natgillin/translations-raw huggingface dataset:
The opinions conclude that the characteristics of PHMB (1600; 1.8) render it very persistent (vP) and toxic (T) in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council [3].
Iz mnenj je razvidno tudi, da je PHMB (1600; 1.8) v skladu s kriteriji iz Priloge XIII k Uredbi (ES) št. 1907/2006 Evropskega Parlamenta in Sveta zaradi svojih lastnosti zelo obstojen (vP) in strupen (T) [3].
PHMB (1600; 1.8) meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should therefore be considered a candidate for substitution.
PHMB (1600; 1.8) izpolnjuje pogoje, določene v točki (d) člena 10(1) Uredbe (EU) št. 528/2012, in bi ga bilo zato treba obravnavati kot možno snov za zamenjavo.
Pursuant to Article 10(4) of Regulation (EU) No 528/2012, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding 7 years.
V skladu s členom 10(4) Uredbe (EU) št. 528/2012 je treba odobritev aktivne snovi, ki se šteje kot možna snov za zamenjavo, podati za obdobje največ sedem let.
Since PHMB (1600; 1.8) meets the criteria for being very persistent (vP) according to Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating PHMB (1600; 1.8) should be appropriately labelled when placed on the market.
Ker PHMB (1600; 1.8) izpolnjuje kriterije za razvrstitev kot zelo obstojna snov (vP) v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006, bi bilo treba proizvode, ki so tretirani z njim ali ga vsebujejo, ustrezno označiti, ko se dajo v promet.
PHMB (1600; 1.8) is approved as an active substance for use in biocidal products for product-types 2, 3, and 11, subject to the specifications and conditions set out in the Annex.
PHMB (1600; 1.8) se odobri kot aktivna snov za uporabo v biocidnih proizvodih 2., 3. in 11. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
PHMB (1600; 1.8) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8)
PHMB (1600; 1.8) (poliheksametilen bigvanid hidroklorid s srednjo povprečno molekulsko maso (Mn) 1600 in srednjo polidisperznostjo (PDI) 1.8)
CoPoly(bisiminoimidocarbonyl, hexamethylene hydrochloride), (iminoimidocarbonyl, hexamethylene hydrochloride)
CoPoly (bisiminoimidokarbonil, heksametilen hidroklorid), (iminoimidokarbonil, heksametilen hidroklorid)
n.a.
ni relevantno
956 g/kg (calculated dry weight specification).
27083-27-8 in 32289-58-0
The active substance as manufactured is an aqueous solution of 20 % w/w of PHMB (1600; 1.8)
956 g/kg (izračunana specifikacija suhe snovi)
1 July 2017
Aktivna snov, kot se proizvaja, je vodna raztopina z 20 mas. % PHMB (1600; 1.8).
30 June 2024
1. julij 2017
PHMB (1600; 1.8) is considered a candidate for substitution in accordance with Article 10(1)(d) of Regulation (EU) No 528/2012.
30. junij 2024
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
PHMB (1600; 1.8) se šteje kot možna snov za zamenjavo v skladu s členom 10(1)(d) Uredbe (EU) št. 528/2012.
The authorisations of biocidal products are subject to the following conditions.
Pri oceni proizvoda je treba posebno pozornost nameniti vidikom izpostavljenosti, tveganja in učinkovitosti, povezanim s katero koli uporabo, zajeto v vlogi za izdajo dovoljenja, ki niso bili obravnavani v oceni tveganja aktivne snovi na ravni Unije.
Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
Za industrijske ali poklicne uporabnike se vzpostavijo postopki varnega ravnanja in primerni organizacijski ukrepi za zmanjševanje tveganja.
In view of the risks identified for human health and the environment, products shall not be authorised for the treatment of swimming pools, unless it can be demonstrated that risks can be reduced to an acceptable level.
Če izpostavljenosti ni mogoče zmanjšati na sprejemljivo raven z drugimi načini, se proizvodi uporabljajo z ustrezno osebno zaščitno opremo.
In view of the risks identified for human health and the environment, products shall not be authorised for disinfection of medical equipment by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level.
Zaradi ugotovljenega tveganja za zdravje ljudi in okolje se proizvodi ne smejo uporabljati za tretiranje plavalnih bazenov, razen če se lahko dokaže, da je tveganje mogoče zmanjšati na sprejemljivo raven.
