natgillin/translations-raw huggingface dataset:
The measures provided for in this Recommendation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
Ukrepi, predvideni s tem priporočilom, so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali –
For the distinction between feed materials, feed additives and other kinds of products the guidelines provided in the Annex to this Recommendation should be taken into account.
Za ločevanje med posamičnimi krmili, krmnimi dodatki in drugimi vrstami proizvodov je treba upoštevati smernice iz Priloge k temu priporočilu.
GUIDELINES FOR THE DISTINCTION BETWEEN FEED MATERIALS, FEED ADDITIVES AND OTHER PRODUCTS
SMERNICE ZA LOČEVANJE MED POSAMIČNIMI KRMILI, KRMNIMI DODATKI IN DRUGIMI PROIZVODI
These guidelines are intended to assist the national competent authorities and the feed business operators to enforce and to apply the relevant legislation.
Namen teh smernic je pomagati pristojnim nacionalnim organom ter nosilcem dejavnosti poslovanja s krmo pri zagotavljanju izvajanja zadevne zakonodaje in njeni uporabi.
They are based on the provisions laid down in the legislative framework governing the different kinds of products concerned, with a particular view to the definitions of these products provided therein, in order to identify indications for a distinction between the product types.
Temeljijo na določbah zakonodajnega okvira, ki ureja različne vrste zadevnih proizvodov, s posebnim poudarkom na opredelitvah teh proizvodov iz zakonodajnega okvira, da se ugotovijo znaki za ločevanje med vrstami proizvodov.
For any product, the criteria proposed for the distinction between the different kinds of products should not be applied subsequently but simultaneously in order to create a profile of each specific product, taking into account all its characteristics.
Merila, predlagana za ločevanje med različnimi vrstami proizvodov, se za vsak proizvod ne smejo uporabiti naknadno ampak hkrati, da se ustvari profil za vsak posamezni proizvod ob upoštevanju vseh njegovih lastnosti.
None of the criteria can be used exclusively or takes precedence over another.
Nobeno merilo se ne sme uporabiti izključno ali imeti prednosti pred drugim merilom.
Analogy with other products cannot be used as a discriminatory criterion but may be helpful to review a decision already made based on the application of the established criteria.
Podobnost z drugimi proizvodi se ne sme uporabiti kot diskriminatorno merilo, vendar lahko koristi pri pregledu že sprejete odločitve na podlagi uporabe že vzpostavljenih meril.
However, it can also be used to check for consistency.
Uporabi se lahko tudi za preverjanje doslednosti.
Feed legislation
Zakonodaja o krmi
Legal texts
Pravna besedila
The following definitions can be found in the relevant legislation:
V zadevni zakonodaji so navedene naslednje opredelitve pojmov:
Article 3(4) of Regulation (EC) No 178/2002 [1]:‘feed’
člen 3(4) Uredbe (ES) št. 178/2002 [1]:„krma“
any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals.
vse snovi ali izdelki, vključno z aditivi, predelani, delno predelani ali nepredelani, ki se uporabljajo za krmljenje živali.
Following on from this broad definition of feed, recital 3 of Regulation (EC) No 767/2009 states that ‘feed may take the form of feed materials, compound feed, feed additives, premixtures or medicated feedingstuffs.’
