohexyl-
methaneSML=0,05mg/kg(32).To
beusedonlyinpolyamides.
16240 000091-97-4 3,3 ′-Dimethyl-4,4 ′-diisocyanatobiphenyl QM(T)=1mg/kg(expressed
asNCO)(26)
16360 000576-26-1 2,6-Dimethylphenol SML=0,05mg/kg2002L0072—EN—30.03.2004—002.001—17
▼M2
▼C1
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
16390 000126-30-7 2,2-Dimethyl-1,3-propanediol SML=0,05mg/kg
16450 000646-06-0 1,3-Dioxolane SML=0,05mg/kg
16480 000126-58-9 Dipentaerythritol
16540 000102-09-0 Diphenylcarbonate SML=0,05mg/kg16570 004128-73-8 Diphenylether-4,4 ′-diisocyanate QM(T)=1mg/kg(expressed
asNCO)(
26)
16600 005873-54-1 Diphenylmethane-2,4 ′-diisocyanate QM(T)=1mg/kg(expressed
asNCO)(26)
16630 000101-68-8 Diphenylmethane-4,4 ′-diisocyanate QM(T)=1mg/kg(expressed
asNCO)(26)
16650 000127-63-9 Diphenylsulphone SML(T)=3mg/kg(25)
16660 000110-98-5 Dipropyleneglycol
16690 001321-74-0 Divinylbenzene QMA=0,01mg/6dm2or
SML=ND(DL=0,02mg/
kg,analyticaltolerance
included)forthesumof
divinylbenzeneandethylvi-
nylbenzeneandincompli-
ancewiththespecifications
laiddowninAnnexV
16694 013811-50-2 N,N ′-Divinyl-2-imidazolidinone QM=5mg/kginFP
16697 000693-23-2 n-Dodecanedioicacid
16704 000112-41-4 1-Dodecene SML=0,05mg/kg
16750 000106-89-8 Epichlorohydrin QM=1mg/kginFP16780 000064-17-5 Ethanol
16950 000074-85-1 Ethylene
16960 000107-15-3 Ethylenediamine SML=12mg/kg16990 000107-21-1 Ethyleneglycol SML(T)=30mg/kg(
3)
17005 000151-56-4 Ethyleneneimine SML=ND(DL=0,01mg/
kg)
17020 000075-21-8 Ethyleneoxide QM=1mg/kginFP
17050 000104-76-7 2-Ethyl-1-hexanol SML=30mg/kg
17110 016219-75-3 5-Ethylidenebicyclo[2,2,1]hept-2-ene QMA=0,05mg/6dm2.The
ratiosurface/quantityoffood
shallbelowerthan2dm2/kg
17160 000097-53-0 Eugenol SML=ND(DL=0,02mg/
kg,analyticaltolerance
included)
17170 061788-47-4 Fattyacids,coco2002L0072—EN—30.03.2004—002.001—18
▼M2
▼C1
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
17200 068308-53-2 Fattyacids,soya
17230 061790-12-3 Fattyacids,talloil17260 000050-00-0 Formaldehyde SML(T)=15mg/kg(
22)
17290 000110-17-8 Fumaricacid
17530 000050-99-7 Glucose18010 000110-94-1 Glutaricacid
18070 000108-55-4 Glutaricanhydride
18100 000056-81-5 Glycerol18220 068564-88-5 N-Heptylaminoundecanoicacid SML=0,05mg/kg(
1)
18250 000115-28-6 Hexachloroendomethylenetetrahydroph-
thalicacidSML=ND(DL=0,01mg/
kg)
18280 000115-27-5 Hexachloroendomethylenetetrahydroph-
thalicanhydrideSML=ND(DL=0,01mg/
kg)
18310 036653-82-4 1-Hexadecanol
18430 000116-15-4 Hexafluoropropylene SML=ND(DL=0,01mg/
kg)
18460 000124-09-4 Hexamethylenediamine SML=2,4mg/kg
18640 000822-06-0 Hexamethylenediisocyanate QM(T)=1mg/kg(expressed
asNCO)(26)
18670 000100-97-0 Hexamethylenetetramine SML(T)=15mg/kg(22)
(expressedasFormaldehyde)
18700 000629-11-8 1,6-Hexanediol SML=0,05mg/kg18820 000592-41-6 1-Hexene SML=3mg/kg
18867 000123-31-9 Hydroquinone See‘1,4-Dihydroxybenzene’18880 000099-96-7 p-Hydroxybenzoicacid
18896 001679-51-2 4-(Hydroxymethyl)-1-cyclohexene SML=0,05mg/kg18897 016712-64-4 6-Hydroxy-2-naphthalenecarboxylicacid SML=0,05mg/kg
18898 000103-90-2 N-(4-Hydroxyphenyl)acetamide ►
M2SML=0,05mg/
kg◄
19000 000115-11-7 Isobutene19060 000109-53-5 Isobutylvinylether QM=5mg/kginFP
19110 004098-71-9 1-Isocyanato-3-isocyanatomethyl-3,5,5-
trimethylcyclohexaneQM(T)=1mg/kg(expressed
asNCO)(
26)
19150 000121-91-5 Isophthalicacid SML=5mg/kg2002L0072—EN—30.03.2004—002.001—19
▼M2
▼C1
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
19210 001459-93-4 Isophthalicacid,dimethylester SML=0,05mg/kg
19243 000078-79-5 Isoprene See‘2-Methyl-1,3-butadiene’
19270 000097-65-4 Itaconicacid
19460 000050-21-5 Lacticacid
19470 000143-07-7 Lauricacid
19480 002146-71-6 Lauricacid,vinylester
19490 000947-04-6 LaurolactamSML=5m g/kg
19510 011132-73-3 Lignocellulose19540 000110-16-7 Maleicacid SML(T)=30mg/kg(
4)
19960 000108-31-6 Maleicanhydride SML(T)=30mg/kg(4)
(expressedasmaleicacid)
19975 000108-78-1 Melamine See‘2,4,6-triamino-1,3,5-
triazine’
19990 000079-39-0 Methacrylamide SML=ND(DL=0,02mg/
kg,analyticaltolerance
included)
20020 000079-41-4 Methacrylicacid
20050 000096-05-9 Methacrylicacid,allylester SML=0,05mg/kg
20080 002495-37-6 Methacrylicacid,benzylester
20110 000097-88-1 Methacrylicacid,butylester
20140 002998-18-7 Methacrylicacid,sec-butylester
20170 000585-07-9 Methacrylicacid,tert-butylester
20260 000101-43-9 Methacrylicacid,cyclohexylester SML=0,05mg/kg20410 002082-81-7 Methacrylicacid,diesterwith1,4-butane-
diolSML=0,05mg/kg
20440 000097-90-5 Methacrylicacid,diesterwithethylene-
glycolSML=0,05mg/kg
20530 002867-47-2 Methacrylicacid,2-(dimethylamino)-ethyl
esterSML=ND(DL=0,02mg/
kg,analyticaltolerance
included)
20590 000106-91-2 Methacrylicacid,2,3-epoxypropylester QMA=0,02mg/6dm
2
20890 000097-63-2 Methacrylicacid,ethylester21010 000097-86-9 Methacrylicacid,isobutylester
21100 004655-34-9 Methacrylicacid,isopropylester
21130 000080-62-6 Methacrylicacid,methylester2002L0072—EN—30.03.2004—002.001—20
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
21190 000868-77-9 Methacrylicacid,monoesterwithethylene-
glycol
21280 002177-70-0 Methacrylicacid,phenylester
21340 002210-28-8 Methacrylicacid,propylester
21400 054276-35-6 Methacrylicacid,sulphopropylester QMA=0,05mg/6dm2
21460 000760-93-0 Methacrylicanhydride
21490 000126-98-7 Methacrylonitrile SML=ND(DL=0,020mg/
kg,analyticaltolerance
included)
21520 001561-92-8 Methallylsulphonicacid,sodiumsalt SML=5mg/kg
21550 000067-56-1 Methanol
21640 000078-79-5 2-Methyl-1,3-butadiene QM=1mg/kginFPor
SML=ND(DL=0,02mg/
kg,analyticaltolerance
included)
21730 000563-45-1 3-Methyl-1-butene QMA=0,006mg/6dm2.For
useonlyinPolypropylene
21765 106246-33-7 4,4 ′-Methylenebis(3-chloro-2,6-diethylani-
line)QMA=0,05mg/6dm2
21821 000505-65-7 1,4-(Methylenedioxy)butane See‘1,4-Butanediolformal’
21940 000924-42-5 N-Methylolacrylamide SML=ND(DL=0,01mg/
kg)
22150 000691-37-2 4-Methyl-1-pentene ►M2SML=0,05mg/
kg◄
22331 025513-64-8 ►M2Mixtureof(35-45%w/w)1,6-
diamino-2,2,4-trimethylhexane and(55-
65%w/w)1,6-diamino-2,4,4-
trimethylhexane ◄QMA=5mg/6dm2
22332 ►M2—◄Mixtureof(40%w/w)2,2,4-trimethyl-
hexane-1,6-diisocyanateand(60%w/w)
2,4,4-trimethylhexane-1,6-diisocyanateQM(T)=1mg/kg(expressed
asNCO)(26)
22350 000544-63-8 Myristicacid
22360 001141-38-4 2,6-Naphthalenedicarboxylicacid SML=5mg/kg
22390 000840-65-3 2,6-Naphthalenedicarboxylicacid,dimethyl
esterSML=0,05mg/kg
22420 003173-72-6 1,5-Naphthalenediisocyanate QM(T)=1mg/kg(expressed
asNCO)(26)
22437 000126-30-7 Neopentylglycol See‘2,2-Dimethyl-1,3-propa-
nediol’
22450 009004-70-0 Nitrocellulose
22480 000143-08-8 1-Nonanol2002L0072—EN—30.03.2004—002.001—21
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
22550 000498-66-8 Norbornene See‘Bicyclo[2.2.1]hept-2-
ene’
22570 000112-96-9 Octadecylisocyanate QM(T)=1mg/kg(expressed
asNCO)(26)
22600 000111-87-5 1-Octanol22660 000111-66-0 1-Octene SML=15mg/kg
22763 000112-80-1 Oleicacid
22775 000144-62-7 Oxalicacid SML(T)=6mg/kg(
29)
22778 007456-68-0 4,4 ′-Oxybis(benzenesulphonylazide) QMA=0,05mg/6dm2
22780 000057-10-3 Palmiticacid
22840 000115-77-5 Pentaerythritol22870 000071-41-0 1-Pentanol
22900 000109-67-1 1-Pentene SML=5mg/kg
22937 001623-05-8 Perfluoropropylperfluorovinylether SML=0,05mg/kg22960 000108-95-2 Phenol23050 000108-45-2 1,3-Phenylenediamine SML=ND(DL=0,02mg/
kg,analyticaltolerance
included)
23070 000102-39-6 (1,3-Phenylenedioxy)diaceticacid QMA=0,05mg/6dm
2
23155 000075-44-5 Phosgene See‘Carbonylchloride’
23170 007664-38-2 Phosphoricacid23175 000122-52-1 Phosphorousacid,triethylester QM=ND(DL=1mg/kgin
FP)
23187 Phthalicacid See‘Terephthalicacid’
23200 000088-99-3 o-Phthalicacid23230 000131-17-9 Phthalicacid,diallylester SML=ND(DL=0,01mg/
kg)
23380 000085-44-9 Phthalicanhydride23470 000080-56-8 alpha-Pinene23500 000127-91-3 beta-Pinene23547 009016-00-6
063148-62-9Polydimethylsiloxane(Mw>6800) Incompliancewiththe
specificationslaiddownin
AnnexV
23590 025322-68-3 Polyethyleneglycol
23651 025322-69-4 Polypropyleneglycol2002L0072—EN—30.03.2004—002.001—22
▼M2
▼C1
▼M2
▼C1
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
23740 000057-55-6 1,2-Propanediol
23770 000504-63-2 1,3-Propanediol SML=0,05mg/kg23800 000071-23-8 1-Propanol
23830 000067-63-0 2-Propanol
23860 000123-38-6 Propionaldehyde23890 000079-09-4 Propionicacid
23920 000105-38-4 Propionicacid,vinylester SML(T)=6mg/kg(
2)
(expressedasAcetaldehyde)
23950 000123-62-6 Propionicanhydride
23980 000115-07-1 Propylene24010 000075-56-9 Propyleneoxide QM=1mg/kginFP
24051 000120-80-9 Pyrocatechol See‘1,2-Dihydroxybenzene’
24057 000089-32-7 Pyromelliticanhydride SML=0,05mg/kg
(expressedasPyromellitic
acid)
24070 073138-82-6 ResinacidsandRosinacids24072 000108-46-3 Resorcinol See‘1,3-Dihydroxybenzene’
24073 000101-90-6 Resorcinoldiglycidylether QMA=0,005mg/6dm
2.Not
foruseinpolymers
contactingfoodsforwhich
simulantDislaiddownin
Directive85/572/EECand
forindirectfoodcontact
only,behindthePETlayer.
