Active and Intelligent Food Packaging A Nordic report ... - Blogs Unpad

Active and IntelligentFood PackagingA Nordic reporton thelegislative aspectsbyBente Fabech, DenmarkTurid Hellstrøm, NorwayGunilla Henrysdotter, SwedenMette Hjulmand-Lassen, DenmarkJeanette Nilsson, SwedenLisbet Rüdinger, DenmarkThea Sipiläinen-Malm, FinlandEva Solli, NorwayKettil Svensson, SwedenÁsmundur E. Thorkelsson, IcelandVesa Tuomaala, Finland

Table of ContentsTable of Contents ................................................................................................... 5Preface .................................................................................................................... 9Introduction ......................................................................................................... 12Summary ................................................................................................................ 5Samantekt .............................................................................................................. 7Yhteenveto.............................................................................................................. 9Resumé ................................................................................................................. 11Chapter 1 What is active and intelligent packaging?........................................ 131.1 Definitions ...................................................................................... 13Some other definitions mentioned in relevant literature are: ..................... 131.2 Active and intelligent packaging – examples.................................. 141.3 Active packaging: scavengers......................................................... 141.4 Active packaging: emitters ............................................................. 161.4.1 Antimicrobial agents....................................................................... 161.4.2 Food additives and flavourings....................................................... 171.4.3 Biocides, pesticides ........................................................................ 181.4.4 Food ingredients ............................................................................. 181.5 Indicators ........................................................................................ 191.5.1 Freshness indicators........................................................................ 201.5.2 Time-temperature indicators ........................................................... 201.5.3 Leak indicators ............................................................................... 201.6 Others ............................................................................................. 211.6.1 Susceptor materials......................................................................... 211.6.2 Hot pot............................................................................................ 211.7 Related subjects not included in this report .................................... 211.7.1 Modified or controlled atmosphere packaging................................ 211.7.2 Edible films..................................................................................... 21Chapter 2 Effectiveness and test requirements ................................................. 242.1 Effectiveness................................................................................... 242.2 The need for testing of materials and articles ................................. 252.3 Functional barriers.......................................................................... 272.4 Active packaging with food additives, flavourings and pesticides.. 27Chapter 3 Legislation relevant to consider........................................................ 283.1 Product safety, general requirements .............................................. 293.2 Packaging ....................................................................................... 303.2.1 Definition........................................................................................ 313.3 Food additives................................................................................. 333.3.1 Definition........................................................................................ 333.3.2 Legislation ...................................................................................... 343.3.3 Food additives and packaging......................................................... 353.4 Flavourings ..................................................................................... 353.4.1 Definitions ...................................................................................... 353.4.2 Legislation ...................................................................................... 365

3.4.3 Special national requirements in the Nordic countries ................... 373.4.4 Food flavourings and packaging..................................................... 373.5 Pesticides........................................................................................ 383.5.1 Definitions...................................................................................... 383.5.2 Legislation...................................................................................... 393.5.3 Pesticides and packaging................................................................ 393.6 Biocides.......................................................................................... 403.6.1 Definition ....................................................................................... 403.7 Hygiene .......................................................................................... 403.7.1 Definitions...................................................................................... 403.7.2 Requirements concerning packaging materials............................... 41Food hygiene directive................................................................ 41Directives concerning animal products..................................... 42Special provisions for quick-frozen foodstuffs ........................ 423.7.3 Requirements concerning temperature and temperature-monitoring........................................................................................................ 423.7.3.1 Food Hygiene Directive.................................................... 423.7.3.2 Directives concerning animal products ............................. 433.7.3.3 Special temperature provisions for quick-frozen foodstuffs433.7.4 Hygiene and food packaging .......................................................... 443.8 Food labelling................................................................................. 443.8.1 Definitions...................................................................................... 443.8.2 Legislation...................................................................................... 453.8.3 Labelling and packaging................................................................. 463.9 Weight and volume control............................................................. 473.9.1 Legislation...................................................................................... 473.9.2 Weight, volume and packaging....................................................... 483.10 Summary ........................................................................................ 49Chapter 4 Legislation and national interpretation of some examples............. 504.1 Beer bottles or beer cans with a widget .......................................... 504.1.1 Legal aspects .................................................................................. 514.2 Temperature indicators ................................................................... 514.2.1 Legal aspects .................................................................................. 514.3 Steak thermometers and doneness-indicators ................................. 524.3.1 Legal aspects .................................................................................. 524.4 Antioxidants in packaging materials............................................... 524.4.1 Legal aspects .................................................................................. 534.5 Triclosan in food packaging ........................................................... 534.5.1 Legal aspects .................................................................................. 534.6 Antimicrobial Packaging Materials ................................................ 544.6.1 Legal aspects .................................................................................. 544.7 The use of allylisothiocyanate (AITC) as an antimicrobial agent andethylene absorber............................................................................................... 554.7.1 Legal aspects .................................................................................. 554.8 Oxygen absorber............................................................................. 564.8.1 Legal aspects .................................................................................. 574.9 Wood in wine processing................................................................ 574.9.1 Legal aspects .................................................................................. 576

Chapter 5 Conclusions and recommendations on legislative aspects ............. 585.1 Viewpoints on the effect of variations in the interpretation of EUdirectives 585.2 The EU Framework Directive on food contact materials and articlesand on active and intelligent packaging............................................................. 595.2.1 Area covered by Article 1 ............................................................... 595.2.1.1 Scope................................................................................. 595.2.1.2 Which articles and materials correspond to a definition ofactive and intelligent packaging?.................................................... 605.2.2 General requirements of Article 2................................................... 615.2.2.1 Should impose no danger to human health........................ 625.2.2.2 Changes in composition .................................................... 625.2.3 Article 3 and specific directives and migration limits..................... 625.2.3.1 Positive lists ...................................................................... 635.2.3.2 Migration limits ................................................................ 635.2.4 Article 6: Labelling requirement for food packaging...................... 645.3 Other directives to be considered.................................................... 645.3.1 Food additives................................................................................. 655.3.2 Flavourings ..................................................................................... 655.3.3 Pesticides ........................................................................................ 655.3.4 Hygiene........................................................................................... 665.3.5 Weight and volume control ............................................................. 665.3.6 Labelling......................................................................................... 675.4 Recommendations and conclusions ................................................ 67Chapter 6 Guidelines for food inspection facilities and other concernedparties, on active and intelligent food packaging .............................................. 696.1 Applicability of EU requirements ................................................... 696.2 General guidance on active and intelligent packaging.................... 696.2.1 An overview ................................................................................... 69General requirements/composition ............................................................ 70Hygiene...................................................................................................... 706.2.2 The evaluation: examples of how to evaluate a product of a twocomponentsachet............................................................................ 706.2.3 Guidelines for food packaging producers ....................................... 716.3 Guidelines for importers/suppliers.................................................. 726.4 Guidelines for food producers ........................................................ 73Annex A Comparison of restriction limits for food additives, pesticides andsubstances used in food contact materials ......................................................... 75Food contact materials ............................................................................... 75Food additives............................................................................................ 75Pesticides ................................................................................................... 75Comparison................................................................................................ 76References ............................................................................................................ 777

PrefaceThe Nordic countries – Denmark, Finland, Iceland, Norway and Sweden –have trade agreements and co-operations in many areas. Official opinions inone country within a specific area will, in many cases, raise questions in theother countries. Frequently, the call for uniform interpretations or decisionsis brought forward, especially when the decisions and opinions within acertain area deviate from one other. This could be the case in areas wherelegislation interpretation is complicated, like, for example, active andintelligent packaging. This area is especially complicated, since many parts ofthe legislation will have to be considered when evaluating the legal aspectsof a product. Furthermore, it seems as if this issue has not been taken up inthe legislation of most countries in the world. This is the case, even thoughmany products classified today as belonging to the group of active andintelligent packaging have been recognised, and they have been applied formany years; such is the case with, e.g., humidity absorbers.The growth in international trade has put pressure on national authorities foruniform legislation or interpretation of international legislation or guidelinesin order to achieve fair competition, as well as appropriate levels ofconsumer protection. The Nordic countries have a long tradition of cooperationin the area of food packaging, as well as in many other areas.Furthermore, these countries have similar legislation in many parts of foodpackaging. With Denmark, Finland and Sweden being members of theEuropean Union, and Iceland and Norway being associated through the EuropeanEconomic Agreement (the EEA agreement), the subject of foodpackaging was dealt with in a project group under the Nordic Council of Ministers.Members of this project group consist of the following persons:Denmark Bente Fabech, Mette Hjulmand-Lassen, Lisbet Rüdinger, DanishVeterinary and Food AdministrationFinland Thea Sipiläinen-Malm, VTT Biotechnology; Vesa Tuomaala,Ministry of Trade and IndustryIcelandNorwaySwedenÁsmundur E. Thorkelsson, Environmental & Food Agency ofIcelandTurid Hellstrøm and Eva Solli, Norwegian Food Control AuthorityKettil Svensson,Gunilla Henrysdotter and Jeanette Nilsson, NationalFood AdministrationBente Fabech directed the project. Layout was by J. Louis Justice, also DanishVeterinary and Food Administration. Chief Food Inspector Christian Balslev,the Food Inspection Laboratory, Skovlunde, contributed with assistance ontemperature indicators in Chapter 4.9

This report has been discussed and approved in the Joint Nordic WorkingGroup on Food Law and sponsored by the Nordic Committee of SeniorOfficials for Food Issues under the Nordic Council of Ministers.10

IntroductionThe main purpose of food packaging is to protect the food from microbialand chemical contamination, oxygen, water vapours and light. The type ofpackaging used, therefore, has an important role in determining the shelf lifeof a food. In most cases, this role is a rather passive and inert one, but duringrecent decades, the idea of active and intelligent packaging has receivedmore attention and many commercial products have been introduced andused in the food area.For packaging materials and articles in contact with food, the generalrequirements are conventionally concentrated on the safety by restricting themigration of substances from the packaging materials into the food and theconsequences of the package on the sensory qualities of the food.The general requirements for legislation in the Nordic countries, as well as inEuropean Union (EU) Framework Directive (89/109/EEC) on food contactmaterials, are expressed as follows:– under normal and foreseeable conditions of use, they should not transfertheir constituents into foodstuffs in quantities, which could:• endanger human health;• bring about an unacceptable change in the composition of the foodstuffsor deterioration in the organoleptic characteristics thereof.Furthermore, EU legislation on food contact materials is based on a principleof safety requirements and positive lists. For plastics, a certain limit foroverall or total migration of all substances to the food has been established.In addition, values for specific migration limits have bee set for a number ofsubstances, in accordance with the safety evaluation. The overall migrationlimit is based on general considerations on safety and hygiene. However, theoverall migration limit will, in certain cases, have implications on thepossibility to make use of active and intelligent food contact materials.National legislation on packaging exists in the individual EU and EEAcountries. (EEA stands for European Economic Area, which was establishedby the EEA agreement.)Active and intelligent packaging introduces new perspectives for thepackaging of food, such as the concept of intentional migration of substances,like e.g. preservatives and antioxidants from the package into the food. Thus,the general requirements in food packaging legislation will have to beconsidered together with requirements in other relevant parts of the foodlegislation.Seen from this legislative viewpoint, active and intelligent packaging do raiseseries of questions like:12

• Which community legislation covers a packaging material or an articlewhich – intentionally – brings about an addition of a substance, like apreservative, or lets any other active component migrate into the food?• Is it the legislation on packaging materials or some other specificlegislation that has to be recognised? Or, should recognition be placed onseveral parts of the legislation?• If there are restrictions in the legislation, which ones are to be observed?• Is there a need for specific legislation in this area, or should existinglegislation be revised? If so, which part of the legislation should berevised?This report will describe some types of active and intelligent food contactmaterials, the legislation which the project group has found relevant toconsider, as well as some conclusions and proposals for administrators forfuture work with recommendations and interpretations of the existinglegislation, or establishing new legislation.The legislation dealt with in this report will only cover legislation within thefood area. Even though active and intelligent packaging could imply aspecial problem in relation to recycling, reuse, waste handling, etc., thesetopics are not included in the report. Users of active and intelligentpackaging have to be aware of the legislation on solid waste and take therelevant precautions needed when using active and intelligent packaging.13

SummaryThe main purpose of food packaging is to protect the food from biological,physical and chemical contamination from alteration due to exposition tooxygen, water vapour and light. This role is in most cases a rather passiveand inert role, but during the last decades the idea of active and intelligentpackaging has got more attention and many commercial products areintroduced and used in the food area. The food industry, inspection andadministration as well as consumers will have to consider the legality ofthese types of packaging.The intention of this report is to point out and, if possible, clarify theambiguities on the middle ground between food packaging legislation andother parts of food legislation, which are found relevant to those who shouldevaluate the legal aspects of active and intelligent packaging. This would be,e.g. legislation on food additives, labelling, flavourings and hygiene. Theword “packaging” is generally used in this report to cover all “food contactmaterials and articles”, since many types of active packaging are wrappings.Furthermore, this report covers all the layers of any food contact material.The purpose is to contribute to a solution of questions by giving a briefoverview of the subject and the actual products in question, and to supplyproposals for advice to concerned parties, such as legislators, food inspectorsand industry.A short overview is given on different types of active and intelligentpackaging materials and articles like absorbers, emitters of food additives,such as preservatives and antioxidants or flavourings, and others. Theseproduct types are already available on the market, but the legal aspects haveneither been clearly defined nor discussed in this context.Many persons involved in the evaluation of the legality may have a solidknowledge on the legislation on food packaging, but most often the samepeople do not have detailed knowledge on all the other relevant parts of thelegislation, e.g. food additives, pesticides or flavourings legislation. Thisreport gives a summary of those parts of the legislation, which the projectgroup found most relevant. Reference is given mainly to legislation in theEuropean Community, as this is the basic legislation in the Nordic countries,with no or few additional national requirements.In addition to the general and specific requirements in the legislation on foodpackaging in the Nordic countries, as well as in the EU Framework Directive(89/109/EEC), etc., many other parts of the legislation obviously must betaken into account. That would include, e.g. the legislation on food additives,flavourings, product safety and hygiene. The EU directive on plasticmaterials has a general limit on the maximum, overall migration of the totaltransfer of substances from food packaging materials of 60 mg/kg, which is5

of importance to consider. The overall migration limit was established beforethe development and use of active and intelligent packaging was extended.This limit is based on general considerations on both hygiene and health, butthe overall migration limit in some cases will also have implications on thepossibility to make use of active and intelligent packaging.Active and intelligent packaging has other intended functions than traditionaltypes of packaging. Some of these functions will be covered by thedefinitions on substances, like food additives, flavourings, pesticides orbiocides. Furthermore, they can affect, e.g. the weight or volume in a prepackagedfood, or have functions regulated in the hygiene area. Theevaluation of the legality of active and intelligent packaging will, therefore,have to take different parts of the legislation, like legislation of foodadditives, food labelling or hygiene, into account.The use of an active or intelligent packaging could, in some cases, be incompliance with the requirements in the legislation of food contact materialsand articles, although not with requirements in the legislation for foodadditives or flavourings. If the use of such types of active or intelligentpackaging should be acceptable in accordance with legislation, the legislationwill have to be reviewed, or special guidance on the interpretation would beneeded. Recommendations are given as to which parts of the legislationshould be reviewed and as to which questions could be solved by interpretationof existing legislation. However, interpretation of harmonisedlegislation should preferably be done in an international co-operation inorder to avoid deviations in the interpretation, which could lead to technicalbarriers to trade. On questions as to where the problems could be solved byinterpretation, some proposals are given.Finally, some guidance is given to the authorities in the Nordic countries,among these, the food inspection systems, on how to conduct an evaluation,as well as proposals for initiatives to be taken by legislators when drafting orrevising the legislation on active and intelligent packaging. These proposalsmay freely be considered both nationally and in the EU.6

SamantektMeginhlutverk umbúða er að verja matvæli fyrir örveru- og efnafræðilegumbreytingum sem geta orðið fyrir tilstilli súrefnis, vatnsgufu og ljósa.Umbúðirnar gegna þessu hlutverki á frekar hlutlausan hátt. Á síðustuáratugum hefur hugmyndin um virkar og greindar umbúðir fengið meiriathygli og margar slíkar nýjungar verið teknar í notkun í matvælageiranum.Matvælaiðnaðurinn, opinbert eftirlit og stjórnvöld, að ógleymdumneytendum, verða að meta lagalega stöðu nýjunga af þessu tagi.Markmiðið með þessari skýrslu er að benda á, og helst leysa úr þeimvafamálum sem tengjast því bili sem er á milli umbúðareglugerða og annarrareglugerða á matvælasviði sem ná til virkra og greindra umbúða. Sem dæmium slíka löggjöf eru aukefna-, merkingar-, braðefna- oghollustuháttareglugerðir. Hér er notkun orðsins umbúðir þannig háttað aðþað nær til allra efna og hluta sem koma í snertingu við matvæli og nær þarmeð einnig til filma og alla hluta lagskiptra umbúðaefna.Ætlunin er að koma með tillögur að lausnum á þeim vandamálum sem uppieru með því að gefa yfirlit yfir viðfangsefnið og setja fram ráðgjöf til þeirrasem vinna að löggjafarsmíði, matvælaeftirliti og framleiðslu.Kynntar eru mismunandi útgáfur af virkum og greindum umbúðum, s.s.umbúðir sem draga í sig efni og umbúðir sem gefa frá sér rotvarnar-,þráavarnar- og bragðefni, svo eitthvað sé nefnt. Slíkar umbúðir finnast núþegar á markaðinum, þrátt fyrir að lagalega staða þeirra sé óljós.Margir þeirra sem koma að mati á lagalegri stöðu virkra og greindra umbúðahafa sérfræðiþekkingu á umbúðalöggjöfinni, þó í flestum tilvikum hafi sömueinstaklingar ekki jafn yfirgripsmikla þekkingu á öðrum sviðum sem máligeta skipt, s.s. löggjöf um aukefni, varnarefni og bragðefni. Í þessari skýrsluer að finna yfirlit yfir þá hluta þessarar löggjafar sem vinnuhópurinn taldimikilvægasta m.t.t. viðfangsefnisins. Aðallega er vísað löggjafarEvrópusambandsins, þar sem löggjöf Norðurlandanna er samhljóða í öllumaðalatriðum.Til viðbótar við almennar og sértækar kröfur sem er að finna íumbúðalöggjöf Norðurlandanna sem og rammalöggjöf Evrópusambandsinsþarf að íhuga marga aðra hluta matvælalöggjafarinnar. Dæmi um það erulöggjöf um aukefni, bragðefni, öryggi vöru og hollustuhætti. TilskipunEvrópusambandsins um plast í umbúðum matvæla inniheldur almennahámarksgildið 60 mg/kg fyrir heildarflæði efna úr umbúðaefnum yfir ímatvæli, sem er mikilvægt að hafa í huga. Þetta hámarksgildi kom fram áðuren notkun virkra og greindra umbúða varð útbreidd. Ákvörðun umhámarksgildið var tekin með hliðsjón af hollustuháttum og heilsu neytenda.Hámarksgildið getur í sumum tilvikum haft áhrif á möguleika á notkunvirkra og greindra umbúða.7

