natgillin/translations-raw huggingface dataset:
(except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)
(razen za pripravke, ki vsebujejo več kot eno aktivno snov, za katere je rok za uskladitev s členom 16(3) enak roku, določenem v zadnji odločbi o vključitvi njegove aktivne snovi)
Expiry date of inclusion
Datum izteka veljavnosti vključitve
Specific provisions [1]
Posebne določbe [1]
sulfuryl fluoride
sulfuril fluorid
sulfuryl difluoride
sulfuril difluorid
EC No: 220-281-5
Št. ES: 220-281-5
CAS No: 2699-79-8
Št. CAS: 2699-79-8
1 January 2009
januar 2009
31 December 2010
december 2010
31 December 2018
december 2018
Member States shall ensure that authorisations are subject to the following conditions:
Države članice zagotovijo, da so za izdajo dovoljenj izpolnjeni naslednji pogoji:
the product may only be sold to and used by professionals trained to use it;
pripravek se lahko prodaja samo strokovnjakom, usposobljenim za njegovo uporabo, ki ga edini lahko uporabljajo;
appropriate risk mitigation measures are included for operators and bystanders;
predvideni so ustrezni ukrepi za zmanjšanje tveganja za delavce/uporabnike in druge navzoče osebe;
concentrations of sulfuryl fluoride in remote tropospheric air are monitored.
nadzorujejo se koncentracije sulfuril fluorida v oddaljenem troposferskem ozračju.
Member States shall also ensure that reports of the monitoring referred to in point (3) are transmitted by authorisation holders directly to the Commission every fifth year starting from 1 January 2009.
Države članice tudi zagotovijo, da imetniki dovoljenj pošljejo poročila nadzora iz točke (3) vsakih pet let, z začetkom 1. januarja 2009, neposredno Komisiji.
For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm’
Za izvajanje splošnih načel Priloge VI so vsebina in sklepne ugotovitve poročil o oceni na voljo na naslednji spletni strani Komisije: http://ec.europa.eu/comm/environment/biocides/index.htm“
Commission Directive 2006/141/EC
Direktiva Komisije 2006/141/ES
on infant formulae and follow-on formulae and amending Directive 1999/21/EC
o začetnih formulah za dojenčke in nadaljevalnih formulah za dojenčke in majhne otroke in o spremembi Direktive 1999/21/ES
Having regard to 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 [1], and in particular Article 4(1) thereof,
ob upoštevanju Direktive Sveta 89/398/EGS z dne 3. maja 1989 o približevanju zakonodaje držav članic, ki se nanaša na živila za posebne prehranske namene [1], in zlasti člena 4(1) Direktive,
After consulting the European Food Safety Authority (the Authority),
po posvetovanju z Evropsko agencijo za varno hrano („Agencija“),
Directive 89/398/EEC concerns foodstuffs intended for particular nutritional uses.
Direktiva 89/398/EGS zadeva živila za posebne prehranske namene.
The specific provisions applicable to certain groups of foods for particular nutritional uses are laid down by specific Directives.
Posebne določbe, ki se uporabljajo za nekatere skupine živil za posebne prehranske namene, so določene s posebnimi direktivami.
Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae [2] is a specific Directive adopted pursuant to Directive 89/398/EEC.
Direktiva Komisije 91/321/EGS z dne 14. maja 1991 o začetnih in nadaljevalnih formulah za dojenčke in majhne otroke [2] je posebna direktiva, sprejeta v skladu z Direktivo 89/398/EGS.
That Directive has been substantially amended several times [3].
Navedena direktiva je bila večkrat znatno spremenjena [3].
Since further amendments are to be made, it should be recast in the interests of clarity.
Ker so predvidene nadaljnje spremembe, jo je treba zaradi jasnosti preoblikovati.
In the light of discussions in international fora, in particular Codex Alimentarius, in relation to the timing of the introduction of complementary foods into the diet of infants, it is appropriate to amend the current definitions of infant formulae and follow-on formulae and certain provisions on the labelling of follow-on formulae in Directive 91/321/EEC.
