natgillin/translations-raw huggingface dataset:
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
Direktiva 2001/83/EZ Europskog parlamenta i Vijeća od 6. studenoga 2001. o zakoniku Zajednice koji se odnosi na lijekove za humanu primjenu (SL L 311, 28.11.2001., str. 67.).
Act referred to at point 15q of Chapter XIII of Annex II to the EEA Agreement.
Akt iz točke 15.q poglavlja XIII. Priloga II. Sporazumu o EGP-u.
Act referred to at point 15p of Chapter XIII of Annex II to the EEA Agreement.
Akt iz točke 15.q poglavlja XIII. Priloga II. Sporazumu o EGP-u.
Act referred to at point 1 of Chapter XXX of Annex II to the EEA Agreement.
Akt iz točke 1. poglavlja XXX. Priloga II. Sporazumu o EGP-u.
Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).
Direktivom 98/79/EZ Europskog parlamenta i Vijeća od 27. listopada 1998. o in vitro dijagnostičkim medicinskim proizvodima (SL L 331, 7.12.1998., str. 1.).
Act referred to at point 2 of Chapter XXX of Annex II to the EEA Agreement.
Akt iz točke 2. poglavlja XXX. Priloga II. Sporazumu o EGP-u.
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
Direktivom Vijeća 90/385/EEZ od 20. lipnja 1990. o usklađivanju zakonodavstva država članica koja se odnose na aktivne medicinske proizvode za ugradnju (SL L 189, 20.7.1990., str. 17.).
Act referred to at point 7 of Chapter X of Annex II to the EEA Agreement.
Akt iz točke 7. poglavlja X. Priloga II. Sporazumu o EGP-u.
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (OJ L 204, 21.7.1998).
Direktiva 98/34/EZ Europskog parlamenta i Vijeća od 22. lipnja 1998. kojom se utvrđuje postupak za pružanje informacija u području tehničkih standarda i pravila o uslugama Informacijskog društva (SL L 204, 21.7.1998.).
Act referred to at point 1 of Chapter XIX of Annex II to the EEA Agreement.
Akt iz točke 1. poglavlja XIX. Priloga II. Sporazumu o EGP-u.
For more information about deadlines, see Chapter 3.10. of the Guidelines.
Za dodatne informacije o vremenskim rokovima vidjeti poglavlje 3.10. smjernica.
For more information about the RAPEX contact points and their obligations, see Chapter 5.1 of the Guidelines.
Za dodatne informacije o kontaktnim točkama RAPEX i njihovim obvezama vidjeti poglavlje 5.1. smjernica.
For more information on follow-up actions, see Chapter 3.7.
Za dodatne informacije o pratećim aktivnostima vidjeti poglavlje 3.7.
For more information on notifications on safety aspects subject to discussions at EEA level, see Chapters 3.5.2 and 3.8.1.
Za dodatne informacije o obavijestima o sigurnosnim aspektima podložnima raspravama na razini EGP-a vidjeti poglavlja 3.5.2. i 3.8.1.
For more information on notifications on safety aspects subject to discussions at EU level, see Chapters 3.1.2.d and 3.8.1.
Za dodatne informacije o obavijestima o sigurnosnim aspektima podložnim raspravama na razini Europske unije vidjeti poglavlja 3.1.2.d. i 3.8.1.
For more information on the RAPEX notification criteria, see Chapter 2.
Za dodatne informacije o kriterijima obavješćivanja putem RAPEX-a vidjeti poglavlje 2.
For more information on notifications sent through the RAPEX application before measures are taken, see Chapter 3.1.2.b.
Za dodatne informacije o obavijestima koje se dostavljaju preko aplikacije RAPEX prije poduzimanja mjera vidjeti poglavlje 3.1.2.b.
For more information on notifications on safety aspects subject to discussions at EU level, see Chapters 3.1.2.d and 3.5.2.
Za dodatne informacije o obavijestima o sigurnosnim aspektima podložnima raspravama na razini EU-a vidjeti poglavlja 3.1.2.d. i 3.5.2.
All deadlines mentioned in the Guidelines are expressed in calendar days.
Svi vremenski rokovi navedeni u smjernicama izraženi su u kalendarskim danima.
For the purpose of these appendices, references to the Commission shall be read as references to the EFTA Surveillance Authority.
Za potrebe ovih dodataka pozivanje na Komisiju znači pozivanje na Nadzorno tijelo EFTA-e.
References to the Member States shall be read as references to the EFTA States.
Pozivanje na države članice znači pozivanje na države EFTA-e.
Report prepared by Risk & Policy Analysts (RPA), Loddon, Norfolk, UK.
Izvješće sastavili Risk & Policy Analysts (RPA), Loddon, Norfolk, Ujedinjena Kraljevina.
