Regulation (EC) No 1333/2008 of the European Parliament and of the Council

Uredba (ES) št. 1333/2008 Evropskega parlamenta in Sveta

of 16 December 2008

z dne 16. decembra 2008

on food additives

o aditivih za živila

(Text with EEA relevance)

(Besedilo velja za EGP)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

EVROPSKI PARLAMENT IN SVET EVROPSKE UNIJE STA –

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti in zlasti člena 95 Pogodbe,

Having regard to the proposal from the Commission,

ob upoštevanju predloga Komisije,

Having regard to the opinion of the European Economic and Social Committee [1],

ob upoštevanju mnenja Evropskega ekonomsko-socialnega odbora [1],

Acting in accordance with the procedure laid down in Article 251 of the Treaty [2],

v skladu s postopkom, določenim v členu 251 Pogodbe [2],

Whereas:

ob upoštevanju naslednjega:

(1) The free movement of safe and wholesome food is an essential aspect of the internal market and contributes significantly to the health and well-being of citizens, and to their social and economic interests.

(1) Prosti pretok varnih in zdravstveno ustreznih živil je pomemben vidik notranjega trga in znatno prispeva k zdravju in dobremu počutju državljanov ter njihovim socialnim in gospodarskim interesom.

(2) A high level of protection of human life and health should be assured in the pursuit of Community policies.

(2) Pri uresničevanju politik Skupnosti bi bilo treba zagotoviti visoko raven varovanja življenja in zdravja ljudi.

(3) This Regulation replaces previous Directives and Decisions concerning food additives permitted for use in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests, via comprehensive and streamlined procedures.

(3) Ta uredba nadomešča prejšnje direktive in odločbe v zvezi z aditivi za živila, dovoljenimi za uporabo v živilih, da se zagotovi učinkovito delovanje notranjega trga ter hkrati visoka raven varovanja zdravja ljudi in visoka raven varstva potrošnikov, vključno z zaščito interesov potrošnikov, s celovitimi in poenostavljenimi postopki.

(4) This Regulation harmonises the use of food additives in foods in the Community. This includes the use of food additives in foods covered by Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses [3] and the use of certain food colours for the health marking of meat and the decoration and stamping of eggs. It also harmonises the use of food additives in food additives and food enzymes thus ensuring their safety and quality and facilitating their storage and use. This has not previously been regulated at Community level.

(4) Ta uredba usklajuje uporabo aditivov za živila v živilih v Skupnosti. To vključuje uporabo aditivov za živila v živilih, ki jih zajema Direktiva Sveta 89/398/EGS z dne 3. maja 1989 o približevanju zakonodaje držav članic, ki se nanaša na živila za posebne prehranske namene [3], ter uporabo nekaterih barvil za živila za označevanje zdravstvene ustreznosti mesa ter za okrasitev in žigosanje jajc. Usklajuje tudi uporabo aditivov za živila v aditivih za živila in encimih za živila, s čimer zagotavlja njihovo varnost in kakovost ter omogoča njihovo hrambo in uporabo. To področje doslej ni bilo urejeno na ravni Skupnosti.

(5) Food additives are substances that are not normally consumed as food itself but are added to food intentionally for a technological purpose described in this Regulation, such as the preservation of food. All food additives should be covered by this Regulation, and therefore in the light of scientific progress and technological development the list of functional classes should be updated. However, substances should not be considered as food additives when they are used for the purpose of imparting flavour and/or taste or for nutritional purposes, such as salt replacers, vitamins and minerals. Moreover, substances considered as foods which may be used for a technological function, such as sodium chloride or saffron for colouring and food enzymes should also not fall within the scope of this Regulation. However, preparations obtained from foods and other natural source material that are intended to have a technological effect in the final food and which are obtained by selective extraction of constituents (e.g. pigments) relative to the nutritive or aromatic constituents, should be considered additives within the meaning of this Regulation. Finally, food enzymes are covered by Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes [4], which excludes the application of this Regulation.

(5) Aditivi za živila so snovi, ki se običajno ne uživajo kot živilo, ampak se iz tehnoloških razlogov, opisanih v tej uredbi, namensko dodajajo živilu, kot je konzerviranje živil. Ta uredba bi morala zajeti vse aditive za živila, zaradi znanstvenega napredka in tehnološkega razvoja pa bi bilo treba posodobiti seznam funkcijskih razredov. Vendar se snovi ne bi smelo šteti za aditive za živila, če se uporabljajo za dodajanje arome in/ali okusa ali za prehranske namene, kot so nadomestki za sol, vitamini in minerali. Poleg tega v področje uporabe te uredbe ne bi smele biti vključene snovi, ki se štejejo za živila in se lahko uporabljajo za tehnološke namene, kot so natrijev klorid ali žafran za obarvanje in encimi za živila. Kljub temu bi morali za aditive v smislu te uredbe šteti pripravke iz živil in druge naravne izvorne snovi, ki se jih lahko uporabi zaradi tehnološkega učinka v končnem živilu in so pridobljeni s selektivno ekstrakcijo sestavin (npr. pigmenti), povezanih s hranilnimi ali aromatskimi sestavinami. Encimi za živila pa so zajeti v Uredbi (ES) št. 1332/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o encimih za živila [4], ki izključuje uporabo te uredbe.

(6) Substances not consumed as food itself but used intentionally in the processing of foods, which only remain as residues in the final food and do not have a technological effect in the final product (processing aids), should not be covered by this Regulation.

(6) Snovi, ki se ne uživajo kot živilo, ampak se namensko uporabljajo pri predelavi živil, in so prisotne le kot ostanki v končnem živilu ter nimajo tehnološkega vpliva na končni izdelek (pomožna tehnološka sredstva), ne bi smele biti zajete v tej uredbi.

(7) Food additives should be approved and used only if they fulfil the criteria laid down in this Regulation. Food additives must be safe when used, there must be a technological need for their use, and their use must not mislead the consumer and must be of benefit to the consumer. Misleading the consumer includes, but is not limited to, issues related to the nature, freshness, quality of ingredients used, the naturalness of a product or of the production process, or the nutritional quality of the product, including its fruit and vegetable content. The approval of food additives should also take into account other factors relevant to the matter under consideration including societal, economic, traditional, ethical and environmental factors, the precautionary principle and the feasibility of controls. The use and maximum levels of a food additive should take into account the intake of the food additive from other sources and the exposure to the food additive by special groups of consumers (e.g. allergic consumers).

(7) Aditivi za živila bi se smeli odobriti in uporabljati le, če izpolnjujejo merila iz te uredbe. Uporaba aditivov za živila mora biti varna, obstajati mora tehnološka potreba po njihovi uporabi, njihova uporaba ne sme zavajati potrošnika in mu mora koristiti. Zavajanje potrošnika med drugim vključuje zadeve, povezane z vrsto, svežostjo, kakovostjo uporabljenih sestavin, naravnostjo izdelka oziroma proizvodnega postopka ali prehransko kakovostjo izdelka, vključno z vsebnostjo sadja in zelenjave, vendar ni omejeno izključno nanje. Pri odobritvi aditivov za živila bi se morali upoštevati tudi drugi dejavniki v zvezi z obravnavanim primerom, med drugim družbeni, gospodarski, etični, okoljski dejavniki in dejavniki, povezani s tradicijami, ter previdnostno načelo in možnost izvajanja nadzora. Pri uporabi in najvišji dovoljeni vsebnosti aditiva za živilo bi bilo treba upoštevati vnos aditiva za živilo iz drugih virov ter izpostavljenost skupin potrošnikov s posebnimi prehranskimi potrebami temu aditivu za živilo (na primer potrošniki, ki imajo alergijo).

(8) Food additives must comply with the approved specifications, which should include information to adequately identify the food additive, including origin, and to describe the acceptable criteria of purity. The specifications previously developed for food additives included in Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs [5], Commission Directive 95/45/EC of 26 July 1995 laying down specific purity criteria concerning colours for use in foodstuffs [6] and Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners [7] should be maintained until the corresponding additives are entered in the Annexes to this Regulation. At that time, the specifications related to such additives should be set out in a Regulation. Those specifications should relate directly to the additives included in the Community lists in the Annexes to this Regulation. However, considering the complex character and substance of such specifications, for the sake of clarity they should not be integrated as such in the Community lists but should be set out in one or more separate Regulations.

(8) Aditivi za živila morajo biti v skladu z odobrenimi specifikacijami, ki bi morale vključevati informacije, ki ustrezno določajo aditiv za živila, vključno z izvorom, in opisujejo sprejemljiva merila čistosti. Predhodno oblikovane specifikacije za aditive za živila, vključene v Direktivo Komisije 95/31/ES z dne 5. julija 1995 o določitvi posebnih meril čistosti sladil za uporabo v živilih [5], Direktivo Komisije 95/45/ES z dne 26. julija 1995 o določitvi posebnih meril čistosti v zvezi z barvili za uporabo v živilih [6] in Direktivo Komisije 96/77/ES z dne 2. decembra 1996 o posebnih merilih čistosti aditivov za živila razen barvil in sladil [7], bi bilo treba ohraniti, dokler ustrezni aditivi niso vključeni v priloge k tej uredbi. Ob vključitvi bi bilo treba specifikacije v zvezi s temi aditivi navesti v uredbi. Navedene specifikacije bi se morale neposredno navezovati na aditive, vključene na sezname Skupnosti iz prilog k tej uredbi. Vendar se kot take glede na kompleksen značaj in vsebino takšnih specifikacij zaradi jasnosti ne bi smele vključiti v sezname Skupnosti, ampak bi jih bilo treba navesti v eni ali več ločenih uredbah.

(9) Some food additives are permitted for specific uses for certain authorised oenological practices and processes. The use of such food additives should comply with this Regulation and with the specific provisions laid down in the relevant Community legislation.

(9) Za nekatere aditive za živila je dovoljena posebna uporaba v nekaterih odobrenih enoloških postopkih in obdelavah. Uporaba takšnih aditivov za živila bi morala biti v skladu s to uredbo in posebnimi določbami iz ustrezne zakonodaje Skupnosti.

(10) In order to ensure harmonisation, the risk assessment and approval of food additives should be carried out in accordance with the procedure laid down in Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings [8]

(10) Da se zagotovi usklajenost, bi bilo treba oceno tveganja in odobritev aditivov za živila opraviti v skladu s postopkom iz Uredbe (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila [8].

(11) Under Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [9], the European Food Safety Authority (hereinafter referred to as the Authority) is to be consulted on matters likely to affect public health.

(11) V skladu z Uredbo (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [9], se je treba z Evropsko agencijo za varnost hrane (v nadaljnjem besedilu "Agencija") posvetovati o stvareh, ki bi lahko vplivale na javno zdravje.

(12) A food additive which falls within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [10] should be authorised in accordance with that Regulation as well as under this Regulation.

(12) Za aditiv za živila, ki spada na področje uporabe Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi [10], bi bilo treba odobriti v skladu z navedeno uredbo in v skladu s to uredbo.

(13) A food additive already approved under this Regulation which is prepared by production methods or using starting materials significantly different from those included in the risk assessment of the Authority, or different from those covered by the specifications laid down, should be submitted for evaluation by the Authority. "Significantly different" could mean, inter alia, a change of the production method from extraction from a plant to production by fermentation using a micro-organism or a genetic modification of the original micro-organism, a change in starting materials, or a change in particle size, including the use of nanotechnology.

(13) Aditiv za živila, ki je že odobren v skladu s to uredbo in pridobljen s proizvodnimi metodami ali z uporabo vhodnih sestavin, ki se znatno razlikujejo od tistih, ki so vključene v oceno tveganja Agencije, ali od tistih, ki jih zajemajo navedene specifikacije, bi bilo treba predložiti Agenciji v oceno. "Znatna različnost" bi lahko med drugim pomenila spremembo proizvodne metode iz izvlečkov iz rastlin v proizvodnji s fermentacijo z uporabo mikroorganizma ali gensko spremenjenega prvotnega mikroorganizma, spremembo vhodnih sestavin ali spremembo velikosti delcev, vključno z uporabo nanotehnologije.

(14) Food additives should be kept under continuous observation and must be re-evaluated whenever necessary in the light of changing conditions of use and new scientific information. Where necessary, the Commission together with the Member States should consider appropriate action.

(14) Aditive za živila bi bilo treba stalno nadzorovati in jih je treba po potrebi ponovno oceniti glede na spreminjajoče se pogoje uporabe in nove znanstvene podatke. Po potrebi bi morala Komisija v sodelovanju z državami članicami preučiti, kakšne ukrepe je treba sprejeti.

(15) Member States which maintained on 1 January 1992 prohibitions on the use of certain additives in certain specific foods which are considered traditional and are produced on their territory should be permitted to continue to apply those prohibitions. Moreover, as regard products such as "Feta" or "Salame cacciatore", this Regulation should be without prejudice to more restrictive rules linked to the use of certain denominations under Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs [11] and Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed [12].

