natgillin/translations-raw huggingface dataset:
For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing glutaraldehyde in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council [6].
Glede uporabe v 4. vrsti proizvodov v presoji ni bila obravnavana vključitev biocidnih proizvodov, ki vsebujejo glutaraldehid, v materiale in izdelke, namenjene za neposreden ali posreden stik z živili v smislu člena 1(1) Uredbe Evropskega parlamenta in Sveta (ES) št. 1935/2004 [6].
Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of Regulation (EC) No 1935/2004.
Taki materiali lahko zahtevajo določitev posebnih mejnih vrednosti za živila, kot je določeno v členu 5(1)(e) Uredbe (ES) št. 1935/2004.
Since glutaraldehyde meets the criteria for classification as respiratory sensitiser, and as skin sensitiser sub-category 1A as defined in Annex I to Regulation (EC) No 1272/2008, treated articles treated with or incorporating glutaraldehyde should be appropriately labelled when placed on the market.
Ker glutaraldehid izpolnjuje kriterije za razvrstitev kot povzročitelj preobčutljivosti dihal in povzročitelj preobčutljivosti kože podkategorije 1A, kot sta opredeljena v Prilogi I k Uredbi (ES) št. 1272/2008, bi izdelki, ki so bili tretirani z glutaraldehidom ali ga vsebujejo, pri dajanju v promet morali biti ustrezno označeni.
Glutaraldehyde is approved as an active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12, subject to the specifications and conditions set out in the Annex.
Glutaraldehid se odobri kot aktivna snov za uporabo v biocidnih proizvodih 2., 3., 4., 6., 11. in 12. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
EC No: 203-856-5
št.
CAS No: 111-30-8
EC: 203-856-5
950 g/kg dry weight (95 %)
št.
30 September 2026
950 g/kg s.s.
Glutaraldehyde is considered a candidate for substitution in accordance with Article 10(1)(b) of Regulation (EU) No 528/2012.
(95 %)
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.
1. oktober 2016
The authorisations of biocidal products are subject to the following conditions.
30. september 2026
For industrial or professional users, safe operational procedures and appropriate organisational measures shall be established.
Glutaraldehid se šteje kot snov za zamenjavo v skladu s členom 10(1)(b) Uredbe (EU) št. 528/2012.
Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
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 pa ni bila obravnavana v oceni tveganja aktivne snovi na ravni Unije.
In view of the risks to professional users, products cannot be applied by wiping unless it can be demonstrated that risks can be reduced to an acceptable level.
Dovoljenja za biocidne proizvode se izdajo pod naslednjimi pogoji:
The placing on the market of treated articles is subject to the following condition.
za industrijske ali poklicne uporabnike se vzpostavijo postopki varnega ravnanja in primerni organizacijski ukrepi.
The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde 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.
Proizvodi se uporabljajo z ustrezno osebno zaščitno opremo, če izpostavljenosti ni mogoče zmanjšati na sprejemljivo raven z drugimi načini;
Application by fogging shall be restricted to trained professionals.
glede na tveganja za poklicne uporabnike se proizvodi ne smejo nanašati z brisanjem, razen če se lahko dokaže, da se tveganja lahko 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.
Za dajanje tretiranih izdelkov v promet velja naslednji pogoj:
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 or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
Oseba, odgovorna za dajanje v promet izdelka, ki je bil tretiran z glutaraldehidom ali pa ga vsebuje, zagotovi, da so na označbi tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
Products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of glutaraldehyde into food or it has been established pursuant to that Regulation that such limits are not necessary.
nanašanje z zamegljevanjem je omejeno na usposobljene poklicne uporabnike;
The person responsible for the placing on the market of a treated article treated with or incorporating glutaraldehyde 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 proizvode, ki lahko povzročajo 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 zmanjšanje tveganja, da se veljavne mejne vrednosti ostankov ne presežejo.
In view of the risks to human health, products intended for non-professional users shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment.
za proizvode, ki lahko povzročajo 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 ali Uredbo Evropskega parlamenta in Sveta (ES) št. 396/2005, in sprejmejo se vsi ustrezni ukrepi za zmanjšanje tveganja, da se veljavne mejne vrednosti ostankov ne presežejo;
In view of the risks to the environment, products shall not be authorised for preservation of drilling and cementing fluids unless it can be demonstrated that risks can be reduced to an acceptable level.
proizvodi, ki vsebujejo glutaraldehid, se ne vključijo v materiale in izdelke, namenjene za stik z živili v smislu člena 1(1) Uredbe (ES) št. 1935/2004, razen če je Komisija določila posebne mejne vrednosti o migraciji glutaraldehida v živila ali če je bilo v skladu z navedeno uredbo določeno, da takšne mejne vrednosti niso potrebne.
