natgillin/translations-raw huggingface dataset:
point (g) is replaced by the following:
zagotavljanje podpore posameznikom ali subjektom, vključno z oboroženimi skupinami ali kriminalnimi mrežami, ki z nezakonitim izkoriščanjem ali trgovanjem z naravnimi viri, med drugim z zlatom ali divjimi živalmi in proizvodi iz takih živali, sodelujejo pri dejavnostih za destabilizacijo DR Kongo;“.
supporting individuals or entities, including armed groups or criminal networks, involved in destabilizing activities in the DRC through the illicit exploitation or trade of natural resources, including gold or wildlife as well as wildlife products;’.
Člen 2
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.
V Bruslju, 18. julija 2016
Done at Brussels, 18 July 2016.
Za Svet
The President
Sklep Sveta 2010/788/SZVP z dne 20. decembra 2010 o omejitvenih ukrepih proti Demokratični republiki Kongo in razveljavitvi Skupnega stališča 2008/369/SZVP (UL L 336, 21.12.2010, str. 30).
Commission Implementing Decision (EU) 2016/1174
Izvedbeni sklep Komisije (EU) 2016/1174
of 15 July 2016
z dne 15. julija 2016
on the terms and conditions of the authorisation of a biocidal product containing difenacoum referred by Spain in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council
o določilih in pogojih za izdajo dovoljenja za biocidni proizvod, ki vsebuje difenakum, ki jih je predložila Španija v skladu s členom 36 Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta
(notified under document C(2016) 4380)
(notificirano pod dokumentarno številko C(2016) 4380)
The company Will Kill S.A. (‘the applicant’) submitted a complete application to France (‘the Member State concerned’) on 20 December 2013 for the mutual recognition of an authorisation granted by Spain (‘the reference Member State’) in respect of a rodenticide biocidal product containing the active substance difenacoum as a liquid formulation (‘the contested product’).
Podjetje Will Kill S.A. (v nadaljnjem besedilu: vložnik) je 20. decembra 2013 pri pristojnih organih Francije (v nadaljnjem besedilu: zadevna država članica) vložilo popolno vlogo za medsebojno priznavanje dovoljenja, ki ga je izdala Španija (v nadaljnjem besedilu: referenčna država članica) v zvezi z rodenticidnim biocidnim proizvodom, ki vsebuje aktivno snov difenakum v obliki tekoče formulacije (v nadaljnjem besedilu: sporni proizvod).
The reference Member State authorised the contested product for use against mice and the rat species Rattus norvegicus (‘rats’) for use indoors and in and around buildings by professional users, and outdoors by trained professional users only.
Referenčna država članica je za sporni proizvod izdala dovoljenje za uporabo proti vrstam miši in vrsti podgan Rattus norvegicus (v nadaljnjem besedilu: podgane) za uporabo v zaprtih prostorih, v in okoli stavb s strani poklicnih uporabnikov ter na prostem samo s strani usposobljenih poklicnih uporabnikov.
The contested product is supplied in non-reusable bottles together with a roll-on dispenser and a bait station (‘the device’) in order to avoid primary and secondary poisoning.
Sporni proizvod je dobavljen v stekleničkah s kroglico za enkratno uporabo in postajo za nastavljanje vabe (v nadaljnjem besedilu: pripomoček), da se preprečita primarna in sekundarna zastrupitev.
After use, the whole device is to be disposed of in order to avoid exposure to the user.
Po uporabi je treba zavreči celotni pripomoček, da se prepreči izpostavljenost uporabnika.
Pursuant to Article 35(2) of Regulation (EU) No 528/2012, the Member State concerned referred a number of points of disagreement to the coordination group indicating that the contested product does not meet the conditions laid down in Article 19(1)(b)(i), (iii) and (iv) of that Regulation.
V skladu s členom 35(2) Uredbe (EU) št. 528/2012 je zadevna država članica koordinacijski skupini predložila več spornih točk, ki kažejo, da sporni proizvod ne izpolnjuje pogojev iz člena 19(1)(b)(i), (iii) in (iv) navedene uredbe.