Virkar og greindar umbúiðr hafa í sumum tilvikum annað hlutverk enhefðbundar gerðir umbúða. Í sumum tilvikum fellur þessi virkni undirskilgreiningu á aukefnum, bragðefnum og varnarefnum. Til viðbótar getaþessar umbúðir t.d. haft áhrif á þyngd og rúmmál innpakkaðrar matvöru eðahaft virkni sem fellur undir reglur um hollustuhætti. Því verður að hafa tilhliðsjónar ýmsa þætti matvælalöggjafarinnar þegar lagt er mat á hvort virkarog greindar umbúðir samrýmast núggildandi löggjöf. Dæmi um slíkt erulöggjöf um aukefni, umbúðamerkingar og hollustuhætti.Notkun virkra og greindra umbúða getur í sumum tilvikum verið í samræmivið ákvæði í reglum um efni og hluti sem koma í snertingu við matvæli enekki ákvæði í reglum um aukefni og bragðefni. Ef notkun slíkra umbúða á aðsamrýmast þessum reglum þarf annaðhvort að endurskoða þær eða gerasérstakar leiðbeiningar um túlkun reglnanna. Í þessari skýrslu er að finnaráðgjöf um hvaða hluta löggjafarinnar þarf að endurskoða og hvaða málmætti leysa með skýrri túlkun á gildandi reglum. Hins vegar er æskilegt aðtúlkun löggjafar sem gildir á öllu Evrópska efnahagssvæðinu fari fram áþeim vettvangi til að fyrirbyggja ósamræmi í túlkun milli ríkja sem síðangætu orðið að viðskiptahindrunum. Í skýrslunni er að finna tillögur umhvernig mætti leysa ýmis mál með skýrri túlkun á gildandi löggjöf.Að lokum eru settar fram leiðbeiningar til Norðurlandanna um hvernigleggja skuli mat á lögmæti þessara umbúða, ásamt tillögum um hvernigmætti haga endurskoðun löggjafar um virkar og greindar umbúðir. Þessartillögur ætti að skoða bæði í hverju landi fyrir sig og einnig íEvrópusambandinu..8

YhteenvetoElintarvikkeen pakkauksen pääasiallinen tehtävä on suojata elintarvikettamikrobiologiselta ja kemialliselta kontaminaatiolta sekä hapen, kosteuden javalon vaikutukselta. Tässä tehtävässä pakkauksella on tavallisesti jokseenkinpassiivinen ja inertti rooli, mutta viime vuosikymmenien aikana on ajatusaktiivisesta ja älykkäästä pakkaamisesta saanut yhä enemmän huomiota jamonia kaupallisiakin tuotteita on tuotu markkinoille, myös elintarvikealalla.Tässä tilanteessa elintarviketeollisuus, elintarvikevalvonta ja hallinto, samoinkuin kuluttajatkin joutuvat arvioimaan tämän uuden pakkaustyypinlaillisuutta ja turvallisuutta.Tämän raportin pyrkimys on tunnistaa, ja mahdollisuuksien mukaanselventää, sellaisia ongelmakohtia elintarvikkeiden pakkauksia koskevanlainsäädännön ja muun elintarvikelainsäädännön välimaastossa, joita onpidettävä keskeisinä niiden kannalta joiden tehtävänä aktiivisten jaälykkäiden pakkausten laillisuuden arviointi on. Tässä mielessähuomioitavia voivat olla esimerkiksi määräykset elintarvikkeiden lisäaineista,päällysmerkinnöistä, aromiaineista ja hygieniasta. Raportissa sanaa’pakkaus’ käytetään yleisessä merkityksessä ’elintarvikkeen kanssakosketukseen joutuvat materiaalit ja tarvikkeet', sillä monet aktiivisetpakkaukset ovat kääreitä. Käsitteeseen sisällytetään tässä raportissa mm.monikerroksisen materiaalin kaikki kerrokset.Tavoitteena on osallistua keskusteluun ja edistää ongelmakohtienratkaisemista esittämällä lyhyt katsaus aiheeseen ja ko. tuotteisiin, sekätarjota ehdotuksia ohjeiksi, joita asianomaisiet tahot kuten lainsäätäjät,elintarvikevalvonta ja teollisuus voivat hyödyntää.Aluksi raportissa kuvataan eri tyyppisiä aktiivisia ja älykkäitäpakkausmateriaaleja ja tarvikkeita kuten absorbentteja ja eri aineiden erittäjiämm. elintarvikelisäaineiden, säilöntäaineiden, hapetuksenestoaineiden taiaromiaineiden erittäjiä sekä muita pakkausratkaisuja. Useita tuotetyyppejäon jo nyt markkinoilla, mutta lainsäädännöllisiä yksityiskohtia ei ole tarkastimääritelty eikä pohdittu.Monet lainmukaisuuden arviointiin osallistuvat asiantuntijat ovat tarkoinperillä elintarvikkeiden pakkauksia koskevasta lainsäädännöstä, mutta näilläsaattaa olla vähäisempi tietämys muista elintarvikesäädöksistä, esimerkiksilisäaine-, pestisidi- tai aromiainemääräyksistä. Raportti on tiivis katsausniihin lainsäädännön osiin, joita projektiryhmä piti tärkeimpinähuomioitavina. Painopiste on Euroopan yhteisön lainsäädännössä, silläsäädökset Pohjoismaissa perustuvat tähän ja muita kansallisia määräyksiä onvain vähän tai ei ollenkaan.Elintarvikkeiden pakkauksia koskevan pohjoismaisen lainsäädännön, kutenmyös EUn kehysdirektiivin (89/109/ETY), antaman yleisen ja9

erityislainsäädännön lisäksi on ilmeistä että monet muut lainsäädännön osaalueeton huomioitava. Näitä ovat esimerkiksi elintarvikelisäaineita,aromiaineita, tuoteturvallisuutta ja hygieniaa koskevat lainsäädännöt. EUnmuovimateriaaleja koskevassa direktiivissä on yleinen kokonaismigraatiolleasetettu raja-arvo 60 mg/kg pakkauksesta elintarvikkeeseen mahdollisestisiirtyville aineille. Kokonaismigraatioraja on asetettu ennen aktiivisten jaälykkäiden pakkausten laatimista ja käyttöönottoa ja rajan asettaminen onperustunut sekä yleisiin hygienia- että terveysnäkökohtiin. Raja-arvolla oneräissä tapauksissa myös vaikutusta aktiivisten ja älykkäiden pakkaustenkäyttömahdollisuuksiin.Aktiivisilla ja älykkäillä pakkauksilla on tietyissä sovelluksissa sellaisia tarkoituksellisialisäfunktioita, joita perinteisellä pakkauksella ei ole. Eräätnäistä funktioista ovat samoja, joita aineryhmillä kuten elintarvikelisäaineilla,aromiaineilla, pestisideillä tai biosideillä määritelmän mukaan on. Lisäksiniillä voi olla vaikutusta pakatun elintarvikkeen painoon tai tilavuuteen tainiillä voi olla vaikutuksia, joita säännellään hygieniasäädöksissä. Nämämonet lainsäädännölliset näkökulmat on sen vuoksi huomiotava aktiivistenja älykkäiden pakkausten lainmukaisuutta arvioitaessa.On mahdollista, että nykyisen lainsäädännön aikana syntyy tilanteita jolloinaktiivisen tai älykkään pakkauksen käyttö täyttääpakkausmateriaalisäädösten vaatimukset, mutta ei täytä esimerkiksi lisäainetaiaromiainemääräysten vaatimuksia. Mikäli kuitenkin periaatteessakatsotaan ko. pakkausten käyttö asianmukaiseksi ja hyväksyttäväksi, onlainsäädäntö tarkistettava tai annettava ohjeet olemassaolevan lainsäädännöntulkinnasta. Raportti osoittaa mitkä lainsäädännön osat kaipaavattarkistusta ja mitkä kysymykset voidaan ratkaista nykyisten säädöstentulkinnalla. Harmonisoidun lainsäädännön tulkinnat on kuitenkin tehtäväkansainvälisen yhteistyön puitteissa mahdollisten erilaisten tulkintojenaiheuttamien kaupan esteiden välttämiseksi. Raportti tarjoaa eräitäehdotuksia sellaisiin ongelmakohtiin, joissa arvellaan löytyvän ratkaisuyhtäläisen säädösten tulkinnan avulla, .Lopuksi raportti antaa neuvoja ko. pakkausten arvioinnin suorittamisestaPohjoismaiden viranomaisille ja elintarvikevalvonnasta vastaaville, sekäesittää lainsäätäjille ehdotuksia aloitteiksi aktiivisia ja älykkäitä pakkauksiakoskevien säädösten laatimisesta tai muuttamisesta. Ehdotukset ovatvapaasti käytettävissä käsiteltäessä aihetta sekä kansallisesti että EUn piirissä.10

ResuméHovedformålet med fødevareindpakning er, at beskytte fødevarerne framikrobiologiske og kemiske forureninger og fra ændringer pga. oxygen,vanddamp og lys. Denne funktion er i de fleste tilfælde en ret passiv og inertfunktion. Gennem de sidste årtier har ideen om aktive og intelligentepakninger imidlertid fået mere opmærksomhed, og mange kommercielleprodukter er kommet på marked med sådanne anvendelser påfødevareområdet. Fødevareindustrien, kontrollen og administrationen samtforbrugerne bliver derfor nød til at overveje lovligheden af denne typepakninger.Rapporten har til formål at fremhæve, og hvor det er muligt, at udpege deuklarheder, der er i lovgivningen. Den omfatter området mellemlovgivningen om fødevarepakninger og andre dele af fødevarelovgivningen,som er fundet relevant at inddrage, for de som skal vurdere lovligheden afaktiv og intelligent pakning. Det vil f.eks. være lovgivningen omtilsætningsstoffer, mærkning, aromaer og hygiejne. I rapporten bruges ordet” emballage” generelt som et udtryk, som gælder alle ”materialer og genstandebestemt til at komme i berøring med fødevarer”, da mange af deaktive pakninger er emballage. Ordet ”emballage” bruges for at dække alledisse materialer og genstande, ligesom det også anvendes om alle lag i ethvert af de materialer eller genstande (bestemt til fødevarekontakt), deromtales i rapporten.Formålet med redegørelsen er også at bidrage til løsningen af de problemer,der er, ved at give et generelt overblik emnet og de produkter, der findessamt at give forslag til vejledning til lovgiver, fødevarekontrol og industri.Der gives en kort oversigt over de forskellige typer af aktive og intelligentematerialer og genstande så som emitter er karakteriseret ved, at de afgivertilsætningsstoffer som f.eks. konserveringsmidler og antioxidanter elleraromaer, absorbenter eller har andre aktive funktioner. Disse produkter erallerede på markedet, men de lovgivningsmæssige aspekter er ikke klare.Mange af de personer, der er involveret i vurdering af lovligheden, afprodukterne kan have en grundlæggende viden om lovgivningen omfødevareindpakning, men i de fleste tilfælde har disse folk ikke detaljeretkendskab til alle, andre relevante dele af lovgivningen så som lovgivningenom tilsætningsstoffer, pesticider og om aromaer. I rapporten gives et resumeaf de dele af lovgivningen, som projektgruppen har fundet, som det var mestrelevant at overveje. Referencerne er hovedsagelig givet til EU lovgivningen,da det er basis for lovgivningen i de nordiske lande. De nordiske lande harderudover enten ingen eller få nationale krav.Ved vurderingen af aktive og intelligente emballage skal der ud over degenerelle og specifikke krav i EU’s rammedirektiv om pakkematerialer11

d. Active packaging does more than simply provide a barrier to outsideinfluences on the packed food; it can control, and even react to, eventstaking place inside the package.e. Smart, intelligent or clever packaging is defined as a packaging techniquecontaining an external or internal indicator for the active product historyand quality.f. An active or intelligent packaging is a packaging, which has an additional,desired role that improves the quality of the food product as asupplement to pure packaging properties. These properties can either beintegrated in the packaging material or separated from it.g. Smart packaging is a packaging which has an inherent ability to gatherinformation on its operating environment or history, to process thatinformation in order to draw intelligent inferences from it and to act onthose inferences by changing its characteristics in an advantageousmanner.1.2 Active and intelligent packaging – examplesIn the following, some basic concepts are explained, and examples of activeand intelligent packaging are given to serve as background information forthe discussion of the legal aspects of the subject. As mentioned above, it isneither the intention of this report to go into a detailed discussion of thefunction of individual products on the market, nor to be complete withregards to all available products.For the benefits of the discussion on the legal aspects, the different types ofactive packaging are categorised into four groups, with regard to their wayof functioning.• Scavengers• Emitters• Indicators• OthersThe legality of some types of active and intelligent packaging are describedand discussed in Chapter 4.1.3 Active packaging: scavengersThis group of active packaging consists of ingredients, which are intended toabsorb, remove and then eliminate substances, such as oxygen, ethylene,moisture, or taint from the interior of a food package. The constituents in thistype of active packaging material and articles are not intended to have anydirect effect through migration on the food itself, but will, however, in mostcases, have an effect on the shelf life or the organoleptic properties of thefood.14

Some well-known examples are the oxygen scavengers and ethylene scavengers,which are used for eliminating oxygen respective ethylene from the package.The outcome is an extended shelf life of the food. Ethylene scavengers can beused in packed fruits, where the removal of ethylene will delay the ripeningof the fruits. The oxygen scavenger can be used in controlled atmospherepackaging. The controlled atmosphere package is a combination of amodified atmosphere packaging with a scavenger, which is used to removeresidual oxygen and prevent growth of an aerobic spoilage flora or moulds.A similar effect can be obtained by the use of water/moisture absorbers.Furthermore, an anti-caking effect on powders or improved appearance offresh meat when the meat juice is absorbed in the packaging can be obtained.Research is ongoing in the removal of other undesired substances, like bittertasting components in orange juice, aldehydes or amines causing offflavours,or components, like lactose and cholesterol.Table 1. Examples of active packaging – absorbers.Type Example of use areas Examples of componentsusedOxygen absorber Cheese, bakery wares, confectionery, Ferro-compounds, ascorbicnuts, milk powder, coffee, tea, beans, acid, metal salts, glucosegrains, pasta, meat products, ready-toeatoxidasesproductsHumidityabsorbersCarbon dioxideabsorbersBakery wares, meat, fish and poultry,ready-to-eat dishes, cuts of fruits andvegetablesGlycerol, clay, siliciumoxide, propylene glycol,poly acrylatesRoasted coffee Calcium hydroxide andsodium hydroxide orpotassium hydroxideEthene absorbers Fruits like apples, apricots, banana,mango, cucumber, tomatoes,avocados, vegetables like carrots,potatoes and Brussels sproutsAluminium oxide andpotassium permanganate,carbon, zeoliteAbsorbers of offflavours; aminesand aldehydesFood which can easily be oxidised,like proteins; fats in fish products,snacks and fruit juicesCitric acid in polymers;cellulose esters; polyamideCommercial oxygen scavengers are in most cases based on iron powder,which, in the presence of oxygen, forms iron oxide. Non-metallic andorgano-metallic compounds have also been developed. Other systems arebased on oxidising enzymes, e.g., glucose oxidase and catalase. Ethylene canbe removed by ethylene scavengers containing a number of chemicals, such aspotassium permanganate and activated charcoal, or destroyed by ozone.The most common moisture absorber is silica gel.Absorbers can be applied to the food package either by incorporating themin the packaging, sometimes as layers in the material, or as separate food15

contact articles, like sachets or other types of articles. Some examples aregiven in table 1.1.4 Active packaging: emittersThis group of active packaging contains, or produces, substances, which aremeant to migrate into the food packaging headspace or into the food in orderto obtain a technological effect in the atmosphere in the packaging or in thefood itself as e.g., either food additives, flavourings or biocides. In thesecases, the consumer together with the food ingests the components. Somegroups of emitters are described in details below, and, in Table 2, examplesare given.Table 2. Examples of active packaging – emitters.Type Effect Examples of use areasHumidity regulators Regulation of humidity content VegetablesCarbon dioxide emittersGrowth inhibition of gram negativemicroorganismsMeat, fish, poultry, ready-to-eatdishesShelf life extensionEthanol emitters Growth inhibition of microorganisms,including pathogensUnprocessed vegetables andfruitsBakery wares, dried fishproductsOrganic acid emitters, e.g. AntimicrobialMiscellaneoussorbic acidHinokitol emitter Antimicrobial MiscellaneousSulphur dioxide emittersPesticide emitters, e.g.imazalil, pyrethrinsBleaching agentAntioxidantAntimicrobialAntimicrobial, fungicidal or pestcontrolDried, white vegetablesVarious heat treated foodstuffsVarious unprocessed andprocessed foodsDried, sacked foodstuffs e.g.flour, rice, grainsPreservatives e.g. AntimicrobialMeat, unprocessed fruitsallylisothiocyanateAntioxidants, e.g. BHA, AntioxidationDried foodstuffs, fat containingBHT, tocopherolfoodstuffsFlavouring emitters Prevention of off-flavour Miscellaneous1.4.1 Antimicrobial agentsQuite recently, the idea of incorporating antimicrobial agents directly intopackaging films has been developed. Thus, the packaging material can serveas a source of releasing preservatives or antimicrobial agents, or even16

prevent the growth of microorganisms by presenting antimicrobialproperties by itself.The different substances that have been mentioned for the use asantimicrobials include, for instance,• food ingredients like ethanol;• food additives which can be other alcohols, e.g. polyols, sugar alcohols,organic acids and salts (sorbates, benzoate’s, propionates), andantimicrobials, such as nisin, natamycin and pediocin.• substances like imazalil, triclosan or naturally-occurring preservatives,etc., that might be regarded as pesticides or biocides are mentioned assubstances that are considered to be used as antimicrobial agents.The use of materials with antimicrobial agents can be divided into two types:• those, from which an active substance migrates to the surface of food, and• those, that are effective against microbial growth without migration of theactive agents to the food.The technology development work of various functional materials has beenactive since the latter half of the 1980s, mainly in Japan.The release of substances can be achieved by conventionally adding apermeable or porous sachet containing the substances into the package.Some preservatives can be incorporated into or onto, e.g. paper, board orpolymeric packaging materials to provide antimicrobial activity. The agentscan be applied to the packaging material by impregnation, mixing or usingvarious coating techniques. The active agents can be placed in intermediatelayers or encapsulated to achieve slow release into food. A moresophisticated concept is the use of immobilised enzymes, and materialshaving chemically bound antimicrobial functional groups on the materialsurface.1.4.2 Food additives and flavouringsThe addition of food additives or flavourings through the packagingmaterials or articles is examples of emitters. A function of active packagingcan be the emission of preservatives, flavourings, antioxidants, metal-ionsand gases. For instance, the uses of ethanol (regarded as a foodstuff) andother alcohols, and organic acids, like sorbic acid, benzoic acid and propionicacids are widely applied preservation methods.Other examples of uses of active packaging, with the intention of having anaddition of substances with functions covered by the definition on foodadditives, are, e.g. sachets with sodium metabisulphites in fresh grapes. Thesulphites evaporate, and the sulphur dioxide gas functions as a preservativeon the grapes.It is recognised that metallic ions of silver, copper, tin, and others presentanti-microbial properties. Silver substituted zeolite is the most frequently17