The placing on the market of treated articles is subject to the following conditions.
Oseba, odgovorna za dajanje v promet izdelka, ki je bil tretiran z glutaraldehidom ali pa ga vsebuje, zagotovi, da so na označbi tretiranega izdelka navedene informacije iz drugega pododstavka člena 58(3) Uredbe (EU) št. 528/2012.
Mixtures treated with or incorporating glutaraldehyde shall not contain glutaraldehyde at a concentration triggering classification as skin sensitiser, unless exposure can be reduced to an acceptable level by other means than the wearing of personal protective equipment.
glede na tveganja za zdravje ljudi proizvodi, namenjeni nepoklicnim uporabnikom, ne vsebujejo glutaraldehida v koncentraciji, ki povzroči, da se razvrstijo kot povzročitelji preobčutljivosti kože, razen če je mogoče izpostavljenost zmanjšati na sprejemljivo raven drugače kot z uporabo osebne zaščitne opreme;
In view of the risks to the soil and surface water, products shall not be authorised for use in small open recirculating cooling systems, unless it can be demonstrated that risks can be reduced to an acceptable level.
glede na tveganja za okolje se proizvodi ne odobrijo za konzerviranje vrtalnih tekočin in tekočin za cementiranje, razen če se lahko dokaže, da je tveganja mogoče zmanjšati na sprejemljivo raven.
In view of the risks to the environment, products shall not be authorised for preservation of hydrotesting water unless it can be demonstrated that risks can be reduced to an acceptable level.
Za dajanje tretiranih izdelkov v promet veljata naslednja pogoja:
In view of the risks to the environment, products shall not be authorised for use in pulp or paper mills which are not connected to a wastewater treatment plant unless it can be demonstrated that risks can be reduced to an acceptable level.
zmesi, ki so bile tretirane z glutaraldehidom ali ga vsebujejo, ne vsebujejo glutaraldehida v koncentraciji, ki povzroči, da se ravzrstijo kot povzročitelji preobčutljivosti kože, razen če je mogoče izpostavljenost zmanjšati na sprejemljivo raven drugače kot z uporabo osebne zaščitne opreme;
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.
glede na tveganja za tla in površinsko vodo se proizvodi ne odobrijo za uporabo v majhnih odprtih recirkulacijskih hladilnih sistemih, razen če se lahko dokaže, da je tveganja mogoče zmanjšati na sprejemljivo raven;
The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
glede na tveganja za okolje se proizvodi ne odobrijo za konzerviranje vode za hidrostatično preskušanje, razen če se lahko dokaže, da je tveganja mogoče zmanjšati na sprejemljivo raven.
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
glede na tveganja za okolje se proizvodi ne odobrijo za uporabo v tovarnah celuloze ali papirja, ki niso povezane na čistilno napravo za odpadne vode, razen če se lahko dokaže, da je tveganja mogoče zmanjšati na sprejemljivo raven.
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
Čistost, navedena v tem stolpcu, je bila minimalna stopnja čistosti aktivne snovi, uporabljene za oceno v skladu s členom 16(2) Direktive 98/8/ES.
amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards removal from the Union list of the flavouring substance p-mentha-1,8-dien-7-al
o spremembi Priloge I k Uredbi (ES) št. 1334/2008 Evropskega parlamenta in Sveta glede umika aromatične snovi p-menta-1,8-dien-7-al s seznama Unije
Having regard to 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 and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC [1], and in particular Article 11(3) thereof,
ob upoštevanju Uredbe (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 ter spremembi Uredbe Sveta (EGS) št. 1601/91, uredb (ES) št. 2232/96 in (ES) št. 110/2008 ter Direktive 2000/13/ES [1] ter zlasti člena 11(3) Uredbe,
Having regard to 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 [2], and in particular Article 7(6) thereof,
ob upoštevanju 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 [2] in zlasti člena 7(6) Uredbe,
Commission Implementing Regulation (EU) No 872/2012 [3] adopted a list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.
Z Izvedbeno uredbo Komisije (EU) št. 872/2012 [3] je bil sprejet seznam aromatičnih snovi in ta seznam vključen v del A Priloge I k Uredbi (ES) št. 1334/2008.
The flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117) is included in the list as a flavouring substance under evaluation for which additional scientific data must be submitted.
Aromatična snov p-menta-1,8-dien-7-al (št.
Such data has been submitted by the applicant.
FL 05.117) je vključena na seznam kot aromatična snov v postopku ocenjevanja, za katero je treba predložiti dodatne znanstvene podatke.