Glede na razprave v okviru mednarodnih forumov, zlasti Codex Alimentariusa, v zvezi s časom uvedbe dopolnilnih živil v prehrano za dojenčke je primerno spremeniti sedanje opredelitve začetnih formul za dojenčke in nadaljevalnih formul za dojenčke in majhne otroke in nekatere določbe o označevanju nadaljevalnih formul za dojenčke in majhne otroke v Direktivi 91/321/EGS.
Infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first months of life until the introduction of appropriate complementary feeding.
Začetne formule za dojenčke so edina pripravljena živila, ki v celoti zadovoljujejo prehranske potrebe dojenčkov v prvih mesecih življenja do uvedbe ustrezne dopolnilne hrane.
In order to safeguard the health of such infants it is necessary to ensure that the only products marketed as suitable for such use during the period would be infant formulae.
Za varovanje zdravja teh dojenčkov je treba zagotoviti, da so edini proizvodi, s katerimi se trguje kot s primernimi za tako uporabo v navedenem obdobju, začetne formule za dojenčke.
The essential composition of infant formulae and follow-on formulae must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data.
Osnovna sestava začetnih formul za dojenčke in nadaljevalnih formul za dojenčke in majhne otroke mora zadovoljevati prehranske potrebe zdravih dojenčkov, kakor jih opredeljujejo splošno sprejeta znanstvena spoznanja.
The requirements concerning the essential composition of infant formulae and follow-on formulae should include detailed provisions on the protein content.
Zahteve v zvezi z osnovno sestavo začetnih formul za dojenčke in nadaljevalnih formul za dojenčke in majhne otroke morajo zajemati podrobne določbe o vsebnosti beljakovin.
Notwithstanding that traditionally different appropriate conversion factors have been used for the calculation of the protein content from the nitrogen content of different protein sources, recent scientific advice indicates that for the specific purposes of calculating the protein content of infant formulae and follow-on formulae it is appropriate to use a single conversion factor adapted to these products.
Ne glede na to, da so se za izračun vsebnosti beljakovin iz vsebnosti dušika iz različnih virov beljakovin tradicionalno uporabljali različni primerni pretvorbeni faktorji, znanstveniki v zadnjem času svetujejo, da je za posebne namene izračuna vsebnosti beljakovin v začetnih formulah za dojenčke in nadaljevalnih formulah za dojenčke in majhne otroke primerno uporabiti enoten pretvorbeni faktor, prilagojen tem proizvodom.
As infant formulae and follow-on formulae are sophisticated products that are specially formulated for their intended purpose, additional essential requirements on protein, including minimum and maximum levels of protein and minimum levels of certain amino acids, should be established.
Ker so začetne formule za dojenčke in nadaljevalne formule za dojenčke in majhne otroke visoko razviti proizvodi, sestavljeni posebej za svojo namembnost, je treba določiti dodatne osnovne zahteve glede beljakovin, vključno z najnižjimi in najvišjimi mejnimi vrednostmi beljakovin ter najnižjimi mejnimi vrednostmi določenih aminokislin.
The protein requirements specified in this Directive should relate to the final products as such, prepared ready for consumption.
Zahteve glede beljakovin, določene v tej direktivi, bi se morale nanašati na končne proizvode kot take, pripravljene za uživanje.
On the basis of such data, the essential composition of infant formulae and follow-on formulae manufactured from cows' milk proteins and soya proteins alone or in a mixture, as well as infant formulae based on protein hydrolysates, can already be defined.
Na podlagi teh spoznanj je že mogoče določiti osnovno sestavo začetnih in nadaljevalnih formul za dojenčke in majhne otroke, ki so izdelane samo iz beljakovin kravjega mleka, sojinih beljakovin ali iz mešanice, ter začetnih formul za dojenčke, ki temeljijo na beljakovinskih hidrolizatih.
The same is not true for preparations based wholly or partly on other sources of protein.
To ne velja za pripravke, ki so v celoti ali delno izdelani iz drugih virov beljakovin.
For this reason specific rules for such products, if necessary, should be adopted at a later date.
Zato bo treba za take proizvode, če bo potrebno, naknadno sprejeti posebne predpise.
It is important that ingredients used in the manufacture of infant formulae and follow-on formulae are suitable for the particular nutritional use by infants and that their suitability has been demonstrated, when necessary, by appropriate studies.