Method used by the Belgian authorities.
Metoda kojom se koriste belgijske vlasti.
Cited in: European Commission (2005) Establishing a Comparative Inventory of Approaches and Methods Used by Enforcement Authorities for the Assessment of the Safety of Consumer Products Covered by Directive 2001/95/EC on General Product Safety and Identification of Best Practices.
Citirano u: Europska Komisija (2005.) Uspostava usporednog popisa pristupa i metoda kojima se koriste provedbena tijela pri procjeni sigurnosti potrošačkih proizvoda obuhvaćenih Direktivom 2001/95/EZ o općoj sigurnosti proizvoda i prepoznavanju najboljih praksi.
Decision 2004/418/EC.
Odluka 2004/418/EZ.
Directive 2001/95/EC.
Direktiva 2001/95/EZ.
NB: uncertainty always has to be taken into account when comparing a test result with a limit.
NB: neizvjesnost prilikom usporedbi rezultata testiranja s graničnom vrijednošću se uvijek treba uzeti u obzir.
See, for example,the ‘Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation …’ http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf the Summary report on the ‘Preparation of a working document in support of the uniform interpretation of legislative standards and the laboratory quality standards prescribed under Directive 93/99/EEC’. http://ec.europa.eu/food/fs/scoop/9.1_sr_en.pdf.
Vidjeti, primjerice:„Izvješće o odnosu analitičkih rezultata, neizvjesnosti mjerenja, faktora oporavka i odredaba zakonskih propisa EU-a o prehrambenim proizvodima i hrani za životinje…” http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf; Sažeto izvješće o „Pripremi radnog dokumenta u potporu jednoobraznog tumačenja zakonodavnih normi i normi o kvaliteti laboratorija propisanih Direktivom 93/99/EEZ”. http://ec.europa.eu/food/fs/scoop/9.1_sr_en.pdf
Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (OJ L 164, 26.6.2009, p. 7).
Uredba Komisije (EZ) br. 552/2009 od 22. lipnja 2009. o izmjeni Uredbe (EZ) br. 1907/2006 Europskog parlamenta i Vijeća o registraciji, evaluaciji, autorizaciji i ograničavanju kemikalija (REACH) u pogledu njezinog Priloga XVII. (SL L 164, 26.6.2009., str. 7.).
Standard EN 71-1:2005, Section 8.2 +A6:2008.
Norma EN 71-1:2005, odjeljak 8.2 + A6:2008.
Article 7a(1)(d) of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to (OJ L 262, 27.9.1976, p. 169).
Članak 7.a stavak 1. točka (d) Direktive Vijeća 76/768/EEZ od 27. srpnja 1976. o usklađivanju zakonodavstava država članica u odnosu na kozmetičke proizvode (SL L 262, 27.9.1976., str. 169.).
Regulation (EC) No 1907/2006 (REACH Regulation) and guidance documents on REACH, see http://echa.europa.eu/
Uredba (EZ) br. 1907/2006 (Uredba REACH). Dokumenti sa smjernicama o REACH-u, vidjeti http://echa.europa.eu/
Scientific Committee on Consumer Products (SCCP), The SCCP's Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 6th revision, 19 December 2006. http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf
Znanstveni odbor za kozmetičke proizvode (SCCP), Napomene smjernica SCCP-a za testiranje kozmetičkih sastojaka i procjenu njihove sigurnosti, 6. revizija, 19. prosinca 2006.: http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_03j.pdf.
This is taken from the definition of ‘safe product’ in Article 2(b) of Directive 2001/95/EC.
Ovo je preuzeto iz definicije „sigurnog proizvoda” iz članka 2. točke (b) Direktive 2001/95/EZ.
The term ‘working days’ is to be understood as Monday through Friday except for those days published in the Official Journal of the European Union as the Authority's public holidays, whereas the term ‘working hours’ is to be understood as the time between 0700 and 1630 GMT+1.
Izraz „radni dani” znači dani od ponedjeljka do petka, osim dana koji su u Službenom listu Europske unije objavljeni kao praznici Nadzornog tijela, a izraz „radno vrijeme” znači vrijeme između 07:00 i 16:30 GMT+1.
If the notification is received by the ESA RAPEX contact point at a point in time which is not on a working day within working hours, for example on a public holiday, on a Saturday or Sunday, or on a Friday at 1700 GMT+1, the 24 hours response deadline for the ESA RAPEX contact point will start running from the next working hour of the next working day, following the actual receipt of the notification.
Ako kontaktna točka RAPEX Nadzornog tijela EFTA-e primi obavijest na dan koji nije radni dan ili izvan radnog vremena, primjerice na državni praznik, u subotu ili u nedjelju, ili u petak u 17:00 GMT+1, rok od 24 sata za odgovor kontaktne točke RAPEX Nadzornog tijela EFTA-e započinje sljedećeg radnog sata sljedećeg radnog dana nakon stvarnog primitka obavijesti.