The European Food Safety Authority evaluated the submitted data and concluded in its scientific opinion of 24 June 2015 [4] that p-mentha-1,8-dien-7-al (FL-no 05.117) is genotoxic in vivo and therefore its use as a flavouring substance raises a safety concern.
Vložnik je te podatke predložil.
The substance p-mentha-1,8-dien-7-al (FL-no 05.117) occurs naturally in the peel of fruits from some plants from the genera Perilla, Citrus and others.
Evropska agencija za varnost hrane je ocenila predložene podatke in je v svojem znanstvenem mnenju z dne 24. junija 2015 [4] navedla, da je p-menta-1,8-dien-7-al (št.
Consequently, that substance should be removed from the list without delay in order to protect human health.
Snov p-menta-1,8-dien-7-al (št.
The Commission should use the urgency procedure for the removal of a substance which raises a safety concern from the Union list.
FL 05.117) je naravno prisotna v lupinah sadja nekaterih rastlin iz rodu Perilla, Citrus in drugih.
Due to low use levels and the low total amount that p-mentha-1,8-dien-7-al (FL-no 05.117) has been added to foods in the Union, the presence of that substance in food does not raise immediate safety concerns.
Komisija bi morala uporabiti nujni postopek za črtanje snovi, ki povzroča zaskrbljenost glede varnosti, s seznama Unije.
Therefore, taking into account also technical reasons, transitional periods should be laid down to cover food containing the flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117), which has been placed on the market or dispatched from third countries for the Union, before the date of entry into force of this Regulation.
Zaradi nizkih ravni uporabe in nizke skupne količine snovi p-menta-1,8-dien-7-al (št.
Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.
FL 05.117), ki je bila dodana živilom v Uniji, prisotnost navedene snovi v živilih ne vzbuja takojšnje zaskrbljenosti glede varnosti.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Zato bi bilo treba ob upoštevanju tehničnih razlogov določiti prehodna obdobja za živila, ki vsebujejo aromatično snov p-menta-1,8-dien-7-al (št.
HAS ADOPTED THIS REGULATION:
FL 05.117) in so bila dana v promet ali poslana v Unijo iz tretjih držav pred datumom začetka veljavnosti te uredbe.
Article 1
Del A Priloge I k Uredbi (ES) št. 1334/2008 bi bilo zato treba ustrezno spremeniti.
Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za rastline, živali, hrano in krmo –
Foods to which the flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117) has been added which were lawfully placed on the market before the date of entry into force of this Regulation may be marketed until their date of minimum durability or use by date.
Člen 1
Foods imported into the Union to which the flavouring substance p-mentha-1,8-dien-7-al (FL-no 05.117) has been added may be marketed until their date of minimum durability or use by date where the importer of such food can demonstrate that they were dispatched from the third country concerned and were en route to the Union before the date of entry into force of this Regulation.
Del A Priloge I k Uredbi (ES) št. 1334/2008 se spremeni v skladu s Prilogo k tej uredbi.
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
Živila, ki jim je bila dodana aromatična snov p-menta-1,8-dien-7-al (št.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
FL 05.117) in so bila zakonito dana na trg pred datumom začetka veljavnosti te uredbe, se lahko tržijo do minimalnega roka trajanja ali datuma uporabe.
Done at Brussels, 1 October 2015.
Živila, uvožena v Unijo, ki jim je dodana aromatična snov p-menta-1,8-dien-7-al (št.
For the Commission
FL 05.117), se lahko tržijo do minimalnega roka trajanja ali datuma uporabe, če uvoznik takih živil lahko dokaže, da so bila poslana iz zadevne tretje države in so bila na poti v Unijo pred datumom začetka veljavnosti te uredbe.
OJ L 354, 31.12.2008, p. 34.
Ta uredba začne veljati dan po objavi v Uradnem listu Evropske unije.
OJ L 354, 31.12.2008, p. 1.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).
V Bruslju, 1. oktobra 2015
Scientific Opinion on Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1): Consideration of genotoxicity data on representatives for 10 alicyclic aldehydes with the α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19.
Za Komisijo
EFSA Journal 2015;13(7):4173, 28 pp. doi:10.2903/j.efsa.2015.4173 Available online: www.efsa.europa.eu/efsajournal
Predsednik
ANNEX
UL L 354, 31.12.2008, str. 34.
In Part A of Annex I to Regulation (EC) No 1334/2008, the following entry is deleted:
UL L 354, 31.12.2008, str. 1.
p-Mentha-1,8-dien-7-al
Izvedbena uredba Komisije (EU) št. 872/2012 z dne 1. oktobra 2012 o sprejetju seznama aromatičnih snovi iz Uredbe (ES) št. 2232/96 Evropskega parlamenta in Sveta, njegovi uveljavitvi v Prilogi I k Uredbi (ES) št. 1334/2008 Evropskega parlamenta in Sveta ter razveljavitvi Uredbe Komisije (ES) št. 1565/2000 in Odločbe Komisije 1999/217/ES (UL L 267, 2.10.2012, str. 1).