used antimicrobial agent in plastic materials in Japan. The metal tin (Sn) actsas an antioxidant, and is used as a technological food additive in somecanned products. In certain applications of canning, tin is deliberatelyreleased into the food, which can be obtained by using uncoated canscontaining tin in the alloys used. This use of tin prevents discoloration ofwhite vegetables and, thus, does have a technological effect covered by thedefinition of food additives on the food itself.One example on the use of active packaging with the purpose of adding foodadditives can be seen in beer. This is the so-called “widget”, a small plasticball, with a content of carbon dioxide. When the bottle is opened, the ballliberates the gas into the beer, resulting in rich and more stable foam on thebeer.In earlier years, the traditional use of different types of wood barrels forstorage of wine and other alcoholic beverages were the normal storageconditions for liquids and other types of food. Nowadays, for hygienicreasons, food producers often use, e.g. stainless steel. However, forapplications where wood barrels are still used, one explanation will be thatthe migration of flavouring substances from the wood to the wines, etc., is adesired addition of flavour to the wine or alcoholic beverages, like, forexample, whisky or cognac. In some cases, storage in wood barrels issubstituted by a combination of storage in stainless steel containerssupplemented with the addition of flaked wood into the wine for flavouringpurposes. Wood barrels for the storage of wine is one example of an activepackaging used with the intention of adding flavourings.1.4.3 Biocides, pesticidesSome substances that are normally regarded as pesticides or biocides havebeen recognised in use in active packaging. An example would be conveyorbelts with antimicrobial effects, which are developed. Here, the addition ofthe compound triclosan has been used with the intention to prevent or delaybuild-up of biofilm (i.e., surface adherent microflora) on food contactsurfaces.More efforts and resources should today be focussed on identifyingpesticides and biocides that really are used or have the potential to be used inactive food packaging and food contact situations. In this context, it seemsclear that fungicides and antimicrobial pesticides could have a clearrelevance to consider. Some insecticides have also potential uses in this area.1.4.4 Food ingredientsSome types of active and intelligent packaging concepts contain foodingredients or inert substances as carriers or fillers. Ingredients like sugars,starch, cellulose, water, proteins, salt, various silicates, etc., can be included.Even if the substances might not be harmful, some problems may arisebecause of their migrational behaviour and possible lack of labellinginformation to the consumer.18

In Japan, sachets have been developed containing a fine inert powder, ontowhich ethanol is absorbed. When the powder absorbs moisture from thefood, ethanol is released through the permeable sachet material.Ethanol is regarded as a foodstuff in the legislation of many countries. Theuse of ethanol for preservation purposes could be undertaken withbackground in the public aversion towards food additives. However, the useof ethanol would require proper labelling, as for foods in general, andattention should be given to the special problems for, e.g., alcohol abusers orpeople with religious considerations of introducing extended use of ethanolin food.1.5 IndicatorsVarious indicators have been presented to the producers of packedfoodstuffs – indicators for temperature, microbial spoilage, package integrity,physical shock, and product authenticity. Indicators in or on the foodpackage can give information on the quality of the food product directly, onthe package and its headspace gases, as well as on the storage conditions ofthe package. Some indicators do not need to interact with the product or theheadspace, while others do. These indicators are often called intelligentpackaging and certain concepts are already commercially available, and theiruses seem to be increasing. New concepts of leak indicators and freshnessindicators are patented, and it can be expected that new commerciallyavailable products will be assessable in the near future. Some groups ofintelligent packaging are described below and examples are given in Table 3.Table 3. Example on intelligent packaging.Type Effect Examples of use areasTime-temperatureindicatorInformation on temperature/-history and variation intemperatureAs supplement tolabelling in storage ortransportationOxygen indicator Information on leakage Modified orcontrolled atmospherefood packagingCarbon dioxide indicator Information on concentrationof carbon dioxide in modifiedatmosphere packagingModifiedorcontrolled atmospherefood packagingColour indicatorInformation on temperature ina food packagingFood for microwavepreparationPathogen indicator Information onmicrobiological statusBreakage indicator Information on brokenpackagingMeat, fish or poultryCanned baby food19

1.5.1 Freshness indicatorsFreshness indicators indicate directly the microbial quality of the product byreacting to the metabolites produced in the growth of microorganisms. Atpresent, the Nordic group is aware of only one commercially availableconcept. However, a variety of concepts have been presented in scientificliterature. Freshness detector concepts have been proposed for, e.g., carbondioxide, diacetyl, amines, ammonia, ethanol, and hydrogen sulphide. Aspecific indicator material for the detection of E. coli O157 enterotoxin hasbeen developed, and the possibility for applying the technology for thedetection of other toxins is currently being explored. In addition, otherconcepts for contamination indicators have been proposed. The indicatorcould be based on a colour change of chromogenic substrates of enzymesproduced by contaminating microbes, the consumption of certain nutrientsin the product, or on the detection of microorganisms, as such.1.5.2 Time-temperature indicatorsIf perishable food products are stored above the correct storage temperature,a rapid microbial growth takes place. The product is spoiled before theestimated “use by”-date. Time-temperature indicators (TTI) attached to thepackage surface is intended to integrate the cumulative time-temperaturehistory of the package throughout the whole distribution chain, and hence,gives indirect information on the product quality. The time-temperaturehistory is visualised as a colour change or colour movement. Commerciallyavailable time-temperature indicators are based on various reaction mechanisms(polymerisation, diffusion or enzyme reaction). A common feature forall concepts is the temperature dependent reaction kinetics of the indicatorand activation of the indicator at the moment of packaging.1.5.3 Leak indicatorsA leak indicator attached into the package gives information on the packageintegrity throughout the whole distribution chain. For many perishableproducts, exclusion of oxygen and high concentration of carbon dioxideimproves the stability of the product as the growth of aerobicmicroorganisms is prevented. As a result of package leaks, the protectingatmosphere is deteriorated. Package leaks also increase the microbialspoilage by enabling the product contamination with harmful microorganisms.A typical visual O 2indicator consists of a redox-dye (e.g., methyleneblue), a reducing compound (e.g., reducing sugars) and an alkalinecompound (e.g., sodium hydroxide). Oxygen indicators based on oxidativeenzymes have been recently described. In addition to these main components,compounds such as a solvent (typically water and/or an alcohol) andbulking agent (e.g., zeolite, silica gel, cellulose materials, polymers) areadded to the indicator. The indicator can be formulated as a tablet, a label, aprinted layer, or it can also be laminated in a polymer film.20

1.6 OthersThe above-mentioned groups of active and intelligent packaging can beevaluated as groups, because the similarities in the intended function of theproduct. The similarities in the intended function of the product can lead toparallel conclusions as concerns the legal aspects. For other types of activepackaging, an individual evaluation will have to be done from case to case.Some of these are mentioned in this section as examples.1.6.1 Susceptor materialsSusceptor materials are an example of materials, which effect the foodthrough physical treatment; e.g., a microwave susceptor will lead to highertemperatures in the food than normally achieved by microwave heating. Thismaterial is one kind of active packaging. However, the Nordic group regardsit as a conventional packaging material from a legal point of view.1.6.2 Hot potAnother example of a special kind of active package is the so-called “hotpot”.A “hot-pot” is a can with double layer walls, between which there aretwo chemicals. When the can is opened, the chemicals are mixed and thereaction creates heath to make the food ready for consumption. Thechemicals are not intended to come into contact with the food or to be eatenbut to have a function as “heating agent”. However, a possibility of leakagedoes exist and such a concept will have to be evaluated specifically.1.7 Related subjects not included in this report1.7.1 Modified or controlled atmosphere packagingPackaging of food in modified atmosphere is not considered as active orintelligent packaging in this report, as the package gases are not regarded aspart of the food packaging but are regarded as food additives. These aresolely covered by food additive legislation in the Nordic countries, in the EU,as well as in Codex Alimentarius. According to our knowledge, these gaseswill be added directly into the package, and the balance may be controlled bythe use of certain types of active packaging, which are included andmentioned earlier in this report.Controlled atmosphere packaging is regarded as a combination of modifiedatmosphere packaging and an active packaging, such as an absorber.1.7.2 Edible filmsEdible materials are often mentioned in the literature in connection to activepackaging. However, an edible film is a special active part of the food, andseen from a legal point of view, it is to be regarded as a foodstuff, along withthe food packed in the film. Therefore, the requirements such films will haveto fulfil do not differ from the requirements for food in general. If the edible21

film is not marketed as edible, then the film should be regarded as any otherfood packaging.It should be mentioned, however, that due to hygienic reasons, it isanticipated that food products in edible films need to have an outer package,otherwise the film should not be eaten.22

Chapter 2Effectiveness and test requirementsSafety evaluation of active and intelligent packaging is more complex thanthat of ordinary food packaging in general. The substances involved,compounds produced, and migration into food are one part of the aspects,while the proper function of the active or intelligent package is another. Thesafety of current packaging is mainly determined by the limited migration ofpackaging material components to food and by the ability of the package toprotect the food from impurities, ambient gases, and from microorganisms.These qualities are substantial for active and intelligent packages, as well.However, in addition to this, a new principle will be the possible acceptanceand allowance of a defined set migration for certain packages instead of minimummigration, which has been the central principle up to the present forthe legislation on food packaging.The basic principles of full knowledge on what substances are used in themanufacture of the materials, what substances are present in the packagingmaterial, and what substances, and to which extent, are migrating into thefood, and of their toxicological implications, are prerequisite. At the moment,in the EU, migration test requirements are defined only for certain materials,e.g., those consisting exclusively of plastics. The methods for migrationtesting might be useful for a large group of active and intelligent packages,too, but certainly not for all.Some active, migrating ingredients are food additives, which normally areregulated and evaluated for direct use in food by a competent internationalbody, like the Scientific Committee on Food (SCF). Others are substancesevaluated for use in plastics by, e.g., national authorities or the SCF, but alsonew substances, or well-known substances in new concepts, can be present.All substances need to be evaluated to guarantee their safety if they migratedinto the food. In some active concepts the composition of the material maychange as the result of release or as a result of reaction with the compound tobe removed. The migration behaviour and the safety of the reaction productsand by-products need to be studied.2.1 EffectivenessActive scavenging and releasing concepts may change the living conditionsof microorganisms. This must be studied to inhibit the formation of anyunfavourable microbial flora and the control of the packed foodstuffs willhave to be adjusted accordingly. The inclusion of chemical substances in aplastic material may also change the permeability of the film, the mechanicalproperties, and sealability. These properties can have an effect on the risk of24

damages and leaking. Active release of substances from packaging usesraises questions on quantity of substance released, also in relation to the timeperiod, on distribution in food, on the effect of various factors on the releaseprocess, on the effect of the substance compared to the optimum effect, ontesting required, etc. A central issue is to demonstrate the microbial safety ofthe food products as regards sufficient capacity of active or intelligentconcepts, and to study the risk of miss-indication. As a consequence,instructions for storage and shelf life of the active packaging or the indicatoritself will be necessary.Time-temperature indicators (TTIs) are, in most cases, placed on the outerside of the package and need not interact with the food. The reliability ofTTIs is essential to prevent incorrect signals, which can result in consumptionof a deteriorated product, or, on the other hand, in rejection of serviceablefoods. Thus, a calibration of the accuracy of the signal of the indicators in animpartial laboratory might be a necessary requirement.2.2 The need for testing of materials and articlesA testing scheme for classification of active and intelligent packaging, inview of current legislation, has been sketched in FAIR project CT98-4170‘Actipack’. The scheme is primarily applicable to plastics. Using the scheme,the concepts may be classified in five categories:Category A: The active or intelligent packaging concept is separated from food by afunctional barrier, or the concept is in direct contact with food and the components ofthe concept are registered on positive lists for food packaging materials, and meetsmigration limits.• Only testing of effectiveness and shelf life extending capacity is needed.Category B: The active or intelligent packaging concept is in direct contact withfood, the components of the concept are not registered on positive lists for foodpackaging materials, but they are food additives or natural compounds (such asflavourings or food ingredients) with toxicological data available, and the conceptmeets the overall migration limit.• Safety should be evaluated based on the toxicological data. Testing ofeffectiveness and shelf life extending capacity is needed.Category C: The active or intelligent packaging concept is in direct contact withfood and the components of the concept are food additives or natural compoundswhich are registered on positive lists, but do not meet migration limits.• Specific migration tests need to be elaborated.• Testing of effectiveness and shelf life extending capacity is needed.Category D: The active or intelligent packaging concept is in direct contact withfood, the components of the concept are not registered on positive lists (for packaging25

materials), but they are food additives or natural compounds with toxicological dataavailable. The concept does not meet the overall migration limit.• Safety should be evaluated based on the toxicological data.• Specific migration tests need to be elaborated.• Testing of effectiveness and shelf life extending capacity.Category E: The active or intelligent packaging concept is in direct contact withfood, the components of the concept are not registered on positive lists, and they arenot food additives or natural compounds with toxicological data available. Theconcept meets the overall migration limit.• Safety should be evaluated based on full toxicological data as for SCFpetitioning. Testing of effectiveness and shelf-life extending capacity.The need for testing will have to be considered in details on a case by casebasis.Table 4. Existing test requirements and needs in overview.Type FunctionalbarrierA yesEvaluatedsubstancesyesMigration limitsexceedednoTest requirements + needsTesting of effectiveness andshelf life extending capacitynoyesnoB no yes (not onpositivelists)C no yes(on positivelists)D no yes (not onpositivelists)noyesyesSafety evaluationTesting of effectiveness andshelf life extending capacityTesting of effectiveness andshelf life extending capacityis needed.Specific migration method isneeded.Safety evaluation.Testing of effectiveness andshelf life extending capacity.Specific migration method isneeded.E no no no Safety evaluation.Specific migration testing.Testing of effectiveness andshelf life extending capacity.26

2.3 Functional barriersThe use of the concept of functional barriers will also require testing. Afunctional barrier has been defined in the Council of Europe Resolution onsurface coatings as follows:“… any integral layer, which under normal and foreseeable conditions of use, reducesall possible material transfer (permeation and migration) from any layer beyond thebarrier into food to a toxicologically and organoleptically insignificant and to a technologicallyunavoidable level... ”.However, substances can migrate through a functional barrier. A functionalbarrier will normally operate as a barrier for a certain period of time, calledthe lag phase, when the migration is suppressed or delayed. After the lagphase, the migration can be reduced and/or slowed down. The lag phase isdepending on the chemical substance, the type of material, and temperature.It will vary from substance to substance, and specific information onmigration kinetics should be taken into account when a certain functionalbarrier is evaluated.The evaluation and testing of the functional barrier is dependent on theproperties of the individual materials, food products in contact with it, theshelf life and storage temperature of the food.2.4 Active packaging with food additives, flavouringsand pesticidesFood additives, flavourings and pesticides, which are potential ingredients tobe used in active packaging, are subject to limitations in or on foodstuffs.Limitations for food additives and, in some cases, flavourings, coverprovisions for the use in specific foods and maximum use limits. Also, forpesticides, specific provisions are found, including maximum residue levelsspecified for single agricultural products or groups of items.Foodstuffs will have to be tested in accordance with the generally usedmethods of analysis used for food additives, flavourings, etc. The results ofthe analysis will be compared to the particular limit values in the foodlegislation.Food additives used, furthermore, will have to comply with requirements onidentity and specification, either in EU directives, or in national legislation.27