In view of the risks identified for human health, ready-to-use wipes shall not be authorised for non-professionals, unless it can be demonstrated that risks can be reduced to an acceptable level.
Zaradi ugotovljenega tveganja za zdravje ljudi in okolje se proizvodi ne smejo uporabljati za razkuževanje medicinske opreme s pomakanjem, razen če se lahko dokaže, da je tveganje mogoče zmanjšati na sprejemljivo raven.
In view of the risks identified for human health, labels, and where provided, safety data sheets of ready-to-use wipes shall indicate that the use is restricted to areas not accessible to the general public, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.
Zaradi ugotovljenega tveganja za zdravje ljudi robčkov, pripravljenih za uporabo, ne smejo uporabljati nepoklicni uporabniki, razen če se lahko dokaže, da je tveganje mogoče zmanjšati na sprejemljivo raven.
The placing on the market of treated articles is subject to the following condition:
Zaradi ugotovljenega tveganja za zdravje ljudi se na oznakah in, kjer so na voljo, varnostnih listih robčkov, pripravljenih za uporabo, navede, da je uporaba omejena na območja, ki niso dostopna javnosti, razen če se lahko dokaže, da je tveganje mogoče zmanjšati na sprejemljivo raven z drugimi načini.
The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1600; 1.8) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
Za dajanje tretiranih proizvodov na trg velja naslednji pogoj:
For professional users, safe operational procedures and appropriate organisational measures shall be established.
oseba, odgovorna za dajanje na trg proizvoda, ki je bil tretiran s PHMB (1600; 1.8) ali pa ga vsebuje, zagotovi, da so na oznaki tretiranega proizvoda navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
In view of the risks identified for human health, products shall not be authorised for disinfection of equipment by dipping, unless it can be demonstrated that risks can be reduced to an acceptable level.
Za poklicne uporabnike se vzpostavijo postopki varnega ravnanja in primerni organizacijski ukrepi za zmanjševanje tveganja.
In addition, in case products are authorised, in view of the risks identified for the environment, labels, and where provided, safety data sheets shall indicate that no release to sewage treatment plants shall be allowed, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.
Zaradi ugotovljenega tveganja za zdravje ljudi se proizvodi ne smejo uporabljati za razkuževanje opreme z namakanjem, razen če je mogoče dokazati, da se lahko tveganja zmanjšajo na sprejemljivo raven.
For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council [2] or Regulation (EC) No 396/2005 of the European Parliament and of the Council [3] shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
Poleg tega se v primeru odobritve uporabe proizvodov zaradi ugotovljenega tveganja za okolje na oznakah in, kjer so na voljo, varnostnih listih navede, da sprostitev v čistilne naprave za odplake ni dovoljena, razen če se lahko dokaže, da je tveganje mogoče zmanjšati na sprejemljivo raven z drugimi načini.
In view of the risks identified for human health, labels and, where provided, safety data sheets shall indicate that loading of product into the cooling system shall be automated, that the pump shall be rinsed before cleaning and that appropriate personal protective equipment shall be worn during the cleaning phase, unless it can be demonstrated that risks can be reduced to an acceptable level by other means.
Za proizvode, ki lahko puščajo ostanke v živilih ali krmi, se preveri, ali je treba določiti nove ali spremeniti obstoječe mejne vrednosti ostankov (MRL) v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta [2] ali Uredbo Evropskega parlamenta in Sveta (ES) št. 396/2005 [3], in sprejmejo se vsi ustrezni ukrepi za zmanjševanje tveganja, da se veljavne mejne vrednosti ostankov ne presežejo.
In view of the risks identified for water, sediments and soil, labels and, where provided, safety data sheets shall indicate that disposal of preserved liquids following drainage of the closed recirculating system shall be handled as hazardous waste, unless it can be demonstrated at product authorisation that risks to the environment can be reduced to an acceptable level by other means.
Zaradi ugotovljenega tveganja za zdravje ljudi se na oznakah in, kjer so na voljo, varnostnih listih navede, da je nakladanje proizvoda v hladilni sistem avtomatiziran, da se črpalka pred čiščenjem izpere in da se med čiščenjem uporablja osebna zaščitna oprema, razen če se lahko dokaže, da je tveganje mogoče zmanjšati na sprejemljivo raven z drugimi načini.
