natgillin/translations-raw huggingface dataset:
Ne glede na to je pomembno upoštevati potrebe različnih zainteresiranih strani, zato je v nadaljevanju podanih več predlogov.
It is, however, important to ensure that the needs of the various stakeholders are addressed and for this reason a range of proposals have been outlined below.
Predlagane spremembe
Proposed Amendments
Razširjen centralizirani postopek odobritve
Extended Centralised Authorisation Procedure
Pripravljavec mnenja pozdravlja predloge za uvedbo možnosti centraliziranega postopka za odobritev aktivnih snovi in biocidnih pripravkov za proizvajalce.
The draftsman welcomes the proposals to introduce the option of a centralised authorisation procedure for active substances and biocidal products for producers.
Zdi se, da sedanja opredelitev biocidnega pripravka z nizkim tveganjem določa ta postopek za preveč omejeno kategorijo pripravkov, zato pripravljavec mnenja priporoča delno razširitev te kategorije.
The current definition of a "low-risk biocidal product" appears to limit this procedure to an unduly restrictive category of products and the draftsman recommends a partial widening of this category.
Tudi datum pregleda uredbe bi bilo treba z leta 2023 pomakniti na 2016, da se omogoči pregled in morebitna razširitev centralnega postopka odobritve, če bo učinkovit.
The review date for the regulation should also be brought forward from 2023 to 2016 to allow for a review and possible expansion of the central authorisation procedure if it is operating effectively.
Poleg tega bi morale države članice vzpostaviti službe za pomoč uporabnikom kot dopolnitev smernic, ki jih zagotavlja Evropska agencija za kemikalije (ECHA).
In addition, Member States should establish helpdesks to supplement the guidance documents provided by the European Chemicals Agency (ECHA).
Določanje rokov
Streamlining of Deadlines
V predlogu je treba, kjer je mogoče, določiti specifične časovne okvire, da se industriji omogoči načrtovanje vnaprej.
Throughout the proposal, specific timeframes should be set where possible to allow industry to plan ahead.
Določiti je treba časovne načrte za različne faze ocenjevanja dokumentacije.
There should be set timelines for the different stages of evaluation of a dossier.
Kjer je mogoče , je treba roke skrajšati, da se zagotovi kar največja učinkovitost postopka odobritve.
Deadlines should be shortened, where viable, to ensure the greatest possible efficiency in the authorisation process.
Okrepitev raziskav in razvoja
Enhancing Research and Development (R&D)
Omogočiti je treba več raziskav in razvoja v tej panogi, ki lahko v veliki meri vpliva na varstvo okolja in zdravje ljudi.
It is appropriate to facilitate greater R&D in an industry critical to the protection of environmental and human health.
V skladu s predlogom je za poskuse oziroma preskuse, ki utegnejo vključevati sproščanje nedovoljenega biocidnega pripravka v okolje, potrebno nacionalno dovoljenje.
Under the proposal, experiments/tests which may involve the release of an unauthorised biocidal product into the environment require a national authorisation.
Uvesti bi bilo treba enostavnejši postopek priglasitve, ki bi pristojnemu organu sicer še vedno omogočal določitev strožjih pogojev, vendar zapleten sistem izdajanja dovoljenj ne bi smel biti pravilo.
A simpler notification procedure should be put in place which still allows the competent authority to issue more stringent conditions, but where burdensome authorisation is not a default option.
Okvirne formulacije
Frame Formulations
Pripravljavec mnenja za večjo učinkovitost predlaga razlikovanje med upravnimi, manjšimi in večjimi spremembami odobritev za okvirne formulacije.
In the interests of efficiency, the draftsman proposes distinguishing between administrative, minor and major amendments regarding authorisations for frame formulations.
Upravne spremembe bi bilo mogoče obravnavati po poenostavljenem postopku priglasitve, manjše spremembe v skrajšanem obdobju ocenjevanja, pri večjih spremembah pa bi bilo obdobje ocenjevanja lahko sorazmerno z obsegom predlagane spremembe.
Administrative amendments could be processed via a simplified notification procedure; minor amendments could be assessed in a reduced evaluation period; and, for major changes, the evaluation period could be proportionate to the extent of the proposed change.
Poleg tega pripravljavec mnenja za zagotovitev pomoči proizvajalcem priporoča, da se vsem biocidnim pripravkom, ki sodijo v ta okvir, dodeli ena sama številka odobritve.
In addition, in order to assist producers, the draftsman recommends that one single authorisation number be provided for all biocidal products which belong to that frame.