The coordination group secretariat invited the other Member States and the applicant to submit written comments about the referral.
Sekretariat koordinacijske skupine je druge države članice in vložnika pozval k predložitvi pisnih pripomb na sporno točko.
Austria, France, Germany, Italy, the Netherlands, Norway, Portugal, Spain, Sweden, the United Kingdom and the applicant submitted comments.
Pripombe so predložili Avstrija, Francija, Italija, Nemčija, Nizozemska, Norveška, Portugalska, Španija, Švedska, Združeno kraljestvo in vložnik.
The identified points of disagreement were discussed by the Member States' competent authorities for biocidal products in the coordination group's meetings of 23 January and 17 March 2015.
Ugotovljene sporne točke so obravnavali pristojni organi držav članic za biocidne proizvode na sestankih koordinacijske skupine 23. januarja in 17. marca 2015.
Pursuant to Article 36(1) of Regulation (EU) No 528/2012, the reference Member State provided the Commission with a detailed statement of the matters on which Member States were unable to reach agreement and the reasons for their disagreement on 30 June 2015.
V skladu s členom 36(1) Uredbe (EU) št. 528/2012 je referenčna država članica Komisiji 30. junija 2015 predložila podroben opis zadev, o katerih države članice niso mogle doseči dogovora, ter razloge za njihovo nestrinjanje.
A copy of that statement was also forwarded to the Member States concerned and the applicant.
Izvod tega opisa je bil poslan tudi zadevnim državam članicam in vložniku.
The unresolved objections referred to the Commission concerned the efficacy of the contested product against rats and mice, which was insufficiently demonstrated in well-documented field trials; the efficacy in Member States with wet climates, which might be reduced as a result of the target organisms having easier access to water; the efficiency of the device as a risk mitigation measure to avoid leaching; and an unacceptable risk to the health of users during the cleaning of bait stations.
Nerešeni ugovori, ki so bili predloženi Komisiji, so zadevali: učinkovitost spornega proizvoda na podgane in miši, ki ni bila zadostno dokazana v dobro dokumentiranih terenskih študijah; morebitno manjšo učinkovitost v državah članicah z vlažnim podnebjem, kjer imajo ciljni organizmi lažji dostop do vode; učinkovitost pripomočka kot ukrepa za zmanjševanje tveganja, da se prepreči izpiranje; ter nesprejemljivo tveganje za zdravje uporabnikov med čiščenjem postaj za nastavljanje vabe.
Pursuant to paragraph 12 of Annex VI to Regulation (EU) No 528/2012, the reference Member State considered the contested product to be sufficiently effective on the basis of field data generated by using a prototype device and the judgment of its experts.
V skladu z odstavkom 12 Priloge VI k Uredbi (EU) št. 528/2012 je referenčna država članica na podlagi podatkov s terena, pridobljenih s prototipnim pripomočkom, in presoje svojih strokovnjakov, menila, da je sporni proizvod dovolj učinkovit.
That conclusion was conditional, however, on the submission of field data corroborating those findings.
Ta sklep pa je bil pogojen s predložitvijo podatkov s terena, ki potrjujejo te ugotovitve.
The reference Member State concluded that the results of the field trials submitted by the applicant demonstrate an acceptable level of efficacy in accordance with the criteria established in the Union guidance on efficacy evaluation of rodenticides [2].
Referenčna država članica je ugotovila, da rezultati terenskih študij, ki jih je predložil vložnik, dokazujejo sprejemljivo raven učinkovitosti v skladu z merili iz smernic Unije za ocenjevanje učinkovitosti rodenticidov [2].
Concerning efficacy in wet climates, the indoor use of the product in areas where abundant food or feed is available to rodents shows no significant difference across Member States.