Pomembno je, da so sestavine, uporabljene za izdelavo začetnih formul za dojenčke in nadaljevalnih formul za dojenčke in majhne otroke, primerne za posebne prehranske namene za dojenčke in da se njihova primernost po potrebi dokaže z ustreznimi študijami.
Guidance on the design and conduct of appropriate studies has been published by expert scientific groups such as the Scientific Committee on Food, the UK Committee on the Medical Aspects of Food and Nutrition Policy, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition.
Navodila za zasnovo in izvedbo ustreznih študij so objavile strokovne znanstvene skupine, kot so Znanstveni odbor za hrano, Odbor za medicinske vidike glede prehranske politike Združenega kraljestva in Evropsko društvo za pediatrično gastroentrologijo, hepatologijo in prehrano.
Such guidance should be taken into consideration when ingredients are introduced into infant formulae or follow-on formulae.
Taka navodila je treba upoštevati pri uvedbi sestavin v začetne formule za dojenčke ali nadaljevalne formule za dojenčke in majhne otroke.
A number of the substances that may be used in the manufacture of infant formulae and follow-on formulae may also be used in foodstuffs as food additives.
Številne snovi, ki se smejo uporabljati za izdelavo začetnih formul za dojenčke in nadaljevalnih formul za dojenčke in majhne otroke, se smejo v živilih uporabiti tudi kot aditivi za živila.
In that context, purity criteria have already been or are to be adopted at Community level in accordance with 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 [4].
V tem smislu so merila čistosti že sprejeta ali pa jih je treba sprejeti na ravni Skupnosti v skladu z 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 [4].
Those purity criteria should apply to those substances whatever the purpose of their use in foodstuffs.
Ta merila čistosti je treba uporabiti za navedene snovi ne glede na namen njihove uporabe v živilih.
Pending the adoption of purity criteria for substances for which such criteria have not yet been adopted at Community level, and in order to ensure a high level of protection for public health, generally acceptable purity criteria recommended by international organisations or agencies, such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA) or European Pharmacopoeia (EUP), should apply.
Dokler se ne sprejmejo merila čistosti za snovi, za katere taka merila na ravni Skupnosti še niso bila sprejeta, in da se zagotovi visoka stopnja zaščite javnega zdravja, je treba uporabljati splošno sprejemljiva merila čistosti, ki jih priporočajo mednarodne organizacije ali agencije, kot sta Skupni strokovni odbor FAO/WHO za aditive za živila (JECFA) in Evropska farmakopeja (EUP).
In addition, Member States should be permitted to maintain national rules setting stricter purity criteria.
Poleg tega se državam članicam dovoli, da obdržijo nacionalne predpise, ki določajo strožja merila čistosti.
Given the particular nature of infant formula, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products.
Glede na posebno naravo začetne formule za dojenčke so organom za spremljanje in nadzor ob običajnih sredstvih na voljo še dodatna sredstva, ki lahko omogočijo učinkovito spremljanje teh proizvodov.
Infant formulae based on protein hydrolysates are distinct from semi-elemental diet products based on high degree hydrolysates used for the dietary management of diagnosed medical conditions, which are not covered by this Directive.
Začetne formule, temelječe na beljakovinskih hidrolizatih, se ločijo od polelementarnih dietetičnih proizvodov, ki temeljijo na visokem deležu hidrolizatov, v uporabi za prehrano pri diagnosticiranih medicinskih stanjih, ki niso urejena s to direktivo.
This Directive reflects current knowledge about the products concerned.
Ta direktiva odraža sedanja spoznanja o zadevnih proizvodih.
Any amendment, to allow innovation based on scientific and technical progress, should be decided by the procedure referred to in Article 13(2) of Directive 89/398/EEC.
Da bi omogočili upoštevanje inovacij na podlagi znanstvenega in tehničnega napredka, je treba o vseh spremembah odločiti po postopku iz člena 13(2) Direktive 89/398/EGS.
Maximum levels for pesticide residues set out in relevant Community legislation, in particular Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables [5], in Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals [6], in Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin [7], and in Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables [8], should apply without prejudice to specific provisions set out in this Directive.