Na podlagi te široke opredelitve pojma krme uvodna izjava 3 Uredbe (ES) št. 767/2009 nadalje navaja: „Krma je lahko v obliki posamičnih krmil, krmnih mešanic, krmnih dodatkov, premiksov ali medicirane krme.“
Article 3(2) of Regulation (EC) No 767/2009:
člen 3(2) Uredbe (ES) št. 767/2009:
‘feed materials’
„posamična krmila“
products of vegetable or animal origin, whose principal purpose is to meet animals’ nutritional needs, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether or not containing feed additives, which are intended for use in oral animal-feeding either directly as such, or after processing, or in the preparation of compound feed, or as carrier of premixtures;
sveži ali konzervirani proizvodi rastlinskega ali živalskega izvora v naravnem stanju, namenjeni predvsem za zadostitev živalskih prehranskih potreb, in proizvodi, ki so pridobljeni z industrijsko obdelavo, ter organske ali anorganske snovi s krmnimi dodatki ali brez njih za oralno krmljenje živali, bodisi kot takšne bodisi po obdelavi, ali za pripravo krmnih mešanic ali kot nosilna snov za premikse;
‘carrier’
„nosilec“
a substance used to dissolve, dilute, disperse or otherwise physically modify a feed additive in order to facilitate its handling, application or use without altering its technological function and without exerting any technological effect itself;
snov, ki se uporablja za raztopitev, razredčitev, razpršitev ali drugo fizikalno spremembo krmnega dodatka, da olajša ravnanje z njim, njegovo dajanje ali uporabo brez spreminjanja njegove tehnološke funkcije in ki ne povzroča nobenih tehnoloških učinkov;
‘feed intended for particular nutritional purposes’
„krma za posebne prehranske namene“
feed which can satisfy a particular nutritional purpose by virtue of its particular composition or method of manufacture, which clearly distinguishes it from ordinary feed.
krma, ki lahko zadosti posebne prehranske potrebe zaradi svoje posebne sestave ali metode proizvodnje, ki jo jasno loči od običajne krme.
‘oral feeding of animals’
„oralno krmljenje živali“
the introduction of feed into an animal’s gastrointestinal tract through the mouth with the aim of meeting the animal’s nutritional needs and/or maintaining the productivity of normally healthy animals.
vnos krmil v prebavni trakt živali prek ust, da se zadosti prehranskim potrebam živali in/ali ohrani produktivnost navadno zdravih živali;
Article 2(2)(a) of Regulation (EC) No 1831/2003 [2]:‘feed additives’
člen 2(2)(a) Uredbe (ES) št. 1831/2003 [2]:„krmni dodatki“
substances, micro-organisms or preparations, other than feed material and premixtures, which are intentionally added to feed or water in order to perform, in particular, one or more specific functions that are enumerated in Article 5(3) of the Regulation:
snovi, mikroorganizmi ali pripravki, ki niso posamična krmila niti premiksi in se namenoma dodajajo krmi ali vodi, da bi izpolnili eno ali več funkcij, navedenih v členu 5(3) Uredbe:
favourably affect the characteristics of feed;
ugodno vplivati na lastnosti krme;
favourably affect the characteristics of animal products;
ugodno vplivati na lastnosti živalskih proizvodov;
favourably affect the colour of ornamental fish and birds;
ugodno vplivati na barvo okrasnih ribic in ptic;
satisfy the nutritional needs of animals;
izpolnjevati prehranske potrebe živali;
favourably affect the environmental consequences of animal production;
ugodno vplivati na okoljske posledice reje živali;
favourably affect animal production, performance or welfare, particularly by affecting the gastro-intestinal flora or digestibility of feedingstuffs; or
ugodno vplivati na rejo, prirejo ali dobro počutje živali, zlasti z vplivom na želodčno-črevesno floro ali prebavljivost krme, ali
have a coccidiostatic or histomonostatic effect.
imeti kokcidiostatični ali histomonostatični učinek.
Article 2(2)(h) of Regulation (EC) No 1831/2003:
člen 2(2) Uredbe (ES) št. 1831/2003:
‘processing aids’
„pomožna tehnološka sredstva“
any substance not consumed as a feedingstuff by itself, intentionally used in the processing of feedingstuffs or feed materials to fulfil a technological purpose during treatment or processing which may result in the unintentional but technologically unavoidable presence of residues of the substance or its derivatives in the final product, provided that these residues do not have an adverse effect on animal health, human health or the environment and do not have any technological effects on the finished feed.
kakršne koli snovi, ki niso zaužite kot krma sama po sebi in se namenoma uporabljajo pri predelavi krme ali posamičnih krmil, da služijo tehnološkemu namenu med obdelavo ali predelavo, ki lahko povzroči nenamensko, vendar neizogibno prisotnost ostankov snovi ali njenih derivatov v končnem proizvodu, pod pogojem, da ti ostanki ne škodijo zdravju ljudi in živali ali okolju in da nimajo nobenih tehnoloških vplivov na končno krmo.