Merila za izključitev
Exclusion Criteria
Glede meril za izključitev pripravljavec mnenja meni, da je bila izključitev nekaterih vrst pripravkov aktivnih snovi (4 ter 14 do 19) iz splošnega testa za odobritev po nepotrebnem omejevalna.
In regard to exclusion criteria, the draftsman felt that excluding certain active substance product types (4 and 14 to 19) from the general authorisation test was unnecessarily restrictive.
Vse vrste pripravkov bi moralo biti mogoče ocenjevati v skladu z merili.
It should be possible for all product types to be assessed according to the criteria.
Prepoved tovrstnih pripravkov po zakonodaji o fitofarmacevtskih sredstvih ne upravičuje takšne prepovedi (z redkimi izjemami) v zakonodaji o biocidnih pripravkih, saj se pesticidi in biocidni pripravki med seboj razlikujejo glede na uporabo in raven izpostavljenosti.
Banning such products under the plant protection legislation does not justify such a ban (with narrow exceptions) under the biocides legislation because pesticides and biocides have different uses and different levels of exposure.
Jezikovne zahteve
Language Requirements
Edina zahteva bi morala biti, da so vloge za odobritev izdelka in označevanje izdelka le v enem uradnem jeziku zadevne države članice (če jih je več), da se prepreči nepotrebno obremenjevanje industrije.
It should only be a requirement that product authorisation applications and product labelling are in only one of the official languages of the relevant Member State (if more than one) to avoid an excessive burden for industry.
Vrsto biocidnega pripravka 20 (sredstva za konzerviranje hrane ali krme) je treba ohraniti, vendar je treba spremeniti njeno opredelitev, saj ti pripravki niso konzervansi, temveč dezinfekcijska sredstva.
It is necessary to keep biocidal product type 20 (‘Preservatives for food or feedstocks’) but its definition needs to be amended, since these biocidal products are not preservatives but disinfectants.
Prav tako ne delujejo kot konzervansi, ki bi preprečevali slabšanje živalske krme.
Neither do they act as preservatives to prevent animal feed from deteriorating.
Zato je treba te pripravke obravnavati kot dezinfekcijska sredstva.
These products must be therefore considered as disinfectant agents.
(24) Da bi olajšali dostop do notranjega trga, se izognili dodatnim stroškom in prihranili čas, potreben za pridobitev posameznih nacionalnih dovoljenj v posameznih državah članicah, lahko Komisija ob upoštevanju izkušenj z določbami o dovoljenjih Skupnosti odloči, da razširi področje uporabe postopka izdaje dovoljenj Skupnosti na druge biocidne pripravke.
(24) In order to facilitate access to the internal market and to avoid the additional costs and time involved in obtaining separate national authorisations in separate Member States, the Commission , taking into account the experience with the provisions on Community authorisations, may decide to extend the scope of the Community authorisation procedure to other biocidal products.
(24) Da bi olajšali dostop do notranjega trga, se izognili dodatnim stroškom in prihranili čas, potreben za pridobitev posameznih nacionalnih dovoljenj v posameznih državah članicah, je Komisija odločila, da uvede postopek izdaje dovoljenj Skupnosti za vse biocidne pripravke.
(24) In order to facilitate access to the internal market and to avoid the additional costs and time involved in obtaining separate national authorisations in separate Member States, the Commission has decided to introduce a Community authorisation procedure for all biocidal products.
(31a) V pomoč predlagateljem, zlasti malim in srednje velikim podjetjem, pri izpolnjevanju zahtev te uredbe bi morale države članice poleg navodil, ki jih zagotovi agencija, vzpostaviti nacionalne službe za pomoč uporabnikom.
(31a) In order to help applicants, and in particular SMEs, to comply with the requirements of this Regulation, Member States, in addition to the operational guidance documents provided by the Agency, should establish national helpdesks.
(45) Glede na koristi za notranji trg in potrošnika je zaželeno, da se oblikujejo usklajena pravila za vzporedno trgovino za med sabo podobne biocidne pripravke, ki so odobreni v različnih državah članicah.
(45) In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trade of identical biocidal products that are authorised in different Member States.
Vzporedno trgovanje mora biti omejeno na pripravke, ki imajo enake tehnične specifikacije in vsebujejo enake aktivne snovi in pomožne snovi v formulaciji.
Parallel trade should be confined to identical products which have the same specifications and contain the same active substances and co-formulants.