Chapter 3Legislation relevant to considerThe basic principles of the EU Treaty require the Member States of theEuropean Union (hereinafter, the EU) to ensure not only free movement ofgoods within the internal market, but also a high level of protection of publichealth. To fulfil these aims, the European Council, in co-operation with theEuropean Parliament, or the European Commission, issue legislation toapproximate the laws of the Member States.However, though the EU food legislation sets out series of specificobligations on food businesses, it does not in addition to the general ProductSafety Directive, currently contain a general obligation on food safety.Instead, acts are issued on a number of fields. As pointed out, active andintelligent food packaging materials and articles are, by definition, notserving as wrapping or packaging materials, only. They also have otherproperties with other intended functions on the food itself as indicatedearlier. Therefore, not only the legislation on food packaging material and articleshas to be taken into account when considering whether a product canlegally be placed on the market. In many cases, a final product will have tobe in compliance with legislation on the specific ingredient with atechnological function on or in the food, e.g., the legislation of food additives,flavourings or pesticide residues, as well. In these directives arerequirements found in specific areas, such as permitted substances,maximum residue limits, etc., and they supplement directives that set the basicgeneral requirements.Contrary to EU Regulations, EU Directives are not directly applicable as suchin the Member States. Thus, the Member States have to transpose the contentof the EU directives into national legislation. The Member States are free tochoose what legislative method to use, and they may deviate from thestructure and the wording of the directive, but have to comply with thecontent of the directives.All acts are based on scientific evidence and risk assessment. This high levelof protection is kept under constant review, and where necessary, it can beadjusted to take into account new information, or a re-evaluation of existinginformation. For this purpose, safeguard clauses are included into thedirectives.When preparing new legislation, the Commission may take into account thework done by the Council of Europe Committee of Experts on Materials andArticles coming into Contact with Food, which has established a committeeon food contact materials. The aim of this committee is to issuerecommendations to be followed by the members of the Council of Europe.Furthermore, within the European Committee for Standardisation, CEN,28

analytical methods are developed and standardised for checking that thelimit values on, e.g., migration from food packaging materials are notexceeded.The lack of one single piece of legislation concerning packaging can lead tothe adoption of requirements, which may be in conflict with each other. Ahierarchy of norms may solve such rule conflicts. There is no writtenhierarchy of norms in the EU legal system, although a few general principlesof law on this matter could be of guidance. For example, it is anticipated thatgeneral directives are secondary to community acts that are more specific.And another common principle stipulates that older legislation would besecondary to more recent ones.EU legislation is aiming at totally harmonised legislation in many fields. Ifsuch legislation does not exist, Member States may maintain or introducenational legislation, however, while observing certain special rules onnotification of drafts. The purpose of these procedures is to inform theCommission and other Member States of the proposal for new legislation inorder to avoid a trade barrier being created. The draft may result in theCommission taking an initiative toward new Community legislation.In practice, not only national legislation may create barriers to trade, but alsothe fact that Member States may establish different interpretations ofCommunity rules. Although great efforts are made to interpret those in auniform and correct way, it must be observed that all authorities and courtsdealing with such matters make their own autonomous decisions. Thus, ineach and every case, a conclusive judgement can only be made at the Courtof Justice of the European Communities – and when it comes to the EEAagreement,the conclusive judgement is made by the EFTA Court of Justice –which, we can state, rarely is available. This fact leads to a certain uncertaintyin the application of law.In this chapter, the parts of the legislation, which the Nordic group foundrelevant to take into consideration, are described in general terms, in order toserve as background information for those who have to consider the legalaspects of an active or intelligent package.The chapter has no intention of giving all details, but includes somereferences to mainly the harmonised legislation in the EU, although also tonational legislation in the Nordic countries, if it is found of particularrelevance. However, the legislation will have to be consulted if specificdetails are needed for an evaluation of a specific product.3.1 Product safety, general requirementsIt is, in practise, impossible to adopt EU legislation for every product thatexists on the market or which may be developed. Therefore, it has beennecessary to establish a broadly based, legislative framework of a horizontalnature to deal with all products. It also covers gaps in existing or29

forthcoming specific legislation, in particular to ensure a high level ofprotection of safety and health of consumers.Thus, it has been considered as necessary to establish on an EU level, ageneral safety requirement for any product placed on the market that isintended for consumers, or likely to be used by consumers. In the absence ofmore specific safety provisions within the framework of Communityregulations covering the products concerned, the Product Safety Directive(92/59/EEC) is to apply. However, where there are specific rules ofCommunity law of the total harmonisation type – as is the case withpackaging – there is no room for application of the Product Safety Directive.Some of the articles in the product safety directives to be mentioned are:Article 1 states that the purpose of the directive is to ensure that productsplaced on the market are safe. Thus, the directive is secondary to specificlegislation on rules on safety of products. According to the definition in Art.2 (a), product shall mean any new, used or reconditioned product intendedfor consumers or likely to be used by consumers, supplied in the course of acommercial activity. Second-hand products are exempted from the scope ofthe directive. The definition of a safe product is given in Art. 2 (b): Safety isrelated to the characteristics of the product, as well as by the intended user.In Article 4, it is stated that the national laws of the Member States shall beapplied when there are no specific EU provisions. A product must complywith the laws of the state, in which it is in circulation, and must also complywith the EU Treaty, in particular, with Arts. 28 (formerly Art. 30) and 30(formerly Art. 36).Authorities, whose duty it is to monitor compliance of this directive, canprohibit the supplying of a product, withdraw, or, if necessary, destroy aproduct, and prohibit a product from being placed on the market (Art. 6.1).These measures shall be addressed to producers or distributors.In case of a serious or immediate risk, a Member State can decide to adoptemergency measures. In the event the adopted measure reaches beyond theterritory of the Member State, the Commission must be notified (Art. 8.1).3.2 PackagingThe EU legislation in this field (“materials and articles intended to come intocontact with foodstuffs”) is expressed in general terms in FrameworkDirective 89/109/EEC and in specific directives, in which details are given.To date, there are only specific directives laid down for regenerated cellulose,plastics materials – including directives for testing migration with specifiedsimulants – for the migration of nitrosamines or nitrosable substances fromelastomers or rubber teats, and for the migration of cadmium and lead fromceramics. (See Table 1 for EEC directives in force.)30

3.2.1 DefinitionArticle 1 of the framework directive provides the directive’s applicability;Article 2 offers some general requirements to ensure safety (see below).Article 1:“This Directive shall apply to materials and articles which, in their finished state,are intended to be brought into contact with foodstuffs or which are brought intocontact with foodstuffs and are intended for that purpose, hereinafter referred to as“materials and articles”.Covering or coating substances, such as the substances covering cheese rinds, preparedmeat products or fruit, which form part of foodstuffs and may be consumedtogether with those foodstuffs, shall not be subject to this Directive.2. This Directive shall apply to materials and articles, which are in contact withwater, which is intended for human consumption. It shall not, however, apply tofixed public or private water supply equipment.3. This Directive shall not apply to antiques.....”Article 2:“Materials and articles must be manufactured in compliance with good manufacturingpractise so that, under their normal or foreseeable conditions of use, they donot transfer their constituents to foodstuffs in quantities, which could:– endanger human health,– bring about an unacceptable change in the composition of the foodstuffs ordeterioration in the organoleptic characteristics thereof....”Furthermore, the directive stipulates that materials and articles should belabelled (see Article 6), for example, with a symbol – a drinking glass andfork – andeither the• name, or trade name, and the address or registered office, or• registered trade mark of the manufacturer, the processor or a sellerestablished within the European Community.EU legislation on food packaging is based on a principle of positive lists,with a limit for overall migration of substances and specific migration limitsestablished for some substances in accordance with the safety evaluation.The overall migration limit, presently only valid for plastics, but is expectedfor forthcoming materials regulated in detail, is based on generalconsiderations on safety and hygiene. However, the overall migration limitwill, in some cases, have implications on the possibilities to use active andintelligent packaging.The directive, which has attracted the most attention, is the Plastic Directive(90/128/EEC). It first contains a definition of plastics, thereafter sets a31

general overall migration limit that means a limit on transfer of constituentsfrom the packaging material to the foodstuff. Thus, it states that the sum ofcompounds migrating from 1 dm 2 plastic surface must be less than 10 mg, orthat the maximum concentration in food should be less than 60 mg/kg. Thedirective also includes positive lists ofa) monomers and starting substances andb) additives (although an incomplete list, first directive 95/3/EC) and, forsome of them, specific migration limits (SML) in the foods and/ormaximum allowable concentrations in the plastic product (QM).Presently, the directives on plastics only covers materials solely made ofplastics. They do not apply to materials and articles composed of two ormore layers, one or more of which do not consist exclusively of plastics. Thisis the status even if the one layer intended to come into direct contact withfoodstuffs does consist exclusively of plastics.Table 1. EU directives in force.FRAMEWORK DIRECTIVE – 89/109/EECSYMBOL – 80/590/EECMONOMERS & ADDITIVES – 90/128/EECMONOMERS & ADDITIVES – 1st amendment, 92/39/EECMONOMERS & ADDITIVES – 2nd amendment, 93/9/EECMONOMERS & ADDITIVES – 3rd amendment, 95/3/ECMONOMERS & ADDITIVES – 4 th amendment, 96/11/ECMONOMERS & ADDITIVES – 5 th amendment, 1999/91/ECPLASTICS TESTING – 82/711/EECPLASTICS TESTING – 93/8/EEC, 1st amendment to 82/711/EECPLASTICS TESTING – 97/48/EEC, 2nd amendment to 82/711/EECPLASTICS TESTING (simulants) – 85/572/EECVINYL CHLORIDE MONOMER – 78/142/EECVINYL CHLORIDE MONOMER – 80/766/EECVINYL CHLORIDE MONOMER – 81/432/EECREGENERATED CELLULOSE FILM – 93/10/EECREGENERATED CELLULOSE FILM – 93/111/ECCERAMICS – 84/500/EECNITROSOAMINES IN RUBBERTEATS – 93/11/EEC32

The testing of migration should be carried out following standard testingconditions stated in the specific directives, 82/711/EEC and 85/572/EEC,with amendments.The directive on regenerated cellulose film includes positive lists ofcompounds, which can be used in the manufacturing of regeneratedcellulose, as well as compositional limits in the material and some very fewspecific limits of constituents transferred into the foodstuff.3.3 Food additives3.3.1 DefinitionA food additive is a substance, which is added to foodstuffs in order toobtain an effect, for instance, colour or shelf life.The definition of a food additive in EU Framework Directive 89/107/EEC isstipulated in Article 1:«… any substance not normally consumed as a food itself and not normally used as acharacteristic ingredient of food whether or not it has nutritive value, the intentionaladdition of which to food for a technological purpose in the manufacture, processing,preparation, treatment, packaging, transport or storage of such food results, or maybe reasonably expected to result, in or its by-products becoming directly or indirectlya component of such foods ... ».The essential point in the above definition is whether or not the food additivehas been added to the foodstuffs with the intention of achieving atechnological function, such as, for instance, the addition of aspartame tochewing gum in order to give a sweet taste.Processing aids are a group of food additives, which can be used inaccordance with general requirements, e.g. on safety. However, processingaids are not regulated in detail. They are excluded from the scope of theframework directive on additives, but, in a footnote to Article 1, have beendefined as:«… any substance not consumed as a food ingredient by itself, intentionally used inthe processing of raw materials, foods or their ingredients, to fulfil a certain technologicalpurpose during treatment or processing and which may result in the unintentional,but technically unavoidable, presence of residues of the substance or its deviatesin the final product, provided that their residues do not present any health riskand do not have any technological effect on the finished product … ».That means that such substances are used to fulfil a technological purposeduring treatment or processing. Whether a substance is a food additive or aprocessing aid is a matter of evaluation and interpretation of the intendeduses, and must be established from case to case. Beside the definition,processing aids are not regulated in the food additive directive.33

3.3.2 LegislationCouncil Directive 89/107/EEC on food additives authorised for use infoodstuffs intended for human consumption is the framework directive. Thedirective does not regulate the use of processing aids, pesticides, flavourings,or enrichment substances.The use of food additives shall be authorised only on the basis of agreedscientific and technological criteria. Food additives can be approved only if• there is a technological need,• they represent no hazard to public health, and• they do not mislead the consumer.In the EU, the SCF should, in principle, be consulted before the adoption ofprovisions likely to affect public health. As a main rule, the Committee shallevaluate all food additives before they are authorised for use. Since a numberof substances approved as food additives can also be used as additives inpackaging materials, comparison of limits of restrictions for food additivesand substances used in food packaging are given in Annex A.Food additives will have to comply with established purity criteria foridentity and specification.The use of food additives is regulated in a positive list system. The additivesare, in general, approved for use in one or more food groups and underspecified restrictions. Only food additives, which have been approved for usein accordance with this list, may be used in foodstuffs. In addition, the listregulates the conditions for use of the authorised food additives, inter alia,the authorised quantity. A member state, or an EEA country, mayprovisionally authorise the marketing and use within its territory of anadditive not included in the list for a period of two years. The Commissionmay propose the use of these additives for inclusion in the directive beforethe end of this time frame.As concerns the labelling of food additives, the legislation has provisions onlabelling of food additives which are intended for sale to the ultimateconsumer, and labelling of food additives which are not intended for sale tothe ultimate consumer. For instance, there shall be an instruction for use ifthis is necessary in order to use the food additive properly, and specificterms for storage. There are also provisions on the language of the labelling.The consumer shall get the necessary information as concerns the product,and understand it. See also chapter 3.8 on food labelling.Council Directive 94/36/EC on sweeteners for use in foodstuffs, Directive94/35/EC on colours for use in foodstuffs, and Directive 95/2/EC on foodadditives other than colours and sweeteners, are specific directives adoptedin accordance with the provisions in the Framework Directive 89/107/EEC.They are often called the EU positive list on food additives.34

Council Directives 94/36/EC, 94/35/EC, and 95/2/EC have not yet beenimplemented completely in all the Nordic countries, and some countrieshave objections against the authorisation of certain food additives referringto the environment clause in the treaty (Article 95, formerly 100a).3.3.3 Food additives and packagingFood additives, which are used for technological purposes in foodstuffs,must be authorised for use in foodstuffs in accordance with legislation onfood additives. Through active packaging applications, it is possible to addsubstances via packaging into the foodstuffs. When a food additive is addedinto the foodstuffs via the packaging for a technological purpose in thefoodstuffs, the food additive legislation including the labelling requirementsand the food packaging legislation will have to be applied.3.4 Flavourings3.4.1 DefinitionsFlavourings are covered by the definition on food additives, but excludedfrom the scope of the additive framework directive and regulated separately.A flavouring is a substance, which is added to foodstuffs in order to impartodour or taste. The legislation has definitions on different types offlavourings, which refer to the chemical terms and the production process offlavourings. Only substances, which correspond to this definition, are«flavourings» according to the legislation.35

Some of the relevant definitions would be the following:• «… flavourings substance means a defined chemical substance withflavour properties which is obtained:• i) by appropriate physical processes (including distillation and solventextraction) or enzymatic or microbiological processes from material ofvegetable or animal origin either in the raw state or after processing forhuman consumption by traditional food-preparation processes (includingdrying, torrefaction and fermentation),• ii) by chemical synthesis or isolation by chemical processes and which ischemically identical to a substance naturally present in material ofvegetable or animal origin described in i)• iii) by chemical synthesis, but which is not chemically identical to asubstance naturally present in material of vegetable or animal origin asdescribed in i)• Flavouring preparations means a product, other than the substancedefines above, whether concentrated or not, with flavouring properties,which are obtained by appropriate physical processes (includingdistillation and solvent extraction) or by enzymatic or microbiologicalprocesses from material of vegetable or animal origin, either in the rawstate or after processing for human consumption by traditional foodpreparation processes ... »3.4.2 LegislationIn the EU, Council Directive 88/388/EEC on flavourings for use in foodstuffsand source materials for their production is the framework directive coveringthis area. Only flavourings, which comply with the requirements in thelegislation, are permitted for use in foodstuffs.Special attention must be given to Article 4, which states:« … Member States shall take all measures necessary to ensure that:– flavourings do not contain any element or substance in a toxicologically dangerousquantity... »In addition, there are provisions on maximum residue limits of somesubstances. According to the directive, the EU Council will adopt provisionsconcerning individual categories of flavourings, source materials, andnecessary measures concerning the use and methods of production of theflavourings. Purity criteria for flavourings will be established.As concerns the labelling of flavourings, the sales description has to state«flavouring», or a more specific name or description. There are also morespecific provisions on labelling. For instance, there shall be an instruction foruse if this is necessary in order to use the flavouring properly, and specific36

terms for storage. There are also provisions on the language of the labelling.The consumer shall get the necessary information as concerns the product.According to EU Council Regulation EC/2232/96, the Commission has laiddown a list based on the flavourings currently used in the Member Statesand EEA countries (Commission Decision 1999/217/EC). The flavourings inthe list will be evaluated, and there will be established conditions for usewithin five years. According to EC/2232/96, each of the Member States andthe EEA countries has sent a list of chemical substances, which werecurrently accepted, on their territory. On this basis, the Commission haselaborated a temporary register of flavourings to be evaluated. Thelegislation has a safeguard clause, under which Member States can makereservations against the use of certain substances. The flavourings in theregister shall comply with the general use criteria in the framework directive.This register is the first step to adopt a list of flavourings authorised for usein the EU Member States and EEA countries. The register is divided intodistinct parts. The register contains 2800 substances, but this number can bereduced in the future.3.4.3 Special national requirements in the Nordic countriesThe EU Directive has been implemented in all the Nordic countries. TheMember States can have national provisions on flavourings, but theseprovisions must not be in contradiction with the EU rules. A brief overviewon national requirements in this area is:Denmark has special requirements for flavourings for milk products andsmoke flavourings. These flavourings can legally be used, only if they areevaluated and approved by the Danish Veterinary and Food Administration.The approvals are based on safety evaluations.Norway and Sweden also have national legislation on smoke flavourings.Smoke flavourings can only be used if they are evaluated and approved bythe National Authorities. The approvals are based on safety evaluations, too.Finland and Iceland have no additional requirements to those set forth in theEU directive.3.4.4 Food flavourings and packagingWith active packaging it is possible to add substances via packaging intofoodstuffs. Food flavourings, which are used in packaging for technologicalpurpose in foodstuffs, have to be permitted for use in the foodstuffsaccording to the flavouring legislation. The essential point is not whether theflavouring is added to the foodstuffs under the production process of thefoodstuffs or via the packaging. The essential point is whether the flavouringhas been added to the foodstuffs (via the packaging) for technologicalpurposes.37

3.5 PesticidesIn general, the use of pesticides can only take place legally if it is approvedfor the specific use in or on specific agricultural products. As far as thisgroup is informed, to date (year 2000), there are no pesticides approved forthe use as indirectly added substances, incorporated into food packagingmaterial. Consequently, the use of pesticides as, e.g. post harvest treatmentthrough a food container, cannot legally take place at present. However,several pesticides have been authorised for post-harvest application. Certainplant growth regulators for potatoes and carrots are authorised uses, as wellas application of certain fungicides on fruits and application of certain insecticidesin or on cereal grains.Within the EU there are several relevant directives dealing with pesticides.Council Directive 91/414/EEC concerns the placing on the market of plantprotection products. The directive states that plant production has a veryimportant place in the Community, and that it is absolutely essential toprotect plants against risks arising from harmful organisms. One of the mostimportant ways of protecting plants and plant products is to use plantprotection products. The use of such products can involve risks and hazardsfor humans. In order to prevent barriers to trade (not only in plant protectionproducts, but also to trade in plant products), there has to be a Communityauthorisation procedure of such products.In connection with registration of a pesticide, the EU Scientific Committee forPlants (SCP) evaluates its chemical and physical properties, toxicity tohuman health and behaviour and effects in the environment. At this stage,Good Agricultural Practice (GAP) is defined, containing instructions for useon different agricultural products. Residue information is specificallyevaluated, and as a result, Community maximum residue limits in or onfoodstuffs are established. National limits may exist for other foodstuffs, aswell.3.5.1 DefinitionsPlant protection products, as defined in Directive 91/414/EEC, are«… Active substances and preparations containing one or more active substances,put up in the form in which they are supplied to the user, intended to…1.1 protect plants or plant products against all harmful organisms…1.3 preserve plant products, in so far as such substances or products are not subjectto special Council or Commission provisions on preservatives; »Harmful organisms are defined as«… pest of plants or plant products belonging to the animal or plantkingdom, and also viruses, bacteria and mycoplasmas and other pathogens ...»38