24100 008050-09-7 Rosin24130 008050-09-7 RosingumSee‘Rosin’
24160 008052-10-6 Rosintalloil
24190 ►
M2
065997-05-9
◄Rosinwood
24250 009006-04-6 Rubber,natural
24270 000069-72-7 Salicylicacid
24280 000111-20-6 Sebacicacid24430 002561-88-8 Sebacicanhydride
24475 001313-82-2 Sodiumsulphide
24490 000050-70-4 Sorbitol24520 008001-22-7 Soybeanoil
24540 009005-25-8 Starch,edible2002L0072—EN—30.03.2004—002.001—23
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
24550 000057-11-4 Stearicacid
24610 000100-42-5 Styrene24760 026914-43-2 Styrenesuphonicacid SML=0,05mg/kg24820 000110-15-6 Succinicacid
24850 000108-30-5 Succinicanhydride
24880 000057-50-1 Sucrose24887 006362-79-4 5-Sulphoisophthalicacid,monosodiumsalt SML=5mg/kg24888 003965-55-7 5-Sulphoisophthalicacid,monosodiumsalt,
dimethylesterSML=0,05mg/kg
24910 000100-21-0 Terephthalicacid SML=7,5mg/kg
24940 000100-20-9 Terephthalicaciddichloride SML(T)=7,5mg/kg
(expressedasTerephthalic
acid)
24970 000120-61-6 Terephthalicacid,dimethylester25080 001120-36-1 1-Tetradecene SML=0,05mg/kg
25090 000112-60-7 Tetraethyleneglycol
25120 000116-14-3 Tetrafluoroethylene SML=0,05mg/kg25150 000109-99-9 Tetrahydrofuran SML=0,6mg/kg25180 000102-60-3 N,N,N ′,N′,-Tetrakis(2-hydroxypropyl)ethy-
lenediamine
25210 000584-84-9 2,4-Toluenediisocyanate QM(T)=1mg/kg(expressed
asNCO)(
26)
25240 000091-08-7 2,6-Toluenediisocyanate QM(T)=1mg/kg(expressed
asNCO)(26)
25270 026747-90-0 2,4-Toluenediisocyanatedimer QM(T)=1mg/kg(expressed
asNCO)(26)
25360 Trialkyl(C5-C15)aceticacid,2,3-epoxy-
propylesterQM=1mg/kginFP
(expressedasEpoxygroup,
Mw=43)
25380 — Trialkylaceticacid(C7-C17),vinylesters
(=Vinylversatate)QMA=0,05mg/6dm2
25385 000102-70-5 Triallyamine Incompliancewiththe
specificationslaiddownin
AnnexV
25420 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML=30mg/kg25450 026896-48-0 Tricyclodecanedimethanol SML=0,05mg/kg25510 000112-27-6 Triethyleneglycol25600 000077-99-6 1,1,1-Trimethylolpropane SML=6mg/kg
25840 003290-92-4 1,1,1-Trimethylolpropanetrimethacrylate SML=0,05mg/kg2002L0072—EN—30.03.2004—002.001—24
▼C1
Ref.
No.CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
25900 000110-88-3 Trioxane SML=0,05mg/kg
25910 024800-44-0 Tripropyleneglycol
25927 027955-94-8 1,1,1-Tris(4-hydroxyphenol)ethane QM=0,5mg/kginFP.For
useonlyinpolycarbonates
25960 000057-13-6 Urea26050 000075-01-4 Vinylchloride SeeCouncilDirective78/
142/EEC
26110 000075-35-4 Vinylidenechloride QM=5mg/kginFPor
SML=ND(DL=0,05mg/
kg)
26140 000075-38-7 Vinylidenefluoride SML=5mg/kg
26155 001072-63-5 1-Vinylimidazole QM=5mg/kginFP
26170 003195-78-6 N-Vinyl-N-methylacetamide QM=2mg/kginFP
26320 002768-02-7 Vinyltrimethoxysilane QM=5mg/kginFP
26360 007732-18-5 Water IncompliancewithDirective
98/83/EC2002L0072—EN—30.03.2004—002.001—25
▼C1
Section B
List of monomers and other starting substances which may continue to be used pending a deci-
sion on inclusion in Section A
Ref.No CASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
11500 000103-11-7 Acrylicacid,2-ethylhexylester
13050 000528-44-9 1,2,4-Benzenetricarboxylicacid See‘Trimelliticacid’
14260 000502-44-3 Caprolactone
15730 000077-73-6 Dicyclopentadiene
18370 000592-45-0 1,4-Hexadiene
21370 010595-80-9 Methacrylicacid,2-sulphoethylester
21970 000923-02-4 N-Methylolmethacrylamide22210 000098-83-9 alpha-Methylstyrene25540 000528-44-9 Trimelliticacid QM(T)=5mg/kginFP
25550 000552-30-7 Trimelliticanhydride QM(T)=5mg/kginFP
(expressedasTrimellitic
acid)
26230 000088-12-0 Vinylpyrrolidone2002L0072—EN—30.03.2004—002.001—26
▼M2
▼C1
▼M2
▼C1
▼M2
▼C1
▼M2
▼C1
▼M2
▼C1
▼C1
ANNEX III
INCOMPLETE LIST OF ADDITIVES WHICH MAY BE USED IN THE
MANUFACTURE OF PLASTIC MATERIALS AND ARTICLES
GENERALINTRODUCTION
1. ThisAnnexcontainsthelistof:
(a) substances which are incorporated into plastics to achieve a technical
effect in the finished product, including ‘polymeric additives’. They are
intendedtobepresentinthefinishedarticles;
(b) substances used to provide a suitable medium in which polymerisation
occurs.
ForthepurposesofthisAnnex,thesubstancesreferredtoin(a)and(b)are
hereinafterreferredtoas‘additives’.
For the purpose of this Annex, ‘Polymeric additives’ means any polymer
and/or prepolymerand/or oligomer whichmaybeadded toplasticsinorder
to achieve a technical effect but which cannot be used in absence of other
polymersasthemainstructuralcomponentoffinishedmaterialsandarticles.
It includes also substances which may be added to the medium in which
polymerisationoccurs.
Thelistdoesnotinclude:
(a) thesubstanceswhichdirectlyinfluencetheformationofpolymers;
(b) colorants;
(c) solvents.
2. The list does not include the salts (including double salts and acid salts) of
aluminium, ammonium, calcium, iron, magnesium, potassium, sodium and
zinc of the authorised acids, phenols or alcohols which are also authorised.
However,namescontaining‘…acid(s),salts’appearinthelistsifthecorre-
spondingfreeacid(s)is(are)notmentioned.Insuchcasesthemeaningofthe
term ‘salts’ is ‘salts of aluminium ammonium, calcium, iron, magnesium,
potassium,sodiumandzinc’.
3. The list does not include the following substances although they may be
present:
(a) substanceswhichcouldbepresentinthefinishedproductsuchas:
— impuritiesinthesubstancesused,
— reactionintermediates,— decompositionproducts;
(b) mixturesoftheauthorisedsubstances.
The materials andarticles whichcontain the substancesindicated in(a)and
(b)shallcomplywiththerequirementsstatedinarticle2ofDirective89/109/
EEC.
4. Substancesshallbeofgoodtechnicalqualityasregardsthepuritycriteria.
5. Thelistcontainsthefollowinginformation:
— column1(Ref.No):theEECpackagingmaterialreferencenumberofthe
substancesonthelist,
— column 2 (CAS No): the CAS (Chemical Abstracts Service) registry
number,
— column3(Name):thechemicalname,— column4(Restrictionsand/orspecifications).Thesemayinclude:
— specificmigrationlimit(SML),
— maximumpermittedquantityofthesubstanceinthefinishedmaterial
orarticle(QM),
— maximumpermittedquantityofthesubstanceinthefinishedmaterial
or article expressed as mg per 6 dm
2of the surface in contact with
foodstuffs(QMA),
— anyotherrestrictionspecificallylaiddown,— anytypeofspecificationrelatedtothesubstanceorpolymer.2002L0072—EN—30.03.2004—002.001—27
▼M2
▼C1
▼C1
6. If a substance appearing on the list as an individual compound is also
covered by a generic term, the restrictions applying to this substance shall
bethoseindicatedfortheindividualcompound.