V povezavi z učinkovitostjo v vlažnem podnebju uporaba proizvoda v zaprtih prostorih na površinah, kjer je glodalcem na voljo veliko hrane in krme, ne kaže bistvenih razlik med državami članicami.
Regarding use in and around buildings and outdoors, the product authorisation already includes a condition to restrict the use of the product to situations where it is difficult to access water.
V zvezi z uporabo v in okoli stavb ter na prostem dovoljenje za proizvod že vključuje pogoj, da se uporaba proizvoda omeji v primerih, kadar je dostop do vode otežen.
Given that the product was sufficiently effective in field trials in areas with full access to water, the product authorisation should not be subject to any restriction on the grounds of specific weather conditions.
Glede na to, da je bil v terenskih študijah na površinah s popolnim dostopom do vode proizvod dovolj učinkovit, za dovoljenje za proizvod ne bi smele veljati nobene omejitve zaradi posebnih vremenskih razmer.
The reference Member State considered the device to be a suitable risk mitigation measure to prevent spillage and avoid primary and secondary poisoning compared to the application of the contested product in open trays.
Referenčna država članica je menila, da je pripomoček ustrezen ukrep za zmanjševanje tveganja, da se preprečijo razlitje ter primarna in sekundarna zastrupitev, v primerjavi z uporabo spornega proizvoda v odprtih posodicah.
This conclusion was confirmed in the field trials where spillage only occurred twice due to an accident with agriculture machinery or vandalism.
Ta ugotovitev je bila potrjena s terenskimi študijami, pri katerih je do razlitja prišlo samo dvakrat zaradi nesreče s kmetijskimi stroji ali vandalizma.
In order to limit accidental spillage as much as possible, the product authorisation should include additional instructions for use such as fixing the bait station to the ground and a recommendation that in the event of an accidental spillage, the bait station is to be disposed of as hazardous waste.
Da bi se nenamerno razlitje čim bolj omejilo, bi dovoljenje za proizvod moralo vključevati dodatna navodila za uporabo, kot je pritrditev postaje za nastavljanje vabe na tla in priporočilo, da se v primeru nenamernega razlitja postaja zavrže kot nevaren odpadek.
The reference Member State assessed the health risk to users of the product by using a model developed for solid bait formulations and by using very conservative parameters under a worst case scenario.
Referenčna država članica je ocenila tveganje za zdravje uporabnikov proizvoda z uporabo modela, razvitega za formulacije v obliki trdne vabe, in z uporabo konservativnih parametrov v okviru najslabšega možnega scenarija.
As an unacceptable risk to the user was identified, a risk mitigation measure was introduced stating that the device was to be disposed of after use in order to prevent any potential exposure during the cleaning of the bait stations.
Ugotovljeno je bilo nesprejemljivo tveganje za uporabnika, zato je bil uveden ukrep za zmanjševanje tveganja z navedbo, da je treba pripomoček po uporabi zavreči, da se prepreči morebitna izpostavljenost med čiščenjem postaj za nastavljanje vabe.
The product authorisation has been subject to an agreed change based on a recalculation of the risk to human health as a result of exposure to the contested product based on a product-specific dermal absorption study and new parameters generated by the applicant based on the real use of the contested product (for example the number of splashes to which the user may be exposed as well as the droplet size of the splash).
Dovoljenje za proizvod je bilo spremenjeno na podlagi ponovnega izračuna tveganja za zdravje ljudi zaradi izpostavljenosti spornemu proizvodu, ki je temeljil na študiji dermalne absorpcije za ta proizvod in na novih parametrih vložnika glede na dejansko uporabo spornega proizvoda (na primer število pljuskov, ki jim je uporabnik lahko izpostavljen, in velikost kapljic v pljusku).
Given the risk of accidental splash, additional risk mitigation measures should be included in the authorisation.
Glede na tveganje za nenameren pljusk bi bilo v dovoljenje treba vključiti dodatne ukrepe za zmanjševanje tveganja.
Those measures should include restricting use to trained professional users only and the specification that users wear protective gloves.