(48) Predlagateljem, ki so vložili denar v podporo vključitve aktivne snovi v Prilogo I ali izdaje dovoljenja za biocidni pripravek v skladu z določbami te uredbe in/ali določbami Direktive 98/8/ES , mora biti omogočeno, da dobijo nazaj del njihove naložbe s prejetjem pravičnega nadomestila, kadar koli se zaščitena informacija, ki so jo predložili v podporo takšne vključitve ali izdaje dovoljenja, uporabi v korist poznejših predlagateljev.
(48) Applicants that have invested in supporting the inclusion of an active substance in Annex I or in the authorisation of a biocidal product in accordance with the provisions of this Regulation and/or those of Directive 98/8/EC should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such inclusions or authorisations is made for the benefit of subsequent applicants.
Ne sme se izključiti tistih, ki so vložili denar v okviru veljavnega pravnega okvira.
Those who have undertaken investment under the existing legislation must not be excluded.
(49) Zaradi zagotovitve, da se vse zaščitene informacije, predložene v podporo vključitve aktivne snovi v Prilogi I ali za izdajo dovoljenja za biocidni pripravek, zaščitijo od trenutka njihove predložitve in da se prepreči, da bi bile katere koli informacije nezaščitene, morajo določbe o obdobjih za varstvo podatkov veljati tudi za informacije, predložene za namene Direktive 98/8/ES.
(49) In view of ensuring that all proprietary information submitted in support of an inclusion of an active substance in Annex I or an authorisation of a biocidal product is protected from the moment of its submission and to prevent situations where some information is without protection, the provision on information protection periods should also apply to information submitted for the purposes of Directive 98/8/EC.
Zaradi jasnosti.
In the interests of clarity .
(61) Zlasti mora Komisija imeti pooblastilo za sprejetje ukrepov o odločanju o vlogah za vključitev aktivne snovi v Prilogo I ali za obnovitev ali ponovni pregled vključitve, za natančno določitev postopkov, povezanih s ponovnim pregledom ali obnovitvijo vključitve aktivne snovi v Prilogo I, za natančno določitev meril in postopkov, povezanih s preklicem dovoljenja ali spremembi pogojev za dovoljenje, vključno z mehanizmom za reševanjem sporov, za natančno določitev splošno veljavnih največjih količin aktivnih snovi ali biocidnih pripravkov, ki se jih sme sprostiti med preskusi, ter najnujnejših podatkov, ki jih je treba predložiti, za oblikovanje usklajene strukture pristojbin in drugih pravil v zvezi s plačili pristojbin in stroškov pristojnim organom in agenciji, za prilagajanje prilog znanstvenemu in tehničnemu napredku, za izvajanje delovnega programa in natančno določitev povezanih pravic in dolžnosti pristojnih organov in udeležencev v programu ter za podaljšanje delovnega programa za določeno obdobje.
(61) In particular, the Commission should be empowered to adopt measures to decide on the application to include the active substance in Annex I or to renew or review the inclusion, to specify the procedures related to the renewal and review of an inclusion of an active substance in Annex I, to specify the criteria and procedures related to a cancellation of an authorisation or amendments of the terms and conditions of an authorisation, including a dispute settlement mechanism, to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted, to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competent authorities and the Agency, to adapt the Annexes to scientific and technical progress, to carry out the work programme and to specify the related rights and obligations of the competent authorities and the participants in the programme and to extend the duration of the work programme for a determined period.
(66) Ob upoštevanju, da nekateri pripravki niso bili predhodno zajeti v zakonodajo Skupnosti na področju biocidnih pripravkov, je primerno, da se omogoči prehodno obdobje, da se podjetja pripravijo na uporabo pravil v zvezi z aktivnimi snovmi, pridobljenimi na kraju samem, tretiranimi izdelki in snovmi ter snovmi, ki so v stiku s živili .
(66) Taking into consideration that some products were not previously covered by the Community legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances, treated articles and materials and food contact materials .
(66) Ob upoštevanju, da nekateri pripravki niso bili predhodno zajeti v zakonodajo Skupnosti na področju biocidnih pripravkov, je primerno, da se omogoči prehodno obdobje, da se podjetja pripravijo na uporabo pravil v zvezi z aktivnimi snovmi, pridobljenimi na kraju samem, tretiranimi izdelki in snovmi.
(66) Taking into consideration that some products were not previously covered by the Community legislation in the field of biocidal products, it is appropriate to allow for a transitional period for the companies to be prepared to apply the rules concerning in situ generated active substances, treated articles and materials.