Moreover, recital 11 of Regulation (EC) No 767/2009 reads as follows: ‘(…).
Poleg tega se uvodna izjava 11 Uredbe (ES) št. 767/2009 glasi: „[…].
(…)’
[…].“
Consequences for the distinction between feed materials and feed additives
Posledice za ločevanje med posamičnimi krmili in krmnimi dodatki
Derivation from the legal texts
Izpeljava iz pravnih besedil
‘Feed additives are substances (…) other than feed material’
„krmni dodatki pomenijo snovi […], ki niso posamična krmila“
A product cannot be a feed material and a feed additive at the same time,
proizvod ne more biti hkrati posamično krmilo in krmni dodatek,
‘Animals’ nutritional needs’
„živalske prehranske potrebe“
It is not possible to indicate an exhaustive list of relevant elements but the following characteristics of feed materials can be considered to be the most important:
izčrpnega seznama zadevnih elementov ni mogoče navesti, vendar se za najpomembnejše lahko štejejo naslednje lastnosti posamičnih krmil:
to supply energy, nutrients, minerals or dietary fibre; and
zagotavljanje energije, hranil, mineralov ali prehranskih vlaknin in
to maintain the function of the intestinal tract,
ohranjanje delovanja prebavnega trakta,
‘Principal purpose is to meet animals’ nutritional needs’ and ‘primarily used to meet animals’ needs’
„namenjeni predvsem za zadostitev živalskih prehranskih potreb“ in „se uporabljajo primarno za zadostitev potreb živali“
Apart from the usual primary function of delivering nutrients to the animal, feed materials can have other purposes, for example if they are used as carriers or if they are not digestible in the animals' intestinal tract.
poleg običajne osnovne funkcije zagotavljanja hranil živalim imajo posamična krmila lahko druge namene, na primer če se uporabijo kot nosilne snovi ali če niso prebavljive v prebavnem traktu živali.
This is in line with the aims of ‘oral feeding’ (‘meeting the animal’s nutritional needs and/or maintaining the productivity of normally healthy animals’) which corresponds to the primary intended use according to the ‘feed’ definition.
To je v skladu s cilji „oralnega krmljenja“ („da se zadosti prehranskim potrebam živali in/ali ohrani produktivnost navadno zdravih živali“), kar ustreza osnovni predvideni uporabi v skladu z opredelitvijo pojma „krma“.
Criteria to be simultaneously considered in a case-by-case evaluation
Merila, ki jih je treba upoštevati hkrati pri ocenjevanju vsakega posameznega primera
Production and processing method — chemical definition and level of standardisation or purification Products of vegetable or animal origin in their natural state, fresh or preserved, and products derived from the simple processing thereof, as well as organic or inorganic substances can be considered feed materials (e.g. fatty acids or calcium carbonate).
Metoda pridelave in predelave – kemijska definicija in stopnja standardizacije ali čiščenja sveži ali konzervirani proizvodi rastlinskega ali živalskega izvora v naravnem stanju, proizvodi, ki so pridobljeni z enostavnimi postopki predelave, ter organske ali anorganske snovi se lahko štejejo za posamična krmila (na primer maščobne kisline ali kalcijev karbonat).
Chemically well-defined substances that are purified and give a certain level of standardisation guaranteed by the manufacturer might qualify as feed additives (e.g. aromatic oil specifically extracted from plant material).
Kemično natančno opredeljene snovi, ki so očiščene in dajejo določeno stopnjo standardizacije, ki jo zagotavlja proizvajalec, se lahko štejejo za krmne dodatke (npr. aromatično olje, posebej pridobljeno iz rastlinskega materiala).