3.5.2 LegislationDirective 91/414/EEC contains uniform rules on the conditions andprocedures for the authorisation of plant protection products that must beapplied by the Member States. It ensures a high standard of protection,especially regarding the protection of human and animal health. Thedirective has provided for a mechanism linking the authorisation of aproduct to an obligation for the Member State having granted the authorisationto establish a provisional MRL (maximum residue limit); it alsoprovides for the Commission to establish EU MRLs applicable throughoutthe Community. Using a so-called Committee procedure, such MRLs areintegrated in the annexes of EC directives on pesticide residues. The Communityprocedure does not prevent Member States from authorisingpesticides for use in their territory for limited period products containingsubstances not yet entered on the Community list.Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC, and90/642/EEC – all fixing maximum levels for pesticide residues in and onfoodstuffs of vegetable or animal origin – state that the yield from crop andanimal production is continuously infected by harmful organisms. It isessential to protect plants, plant products and livestock against harmfulorganisms, and one of the most important methods of protection is the use ofchemical pesticides. As these pesticides may have harmful effects onconsumers, maximum levels have to be set for residues of these products.Thus, maximum residue limits (MRL) are set in these directives. Pesticideresidue, as formulated in the more recent directive on maximum levels forpesticide residues, means«… residues of the pesticides and of their metabolites, and breakdown or reactionproducts…which are present in or on the products…»MRLs for each specific substance are set either for a group of products (e.g.citrus fruit or cereals), or for individual products (e.g. grapefruit or wheat).3.5.3 Pesticides and packagingIn this context, mainly pesticides used for post harvest treatment arerelevant. Insecticides and repellents might be used as well. Instead ofspreading the pesticide directly onto the field, it could be foreseen that inproduct development there might be a wish to add the pesticide to amaterial, from which it migrates to the foodstuff in order to achieve abactericidal or fungicidal effect. It should also be observed that application ofthe plant protection directive is excluded where EU provisions onpreservatives exist.Fungicides, such as imazalil and benomyl, have been mentioned as potentialcompounds for active packaging materials.39

Large amounts of single pesticides with antimicrobial effects or some othereffects, in addition to imazlil and benomyl, mentioned above, are known.However, several possibilities might arise if consideration would be paid onpesticides with the potential to be used in paper, board or wooden boxesintended for the packaging of fruits and vegetables. If a pesticide could beadded to a foodstuff via the packaging in order to achieve a technologicaleffect as pesticides on the food, the provisions in the directives on pesticideslegislation and food packaging legislation have to be observed.3.6 Biocides3.6.1 DefinitionEU Directive 98/8/EC, concerning the placing of biocidal products on themarket, defines biocidal products as:«… Active substances and preparations containing one or more active substances,put up in the form in which they are supplied to the user, intended to destroy, deter,render harmless, prevent the action of, or otherwise exert a controlling effect on anyharmful organism by chemical or biological means … »The directive has been agreed upon on the grounds that “...biocidal productsare necessary for the control of organisms that are harmful to human oranimal health and for the control of organisms that cause damage to naturalor manufactured products...”. Furthermore, that “ ...biocidal products canpose risks to humans, animals and the environment in a variety of ways dueto their intrinsic properties and associated use patterns ... ”.The directive provides risk management of non-agricultural pesticides. Itestablishes a positive list of active substances, which may be used in biocidalproducts.However, several areas are excluded from the directive. These areas are,among others, food additives authorised for use in foodstuffs intended forhuman consumption and packaging materials.3.7 Hygiene3.7.1 DefinitionsLegislation on hygiene includes provisions concerning temperature and thehygienic conditions of the packaging. These aspects will be relevant toconsider in the evaluation of active packaging, and especially, of intelligentpackaging. The legislation on hygiene is very detailed and complexlegislation and only the provisions relevant to the subject will be mentionedhere.Council Directive 93/43/EEC of 14 June 1993 on the hygiene of foodstuffs,hereinafter referred to as the Food Hygiene Directive, lays down the general40

ules of hygiene for foodstuffs and does not apply where more specifichygiene rules exist.For products of animal origin, more specific hygiene rules are laid down in anumber of product specific hygiene directives. The directives concerninganimal products apply to the production and wholesale level, and not to theretail level.Article 3 of the Food Hygiene Directive states that« … the preparation, processing, manufacturing, packaging, storing,transportation, distribution, handling and offering for sale or supply of foodstuffsshall be carried out in a hygienic way …»“Hygiene” is, in Article 2, defined as follows:« … Hygiene means all measures necessary to ensure the safety and wholesomenessof foodstuffs. The measures shall cover all stages after primary production (the latterincluding, for example, harvesting slaughter and milking) during preparation, processing,manufacturing, packaging, storing, transportation, distribution, handlingand offering for sale or supply to the consumer … »Article 3, No. 2 further demands that food business operators shall identifyany step in their activities which is critical to ensuring food safety and ensurethat adequate safety procedures are identified, implemented, maintained andreviewed on the basis of principles used to develop the system of HACCP(Hazard analysis and critical control points).In Codex Alimentarius’ “Recommended International Code of PracticeGeneral Principles of Food Hygiene”, food safety is defined as:« … Assurance that food will not cause harm to the consumer when it isprepared and/or eaten according to its intended use … »3.7.2 Requirements concerning packaging materialsFood hygiene directiveRequirements for equipment provisions are laid down in Food HygieneDirective, Annex, Chapter V:« … All articles, fittings and equipment with which food comes into contact shall beclean and be so constructed, be of such material and be kept in such order, repair andcondition as to minimise any risk of contamination of the food….»Packaging materials are also regarded as equipment and must fulfil theseconditions.In Chapter IX, the hygiene provisions also cover the packaging of foodstuffs:« … All food which is handled stored, packaged, displayed and transported shall bekept in appropriate conditions designed to prevent harmful deterioration and to protectthem from contamination.»41

Directives concerning animal productsWrapping and packaging is defined in some of the directives concerninganimal products. “Wrapping” means the protection of the product by the useof a wrapping or initial container in direct contact with the productconcerned and the initial wrapper or initial container itself. “Packaging”means the placing of the wrapped product in a second container and thelatter container itself.The hygiene provisions for the packaging material could be summarised asfollows:• Packaging must fulfil all rules of hygiene.• Packaging must not alter the organoleptic characteristics of the product.• Packaging must not be capable of transmitting to the product substancesharmful to human health.• Packaging must be strong enough to ensure effective protection of theproduct during transportation and handling.• Packaging must not, as the principal rule, be re-used.Special provisions for quick-frozen foodstuffsCouncil Directive 89/108/EEC on the approximation of the laws of theMember States relating to quick-frozen foodstuffs for human consumptionestablishes special provisions for quick-frozen foodstuffs.Article 7 of this Directive contains the following provision for the packagingof quick-frozen foodstuffs:«Quick-frozen foodstuffs intended for supply to the ultimate consumer must bepacked by the manufacturer or packer in suitable pre-packaging which protects themfrom microbial or other forms of external contamination and against drying».3.7.3 Requirements concerning temperature and temperaturemonitoring3.7.3.1 Food Hygiene DirectiveSome intelligent packaging concepts are the time-temperature indicators andtemperature indicators. Therefore, it is relevant to focus on the legislation concerningtemperature and monitoring of temperature.In the Food Hygiene Directive, temperature requirements and the role oftemperature is mentioned in the Annex, Chapter IX, and point 4.«Raw materials, ingredients, intermediate products, and finished products, likely tosupport the growth of pathogenic microorganisms or the formation of toxins, must bekept at temperatures which would not result in a risk to health. Consistent with foodsafety, limited periods outside temperature control are permitted where necessary toaccommodate the practicalities of handling during preparation, transport, storagedisplay and service of food.»42

According to Article 4 in the Food Hygiene Directive microbiological criteriaand temperature control criteria for certain classes of foodstuffs may beadopted in accordance with a Committee procedure. Until now, such criteriahave not been adopted. According to Article 7, No. 2, Member States maymaintain, amend, or introduce the relevant national provisions until detailedprovisions have been laid down in accordance with the above-mentionedArticle 4.Denmark and Sweden, for instance, has made a list of certain categories ofproducts, which must be stored below a certain temperature, but there hasn’tbeen laid down legislation for all categories of foods. In cases where there isno legislation, the manufacturer may freely stipulate the storage temperatureon the labelling of the product. In this event, the storage temperature must bekept in all links of the distribution chain in order to maintain the shelf life ofthe product.Furthermore, there are no specific requirements on temperature monitoringin the EU, but the Member States may, according to Article 7, No. 1,maintain, amend, or introduce national hygiene provisions that are morespecific than those laid down in the Directive.To mention an example relating to this, Denmark has made a provision inwhich it is demanded that heating, cooling and freezing equipment, whereinfood is stored, must be provided with an easy-to-read thermometer. Theother Nordic countries do not have such requirements.3.7.3.2 Directives concerning animal productsContrary to the Food Hygiene Directive, the directives concerning animalproducts contain specific temperature requirements for the various products.These temperature requirements are, in most cases, specified for the productitself and not for the temperature in the storage surroundings. Thetemperatures are all maximum temperatures, and temperatures exceedingthe specific maximum are not accepted.The temperature requirements apply until delivery of the product to a retailfood business, at which point the provisions laid down in the Food HygieneDirective take over. During transportation, the vehicles or containers fortransport must be equipped in such way that the temperatures specified inthe directives concerning animal products are maintained throughouttransportation.In some of the directives concerning animal products, there is a provision ofa recording thermometer or a recording Tele-thermometer for each storagearea.3.7.3.3 Special temperature provisions for quick-frozen foodstuffsIn Article 5 of Council Directive 89/108/EEC on the approximation of thelaws of the Member States relating to quick-frozen foodstuffs for humanconsumption, there are the following provisions for the temperature andtolerance of temperature fluctuations of quick-frozen foodstuffs:43

• «The temperature of quick-frozen foodstuffs must be stable and maintained at allpoints in the product at -18°C or lower, with possible brief upward fluctuation ofno more than 3°C during transport. However, tolerances in the temperature ofthe product in accordance with good storage and distribution practice shall bepermitted during local distribution and in retail display cabinets subject to thefollowing conditions:• These temperatures shall not exceed 3°C;• They may, however, reach 6°C in retail display cabinets, and if so, to the extentthat the Member States decide. In such a case, the Member States shall select thetemperature in the light of stock or product rotation in the retail trade.... »In accordance with Commission Directive 92/1/EEC, on monitoringtemperatures in the means of transport, warehousing, and storage of quickfrozenfoodstuffs intended for human consumption, the means of transport,warehousing, and storage must be fitted with suitable recording instrumentsto monitor, at frequent and at regular intervals, the air temperature to whichquick-frozen foods intended for human consumption are subjected. The airtemperature during storage in retail display cabinets and in the course oflocal distribution, shall be measured by at least one easily visiblethermometer, which, in the case of open retail display cabinets, shall indicatethe temperature at the air return side at the level of the clearly marked maximumload line.3.7.4 Hygiene and food packagingSince the Food Hygiene Directive deals with food safety from an overallpoint of view, it is not possible to come to conclusions on the legaljustification of the use of intelligent and active packaging. Each specificpackaging concept must be evaluated in relation to the definitions on foodhygiene, including food safety aspects and more specific requirements in thedirectives.3.8 Food labelling3.8.1 DefinitionsFood labelling is any information on foodstuffs, which is on the packaging,or on the documents – it’s notice or label – accompanying the foodstuff.Labelling is defined as:« … Any words, particulars, trade marks, brand name, pictorial matter or symbolrelating to a foodstuff and placed on any packaging, document, notice, label, ring orcollar accompanying or referring to such foodstuff….»The main scope of the legislation on labelling is to give the consumer thecorrect information as concerns the foodstuffs, and to protect the consumer.The consumer shall have the possibility to choose the appropriate foodstuff.44

In order to give the consumer the possibility to make comparisons, it isessential that the legislation on labelling be standardised.3.8.2 LegislationThere are several directives on labelling. The European CommunityFramework Directive is 79/112/EEC. This is a so-called horizontal directive,which means that it is applicable to all foodstuffs. However, there are someexceptions from the general requirements, e.g. for wine and chocolate. Theapplication of the directive is limited to foodstuffs intended for sale to theultimate consumer or to mass caterers.There is specific legislation on labelling, for instance, legislation on labellingin the Food Additives Directive (89/107/EEC) and the Food PackagingDirective (89/109/EEC).As a general rule, there exists an obligation to label all foodstuffs. Forinstance, the packaging or the document accompanying the foodstuff has tobe labelled with the ingredients, the net quantity, the durability, theconditions for use, and the name, under which the product is sold.As concerns the ingredients, there is an obligation to label a list of ingredientson the foodstuff packaging. As a main rule, the list of ingredients shallinclude all the ingredients of the foodstuff, in descending order of weight, asrecorded at the time of their use in the manufacture of the foodstuff. Thelabelling Directive defines “ingredient” as«…any substance, including additives, used in the manufacture or preparation of afoodstuff and still present in the finished product, even if in altered form …»This could give rise to a question to whether an additive that is added to afoodstuff only through the packaging material really is used in themanufacture or preparation. However, if the additive is used intentionally toreach a certain effect on the foodstuff, it seems reasonable to make aninterpretation that the manufacture or preparation is not completed beforethe packaging. According to that approach, the additive added through thematerial should be considered to be an ingredient and, thus, included in thelist of ingredients. This interpretation is supported by the definition of “additive”,which includes any substance intentionally added to food for a technologicalpurpose in the manufacture, processing, preparation, treatment,packaging, etc., resulting in it becoming directly or indirectly a component ofsuch foods.Also, the use of additives will affect the shelf life of the foodstuffs. The dateof the minimum durability, or “use by” date also has to be included in thelabelling.Important in the labelling legislation are the provisions on misleadinglabelling. Whether or not the labelling is misleading has to be established ona case by case basis. This is, in particular, important for persons who are45

hypersensitive, but also for others who may have specific reasons for notwanting to eat certain substances.As concerns food additives, their category and EEC-number or their specificname shall be declared. The main rule is that food additives, which have atechnological purpose in the final product, have to be declared.In the case when the pre-packaged foodstuffs are marketed at a stage prior tosale to the ultimate consumer, or when they are intended for supply to masscaterers for preparation, processing, etc., it is sufficient that some particularsare given only in trade documents. In that way, the retailer is provided withall information needed to label the foodstuff before the sale to the ultimateconsumer.3.8.3 Labelling and packagingThe information needed relates to the list of ingredients, which has to includeall ingredients in descending order of weight. This implies that the packer(whether also manufacturer or not) has to be informed about all facts relatedto the composition. Thus, the material producer has to provide allinformation that affects the list of ingredients. This information has to bedetailed enough to make it possible to make the list in descending order ofweight.By the methods of active packaging, it is possible to add substances via thepackaging into the foodstuffs, and this is a special situation in relation tolabelling of the final food product.Food additives, which have a technological purpose in or on the foodstuffs,shall be declared on the labelling. If food additives were added indirectly bymeans of the packaging, it would be misleading if the food additives werenot declared on the foodstuff packaging. As emphasised, the main scope ofthe legislation on labelling is to give the consumer the correct information asconcerns the foodstuff, and to protect the consumer. The essential point forthe consumer is not whether the food additive is added directly into thefoodstuff during the production process, or indirectly, by means of thepackaging during the storage period. The essential point for the consumer iswhether or not the foodstuff contains the additive. If the addition of food additivesis not mentioned on the labelling when it is added indirectly via thepackaging, the consumer will not have the correct information concerningthe foodstuff, and the purpose of the labelling legislation will not be fulfilled.According to packaging legislation, when necessary the packaging has to belabelled with instructions for use, in order to use the product correctly.Furthermore, the packaging must not contain substances which migrate intothe foodstuffs and which lead to an «unacceptable change» in the foodstuffs.The use of time/temperature indicators can not replace conventionallabelling of “sell by date”. In addition, if such indicators are used as asupplement to the normal labelling, actions should be taken to ensure thatthe consumer is not mislead.46

3.9 Weight and volume controlLegislation covering weight and volume control of liquid and non-liquidfoodstuffs has, as its primary purpose, to enable consumers to be correctlyinformed on the exact weight or volume of foodstuffs to be sold prepackaged.3.9.1 LegislationCouncil Directive 75/106/EEC covers certain pre-packaged liquids. Thedirective relates to pre-packages containing liquid products measured byvolume for their purpose of sale in individual quantities of between 5 ml and10 litres, inclusive. Categories of liquid foodstuffs are listed in Annex III ofthe directive. Pre-packages shall satisfy requirements of actual volume of thecontents, which shall not be less, on the average, than the nominal volume ofthe contents. Specific rules define the tolerances accepted in indication ofvolume.Council Directive 76/211/EEC relating to composition by weight or volumeof certain pre-packaged products relates to pre-packages containing productswith the exception of those referred to in the Council Directive 75/106/EEC.These, in effect, are pre-packages equal to values pre-determined by thepacker, expressed in units of weight or volume, and are neither less than 5gor 5ml, nor more than 10kg or 10 1itre. A pre-package within the meaning ofthis directive is the combination of a product and the individual package inwhich it is prefaced. All packages bearing the EEC sign must, in accordancewith Annex I (covering objectives and definitions, inscriptions of markings,duties of the packer, and matters related to checks), bear an indication ofproduct weight or volume, known as ‘nominal weight’ or ‘nominal volume’,which they are required to contain. Precise methods of procedure for thereference method of statistically checking batches and pre-packages areincluded in Annex II of the directive.Directive 98/6/EC of the European Parliament and the Council on consumerprotection in the indication of the prices of products offered to consumerswent into effect 18 March 2000 2 . The purpose of the directive (98/6/EEC) isto stipulate indication of the selling price and price per unit of measurementof products offered by traders to consumers in order to improve consumerinformation and facilitate comparison of prices.Council Directive 80/232/EEC, relating to the range of nominal quantitiesand nominal capacities permitted for certain prefaced products apply toproducts put up in pre-packages in accordance with Directive 76/211/EEC,Annex I, defines range of nominal quantities of contents and pre-packages.Annex II describes range of permissible container capacities and coverspreserves and semi-preserves in cans and glass containers, such as vegetableproducts for human consumption. Annex III describes ranges of mess of nonfoodproducts, such as aerosols and medicinal products.2This directive will replace Council Directive 79/581/EEC and 88/314/EEC.47