7. WherethereisanyinconsistencybetweentheCASnumberandthechemical
name, the chemical name shall take precedence over the CAS number. If
thereisaninconsistencybetweentheCASnumberreportedinEINECSand
theCASregistry,theCASnumberintheCASregistryshallapply.
Section A
Incomplete list of additives fully harmonised at Community level
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
30000 000064-19-7 Aceticacid
30045 000123-86-4 Aceticacid,butylester
30080 004180-12-5 Aceticacid,coppersalt SML(T)=30mg/kg(7)
(expressedasCopper)
30140 000141-78-6 Aceticacid,ethylester30280 000108-24-7 Aceticanhydride
30295 000067-64-1 Acetone
30370 — Acetylaceticacid,salts
30400 — Acetylatedglycerides
30610 — Acids,C
2-C24,aliphatic,linear,monocar-
boxylicfromnaturaloilsandfats,andtheir
mono-,di-andtriglycerolesters(branched
fattyacidsatnaturallyoccuringlevelsare
included)
30612 — Acids,C2-C24,aliphatic,linear,monocar-
boxylic,syntheticandtheirmono-,di-and
triglycerolesters
30960 — Acids,aliph.,monocarb.(C6-C22),esters
withpolyglycerol
31328 — Acids,fatty,fromanimalorvegetablefood
fatsandoils
31530 123968-25-2 Acrylicacid,2,4-di-tert-pentyl-6-(1-(3,5-di-
tert-pentyl-2-hydroxyphenyl)ethyl)phenyl
esterSML=5mg/kg
31730 000124-04-9 Adipicacid
33120 — Alcohols,aliph,monoh.,sat.,linear,
primary(C4-C24)
33350 009005-32-7 Alginicacid
33801 — n-Alkyl(C10-C13)benzenesulphonicacid SML=30mg/kg
34240 — Alkyl(C10-C20)sulphonicacid,esterswith
phenolsSML=6mg/kg.Authorised
until1January2002
34281 — Alkyl(C8-C22)sulphuricacids,linear,
primarywithanevennumberofcarbon
atoms
34475 — Aluminumcalciumhydroxidephosphite,
hydrate2002L0072—EN—30.03.2004—002.001—28
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
34480 — Aluminiumfibers,flakesandpowders
34560 021645-51-2 Aluminiumhydroxide34690 011097-59-9 Aluminiummagnesiumcarbonatehydro-
xide
34720 001344-28-1 Aluminiumoxide
34850 143925-92-2 Amines,bis(hydrogenatedtallowalkyl)
oxidisedQM=Foruseonly:
(a) in polyolefines at 0,1 %
(w/w)butnotinLDPE
whenitisincontactwith
foodsforwhichthe
Directive85/572/EEC
establishesareduction
factorlessthan3;
(b) in PETat 0,25 % (w/w)
incontactwithfoods
otherofthoseforwhich
thesimulantDislaid
downinDirective85/
572/EEC85/572/EEC
34895 000088-68-6 2-Aminobenzamide SML=0,05mg/kg.Tobe
usedonlyforPETforwater
andbeverages
35120 013560-49-1 3-Aminocrotonicacid,diesterwiththiobis
(2-hydroxyethyl)ether
35160 006642-31-5 6-Amino-1,3-dimethyluracil SML=5mg/kg
35170 000141-43-5 2-Aminoethanol SML=0,05mg/kg.Notfor
useinpolymerscontacting
foodsforwhichsimulantD
islaiddowninDirective85/
572/EECandforindirect
foodcontactonly,behindthe
PETlayer
35284 000111-41-1 N-(2-aminoethyl)ethanolamine SML=0,05mg/kg.Notfor
useinpolymerscontacting
foodsforwhichsimulantD
islaiddowninDirective85/
572/EECandforindirect
foodcontactonly,behindthe
PETlayer.
35320 007664-41-7 Ammonia
35440 001214-97-9 Ammoniumbromide35600 001336-21-6 Ammoniumhydroxide
35840 000506-30-9 Arachidicacid
35845 007771-44-0 Arachidonicacid36000 000050-81-7 Ascorbicacid
36080 000137-66-6 Ascorbylpalmitate
36160 010605-09-1 Ascorbylstearate2002L0072—EN—30.03.2004—002.001—29
▼M2
▼C1
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
36640 000123-77-3 Azodicarbonamide ►M1Foruseonlyas
blowingagent.Useprohib-
itedasfrom2August
2005.◄
36840 012007-55-5 Bariumtetraborate SML(T)=1mg/kg
expressedasBarium(12)and
SML(T)=6mg/kg(23)
expressedasBoron)without
prejudicetotheprovisionsof
Directive98/83/EConwater
forhumanconsumption(OJ
L330,5.12.1998,p.32).
36880 008012-89-3 Beeswax
36960 003061-75-4 Behenamide37040 000112-85-6 Behenicacid
37280 001302-78-9 Bentonite
37360 000100-52-7 Benzaldehyde Incompliancewithnote9in
AnnexVI
37600 000065-85-0 Benzoicacid37680 000136-60-7 Benzoicacid,butylester
37840 000093-89-0 Benzoicacid,ethylester
38080 000093-58-3 Benzoicacid,methylester38160 002315-68-6 Benzoicacid,propylester
38320 005242-49-9 4-(2-Benzoxazolyl)-4'-(5-methyl-2-benzox-
azolyl)stilbeneIncompliancewiththe
specificationslaiddownin
AnnexV
38510 136504-96-6 1,2-Bis(3-aminopropyl)ethylenediamine,
polymerwithN-butyl-2,2,6,6-tetramethyl-
4-piperidinamineand2,4,6-trichloro-1,3,5-
triazineSML=5mg/kg
38515 001533-45-5 4,4'-Bis(2-benzoxazolyl)stilbene SML=0,05mg/kg(
1)
38810 080693-00-1 Bis(2,6-di-tert-butyl-4-methylphenyl)pen-
taerythritoldiphosphiteSML=5mg/kg(sumof
phosphiteandphosphate)
38840 154862-43-8 Bis(2,4-dicumylphenyl)pentaerythritol-
diphosphiteSML=5mg/kg(assumof
thesubstanceitself,its
oxidisedformbis(2,4-dicu-
mylphenyl)pentaerythritol-
phosphateanditshydrolysis
product(2,4-dicumyl-
phenol)).
38879 135861-56-2 Bis(3,4-dimethylbenzylidene)sorbitol
38950 079072-96-1 Bis(4-ethylbenzylidene)sorbitol39200 006200-40-4 Bis(2-hydroxyethyl)-2-hydroxypropyl-3-
(dodecyloxy)methylammoniumchlorideSML=1,8mg/kg
39680 000080-05-7 2,2-Bis(4-hydroxyphenyl)propane SML(T)=0,6mg/kg(
28)2002L0072—EN—30.03.2004—002.001—30
▼M2
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
39815 182121-12-6 9,9-Bis(methoxymethyl)fluorene QMA=0,05mg/6dm2
39890 087826-41-3
069158-41-4
054686-97-4081541-12-0Bis(methylbenzylidene)sorbitol
39925 129228-21-3 3,3-Bis(methoxymethyl)-2,5-dimethyl-
hexaneSML=0,05mg/kg
40120 068951-50-8 Bis(polyethyleneglycol)hydroxymethylpho-
sphonateSML=0,6mg/kg
40320 010043-35-3 Boricacid SML(T)=6mg/kg(
23)
(expressedasBoron)without
prejudicetotheprovisionsof
Directive98/83/EConwater
forhumanconsumption(OJ
L330,5.12.1998,p.32).
40400 010043-11-5 Boronnitride
40570 000106-97-8 Butane40580 000110-63-4 1,4-Butanediol SML(T)=0,05mg/kg(
24)
41040 005743-36-2 Calciumbutyrate
41120 010043-52-4 Calciumchloride
41280 001305-62-0 Calciumhydroxide
41520 001305-78-8 Calciumoxide41600 012004-14-7
037293-22-4Calciumsulphoaluminate
41680 000076-22-2 Camphor Incompliancewithnote9in
AnnexVI
41760 008006-44-8 Candelillawax
41840 000105-60-2 CaprolactamSML(T)=15m g/kg(
5)
41960 000124-07-2 Caprylicacid42160 000124-38-9 Carbondioxide
42320 007492-68-4 Carbonicacid,coppersalt SML(T)=30mg/kg(
7)
(expressedasCopper)
42500 — Carbonicacid,salts
42640 009000-11-7 Carboxymethylcellulose42720 008015-86-9 Carnaubawax
42800 009000-71-9 Casein
42880 008001-79-4 Castoroil
42960 064147-40-6 Castoroil,dehydrated2002L0072—EN—30.03.2004—002.001—31
▼M2
▼C1
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
43200 — Castoroil,mono-anddiglycerides
43280 009004-34-6 Cellulose
43300 009004-36-8 Celluloseacetatebutyrate43360 068442-85-3 Cellulose,regenerated
43440 008001-75-0 Ceresin
43515 — Chloridesofcholineestersofcoconutoil
fattyacidsQMA=0,9mg/6dm
2
44160 000077-92-9 Citricacid
44640 000077-93-0 Citricacid,triethylester
45195 007787-70-4 Copperbromide SML(T)=30mg/kg(7)
(expressedasCopper)
45200 001335-23-5 Copperiodide SML(T)=30mg/kg(7)
(expressedasCopper)and
SML=1mg/kg(11)
(expressedasIodine)
45280 — Cottonfibers
45450 068610-51-5 p-Cresol-dicyclopentadiene-isobutylene,
copolymer►M2SML=5mg/kg ◄
45560 014464-46-1 Cristobalite
45600 003724-65-0 Crotonicacid QMA(T)=0,05mg/6dm2
(33)
45640 005232-99-5 2-Cyano-3,3-diphenylacrylicacid,ethyl
esterSML=0,05mg/kg
45760 000108-91-8 Cyclohexylamine
45920 009000-16-2 Dammar45940 000334-48-5 n-Decanoicacid
46070 010016-20-3 alpha-Dextrin
46080 007585-39-9 beta-Dextrin46375 061790-53-2 Diatomaceousearth
46380 068855-54-9 Diatomaceousearth,sodaashflux-calcined
46480 032647-67-9 Dibenzylidenesorbitol
46700 — 5,7-di-tert-Butyl-3-(3,4-and2,3-dimethyl-
phenyl)-3H-benzofuran-2-onecontaining:
a)5,7-di-tert-butyl-3-(3,4-dimethylphenyl)-
3H-benzofuran-2-one(80to100%w/w)
andb)5,7-di-tert-butyl-3-(2,3-dimethyl-
phenyl)-3H-benzofuran-2-one(0to20%
w/w)SML=5mg/kg
46720 004130-42-1 2,6-Di-tert-butyl-4-ethylphenol QMA=4,8mg/6dm
22002L0072—EN—30.03.2004—002.001—32
▼M2
▼C1
▼M2
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
46790 004221-80-1 3,5-Di-tert-butyl-4-hydroxybenzoicacid,
2,4-di-tert-butylphenylester
46800 067845-93-6 3,5-Di-tert-butyl-4-hydroxybenzoicacid,
hexadecylester
46870 003135-18-0 3,5-Di-tert-butyl-4-hydroxybenzylpho-
sphonicacid,dioctadecylester
46880 065140-91-2 3,5-Di-tert-butyl-4-hydroxybenzylpho-
sphonicacid,monoethylester,calciumsaltSML=6mg/kg
47210 026427-07-6 Dibutylthiostannoicacidpolymer[=Thio-
bis(butyl-tinsulphide),polymer]Incompliancewiththe
specificationslaiddownin
AnnexV.