(15) Državam članicam, ki so 1. januarja 1992 ohranile prepoved uporabe nekaterih aditivov v nekaterih posebnih živilih, ki se štejejo za tradicionalna in se proizvajajo na njihovem ozemlju, bi morala biti dovoljena nadaljnja uporaba navedene prepovedi. Poleg tega ta uredba v zvezi z izdelki, kot sta "Feta" ali "Salame cacciatore", ne posega v strožje predpise, povezane z uporabo nekaterih poimenovanj iz Uredbe Sveta (ES) št. 510/2006 z dne 20. marca 2006 o zaščiti geografskih označb in označb porekla za kmetijske proizvode in živila [11] ter Uredbe Sveta (ES) št. 509/2006 z dne 20. marca 2006 o zajamčenih tradicionalnih posebnostih kmetijskih proizvodov in živil [12].

(16) Unless subject to further restrictions, an additive may be present in food, other than by direct addition, as a result of carry-over from an ingredient in which the additive was permitted, provided that the level of the additive in the final food is no greater than would be introduced by the use of the ingredient under proper technological conditions and good manufacturing practice.

(16) S pridržkom dodatnih omejitev za aditiv lahko živila vsebujejo aditiv, ki jim ni bil dodan neposredno, ki pa je bil vanje prenesen s sestavino, v kateri je bil aditiv dovoljen, pod pogojem, da vsebnost aditiva v končnem živilu ni višja od vsebnosti, ki bi nastala na podlagi uporabe te sestavine v skladu s primernimi tehnološkimi pogoji in dobro proizvodno prakso.

(17) Food additives remain subject to the general labelling obligations as provided for in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs [13] and, as the case may be, in Regulation (EC) No 1829/2003 and in Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms [14]. In addition, specific provisions on the labelling of food additives sold as such to the manufacturer or to the final consumer should be contained in this Regulation.

(17) Za aditive za živila še vedno veljajo splošne obveznosti označevanja iz Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [13] ter, odvisno od primera, Uredbe (ES) št. 1829/2003 oziroma Uredbe (ES) št. 1830/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o sledljivosti in označevanju gensko spremenjenih organizmov ter sledljivosti živil in krme, proizvedenih iz gensko spremenjenih organizmov [14]. Poleg tega bi bilo treba posebne določbe za označevanje aditivov za živila, ki se kot taki prodajo proizvajalcu ali končnemu potrošniku, vključiti v to uredbo.

(18) Sweeteners authorised under this Regulation may be used in table-top sweeteners sold directly to consumers. Manufacturers of such products should make information available to the consumer by appropriate means to allow them to use the product in a safe manner. Such information could be made available in a number of ways including on product labels, Internet websites, consumer information lines or at the point of sale. In order to adopt a uniform approach to the implementation of this requirement, guidance drawn up at Community level may be necessary.

(18) Sladila, odobrena na podlagi te uredbe, se lahko uporabljajo kot namizna sladila, prodana neposredno potrošnikom. Proizvajalci takšnih izdelkov bi morali potrošnikom dati na voljo informacije s pomočjo ustreznih načinov, da bi jim omogočili varno uporabo izdelkov. Takšne informacije bi lahko bile dostopne na različne načine, med drugim na označbah na izdelkih, spletnih mestih, informacijskih linijah za potrošnike ali na prodajnih mestih. Da bi zagotovili enotni pristop glede izvajanja te zahteve, bi lahko bila potrebna usmeritev, sprejeta na ravni Skupnosti.

(19) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [15].

(19) Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s Sklepom Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [15].

(20) In particular the Commission should be empowered to amend the Annexes of this Regulation and to adopt appropriate transitional measures. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(20) Komisiji bi bilo zlasti treba podeliti pooblastila za spremembo prilog te uredbe in za sprejetje ustreznih prehodnih ukrepov. Ker so ti ukrepi splošnega obsega in so namenjeni spreminjanju nebistvenih določb te uredbe, med drugim z njenim dopolnjevanjem z novimi nebistvenimi določbami, jih je treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.

(21) On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adoption of certain amendments to Annexes II and III relating to substances already authorised under other Community law as well as any appropriate transitional measures related to these substances.

(21) Zaradi večje učinkovitosti bi bilo treba skrajšati običajne roke za regulativni postopek s pregledom za sprejetje nekaterih sprememb prilog II in III v zvezi z snovmi, ki so bile že odobrene v skladu z drugo zakonodajo Skupnosti, kakor tudi s katerimi koli ustreznimi prehodnimi ukrepi v zvezi s temi snovmi.

(22) In order to develop and update Community law on food additives in a proportionate and effective way, it is necessary to collect data, share information and coordinate work between Member States. For that purpose, it may be useful to undertake studies to address specific issues with a view to facilitating the decision-making process. It is appropriate that the Community finance such studies as part of its budgetary procedure. The financing of such measures is covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules [16].

(22) Da bi se zakonodaja Skupnosti na področju aditivov za živila razvijala in posodabljala na skladen in učinkovit način, je treba zbirati podatke, izmenjavati informacije in usklajevati delo med državami članicami. V ta namen bi lahko bilo koristno izvesti raziskave, ki bi obravnavale posebna vprašanja, da se olajša postopek odločanja. Primerno je, da takšne študije financira Skupnost kot del svojega proračunskega postopka. Financiranje takih ukrepov zajema Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali [16].

(23) Member States are to carry out official controls in order to enforce compliance with this Regulation in accordance with Regulation (EC) No 882/2004.

(23) Države članice morajo izvajati uradni nadzor, da se v skladu z Uredbo (ES) št. 882/2004 doseže skladnost s to uredbo.

(24) Since the objective of this Regulation, namely to lay down Community rules on food additives, cannot be sufficiently achieved by the Member States and can therefore, in the interests of market unity and a high level of consumer protection, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

(24) Ker cilja te uredbe, in sicer določitve pravil Skupnosti o aditivih za živila, države članice ne morejo zadovoljivo doseči in ker ta cilj zaradi enotnosti trga in visoke ravni varstva potrošnikov lažje doseže Skupnost, Skupnost lahko sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe. Skladno z načelom sorazmernosti iz navedenega člena ta uredba ne prekoračuje okvirov, ki so potrebni za doseganje navedenega cilja.

(25) Following the adoption of this Regulation the Commission, assisted by the Standing Committee on the Food Chain and Animal Health, should review all the existing authorisations for criteria, other than safety, such as intake, technological need and the potential to mislead the consumer. All food additives that are to continue to be authorised in the Community should be transferred to the Community lists in Annexes II and III to this Regulation. Annex III to this Regulation should be completed with the other food additives used in food additives and food enzymes as well as carriers for nutrients and their conditions of use in accordance with Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings]. To allow a suitable transition period, the provisions in Annex III, other than the provisions concerning carriers for food additives and food additives in flavourings, should not apply until 1 January 2011.

(25) Po sprejetju te uredbe bi morala Komisija skupaj s Stalnim odborom za prehranjevalno verigo in zdravje živali pregledati vse obstoječe odobritve glede na merila, razen varnosti, kot so vnos, tehnološka potreba in možnost zavajanja potrošnika. Vse aditive za živila, ki bodo še naprej odobreni v Skupnosti, bi bilo treba vključiti v sezname Skupnosti iz prilog II in III k tej uredbi. Prilogo III k tej uredbi bi bilo treba dopolniti z drugimi aditivi za živila, ki se uporabljajo v aditivih za živila in encimih za živila, kot tudi v nosilcih v hranilih, ter pogoji za njihovo uporabo v skladu z Uredbo (ES) št. 1331/2008 [o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila]. Za zagotovitev ustreznega prehodnega obdobja se določbe iz Priloge III, razen tistih, ki zadevajo nosilce za aditive za živila in aditive za živila v aromah, ne bi smele začeti uporabljati pred 1. januarjem 2011.

(26) Until the future Community lists of food additives are established, it is necessary to provide for a simplified procedure allowing the current lists of food additives contained in the existing Directives to be updated.

(26) Dokler seznami Skupnosti aditivov za živila ne bodo pripravljeni, je treba določiti poenostavljen postopek za posodabljanje sedanjih seznamov aditivov za živila, navedenih v obstoječih direktivah.

(27) Without prejudice to the outcome of the review referred to in recital 25, within one year following the adoption of this Regulation the Commission should set up an evaluation programme for the Authority to re-evaluate the safety of the food additives that were already approved in the Community. That programme should define the needs and the order of priorities according to which the approved food additives are to be examined.

(27) Brez poseganja v rezultat pregleda iz uvodne izjave 25 bi morala Komisija v enem letu po sprejetju te uredbe določiti program ocenjevanja, da Agencija ponovno oceni varnost aditivov za živila, ki so že bili odobreni v Skupnosti. Ta program bi moral opredeliti potrebe in vrstni red prednostnih nalog, v skladu s katerimi je treba preveriti odobrene aditive za živila.

(28) This Regulation repeals and replaces the following acts: Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorised for use in foodstuffs intended for human consumption [17], Council Directive 65/66/EEC of 26 January 1965 laying down specific criteria of purity for preservatives authorised for use in foodstuffs intended for human consumption [18], Council Directive 78/663/EEC of 25 July 1978 laying down specific criteria of purity for emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs [19], Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity for antioxidants which may be used in foodstuffs intended for human consumption [20], First Commission Directive 81/712/EEC of 28 July 1981 laying down Community methods of analysis for verifying that certain additives used in foodstuffs satisfy criteria of purity [21], Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption [22], Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs [23], Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs [24], Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners [25], Decision No 292/97/EC of the European Parliament and of the Council of 19 December 1996 on the maintenance of national laws prohibiting the use of certain additives in the production of certain specific foodstuffs [26] and Commission Decision 2002/247/EC of 27 March 2002 suspending the placing on the market and import of jelly confectionary containing the food additive E 425 konjac [27]. However, it is appropriate that certain provisions of those acts remain in force during a transitional period to allow time for the preparation of the Community lists in the Annexes to this Regulation,

(28) Ta uredba razveljavlja in nadomešča naslednje pravne akte: Direktivo Sveta z dne 23. oktobra 1962 o približevanju zakonodaj držav članic o barvilih, ki se smejo uporabiti v živilih, namenjenih za prehrano ljudi [17], Direktivo Sveta 65/66/EGS z dne 26. januarja 1965 o določitvi posebnih meril čistosti za konzervanse, katerih uporaba je dovoljena v živilih, namenjenih za prehrano ljudi [18], Direktivo Sveta 78/663/EGS z dne 25. julija 1978 o določitvi posebnih meril čistosti za emulgatorje, stabilizatorje, gostila in želirna sredstva za uporabo v živilih [19], Direktivo Sveta 78/664/EGS z dne 25. julija 1978 o določitvi posebnih meril čistosti za antioksidante, katerih uporaba je dovoljena v živilih, namenjenih za prehrano živil [20], Prvo direktivo Komisije 81/712/EGS z dne 28. julija 1981 o določitvi analiznih metod Skupnosti za preverjanje, da nekateri aditivi za živila izpolnjujejo merila čistosti [21], Direktivo Sveta 89/107/EGS z dne 21. decembra 1988 o približevanju zakonodaj držav članic o aditivih za živila, ki se smejo uporabljati v živilih, namenjenih za prehrano ljudi [22], Direktivo 94/35/ES Evropskega parlamenta in Sveta z dne 30. junija 1994 o sladilih za uporabo v živilih [23], Direktivo 94/36/ES Evropskega parlamenta in Sveta z dne 30. junija 1994 o barvilih za uporabo v živilih [24], Direktivo 95/2/ES Evropskega parlamenta in Sveta z dne 20. februarja 1995 o aditivih za živila razen barvil in sladil [25] in Odločbo št. 292/97/ES Evropskega parlamenta in Sveta z dne 19. decembra 1996 o ohranjanju nacionalnih predpisov o prepovedi uporabe nekaterih aditivov pri proizvodnji nekaterih posebnih živil [26] ter Odločbo Komisije 2002/247/ES z dne 27. marca 2002 o prekinitvi dajanja v promet in uvoza slaščic iz želeja, ki vsebujejo živilski aditiv E 425 konjak [27]. Kljub temu je primerno, da nekatere določbe navedenih pravnih aktov še naprej veljajo v prehodnem obdobju, da se omogoči dovolj časa za pripravo seznamov Skupnosti iz prilog k tej uredbi –

HAVE ADOPTED THIS REGULATION:

SPREJELA NASLEDNJO UREDBO:

CHAPTER I

POGLAVJE I

SUBJECT MATTER, SCOPE AND DEFINITIONS

VSEBINA, PODROČJE UPORABE IN OPREDELITEV POJMOV

Article 1

Člen 1

Subject matter

Vsebina

This Regulation lays down rules on food additives used in foods with a view to ensuring the effective functioning of the internal market whilst ensuring a high level of protection of human health and a high level of consumer protection, including the protection of consumer interests and fair practices in food trade, taking into account, where appropriate, the protection of the environment.