Snovi, ki so v stiku z živili, že ureja Uredba (ES) št. 1935/2004, zato ne bi smele biti vključene v področje uporabe tega predloga, saj bi to povzročilo dvojno ocenjevanje in urejanje.
Food contact materials are already governed by Regulation (EC) No 1935/2004.
Morebitne vrzeli v zakonodaji bi bilo treba popraviti s spremembo uredbe o snoveh, ki so v stiku s živili.
Such materials should not fall within the scope of the proposal, as that would result in duplication of evaluation and regulation.
Člen 2 –odstavek 2 – točka p a (novo)
Article 2 – paragraph 2 – point p a (new)
(pa) Uredbe (ES) št. 1935/2004 Evropskega parlamenta in Sveta z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili 1 ;
(pa) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food 1 .
1 UL L 338, 13.11.2004, str.
1 OJ L 338, 13.11.2004, p.
Člen 3 – odstavek 1 – točka f – pododstavek 2 a (novo)
Article 3 – paragraph 1 – point f – subparagraph 2 a (new)
Če ni drugih razlogov za zaskrbljenost, bi bilo treba takšno snov v skladu z Direktivo 67/548/EGS z dne27. junija 1967 praviloma opredeliti kot nevarno in bi bila v biocidnem pripravku prisotna v koncentraciji, zaradi katere bi pripravek veljal za nevarnega v skladu z določbami Direktive 1999/45/ES ali Uredbe (ES) št. 1272/2008.
Unless there are other grounds for concern, such a substance shall be a substance classified as hazardous pursuant to Directive 67/548/EEC and be present in the biocidal product in a concentration such as to require it to be regarded as hazardous within the meaning of Directive 1999/45/EC or Regulation (EC) No 1272/2008.
Gre za opredelitev, ki je že v Direktivi 98/8/ES in ki bi jo bilo treba zaradi jasnosti vključiti v novo uredbo.
The definition is already to be found in Directive 98/8/EC, and should be incorporated in the new Regulation in the interests of clarity.
vsaka snov, mešanica, material ali izdelek, ki je bil tretiran z biocidnimi pripravki ali jih vsebuje, z namenom, da se snov, mešanica, material ali izdelek zaščiti pred kvarjenjem, ki ga povzročajo škodljivi organizmi ;
any substance, mixture, material or article which was treated with or incorporates one or more biocidal products with the intention to protect the substance, mixture, material or article from deterioration caused by harmful organisms ;
vsaka snov, mešanica, material ali izdelek, ki je bil tretiran z biocidnimi pripravki ali jih vsebuje, z namenom, da pridobi biocidni učinek, ki ustreza njegovi rabi ;
any substance, mixture, material or article which was treated with or incorporates one or more biocidal products with the intention to produce the biocidal effect which is their purpose ;
Predlog spremembe razširi opredelitev tretiranih snovi ali izdelkov, da bi vključevala izdelke, kot so barve, ki so bile konzervirane, pa tudi izdelke z zunanjim učinkom, kot so mreže proti komarjem.
This amendment extends the definition of treated articles and materials to include both articles such as paints which have been preserved and articles with an external effect, such as mosquito nets.
Izvede se torej kemijska ocena.
The evaluation is thus a chemical one.
Člen 3 – odstavek l – točka n
Article 3 – paragraph 1 – point n
nacionalno dovoljenje ali dovoljenje Skupnosti;
national authorisation or Community authorisation;
prvo nacionalno dovoljenje ali dovoljenje Skupnosti ali drugo ali dodatno dovoljenje ;
primary national or Community authorisation , or duplicate authorisation or additional authorisation ;
Člen 3 – odstavek 1 – točka n a (novo)
Article 3 – paragraph 1 – point n a (new)
(na) „drugo dovoljenje“
(na) 'duplicate authorisation' means
upravni akt – v korist imetnika prvega dovoljenja – s katerim država članica ali Komisija odobri dajanje enakega biocidnega pripravka v promet in njegovo uporabo pod drugim tržnim imenom;
an administrative act by which, for the benefit of the holder of a primary authorisation, a Member State or the Commission authorises the placing on the market and the use of the same biocidal product under a different name;
Člen 3 – odstavek 1 – točka n b (novo)
Article 3 – paragraph 1 – point n b (new)
(nb) „dodatno dovoljenje“
(nb) 'additional authorisation' means
upravni akt, s katerim država članica ali Komisija odobri dajanje biocidnega pripravka v promet in njegovo uporabo pod drugim tržnim imenom, in sicer na podlagi prvega dovoljenja in sporazumno z njegovim imetnikom;
an administrative act by which a Member State or the Commission authorises the placing on the market and the use, under a different name, of a biocidal product based on a primary authorisation and on approval by the holder of the primary authorisation;