47440 000461-58-5 Dicyanodiamide47540 027458-90-8 Di-tert-dodecyldisulphide SML=0,05mg/kg
47680 000111-46-6 Diethyleneglycol SML(T)=30mg/kg(
3)
48460 000075-37-6 1,1-Difluoroethane
48620 000123-31-9 1,4-Dihydroxybenzene SML=0,6mg/kg
48720 000611-99-4 4,4'-Dihydroxybenzophenone SML(T)=6mg/kg(15)
49485 134701-20-5 2,4-Dimethyl-6-(1-methylpentadecyl)-
phenolSML=1mg/kg
49540 000067-68-5 Dimethylsulphoxide
51200 000126-58-9 Dipentaerythritol
51700 147315-50-2 2-(4,6-Diphenyl-1,3,5-triazin-2-yl)-5-(hexy-
loxy)phenolSML=0,05mg/kg
51760 025265-71-8
000110-98-5Dipropyleneglycol
52640 016389-88-1 Dolomite
52645 010436-08-5 cis-11-Eicosenamide
52720 000112-84-5 Erucamide
52730 000112-86-7 Erucicacid52800 000064-17-5 Ethanol
53270 037205-99-5 Ethylcarboxymethylcellulose
53280 009004-57-3 Ethylcellulose53360 000110-31-6 N,N'-Ethylenebisoleamide
53440 005518-18-3 N,N'-Ethylenebispalmitamide
53520 000110-30-5 N,N'-Ethylenebisstearamide53600 000060-00-4 Ethylenediaminetetraacetic acid
53610 054453-03-1 Ethylenediaminetetraacetic acid,copper
saltSML(T)=30mg/kg(
7)
(expressedasCopper)2002L0072—EN—30.03.2004—002.001—33
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
53650 000107-21-1 Ethyleneglycol SML(T)=30mg/kg(3)
54005 005136-44-7 Ethylene-N-palmitamide-N'-stearamide
54260 009004-58-4 Ethylhydroxyethylcellulose
54270 — Ethylhydroxymethylcellulose
54280 — Ethylhydroxypropylcellulose
54300 118337-09-0 2,2'-Ethylidenebis(4,6-di-tert-butylphenyl)
fluorophosphoniteSML=6mg/kg
54450 — Fatsandoils,fromanimalorvegetable
foodsources
54480 — Fatsandoils,hydrogenated,fromanimalor
vegetablefoodsources
54930 025359-91-5 Formaldehyde-1-naphthol,copolymer
[=poly(1-hydroxynaphthylmethane)]SML=0,05mg/kg
55040 000064-18-6 Formicacid
55120 000110-17-8 Fumaricacid
55190 029204-02-2 Gadoleicacid
55440 009000-70-8 Gelatin
55520 — Glassfibers
55600 — Glassmicroballs
55680 000110-94-1 Glutaricacid
55920 000056-81-5 Glycerol
56020 099880-64-5 Glyceroldibehenate
56360 — Glycerol,esterswithaceticacid56486 — Glycerol,esterswithacids,aliph.,sat.,
linear,withanevennumberofcarbon
atoms(C
14-C18)andwithacids,aliph.,
unsat.,linear,withanevennumberof
carbonatoms(C16-C18)
56487 — Glycerol,esterswithbutyricacid
56490 — Glycerol,esterswitherucicacid
56495 — Glycerol,esterswith12-hydroxystearic
acid
56500 — Glycerol,esterswithlauricacid
56510 — Glycerol,esterswithlinoleicacid
56520 — Glycerol,esterswithmyristicacid
56535 — Glycerol,esterswithnonanoicacid2002L0072—EN—30.03.2004—002.001—34
▼M2
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
56540 — Glycerol,esterswitholeicacid
56550 — Glycerol,esterswithpalmiticacid
56570 — Glycerol,esterswithpropionicacid56580 — Glycerol,esterswithricinoleicacid
56585 — Glycerol,esterswithstearicacid56610 030233-64-8 Glycerolmonobehenate
56720 026402-23-3 Glycerolmonohexanoate
56800 030899-62-8 Glycerolmonolauratediacetate
56880 026402-26-6 Glycerolmonooctanoate
57040 — Glycerolmonooleate,esterwithascorbic
acid
57120 — Glycerolmonooleate,esterwithcitricacid
57200 — Glycerolmonopalmitate,esterwith
ascorbicacid
57280 — Glycerolmonopalmitate,esterwithcitric
acid
57600 — Glycerolmonostearate,esterwithascorbic
acid
57680 — Glycerolmonostearate,esterwithcitric
acid
57800 018641-57-1 Glyceroltribehenate
57920 000620-67-7 Glyceroltriheptanoate58300 — Glycine,salts
58320 007782-42-5 Graphite
58400 009000-30-0 Guargum58480 009000-01-5 Gumarabic
58720 000111-14-8 Heptanoicacid
59280 000100-97-0 Hexamethylenetetramine SML(T)=15mg/kg(
22)
(expressedasFormaldehyde)
59360 000142-62-1 Hexanoicacid
59760 019569-21-2 Huntite
59990 007647-01-0 Hydrochloricacid
60030 012072-90-1 Hydromagnesite2002L0072—EN—30.03.2004—002.001—35
▼M2
▼C1
▼M2
▼C1
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
60080 012304-65-3 Hydrotalcite
60160 000120-47-8 4-Hydroxybenzoicacid,ethylester
60180 004191-73-5 4-Hydroxybenzoicacid,isopropylester60200 000099-76-3 4-Hydroxybenzoicacid,methylester
60240 000094-13-3 4-Hydroxybenzoicacid,propylester
60480 003864-99-1 2-(2'-Hydroxy-3,5'-di-tert-butylphenyl)-5-
chlorobenzotriazoleSML(T)=30mg/kg(
19)
60560 009004-62-0 Hydroxyethylcellulose
60880 009032-42-2 Hydroxyethylmethylcellulose
61120 009005-27-0 Hydroxyethylstarch
61390 037353-59-6 Hydroxymethylcellulose61680 009004-64-2 Hydroxypropylcellulose
61800 009049-76-7 Hydroxypropylstarch
61840 000106-14-9 12-Hydroxystearicacid
62140 006303-21-5 Hypophosphorousacid
62240 001332-37-2 Ironoxide62450 000078-78-4 Isopentane
62640 008001-39-6 Japanwax
62720 001332-58-7 Kaolin62800 — Kaolin,calcined
62960 000050-21-5 Lacticacid
63040 000138-22-7 Lacticacid,butylester63280 000143-07-7 Lauricacid
63760 008002-43-5 Lecithin
63840 000123-76-2 Levulinicacid63920 000557-59-5 Lignocericacid
64015 000060-33-3 Linoleicacid
64150 028290-79-1 Linolenicacid
64500 — Lysine,salts
64640 001309-42-8 Magnesiumhydroxide64720 001309-48-4 Magnesiumoxide
64800 00110-16-7 Maleicacid SML(T)=30mg/kg(
4)
65020 006915-15-7 Malicacid2002L0072—EN—30.03.2004—002.001—36
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
65040 000141-82-2 Malonicacid
65520 000087-78-5 Mannitol
65920 066822-60-4 N-Methacryloyloxyethyl-N,N-dimethyl-N-
carboxymethylammoniumchloride,sodium
salt-octadecylmethacrylate-ethyl metha-
crylate-cyclohexylmethacrylate-N-vinyl-2-
pyrrolidone,copolymers
66200 037206-01-2 Methylcarboxymethylcellulose
66240 009004-67-5 Methylcellulose
66560 004066-02-8 2,2'-Methylenebis(4-methyl-6-cyclohexyl-
phenol)SML(T)=3mg/kg(6)
66580 000077-62-3 2,2'-Methylenebis(4-methyl-6-(1-methylcy-
clohexyl)phenol)SML(T)=3mg/kg(6)
66640 009004-59-5 Methylethylcellulose
66695 — Methylhydroxymethylcellulose
66700 009004-65-3 Methylhydroxypropylcellulose
66755 002682-20-4 2-Methyl-4-isothiazolin-3-one SML=ND(DL=0,02mg/
kg,analyticaltolerance
included)
67120 012001-26-2 Mica
67180 — Mixtureof(50%w/w)phthalicacid,n-
decyln-octylester,(25%w/w)phthalic
aciddi-n-decylester,and(25%w/w)
phthalicaciddi-n-decylester,and(25%
w/w)phthalicaciddi-n-octylesterSML=5mg/kg(1)
67200 001317-33-5 Molybdenumdisulphide
67840 — Montanicacidsand/ortheiresterswith
ethyleneglycoland/orwith1,3-butanediol
and/orwithglycerol
67850 008002-53-7 Montanwax67891 000544-63-8 Myristicacid
68040 003333-62-8 7-[2H-Naphtho-(1,2-D)triazol-2-yl]-3-
phenylcoumarin
68078 027253-31-2 Neodecanoicacid,cobaltsalt SML(T)=0,05mg/kg
(expressedasNeodecanoic
acid)andSML(T)=0,05mg/
kg(
14)(expressedasCobalt).
Notforuseinpolymers
contactingfoodsforwhich
simulantDislaiddownin
Directive85/572/EEC.