Ta uredba določa pravila za aditive za živila, ki se uporabljajo v živilih, z namenom zagotoviti učinkovito delovanje notranjega trga in hkrati visoko raven varovanja zdravja ljudi in visoko raven varstva potrošnikov, vključno z zaščito interesov potrošnikov in poštenim ravnanjem v trgovini z živili, pri tem pa se po potrebi upošteva varstvo okolja.

For those purposes, this Regulation provides for:

Za navedene namene ta uredba določa:

(a) Community lists of approved food additives as set out in Annexes II and III;

(a) sezname Skupnosti odobrenih aditivov za živila, določene v prilogah II in III;

(b) conditions of use of food additives in foods, including in food additives and in food enzymes as covered by Regulation (EC) No 1332/2008 [on food enzymes], and in food flavourings as covered by Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods [28];

(b) pogoje uporabe aditivov za živila v živilih, tudi v aditivih za živila in encimih za živila, zajetih v Uredbi (ES) št. 1332/2008 [o encimih za živila], in v aromah za živila, zajetih v Uredbi (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih [28];

Article 2

Člen 2

Scope

Področje uporabe

1. This Regulation shall apply to food additives.

1. Ta uredba se uporablja za aditive za živila.

2. This Regulation shall not apply to the following substances unless they are used as food additives:

2. Ta uredba se ne uporablja za naslednje snovi, razen če se uporabljajo kot aditivi za živila:

(a) processing aids;

(a) pomožna tehnološka sredstva;

(b) substances used for the protection of plants and plant products in accordance with Community rules relating to plant health;

(b) snovi, ki se uporabljajo za varstvo rastlin in rastlinskih proizvodov v skladu s pravili Skupnosti o zdravstvenem varstvu rastlin;

(d) substances used for the treatment of water for human consumption falling within the scope of Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption [29];

(d) snovi, ki se uporabljajo za čiščenje vode za prehrano ljudi in spadajo na področje uporabe Direktive Sveta 98/83/ES z dne 3. novembra 1998 o kakovosti vode, namenjene za prehrano ljudi [29];

(e) flavourings falling within the scope of Regulation (EC) No 1334/2008 [on flavourings and certain food ingredients with flavouring properties for use in and on foods].

(e) arome, ki spadajo na področje uporabe Uredbe (ES) št. 1334/2008 [o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo v in na živilih].

3. This Regulation shall not apply to food enzymes falling within the scope of Regulation (EC) No 1332/2008 [on food enzymes], with effect from the date of adoption of the Community list of food enzymes in accordance with Article 17 of that Regulation.

3. Ta uredba se ne uporablja za encime za živila, ki spadajo v področje uporabe Uredbe (ES) št. 1332/2008 [o encimih za živila] z učinkom od dne sprejetja seznama Skupnosti za encime za živila v skladu s členom 17 navedene uredbe.

4. This Regulation shall apply without prejudice to any specific Community rules concerning the use of food additives:

4. Ta uredba se uporablja brez poseganja v kakršna koli posebna pravila Skupnosti v zvezi z uporabo aditivov za živila:

(a) in specific foods;

(a) v posebnih živilih;

(b) for purposes other than those covered by this Regulation.

(b) za namene, ki niso vključeni v to uredbo.

Article 3

Člen 3

Definitions

Opredelitev pojmov

1. For the purposes of this Regulation, the definitions laid down in Regulations (EC) No 178/2002 and (EC) No1829/2003 shall apply.

1. Za namene te uredbe se uporabljajo opredelitve iz uredb (ES) št. 178/2002 in št. 1829/2003.

2. For the purposes of this Regulation the following definitions shall also apply:

2. V tej uredbi se uporabljajo tudi opredelitve:

(a) "food additive" shall mean any substance not normally consumed as a food in itself and not normally used as a characteristic ingredient of food, whether or not it has nutritive value, the intentional addition of which to food for a technological purpose in the manufacture, processing, preparation, treatment, packaging, transport or storage of such food results, or may be reasonably expected to result, in it or its by-products becoming directly or indirectly a component of such foods;

(a) "aditiv za živilo" pomeni vsako snov, ki se običajno ne uživa kot živilo in običajno ni tipična sestavina živila, ki se iz tehnoloških razlogov namensko dodaja živilu med proizvodnjo, predelavo, pripravo, obdelavo, pakiranjem, prevozom ali hrambo, ne glede na to, ali ima hranilno vrednost ali ne, ter neposredno ali posredno postane ali lahko postane sestavina živila kot taka ali kot stranski proizvod živila;

The following are not considered to be food additives:

K aditivom za živila ne spadajo:

(i) monosaccharides, disaccharides or oligosaccharides and foods containing these substances used for their sweetening properties;

(i) monosaharidi, disaharidi ali oligosaharidi in živila, v katerih so vsebovane te snovi, ki se uporabljajo zaradi njihovih sladilnih lastnosti;

(ii) foods, whether dried or in concentrated form, including flavourings incorporated during the manufacturing of compound foods, because of their aromatic, sapid or nutritive properties together with a secondary colouring effect;

(ii) živila, posušena ali zgoščena, vključno z aromami, ki so med postopkom proizvodnje sestavljenih živil dodana zaradi arome in okusa ali hranilnih lastnosti ter drugotnega barvnega učinka;

(iii) substances used in covering or coating materials, which do not form part of foods and are not intended to be consumed together with those foods;

(iii) snovi, ki se uporabljajo v materialih za pokrivanje ali ovijanje ter ki niso del živil in niso namenjene za zaužitje skupaj z njimi;

(iv) products containing pectin and derived from dried apple pomace or peel of citrus fruits or quinces, or from a mixture of them, by the action of dilute acid followed by partial neutralisation with sodium or potassium salts (liquid pectin);

(iv) izdelki, ki vsebujejo pektin in so pridobljeni iz posušenih jabolčnih tropin ali lupin citrusov ali kutine ali iz njihove mešanice, z obdelavo z razredčeno kislino, ki ji sledi delna nevtralizacija z natrijevimi ali kalijevimi solmi ("tekoči pektin");

(v) chewing gum bases;

(v) baze za žvečilni gumi;

(vi) white or yellow dextrin, roasted or dextrinated starch, starch modified by acid or alkali treatment, bleached starch, physically modified starch and starch treated by amylolitic enzymes;

(vi) beli ali rumeni dekstrin, pražen ali dekstriniran škrob, škrob, modificiran s kislinsko ali alkalno obdelavo, beljen škrob, fizikalno modificiran škrob in škrob, obdelan z amilolitičnimi encimi;

(vii) ammonium chloride;

(vii) amonijev klorid;

(viii) blood plasma, edible gelatin, protein hydrolysates and their salts, milk protein and gluten;

(viii) krvna plazma, jedilna želatina, beljakovinski hidrolizati in njihove soli, mlečne beljakovine in gluten;

(ix) amino acids and their salts other than glutamic acid, glycine, cysteine and cystine and their salts having no technological function;

(ix) aminokisline in njihove soli, ki nimajo tehnološke funkcije, razen glutaminske kisline, glicina, cisteina ter cistina in njunih soli;

(x) caseinates and casein;

(x) kazeinati in kazein;

(xi) inulin;

(b) "processing aid" shall mean any substance which:

(b) "pomožno tehnološko sredstvo" pomeni vsako snov, ki:

(i) is not consumed as a food by itself;

(i) se kot živilo ne uživa sama;

(ii) is intentionally used in the processing of raw materials, foods or their ingredients, to fulfil a certain technological purpose during treatment or processing; and

(ii) se namenoma uporablja pri predelavi surovin, živil ali njihovih sestavin za nekatere tehnološke namene med obdelavo ali predelavo; in

(iii) may result in the unintentional but technically unavoidable presence in the final product of residues of the substance or its derivatives provided they do not present any health risk and do not have any technological effect on the final product;

(iii) lahko povzroči nenamerno, vendar tehnično neizogibno prisotnost ostankov snovi ali njenih derivatov v končnem izdelku, če ti ostanki niso nevarni za zdravje ljudi in nimajo nobenega tehnološkega učinka na končni izdelek;

(c) "functional class" shall mean one of the categories set out in Annex I based on the technological function a food additive exerts in the foodstuff;

(c) "funkcijski razred" pomeni eno od kategorij iz Priloge I, ki temelji na tehnološki funkciji, ki jo ima aditiv za živilo v živilu;

(d) "unprocessed food" shall mean a food which has not undergone any treatment resulting in a substantial change in the original state of the food, for which purpose the following in particular are not regarded as resulting in substantial change: dividing, parting, severing, boning, mincing, skinning, paring, peeling, grinding, cutting, cleaning, trimming, deep-freezing, freezing, chilling, milling, husking, packing or unpacking;

(d) "nepredelano živilo" pomeni živilo, ki ni bilo obdelano z nobenim postopkom, ki bi povzročil bistveno spremembo prvotnega stanja živila, pri čemer se za postopke, ki povzročijo bistveno spremembo, ne štejejo zlasti: razdelitev, ločitev, razrezanje, izkoščenje, sekljanje, odrtje, odrezanje, lupljenje, mletje, rezanje, čiščenje, obrezovanje, globoko zamrznjenje, zamrznjenje, hlajenje, brušenje, luščenje, pakiranje ali razpakiranje;

(e) "food with no added sugars" shall mean a food without the following:

(e) "živilo brez dodanih sladkorjev" pomeni:

(i) any added monosaccharides or disaccharides;

(i) živilo brez dodanih monosaharidov ali disaharidov;

(ii) any added food containing monosaccharides or disaccharides which is used for its sweetening properties;

(ii) živilo brez dodanega živila, ki vsebuje monosaharide ali disaharide, uporabljenega zaradi njegovih sladilnih lastnosti;

(f) "energy-reduced food" shall mean a food with an energy value reduced by at least 30 % compared with the original food or a similar product;

(f) "živilo z zmanjšano energijsko vrednostjo" pomeni živilo z energijsko vrednostjo, ki je najmanj za 30 % nižja v primerjavi z istovrstnim živilom ali podobnimi izdelki;

(g) "table-top sweeteners" shall mean preparations of permitted sweeteners, which may contain other food additives and/or food ingredients and which are intended for sale to the final consumer as a substitute for sugars;

(g) "namizna sladila" pomenijo pripravke iz dovoljenih sladil, ki lahko vsebujejo druge aditive za živila in/ali sestavine živil ter so namenjeni za prodajo končnemu potrošniku kot nadomestek za sladkorje;

(h) "quantum satis" shall mean that no maximum numerical level is specified and substances shall be used in accordance with good manufacturing practice, at a level not higher than is necessary to achieve the intended purpose and provided the consumer is not misled.

(h) "quantum satis" pomeni, da najvišja dovoljena vsebnost numerično ni določena, snovi pa se uporabljajo v skladu z dobro proizvodno prakso in njihova vsebnost ni višja od tiste, ki je potrebna za doseganje predvidenega namena, pri tem pa se ne zavaja potrošnika.

CHAPTER II

POGLAVJE II

COMMUNITY LISTS OF APPROVED FOOD ADDITIVES

SEZNAMI SKUPNOSTI ODOBRENIH ADITIVOV ZA ŽIVILA

Article 4

Člen 4

Community lists of food additives

Seznami Skupnosti aditivov za živila

1. Only food additives included in the Community list in Annex II may be placed on the market as such and used in foods under the conditions of use specified therein.

1. Le aditivi za živila, vključeni v seznam Skupnosti iz Priloge II, se lahko dajo v promet kot taki in uporabljajo v živilih v skladu s pogoji uporabe, določenimi v navedeni prilogi.

2. Only food additives included in the Community list in Annex III may be used in food additives, in food enzymes and in food flavourings under the conditions of use specified therein.

2. Le aditivi za živila, vključeni v seznam Skupnosti iz Priloge III, se lahko uporabljajo v aditivih za živila, encimih za živila in aromah za živila v skladu s pogoji uporabe, določenimi v navedeni prilogi.

3. Food additives in Annex II shall be listed on the basis of the categories of food to which they may be added.

3. Seznam aditivov za živila iz Priloge II se sestavi na podlagi kategorij živil, katerim se lahko dodajo aditivi.

4. Food additives in Annex III shall be listed on the basis of the food additives, food enzymes, food flavourings and nutrients or categories thereof to which they may be added.

4. Seznam aditivov za živila iz Priloge III se sestavi na podlagi aditivov za živila, encimov za živila, arom za živila in hranil ali njihovih kategorij, katerim se lahko dodajo.