Nonetheless, certain feed materials are chemically well-defined substances and standardised (e.g. sucrose).
Kljub temu so nekatera posamična krmila kemično natančno opredeljene snovi in so standardizirana (npr. saharoza).
On the other hand, natural products of whole plants and parts of these or products thereof resulting from a limited physical processing such as crushing, grinding or drying would be feed materials.
Po drugi strani se za posamična krmila lahko štejejo naravni proizvodi iz celih rastlin in njihovih delov ali proizvodi iz njih, ki nastanejo z omejeno fizikalno predelavo, kot je trenje, drobljenje ali sušenje.
Safety and mode of use If for reasons of animal or human health it is necessary to set a maximum content of the product in the daily ration the products qualify for classification as additive.
Varnost in način uporabe če je zaradi zdravja živali ali ljudi treba določiti najvišjo vsebnost proizvoda v dnevnem obroku, proizvodi izpolnjujejo pogoje za razvrstitev kot dodatek.
However, also for certain feed materials maximum inclusion rates apply.
Vendar veljajo najvišje stopnje vključitve tudi za nekatera posamična krmila.
Feed additive status might offer improved scope for effective management of the product in terms of stability, homogeneity and with respect to over-dosage.
Status krmnega dodatka bi lahko omogočil izboljšan obseg uporabe za učinkovito upravljanje proizvoda z vidika stabilnosti, homogenosti in prevelikega odmerjanja.
Feed additives are usually used at low incorporation rates.
Krmni dodatki se običajno uporabljajo pri nizkih stopnjah vključenosti.
However, many feed materials, such as mineral salts, are also used at low incorporation rates in the feed ration.
Vendar se tudi številna posamična krmila, na primer mineralne soli, uporabljajo pri nizkih stopnjah vključenosti v obroku krmil.
Functionality Feed additives are defined by their functions as laid down in Article 5(3) of Regulation (EC) No 1831/2003.
Funkcije krmni dodatki so opredeljeni glede na svoje funkcije iz člena 5(3) Uredbe (ES) št. 1831/2003.
However, these functions are not exclusive to feed additives.
Vendar te funkcije ne veljajo izključno za krmne dodatke.
Thus, a feed material can also exert an additive function (e.g. as a thickener) but this should not be the only intended use.
Tako lahko posamično krmilo opravlja tudi funkcijo dodatka (npr. kot sredstvo za zgoščevanje).
Biocidal products
Biocidni pripravki
Article 2(1) of Directive 98/8/EC [3]:‘biocidal products’
člen 2(1) Direktive 98/8/ES [3]:„biocidni pripravki“
active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means;
aktivne snovi in pripravki, ki vsebujejo eno ali več aktivnih snovi, pripravljeni v obliki, v kakršni se dobavljajo uporabniku, in predvideni, da se z njimi uničuje, odvrača, naredi neškodljivo, prepreči delovanje ali kako drugače vpliva na škodljivi organizem na kemičen ali biološki način;
‘active substance’
„aktivna snov“
a substance or micro-organism including a virus or a fungus having general or specific action on or against harmful organisms;
snov ali mikroorganizem, tudi virus ali gliva, s splošnim ali posebnim delovanjem na škodljive organizme ali proti njim;
‘harmful organism’
„škodljiv organizem“
any organism which has an unwanted presence or a detrimental effect for humans, their activities or the products they use or produce, or for animals or for the environment.
vsak organizem, katerega prisotnost je nezaželena ali ki ima škodljiv učinek na človeka ali njegove dejavnosti ali na proizvode, ki jih uporablja ali proizvaja, ali pa na živali ali okolje.
Point 1(a) of Annex I to Regulation (EC) No 1831/2003:
točka 1(a) Priloge I k Uredbi (ES) št. 1831/2003:
‘preservatives’
„konzervansi“
substances or, when applicable, micro-organisms which protect feed against deterioration caused by micro-organisms or their metabolites.
so snovi ali, kadar se uporabljajo, mikroorganizmi, ki ščitijo krmo pred kvarjenjem, ki ga povzročajo mikroorganizmi in njihovi metaboliti.