Council Directive 75/107/EEC, relating to bottles used as measuringcontainers, applies to containers commonly called bottles. They are made ofglass or any other material having such rigidity and stability that it offers thesame metrological guarantees as glass when such containers are stoppered ordesigned to be stoppered and are intended for the storage, transport ordelivery of liquids. Such containers have a nominal capacity of between 0,05litres and 5 litres, inclusive, and have such metrological characteristics suchthat they can be used as measuring containers, i.e. when filled to a specificlevel or specific percentage of their brim capacity, their contents can bemeasured with sufficient accuracy. Measuring container bottles by theircapacities (always at a temperature of 20 o C) are characterised in Annex I ofthe directive, while Annex II lays down the procedures for statistically checkingmeasuring container bottles in order to meet the directive’s requirements.3.9.2 Weight, volume and packagingAt present, no specific rules have been given as regards the weight andvolume control of active and intelligent food packaging. Active andintelligent packaging uses techniques such as sacks, pouches, cubes,absorbing or emitting materials, indicators, etc. These are either insertedinside or outside the pre-package, and in some liquid foodstuffs, even intothe liquid itself (e.g. C0 2 releasing cubes in beer), or the active component areconstituents of the packaging materials themselves.Multilayer packaging techniques might be needed in order to receive efficacyof active components.All the articles mentioned, or similar articles, might have influence on theweight and volume of pre-packaged food. In general, it may be relevant toconclude that their effect on weight and volume in most cases is small oreven negligible. For instance, food additives, preservatives, flavouringcompounds, colours, etc., applied via package have a negligible effect on theweight or volume of the food. However, if active and intelligent packagingtechniques are used for lightweight foodstuff, e.g. chips, dried herbs, somecandies, etc., the effect on weight or volume might have relevance. Alsoitems like the widget, mentioned in Chapter 4, would have influence on thevolume of the food.The aim of Directives 75/106, 76/211, 80/232 and 75/105 is to ensureconsumers that weight or volume of the food itself is correctly indicated.According to the Nordic countries, when an active or intelligent packaging isused, it seems relevant to follow the main principle of the directives.However, if active and intelligent packaging has a significant effect on theweight or volume of a pre-packed food, specific legislation or interpretationof the existing legislation might be needed.48

3.10 SummaryWhen evaluating an active and intelligent packaging and its legal status, theproduct and its function will have to be considered taken in account forseveral parts of the legislation.Requirements can be conflicting, and the legal status of a specific product canbe difficult to determine. In many situations, interpretation and commonagreement can clarify conflicting points; in general, the active and intelligentpackaging will still have to comply with the sum of requirements.49

Chapter 4Legislation and national interpretationof some examplesWithin the area of active and intelligent packaging a large number ofconcepts are developed significantly different from one other, both infunction and in relation to which part of the legislation should be taken intoaccount. This chapter will cover some, but not all, of the examples, which, forvarious reasons, have become known to authorities in the Nordic countries.These are examples of specific products that have been studied, and theevaluation or conclusion made in one of these countries is presented. Theexamples have been chosen in an attempt to illustrate the legal aspects in theareas in which active and intelligent packaging are found.4.1 Beer bottles or beer cans with a widgetIn Denmark, active packaging, including the various types of absorbents andemitters, has been regarded as food packaging, in general, and theseproducts should be produced in accordance with the legislation in this area.If an active packaging is produced with the purpose of, for instance, emittinggases that can affect the shelf life of the products, these substances (the gases)will be regarded as food additives and must be in compliance with the foodadditive legislation. The same would be the case, for instance, for food canshaving an inner surface of tin for the purpose of adding migrating tin to thecanned food, the aim of which would be prevention of de-coloration of whitevegetables. This would, in principle, also be regarded as a food additive useand covered by the legislation on food packaging materials, also.An example of an active packaging, which has been evaluated, is a so-called“widget” in beer, either bottled or canned, found on the market. The widgetin this example was a hard plastic bowl found inside the bottle, with a diameterof approximately 4-5 cm. The size of this bowl was big enough to keepit inside the bottle or can when pouring out the beer. The widget’s purposehas been described as a beer cooler, or an object, which, by liberation ofcarbon dioxides or other gases into the beer, would allow for more stablebeer foam. The beer contained a spherical insert, which allows foam todevelop when the container is opened. The insert has one restricted aperture,and when submerged in the beverage, it floats naturally. After the containeris filled with the beverage, it is sealed and pressurised. Duringpressurisation, the insert aperture is raised above the level of the liquid andbecomes filled with gas at a pressure similar to that of the headspace abovethe liquid. After pressurisation, the insert will be submerged in the beer oncemore. When the bottle or can is opened, the insert gas escapes from the aper-50

ture into the beverage, thereby developing foam. The Danish Veterinary andFood Administration evaluated this product to determine which legislationshould be taken into account. It was found that the following parts of thelegislation should be considered:a. legislation on food packaging materialsb. legislation on product safetyc. legislation on food additives4.1.1 Legal aspectsConcerning the legislation on product safety, the Danish Veterinary andFood Administration found that, even though the bowl or insert seems to bevery solid, it would have to be placed into the bottle or can. On someoccasions the widget could be spoiled and the plastic pieces, of which thebowl consisted, could otherwise be poured out into the glass of beer oringested immediately by the consumer, with the risk of some physicaldamage to the human throat.Following the legislation on packaging materials, migration should be tested.Finally, if the content of the widget was supposed to have an effect on thefinal food, in this case, producing the foam, the legislation on food additiveswill have to be recognised, including that additives must be labelled inaccordance with the food additive legislation.As recycling is of importance for many countries and the environment, ingeneral, the use of a widget and the consequences for recycling or reuse ofthe bottle or can should be considered in more detail.4.2 Temperature indicatorsTemperature indicators have been on the market for many years, used, forinstance, as stickers on sterilised products. Another concept coming up hasbeen a system including enzymes that are activated to produce a change incolour by time and temperature changes during storage of the food item. Theindicator is added as a label on the outer surface of the food packaging materials.4.2.1 Legal aspectsThe outcome of an evaluation was that this indicator should, first of all, meetthe requirements for food packaging materials. Furthermore, the foodstuffitself should be labelled with the sell-by date, which is a requirement forobligatory labelling. The temperature indicator could be seen as asupplement to this labelling. However, the producer was advised to take the“Legislation on misleading consumers” into account when labelling theproduct for the reason that the consumers could come into a situation wherethe temperature indicator hasn’t changed the colour while the shelf life indicationon the label had been exceeded. The Danish Veterinary and Food51

Administration has evaluated that, having taken this legislation into account,the temperature indicator could legally be used on food products on themarket.A general remark on temperature indicators would be that they should betested with respect to reliability in measuring temperature. Small pilot testshave shown that the temperature indicators themselves can have a limitedshelf life, and the food producers who use the indicators should observe theshelf life of the indicator itself and require information on the tolerance ofthis indicator before using it.4.3 Steak thermometers and doneness-indicatorsSingle use, frying thermometers to be inserted in meat and sold together withthe fresh meat were marketed in Denmark during the summer of 1999. Thefood inspection services, one for poultry and one for pork meat, evaluatedtwo different thermometers, consisting of polystyrene, and which wereapproved by the U.S. Food and Drug Administration (FDA) aftertoxicological evaluation. One end of the thermometer has a dark colouredband, in which the sensor is encapsulated. The thermometer for beef hadthree sensors, which change colour for rare, medium and well done.Another type is the pop-up doneness-indicator, which is frequently used forsteaks and poultry. This plastic device is inserted into the meat prior topacking and kept in place during preparation in the consumer’s oven. A thinstick pops up from the device indicating that the inner temperature of thesteak has been reached. Inside a plastic device contained in the indicator is asmall amount of a substance, e.g. a metal alloy, which is designed to melt at acertain temperature. When melting, a spring is detached and the stick isejected.4.3.1 Legal aspectsThe Danish food inspection did control the sensitivity of the thermometersand concluded that they were accurate. Furthermore, a migration studyconducted following the guidelines of the EU Plastics Directive determinedthat the contact time is approximately 10 seconds. The overall migration wasmeasured to be 2.5 mg/kg, well below the EU limit of 10 mg/kg.The doneness-indicator has not been officially evaluated, but obviously theplastic parts must meet the requirements on materials in contact withfoodstuffs. It must be ensured that no unacceptable migration of the metalsoccur.4.4 Antioxidants in packaging materialsAn example of interpretation of legislation is a product of “Fortified breakfastcereal”, which has been evaluated by the Icelandic Authorities.The composition of the product was given as the following:52

Ingredients: Corn meal, sugar, wheat starch, tricalcium phosphate, salt, brown sugarsyrup, malt syrup, corn syrup, high maltose corn syrup, calcium carbonate, trisodiumphosphate, zinc and iron (mineral nutrients), vitamin E (tocopherolyl acetate),a B vitamin (calcium pantothenate), vitamin B6 (pyridoxine hydrochloride), vitaminB2 (riboflavin), vitamin B1 (thiamin mononitrate), a B vitamin (folic acid), vitaminA (palmitate), vitamin B12, Vitamin D – Freshness preserved by BHT.This product came in a double packaging: an outer paperboard box and aninner laminated plastic bag. It was stated in the ingredients’ description thatthe product’s freshness is preserved by BHT (E 321), although BHT is notlisted as an ingredient or an additive. According to the importer of thisproduct, BHT has been applied to the inner surface layer of the inner bag.Information on mode of application of the substance to the film is lacking. Asthe antioxidant BHT prolongs the shelf life of the product, it can be assumedthat it migrates into the product. It is, therefore, assumed that BHT isindirectly, although intentionally, added to the foodstuff to prolong its shelflife.4.4.1 Legal aspectsIt was stated that both the legislation on food additives and the legislation onfood labelling were relevant to consider. The product falls into category “6.3Breakfast cereals” in the report on food additive legislation “Food Additives– a Nordic model for the implementation of EU’s directives concerning foodadditives”. It is not permitted to add BHT to any product in this category.The additive should also have been listed to the list of ingredients, as wouldany other additive with the effect of an antioxidant. This product does notcomply with Icelandic food legislation and cannot be marketed in Iceland.4.5 Triclosan in food packagingTriclosan (2,4,4'-trichloro-2'-hydroxydiphenyl ether) is a broad-spectrumantimicrobial agent that has been incorporated in various plastic products.Triclosan is added to articles, such as cutting boards, toothbrushes, toys, ande.g., conveyor belts for the food industry, with the intention of obtaining anantimicrobial effect.4.5.1 Legal aspectsIn Europe, the legislative status of triclosan is unclear. In principle, the plasticadditive’s positive list is incomplete, meaning that substances outside the listcan be used, provided their safety in the meaning of the FrameworkDirective is ascertained, and provided the substance does not have a foodpreservation effect.The authorities of the Nordic countries have not been officially asked theiropinion on triclosan in any use in packaging. One central question is thefunction of the substance in plastic: does it actively reduce the bacterialpopulation on food surfaces, or just on plastic surfaces?53

The results of a recent study show that plastic containing 1500 mg/kgtriclosan, combined with vacuum packaging and refrigerated storage, doesnot effectively reduce bacteria on meat surfaces.4.6 Antimicrobial Packaging MaterialsIn Norway, the interpretation of the legal status of the use of natamycin incheese rind has been dealt with.Natamycin (pimaricin) is an antimicrobial agent and approved as a foodadditive as a surface treatment agent on cheese (and dried cured sausage). Inthe EU, this substance is covered by the provisions in Directive 95/2/EC onfood additives other than colours and sweeteners. Natamycin prolongs theshelf life of cheese by preventing or retarding mould growth on the surface.Some cheeses have inedible rinds, and these are considered to be packagingmaterials. Such rinds very often consist of a plastic film, usually in twolayers. Natamycin is added to the plastic emulsion, which is spread aroundthe cheese, one layer at a time. The cheese is dried before the second layer isadded.Natamycin diffuses from the plastic rind to the surface of the cheese.Analyses, carried out by the manufacturer, show a limited amount ofnatamycin on the surface and at a certain depth of the cheese. The amount iswell below the restriction set in the legislation (EU Directive 95/2/EC), andin lower amounts than when the surface of the cheese has been treateddirectly with natamycin.4.6.1 Legal aspectsIn Norway, two parts of the legislation were considered. The use ofnatamycin had to be in compliance, both witha. food additive legislation, and withb. legislation concerning food packaging materials.Re. a. Natamycin is primarily a food additive in this case. Its mainfunction is as an additive to cheese that is added indirectly.Natamycin must, therefore, be in accordance with EU legislationon food additives 3 . If the substance had not been an approvedfood additive to cheese, it would not have been permitted for theuse in packaging materials with an effect on the cheese.Re. b. Natamycin is added to the packaging material and the use of thesubstance in the packaging must, therefore, be in compliancewith legislation on food packaging materials 4 , that is the overall3Directive 95/2/EC on food additives other than colours and sweeteners/Surface treatmentof hard, semi-hard and semi-soft cheese – 1 mg/dm 2 surface not present at a depth of 5mm.4General provisions or Framework Directive 89/109/EEC and Plastic Directive90/128/EEC, as amended.54

migration limit, including natamycin, is 10 mg/dm 2 or 60 mg/kgcheese. If the overall migration limit exceeds this set value, theconsequence would be that this kind of active packaging couldnot be used. EU legislation concerning additives to plastic hasnot yet been completed. However, additives to plastic must, ofcourse, comply with the general legislation, or the FrameworkDirective.In this example, natamycin has been added to the packaging materialsinstead of being applied directly on the surface of the cheese itself. Accordingto the cheese producer, less natamycin is needed to obtain an effect in thecheese by adding natamycin to the packaging materials.Natamycin must be declared on the label as if the food additive had beenadded directly to the surface of the food – that is, with the functional nameand specific name, or with the EEC number (E 235).4.7 The use of allylisothiocyanate (AITC) as anantimicrobial agent and ethylene absorberAITC is the active agent in several products, with different applications. It isused in oil cassettes, in laminated plastic pads, and in pouches. The cassetteis put into the refrigerator or freezer – the pads in direct contact with themeat or fish – and the pouches are placed into cartons made of corrugatedboard together with, e.g., fruit. The purpose of these applications is partly toabsorb ethylene in order to improve quality and freshness, etc., and partly toexert an antimicrobial influence. The latter takes place through a gas transferof AITC to the foodstuff. According to the manufacturer, up to 4.5 mg AITCmay migrate to 1 kg of foodstuff, for instance, to tomatoes when using it inproducts like oil cassettes or pads.AITC is a colourless liquid with an intensive pungent smell. It is formed fromthe glucosinolate sinigrin during break down. Glucosinolates are naturallyoccurring in, e.g., mustard, horseradish, and cabbage.AITC is not approved as a food additive, neither in Sweden, nor in other EUMember States. However, it is permitted to use as a GRAS-substance(Generally Recognised as Safe) in American food legislation (FDA), both as amustard seed and as oil derived therefrom.4.7.1 Legal aspectsAccording to a general rule in the Swedish Food Act, foods which are offeredfor sale may not be of such composition or quality in other respects that itcan be assumed to be harmful to consume, a carrier of infection, or otherwiseunfit for human consumption (§5). According to the same Act (§8), whenfood is handled, precautions should be taken to eliminate the risk of it beingcontaminated or rendered unfit for human consumption.55

The evaluation of the products of concern was carried out according to twodifferent parts of the food legislation: on one hand, the• food additives legislation, and on the other hand,• legislation on materials and articles intended to come into contact withfoods.The concept, food additive, is defined in the Ordinance on Food Additives(based on the definition in Framework Directive 89/107/EEC). From that, itcan be concluded that if a substance is deliberately added to foods with atechnological purpose, as for, e.g., storage, and thereby resulting in thesubstance becoming a component of the foodstuff, it should then beconsidered a food additive. According to the Food Act, these substances areauthorised in specified kinds of foodstuffs only. Only those authorised eitheron community or national level can be used in foodstuffs. Since AITC invarious applications exert a direct influence and is transferred to the foods, ithas to be considered a food additive. Consequently, there is an authorisationrequired before this kind of use can be allowed. An authorisation can begiven nationally for a maximum of two years, based on a toxicologicalevaluation of the substance used.From the toxicological point of view, a consumption of any product (e.g. upto 4.5 mg AITC/kg tomatoes), to which AITC has been used to exert an effecton the foods, may lead to a relatively high intake of AITC with the followingaspects. The Council of Europe Expert Committee on Flavouring Substanceshas, for instance, adopted a tolerable daily intake (TDI) of 3.6 mg AITC perperson, per day for the substance when used as flavouring agent. The NTP(National Toxicology Programme, 1982) has further reported that AITC cangive rise to tumours in the bladder in rats.With respect to the toxicological properties of AITC, this substance,therefore, is not suitable for use as food additives or as additives in materialsintended to come into contact with foods (cf. Article 2, Framework Directive89/109/EEC).4.8 Oxygen absorberSmall sachets containing a powder, which functions as oxygen absorbers, arewell known both by the food producing industry and by food authorities.The powder is usually in the form of iron fillings, but also other kinds ofoxygen absorbing powders are in use. By removing the remaining oxygen,the shelf life of the foodstuffs is extended.The packaging sachet materials are manufactured of aluminium or plastic.All printing on the sachets, such as «Do not eat», are covered with a plasticfilm to prevent food contact with printing inks.The sachets are supposed to be in direct food contact with products, such ascured meat, bakery products, etc. The film has suitable permeability, both formoisture from the food product and the residual oxygen from the packaging56

procedure. The absorbed oxygen reacts with the moisturised powder andforms oxides.4.8.1 Legal aspectsIn Norway, the first inquiry concerning sachets containing oxygen absorberwas received in 1987. The inquiry came from a Japanese company.In 1987, the Norwegian Food Control Authority did not evaluate this itembecause the Authority did not receive inquiries from Norwegian foodproducers wanting to use the product.New inquiries were received in 1991 (for meat products) and 1994 (forbakery products/tortillas) from Norwegian food producing companies. TheNorwegian Food Control Authority reached the following conclusion:• The oxygen absorber is not considered a food additive, as the substance isnot added to the food, but, on the contrary, removes the remainingoxygen.• Consumers are unaccustomed to finding small sachets inside foodpackets, not intended for consumption.Therefore, in 1991, the Authority answered that the product could be usedwithin the industry itself and in catering establishments. Meat would have tobe kept refrigerated in order to prevent the growth of anaerobic bacteria. Thematerials of the sachets would have to be strong and in accordance with theregulations on packaging materials.Pertaining to food products sold directly to consumers, the outside of thefood package must be marked to give information to the fact that the productcontains a small package, which must not be eaten.4.9 Wood in wine processingWine and other alcoholic beverages have been matured and stored forcenturies in wooden barrels. The barrels were earlier a normal type ofstorage container, but, in addition to this, the wood contributes significantlyto the flavour of the final beverage. In modern production facilities thebarrels, in some cases, have been substituted by the use of stainless steelcontainers, which have no taste. Therefore, producers use wood flakes, insome cases, treated by, e.g., microwaves in order to get the required taste.4.9.1 Legal aspectsThe Danish Veterinary and Food Administration evaluated that the use ofwood might be covered by the flavour legislation, in addition to thelegislation on packaging materials.57