5. Food additives shall comply with the specifications as referred to in Article 14.

5. Aditivi za živila so v skladu s specifikacijami iz člena 14.

Article 5

Člen 5

Prohibition of non-compliant food additives and/or non-compliant food

Prepoved aditivov za živila in/ali živil, ki niso skladni s to uredbo

No person shall place on the market a food additive or any food in which such a food additive is present if the use of the food additive does not comply with this Regulation.

Nihče ne sme dati v promet aditiva za živilo ali kakršnega koli živila, ki vsebuje tak aditiv za živilo, če uporaba tega aditiva za živilo ni v skladu s to uredbo.

Article 6

Člen 6

General conditions for inclusion and use of food additives in Community lists

Splošni pogoji za vključitev aditivov za živila v seznam Skupnosti in njihovo uporabo

1. A food additive may be included in the Community lists in Annexes II and III only if it meets the following conditions and, where relevant, other legitimate factors, including environmental factors:

1. Aditiv za živila se lahko vključi v sezname Skupnosti iz prilog II in III le, če izpolnjuje naslednje pogoje in po potrebi še druge utemeljene dejavnike, vključno z okoljskimi:

(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer at the level of use proposed;

(a) na podlagi razpoložljivih znanstvenih dokazov v predlagani količini ne ogroža zdravja potrošnika;

(b) there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means; and

(b) zanj obstaja upravičena tehnološka potreba, ki je ni mogoče doseči z drugimi ekonomsko in tehnološko izvedljivimi sredstvi, in

2. To be included in the Community lists in Annexes II and III a food additive must have advantages and benefits for the consumer and therefore serve one or more of the following purposes:

2. Da se aditiv za živila vključi v sezname Skupnosti iz prilog II in III, mora imeti za potrošnika prednosti in ugodnosti ter zato izpolnjevati enega ali več naslednjih namenov:

(a) preserving the nutritional quality of the food;

(a) ohranitev hranilne vrednosti živila;

(b) providing necessary ingredients or constituents for foods manufactured for groups of consumers with special dietary needs;

(b) zagotovitev potrebnih surovin ali sestavin živil, proizvedenih za skupine potrošnikov s posebnimi prehranskimi potrebami;

(c) enhancing the keeping quality or stability of a food or improving its organoleptic properties, provided that the nature, substance or quality of the food is not changed in such a way as to mislead the consumer;

(c) izboljšanje ohranjanja kakovosti ali obstojnosti živila ali izboljšanje njegovih organoleptičnih lastnosti, če se ne spremeni narava, sestava ali kakovost živila tako, da bi zavajala potrošnika;

(d) aiding in the manufacture, processing, preparation, treatment, packing, transport or storage of food, including food additives, food enzymes and food flavourings, provided that the food additive is not used to disguise the effects of the use of faulty raw materials or of any undesirable practices or techniques, including unhygienic practices or techniques, during the course of any such activities.

(d) zagotovitev pomoči pri proizvodnji, predelavi, pripravi, obdelavi, pakiranju, prevozu ali skladiščenju živila, vključno z aditivi za živila, encimi za živila in aromami za živila, če aditiv za živila ni uporabljen za prikrivanje učinkov uporabe neustreznih surovin ali katerih koli neželenih praks ali postopkov, vključno z nehigienskimi praksami ali postopki, med izvajanjem katere koli od teh dejavnosti.

3. By way of derogation from paragraph 2(a), a food additive which reduces the nutritional quality of a food may be included in the Community list in Annex II provided that:

3. Z odstopanjem od odstavka 2(a) se lahko aditiv za živila, ki zmanjšuje hranilno vrednost živila, vključi v seznam Skupnosti iz Priloge II, če:

(a) the food does not constitute a significant component of a normal diet; or

(a) živilo ni pomembna sestavina običajne prehrane ali

(b) the food additive is necessary for the production of foods for groups of consumers with special dietary needs.

(b) če je aditiv za živila potreben za proizvodnjo živil za skupine potrošnikov s posebnimi prehranskimi potrebami.

Article 7

Člen 7

Specific conditions for sweeteners

Posebni pogoji za sladila

A food additive may be included in the Community list in Annex II for the functional class of sweetener only if, in addition to serving one or more of the purposes set out in Article 6(2), it serves one or more of the following purposes:

Aditiv za živila se lahko vključi v seznam Skupnosti iz Priloge II v funkcijski razred za sladilo le, če izpolnjuje, poleg izpolnjevanja enega ali več namenov iz člena 6(2), tudi enega ali več naslednjih namenov:

(a) replacing sugars for the production of energy-reduced food, non-cariogenic food or food with no added sugars; or

(a) nadomeščanje sladkorjev za proizvodnjo živil z zmanjšano energijsko vrednostjo, živil proti kariesu ali živil brez dodanih sladkorjev; ali

(b) replacing sugars where this permits an increase in the shelf-life of the food; or

(b) nadomeščanje sladkorjev, če se s tem omogoči podaljšanje roka uporabnosti živil; ali

Article 8

Člen 8

Specific conditions for colours

Posebni pogoji za barvila

A food additive may be included in the Community list in Annex II for the functional class of colour only if, in addition to serving one or more of the purposes set out in Article 6(2), it serves one of the following purposes:

Aditiv za živila se lahko vključi v seznam Skupnosti iz Priloge II v funkcijski razred za barvilo le, če izpolnjuje, poleg izpolnjevanja enega ali več namenov iz člena 6(2), tudi enega od naslednjih namenov:

(a) restoring the original appearance of food of which the colour has been affected by processing, storage, packaging and distribution, whereby visual acceptability may have been impaired;

(a) povrnitev prvotnega videza živilu, katerega barva je bila spremenjena pri predelavi, skladiščenju, pakiranju in dostavi, s čimer se je lahko poslabšala vizualna podoba živila;

(b) making food more visually appealing;

(b) zagotovitev privlačnejše vizualne podobe živila;

Article 9

Člen 9

Functional classes of food additives

Funkcijski razredi aditivov za živila

1. Food additives may be assigned in Annexes II and III to one of the functional classes in Annex I on the basis of the principal technological function of the food additive.

1. Aditivi za živila se lahko uvrstijo v prilogi II in III, v enega od funkcijskih razredov iz Priloge I, na podlagi glavne tehnološke funkcije aditiva za živila.

Allocating a food additive to a functional class shall not preclude it from being used for several functions.

Uvrstitev aditiva za živila v funkcijski razred ne izključuje njegove uporabe za več funkcij.

2. Where necessary, as a result of scientific progress or technological development, the measures, designed to amend non-essential elements of this Regulation, relating to additional functional classes which may be added to Annex I shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3).

2. Po potrebi se lahko zaradi znanstvenega napredka ali tehnološkega razvoja ukrepi za spremembo nebistvenih določb te uredbe, povezani z dodatnimi funkcijskimi razredi, ki se lahko vključijo v Prilogo I, sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 28(3).

Article 10

Člen 10

The content of the Community lists of food additives

Vsebina seznamov Skupnosti aditivov za živila

1. A food additive which complies with the conditions set out in Articles 6, 7 and 8 may, in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings] be included in:

1. Aditiv za živila, ki izpolnjuje pogoje iz členov 6, 7 in 8, se lahko v skladu s postopkom iz Uredbe (ES) št. 1331/2008 [o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila] vključi v:

(a) the Community list in Annex II to this Regulation; and/or

(a) seznam Skupnosti iz Priloge II k tej uredbi in/ali

(b) the Community list in Annex III to this Regulation.

(b) seznam Skupnosti iz Priloge III k tej uredbi.

2. The entry for a food additive in the Community lists in Annexes II and III shall specify:

2. Pri vključitvi aditiva za živila na sezname Skupnosti iz prilog II in III se podrobno navede:

(a) the name of the food additive and its E number;

(a) ime aditiva za živila in njegovo E-številko.

(b) the foods to which the food additive may be added;

(b) živila, katerim se lahko doda aditiv za živila;

(d) if appropriate, whether there are any restrictions on the sale of the food additive directly to the final consumer.

(d) po potrebi kakršne koli omejitve v zvezi s prodajo aditiva za živila neposredno končnemu potrošniku.

3. The Community lists in Annexes II and III shall be amended in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings].

3. Seznami Skupnosti iz prilog II in III se spremenijo v skladu s postopkom iz Uredbe (ES) št. 1331/2008 [o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila].

Article 11

Člen 11

Levels of use of food additives

Najvišje dovoljene vsebnosti aditivov za živila

1. When establishing the conditions of use referred to in Article 10(2)(c):

1. Pri določitvi pogojev uporabe iz člena 10(2)(c) se:

(a) the level of use shall be set at the lowest level necessary to achieve the desired effect;

(a) za najvišjo dovoljeno vsebnost določi najmanjša vrednost, ki je potrebna za dosego želenega učinka;

(b) the levels shall take into account:

(b) glede najvišje dovoljene vsebnosti je treba upoštevati:

(i) any acceptable daily intake, or equivalent assessment, established for the food additive and the probable daily intake of it from all sources;

(i) vsak sprejemljiv dnevni vnos ali drugo oceno vnosa aditiva za živila in verjetni dnevni vnos aditiva za živila iz vseh virov;

(ii) where the food additive is to be used in foods eaten by special groups of consumers, the possible daily intake of the food additive by consumers in those groups.

(ii) kadar se aditiv za živila uporablja v živilih za skupine potrošnikov s posebnimi prehranskimi potrebami, verjetni dnevni vnos aditiva za živila s strani potrošnikov iz teh skupin.

2. Where appropriate, no maximum numerical level shall be fixed for a food additive (quantum satis). In that case, the food additive shall be used in accordance with the principle of quantum satis.

2. Če je primerno, za aditiv za živila numerično ni določena najvišja dovoljena vsebnost (quantum satis). V tem primeru se aditiv za živila uporablja v skladu z načelom quantum satis.

3. The maximum levels of food additives set out in Annex II shall apply to the food as marketed, unless otherwise stated. By way of derogation from this principle, for dried and/or concentrated foods which need to be reconstituted the maximum levels shall apply to the food as reconstituted according to the instructions on the label taking into account the minimum dilution factor.

3. Najvišje dovoljene vsebnosti aditivov za živila iz Priloge II se uporabljajo za živila, kakor so tržena, razen če ni drugače navedeno. Z odstopanjem od tega načela za posušena in/ali zgoščena živila, ki se morajo pripraviti, veljajo najvišje dovoljene vsebnosti za živila, kakor so pripravljena v skladu z navodili na označbi, ob upoštevanju najmanjšega faktorja razredčenja.

4. The maximum levels for colours set out in Annex II shall apply to the quantities of colouring principle contained in the colouring preparation unless otherwise stated.

4. Najvišje dovoljene vsebnosti za barvila iz Priloge II se uporabljajo za količine barvila, ki ga vsebuje barvni pripravek, razen če ni drugače navedeno.

Article 12

Člen 12

Changes in the production process or starting materials of a food additive already included in a Community list

Spremembe v proizvodnem postopku ali vhodnih sestavin pri aditivu za živila, ki je že vključen v seznam Skupnosti

When a food additive is already included in a Community list and there is a significant change in its production methods or in the starting materials used, or there is a change in particle size, for example through nanotechnology, the food additive prepared by those new methods or materials shall be considered as a different additive and a new entry in the Community lists or a change in the specifications shall be required before it can be placed on the market.

Kadar je aditiv za živila že vključen v seznam Skupnosti in se proizvodne metode ali vhodne sestavine znatno spremenijo, na primer s pomočjo nanotehnologije, se aditiv za živila, pripravljen s temi novimi metodami ali surovinami, obravnava kot drug aditiv za živila, zato je, preden se da na trg, potreben nov vnos v sezname Skupnosti ali pa je potrebno spremeniti specifikacije.

Article 13

Člen 13

Food additives falling within the scope of Regulation (EC) No 1829/2003

Aditivi za živila, ki spadajo na področje uporabe Uredbe (ES) št. 1829/2003

1. A food additive falling within the scope of Regulation (EC) No 1829/2003 may be included in the Community lists in Annexes II and III in accordance with this Regulation only when it is covered by an authorisation in accordance with Regulation (EC) No 1829/2003.

1. Aditiv za živila, ki spada na področje uporabe Uredbe (ES) št. 1829/2003, je lahko vključen v sezname Skupnosti iz prilog II in III v skladu s to uredbo le po odobritvi v skladu z Uredbo (ES) št. 1829/2003.

2. When a food additive already included in the Community list is produced from a different source falling within the scope of Regulation (EC) No 1829/2003, it will not require a new authorisation under this Regulation, as long as the new source is covered by an authorisation in accordance with Regulation (EC) No 1829/2003 and the food additive complies with the specifications established under this Regulation.

2. Kadar je aditiv za živila, ki je že vključen v seznamu Skupnosti, proizveden iz drugega vira, ki spada v področje uporabe Uredbe (ES) št. 1829/2003, zanj ni potrebna ponovna odobritev v skladu s to uredbo, če je novi vir odobren v skladu z Uredbo (ES) št. 1829/2003 in je aditiv za živila skladen s specifikacijami, določenimi v skladu s to uredbo.