Article 1(2) of Directive 98/8/EC provides for the following:
člen 1(2) Direktive 98/8/ES določa:
‘This Directive shall apply to biocidal products as defined in Article 2(1)(a) but shall exclude products that are defined or within the scope of the following instruments for the purposes of these Directives:
„Ta direktiva se uporablja za biocidne pripravke, kot so opredeljeni v členu 2(1)(a), ne vključuje pa pripravkov, ki so opredeljeni v ali jih obsegajo naslednji instrumenti za potrebe teh direktiv:
Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs, Council Directive 82/471/EEC of 30 June 1982 on certain products used in animal nutrition and Council Directive 77/101/EEC of 23 November 1976 on the marketing of straight feedingstuffs,
Direktiva Sveta 70/524/EGS z dne 23. novembra 1970 o dodatkih v krmi, Direktiva Sveta 82/471/EGS z dne 30. junija 1982 o posebnih proizvodih, ki se uporabljajo v prehrani živali, in Direktiva Sveta 77/101/EGS z dne 23. novembra 1976 o trženju posamičnih krmil,
Annex V to Directive 98/8/EC contains an exhaustive list of 23 product types with an indicative set of descriptions within each type, including the following feed related product types:
Priloga V k Direktivi 98/8/ES vsebuje izčrpen seznam 23 vrst pripravkov z opisom posameznih vrst, vključno z naslednjimi vrstami izdelkov v zvezi s krmo:
Product-type 3 Veterinary hygiene biocidal products: Products in this group are biocidal products used for veterinary hygiene purposes including products used in areas in which animals are housed, kept or transported.
vrsta izdelkov veterinarsko higienski biocidni pripravki: Izdelki v tej skupini so biocidni pripravki, ki se uporabljajo za veterinarsko higienske namene, vključno s pripravki, ki se uporabljajo v območjih, kjer so živali nastanjene, kjer začasno bivajo ali na sredstvih za prevoz.
Product-type 4 Food and feed area disinfectants: Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food, feed or drink (including drinking water) for humans and animals.
vrsta izdelkov dezinfekcijska sredstva za območja s hrano in krmo: Pripravki, ki se uporabljajo za razkuževanje opreme, posod, posod za hrano, orodja, površin ali cevovodov, ki so povezani s proizvodnjo, prevozom, skladiščenjem ali uživanjem hrane, krme ali pijač (vključno s pitno vodo) za ljudi in živali.
Product-type 5 Drinking water disinfectants: Products used for the disinfection of drinking water (for both humans and animals).
vrsta izdelkov sredstva za razkuževanje pitne vode: Pripravki, ki se uporabljajo za razkuževanje pitne vode (za ljudi in živali).
Product-type 20 Preservatives for food or feedstocks: Products used for the preservation of food or feedstocks by the control of harmful organisms.
vrsta izdelkov konzervansi za hrano ali krmo: Pripravki, ki se uporabljajo za konzerviranje hrane ali krme z nadzorom škodljivih organizmov.
Consequences for the distinction between feed and biocidal products
Posledice za ločevanje med krmo in biocidnimi pripravki
By virtue of Article 1(2) of Directive 98/8/EC, products that are defined or that fall under the scope of the feed legislation, including processing aids, are no biocidal products but are to be considered as feed (Precedence of the feed legislation over the legislation on biocidal products).
V skladu s členom 1(2) Direktive 98/8/ES proizvodi, ki so opredeljeni v zakonodaji o krmi ali so njen predmet, vključno s pomožnimi tehnološkimi sredstvi, niso biocidni pripravki, ampak se štejejo za krmo (prednost zakonodaje o krmi pred zakonodajo o biocidnih pripravkih).
Products in products types 3 and 4, as set out in Annex V to Directive 98/8/EC, are not considered to be feed.
Proizvodi, ki sodijo v 3. in 4. vrsto izdelkov iz Priloge V k Direktivi 98/8/ES, se ne štejejo za krmo.