Ti ukrepi bi morali biti omejevalni, da bi proizvod lahko uporabljali samo usposobljeni poklicni uporabniki, in vsebovati specifikacijo, da morajo uporabniki nositi zaščitne rokavice.
Taking into account that trained professional users are expected to follow the instructions for use closely, the contested product is expected to be safe for this category of user under the proposed terms and conditions.
Ker se od usposobljenih poklicnih uporabnikov pričakuje, da bodo natančno sledili navodilom za uporabo, se za sporni proizvod pričakuje, da je pod predlaganimi določili in pogoji za to kategorijo uporabnikov varen.
In order to avoid unnecessary plastic waste, the current condition of the authorisation to supply the product and the roll-on dispenser together with the bait station as a single device and to dispose of the whole device, including the bait station, after use should be removed from the authorisation.
V izogib nepotrebnim plastičnim odpadkom bi bilo treba iz dovoljenja črtati trenutni pogoj, da se proizvod in steklenička za enkratno uporabo dobavita skupaj s postajo za nastavljanje vabe kot en pripomoček in da se po uporabi zavrže celotni pripomoček, vključno s postajo za nastavljanje vabe.
This Decision applies to the product identified by the asset number ES-0000196-0000, as provided for by the Register for Biocidal Products.
Ta sklep se uporablja za proizvod s številko sredstva ES-0000196-0000, kakor je določen v registru biocidnih proizvodov.
The product meets the conditions laid down in Article 19(1)(b)(i) of Regulation (EU) No 528/2012.
Proizvod izpolnjuje pogoje iz člena 19(1)(b)(i) Uredbe (EU) št. 528/2012.
The condition restricting the use of the product to situations where it is difficult to access water shall be removed from the product authorisation.
Pogoj, ki omejuje uporabo proizvoda na primere, kadar je dostop do vode otežen, se črta iz dovoljenja za proizvod.
The user category in the authorised uses of the product shall be restricted to trained professional users only.
Kategorija uporabnikov, ki se ji dovoli uporaba proizvoda, se omeji samo na usposobljene poklicne uporabnike.
The product authorisation shall include the following risk mitigation measure: ‘Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)’.
Dovoljenje za proizvod vključuje naslednji ukrep za zmanjševanje tveganja: „Pri ravnanju s proizvodom nosite zaščitne rokavice, odporne na kemikalije (material za rokavice določi imetnik dovoljenja v informacijah o proizvodu).“
The condition to supply the product and the roll-on dispenser together with the bait station as a single device and to dispose of the bait station as part of the whole device after use of the product shall be removed from the product authorisation.
Iz dovoljenja za proizvod se črta pogoj, da se proizvod in steklenička za enkratno uporabo dobavita skupaj s postajo za nastavljanje vabe kot en pripomoček in da se po uporabi postaja za nastavljanje vabe zavrže kot del celotnega pripomočka.
Under the terms and conditions set out in paragraphs 1, 2 and 3, the product meets the conditions laid down in Article 19(1)(b)(iii) of Regulation (EU) No 528/2012.
Pod določili in pogoji iz odstavkov 1, 2 in 3 proizvod izpolnjuje pogoje iz člena 19(1)(b)(iii) Uredbe (EU) št. 528/2012.
The following instructions for use shall be included in the product authorisation:
Naslednja navodila za uporabo so vključena v dovoljenje za proizvod:
‘Fix the bait station to the ground’.
„Postajo za nastavljanje vabe pritrdite na tla.“
‘In case of accidental spillage of the liquid, dispose of the bait station as hazardous waste’.
„V primeru nenamernega razlitja tekočine postajo za nastavljanje vabe zavrzite kot nevaren odpadek.“
Under the terms and conditions set out in paragraph 1, the product meets the conditions laid down in Article 19(1)(b)(iv) of Regulation (EU) No 528/2012.
Pod določili in pogoji iz odstavka 1 proizvod izpolnjuje pogoje iz člena 19(1)(b)(iv) Uredbe (EU) št. 528/2012.