Article 14

Člen 14

Specifications of food additives

Specifikacije aditivov za živila

The specifications of food additives relating, in particular, to origin, purity criteria and any other necessary information, shall be adopted when the food additive is included in the Community lists in Annexes II and III for the first time, in accordance with the procedure referred to in Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings].

Specifikacije aditivov za živila, zlasti v zvezi s poreklom, merili čistosti in katerimi koli drugimi potrebnimi informacijami se sprejmejo ob prvi vključitvi aditiva za živila v sezname Skupnosti iz prilog II in III, v skladu s postopkom iz Uredbe (ES) št. 1331/2008 [o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila].

CHAPTER III

POGLAVJE III

USE OF FOOD ADDITIVES IN FOODS

UPORABA ADITIVOV ZA ŽIVILA V ŽIVILIH

Article 15

Člen 15

Use of food additives in unprocessed foods

Uporaba aditivov za živila v nepredelanih živilih

Food additives shall not be used in unprocessed foods, except where such use is specifically provided for in Annex II.

Aditivi za živila se ne uporabljajo v nepredelanih živilih, razen če je takšna uporaba posebej določena v Prilogi II.

Article 16

Člen 16

Use of food additives in foods for infants and young children

Uporaba aditivov za živila v živilih za dojenčke in majhne otroke

Food additives shall not be used in foods for infants and young children as referred to in Directive 89/398/EEC, including dietary foods for infants and young children for special medical purposes, except where specifically provided for in Annex II to this Regulation.

Aditivi za živila se ne uporabljajo v živilih za dojenčke in majhne otroke iz Direktive 89/398/EGS, vključno z dietnimi živili za dojenčke in majhne otroke za posebne zdravstvene namene, razen če je to izrecno določeno v Prilogi II k tej uredbi.

Article 17

Člen 17

Use of colours for markings

Uporaba barvil za označevanje

Only food colours listed in Annex II to this Regulation may be used for the purpose of health marking as provided for in Council Directive 91/497/EEC of 29 July 1991 amending and consolidating Directive 64/433/EEC on health problems affecting intra-Community trade in fresh meat to extend it to the production and marketing of fresh meat [30] and other markings required on meat products, for the decorative colouring of eggshells and for the stamping of eggshells as provided for in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin [31].

Za označevanje zdravstvene ustreznosti v skladu z Direktivo Sveta 91/497/EGS z dne 29. julija 1991 o spremembi in pripravi prečiščenega besedila Direktive 64/433/EGS o zdravstvenih problemih, ki vplivajo na trgovino s svežim mesom v Skupnosti, z namenom njene razširitve na proizvodnjo in trženje svežega mesa [30] in druga označevanja, ki so potrebna za mesne izdelke, ter okrasno barvanje in žigosanje jajčnih lupin v skladu z Uredbo (ES) št. 853/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o posebnih higienskih pravilih za živila živalskega izvora [31] se lahko uporabljajo le barvila za živila iz Priloge II k tej uredbi.

Article 18

Člen 18

Carry-over principle

Načelo prenosa

1. The presence of a food additive shall be permitted:

1. Prisotnost aditiva za živila je dovoljena:

(a) in a compound food other than as referred to in Annex II, where the food additive is permitted in one of the ingredients of the compound food;

(a) v sestavljenih živilih, razen tistih iz Priloge II, kadar je aditiv za živila dovoljen v eni od sestavin sestavljenega živila;

(b) in a food to which a food additive, food enzyme or food flavouring has been added, where the food additive:

(b) v živilu, ki mu je dodan aditiv za živila, encim za živila ali aroma za živila, kadar je aditiv za živila:

(i) is permitted in the food additive, food enzyme or food flavouring in accordance with this Regulation; and

(i) dovoljen v aditivu za živila, encimu za živila ali aromi za živila v skladu s to uredbo; in

(ii) has been carried over to the food via the food additive, food enzyme or food flavouring; and

(ii) je bil prenesen v živilo z aditivom za živila, encimom za živila ali aromo za živila in

(iii) has no technological function in the final food;

(iii) nima tehnološke funkcije v končnem živilu;

(c) in a food which is to be used solely in the preparation of a compound food and provided that the compound food complies with this Regulation.

2. Paragraph 1 shall not apply to infant formulae, follow-on formulae, processed cereal-based foods and baby foods and dietary foods for special medical purposes intended for infants and young children as referred to in Directive 89/398/EEC, except where specifically provided for.

2. Odstavek 1 se ne uporablja za začetne formule in nadaljevalne formule za dojenčke, žitne kašice in otroško hrano ter dietna živila za posebne zdravstvene namene za dojenčke in majhne otroke iz Direktive 89/398/EGS, razen če je izrecno določeno.

3. Where a food additive in a food flavouring, food additive or food enzyme is added to a food and has a technological function in that food, it shall be considered a food additive of that food and not a food additive of the added flavouring, food additive or food enzyme, and must then comply with the conditions of use for that food as provided for.

3. Kadar je aditiv za živila dodan aromi za živila, aditivu za živila ali encimu za živila in ima v tem živilu tehnološko funkcijo, se šteje za aditiv za živilo tega živila in ne za aditiv za živilo dodane arome, aditiva za živila ali encima za živila in mora torej biti v skladu s pogoji uporabe, določenimi za to živilo.

4. Without prejudice to paragraph 1, the presence of a food additive used as a sweetener shall be permitted in a compound food with no added sugars, in an energy-reduced compound food, in compound dietary foods intended for low-calorie diets, in non-cariogenic compound foods, and in a compound food with an increased shelf-life, provided that the sweetener is permitted in one of the ingredients of the compound food.

4. Brez poseganja v odstavek 1 je prisotnost aditiva za živilo, ki se uporablja kot sladilo, dovoljena v sestavljenem živilu brez dodanih sladkorjev, sestavljenem živilu z zmanjšano energijsko vrednostjo, sestavljenih živilih za uporabo v energijsko omejenih dietah za znižanje telesne teže, sestavljenem živilu proti kariesu in sestavljenem živilu s podaljšanim rokom uporabnosti, če je sladilo dovoljeno v eni od sestavin sestavljenega živila.

Article 19

Člen 19

Interpretation decisions

Razlagalne odločitve

Where necessary, it may be decided in accordance with the regulatory procedure referred to in Article 28(2) whether or not:

Po potrebi se lahko v skladu z regulativnim postopkom iz člena 28(2) odloči, ali:

(a) a particular food belongs to a category of food referred to in Annex II; or

(a) posamezno živilo spada v kategorijo živil iz Priloge II; ali

(b) a food additive listed in Annexes II and III and permitted at "quantum satis" is used in accordance with the criteria referred to in Article 11(2); or

(b) se aditiv za živila, ki je naveden v prilogah II in III ter dovoljen z vsebnostjo "quantum satis", uporablja v skladu z merili iz člena 11(2); ali

Article 20

Člen 20

Traditional foods

Tradicionalna živila

The Member States listed in Annex IV may continue to prohibit the use of certain categories of food additives in the traditional foods produced on their territory as listed in that Annex.

Države članice iz Priloge IV lahko še naprej prepovedujejo uporabo nekaterih kategorij aditivov za živila v tradicionalnih živilih, ki se proizvajajo na njihovem ozemlju in so našteta v navedeni prilogi.

CHAPTER IV

POGLAVJE IV

LABELLING

OZNAČEVANJE

Article 21

Člen 21

Labelling of food additives not intended for sale to the final consumer

Označevanje aditivov za živila, ki niso namenjeni za prodajo končnemu potrošniku

1. Food additives not intended for sale to the final consumer, whether sold singly or mixed with each other and/or with food ingredients, as defined in Article 6(4) of Directive 2000/13/EC, may only be marketed with the labelling provided for in Article 22 of this Regulation, which must be easily visible, clearly legible and indelible. The information shall be in a language easily understandable to purchasers.

1. Aditivi za živila, ki niso namenjeni za prodajo končnemu potrošniku in ki se prodajajo posamično ali v mešanici z drugimi aditivi za živila in/ali z drugimi živilskimi sestavinami, kot je opredeljeno v členu 6(4) Direktive 2000/13/ES, se lahko tržijo le, če so v skladu z označbo iz člena 22 te uredbe, ki mora biti dobro vidna, jasno berljiva in neizbrisna. Informacije so v jeziku, ki je kupcem lahko razumljiv.

2. Within its own territory, the Member State in which the product is marketed may, in accordance with the Treaty, stipulate that the information provided for in Article 22 shall be given in one or more of the official languages of the Community, to be determined by that Member State. This shall not preclude such information from being indicated in several languages.

2. Država članica, v kateri se izdelek trži, lahko na svojem ozemlju v skladu s Pogodbo določi, da se informacije iz člena 22 navedejo v enem ali več uradnih jezikih Skupnosti, ki jih določi navedena država članica. To ne izključuje navajanja teh informacij v več jezikih.

Article 22

Člen 22

General labelling requirements for food additives not intended for sale to the final consumer

Splošne zahteve glede označevanja za aditive za živila, ki niso namenjeni prodaji končnemu potrošniku

1. Where food additives not intended for sale to the final consumer are sold singly or mixed with each other and/or other food ingredients and/or with other substances added to them, their packaging or containers shall bear the following information:

1. Kadar se aditivi za živila, ki niso namenjeni za prodajo končnemu potrošniku, prodajajo posamično ali v mešanici in/ali skupaj z drugimi sestavinami živil in/ali ki so jim dodane druge snovi, so na njihovi embalaži ali posodah navedene naslednje informacije:

(a) the name and/or E-number laid down in this Regulation in respect of each food additive or a sales description which includes the name and/or E-number of each food additive;

(a) ime in/ali E-številka iz te uredbe za vsak aditiv za živila ali prodajno ime z imenom in/ali E-številko vsakega aditiva za živila;

(b) the statement "for food" or the statement "restricted use in food" or a more specific reference to its intended food use;

(b) navedba "za živila" ali navedba "za omejeno uporabo v živilih" ali podrobnejši opis namena uporabe v živilih;

(d) a mark identifying the batch or lot;

(d) označba serije ali lota;

(e) instructions for use, if the omission thereof would preclude appropriate use of the food additive;

(e) navodila za uporabo, če bi se sicer brez njih aditiv za živila lahko uporabil nepravilno;

(f) the name or business name and address of the manufacturer, packager or seller;

(f) ime ali firma in naslov proizvajalca, pakirnice ali prodajalca;

(g) an indication of the maximum quantity of each component or group of components subject to quantitative limitation in food and/or appropriate information in clear and easily understandable terms enabling the purchaser to comply with this Regulation or other relevant Community law; where the same limit on quantity applies to a group of components used singly or in combination, the combined percentage may be given as a single figure; the limit on quantity shall be expressed either numerically or by the quantum satis principle;

(g) navedba najvišje dovoljene vsebnosti za vsako sestavino ali skupino sestavin, za katero velja količinska omejitev pri uporabi v živilu, in/ali ustreznih informacij, navedenih z jasnimi in razumljivimi izrazi, da se kupcu omogoči ravnanje v skladu s to uredbo ali drugo zadevno zakonodajo Skupnosti; kadar enake količinske omejitve veljajo za skupino sestavin, ki se lahko uporabljajo posamično ali v kombinaciji, se lahko navede le skupni odstotni delež; količinska omejitev se izrazi v številkah ali po načelu quantum satis;

(h) the net quantity;

(h) neto količina;

(i) the date of minimum durability or use-by-date;

(i) datum minimalne trajnosti ali datum uporabe;

(j) where relevant, information on a food additive or other substances referred to in this Article and listed in Annex IIIa to Directive 2000/13/EC as regards the indication of the ingredients present in foodstuffs.

(j) kadar je ustrezno, informacije o aditivu za živila ali drugih snoveh, kakor so navedene v tem členu in naštete v Prilogi IIIa k Direktivi 2000/13/ES v zvezi z navedbo sestavin, ki so prisotne v živilih.

2. Where food additives are sold mixed with each other and/or with other food ingredients, their packaging or containers shall bear a list of all ingredients in descending order of their percentage by weight of the total.

2. Kadar se aditivi za živila prodajajo v mešanici z drugimi aditivi za živila in/ali z drugimi sestavinami živil, so na embalaži ali posodi navedene vse sestavine v padajočem vrstnem redu glede na utežni odstotek celote.

3. Where substances (including food additives or other food ingredients) are added to food additives to facilitate their storage, sale, standardisation, dilution or dissolution, their packaging or containers shall bear a list of all such substances in descending order of their percentage by weight of the total.

3. Kadar so aditivom za živila dodane snovi (vključno z aditivi za živila ali z drugimi sestavinami živil), da se izboljša njihovo shranjevanje, prodaja, standardizacija, razredčenje ali raztapljanje, je na embalaži ali posodi naveden seznam vseh teh sestavin v padajočem vrstnem redu glede na utežni odstotek celote.