(p) „okvirna formulacija“
(p) 'frame formulation' means
skupina biocidnih pripravkov, ki imajo podobne uporabe in so omejene različice referenčnega biocidnega pripravka iz te skupine, ki vsebuje iste aktivne snovi istih specifikacij , ki pa ne vplivajo škodljivo na raven tveganja , povezano z njimi, in njihovo učinkovitost zaradi dovoljenih razlik v njihovi sestavi ;
a group of biocidal products having similar uses and presenting limited variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products ;
skupina biocidnih pripravkov, ki imajo podobne uporabe in so različice referenčnega biocidnega pripravka iz te skupine, ki vsebuje iste aktivne snovi istih specifikacij, če kljub razlikam ne povzročajo večjega tveganja v primerjavi z referenčnim biocidnim pripravkom in ohranjajo oglaševano učinkovitost delovanja na ciljne organizme ;
a group of biocidal products having similar uses and presenting variations in their composition with regard to a reference biocidal product belonging to that group which contains the same active substances of the same specifications , provided that, irrespective of these variations, the level of risk does not exceed that attached to the reference biocidal products and the efficacy on the target organism corresponds to what is indicated on the label of the product ;
Pomembno je, da se raven tveganja v primerjavi z referenčnim biocidnim pripravkom ne poveča in da se ohrani oglaševana učinkovitost delovanja na ciljne organizme.
It is important to establish that the risk potential must not be greater than that of the reference biocidal product and that the efficacy on the target organisms is consistent with the product label.
originalni dokument, ki so ga podpisali lastnik ali lastniki informacij ali njihov pooblaščenec , v katerem je navedeno, da lahko imenovani pristojni organ, Evropska agencija za kemikalije ali Komisija uporabljajo informacije, in sicer za ocenjevanje aktivne snovi ali podelitev dovoljenja v korist tretje strani ;
an original document, signed by the owner or owners of information or their representative , which states that the information may be used by the designated competent authorities, the European Chemicals Agency, or the Commission for the purpose of evaluating an active substance or granting an authorisation to a third party ;
Pojasniti je treba opredelitev izjave o dostopnosti.
It is felt necessary to clarify the definition of 'letter of access'.
Člen 3 – odstavek l – točka s
Article 3 – paragraph 1 – point s
(s) „snovi, ki so v stiku z živili“
(s) 'food contact materials' means
Člen 3 – odstavek 1 – točka a (novo)
Article 3 – paragraph 1 – point t a (new)
(ta) „upravna sprememba“ sprememba obstoječega dovoljenja, ki je povsem upravne narave in ne zajema ponovne ocene tveganja za javno zdravje ali okolje in učinkovitosti proizvoda;
(ta) 'administrative change' means a variation to an existing authorisation of a purely administrative nature, which does not involve a re-assessment of the risk for public health or the environment or the efficacy of the product ;
Opredeliti je treba vrste sprememb, ki so mogoče pri obstoječem dovoljenem biocidnem pripravku.
It is necessary to define the type of variations that can be made to an existing authorised biocidal product.
(tb) „manjša sprememba“ sprememba obstoječega dovoljenja, ki je ne moremo šteti za upravno spremembo, saj zahteva manjšo ponovno oceno tveganja za javno zdravje ali okolje in/ali učinkovitosti proizvoda ter ne vpliva negativno na stopnjo tveganja za javno zdravje ali okolje in na učinkovitost proizvoda.
(tb) 'minor change' means a variation to an existing authorisation which cannot be deemed to be an administrative variation as it requires a limited re-assessment of the risk for public health or the environment and/or of the efficacy of the product, and does not adversely affect the level of risk for public health or the environment and the efficacy of the product ;
(tc) „večja sprememba“ sprememba obstoječega dovoljenja, ki ne more šteti za upravno ali manjšo spremembo.
(tc) 'major change' means a variation to an existing authorisation which cannot be deemed to be an administrative change or a minor change ;
Člen 3 – odstavek l – točka u a (novo)
Article 3 – paragraph 1 – point u a (new)
(ua) „MSP“ mala in srednje velika podjetja, kakor so opredeljena v priporočilu Komisije 2003/361/ES z dne 6. maja 2003 o opredelitvi mikro, malih in srednje velikih podjetij 1 .
(ua) 'SMEs' mean small and medium-sized enterprises as defined in the Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium - sized enterprises 1 .