Done at Brussels, 15 July 2016.
V Bruslju, 15. julija 2016
See Technical Notes for Guidance on Product Evaluation.
Glej Tehnične zapiske z navodili za ocenjevanje proizvoda (Technical Notes for Guidance on Product Evaluation).
Appendices to Chapter 7.
Dodatki k poglavju 7.
Product Type 14: Efficacy Evaluation of Rodenticidal Biocidal Products, available on the website http://echa.europa.eu/documents/10162/16960215/bpd_guid_revised_appendix_chapter_7_pt14_2009_en.pdf
Vrsta proizvodov 14: Ocenjevanje učinkovitosti biocidnih proizvodov kot rodenticidov (Efficacy Evaluation of Rodenticidal Biocidal Products), na voljo na spletni strani (v angleškem jeziku) http://echa.europa.eu/documents/10162/16960215/bpd_guid_revised_appendix_chapter_7_pt14_2009_en.pdf.
Commission Implementing Decision (EU) 2016/1175
Izvedbeni sklep Komisije (EU) 2016/1175
on the terms and conditions of the authorisation of a biocidal product containing spinosad referred by the United Kingdom in accordance with Article 36 of Regulation (EU) No 528/2012 of the European Parliament and of the Council
o določilih in pogojih za izdajo dovoljenja za biocidni proizvod, ki vsebuje spinosad, ki jih je predložilo Združeno kraljestvo v skladu s členom 36 Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta
(notified under document C(2016) 4385)
(notificirano pod dokumentarno številko C(2016) 4385)
The company Scotts Celaflor GmbH (‘the applicant’) submitted a complete application to Germany (‘the Member State concerned’) on 29 June 2015 for the mutual recognition of an authorisation granted by the United Kingdom (‘the reference Member State’) in respect of an insecticide biocidal product containing the active substance spinosad as a granular solid bait formulation to be applied directly or to be diluted and applied as liquid drench (‘the contested product’).
Podjetje Scotts Celaflor GmbH (v nadaljnjem besedilu: vložnik) je 29. junija 2015 pri pristojnih organih Nemčije (v nadaljnjem besedilu: zadevna država članica) vložilo popolno vlogo za medsebojno priznavanje dovoljenja, ki ga je izdalo Združeno kraljestvo (v nadaljnjem besedilu: referenčna država članica) v zvezi z insekticidnim biocidnim proizvodom, ki vsebuje aktivno snov spinosad v obliki granulatne trdne vabe, ki se uporablja neposredno ali raztopi in uporabi kot tekočina (v nadaljnjem besedilu: sporni proizvod).
The reference Member State authorised the contested product on 23 April 2015 for use by the general public against ants outdoors by means of direct application to ant nests.
Referenčna država članica je 23. aprila 2015 za sporni proizvod izdala dovoljenje za uporabo proti mravljam na prostem neposredno na mravljiščih s strani splošne javnosti.
The authorisation has subsequently been mutually recognised by Ireland.
Dovoljenje je nato medsebojno priznala Irska.
Pursuant to Article 35(2) of Regulation (EU) No 528/2012, the Member State concerned referred a point of disagreement to the coordination group on 26 October 2015 indicating that the contested product does not meet the conditions laid down in Article 19(1)(b)(iv) of that Regulation.
V skladu s členom 35(2) Uredbe (EU) št. 528/2012 je zadevna država članica koordinacijski skupini 26. oktobra 2015 predložila sporno točko, ki kaže, da sporni proizvod ne izpolnjuje pogojev iz člena 19(1)(b)(iv) navedene uredbe.
The Member State concerned considers that the contested product does not fulfil the requirement set out in paragraph 66 of Annex VI to Regulation (EU) No 528/2012 as the PEC/PNEC ratio for the soil compartment is greater than 1 and as a result the contested product poses an unacceptable risk to the environment, albeit in very small areas and for very short periods of time.