4. By way of derogation from paragraphs 1, 2 and 3, the information required in paragraph 1 points (e) to (g) and in paragraphs 2 and 3 may appear merely on the documents relating to the consignment which are to be supplied with or prior to the delivery, provided that the indication "not for retail sale" appears on an easily visible part of the packaging or container of the product in question.

4. Z odstopanjem od odstavkov 1, 2 in 3 se lahko informacije, zahtevane v točkah (e) do (g) odstavka 1 ter v odstavkih 2 in 3, navedejo le v spremnih dokumentih, ki so poslani pred pošiljko ali hkrati z njo, pod pogojem, da je navedba "ni za prodajo na drobno" na dobro vidnem delu embalaže ali posode zadevnega izdelka.

5. By way of derogation from paragraphs 1, 2 and 3, where food additives are supplied in tankers, all of the information may appear merely on the accompanying documents relating to the consignment which are to be supplied with the delivery.

5. Z odstopanjem od odstavkov 1, 2 in 3 se lahko za aditive za živila, ki se pošljejo v cisternah, vse informacije navedejo le v spremnih dokumentih, ki so poslani s pošiljko.

Article 23

Člen 23

Labelling of food additives intended for sale to the final consumer

Označevanje aditivov za živila, namenjenih za prodajo končnemu potrošniku

1. Without prejudice to Directive 2000/13/EC, Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs [32] and Regulation (EC) No 1829/2003, food additives sold singly or mixed with each other and/or other food ingredients intended for sale to the final consumer may be marketed only if their packaging contains the following information:

1. Brez poseganja v Direktivo 2000/13/ES, Direktivo Sveta 89/396/EGS z dne 14. junija 1989 o označbah ali znakih za identifikacijo serije, v katero spada živilo [32], in Uredbo (ES) št. 1829/2003 se aditivi za živila, ki se prodajajo posamično ali v mešanici z drugimi aditivi za živila in/ali z drugimi sestavinami živil in so namenjeni za prodajo končnemu potrošniku, lahko tržijo le, če so na embalaži navedene naslednje informacije:

(a) the name and E-number laid down in this Regulation in respect of each food additive or a sales description which includes the name and E-number of each food additive;

(a) ime in E-številka iz te uredbe za vsak aditiv za živila ali prodajno ime z imenom in E-številko vsakega aditiva za živila;

(b) the statement "for food" or the statement "restricted use in food" or a more specific reference to its intended food use.

(b) navedba "za živila" ali navedba "za omejeno uporaba v živilih" ali podrobnejši opis namena uporabe v živilih.

2. By way of derogation from paragraph 1(a), the sales description of a table-top sweetener shall include the term "… -based table-top sweetener", using the name(s) of the sweetener(s) used in its composition.

2. Z odstopanjem od odstavka 1(a) prodajno ime namiznega sladila vsebuje izraz "… namizno sladilo na osnovi …", pri čemer je(so) navedeno(-a) ime(-na) sladil(-a) v njegovi sestavi.

3. The labelling of a table-top sweetener containing polyols and/or aspartame and/or aspartame-acesulfame salt shall bear the following warnings:

3. Označba namiznega sladila, ki vsebuje poliole in/ali aspartam in/ali sol aspartama-acesulfama, mora imeti naslednje opozorilo:

(a) polyols: "excessive consumption may induce laxative effects";

(a) polioli: "prekomerno uživanje lahko povzroča laksativne učinke";

(b) aspartame/aspartame-acesulfame salt: "contains a source of phenylalanine".

(b) aspartam/sol aspartama-acesulfama: "vsebuje vir fenilalanina".

4. Manufacturers of table-top sweeteners shall make available by appropriate means the necessary information to allow their safe use by consumers. Guidance for the implementation of this paragraph may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3).

4. Proizvajalci namiznih sladil na ustrezen način dajo na voljo informacije, potrebne za njihovo varno uporabo s strani potrošnikov. Smernice za izvajanje tega odstavka se lahko sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 28(3).

5. For the information provided for in paragraphs 1 to 3 of this Article, Article 13(2) of Directive 2000/13/EC shall apply accordingly.

5. Za informacije iz odstavkov 1 do 3 tega člena se smiselno uporablja člen 13(2) Direktive 2000/13/ES.

Article 24

Člen 24

Labelling requirement for foods containing certain food colours

Zahteve za označevanje živil, ki vsebujejo določena barvila za živila

1. Without prejudice to Directive 2000/13/EC, the labelling of food containing the food colours listed in Annex V to this Regulation shall include the additional information set out in that Annex.

1. Brez poseganja v Direktivo 2000/13/ES morajo označbe živil, v katerih so barvila za živila, navedena v Prilogi V te uredbe, vsebovati dodatne informacije, opredeljene v navedeni prilogi.

2. In relation to the information provided in paragraph 1 of this Article, Article 13(2) of Directive 2000/13/EC shall apply accordingly.

2. Za informacije iz odstavka 1 tega člena se ustrezno uporablja člen 13(2) Direktive 2000/13/ES.

3. Where necessary as a result of scientific progress or technical development, Annex V shall be amended by measures, designed to amend non-essential elements of this Regulation, in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).

3. Če je to potrebno zaradi znanstvenega napredka ali tehničnega razvoja se Priloga V spremeni z ukrepi, namenjenimi spreminjanju nebistvenih določb te uredbe, ki se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 28(4).

Article 25

Člen 25

Other labelling requirements

Druge zahteve glede označevanja

Articles 21, 22, 23 and 24 shall be without prejudice to more detailed or more extensive laws, regulations or administrative provisions regarding weights and measures or applying to the presentation, classification, packaging and labelling of dangerous substances and preparations or applying to the transport of such substances and preparations.

Členi 21, 22, 23 in 24 ne posegajo v podrobnejše in obsežnejše zakone ali druge predpise o teži in dimenzijah ali o predstavitvi, razvrstitvi, pakiranju in označevanju nevarnih snovi ter pripravkov ali prevozu takšnih snovi in pripravkov.

CHAPTER V

POGLAVJE V

PROCEDURAL PROVISIONS AND IMPLEMENTATION

POSTOPKOVNE DOLOČBE IN IZVAJANJE

Article 26

Člen 26

Information obligation

Obveznost obveščanja

1. A producer or user of a food additive shall inform the Commission immediately of any new scientific or technical information which might affect the assessment of the safety of the food additive.

1. Proizvajalec ali uporabnik aditiva za živila nemudoma obvesti Komisijo o kakršnih koli novih znanstvenih ali tehničnih informacijah, ki bi lahko vplivale na oceno varnosti aditiva za živila.

2. A producer or user of a food additive shall, at the request of the Commission, inform it of the actual use of the food additive. Such information shall be made available to Member States by the Commission.

2. Proizvajalec ali uporabnik aditiva za živila obvesti Komisijo na njeno zahtevo o dejanski uporabi aditiva za živila. Komisija da te informacije na voljo državam članicam.

Article 27

Člen 27

Monitoring of food additive intake

Spremljanje vnosa aditivov za živila

1. Member States shall maintain systems to monitor the consumption and use of food additives on a risk-based approach and report their findings with appropriate frequency to the Commission and the Authority.

1. Države članice ohranijo sisteme za spremljanje uživanja in uporabe aditivov za živila v skladu z na tveganju temelječim pristopom ter o svojih ugotovitvah v rednih časovnih presledkih poročajo Komisiji in Agenciji.

2. After the Authority has been consulted, a common methodology for the gathering of information by the Member States on dietary intake of food additives in the Community shall be adopted in accordance with the regulatory procedure referred to in Article 28(2).

2. Po posvetovanju z Agencijo se v skladu z regulativnim postopkom iz člena 28(2) sprejme skupna metodologija za zbiranje informacij držav članic o vnosu aditivov za živila z živili v Skupnosti.

Article 28

Člen 28

Committee

Odbor

1. The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health.

1. Komisiji pomaga Stalni odbor za prehranjevalno verigo in zdravje živali.

2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

2. Pri sklicevanju na ta odstavek se uporabljata člena 5 in 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.

The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.

Rok iz člena 5(6) Sklepa 1999/468/ES je tri mesece.

3. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

3. Pri sklicevanju na ta odstavek se uporabljata člen 5a(1) do (4) in člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.

4. Where reference is made to this paragraph, Article 5a(1) to (4) and (5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4. Pri sklicevanju na ta odstavek se uporabljajo člen 5a(1) do (4) in (5)(b) ter člen 7 Sklepa 1999/468/ES, ob upoštevanju določb člena 8 Sklepa.

The time-limits laid down in Article 5a(3)(c) and (4)(b) and (e) of Decision 1999/468/EC shall be 2 months, 2 months and 4 months respectively.

Roki iz člena 5a(3)(c), (4)(b) in (4)(e) Sklepa 1999/468/ES so dva meseca, dva meseca oziroma štiri mesece.

Article 29

Člen 29

Community financing of harmonised policies

Financiranje usklajenih politik s strani Skupnosti

The legal basis for the financing of measures resulting from this Regulation shall be Article 66(1)(c) of Regulation (EC) No 882/2004.

Pravna podlaga za financiranje ukrepov iz te uredbe je člen 66(1)(c) Uredbe (ES) št. 882/2004.

CHAPTER VI

POGLAVJE VI

TRANSITIONAL AND FINAL PROVISIONS

PREHODNE IN KONČNE DOLOČBE

Article 30

Člen 30

Establishment of Community lists of food additives

Uvedba seznamov Skupnosti za aditive za živila

1. Food additives which are permitted for use in foods under Directives 94/35/EC, 94/36/EC and 95/2/EC, as amended on the basis of Article 31 of this Regulation, and their conditions of use shall be entered in Annex II to this Regulation after a review of their compliance with Articles 6, 7 and 8 thereof. The measures relating to the entry of such additives in Annex II, which are designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4). The review shall not include a new risk assessment by the Authority. The review shall be completed by 20 January 2011.

1. Aditivi za živila, ki so dovoljeni za uporabo v živilih v skladu z direktivami 94/35/ES, 94/36/ES in 95/2/ES, kakor se spremenijo na podlagi člena 31 te uredbe, in pogoji za njihovo uporabo se vključijo v Prilogo II k tej uredbi po pregledu njihove skladnosti s členi 6, 7 in 8 te uredbe. Ukrepi v zvezi z vključitvijo teh aditivov v Prilogo II, ki so namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 28(4). Ta pregled ne vključuje nove ocene tveganja, ki jo opravi Agencija. Ta pregled se zaključi do 20. januarja 2011.

Food additives and uses which are no longer needed shall not be entered in Annex II.

Aditivi za živila in uporabe, ki niso več potrebne, se ne vključijo v Prilogo II.

2. Food additives authorised for use in food additives in Directive 95/2/EC and their conditions of use shall be entered in Part 1 of Annex III to this Regulation after a review of their compliance with Article 6 thereof. The measures relating to the entry of such additives in Annex III, which are designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4). The review shall not include a new risk assessment by the Authority. The review shall be completed by 20 January 2011.

2. Aditivi za živila, odobreni za uporabo v aditivih za živila v Direktivi 95/2/ES, in pogoji za njihovo uporabo se vključijo v del 1 Priloge III k tej uredbi po pregledu njihove skladnosti s členom 6 te uredbe. Ukrepi v zvezi z omembo teh aditivov v Prilogi III, ki so namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 28(4). Ta pregled ne vključuje nove ocene tveganja, ki jo opravi Agencija. Ta pregled se zaključi do 20. januarja 2011.

Food additives and uses which are no longer needed shall not be entered in Annex III.

Aditivi za živila in uporabe, ki niso več potrebni, se ne vključijo v Prilogo III.

3. Food additives authorised for use in food flavourings in Directive 95/2/EC and their conditions of use shall be entered in Part 4 of Annex III to this Regulation after a review of their compliance with Article 6 thereof. The measures relating to the entry of such additives in Annex III, which are designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4). The review shall not include a new risk assessment by the Authority. The review shall be completed by 20 January 2011.

3. Aditivi za živila, odobreni za uporabo v aromah za živila v Direktivi 95/2/ES, in pogoji za njihovo uporabo se vključijo v del 4 Priloge III k tej uredbi po pregledu njihove skladnosti s členom 6 te uredbe. Ukrepi v zvezi z omembo teh aditivov v Prilogi III, ki so namenjeni spreminjanju nebistvenih določb te uredbe, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 28(4). Ta pregled ne vključuje nove ocene tveganja, ki jo opravi Agencija. Ta pregled se zaključi do 20. januarja 2011.

Food additives and uses which are no longer needed shall not be entered in Annex III.

Aditivi za živila in uporabe, ki niso več potrebni, se ne vključijo v Prilogo III.