68125 037244-96-5 Nephelinesyenite2002L0072—EN—30.03.2004—002.001—37
▼M2
▼C1
▼M2
▼C1
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
68145 080410-33-9 2,2',2"-Nitrilo(triethyltris(3,3',5,5'-tetra-
tert-butyl-1,1'-bi-phenyl-2,2'-diyl)pho-
sphite)SML=5mg/kg(sumof
phosphiteandphosphate)
68960 000301-02-0 Oleamide
69040 000112-80-1 Oleicacid69760 000143-28-2 Oleylalcohol
69920 000144-62-7 Oxalicacid SML(T)=6mg/kg(
29)
70000 070331-94-1 2,2'-Oxamidobis[ethyl-3-(3,5-di-tert-butyl-
4-hydroxyphenyl)-propionate]
70240 012198-93-5 Ozokerite70400 000057-10-3 Palmiticacid
71020 000373-49-9 Palmitoleicacid
71440 009000-69-5 Pectin71600 000115-77-5 Pentaerythritol
71635 025151-96-6 Pentaerythritoldioleate SML=0,05mg/kg.Notfor
useinpolymerscontacting
foodsforwhichsimulantD
islaiddowninDirective85/
572/EEC
71670 178671-58-4 Pentaerythritoltetrakis(2-cyano-3,3-diphe-
nylacrylate)SML=0,05mg/kg
71680 006683-19-8 Pentaerythritoltetrakis[3-(3,5-di-tert-butyl-
4-hydroxyphenyl)-propionate]
71720 000109-66-0 Pentane
72640 007664-38-2 Phosphoricacid
73160 — Phosphoricacid,mono-anddi-n-alkyl(C
16andC18)estersSML=0,05mg/kg
73720 000115-96-8 Phosphoricacid,trichloroethylester SML=ND(DL=0,02mg/
kg,analyticaltolerance
included)
74010 145650-60-8 Phosphorousacid,bis(2,4-di-tert-butyl-6-
methylphenyl)ethylesterSML=5mg/kg(sumof
phosphiteandphosphate)
74240 031570-04-4 Phosphorousacid,tris(2,4-di-tert-butylphe-
nyl)ester
74480 000088-99-3 o-Phthalicacid
76320 000085-44-9 Phthalicanhydride
76721 009016-00-6
063148-62-9Polydimethylsiloxane(Mw>6800) Incompliancewiththe
specificationslaiddownin
AnnexV
76730 — Polydimethylsiloxane,gamma-hydroxypro-
pylatedSML=6mg/kg2002L0072—EN—30.03.2004—002.001—38
▼M2
▼C1
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
76866 — Polyestersof1,2-propanedioland/or1,3-
and/or1,4-butanedioland/orpolypropyle-
neglycolwithadipicacid,whichmaybe
end-cappedwithaceticacidorfattyacids
C12-C18orn-octanoland/orn-decanolSML=30mg/kg
76960 025322-68-3 Polyethyleneglycol
77600 061788-85-0 Polyethyleneglycolesterofhydrogenated
castoroil
77702 — Polyethyleneglycolestersofaliph.mono-
carb.acids(C6-C22)andtheirammonium
andsodiumsulphates
77895 068439-49-6 Polyethyleneglycol(EO=2-6)monoalkyl
(C16-C18)ether►M2SML=0,05mg/kg
andincompliancewiththe
specificationslaiddownin
AnnexV ◄
79040 009005-64-5 Polyethyleneglycolsorbitanmonolaurate
79120 009005-65-6 Polyethyleneglycolsorbitanmonooleate
79200 009005-66-7 Polyethyleneglycolsorbitanmonopalmitate
79280 009005-67-8 Polyethyleneglycolsorbitanmonostearate
79360 009005-70-3 Polyethyleneglycolsorbitantrioleate79440 009005-71-4 Polyethyleneglycolsorbitantristearate
80240 029894-35-7 Polyglycerolricinoleate
80640 — Polyoxyalkyl(C
2-C4)dimethylpolysiloxane
80720 008017-16-1 Polyphosphoricacids
80800 025322-69-4 Polypropyleneglycol
81220 192268-64-7 Poly-[[6-[N-(2,2,6,6-tetramethyl-4-piperi-
dinyl)-n-butylamino]-1,3,5-triazine-2,4-
diyl][(2,2,6,6-tetramethyl-4-piperidinyl)i-
mino]-1,6-hexanediyl[(2,2,6,6-tetramethyl-
4-piperidinyl)imino]]-alpha-[N,N,N',N'-
tetrabutyl-N"-(2,2,6,6-tetramethyl-4-piperi-
dinyl)-N"-[6-(2,2,6,6-tetramethyl-4-piperi-
dinylamino)-hexyl]-[1,3,5-triazine-2,4,6-
triamine]-omega-N,N,N',N'-tetrabutyl-1,3,5-triazine-2,4-diamine]SML=5mg/kg
81515 087189-25-1 Poly(zincglycerolate)
81520 007758-02-3 Potassiumbromide
81600 001310-58-3 Potassiumhydroxide
81760 — Powders,flakesandfibresofbrass,bronze,
copper,stainlesssteel,tinandalloysof
copper,tinandironSML(T)=30mg/kg(
7)
(expressedasCopper);
SML=48mg/kg(expressed
asIron)
81840 000057-55-6 1,2-Propanediol2002L0072—EN—30.03.2004—002.001—39
▼M2
▼C1
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
81882 000067-63-0 2-Propanol
82000 000079-09-4 Propionicacid
82080 009005-37-2 1,2-Propyleneglycolalginate82240 022788-19-8 1,2-Propyleneglycoldilaurate82400 000105-62-4 1,2-Propyleneglycoldioleate82560 033587-20-1 1,2-Propyleneglycoldipalmitate
82720 006182-11-2 1,2-Propyleneglycoldistearate
82800 027194-74-7 1,2-Propyleneglycolmonolaurate82960 001330-80-9 1,2-Propyleneglycolmonooleate83120 029013-28-3 1,2-Propyleneglycolmonopalmitate83300 001323-39-3 1,2-Propyleneglycolmonostearate83320 — Propylhydroxyethylcellulose
83325 — Propylhydroxymethylcellulose
83330 — Propylhydroxypropylcellulose83440 002466-09-3 Pyrophosphoricacid83455 013445-56-2 Pyrophosphorousacid83460 012269-78-2 Pyrophyllite83470 014808-60-7 Quartz
83599 068442-12-6 Reactionproductsofoleicacid,2-mercap-
toethylester,withdichlorodimethyltin,
sodiumsulphideandtrichloromethyltinSML(T)=0,18mg/kg(
16)
(expressedasTin)
83610 073138-82-6 ResinacidsandRosinacids
83840 008050-09-7 Rosin84000 008050-31-5 Rosin,esterwithglycerol84080 008050-26-8 Rosin,esterwithpentaerythritol
84210 065997-06-0 Rosin,hydrogenated
84240 065997-13-9 Rosin,hydrogenated,esterwithglycerol84320 008050-15-5 Rosin,hydrogenated,esterwithmethanol84400 064365-17-9 Rosin,hydrogenated,esterwithpentaery-
thritol
84560 009006-04-6 Rubber,natural84640 000069-72-7 Salicylicacid2002L0072—EN—30.03.2004—002.001—40
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
85360 000109-43-3 Sebacicacid,dibutylester
85601 — Silicates,natural(withtheexceptionof
asbestos)
85610 — Silicates,natural,silanated(withthe
exceptionofasbestos)
85680 001343-98-2 Silicicacid
85840 053320-86-8 Silicicacid,lithiummagnesiumsodium
saltSML(T)=0,6mg/kg(8)
(expressedasLithium)
86000 — Silicicacid,silylated
86160 000409-21-2 Siliconcarbide
86240 007631-86-9 Silicondioxide86285 — Silicondioxide,silanated86560 007647-15-6 Sodiumbromide86720 001310-73-2 Sodiumhydroxide
87040 001330-43-4 Sodiumtetraborate SML(T)=6mg/kg(
23)
(expressedasBoron)without
prejudicetotheprovisionsof
Directive98/83/EConwaterforhumanconsumption(OJ
L330,5.12.1998,p.32).