Mejne vrednosti ostankov pesticidov, določene v ustrezni zakonodaji Skupnosti, zlasti v Direktivi Sveta 76/895/EGS z dne 23. novembra 1976 o določanju mejnih vrednosti ostankov pesticidov v in na sadju in zelenjavi [5], v Direktivi Sveta 86/362/EGS z dne 24. julija 1986 o določanju mejnih vrednosti ostankov pesticidov v žitih in na njih [6], v Direktivi Sveta 86/363/EGS z dne 24. julija 1986 o določitvi mejnih vrednosti ostankov pesticidov v živilih živalskega izvora in na njih [7], ter v Direktivi Sveta 90/642/EGS z dne 27. novembra 1990 o določitvi mejnih vrednosti ostankov pesticidov v nekaterih proizvodih rastlinskega izvora, vključno s sadjem in zelenjavo, in na njih [8], je treba uporabljati brez poseganja v posebne določbe iz te direktive.
Taking into account the Community’s international obligations, in cases where the relevant scientific evidence is insufficient, the precautionary principle referred to in Article 7 of 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] allows the Community to provisionally adopt measures on the basis of available pertinent information, pending an additional assessment of risk and a review of the measure within a reasonable period of time.
Previdnostno načelo iz člena 7 Uredbe (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], ob upoštevanju mednarodnih obveznosti Skupnosti, kadar so ustrezni znanstveni dokazi nezadostni, omogoča, da Skupnost do izvedbe dodatne ocene tveganja in pregleda ukrepov v primernem času sprejme začasne ukrepe na podlagi razpoložljivih ustreznih informacij.
On the basis of the two opinions given by the Scientific Committee for Food on 19 September 1997 and 4 June 1998, there are at present doubts as to the adequacy of existing acceptable daily intake (ADI) values of pesticides and pesticide residues for the protection of the health of infants and young children.
Na podlagi obeh mnenj, ki jih je dal Strokovni odbor za prehrano 19. septembra 1997 in 4. junija 1998, zdaj obstaja dvom, ki zadeva ustreznost obstoječih vrednosti sprejemljivega dnevnega vnosa (ADI) pesticidov in ostankov pesticidov za varovanje zdravja dojenčkov in majhnih otrok.
Therefore, as far as foodstuffs for particular nutritional uses intended for infants and young children are concerned, it is appropriate to adopt a very low common limit for all pesticides.
Kar zadeva živila za posebne prehranske namene, ki so namenjena dojenčkom in majhnim otrokom, je torej primerno, da se sprejme zelo nizka skupna mejna vrednost za vse pesticide.
This very low common limit should be fixed at 0,01 mg/kg which normally is in practice the minimum detectable level.
Ta zelo nizka skupna mejna vrednost naj bo določena pri 0,01 mg/kg, kar je v praksi običajno najmanjša vrednost zaznavanja.
With careful selection of raw materials, and given that infant formulae and follow-on formulae undergo extensive processing during their manufacture, it is feasible to produce products containing very low levels of pesticide residues.
S skrbno izbiro surovin in glede na to, da se začetne in nadaljevalne formule za dojenčke in majhne otroke obsežno predelujejo med proizvodnjo, je možno izdelati proizvode, ki vsebujejo zelo majhne količine ostankov pesticidov.
However, in the case of a small number of pesticides or metabolites of pesticides even a maximum residue level of 0,01 mg/kg might, under worst-case intake conditions, allow infants and young children to exceed the ADI.
Vendar pomeni pri majhnem številu pesticidov ali presnovnih produktov pesticidov tudi mejna vrednost ostanka 0,01 mg/kg, v najslabših pogojih vnosa, za dojenčke in majhne otroke presežek ADI.
This is the case for pesticides or metabolites of pesticides with an ADI lower than 0,0005 mg/kg body weight.
To zadeva pesticide in presnovne produkte pesticidov, katerih ADI je nižji od 0,0005 mg/kg telesne mase.
This Directive should establish the principle of the prohibition of the use of these pesticides in the production of agricultural products intended for infant formulae and follow-on formulae.
Ta direktiva bi morala uvesti načelo prepovedi uporabe teh pesticidov pri pridelavi kmetijskih proizvodov, namenjenih za proizvodnjo začetnih formul za dojenčke in nadaljevalnih formul.
However, this prohibition does not necessarily guarantee that products are free from such pesticides, since some pesticides contaminate the environment and their residues may be found in the products concerned.