Zadevna država članica meni, da sporni proizvod ne izpolnjuje zahteve iz odstavka 66 Priloge VI k Uredbi (EU) št. 528/2012, ker je razmerje PEC/PNEC za tla večje od 1 in posledično sporni proizvod predstavlja nesprejemljivo tveganje za okolje, čeprav na zelo majhnih površinah in za zelo kratko obdobje.
Belgium, France, the Netherlands, the United Kingdom and the applicant submitted comments.
Pripombe so predložili Belgija, Francija, Nizozemska, Združeno kraljestvo in vložnik.
The referral was also discussed by the Member States' competent authorities for biocidal products in the coordination group's meetings of 17 November 2015 and 20 January 2016.
Sporno točko so obravnavali tudi pristojni organi držav članic za biocidne proizvode na sestankih koordinacijske skupine 17. novembra 2015 in 20. januarja 2016.
As no agreement was reached by the coordination group, the reference Member State provided the Commission on 5 February 2016 with a detailed statement of the matters on which Member States were unable to reach agreement and the reasons for their disagreement, pursuant to Article 36(1) of Regulation (EU) No 528/2012.
Ker koordinacijska skupina ni dosegla dogovora, je v skladu s členom 36(1) Uredbe (EU) št. 528/2012 referenčna država članica Komisiji 5. februarja 2016 predložila podroben opis zadev, o katerih države članice niso mogle doseči dogovora, ter razloge za njihovo nestrinjanje.
As regards the unresolved objection referred to the Commission, paragraph 66 of Annex VI to Regulation (EU) No 528/2012 sets out that where the PEC/PNEC ratio is greater than 1, the evaluating body is to judge, on a case-by-case basis, the elements or the risk mitigation measures to be considered in order to conclude whether the biocidal product complies with Article 19(1)(b)(iv).
Glede predložitve nerešenih ugovorov Komisiji odstavek 66 Priloge VI k Uredbi (EU) št. 528/2012 določa, da v primeru, če je razmerje PEC/PNEC večje od 1, organ za ocenjevanje za vsak primer posebej presodi, kateri elementi ali ukrepi za zmanjševanje tveganja se upoštevajo, da ugotovi, ali biocidni proizvod izpolnjuje pogoje iz člena 19(1)(b)(iv).
From the discussions within the coordination group, it seems that there is a lack of agreed Union guidance to assist the evaluating body in making such a judgment.
Iz razprav v koordinacijski skupini se zdi, da ni dogovorjenih smernic Unije za pomoč organu za ocenjevanje pri taki presoji.
From those discussions it also follows that the unacceptable risk identified is limited because of the use pattern of the product, which is only applied to small areas (for example on ant nests) and is expected to break down in a short period of time so that non-target species can recolonise the treated area after use.
Iz teh razprav izhaja tudi, da je ugotovljeno nesprejemljivo tveganje omejeno zaradi načina uporabe proizvoda, ki se uporablja samo na majhnih površinah (na primer na mravljiščih) in se razgradi v kratkem času, tako da se lahko po njegovi uporabi neciljne vrste ponovno naselijo na tretirani površini.
In the absence of agreed Union guidance, the conclusion of the reference Member State was based on the available information and on the judgement of its experts, pursuant to paragraph 12 of Annex VI to Regulation (EU) No 528/2012.
Ker ni dogovorjenih smernic Unije, je sklep referenčne države članice temeljil na razpoložljivih informacijah in presoji njenih strokovnjakov v skladu z odstavkom 12 Priloge VI k Uredbi (EU) št. 528/2012.
Against this background and until such agreed guidance is formally adopted, the conclusion reached by the reference Member State on the point of disagreement is considered to be valid until the renewal of the product authorisation.
Glede na navedeno in do uradnega sprejetja takih smernic se sklep, ki ga je sprejela referenčna država članica glede sporne točke, šteje za veljavnega do podaljšanja dovoljenja za proizvod.