Chapter 5Conclusions and recommendations onlegislative aspects5.1 Viewpoints on the effect of variations in the interpretationof EU directivesIn most cases, the use of active and/or intelligent food packaging will haveto be considered in the context of not only one, but also several parts of thelegislation, with respect to the legality of the products and their use.In some cases the evaluation will be quite uncomplicated, as, for example,with an active packaging used, since absorbers generally can be evaluated asa product, which must only comply with the packaging legislation. Othertypes of active and/or intelligent packaging will have to be in accordancewith several different parts of legislation, e.g., food packaging, food additivesand/or labelling, and the various parts of legislation might haverequirements in conflict with one another. The main target for the legislationrelevant to this area is to protect consumer health and prohibit misleadingconsumers; simultaneously, however, the target should not be a barrier forinnovation. Therefore, there could be a need for an amendment of thelegislation, preferably internationally. The need of having clear, internationallegislation stems from international trade with food products, and this is ofsignificant importance, since differences in the legislation are often regardedas barriers to trade.This chapter will discuss the legislation, taking it’s starting point in therequirements found relevant in the EU Framework Directive on FoodPackaging.In the Nordic countries and/or in the EU, there is a possibility for having thesubject discussed and solved, either by guidance to the national authorities,or by amendment of the legislation. As many of the countries are alsoparticipating in the Council of Europe Expert Committee on Food ContactMaterials, this could also be a forum for the discussion. The area of activeand/or intelligent food packaging is extremely complex and involvesconsideration and possible amendments in several different legal texts,which are already harmonised in the EU. The utmost priority, therefore,should be given to common discussion and, hopefully, to solutions withinthe EU, which would benefit international trade in this area. As the Councilof Europe Expert Committee on Food Contact Materials deals with the areaof food packaging only and with no other fields of legislation, it would be58

complicated and, perhaps, impossible, to have a common discussion withinthis international body.In the individual countries or within the EU, the solutions for legislativemeasures necessary to cover active and intelligent packaging could contain atleast the following considerations:• guidelines on interpreting existing legislation or• amendment of the provisions in existing legislation and/or• elaboration of specific legislation in the area of active and/or intelligentpackaging with cross references to existing provisionsDevelopment of a new directive solely on active and intelligent packagingwill be very complex and time-consuming and the unclear, legal situationwould last for several years. Following the above-mentioned analysis, theNordic group rather prefers the conclusions, as pointed out in the two firstoptions, than to introduce detailed amendments on active and intelligentpackaging, only, to existing legislation, or introducing a proposal for a newdirective.5.2 The EU Framework Directive on food contactmaterials and articles and on active and intelligentpackagingBelow, the need for guidelines and/or amendments to the legislation will bediscussed, taking the EU Framework Directive on materials and articlesintended to come into contact with foodstuffs as a starting point.Furthermore, the chapter contains comments and recommendations on otherEU directives that were found relevant for consideration in relation to activeand intelligent packaging and the possibility of having a clearer legalsituation.5.2.1 Area covered by Article 15.2.1.1 ScopeArticle 1 of Directive 89/109/EEC states that the directive shall apply toarticles and materials «… which, in their finished state, are intended to bebrought into contact with foodstuffs or which are brought into contact withfoodstuffs and are intended for that purpose … ». These materials andarticles are traditional packaging materials, such as boxes, plastic films, etc.,but also other articles and materials intended to come into contact withfoodstuffs, such as spoons, kettles, and food industrial machinery.Edible covering or coating substances, such as the substances coveringcheese rinds, prepared meat products, or fruit, which form part of foodstuffsand are supposed to be consumed together with the food, shall not be subjectto the directive. These substances make part of the food, and the foodadditive provisions cover food additives in such covering or coatingsubstances.59

5.2.1.2 Which articles and materials correspond to a definition of active and intelligentpackaging?Although the definition in Article 1 clarifies the scope of the legislation, thedefinition neither clarifies whether active and intelligent food packaging andarticles are covered, nor explains when they might be partly covered. This isan inconvenience for authorities, producers, etc., as it leaves room for variousself-interpretations among Member States, and could, in some cases, be abarrier to innovation.Materials and articles, which have technological functions beyond thetraditional function of food packaging, are partly covered by the definition,while the technological function, generally, is not entirely covered. In orderto obtain a clear, legal situation, the definition should be reviewed.In order to know what kind of articles and materials are subject to therequirements in the EU Framework Directive, it is essential to revise thescope, and preferable, to establish definitions of active and intelligentpackaging.Within this project we have used the following definitions (as mentioned inChapter 1):Active packaging:A food contact material or article, which has an additional function ofproviding a barrier to outside influence. It can control, and even react, tophenomena taking place inside the package.Intelligent packaging:Packaging that monitors in order to give information on quality of packedfood.• There will be materials that clearly correspond to the definitions. Forinstance, as concerns active packaging, materials that add preservatives tofoodstuffs in order to keep the quality of foodstuffs.• There will also be materials, which clearly do not correspond to thedefinition of active packaging, such as the gases used to achieve amodified atmosphere are covered by the legislation on food additives.• Then, there will be borderline cases, and these cases have to be evaluatedindividually, in order to decide whether or not the packaging falls underthe definition of active or intelligent packaging.There has been recognised a need for amendment of the scope of, andguidelines for, Article 1 of the Framework Directive. Below, two options arediscussed:Option one: Active and intelligent food packaging is excluded from thescope.Option two: Active and intelligent food packaging is included in the scopewith separate definitions, as mentioned in Chapter 1 of this report.60

Option one will create a situation, in which no unambiguous Communitylegislation is found and this option will not lead to full harmonisation in thearea. Recalling the importance for international trade of harmonisedlegislation, this option should not be chosen.The Nordic group is in favour of option 2, an amendment of Article 1 and thesubsequent articles, where needed. This would facilitate a faster solution tothe issue.The subsequent articles involved in the discussion are discussed below.Recommendation:Recommendations for amendment of the scope could be the following:• Food packaging and articles intended to come into contact with food, andin addition to this, the materials can have additional technologicalfunctions, which directly affect the foodstuffs themselves.• In addition to the substances in the positive lists on monomers, additivesetc., food packaging may also contain other substances, e.g. foodadditives or flavourings added to the packaging materials with theintention of achieving a function in the final food under restrictions laiddown in the relevant legislation.Realising that amendments are time-consuming and that the EU FrameworkDirective is a Council directive, the project group proposes that, after athorough discussion, guidelines be given on how to evaluate the legality ofactive and intelligent food packaging and articles. Chapter 6 on guidelinesfor food inspection will cover this area.5.2.2 General requirements of Article 2According to Article 2 of Directive 89/109/EEC, materials and articles mustbe manufactured in compliance with Good Manufacturing Practice, so that,under their normal or foreseeable conditions of use, they do not transfer theirconstituents to foodstuffs in quantities, which could:• endanger human health• bring about an unacceptable change in the composition of the foodstuffsor deterioration in the organoleptic characteristics thereof.The definition of active packaging used within this project states that someactive packaging inter alia add a qualification to the foodstuffs via migrationfrom the packaging material into the foodstuffs between the moments ofpackaging and actual consumption. However, active packaging must complywith Article 2, as mentioned above. This means, as discussed below, thatarticles and materials may only transfer constituents that are acceptable inrelation to human health, and, furthermore, they shall not change ordeteriorate the foodstuffs.61

5.2.2.1 Should impose no danger to human healthOne of the basic principles of the legislation is that food packaging andarticles should not endanger human health. As active and intelligentpackaging could be regarded as being covered both by legislation on foodadditives, flavourings or pesticides, etc., as well as by food packaginglegislation, there would not be a need for amendments on this requirement,since a similar principle of safety already exists within this legislation.However, as some parts of this legislation have positive lists withrestrictions, and/or maximum limits, these specific restrictions should be observed.5.2.2.2 Changes in compositionAn essential question subject to interpretation is what constitutes an«unacceptable change» in the composition of the foodstuffs or «a deteriorationon the organoleptic characteristics thereof». How should the requirements inArticle 2 be interpreted?Active and intelligent packaging can be used in order to obtain an intendedmigration of, e.g. flavour or preservatives. This will affect both thecomposition and/or the flavour of the food. The purpose of the requirementshould not lead to prohibition of the use of active or intelligent packaging.The interpretation needs thorough discussion, with the aim of providingguidelines to interested parties.The Nordic group does not find a need for amendment of Article 2, but doesfind a clear need for guidelines in accordance with an amended Article 1, or,as an interim solution, more detailed guidelines on Articles 1 and 2.Recommendation:Migration from the food contact material or articles of components, such asfood additives, flavourings, pesticides or biocides, which legally can befound in the foodstuff in accordance with the relevant legislation, generallywill not be regarded as “unacceptably changed” or “deterioration inorganoleptic characteristics”.5.2.3 Article 3 and specific directives and migration limitsThe legislation on food packaging and articles has positive lists on the componentsin certain materials. Furthermore, for packaging made of plastics,the overall, and/or specific, migration limits for the substances used have tobe considered.It has been discussed whether the limit of overall migration 5 should – as onepossibility – be considered as a primary limit in cases where the substancesin packaging materials or packages are in accordance with food additive,flavouring, or pesticide residue legislation, provided that specific restrictionsin these provisions are followed. A prudent interpretation would be thatwhen an overall migration limit exists, this limit has to be complied with.560 mg/kg food, stipulated in Article 2 of Directive 90/128/EEC on plastic materials.62

5.2.3.1 Positive listsIn principle, substances used in active and intelligent packaging should belisted in positive lists in the packaging legislation before they can be usedlegally. However, this would lead to comprehensive lists. Furthermore, itmight be duplicating work to draw up lists including these substances, assome substances, such as food additives and pesticides are already listed inpositive lists, while others, like flavours, are intended to be regulated by apositive list system in the near future. One recommendation would be toamend the Framework Directive on food packaging with a reference to therelevant directives, as follows:Recommendation:Food packaging may – in addition to the substances in the positive lists onmonomers and additives (plastics, regenerated cellulose, etc.) – containpesticides and biocides, food additives or flavourings added to the packagingwith the intention of obtaining a technological function in the final food,under restrictions found in relevant directives.5.2.3.2 Migration limitsConcerning plastics, legislation on an overall migration is in existence.Components used as an incorporated part of an active and intelligentpackaging in principle should be used in compliance with the overallmigration limit of 60 mg/kg in the foodstuff.The Nordic group finds that this would also be the leading principle forsubstances used in active packaging. However, in many cases, the overallmigration limit is lower than the permitted levels for direct addition of, e.g. afood additive, but should be applied in spite of that fact. It has also to be keptin mind that the limit may include all substances migrating into the food, notjust, e.g. a food additive from the packaging.With the intention of using an active packaging being to obtain atechnological function in the foodstuff, this might prove an impossible taskwith a maximum limit of 60 mg/kg. The overall migration limit will, in somecases, be a barrier to the practical use of active packaging.It should be discussed as to whether it is acceptable, on one hand, to addfood additives, etc., via an active packaging, while, one the other hand, suchsubstances may exceed the overall migration limit set in the legislation onplastic materials. A recommendation for a guideline could be the following:Recommendation:A food contact material could contain additives added to the packaging withthe intention of obtaining a technological function in the final food. The typeof uses should be covered by the restrictions set up in the relevant directivesfor the use of these substances when added directly to the food. This shouldbe clarified within the legislation. Where an overall migration limit exists(presently, 60 mg/kg food for plastic materials), this limit has to be compliedwith, as well.63

5.2.4 Article 6: Labelling requirement for food packagingOne of the labelling requirements in Article 6 of the Framework Directiveincludes a requirement for “guideline for uses”, if lack of a guideline can leadto an unintended use of the material or article. The labelling requirementsapply to materials and articles not yet in contact with food. In order to makecompliance with the legislation possible for those who actually pack andlabel the finished product (including the foodstuffs), Article 6.5 may need tobe amended. More specific requirements on the written declaration attestingcompliance with the rules may have to be set in order to facilitate the control.For several kinds of active and intelligent packaging, there would be a needfor some clarification, as e.g. absorbers or emitters found in separate sachetscan be mistaken for being spices or other types of food ingredients.Consumers should have the appropriate information to prevent them fromeating the item, and this information should be written in the nationallanguage and in line with other labelling requirements for the final food.Recommendation:The labelling requirements in Directive 89/109/EEC should be reviewed toalso require the inclusion of sufficient information regarding food packagingin contact with the food. This should cover the requirement for information,from the packaging producer to the users in the food production or theconsumers. A written declaration of compliance with the rules in thedirectives should, in addition, inform the packaging user that, e.g. foodadditives that migrate into the food have been added to the material in orderto perform a technological function in the foodstuff.Guidelines and recommendations should be established in order to clarifythat this covers labelling information, such as• “Do not eat” in the national language or in accordance with therequirements for languages in the national legislation on labelling and• shelf life and storage temperature of the packaging• only for packaging of…(specific foodstuffs)• not for packaging of….(specific foodstuffs)• labelling of food packaging for household use should be consideredcarefully5.3 Other directives to be consideredIn addition to the food packaging legislation, the use of active and intelligentpackaging in many cases will have to be in compliance with other parts ofthe legislation, as described in previous chapters. Amending the directiveson food packaging only could, in most cases, solve conflicting requirementsin the legislation. In some cases, interpretation and guidelines on thedirective can clarify the legal situation.64

In other cases, other directives would also need to be amended orsupplemented with guidelines, too. Below, the directives concerned will bediscussed, and recommendations will be made for guidelines oramendments.5.3.1 Food additivesThe definitions in the food additive directives can be interpreted in such away that substances in active and intelligent packaging are already covered.However, there could be a need for guidelines for control authorities in orderto prevent variations in interpretation. National authorities could providethese guidelines.Recommendation:Guidelines should be provided for food inspection authorities and otherconcerned parties that the active package and/or the packaging materialitself contain food additives for the intention of achieving a technologicaleffect on the foodstuff. This use should comply with food additiveprovisions, including requirements on safety, specifications, and labelling.5.3.2 FlavouringsAs with the definitions in the food additive directives, the definitions in theflavouring directive can be interpreted in such a way that the substances inactive and intelligent packaging are already covered. Again, there could be aneed for guidelines for control authorities in order to prevent variations ininterpretation, with national authorities providing the guidelines. Aparticular subject of discussion could be on the use of wood in the processingof wines and alcoholic beverages, and whether this use should be labelled inaccordance with the flavour directive. In some instances, wood isintentionally added, e.g. as flakes, to obtain flavour. However, it isquestionable whether the traditional use of wooden barrels is always forflavouring purposes.Recommendation:Information that the active packaging contains flavouring substances thathave been intentionally added to the package and/or packaging material forthe purpose of achieving a flavour in the foodstuff should be provided tofood inspection authorities and other concerned parties. This use shouldcomply with flavouring provisions, including requirements on safety andlabelling.5.3.3 PesticidesThe definitions in the pesticide directive can be interpreted in such a waythat the substances in active and intelligent packaging are already covered.However, there could be a need for guidelines for control authorities in orderto prevent variations in interpretation. National authorities could providesuch guidelines.65

Recommendation:Information that the active packaging contains a pesticide intentionallyadded to the package and/or packaging material to achieve afungicidal/insecticidal effect on the foodstuff should be provided for foodinspection authorities and other concerned groups. This use is in accordancewith pesticide residue provisions, including requirements for maximumresidue limits and consumer safety.5.3.4 HygieneEU directives on hygiene are, at present, undergoing a codification, andMember States and the European Commission should bear in mind theexistence of time/temperature indicators, as well as the use of disinfectantsas components of a food contact material or article.Time/temperature indicators should be subject to specified requirements forcalibration and accuracy if they are to be accepted as an alternative orsupplement to ordinary equipment for temperature measurements.Incorporating into the material substances acting as disinfectants, should becarefully discussed. A normal requirement for the use of disinfectants is acleaning procedure with tap water after disinfection to minimise residues ofthe disinfectant. However, the incorporation of the substance into a foodcontact material will, to some extent, normally result in migration into thefood, in which event, cleaning with water becomes obsolete. This should becompared with the theoretical migration of the disinfectant even aftercleaning with water.Recommendation:Guidelines should be provided control authorities on the use oftime/temperature indicators to give special attention to in-house control ofshelf life and measurement accuracy. The possible incorporation ofdisinfectants into food packaging, and the consequences thereof, will have tobe considered and decided on.5.3.5 Weight and volume controlThe use of active and intelligent packaging can contribute to changes inweight or volume of the pre-packaged food. Guidelines are needed in thisarea to clarify how this should be measured. In some products, e.g. breakfastcereals, like corn flakes, the product itself is very lightweight, and the use ofan absorber could have significant influence on the weight. The use of, e.g., awidget could influence the volume of a liquid, as well. The Nordic group hasthe following recommendations for guidelines:Recommendations:• Absorbers should be regarded as part of the package, and the weightshould be calculated according to the same principles as for the package.Concerning volume, articles like, e.g. widgets, should be evaluated insimilarly.66

• Emitters should be discussed in detail. In many cases, emitters containfood additives or other active components, which normally are regardedas food ingredients and which form a part of the food, thus assuming partof the food’s weight or volume. In active packaging, however, they arenormally found separately. By migrating into the food, they become partof the weight of the food. As the situation is unclear, there may be a needfor amendment of the legislation5.3.6 LabellingThe use of active or intelligent packaging can be misleading for consumers.Several examples have been given in this report. Claims on indicators, like,e.g. a “pathogen indicator” should not be used, as it generally would beregarded as misleading. A time/temperature indicator should be used insuch a way that consumers would be in no doubt as to whether they shouldrely on the indicator or the text on the label. Also, the use of active packagingwith ethanol would require guidelines to ensure proper labelling.It should be discussed whether the indicator can be used as a supplement tolabelling, and if certain advice can be given to prevent misleadingconsumers, or if the indicator could be used in lieu of labelling. The lastoption would require changes in the EU directive on labelling. As this wouldrequire a time-consuming process, this option would not be arecommendation from the Nordic group. Furthermore, in accordance withthe labelling directive, the list of ingredients (in descending order of weight)shall contain additives, also. As the amounts migrating into the foodstuff willbe difficult to estimate, the establishment of a correct list will be complicated.This will especially be the case when it is not the food producer who packsthe foodstuff.Recommendation:There will be a need for discussion and guidance in this area. In particular,the use of time/temperature indicators and labelling requirements for shelflife can conflict and should be clarified, as should the issue with correct listsof ingredients.5.4 Recommendations and conclusionsThe recommendation and conclusions of this project group are either:• recommendations for amendment of the EU provisions on foodpackaging and articles (as this is the basis for the legislation in the Nordiccountries and other Member States), or• recommendations for guidelines to producers or users of the activeand/or intelligent food packaging and articles. In this case, a need foramendment of the legislation would not be required.National authorities could provide guidelines; preferably, however,guidelines should be incorporated in the “Practical Guide” from the67