However, certain products could qualify for product types 5 or 20 and also be considered as feed, usually feed additives.
Vendar bi se nekateri proizvodi lahko uvrstili v 5. ali 20. vrsto izdelkov ter se tudi lahko šteli za krmo, običajno za krmne dodatke.
Due to the above mentioned precedence of feed legislation over biocidal product legislation, such products are to be considered feed.
Zaradi navedene prednosti zakonodaje o krmi pred zakonodajo o biocidnih pripravkih se taki proizvodi štejejo za krmo.
Products to preserve feed or water for animals are not biocidal products.
Proizvodi, ki ohranjajo krmo in vodo za živali, niso biocidni pripravki.
If such products are listed in product type 5 or 20, they are not intended to be administered to animals.
Če so taki proizvodi uvrščeni v 5. ali 20. vrsto izdelkov, njihova uporaba ni predvidena za živali.
Veterinary medicinal products (VMPs)
Zdravila za uporabo v veterinarski medicini
Article 1 of Directive 2001/82/EC [4]:‘veterinary medicinal product’
člen 1 Direktive 2001/82/ES [4]:„zdravilo za uporabo v veterinarski medicini“
any substance or combination of substances presented as having properties for treating or preventing disease in animals; or
vsaka snov ali kombinacija snovi, ki so predstavljene z lastnostmi za zdravljenje ali preprečevanje bolezni pri živalih, ali
any substance or combination of substances which may be used in or administered to animals with a view either to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;
vsaka snov ali kombinacija snovi, ki se uporablja za živali ali se daje z namenom, da bi se ponovno vzpostavile, izboljšale ali spremenile fiziološke funkcije pri živalih s pomočjo farmakološkega, imunološkega ali metaboličnega delovanja ali da bi se določila medicinska diagnoza.
‘medicated feedingstuffs’
„medicirana krma“
any mixture of a veterinary medicinal product or products and feed or feeds which is ready prepared for marketing and intended to be fed to animals without further processing, because of its curative or preventive properties or other properties as a medicinal product covered by the definition ‘veterinary medicinal product’.
vsaka mešanica zdravila ali zdravil za uporabo v veterinarski medicini in krme ali krme, ki je pripravljena za prodajo in namenjena krmljenju živali brez nadaljnje predelave, zaradi kurativnih ali preventivnih lastnosti ali drugih lastnosti zdravil, zajetih v opredelitvi pojma „zdravilo za uporabo v veterinarski medicini“.
Article 2(2) of Directive 2001/82/EC provides for the following:
člen 2(2) Direktive 2001/82/ES določa:
Article 3(1) of the same Directive provides for the following:
člen 3(1) navedene direktive določa naslednje:
‘This Directive shall not apply to:
„Ta direktiva se ne uporablja za:
medicated feedingstuffs as defined in Council Directive 90/167/EEC of 26 March 1990 laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community;
medicinirano krmo, opredeljeno z Direktivo Sveta 90/167/EGS z dne 26. marca 1990 o pogojih za pripravo, dajanje v promet in uporabo medicinirane krme v Skupnosti;
any additives covered by Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs, where they are incorporated in animal feedingstuffs and supplementary animal feedingstuffs in accordance with that Directive;
katere koli dodatke, vključene v Direktivo Sveta 70/524/EGS z dne 23. novembra 1970 o dodatkih v krmi, če so vključeni v živalsko krmo ter nadomestno krmo v skladu s to direktivo,
Article 13(3) of Regulation (EC) No 767/2009 reads as follows:
člen 13(3) Uredbe (ES) št. 767/2009 se glasi:
‘The labelling or the presentation of feed materials and compound feed shall not claim that:
„Označevanje ali predstavljanje posamičnih krmil in krmne mešanice ne sme obsegati trditev:
Consequences for the distinction between feed and VMPs
Posledice za ločevanje med krmo in zdravili za uporabo v veterinarski medicini