87200 000110-44-1 Sorbicacid87280 029116-98-1 Sorbitandioleate
87520 062568-11-0 Sorbitanmonobehenate
87600 001338-39-2 Sorbitanmonolaurate87680 001338-43-8 Sorbitanmonooleate87760 026266-57-9 Sorbitanmonopalmitate87840 001338-41-6 Sorbitanmonostearate
87920 061752-68-9 Sorbitantetrastearate
88080 026266-58-0 Sorbitantrioleate88160 054140-20-4 Sorbitantripalmitate88240 026658-19-5 Sorbitantristearate88320 000050-70-4 Sorbitol88600 026836-47-5 Sorbitolmonostearate
88640 008013-07-8 Soybeanoil,epoxidised Incompliancewiththe
specificationslaiddownin
AnnexV2002L0072—EN—30.03.2004—002.001—41
▼M2
▼C1
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
88800 009005-25-8 Starch,edible
88880 068412-29-3 Starch,hydrolysed
88960 000124-26-5 Stearamide89040 000057-11-4 Stearicacid
89200 007617-31-4 Stearicacid,coppersalt SML(T)=30mg/kg(
7)
(expressedasCopper)
89440 — Stearicacid,esterswithethyleneglycol SML(T)=30mg/kg(3)
90720 058446-52-9 Stearoylbenzoylmethane90800 005793-94-2 Stearoyl-2-lactylicacid,calciumsalt
90960 000110-15-6 Succinicacid
91200 000126-13-6 Sucroseacetateisobutyrate91360 000126-14-7 Sucroseoctaacetate
91840 007704-34-9 Sulphur
91920 007664-93-9 Sulphuricacid
92030 010124-44-4 Sulphuricacid,coppersalt SML(T)=30mg/kg(
7)
(expressedasCopper)
92080 014807-96-6 Talc
92150 001401-55-4 Tannicacids AccordingtotheJECFA
specifications
92160 000087-69-4 Tartaricacid
92195 — Taurine,salts92205 057569-40-1 Terephthalicacid,diesterwith2,2'-methy-
lenebis(4-methyl-6-tert-butylphenol)
92350 000112-60-7 Tetraethyleneglycol
92640 000102-60-3 N,N,N',N'-Tetrakis(2-hydroxypropyl)ethyle-
nediamine
92700 078301-43-6 2,2,4,4-Tetramethyl-20-(2,3-epoxypropyl)-
7-oxa-3,20-diazadispiro-[5.1.11.2]-henei-
cosan-21-one,polymerSML=5mg/kg
92930 120218-34-0 Thiodiethanolbis(5-methoxycarbonyl-2,6-
dimethyl-1,4-dihydropyridine-3-carboxy-
late)SML=6mg/kg
93440 013463-67-7 Titaniumdioxide
93520 000059-02-9
010191-41-0alpha-Tocopherol
93680 009000-65-1 Tragacanthgum
93720 000108-78-1 2,4,6-Triamino-1,3,5-triazine SML=30mg/kg94320 000112-27-6 Triethyleneglycol2002L0072—EN—30.03.2004—002.001—42
▼C1
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
94960 000077-99-6 1,1,1-Trimethylolpropane SML=6mg/kg
95000 028931-67-1 Trimethylolpropanetrimethacrylate-methyl
methacrylatecopolymer
95200 001709-70-2 1,3,5-Trimethyl-2,4,6-tris(3,5-di-tert-butyl-
4-hydroxybenzyl)benzene
95270 161717-32-4 2,4,6-Tris(tert-butyl)phenyl-2-butyl-2-ethyl-
1,3-propanediolphosphiteSML=2mg/kg(assumof
phosphite,phosphateandthe
hydrolysisproduct=TTBP)
95725 110638-71-6 Vermiculite,reactionproductwithcitric
acid,lithiumsaltSML(T)=0,6mg/kg(8)
(expressedasLithium)
95855 007732-18-5 Water IncompliancewithDirective
98/83/EEC
95859 — Waxes,refined,derivedfrompetroleum
basedorsynthetichydrocarbonfeedstocksIncompliancewiththe
specificationslaiddownin
AnnexV
95883 — Whitemineraloils,paraffinic,derivedfrom
petroleumbasedhydrocarbonfeedstocksIncompliancewiththe
specificationslaiddownin
AnnexV
95905 013983-17-0 Wollastonite
95920 — Woodflourandfibers,untreated
95935 011138-66-2 Xanthangum96190 020427-58-1 Zinchydroxide
96240 001314-13-2 Zincoxide
96320 001314-98-3 Zincsulphide2002L0072—EN—30.03.2004—002.001—43
▼M2
▼C1
▼C1
Section B
Incomplete list of additives referred to in Article 4, second paragraph
Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
30180 002180-18-9 Aceticacid,manganesesalt SML(T)=0,6mg/kg(10)
(expressedasManganese)
31520 061167-58-6 Acrylicacid,2-tert-butyl-6-(3-tert-butyl-2-
hydroxy-5-methylbenzyl)-4-methylphenyl
esterSML=6mg/kg
31920 000103-23-1 Adipicacid,bis(2-ethylhexyl)ester SML=18mg/kg(1)
34230 — Alkyl(C8-C22)sulphonicacids SML=6mg/kg
34650 151841-65-5 Aluminiumhydroxybis[2,2'-methylenebis
(4,6-di-tert.butylphenyl)phosphateSML=5mg/kg
35760 001309-64-4 Antimonytrioxide SML=0,02mg/kg
(expressedasAntimonyand
analyticaltoleranceincluded)
36720 017194-00-2 Bariumhydroxide SML(T)=1mg/kg(12)
(expressedasBarium)
36800 010022-31-8 Bariumnitrate SML(T)=1mg/kg(12)
(expressedasBarium)
38000 000553-54-8 Benzoicacid,lithiumsalt SML(T)=0,6mg/kg(8)
(expressedasLithium)
38240 000119-61-9 Benzophenone SML=0,6mg/kg
38560 007128-64-5 2,5-Bis(5-tert-butyl-2-benzoxazolyl)thio-
pheneSML=0,6mg/kg
38700 063397-60-4 Bis(2-carbobutoxyethyl)tin-bis(isooctyl
mercaptoacetate)SML=18mg/kg
38800 032687-78-8 N,N'-Bis(3-(3,5-di-tert-butyl-4-hydroxyphe-
nyl)propionyl)hydrazideSML=15mg/kg
38820 026741-53-7 Bis(2,4-di-tert-butylphenyl)pentaerythritol
diphosphiteSML=0,6mg/kg
39060 035958-30-6 1,1-Bis(2-hydroxy-3,5-di-tert-butylpheny-
l)ethaneSML=5mg/kg
39090 — N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine SML(T)=1,2mg/kg(13)
39120 — N,N-Bis(2-hydroxyethyl)alkyl(C8-C18)amine
hydrochloridesSML(T)=1,2mg/kg(13)
expressedasTertiaryamine
(expressedexcludingHCl)
40000 000991-84-4 2,4-Bis(octylmercapto)-6-(4-hydroxy-3,5-
di-tert-butylanilino)-1,3,5-triazineSML=30mg/kg
40020 110553-27-0 2,4-Bis(octylthiomethyl)-6-methylphenol SML=6mg/kg
40160 061269-61-2 N,N'-Bis(2,2,6,6-tetramethyl-4-piperidyl)-
hexamethylenediamine-1,2-dibromoethane,
copolymerSML=2,4mg/kg
40720 025013-16-5 tert-Butyl-4-hydroxyanisole(=BHA)SML=30mg/kg2002L0072—EN—30.03.2004—002.001—44
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Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
40800 013003-12-8 4,4'-Butylidene-bis(6-tert-butyl-3-methyl-
phenyl-ditridecylphosphite)SML=6mg/kg
40980 019664-95-0 Butyricacid,manganesesalt SML(T)=0,6mg/kg(10)
(expressedasManganese)
42000 063438-80-2 (2-Carbobutoxyethyl)tin-tris(isooctyl
mercaptoacetate)SML=30mg/kg
42400 010377-37-4 Carbonicacid,lithiumsalt SML(T)=0,6mg/kg(8)
(expressedasLithium)
42480 000584-09-8 Carbonicacid,rubidiumsalt SML=12mg/kg
43600 004080-31-3 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaada-
mantanechlorideSML=0,3mg/kg
43680 000075-45-6 Chlorodifluoromethane SML=6mg/kgandin
compliancewiththespecifi-
cationslaiddowninAnnex
V
44960 011104-61-3 Cobaltoxide SML(T)=0,05mg/kg(14)
(expressedasCobalt)
45440 — Cresols,butylated,styrenated SML=12mg/kg45650 006197-30-4 2-Cyano-3,3-diphenylacrylicacid,2-ethyl-
hexylesterSML=0,05mg/kg
46640 000128-37-0 2,6-Di-tert-butyl-p-cresol(=BHT) SML=3,0mg/kg
47600 084030-61-5 Di-n-dodecyltinbis(isooctylmercaptoace-
tate)SML=12mg/kg
48640 000131-56-6 2,4-Dihydroxybenzophenone SML(T)=6mg/kg(15)
48800 000097-23-4 2,2'-Dihydroxy-5,5'-dichlorodiphenyl-
methaneSML=12mg/kg
48880 000131-53-3 2,2'-Dihydroxy-4-methoxybenzophenone SML(T)=6mg/kg(15)
49600 026636-01-1 Dimethyltinbis(isooctylmercaptoacetate) SML(T)=0,18mg/kg(16)
(expressedasTin)
49840 002500-88-1 Dioctadecyldisulphide SML=3mg/kg
50160 — Di-n-octyltinbis(n-alkyl(C10-C16)mercap-
toacetate)SML(T)=0,04mg/kg(17)
(expressedasTin)
50240 010039-33-5 Di-n-octyltinbis(2-ethylhexylmaleate) SML(T)=0,04mg/kg(17)
(expressedasTin)
50320 015571-58-1 Di-n-octyltinbis(2-ethylhexylmercaptoa-
cetate)SML(T)=0,04mg/kg(17)
(expressedasTin)
50360 — Di-n-octyltinbis(ethylmaleate) SML(T)=0,04mg/kg(17)
(expressedasTin)
50400 033568-99-9 Di-n-octyltinbis(isooctylmaleate) SML(T)=0,04mg/kg(17)
(expressedasTin)2002L0072—EN—30.03.2004—002.001—45
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Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
50480 026401-97-8 Di-n-octyltinbis(isooctylmercaptoacetate) SML(T)=0,04mg/kg(17)
(expressedasTin)
50560 — Di-n-octyltin1,4-butanediolbis(mercaptoa-
cetate)SML(T)=0,04mg/kg(17)
(expressedasTin)
50640 003648-18-8 Di-n-octyltindilaurate SML(T)=0,04mg/kg(17)
(expressedasTin)
50720 015571-60-5 Di-n-octyltindimaleate SML(T)=0,04mg/kg(17)
(expressedasTin)
50800 — Di-n-octyltindimaleate,esterified SML(T)=0,04mg/kg(17)
(expressedasTin)
50880 — Di-n-octyltindimaleate,polymers(n=2-4) SML(T)=0,04mg/kg(17)
(expressedasTin)
50960 069226-44-4 Di-n-octyltinethyleneglycolbis(mercaptoa-
cetate)SML(T)=0,04mg/kg(17)
(expressedasTin)
51040 015535-79-2 Di-n-octyltinmercaptoacetate SML(T)=0,04mg/kg(17)
(expressedasTin)
51120 — Di-n-octyltinthiobenzoate2-ethylhexyl
mercaptoacetateSML(T)=0,04mg/kg(17)
(expressedasTin)
51570 000127-63-9 Diphenylsulphone SML(T)=3mg/kg(25)
51680 000102-08-9 N,N'-diphenylthiourea SML=3mg/kg
52000 027176-87-0 Dodecylbenzenesulphonicacid SML=30mg/kg
52320 052047-59-3 2-(4-Dodecylphenyl)indole SML=0,06mg/kg52880 023676-09-7 4-Ethoxybenzoicacid,ethylester SML=3,6mg/kg
53200 023949-66-8 2-Ethoxy-2'-ethyloxanilide SML=30mg/kg
54880 000050-00-0 Formaldehyde SML(T)=15mg/kg(
22)
55200 001166-52-5 Gallicacid,dodecylester SML(T)=30mg/kg(34)
55280 001034-01-1 Gallicacid,octylester SML(T)=30mg/kg(34)
55360 000121-79-9 Gallicacid,propylester SML(T)=30mg/kg(34)
58960 000057-09-0 Hexadecyltrimethylammonium bromide SML=6mg/kg
59120 023128-74-7 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-
4-hydroxyphenyl)propionamide)SML=45mg/kg
59200 035074-77-2 1,6-Hexamethylene-bis(3-(3,5-di-tert-butyl-
4-hydroxyphenyl)propionate)SML=6mg/kg
60320 070321-86-7 2-[2-Hydroxy-3,5-bis(1,1-dimethylbenzyl)-
phenyl]benzotriazoleSML=1,5mg/kg
60400 003896-11-5 2-(2'-Hydroxy-3'-tert-butyl-5'-methyl-