4. Specifications of the food additives covered under paragraphs 1 to 3 of this Article shall be adopted, in accordance with Regulation (EC) No 1331/2008 [establishing a common authorisation procedure for food additives, food enzymes and food flavourings], at the moment those food additives are entered in the Annexes in accordance with those paragraphs.

4. Specifikacije aditivov za živila iz odstavkov 1 do 3 tega člena se v skladu z Uredbo (ES) št. 1331/2008 [o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila] sprejmejo takoj, ko se ti aditivi za živila vključijo v priloge v skladu z navedenima odstavkoma.

5. The measures relating to any appropriate transitional measures, which are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(3).

5. Ukrepi v zvezi s katerimi koli ustreznimi prehodnimi ukrepi za spremembo nebistvenih določb te uredbe, med drugim z njenim dopolnjevanjem, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 28(3).

Article 31

Člen 31

Transitional measures

Prehodni ukrepi

Until the establishment of the Community lists of food additives as provided for in Article 30 is completed, the Annexes to Directives 94/35/EC, 94/36/EC and 95/2/EC shall be amended, where necessary, by measures, designed to amend non-essential elements of those Directives, adopted by the Commission in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).

Dokler seznami Skupnosti aditivov za živila iz člena 30 ne bodo pripravljeni, se priloge k direktivam 94/35/ES, 94/36/ES in 95/2/ES po potrebi spremenijo z ukrepi, ki so namenjeni spreminjanju nebistvenih določb teh direktiv in jih Komisija sprejme v skladu z regulativnim postopkom s pregledom iz člena 28(4).

Foods placed on the market or labelled before 20 January 2010 which do not comply with Article 22(1)(i) and (4) may be marketed until their date of minimum durability or use-by-date.

Živila, dana v promet ali označena pred 20. januarjem 2010, ki niso skladna z določbami člena 22(1)(i) in (4), se lahko tržijo do datuma minimalne trajnosti ali datuma uporabe.

Foods placed on the market or labelled before 20 July 2010 which do not comply with Article 24 may be marketed until their date of minimum durability or use-by-date.

Živila, dana v promet ali označena pred 20. julijem 2010, ki niso skladna z določbami člena 24, se lahko tržijo do datuma minimalne trajnosti ali datuma uporabe.

Article 32

Člen 32

Re-evaluation of approved food additives

Ponovna ocena odobrenih aditivov za živila

1. Food additives which were permitted before 20 January 2009 shall be subject to a new risk assessment carried out by the Authority.

1. Agencija za aditive za živila, ki so bili dovoljeni pred 20. januarjem 2009, izvede novo oceno tveganja.

2. After consultation of the Authority, an evaluation programme for those additives shall be adopted by 20 January 2010, in accordance with the regulatory procedure referred to in Article 28(2). The evaluation programme shall be published in the Official Journal of the European Union.

2. Po posvetovanju z Agencijo se do 20. januarja 2010 sprejme program ocenjevanja za navedene aditive v skladu z regulativnim postopkom iz člena 28(2). Program ocenjevanja se objavi v Uradnem listu Evropske unije.

Article 33

Člen 33

Repeals

Razveljavitve

1. The following acts shall be repealed:

1. Razveljavijo se naslednji akti:

(a) Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorised for use in foodstuffs intended for human consumption;

(a) Direktivo Sveta z dne 23. oktobra 1962 o približevanju zakonodaj držav članic o barvilih, ki se smejo uporabiti v živilih, namenjenih za prehrano ljudi;

(b) Directive 65/66/EEC;

(b) Direktiva 65/66/EGS;

(d) Directive 78/664/EEC;

(d) Direktiva 78/664/EGS;

(e) Directive 81/712/EEC;

(e) Direktiva 81/712/EGS;

(f) Directive 89/107/EEC;

(f) Direktiva 89/107/EGS;

(g) Directive 94/35/EC;

(g) Direktiva 94/35/ES;

(h) Directive 94/36/EC;

(h) Direktiva 94/36/ES;

(i) Directive 95/2/EC;

(i) Direktiva 95/2/ES;

(j) Decision No 292/97/EC;

(j) Odločba št. 292/97/ES;

(k) Decision 2002/247/EC.

(k) Odločba 2002/247/ES.

2. References to the repealed acts shall be construed as references to this Regulation.

2. Sklicevanja na razveljavljene akte se štejejo za sklicevanja na to uredbo.

Article 34

Člen 34

Transitional provisions

Prehodne določbe

By way of derogation from Article 33, the following provisions shall continue to apply until the transfer under Article 30(1), (2) and (3) of this Regulation of food additives already permitted in Directives 94/35/EC, 94/36/EC and 95/2/EC has been completed:

Z odstopanjem od člena 33 se naslednje določbe uporabljajo, dokler se ne zaključi prenos iz člena 30(1), (2) in (3) te uredbe za aditive za živila, ki so že dovoljeni v direktivah 94/35/ES, 94/36/ES in 95/2/ES:

(a) Article 2(1), (2) and (4) of Directive 94/35/EC and the Annex thereto;

(a) člen 2(1), (2) in (4) Direktive 94/35/ES in Priloga k Direktivi;

(b) Article 2(1) to (6), (8), (9) and (10) of Directive 94/36/EC and Annexes I to V thereto;

(b) člen 2(1) do (6), (8), (9) in (10) Direktive 94/36/ES in priloge I do V k Direktivi;

Notwithstanding point (c), the authorisations for E 1103 Invertase and E 1105 Lysozyme laid down in Directive 95/2/EC shall be repealed with effect from the date of application of the Community list on food enzymes in accordance with Article 17 of Regulation (EC) No 1332/2008 [on food enzymes].

Ne glede na točko (c) se odobritve za E 1103 invertaza in E 1105 lizocim iz Direktive 95/2/ES razveljavijo z učinkom od dne začetka uporabe seznama Skupnosti encimov za živila v skladu s členom 17 Uredbe (ES) št. 1332/2008 [o encimih za živila].

Article 35

Člen 35

Entry into force

Začetek veljavnosti

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.

It shall apply from 20 January 2010.

Uporablja se od 20. januarja 2010.

However, Article 4(2) shall apply to Parts 2, 3 and 5 of Annex III from 1 January 2011 and Article 23(4) shall apply from 20 January 2011. Article 24 shall apply from 20 July 2010. Article 31 shall apply from 20 January 2009.

Vendar se člen 4(2) za dele 2, 3 in 5 Priloge III uporablja od 1. januarja 2011, člen 23(4) pa se uporablja od 20. januarja 2011. Člen 24 se uporablja od 20. julija 2010. Člen 31 se uporablja od 20. januarja 2009.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.

Done at Strasbourg, 16 December 2008.

V Strasbourgu, 16. decembra 2008

For the European Parliament

Za Evropski parlament

The President

Predsednik

H.-G. Pöttering

For the Council

Za Svet

The President

Predsednik

B. Le Maire

[1] OJ C 168, 20.7.2007, p. 34.

[1] UL C 168, 20.7.2007, str. 34.

[2] Opinion of the European Parliament of 10 July 2007 (OJ C 175 E, 10.7.2008, p. 142), Council Common Position of 10 March 2008 (OJ C 111 E, 6.5.2008, p. 10), Position of the European Parliament of 8 July 2008 (not yet published in the Official Journal) and Council Decision of 18 November 2008.

[2] Mnenje Evropskega parlamenta z dne 10. julija 2007 (UL C 175 E, 10.7.2008, str. 142), Skupno stališče Sveta z dne 10. marca 2008 (UL C 111 E, 6.5.2008, str. 10), Stališče Evropskega parlamenta z dne 8. julija 2008 (še ni objavljeno v Uradnem listu). Sklep Sveta z dne 18. novembra 2008.

[3] OJ L 186, 30.6.1989, p. 27.

[3] UL L 186, 30.6.1989, str. 27.

[4] See page 7 of this Official Journal.

[4] Glej stran 7 tega Uradnega lista.

[5] OJ L 178, 28.7.1995, p. 1.

[5] UL L 178, 28.7.1995, str. 1.

[6] OJ L 226, 22.9.1995, p. 1.

[6] UL L 226, 22.9.1995, str. 1.

[7] OJ L 339, 30.12.1996, p. 1.

[7] UL L 339, 30.12.1996, str. 1.

[8] See page 1 of this Official Journal.

[8] Glej stran 1 tega Uradnega lista.

[9] OJ L 31, 1.2.2002, p. 1.

[9] UL L 31, 1.2.2002, str. 1.

[10] OJ L 268, 18.10.2003, p. 1.

[10] UL L 268, 18.10.2003, str. 1.

[11] OJ L 93, 31.3.2006, p. 12.

[11] UL L 93, 31.3.2006, str. 12.

[12] OJ L 93, 31.3.2006, p. 1.

[12] UL L 93, 31.3.2006, str. 1.

[13] OJ L 109, 6.5.2000, p. 29.

[13] UL L 109, 6.5.2000, str. 29.

[14] OJ L 268, 18.10.2003, p. 24.

[14] UL L 268, 18.10.2003, str. 24.

[15] OJ L 184, 17.7.1999, p. 23.

[15] UL L 184, 17.7.1999, str. 23.

[16] OJ L 165, 30.4.2004, p. 1. Corrected by OJ L 191, 28.5.2004, p. 1.

[16] UL L 165, 30.4.2004, str. 1. Popravljena različica v UL L 191, 28.5.2004, str. 1.

[17] OJ 115, 11.11.1962, p. 2645/62.

[17] UL 115, 11.11.1962, str. 2645/62.

[18] OJ 22, 9.2.1965, p. 373.

[18] UL 22, 9.2.1965, str. 373.

[19] OJ L 223, 14.8.1978, p. 7.

[19] UL L 223, 14.8.1978, str. 7.

[20] OJ L 223, 14.8.1978, p. 30.

[20] UL L 223, 14.8.1978, str. 30.

[21] OJ L 257, 10.9.1981, p. 1.

[21] UL L 257, 10.9.1981, str. 1.

[22] OJ L 40, 11.2.1989, p. 27.

[22] UL L 40, 11.2.1989, str. 27.

[23] OJ L 237, 10.9.1994, p. 3.

[23] UL L 237, 10.9.1994, str. 3.

[24] OJ L 237, 10.9.1994, p. 13.

[24] UL L 237, 10.9.1994, str. 13.

[25] OJ L 61, 18.3.1995, p. 1.

[25] UL L 61, 18.3.1995, str. 1.

[26] OJ L 48, 19.2.1997, p. 13.

[26] UL L 48, 19.2.1997, str. 13.

[27] OJ L 84, 28.3.2002, p. 69.

[27] UL L 84, 28.3.2002, str. 69.

[28] See page 34 of this Official Journal.

[28] Glej stran 34 tega Uradnega lista.

[29] OJ L 330, 5.12.1998, p. 32.

[29] UL L 330, 5.12.1998, str. 32.

[30] OJ L 268, 24.9.1991, p. 69.

[30] UL L 268, 24.9.1991, str. 69.

[31] OJ L 139, 30.4.2004, p. 55. Corrected by OJ L 226, 25.6.2004, p. 22.

[31] UL L 139, 30.4.2004, str. 55. Popravljena različica v UL L 226, 25.6.2004, str. 22.

[32] OJ L 186, 30.6.1989, p. 21.

[32] UL L 186, 30.6.1989, str. 21.