The placing on the market of treated articles is subject to the following condition.
Zaradi ugotovljenega tveganja za vodo, usedline in tla se na oznakah in, kjer so na voljo, varnostnih listih navede, da se odstranjevanje konzerviranih tekočin po drenaži zaprtega recirkulacijskega sistema obravnava kot nevaren odpadek, razen če se lahko pri izdaji dovoljenja dokaže, da je tveganje za okolje mogoče zmanjšati na sprejemljivo raven z drugimi načini.
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p.
Za dajanje tretiranih proizvodov na trg velja naslednji pogoj:
1).
Čistost, navedena v tem stolpcu, je bila minimalna stopnja čistosti aktivne snovi, uporabljene za presojo v skladu s členom 16(2) Direktive 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet.
Commission Implementing Regulation (EU) 2016/126
Izvedbena uredba Komisije (EU) 2016/126
supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for infant formula and follow-on formula and as regards requirements on information relating to infant and young child feeding
o dopolnitvi Uredbe (EU) št. 609/2013 Evropskega parlamenta in Sveta glede posebnih zahtev za sestavo in informacije pri začetnih formulah za dojenčke in nadaljevalnih formulah ter glede zahtev za informacije o hranjenju dojenčkov in majhnih otrok
Having regard to Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 [1], and in particular Article 11(1) thereof,
ob upoštevanju Uredbe (EU) št. 609/2013 Evropskega parlamenta in Sveta z dne 12. junija 2013 o živilih, namenjenih dojenčkom in majhnim otrokom, živilih za posebne zdravstvene namene in popolnih prehranskih nadomestkih za nadzor nad telesno težo ter razveljavitvi Direktive Sveta 92/52/EGS, direktiv Komisije 96/8/ES, 1999/21/ES, 2006/125/ES in 2006/141/ES, Direktive 2009/39/ES Evropskega parlamenta in Sveta ter uredb Komisije (ES) št. 41/2009 in (ES) št. 953/2009 [1], ter zlasti člena 11(1) Uredbe,
Commission Directive 2006/141/EC [2] lays down harmonised rules on infant formula and follow-on formula in the framework of Directive 2009/39/EC of the European Parliament and of the Council [3].
Direktiva Komisije 2006/141/ES [2] določa harmonizirana pravila za začetne formule za dojenčke in nadaljevalne formule v okviru Direktive 2009/39/ES Evropskega parlamenta in Sveta [3].
Directives 2009/39/EC and 2006/141/EC are repealed by Regulation (EU) No 609/2013.
Direktivi 2009/39/ES in 2006/141/ES sta bili razveljavljeni z Uredbo (EU) št. 609/2013.
That Regulation lays down general compositional and information requirements for different categories of food, including infant formula and follow-on formula.
Navedena uredba določa splošne zahteve glede sestave in informacij za različne kategorije živil, vključno z začetnimi formulami za dojenčke in nadaljevalnimi formulami.
The Commission has to adopt specific compositional and information requirements for infant formula and follow-on formula, taking into account the provisions of Directive 2006/141/EC.
Komisija mora sprejeti posebne zahteve glede sestave in informacij za začetne formule za dojenčke in nadaljevalne formule ob upoštevanju določb Direktive 2006/141/ES.
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 edino predelano živilo, ki v celoti zadovolji prehranske potrebe dojenčkov v prvih mesecih življenja do uvedbe ustrezne dopolnilne hrane.
In order to safeguard the health of those infants, it is necessary to ensure that infant formula is the only product marketed as suitable for such use during that period.
Zaradi varovanja zdravja dojenčkov je treba zagotoviti, da so začetne formule za dojenčke edini proizvod, ki se trži kot primeren za tako rabo v navedenem obdobju.
The essential composition of infant formula and follow-on formula 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 mora zadovoljiti prehranske potrebe zdravih dojenčkov, kakor jih opredeljujejo splošno sprejeta znanstvena spoznanja.
Infant formula and follow-on formula are sophisticated products that are specially formulated for a vulnerable group of consumers.
Začetne formule za dojenčke in nadaljevalne formule so napredni proizvodi, posebej pripravljeni za ranljivo skupino potrošnikov.