phenyl)-5-chlorobenzotriazoleSML(T)=30mg/kg(19)
60800 065447-77-0 1-(2-Hydroxyethyl)-4-hydroxy-2,2,6,6-
tetramethylpiperidine-succinicacid,
dimethylester,copolymerSML=30mg/kg2002L0072—EN—30.03.2004—002.001—46
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Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
61280 003293-97-8 2-Hydroxy-4-n-hexyloxybenzophenone SML(T)=6mg/kg(15)
61360 000131-57-7 2-Hydroxy-4-methoxybenzophenone SML(T)=6mg/kg(15)
61440 002440-22-4 2-(2'-Hydroxy-5'-methylphenyl)benzotria-
zoleSML(T)=30mg/kg(19)
61600 001843-05-6 2-Hydroxy-4-n-octyloxybenzophenone SML(T)=6mg/kg(15)
63200 051877-53-3 Lacticacid,manganesesalt SML(T)=0,6mg/kg(10)
(expressedasManganese)
64320 010377-51-2 Lithiumiodide SML(T)=1mg/kg(11)
(expressedasIodine)and
SML(T)=0,6mg/kg(8)
(expressedasLithium)
65120 007773-01-5 Manganesechloride SML(T)=0,6mg/kg(10)
(expressedasManganese)
65200 012626-88-9 Manganesehydroxide SML(T)=0,6mg/kg(10)
(expressedasManganese)
65280 010043-84-2 Manganesehypophosphite SML(T)=0,6mg/kg(10)
(expressedasManganese)
65360 011129-60-5 Manganeseoxide SML(T)=0,6mg/kg(10)
(expressedasManganese)
65440 — Manganesepyrophosphite SML(T)=0,6mg/kg(10)
(expressedasManganese)
66360 085209-91-2 2,2'-Methylenebis(4,6-di-tert-butylphenyl)
sodiumphosphateSML=5mg/kg
66400 000088-24-4 2,2'-Methylenebis(4-ethyl-6-tert-butyl-
phenol)SML(T)=1,5mg/kg(20)
66480 000119-47-1 2,2'-Methylenebis(4-methyl-6-tert-butyl-
phenol)SML(T)=1,5mg/kg(20)
67360 067649-65-4 Mono-n-dodecyltintris(isooctylmercaptoa-
cetate)SML=24mg/kg
67520 054849-38-6 Monomethyltintris(isooctylmercaptoace-
tate)SML(T)=0,18mg/kg(16)
(expressedasTin)
67600 — Mono-n-octyltintris(alkyl(C10-C16)mercap-
toacetate)SML(T)=1,2mg/kg(18)
(expressedasTin)
67680 027107-89-7 Mono-n-octyltintris(2-ethylhexylmercap-
toacetate)SML(T)=1,2mg/kg(18)
(expressedasTin)
67760 026401-86-5 Mono-n-octyltintris(isooctylmercaptoace-
tate)SML(T)=1,2mg/kg(18)
(expressedasTin)
67896 020336-96-3 Myristicacid,lithiumsalt SML(T)=0,6mg/kg(8)
(expressedasLithium)
68320 002082-79-3 Octadecyl3-(3,5-di-tert-butyl-4-hydroxy-
phenyl)propionateSML=6mg/kg2002L0072—EN—30.03.2004—002.001—47
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Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
68400 010094-45-8 Octadecylerucamide SML=5mg/kg
68860 004724-48-5 n-Octylphosphonicacid SML=0,05mg/kg
69840 016260-09-6 Oleylpalmitamide SML=5mg/kg
71935 007601-89-0 Perchloricacid,sodiumsaltmonohydrate SML=0,05mg/kg(31)
72160 000948-65-2 2-Phenylindole SML=15mg/kg
72800 001241-94-7 Phosphoricacid,diphenyl2-ethylhexyl
esterSML=2,4mg/kg
73040 013763-32-1 Phosphoricacid,lithiumsalts SML(T)=0,6mg/kg(8)
(expressedasLithium)
73120 010124-54-6 Phosphoricacid,manganesesalt SML(T)=0,6mg/kg(10)
(expressedasManganese)
74400 — Phosphorousacid,tris(nonyl-and/ordino-
nylphenyl)esterSML=30mg/kg
76680 068132-00-3 Polycyclopentadiene,hydrogenated SML=5mg/kg(1)
77440 — Polyethyleneglycoldiricinoleate SML=42mg/kg
77520 061791-12-6 Polyethyleneglycolesterofcastoroil SML=42mg/kg
78320 009004-97-1 Polyethyleneglycolmonoricinoleate SML=42mg/kg
81200 071878-19-8 Poly[6-[(1,1,3,3-tetramethylbutyl)amino]-
1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetra-
methyl-4-piperidyl)-imino]hexamethy-
lene[(2,2,6,6-tetramethyl-4-piperidyl)
imino]SML=3mg/kg
81680 007681-11-0 Potassiumiodide SML(T)=1mg/kg(11)
(expressedasIodium)
82020 019019-51-3 Propionicacid,cobaltsalt SML(T)=0,05mg/kg(14)
(expressedasCobalt)
83595 119345-01-6 Reactionproductofdi-tert-butylphospho-
nitewithbiphenyl,obtainedbycondensa-
tionof2,4-di-tert-butylphenolwithFriedel
Craftreactionproductofphosphorous
trichlorideandbiphenylSML=18mg/kgandin
compliancewiththespecifi-
cationsmentionedinAnnex
V.
83700 000141-22-0 Ricinoleicacid SML=42mg/kg
84800 000087-18-3 Salicylicacid,4-tert-butylphenylester SML=12mg/kg
84880 000119-36-8 Salicylicacid,methylester SML=30mg/kg85760 012068-40-5 Silicicacid,lithiumaluminiumsalt(2:1:1) SML(T)=0,6mg/kg(
8)
(expressedasLithium)
85920 012627-14-4 Silicicacid,lithiumsalt SML(T)=0,6mg/kg(8)
(expressedasLithium)
86480 007631-90-5 Sodiumbisulphite SML(T)=10mg/kg(30)
(expressedasS02)2002L0072—EN—30.03.2004—002.001—48
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Ref.
NoCASNo NameRestrictionsand/orspecifica-
tions
(1) (2) (3) (4)
86800 007681-82-5 Sodiumiodide SML(T)=1mg/kg(11)
(expressedasIodine)
86880 — Sodiummonoalkyldialkylphenoxybenze-
nedisulphonateSML=9mg/kg
86920 007632-00-0 Sodiumnitrite SML=0,6mg/kg
86960 007757-83-7 Sodiumsulphite SML(T)=10mg/kg(30)
(expressedasS02)
87120 007772-98-7 Sodiumthiosulphate SML(T)=10mg/kg(30)
(expressedasS02)
89170 013586-84-0 Stearicacid,cobaltsalt SML(T)=0,05mg/kg(14)
(expressedasCobalt)
92000 007727-43-7 Sulphuricacid,bariumsalt SML(T)=1mg/kg(12)
(expressedasBarium)
92320 — Tetradecyl-polyethyleneglycol(EO=3-8)
etherofglycolicacidSML=15mg/kg
92560 038613-77-3 Tetrakis(2,4-di-tert-butyl-phenyl)-4,4'-
biphenylylenediphosphoniteSML=18mg/kg
92800 000096-69-5 4,4'-Thiobis(6-terc-butyl-3-methylphenol) SML=0,48mg/kg
92880 041484-35-9 Thiodiethanolbis(3-(3,5-di-tert-butyl-4-
hydroxyphenyl)propionate)SML=2,4mg/kg
93120 000123-28-4 Thiodipropionicacid,didodecylester SML(T)=5mg/kg(21)
93280 000693-36-7 Thiodipropionicacid,dioctadecylester SML(T)=5mg/kg(21)
94400 036443-68-2 Triethyleneglycolbis[3-(3-tert-butyl-4-
hydroxy-5-methylphenyl)propionate]SML=9mg/kg
94560 000122-20-3 Triisopropanolamine SML=5mg/kg
95280 040601-76-1 1,3,5-Tris(4-tert-butyl-3-hydroxy-2,6-
dimethylbenzyl)-1,3,5-triazine-
2,4,6(1H,3H,5H)-trioneSML=6mg/kg
95360 027676-62-6 1,3,5-Tris(3,5-di-tert-butyl-4-hydroxy-
benzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-
trioneSML=5mg/kg
95600 001843-03-4 1,1,3-Tris(2-methyl-4-hydroxy-5-tert-butyl-
phenyl)butaneSML=5mg/kg2002L0072—EN—30.03.2004—002.001—49
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ANNEX IV
PRODUCTS OBTAINED BY MEANS OF BACTERIAL FERMENTATION
Reference
NoCASNo Name Restrictionsand/orspecifications
(1) (2) (3) (4)
18888 080181-31-3 3-Hydroxybutanoic acid-3-hydroxy-
pentanoicacid,copolymerIn compliance with specifica-
tionsincludedinAnnexV2002L0072—EN—30.03.2004—002.001—50
▼C1
ANNEX V
SPECIFICATIONS
PartA: General specifications
Thematerial andarticle manufactured byusingaromatic isocyanatesorcolorantspreparedbydiazo-
coupling, shall not release primary aromatic amines (expressed as aniline) in a detectable quantity
(DL = 0,02 mg/kg of food or food simulant, analytical tolerance included). However, the migration
valueoftheprimaryaromaticamineslistedinthisDirectiveareexcludedfromthisrestriction.
PartB: Other specifications
Ref.No OTHERSPECIFICATIONS
11530 Acrylicacid,2-hydroxypropylester.
Itmaycontainupto25%(m/m)ofacrylicacid,2-hydroxyisopropylester(CASNo
002918-23-2)
16690 Divinylbenzene
Itmaycontainupto45%(m/m)ofEthylvinylbenzene
18888 3-Hydroxybutanoicacid-3-hydroxypentanoicacid,copolymer
Definition Thecopolymersareproducedbythecontrolledfermentation
ofAlcaligeneseutrophususingmixturesofglucoseand
propanoicacidascarbonsources.Theorganismusedhasnot
beengeneticallyengineeredandhasbeenderivedfroma
singlewild-typeorganismAlcaligeneseutrophusstrainHI6
NCIMB10442.Masterstocksoftheorganismarestoredas
freeze-driedampoules.Asubmaster/workingstockis
preparedfromthemasterstockandstoredinliquidnitrogen
andusedtoprepareinoculaforthefermenter.Fermenter
sampleswillbeexamineddailybothmicroscopicallyandfor
anychangesincolonialmorphologyonavarietyofagarsat
differenttemperatures.Thecopolymersareisolatedfromheat
treatmentbacteriabycontrolleddigestionoftheothercellular
components,washinganddrying.Thesecopolymersare
normallyofferedasformulated,meltformedgranules
containingadditivessuchasnucleatingagents,plasticisers,
fillers,stabilisersandpigmentswhichallconformtothe
generalandindividualspecifications
Chemicalname Poly(3-D-hydroxybutanoate-co-3-D-hydroxypentanoate)
CASnumber 080181-31-3
Structuralformula
wheren/(m+n)greaterthan0andlessorequalto0,25
Averagemolecularweight Notlessthan150000Daltons(measuredbygelpermeation
chromatography)
Assay Notlessthan98%poly(3-D-hydroxybutanoate-co-3-D-
hydoxypentanoate)analysedafterhydrolysisasamixtureof
3-D-hydroxybutanoicand3-D-hydroxypentanoicacids
Description Whitetooff-whitepowderafterisolationCharacteristics
Identificationtests:
Solubility Solubleinchlorinatedhydrocarbonssuchaschloroformor
dichloromethanebutpracticallyinsolubleinethanol,aliphatic
alkanesandwater
Restriction QMAforcrotonicacidis0.05mg/6dm
22002L0072—EN—30.03.2004—002.001—51
▼M2
▼M2
Ref.No OTHERSPECIFICATIONS
Purity Priortogranulationtherawmaterialcopolymerpowdermust
contain:
— nitrogen Notmorethan2500mg/kgofplastic— zinc Notmorethan100mg/kgofplastic
— copper Notmorethan5mg/kgofplastic
— lead Notmorethan2mg/kgofplastic— arsenic Notmorethan1mg/kgofplastic— chromium Notmorethan1mg/kgofplastic
23547 Polydimethylsiloxane(Mw>6800)
Minimumviscosity100×10
–6m2/s(=100centistokes)at25ºC
25385 Triallylamine
40mg/kghydrogelataratioof1kgfoodtoamaximumof1,5gramsofhydrogel.For
useonlyinhydrogelsintendedfornon-directfoodcontactuse.