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ANNEX I

PRILOGA I

Functional classes of food additives in foods and of food additives in food additives and food enzymes

Funkcijski razredi aditivov za živila v živilih ter aditivov za živila v aditivih za živila in encimih za živila:

1. "sweeteners" are substances used to impart a sweet taste to foods or in table-top sweeteners;

1. "sladila" so snovi, ki se uporabljajo za sladkanje živil ali kot namizna sladila;

2. "colours" are substances which add or restore colour in a food, and include natural constituents of foods and natural sources which are normally not consumed as foods as such and not normally used as characteristic ingredients of food. Preparations obtained from foods and other edible natural source materials obtained by physical and/or chemical extraction resulting in a selective extraction of the pigments relative to the nutritive or aromatic constituents are colours within the meaning of this Regulation;

2. "barvila" so snovi, ki dodajo ali obnovijo barvo živila ter vsebujejo naravne sestavine živil in so naravnega izvora ter ki se običajno kot take ne zaužijejo kot živilo in se običajno ne uporabljajo kot tipične sestavine živil. Barvila v smislu te uredbe so pripravki iz živil ter druge užitne izvorne snovi naravnega izvora, pridobljene s fizično in/ali kemično ekstrakcijo, pri čemer gre za selektivno ekstrakcijo pigmentov, povezanih s hranilnimi ali aromatskimi sestavinami;

3. "preservatives" are substances which prolong the shelf-life of foods by protecting them against deterioration caused by micro-organisms and/or which protect against growth of pathogenic micro-organisms;

3. "konzervansi" so snovi, ki podaljšajo rok uporabnosti živil tako, da jih ščitijo pred kvarjenjem, ki ga povzročajo mikroorganizmi, in/ali jih ščitijo pred razvojem patogenih mikroorganizmov;

4. "antioxidants" are substances which prolong the shelf-life of foods by protecting them against deterioration caused by oxidation, such as fat rancidity and colour changes;

4. "antioksidanti" so snovi, ki podaljšajo rok uporabnosti živil tako, da jih ščitijo pred kvarjenjem, ki ga povzroča oksidacija, kot sta žarkost maščob in sprememba barve;

5. "carriers" are substances used to dissolve, dilute, disperse or otherwise physically modify a food additive or a flavouring, food enzyme, nutrient and/or other substance added for nutritional or physiological purposes to a food without altering its function (and without exerting any technological effect themselves) in order to facilitate its handling, application or use;

5. "nosilci" so snovi, ki se uporabljajo za raztapljanje, razredčevanje, razprševanje ali drugo fizikalno spremembo aditiva za živila ali arome, encima za živila, hranila in/ali druge snovi, dodane živilu v hranilne ali fiziološke namene, pri čemer se njegova funkcija (in ne da bi imel sam kakršen koli tehnološki učinek) ne spremeni, z namenom olajšanja ravnanja z njim, njegove uporabe ali rabe;

6. "acids" are substances which increase the acidity of a foodstuff and/or impart a sour taste to it;

6. "kisline" so snovi, ki povečajo kislost živila in/ali mu dajejo kisel okus;

7. "acidity regulators" are substances which alter or control the acidity or alkalinity of a foodstuff;

7. "sredstva za uravnavanje kislosti" so snovi, ki spremenijo ali nadzirajo kislost ali alkalnost živila;

8. "anti-caking agents" are substances which reduce the tendency of individual particles of a foodstuff to adhere to one another;

8. "sredstva proti sprijemanju" so snovi, ki zmanjšujejo težnjo posameznih delcev v živilu, da bi se sprijemali med seboj;

9. "anti-foaming agents" are substances which prevent or reduce foaming;

9. "sredstva proti penjenju" so snovi, ki preprečujejo ali zmanjšujejo nastanek pene;

10. "bulking agents" are substances which contribute to the volume of a foodstuff without contributing significantly to its available energy value;

10. "sredstva za povečanje prostornine" so snovi, ki povečajo prostornino živila, ne da bi bistveno povečale njegovo energetsko vrednost;

11. "emulsifiers" are substances which make it possible to form or maintain a homogenous mixture of two or more immiscible phases such as oil and water in a foodstuff;

11. "emulgatorji" so snovi, ki omogočajo nastanek ali ohranjanje homogene mešanice dveh ali več medsebojno nezdružljivih faz, kot sta olje in voda, v živilu;

12. "emulsifying salts" are substances which convert proteins contained in cheese into a dispersed form and thereby bring about homogenous distribution of fat and other components;

12. "emulgirne soli" so snovi, ki spremenijo beljakovine v siru v razpršeno obliko in tako pripomorejo k homogeni porazdelitvi maščobe in drugih sestavin;

13. "firming agents" are substances which make or keep tissues of fruit or vegetables firm or crisp, or interact with gelling agents to produce or strengthen a gel;

13. "utrjevalci" so snovi, ki omogočajo ali ohranjajo čvrstost sadja ali zelenjave ali v povezavi z želirnimi sredstvi tvorijo ali utrdijo žele;

14. "flavour enhancers" are substances which enhance the existing taste and/or odour of a foodstuff;

14. "ojačevalci arome" so snovi, ki izboljšajo obstoječi okus in/ali vonj živila;

15. "foaming agents" are substances which make it possible to form a homogenous dispersion of a gaseous phase in a liquid or solid foodstuff;

15. "sredstva za penjenje" so snovi, ki omogočajo homogeno razpršitev plinaste faze v tekočem ali v trdem živilu;

16. "gelling agents" are substances which give a foodstuff texture through formation of a gel;

16. "želirna sredstva" so snovi, ki dajejo živilu teksturo s tvorbo želeja;

17. "glazing agents" (including lubricants) are substances which, when applied to the external surface of a foodstuff, impart a shiny appearance or provide a protective coating;

17. "sredstva za glaziranje" so snovi (vključno z mazivi), ki dajejo živilu lesk ali tvorijo zaščitno oblogo na njegovi zunanji površini;

18. "humectants" are substances which prevent foods from drying out by counteracting the effect of an atmosphere having a low degree of humidity, or promote the dissolution of a powder in an aqueous medium;

18. "sredstva za ohranjanje vlage" so snovi, ki preprečujejo izsušitev živil pri nizki vlažnosti zraka ali pospešujejo raztapljanje praška v vodi;

19. "modified starches" are substances obtained by one or more chemical treatments of edible starches, which may have undergone a physical or enzymatic treatment, and may be acid or alkali thinned or bleached;

19. "modificirani škrobi" so snovi, pridobljene z enim ali več kemičnimi postopki iz jedilnega škroba, ki je bil lahko izpostavljen fizikalnim ali encimatskim postopkom in ki je lahko beljen ali razredčen s kislino ali lugom;

20. "packaging gases" are gases other than air, introduced into a container before, during or after the placing of a foodstuff in that container;

20. "plini za pakiranje" so plini, razen zraka, ki se dovajajo v embalažo pred namestitvijo živila v navedeno embalažo, med njo ali po njej;

21. "propellants" are gases other than air which expel a foodstuff from a container;

21. "potisni plini" so plini, razen zraka, ki potisnejo živilo iz embalaže;

22. "raising agents" are substances or combinations of substances which liberate gas and thereby increase the volume of a dough or a batter;

22. "sredstva za vzhajanje" so snovi ali njihove kombinacije, ki sproščajo plin in tako povečajo prostornino različnih vrst testa;

23. "sequestrants" are substances which form chemical complexes with metallic ions;

23. "veziva" so snovi, ki tvorijo kemične komplekse s kovinskimi ioni;

24. "stabilisers" are substances which make it possible to maintain the physico-chemical state of a foodstuff; stabilisers include substances which enable the maintenance of a homogenous dispersion of two or more immiscible substances in a foodstuff, substances which stabilise, retain or intensify an existing colour of a foodstuff and substances which increase the binding capacity of the food, including the formation of cross-links between proteins enabling the binding of food pieces into re-constituted food;

24. "stabilizatorji" so snovi, ki vzdržujejo fizikalno-kemično stanje živila; stabilizatorji vključujejo snovi, ki vzdržujejo homogeno razpršenost dveh ali več snovi, ki se v živilu med seboj ne mešajo, snovi, ki stabilizirajo, ohranijo ali poudarijo obstoječo barvo živila, ter snovi, ki povečajo sposobnost vezave živil, vključno z nastankom navzkrižnih povezav med beljakovinami, ki omogočajo vezavo delcev živil v rekonstituiranih živilih;

25. "thickeners" are substances which increase the viscosity of a foodstuff;

25. "sredstva za zgostitev (gostila)" so snovi, ki povečujejo viskoznost živila;

26. "flour treatment agents" are substances, other than emulsifiers, which are added to flour or dough to improve its baking quality.

26. "sredstva za obdelavo moke" so snovi, razen emulgatorjev, ki so dodane moki ali testu za izboljšanje njunih pecilnih lastnosti.

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ANNEX II

PRILOGA II

Community list of food additives approved for use in foods and conditions of use.

Seznam Skupnosti aditivov za živila, odobrenih za uporabo v živilih, in pogoji uporabe

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ANNEX III

PRILOGA III

Community list of food additives approved for use in food additives, food enzymes and food flavourings, and their conditions of use.

Seznam Skupnosti aditivov za živila, odobrenih za uporabo v aditivih za živila, encimih za živila in aromah za živila, ter pogoji uporabe.

Community list of carriers in nutrients and their conditions of use.

Seznam Skupnosti nosilcev v hranilih ter pogoji uporabe

Part 1 | Carriers in food additives |

Del 1 | Nosilci v aditivih za živila |

Part 2 | Food additives other than carriers in food additives |

Del 2 | Aditivi za živila, razen nosilcev v aditivih za živila |

Part 3 | Food additives including carriers in food enzymes |

Del 3 | Aditivi za živila, vključno z nosilci v encimih za živila |

Part 4 | Food additives including carriers in food flavourings |

Del 4 | Aditivi za živila, vključno z nosilci v aromah za živila |

Part 5 | Carriers in nutrients and other substances added for nutritional and/or for other physiological purposes |

Del 5 | Nosilci v hranilih ter druge snovi, dodane v hranilne in/ali druge fiziološke namene |

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ANNEX IV

PRILOGA IV

Traditional foods for which certain Member States may continue to prohibit the use of certain categories of food additives

Tradicionalna živila, za katera lahko nekatere države članice še naprej prepovedujejo uporabo nekaterih kategorij aditivov za živila

Member State | Foods | Categories of additives which may continue to be banned |

Država članica | Živila | Kategorije aditivov, ki so lahko še naprej prepovedane |

Germany | Traditional German beer (Bier nach deutschem Reinheitsgebot gebraut) | All except propellant gases |

Nemčija | tradicionalno nemško pivo ("Bier nach deutschem Reinheitsgebot gebraut") | vse razen potisnih plinov |

France | Traditional French bread | All |

Francija | tradicionalni francoski kruh | vse |

France | Traditional French preserved truffles | All |

Francija | tradicionalne francoske konzervirane gomoljike | vse |

France | Traditional French preserved snails | All |

Francija | tradicionalni francoski konzervirani polži | vse |

France | Traditional French goose and duck preserves (confit) | All |

Francija | tradicionalne francoske gosje in račje konzerve ("confit") | vse |

Austria | Traditional Austrian "Bergkäse" | All except preservatives |

Avstrija | tradicionalni avstrijski "Bergkäse" | vse razen konzervansov |

Finland | Traditional Finnish "Mämmi" | All except preservatives |

Finska | tradicionalni finski "Mämmi" | vse razen konzervansov |

Sweden Finland | Traditional Swedish and Finnish fruit syrups | Colours |

Švedska Finska | tradicionalni švedski in finski sadni sirupi | barvila |

Denmark | Traditional Danish "Kødboller" | Preservatives and colours |

Danska | tradicionalni danski "Kødboller" | konzervansi in barvila |

Denmark | Traditional Danish "Leverpostej" | Preservatives (other than sorbic acid) and colours |

Danska | tradicionalni danski "Leverpostej" | konzervansi (razen sorbinske kisline) in barvila |

Spain | Traditional Spanish "Lomo embuchado" | All except preservatives and antioxidants |

Španija | tradicionalni španski "Lomo embuchado" | vse razen konzervansov in antioksidantov |

Italy | Traditional Italian "Mortadella" | All except preservatives, antioxidants, pH-adjusting agents, flavour enhancers, stabilisers and packaging gas |

Italija | tradicionalna italijanska "Mortadella" | vse razen konzervansov, antioksidantov, sredstev za uravnavanje kislosti, ojačevalcev arome, stabilizatorjev in plina za pakiranje |

Italy | Traditional Italian "Cotechino e zampone" | All except preservatives, antioxidants, pH-adjusting agents, flavour enhancers, stabilisers and packaging gas |

Italija | tradicionalni italijanski "Cotechino e zampone" | vse razen konzervansov, antioksidantov, sredstev za uravnavanje kislosti, ojačevalcev arome, stabilizatorjev in plina za pakiranje |

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ANNEX V

PRILOGA V

List of the food colours referred to in Article 24 for which the labelling of foods shall include additional information

Barvila za živila iz člena 24, za katera je treba pri označevanju živil navesti dodatne informacije

Foods containing one or more of the following food colours | Information |

Živila, ki vsebujejo eno ali več naslednjih barvil za živila | Informacije |

Sunset yellow (E 110) [*] | "name or E number of the colour(s)": may have an adverse effect on activity and attention in children. |

oranžno FCF (E 110) [*] | "ime ali številka E barvil(a)": lahko škodljivo vpliva na aktivnost in pozornost otrok |

Quinoline yellow (E 104) [*] |

kinolinsko rumeno (E 104) [*] |

Carmoisine (E 122) [*] |

karmoizin (E 122) [*] |

Allura red (E 129) [*] |

rdeče AC (E129) [*] |

Tartrazine (E 102) [*] |

tartrazin (E 102) [*] |

Ponceau 4R (E 124) [*] |

rdeče R4 (E 124) [*] |

[*] With the exception of foods where the colour(s) has been used for the purposes of health or other marking on meat products or for stamping or decorative colouring on eggshells.

[*] z izjemo živil, pri katerih je bilo barvilo uporabljeno za označevanje zdravstvene ustreznosti in drugih označevanj, ki so potrebna za mesne izdelke, ter žigosanja ali okrasnega barvanja jajčnih lupin.

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