In order to ensure the safety and suitability of such products, detailed requirements should be laid down on the composition of infant formula and follow-on formula, including requirements on energy value, macronutrient and micronutrient content.
Da bi se zagotovili varnost in primernost takih proizvodov, bi bilo treba določiti podrobne zahteve glede sestave začetnih formul za dojenčke in nadaljevalnih formul, vključno z zahtevami glede energijske vrednosti ter vsebnosti makro- in mikrohranil.
These requirements should be based on the latest scientific advice of the European Food Safety Authority (‘the Authority’) in its opinion on the essential composition of infant and follow-on formulae [4].
Te zahteve bi morale temeljiti na najnovejšem znanstvenem svetovanju Evropske agencije za varnost hrane (v nadaljnjem besedilu: Agencija) iz njenega mnenja o osnovni sestavi začetnih formul dojenčke in nadaljevalnih formul [4].
In order to ensure innovation and product development, the voluntary addition to infant formula and follow-on formula of ingredients not covered by specific requirements of this Regulation should be possible.
Da se zagotovijo inovacije in razvoj proizvodov, bi moralo biti začetnim formulam za dojenčke in nadaljevalnim formulam mogoče dodati sestavine, za katere ne veljajo posebne zahteve iz te uredbe.
All ingredients used in the manufacture of infant formula and follow-on formula should be suitable for infants and their suitability should have been demonstrated, when necessary, by appropriate studies.
Vse sestavine, ki se uporabljajo pri proizvodnji začetnih formul za dojenčke in nadaljevalnih formul, bi morale biti primerne za dojenčke, njihovo primernost pa bi bilo po potrebi treba dokazati z ustreznimi študijami.
It is the responsibility of food business operators to demonstrate such suitability and of national competent authorities to consider, on a case-by-case basis, whether this is the case.
Nosilci živilske dejavnosti so odgovorni, da dokažejo navedeno primernost, pristojni nacionalni organi pa za to, da za vsak primer posebej preučijo, ali to drži.
Such guidance should be taken into consideration in the manufacturing of infant formula or follow-on formula.
Taka navodila bi bilo treba upoštevati pri proizvodnji začetnih formul za dojenčke in nadaljevalnih formul.
Pursuant to Regulation (EU) No 609/2013, the Commission has to adopt provisions restricting or prohibiting the use of pesticides and on pesticide residues in infant formula and follow-on formula, taking account of those currently established in the Annexes to Directive 2006/141/EC.
V skladu z Uredbo (EU) št. 609/2013 mora Komisija sprejeti določbe o omejitvi ali prepovedi uporabe pesticidov ter o ostankih pesticidov v začetnih formulah za dojenčke in nadaljevalnih formulah, pri čemer se upoštevajo tiste, ki so trenutno določene v prilogah k Direktivi 2006/141/ES.
Adopting provisions that are in line with the current scientific knowledge requires a significant amount of time, given that a comprehensive evaluation has to be carried out by the Authority on a number of aspects, including the appropriateness of the toxicological reference values for infants and young children.
Sprejetje določb, ki so v skladu s trenutnimi znanstvenimi spoznanji, zahteva veliko časa, saj mora Agencija celostno oceniti vrsto vidikov, vključno s primernostjo toksikoloških referenčnih vrednosti za dojenčke in majhne otroke.
Taking into account the date of 20 July 2015 set by Regulation (EU) No 609/2013 for the adoption of this Delegated Regulation, the relevant existing requirements of Directive 2006/141/EC should, at this stage, be taken over.
Če se upošteva datum 20. julij 2015, ki je določen v Uredbi (EU) št. 609/2013 za sprejetje te delegirane uredbe, bi bilo na tej stopnji treba prevzeti ustrezne obstoječe zahteve iz Direktive 2006/141/ES.
However, it is appropriate to use the terminology of Regulation (EC) No 1107/2009 of the European Parliament and of the Council [5].
Vendar je primerno, da se uporabi izrazje iz Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta [5].
Directive 2006/141/EC lays down specific requirements on the use of pesticides in products intended for the production of infant formula and follow-on formula and on pesticide residues in such food, based on two opinions given by the Scientific Committee for Food (SCF) on 19 September 1997 [6] and 4 June 1998 [7].