European Commission, after discussion of the topic among EU MemberStates.68

Chapter 6Guidelines for food inspection facilitiesand other concerned parties, on activeand intelligent food packagingActive and intelligent food packaging is regulated by provisions of severallegal regimes, and it is the manufacturer, importer, and/or user of thematerials who has to ensure that all relevant parts of the legislation areobserved. This chapter provides some advice on what can be done to ensurethat an active or intelligent food contact material does not infringe any of therelevant legal regimes.The food industry shall, in general, establish in-house control. This control iscarried out by each company and includes regular checks on procedures, aswell as on products and their compliance with the legislation. The elementsof the in-house control are based on Good Manufacturing Practices,including Hazard Analysis of Critical Control Points and supplier certificatesstating the lawfulness of purchased products and relevant analytical testscarried out when and where needed. By carrying out an in-house controlbased on the same elements, producers of active and intelligent food packagingare able to meet the demands of authorities and the food industry.6.1 Applicability of EU requirementsAs mentioned above, producers or users of active and intelligent packagingwill have to take several different parts of the legislation into account whenconsidering the legality of a product, for which they are responsible.6.2 General guidance on active and intelligent packaging6.2.1 An overviewThe first step in the evaluation of a material or article is to evaluate whetheran active or intelligent food contact material and article is subject to the scopeof the EU Framework Directive on Food Packaging and Articles. One willhave to:1. Establish whether the material or article and its intended use correspondto the definition in Article 1 of Directive 89/109/EEC.2. Establish whether the material or article and its intended use or functioncorrespond to the proposed definition on active or intelligent packaging69

and whether the function would be covered by definitions in otherdirectives in addition to that on food packaging.If a material or article corresponds entirely to the definition in Article 1 ofDirective 89/109/EEC, it should be manufactured and used inaccordance with the requirements in this directive.However, if the function of the material or article corresponds not only tothe definition in Directive 89/109/EEC, but other directives, such as theFood Additives Directive 89/107/EEC, the materials will have to bemanufactured and used in compliance with the requirements in bothdirectives.The table below gives an overview of the most appropriate legislation toconsider by different actors:LegislationMaterialLegislation on foodpackaging:General require-ments/-compositionProduceroOfmaterialImporterofmaterialRetailerofmaterialFoodpackagerPackagedFfoodsellerx x x x xSpecific requirements/compositix x x x xonLabelling x x x – –Declaration x x – – –Other legislation:Hygiene * * * x xPesticides * * * x xAdditives andflavourings* * * x xLabelling – – – x x* The provisions in these fields focus on the food producer; however, the packagingproducer and seller are obligated to supply information covering these aspects, as well.6.2.2 The evaluation: examples of how to evaluate a product of atwo-component sachetHere, we use an example of an emitter of sulphur dioxide in a sachet. Mostoften, the sachet is intended to come into contact with foodstuffs, and inaddition, the content of the sachet is intended to have a technological effecton the food. In this case, the sulphite is not an integrated part of the material.70

There are two options for the evaluation. Such an emitter can either beregarded as1. two separate parts: the sachet and the sulphite powder, or2. one article.In both cases, the sachet and it’s contents should be used in compliance withboth the requirements in the legislation on food packaging, as well as therequirements in the legislation on food additives or any other relevantnational legislation. As a result of such an evaluation, the emitter can only beused in contact with foodstuffs, in which sulphites are permitted in thequantities emitted.Option 1: The sachet should be in compliance with food contact materiallegislation, and emission of sulphites should be in compliance with the limitsfor sulphites in the food additive legislation.As the sulphites the sachets used in this example consist of two separatecomponents, option 1 could be preferred as the basis for the evaluation.Option 2: The sachet should be in compliance with food contact materiallegislation, and transfer of any sachet matter or contents, including theemission of sulphites, should be in compliance with the overall migrationlimit of 60 mg/kg, as well as with limits in the food additives’ legislation.If the sulphite is incorporated as one of the layers in a multilayer sachet orwrapping, the evaluation should be based on option 2. However, the exampleand its legal aspects should be examined in detail, including the question ofwhich general problems the concept of active packaging brings forth.The evaluation: compliance with general requirements of Article 2Migration from active or intelligent packaging of substances intended tohave an effect in the final food should either be in compliance with positivelists of the relevant legislation, or, in lack of legislative positive lists, beevaluated for safety.In addition to this, the general requirements in the food packaging legislationshould be considered. This will include that migration from the food contactmaterial or article of components should not “bring about an unacceptablechange in the composition of the foodstuffs or a deterioration in theorganoleptic characteristics thereof.”Migration from an active packaging of substances like food additives,flavourings, etc., which lawfully can be found in the foodstuffs in accordancewith the relevant legislation, would not – in general – be regarded as“unacceptable change” or a “deterioration in organoleptic characteristics”.6.2.3 Guidelines for food packaging producersProducers of food packaging know the composition of the material and mustensure that their product is in compliance with provisions on materials andarticles in contact with foodstuff; they must provide actors within the food71

sector with sufficient information to enable them to follow food legislationrequirements.Only plastics and regenerated cellulose films are regulated by the directivesin detail. In other cases, producers are left with the general safety clause ofthe Framework Directive’s Article 2, and it is the responsibility of producersto make the evaluation. The general aspects of control are described in theNordic Report, Proposals for Official Control of Materials Intended to Comeinto Contact with Foodstuffs, TemaNord 1997:510.When evaluating whether a substance complies with the requirements ofArticle 2, the producer may first check evaluations carried out by the EUScientific Committee on Food (SCF). SCF has evaluated the toxicology ofmany substances. If a substance has been evaluated and found acceptable bythe SCF, it will also be in compliance with Article 2, provided any restrictionson use are observed.If the SCF has not evaluated the substance, the legislation of some none-Nordic countries can be used as a guideline. This will apply to somelegislation in Germany (BgVV), in the Netherlands (Warenwet), and in theUnited States (FDA). In all cases, it must be examined whether the legislationin question is based on toxicological evaluations – and if reference has beenstated on a certificate, it must be ascertained that the legislation referred to isstill in force.In other cases, reliable information on the toxicology of the substance mustbe sought elsewhere, for example, in the scientific literature.When the food packaging has been sold, the manufacturer must ensure thatthe labelling is in compliance with the labelling provisions that apply to thesematerials. As for active and intelligent materials or articles, the obligation toindicate any special conditions to be observed when the materials or articlesare being used is of particular importance and interest.The composition of the material will limit the possibilities the packer has touse the material.6.3 Guidelines for importers/suppliersGross sale suppliers are obligated to sell packaging in compliance withlegislation on materials and articles in contact with food. The gross salesupplier usually does not know the precise composition of the material.Therefore, reliable certificates and, occasionally, analytical tests can form thebasis for an in-house control. It is important that certificates are exact andclearly refer to the purchased material/article. Active and intelligent foodpackaging must comply with rules on food packaging and must not result inan infringement of the food legislation. Labelling requirements, furthermore,are also of importance.If the use of an active or intelligent material or article can lead to aninfringement of rules on, e.g. food additives, the material must be labelled72

with a clear statement that it should be used only for the type(s) of food, inwhich the additive is legally accepted.6.4 Guidelines for food producersFood producers are the professional users of materials and articles in contactwith food. The manufacturer must observe not only the legislation onmaterials and articles, but also any other relevant provision of the foodlegislation, e.g. the legislation mentioned in chapter 3.Upon purchasing food packaging, the food producer should ask explicitly forproducts suitable for the particular food product. Especially, when buyingactive or intelligent materials or articles, it is important to ensure that the usewill not result in an infringement of provisions on, e.g. hygiene or foodadditives. For instance, an active package with food preserving propertiescan be used only if the substance is accepted as a food additive for thatparticular foodstuff. Furthermore, the total content of that additive in thefood must not exceed legally accepted quantities in the final foodstuff sold tothe consumer.Pertaining to labelling, the producer of a foodstuff packed in an active orintelligent package must list any substance added to the food by means ofthe packaging, as well as ordinary food additives added directly to the fooditself. It must be kept in mind that the overall or specific migration limit(s) ofthe Plastic Directive shall be observed.73

Annex AComparison of restriction limits forfood additives, pesticides and substancesused in food contact materialsFood contact materialsFor substances used in food contact materials made of plastics, there is ageneral limit for the maximum migration into foodstuffs of 60 mg/kg,irrespective of the substance or constituent of the material and of the use ofthe material, i.e., the kind of foodstuff it will contact. Substances that are insome way regarded as toxic have specific restrictions allocated, and these areless than 60 mg/kg – down to a level not detectable (n.d), with a detectionlimit of usually 0.01 mg/kg foodstuff (irrespective of the use of the material).The specific limit of restriction is, in several cases, based on a TDI-value(tolerable daily intake) or an ADI-value (acceptable daily intake). Both ofthese values are identical, expressed as mg/kg body weight and per day.Substances unintentionally migrating from the material are normallyunwanted substances, considered as contamination, which, basically, shouldnot be allowed; therefore, the expression tolerable daily intake.Normally, plastic packaging materials are tested using migration tests withmodel foodstuffs, simulating the intended foodstuff to be packed to take intoaccount different properties of the foodstuff, such as whether the foodstuff isaqueous, acidic, alcoholic or fatty. In no event shall migration exceed thespecific migration limit, nor the general overall migration limit of 60 mg/kgfoodstuff.Food additivesFood additives can be allowed in foodstuffs, either as quantum satis (q.s)levels, which is a sufficient quantity without a maximum, or up to a certainlimit, normally below 50 g/kg foodstuff. Levels vary considerably betweenthe kind of foodstuff it is allowed in, and depending on the purpose with,and the nature of, the food additive. What is important is that food additivesare added deliberately with a certain technological purpose, but only in a specifickind of foodstuff or group of foodstuffs. The basis for the restriction could bean ADI comparable with a TDI for food contact materials.PesticidesThe maximum residue limits (MRLs) for pesticides have been established viadirectives and are usually at levels between level of detection (LoD) and 10mg/kg. In the vast majority, MRLs range from 0.5–5 mg/kg. The overall75

migration limit for plastics on 60 mg/kg is, then, far too high for pesticideresidues.ComparisonThere are no real general differences for the scientific rationale for what, andhow much, is allowed in food as, e. g. a food additive or constituent comingfrom a food contact material. However, the scientific evaluation principlesseem more systematic for food contact materials, since this work startedrather late, compared to the large time span of evaluations carried out for,e.g., food additives.One conclusion which can be drawn from the above is that, according tolegislation on materials, a food additive cannot be allowed to migrate into thefoodstuff at levels higher than 60 mg/kg of the foodstuff. This level mightnot be enough to exert an effect in the foodstuff, although the food additive,when transferred from the packaging material, migrates primarily to thesurface of the packaged foodstuff, the critical area.In most cases, the overall migration limit of 60 mg/kg for plastic materials islower than limits for accepted maximum content on food additives in thefinal food. As previously mentioned, the accepted level of food additives canbe as high as, e.g. 50 g/kg.Secondly, if the food additive is a constituent in the packaging material, thereare changes, such as pH, in the properties of the packaging material and ofthe foodstuff. This leads to questions of whether the foodstuff is aqueous,dry, or fatty, and of time and temperature, and this determines the level ofmigration of the food additive into the foodstuff. Thus, a certain level of thefood additive in a packaging material through migration gives rise to varyinglevels in foodstuffs which cannot be specified without a prior analysis. In allprobability, an aqueous foodstuff will receive a higher amount than a dryfoodstuff.By contrast, it is at least possible to some extent to calculate the intake of afood additive given through the foodstuff based on consumption data andthe limit in the foodstuff.76

ReferencesChapter 1What is active and intelligent packaging?1. FAIR project CT 98-4170 ‘Actipak’, Minutes of meeting of 12-13 April1999.2. Ahvenainen, R., Hurme, E. and Smolander, M. Active and SmartPackaging – Novel packaging methods to assure the quality and safety offoods. SIG Pack Congress. Helsinki, 3-4 Sept. 1998. Visions. Packaginginnovations today and tomorrow. SIG Pack Systems AG. Beringen. 1998,94-115.3. Ahvenainen, R., Alakomi, H., Helander, I., Skyttä, E. and Sipiläinen-Malm, T. Hurdle Concept in Food Preservation, Technical Report, Nordicnetwork on Minimal Processing, July 1999.4. Goddard, N.R.D., Kemp, R.M.J and Lane, R., An overview of smarttechnology, Packaging Technology and Science, 1997, 10, 129-143.5. Cutter, C.N., The Effectiveness of Triclosan-Incorporated Plastic againstBacteria on Beef Surfaces, Journal of Food Protection, 1999, 62, 474-479.Chapter 2Effectivness and test requirements6. Council of Europe: Progress reports on active and smart food packaging,RD 13-33, May 1998.7. Council of Europe: Guideline on control of food packaged in modifiedatmosphere, 1999.8. The National Food Agency, Denmark: Nye pakketeknikker tillevnedsmidler, 1993.9. FAIR project CT98-4170.Chapter 3Some relevant legislation to considerProduct safety10. European Community Council Directive 92/59/EEC on General ProductSafety.11. European Community Council Directive 89/109/EEC on Food ContactMaterials and Articles.12. European Community Commission Directive 80/590/EEC on Symbols.77

13. European Community Commission Directive 90/128/EEC on Monomersand Additives for Plastic (as amended).14. European Community Council Directive 82/711/EEC on Testing ofPlastic (as amended).15. European Community Council Directive 85/572/EEC laying down thelist of simulants to be used for testing migration of constituents of plasticmaterials and articles intended to come into contact with foodstuffs.16. European Community Commission Directive 78/142/EEC on VinylChloride Monomers (as amended) .17. European Community Commission Directive 93/10/EEC onRegenerated Cellulose Film.18. European Community Commission Directive 84/500/EEC on Ceramics.Food Additives19. European Community Council Directive 89/107/EEC on FoodAdditives.20. European Community Council Directive 94/35/EC on Colours for Use inFoodstuffs.21. European Community Council Directive 94/36/EC on Sweeteners forUse in Foodstuffs.22. European Community Council Directive 95/2/EC on Food Additivesother than Colours and Sweeteners.Flavourings23. European Community Council Directive 88/388/EEC on Flavourings forUse in Foodstuffs and Source Materials for their Production.24. Council Regulation EC/2232/96 laying down a Community procedurefor flavouring substances used or intended for use in or on foodstuffs.25. Commissions Decision 1999/217 adopting a register of flavouringsubstances used in or on foodstuffs drawn up in application ofRegulation (EC) No. 2232/96 of the European Parliament and theCouncil.Pesticides26. Council Directive 91/414/EEC of 15 July 1991 concerning the placing ofplant protection products on the market (OJ No L 230, 19.8.1991, p. 1;Celex 391L0414).78

27. Council Directive 76/895/EEC of 23 November 1976 relating to thefixing of maximum levels for pesticide residues in or on fruit andvegetables (OJ No L 340, 9.12.1976, p. 26; Celex 376L0895).28. Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximumlevels for pesticide residues in and on cereals (OJ No L 221, 7.8.1986, p.37; Celex 386L0362).29. Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximumlevels for pesticide residues in and on foods of animal origin (OJ No L221, 7.8.1986, p. 43; Celex 386L0363).30. Council Directive 90/642/EEC of 27 November 1990 on the fixing ofmaximal levels for pesticide residues in and on certain products of plantorigin, including fruit and vegetables (OJ No L 350, 14.12.1990, p. 71;Celex 390L0642).31. Halek, W. and Garg, A., Fungal Inhibition by a Fungicide Coupled to aIonomeric Film. Journal of food safety, 1989, 9, 215-222.32. Weng, Y.M. and Hotchkiss, J.H., Inhibition of surface moulds on cheeseby polyethylene film containing the antimycotic imazalil, Journal of foodprotection, 1992, 55, 367-369.Hygiene33. European Community Council Directive 93/43/EEC of 14 June 1993 onthe hygiene of foodstuffs.34. European Community Commission Directive 92/1/EEC of 13 January1992 on the monitoring of temperatures in the means of transport, warehousingand storage of quick-frozen foodstuffs intended for human consumption.35. Codex Alimentarius “Recommended International Code of PracticeGeneral Principles of Food Hygiene”.36. European Community Commission Directive 92/1/EEC of 13 January1992 on the monitoring of temperatures.37. Council Directive 64/433/EEC of 26 June 1964 on health conditions forthe production and marketing of fresh meat (as amended).38. Council Directive 71/118/EEC of 15 February 1971 on health problemsaffecting the production and placing on the market of fresh poultry meat(as amended).39. Council Directive 77/99/EEC of 21 December 1976 on health problemsaffecting the production and marketing of meat products and certainother products of animal origin (as amended).40. Council Directive 89/437 of 20 June 1989 on hygiene and healthproblems affecting the production and the placing on the market of eggproducts (as amended).79

41. Council Directive 91/492/EEC of 15 July 1991 laying down the healthconditions for the production and the placing on the market of livebivalve molluscs (as amended).42. Council Directive 91/495/EEC of 22 July 1991 laying down the healthconditions for the production and the placing on the market of fisheryproducts (as amended).43. Council Directive 91/495/EEC of 27 November 1990 concerning publichealth and animal health problems affecting the production and placingon the market of rabbit meat and farmed game meat (as amended).44. Council Directive 92/45/EEC of 16 June 1992 on public health andanimal health problems relating to the killing and the placing on the marketof wild game meat (as amended).45. Council Directive 92/46/EEC of 16 June 1992 laying down the healthrules for the production and placing on the market of raw milk, heattreatedmilk and milk-based products (as amended).46. Council Directive 94/65/EC of 14 December 1994 laying down therequirements for the production and placing on the market of mincedmeat and meat preparations (as amended).Labelling47. European Community Directive 79/112/EC on Labelling.48. European Community Directive 89/107/EEC on Food Additives.49. European Community Directive 89/109/EEC on Materials and ArticlesIntended to Come into Contact with Foods.Weight and volume50. Council Directive 75/106/EEC on the approximation of Member Stateslaws relating to the make-up by volume of certain pre-packaged liquids(OJ No: L 42, 15.2.1975, p. 1).51. Council Directive76/211/EEC on the approximation of the MemberStates laws relating to the make-up by weight or by volume of certainpre-packaged products (OJ No: L 46, 21.2.1976, p. 1).52. Directive 98/16/EC of the European Parliament and the Council onconsumer protection in the indication of the prices of products offered toconsumers (OJ No: L 80, 18.3.1998, p 27.53. Council Directive 80/323/EEC on the approximation of the laws of theMember States relating to ranges of nominal quantities and nominalcapacities permitted for certain pre-packed products.80

54. Council Directive 75/107/EEC on the approximation of Member Stateslaws relating to bottles used as measuring containers (OJ No L 42,19.12.1974, p. 14).Biocides55. European Parliament and Council Directive 98/8/EC of February 16,1998.Chapter 6Guidance to producers56. Nordic Report: Proposals for Official Control of Materials Intended toCome into Contact with Foodstuffs, TemaNord 1997:510.81