38320 4-(2-Benzoxazolyl)-4 ′-(5-methyl-2-benzoxazolyl)stilbene
Notmorethan0,05%w/w(quantityofsubstanceused/quantityoftheformulation)
43680 Chlorodifluoromethane
Contentofchlorofluoromethanelessthan1mg/kgofthesubstance
47210 Dibutylthiostannoicacidpolymer
Molecularunit=(C8H18S3Sn2)n(n=1,5-2)
76721 Polydimethylsiloxane(Mw>6800)
Minimumviscosity100×10–6m2/s(=100centistokes)at25ºC
77895 Polyethyleneglycol(E0=2-6)monoalkyl(C16-C18)ether
Thecompositionofthismixtureisasfollows:
— polyethyleneglycol(E0=2-6)monoalkyl(C16-C18)ether(approximately28%)
— fattyalcohols(C16-C18)(approximately48%)
— ethyleneglycolmonoalkyl(C16-C18)ether(approximately24%)
83595 Reactionproductofdi-tert-butylphosphonitewithbiphenyl,obtainedbycondensationof
2,4-di-tert-butylphenolwithFriedelCraftreactionproductofphosphoroustrichlorideand
biphenyl
Composition:
— 4,4′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 38613-77-
3)(36-46%w/w(*)),
— 4,3′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 118421-
00-4(17-23%w/w(*)),
— 3,3′-Biphenylene-bis[0,0-bis(2,4-di-tert-butylphenyl)phosphonite] (CAS.No 118421-
01-5)(1-5%w/w(*)),
— 4-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonite (CAS.No91362-37-7)(11-
19%w/w(*)),
— Tris(2,4-di-tert-butylphenyl)phosphite(CAS.No31570-04-4)(9-18%w/w(*)),— 4,4′-Biphenylene-0,0-bis(2,4-di-tert-butylphenyl)phosphonate-0,0-bis(2,4-di-tert-butyl-
phenyl)phosphonite(CAS.No112949-97-0)(<5%w/w(*)).
Otherspecifications:
— Phosphorcontentofmin.5,4%tomax.5,9%
— Acidvalueofmax.10mgKOHpergram— Meltrangeof85-110ºC
88640 Soybeanoil,epoxidized
Oxirane<8%,iodinenumber<62002L0072—EN—30.03.2004—002.001—52
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Ref.No OTHERSPECIFICATIONS
95859 Waxes,refined,derivedfrompetroleumbasedorsynthetichydrocarbonfeedstocks
Theproductshouldhavethefollowingspecifications:
— ContentofmineralhydrocarbonswithCarbonnumberlessthan25,notmorethan5%
(w/w)
— Viscositynotlessthan11×10–6m2/s(=11centistokes)at100ºC
— Averagemolecularweightnotlessthan500.
95883 Whitemineraloils,paraffinicderivedfrompetroleumbasedhydrocarbonfeedstocks
Theproductshouldhavethefollowingspecifications:
— ContentofmineralhydrocarbonswithCarbonnumberlessthan25,notmorethan5%
(w/w)
— Viscositynotlessthan8,5×10–6m2/s(=8,5centistokes)at100ºC
— Averagemolecularweightnotlessthan480
(*) Quantityofsubstanceused/quantityofformulation2002L0072—EN—30.03.2004—002.001—53
▼M2
ANNEX VI
NOTES RELATED TO THE COLUMN ‘RESTRICTIONS AND/OR
SPECIFICATIONS’
(1) Warning: there is a risk that the SML could be exceeded in fatty food
simulants.
(2) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration of the following substances
mentionedasreferenceNos:10060and23920.
(3) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration of the following substances
mentionedasreferenceNos:15760,16990,47680,53650and89440.
(4) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration of the following substances
mentionedasreferenceNos:19540,19960and64800.
(5) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration of the following substances
mentionedasreferenceNos:14200,14230and41840.
(6) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration of the following substances
mentionedasreferenceNos:66560and66580.
(7) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentioned as reference Nos: 30080, 42320, 45195, 45200, 53610, 81760,
89200and92030.
(8) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentioned as reference Nos: 38000, 42400, 64320, 67896, 73040, 85760,
85840,85920and95725.
(9) Warning:thereisariskthatthemigrationofthesubstancedeterioratesthe
organoleptic characteristics of the food in contact and then, that the
finished product does not comply with the second indent of Article 2 of
Directive89/109/EEC.
(10) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentioned as reference Nos: 30180, 40980, 63200, 65120, 65200, 65280,
65360,65440and73120.
(11) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels (expressed as Iodine) of the
following substances mentioned as reference Nos: 45200, 64320, 81680
and86800.
(12) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:36720,36800,36840and92000.
(13) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:39090and39120.
(14) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:44960,68078,82020and89170.
(15) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentioned as reference Nos: 15970, 48640, 48720, 48880, 61280, 61360
and61600.
(16) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:49600,67520and83599.
(17) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentioned as reference Nos: 50160, 50240, 50320, 50360, 50400, 50480,
50560,50640,50720,50800,50880,50960,51040and51120.
(18) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:67600,67680and67760.2002L0072—EN—30.03.2004—002.001—54
▼M2
(19) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:60400,60480and61440.
(20) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:66400and66480.
(21) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:93120and93280.
(22) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:17260,18670,54880and59280.
(23) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:13620,36840,40320and87040.
(24) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:13720and40580.
(25) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:16650and51570.
(26) QM(T)inthisspecificcasemeansthattherestrictionshallnotbeexceeded
bythesumoftheresidualquantitiesofthefollowingsubstancesmentioned
as reference Nos: 14950, 15700, 16240, 16570, 16600, 16630, 18640,
19110,22332,22420,22570,25210,25240and25270.
(27) QMA(T) in this specific case means that the restriction shall not be
exceededbythesumoftheresidualquantitiesofthefollowingsubstances
mentionedasreferenceNos:10599/90A,10599/91,10599/92Aand10599/
93.
(28) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:13480and39680.
(29) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:22775and69920.
(30) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:86480,86960and87120
(31) Compliance testingwhenthereisafatcontact shouldbeperformedusing
saturatedfattyfoodsimulantsassimulantD.
(32) Compliance testingwhenthereisafatcontact shouldbeperformedusing
isoctaneassubstituteofsimulantD(unstable).
(33) QMA(T) in this specific case means that the restriction shall not be
exceededbythesumoftheresidualquantitiesofthefollowingsubstances
mentionedasreferenceNos:14800and45600.
(34) SML(T) in this specific case means that the restriction shall not be
exceeded by the sumof the m igration levels of the following substances
mentionedasreferenceNos:55200,55280and55360.2002L0072—EN—30.03.2004—002.001—55
▼C1
ANNEX VII
Part A
REPEALED DIRECTIVE AND ITS AMENDMENTS
(ReferredtobyArticle10(1))
CommissionDirective90/128/EEC(OJL349,13.12.1990,p.26)
CommissionDirective92/39/EEC(OJL168,23.6.1992,p.21)
CommissionDirective93/9/EEC(OJL90,14.4.1993,p.26)CommissionDirective95/3/EC(OJL41,23.2.1995,p.44)
CommissionDirective96/11/EC(OJL61,12.3.1996,p.26)
CommissionDirective1999/91/EC(OJL310,4.12.1999,p.41)CommissionDirective2001/62/EC(OJL221,17.8.2001,p.18)
CommissionDirective2002/17/EC(OJL58,28.2.2002,p.19)
Part B
DEADLINES FOR TRANSPOSITION INTO NATIONAL LAW
(ReferredtobyArticle10(1))
DirectiveDeadlines
Fortransposi-
tionTopermittrade
inthose
productswhich
complywith
thisDirectiveToprohibit
tradeinthose
productswhich
donotcomply
withthisDirec-
tive
90/128/EEC(OJL349,
13.12.1990,p.26)31December
19901January
19911January1993
92/39/EEC(OJL168,
23.6.1992,p.21)31December
199231March
19941April1995
93/9/EEC(OJL90,
14.4.1993,p.26)1April1994 1April1994 1April1996
95/3/EC(OJL41,
23.2.1995,p.44)1April1996 1April1996 1April1998
96/11/EC(OJL61,
12.3.1996,p.26)1January
19971January
19971January1999
1999/91/EC(OJL310,
4.12.1999,p.41)31December
20001January
20021January2003
2001/62/EC(OJL221,
17.8.2001,p.18)30November
20021December
20021December
2002
2002/17/EC(OJL58,
28.2.2002,p.19)28February
20031March2003 1March2004
1March2003
formaterials
andarticles
whichcontainDivinylbenzene2002L0072—EN—30.03.2004—002.001—56
▼C1
ANNEX VIII
CORRELATION TABLE
Directive90/128/EEC ThisDirective
Article1 Article1
Article2 Article2Article3 Article3
Article3a Article4
Article3b Article5
Article3c Article6
Article4 Article7
Article5 Article8
Article6 Article9
- Article10
- Article11
- Article12
ANNEXI ANNEXI
ANNEXII ANNEXII
ANNEXIII ANNEXIII
ANNEXIV ANNEXIV
ANNEXV ANNEXV
ANNEXVI ANNEXVI
- ANNEXVII- ANNEXVIII2002L0072—EN—30.03.2004—002.001—57