Direktiva 2006/141/ES določa posebne zahteve za uporabo pesticidov v proizvodih, namenjenih za proizvodnjo začetnih formul za dojenčke in nadaljevalnih formul, ter za ostanke pesticidov v takih živilih na podlagi dveh mnenj, ki ju je izdal Znanstveni odbor za živila (SCF) 19. septembra 1997 [6] in 4. junija 1998 [7].
A very low residue limit of 0,01 mg/kg for all pesticides is set on the basis of the precautionary principle.
Za vse pesticide je po previdnostnem načelu določena zelo nizka mejna vrednost ostankov 0,01 mg/kg.
In addition, more severe limitations are set for a small number of pesticides or metabolites of pesticides for which even a maximum residue level (MRL) of 0,01 mg/kg might, under worst-case intake conditions, lead to an exposure exceeding the acceptable daily intake (ADI) for infants and young children.
Poleg tega so določene strožje omejitve pri manjšem številu pesticidov ali presnovnih produktov pesticidov, za katere bi celo mejna vrednost ostankov (MRL) 0,01 mg/kg v najslabših pogojih vnosa povzročila izpostavljenost, višjo od sprejemljivega dnevnega vnosa (ADI) za dojenčke in majhne otroke.
A prohibition of the use of certain pesticides would not necessarily guarantee that infant formula and follow-on formula are free from those pesticides, since some pesticides are persistent in the environment and their residues can be found in the food.
Prepoved uporabe nekaterih pesticidov ne bi nujno zagotovila, da so začetne formule za dojenčke in nadaljevalne formule brez teh, ker so nekateri pesticidi obstojni v okolju in je njihove ostanke mogoče najti v živilih.
For that reason, those pesticides are considered not to have been used if residues are below a certain level.
Zaradi tega se za navedene pesticide šteje, da niso bili uporabljeni, če so ostanki pod neko mejno vrednostjo.
Infant formula and follow-on formula have to comply with Regulation (EU) No 1169/2011 of the European Parliament and of the Council [8].
Začetne formule za dojenčke in nadaljevalne formule morajo biti v skladu z Uredbo (EU) št. 1169/2011 Evropskega parlamenta in Sveta [8].
In order to take account of the specific nature of infant formula and follow-on formula and in order to promote and protect breast feeding, this Regulation should lay down additions and exceptions to those general rules, where appropriate.
Da bi upoštevali posebno naravo začetnih formul za dojenčke in nadaljevalnih formul ter da bi spodbujali in ščitili dojenje, bi bilo s to uredbo po potrebi treba določiti dodatke in izjeme k navedenim splošnim pravilom.
Given the particular role of infant formula and follow-on formula in the diet of infants, it is important to ensure that products exported to third countries provide food information in a language easily understood by parents and caregivers, in the absence of specific relevant provisions established by or agreed with the importing country.
Glede na posebno vlogo začetnih formul za dojenčke in nadaljevalnih formul v prehrani dojenčkov je pomembno zagotoviti, da proizvodi, izvoženi v tretje države, navajajo informacije o živilih v jeziku, ki ga zlahka razumejo starši in skrbniki, če ni posebnih ustreznih določb, ki jih je uvedla ali se je o njih dogovorila država uvoznica.
Given the different role of infant formula and follow-on formula in the diet of infants, it is appropriate to lay down provisions requiring that a clear distinction can be made between them, so as to avoid any risk of confusion.
Glede na različni vlogi začetne formule za dojenčke in nadaljevalne formule v prehrani dojenčkov je primerno uvesti določbe, da morata biti jasno razločljivi, zato da bi se izognili vsakršni nevarnosti zamenjave.
The nutrition declaration for infant formula and follow-on formula is essential in order to guarantee their appropriate use, both for parents and caregivers and for health care professionals who recommend their consumption.
Označba hranilne vrednosti za začetne formule za dojenčke in nadaljevalne formule je ključnega pomena za zagotovitev, da jih pravilno uporabijo starši in skrbniki ter zdravstveni delavci, ki priporočajo njihovo uživanje.
For that reason and in order to provide more complete information, the nutrition declaration should include more particulars than those required by Regulation (EU) No 1169/2011.
Zaradi tega in zaradi popolnejših informacij bi označba hranilne vrednosti morala vsebovati več podatkov od tistih, ki jih zahteva Uredba (EU) št. 1169/2011.