S to prepovedjo pa vendarle ni zagotovljeno, da proizvodi ne vsebujejo tovrstnih pesticidov, ker nekateri pesticidi onesnažujejo okolje, njihove ostanke pa je mogoče najti v zadevnih proizvodih.
Most of the pesticides which have ADI values lower than 0,0005 mg/kg body weight are already prohibited in the Community.
Večina pesticidov, katerih ADI je nižji od 0,0005 mg/kg telesne mase, je v Skupnosti že prepovedana.
The prohibited pesticides should not be detectable in infant formulae and follow-on formulae by state-of-the-art analytical methods.
Prepovedanih pesticidov se z najsodobnejšimi analiznimi metodami ne sme zaznati v začetnih formulah za dojenčke in nadaljevalnih formulah.
However, some pesticides degrade slowly and still contaminate the environment.
Nekateri pesticidi pa se počasi razgrajujejo in še vedno onesnažujejo okolje.
They might be present in infant formulae and follow-on formulae even if they have not been used.
Zato so lahko prisotni v začetnih formulah za dojenčke in nadaljevalnih formulah, četudi se niso uporabljali.
For the purposes of control, a harmonised approach should be followed.
Zaradi nadzora bi bil potreben usklajen pristop.
Pending Commission decisions on whether they satisfy the safety requirements of Article 5 of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [10], the continued use of authorised pesticides should be permitted as long as their residues comply with the maximum residue levels established in this Directive.
Do odločitve Komisije o tem, ali dovoljeni pesticidi izpolnjujejo varnostne zahteve iz člena 5 Direktive Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [10], je treba njihovo nadaljnjo uporabo dovoliti, dokler so njihovi ostanki v skladu z mejnimi vrednostmi ostankov, določenimi v tej direktivi.
The latter should be set at levels ensuring that their respective ADI values are not exceeded by infants and young children under worst-case intake conditions.
Slednje bi bilo treba določiti na ravneh, ki zagotavljajo, da pri dojenčkih in majhnih otrocih tudi v najslabših pogojih vnosa ne bo presežen ustrezni ADI.
The Annexes to this Directive dealing with pesticides should be amended following the completion of the review programme being carried out under Directive 91/414/EEC.
Priloge k tej direktivi v zvezi s pesticidi je treba po zaključku programa pregledovanja, izvedenega v skladu z Direktivo 91/414/EGS, spremeniti.
Pursuant to Article 7(1) of Directive 89/398/EEC, the products covered by this Directive are subject to the general rules laid down by 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 [11].
Na podlagi člena 7(1) Direktive 89/398/EGS veljajo za proizvode, ki jih zajema ta direktiva, splošna pravila, ki jih določa Direktiva 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil [11].
This Directive adopts and expands upon the additions and exceptions to those general rules, where it is appropriate, in order to promote and protect breast feeding.
Ta direktiva sprejema in razširja dopolnila in izjeme k tem splošnim pravilom, kjer je to primerno, da bi spodbujala in ščitila dojenje.
In particular, the nature and destination of the products covered by this Directive require nutritional labelling showing the energy value and principal nutrients they contain.
Zlasti glede na naravo in namen proizvodov, zajetih s to direktivo, je na teh proizvodih treba označiti hranilno vrednost, ki prikazuje energijsko vrednost in vsebnost glavnih hranil.
On the other hand, the method of use should be specified in accordance with point 9 of Article 3(1) and Article 11(2) of Directive 2000/13/EC, in order to prevent inappropriate uses likely to be detrimental to the health of infants.
Po drugi strani je treba opredeliti način uporabe, da bi preprečili neprimerno uporabo, ki bi lahko škodila zdravju dojenčkov, v skladu s točko 9 člena 3(1) in členom 11(2) Direktive 2000/13/ES.
Given the nature of infant formulae and follow-on formulae the detailed rules as to nutrient declaration on the labelling need to be clarified in order to avoid any problems which may arise from the application of other relevant Community legislation.
Glede na naravo začetnih formul za dojenčke in nadaljevalnih formul je treba pojasniti določbe za označevanje hranilne vrednosti, da bi se izognili vsem težavam, ki bi lahko nastale ob uporabi druge ustrezne zakonodaje Skupnosti.