EFSA’
Scientific Opinion on Flavouring Group Evaluation 208 Revision 1 (FGE.208Rev1): Consideration of genotoxicity data on representatives for 10 alicyclicaldehydes with the α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19.
Accordingly the use of p-mentha-1,8-dien-7-al (FL-no 05.117) does not comply with the general conditions of use for flavourings set out in Article 4(a) of Regulation (EC) No 1334/2008.
EFSA Journal 2015;13(7):4173, 28 str. doi:10.2903/j.efsa.2015.4173 Na voljo na spletu: www.efsa.europa.eu/efsajournal.
Commission Implementing Regulation (EU) 2015/1761
Izvedbena uredba Komisije (EU) 2015/1761
amending Commission Regulation (EC) No 378/2005 as regards the Community Reference Laboratory reports, fees and the laboratories listed in Annex II thereto
o spremembi Uredbe (ES) št. 378/2005 glede poročil referenčnih laboratorijev Skupnosti, pristojbin in laboratorijev iz Priloge II k Uredbi
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition [1], and in particular the first subparagraph of Article 7(4) and the third paragraph of Article 21 thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 z dne 22. septembra 2003 o dodatkih za uporabo v prehrani živali [1] in zlasti prvega pododstavka člena 7(4) in tretjega odstavka člena 21 Uredbe,
Regulation (EC) No 1831/2003 establishes the procedure for authorising the placing on the market and use of feed additives in animal nutrition.
Uredba (ES) št. 1831/2003 določa postopek za izdajo dovoljenja za dajanje na trg in uporabo krmnih dodatkov v prehrani živali.
It provides that any person seeking authorisation for a feed additive or a new use of a feed additive is to submit an application for authorisation in accordance with that Regulation.
Določa, da mora vsaka oseba, ki želi pridobiti dovoljenje za krmni dodatek ali novo uporabo krmnega dodatka, vložiti vlogo za izdajo dovoljenja v skladu z navedeno uredbo.
Commission Regulation (EC) No 378/2005 [2] lays down detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards applications for authorisation of a feed additive or for a new use of a feed additive and the duties and tasks of the Community Reference Laboratory (‘CRL’).
Uredba Komisije (ES) št. 378/2005 [2] določa podrobna pravila za izvajanje Uredbe (ES) št. 1831/2003 glede vlog za izdajo dovoljenja za krmne dodatke ali novo uporabo krmnega dodatka ter dolžnosti in nalog referenčnega laboratorija Skupnosti.
Article 5 of Regulation (EC) No 378/2005 provides that the CRL is to submit a full evaluation report to the European Food Safety Authority (‘the Authority’) for each application for authorisation of a feed additive.
Člen 5 Uredbe (ES) št. 378/2005 določa, da referenčni laboratorij Skupnosti Evropski agenciji za varnost hrane (v nadaljnjem besedilu: Agencija) za vsako vlogo za izdajo dovoljenja za krmni dodatek predloži popolno ocenjevalno poročilo.
Exceptions to the requirement to submit an evaluation report are made for applications for a new use of a feed additive or applications for changing the terms of an existing authorisation, provided that the proposed conditions for the new use or for the change in the terms of the authorisation fall within the scope of the method of analysis previously submitted in accordance with the requirements laid down in Annex II to Commission Regulation (EC) No 429/2008 [3] and already evaluated.
Izjeme pri zahtevi za predložitev ocenjevalnega poročila so vloge za novo uporabo krmnega dodatka ali vloge za spremembo pogojev obstoječega dovoljenja, če predlagani pogoji za novo uporabo ali za spremembo pogojev dovoljenja vključujejo analitsko metodo, ki je predložena v skladu z zahtevami iz Priloge II k Uredbi Komisije (ES) št. 429/2008 [3], in so že ocenjeni.
Furthermore, Article 4 of that Regulation provides that the CRL is to charge applicants fees for submitting applications for authorisation.
Poleg tega člen 4 navedene uredbe določa, da referenčni laboratorij Skupnosti vložniku zaračuna pristojbino za vložitev vlog za izdajo dovoljenja.
Exception is made where no samples are required and the CRL does not need to issue a report, as the method of analysis has already been evaluated.
Izjema so primeri, ko se ne zahtevajo vzorci in referenčnemu laboratoriju Skupnosti ni treba izdati poročila, ker je bila analitska metoda že ocenjena.