Pass on the risk assessment. Highest risk identified?
Množenjem izračunajite ukupnu vjerojatnost.
See table 4: Probability levels from high (> 50 %) to low (< 1/1 000 000)
Vidi tablicu 1.: Vrste potrošača, uključujući ranjive potrošače (posebno djecu) …
See table 3: Severity of injury
namijenjeni/nenamijenjeni korisnik
Sprain, strain, musculoskelelt a disorder
ponašanje potrošača u slučaju incidenta
See table 2: Hazards …
Vidi tablicu 3.: Stupanj ozljede …
See table 1: Consumer types, incl. vulnerable consumers (in particular children)
Vidi tablicu 2.: Opasnosti …
Intended/non-intended user
veličina, oblik i površina
Intended and reasonably foreseeable use
potencijalna energija
Frequency and duration of use
kinetička energija
Benis HG (1990): A Product Risk Assessment Nomograph, report prepared for the New Zealand Ministry of Consumer Affairs, dated February 1990.
Benis HG (1990.): Nomografija procjene rizika proizvoda, izvješće sastavljeno za Ministarstvo potrošačkih poslova Novog Zelanda, iz veljače 1990.
Kinney GF, Wiruth AD (1976) Practical risk analysis for safety management.
Kinney GF, Wiruth AD (1976.) Praktična analiza rizika za upravljanje sigurnošću.
China Lake, CA: NWC Technical Publication 5865, Naval Weapons Center, California, June 1976.
China Lake, CA: NWC Technical Publication 5865, Naval Weapons Center, Kalifornija, lipanj 1976.
https://webgate.ec.europa.eu/idbpa/
https://webgate.ec.europa.eu/idbpa/.
‘Falling off’ is therefore ‘built into the ladder’; it is an intrinsic part of using a ladder and cannot be excluded. ‘Falling off’ is thus called the intrinsic hazard of a ladder.
Kombinirajte opasnost (u smislu težine ozljede) s vjerojatnošću (u smislu razlomka) kako biste izračunali rizik.
European Chemicals Agency (2008).
Europska agencija za kemikalije (2008.).
The Guidance on Information Requirements and Chemical Safety Assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
Smjernice o zahtjevima za informacije i procjenu sigurnosti kemikalija: http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm.
This hazard, however, does not always materialise, since many people climb ladders without falling off and injuring themselves. This suggests that there is a certain likelihood (or probability), but no certainty, of the intrinsic hazard materialising.
Ta se kombinacija može izračunati dobivanjem obiju vrijednosti iz odgovarajućih tablica (vidjeti tablicu 4.); tablica će pružiti razinu rizika u kategorijama „ozbiljan”, „visok”, „srednji” i „nizak” rizik.
When the test results of the product fail by a large margin to come within the limit values required (by the relevant standard or legislation), the probability of the injury (scenario) occurring may be higher than if the product performed close to the limit values. The ‘probability of injury’ in this instance is the probability that the injury scenario may actually happen.
U slučajevima kada su nezgode samo rijetko prijavljene ili uopće nisu poznate, moglo bi biti korisno upitati proizvođača proizvoda je li on upoznat s bilo kakvom nezgodom ili nepovoljnim učinkom koji taj proizvod uzrokuje.
Determine the probability Assign a probability to each step.
Utvrdite vjerojatnost
Multiply to get the overall probability. Yes No
Pridruživanje vjerojatnosti svakom koraku.
All such national measures that apply to only generally defined categories of products, such as all products in general or all products serving the same purpose — and not to (categories of) products specifically identified by their brand, specific look, producer, trader, model name or number, etc. — are notified to the EFTA Surveillance Authority under Directive 98/34/EC of the European Parliament and of the Council [10].2.2.5. Timing of the notification
U skladu s Direktivom 98/34/EZ Europskog parlamenta i Vijeća [10], Nadzorno tijelo EFTA-e obavješćuje se o svim takvim nacionalnim mjerama koje se primjenjuju samo na općenito definirane kategorije proizvoda, kao što su svi proizvodi općenito ili svi proizvodi koji služe istoj namjeni, a ne na (kategorije) proizvoda koji su posebno prepoznati po svojoj robnoj marki, posebnom izgledu, proizvođaču, trgovcu, nazivu ili broju modela itd.2.2.5 Vrijeme dostavljanja obavijesti
The following Chapters in Part II of the Guidelines are relevant to the Article 11 notification procedure: Chapter 3.7 on follow-up activities (objectives, follow up action),
Sljedeća poglavlja iz dijela II. smjernica relevantna su za postupak obavješćivanja iz članka 11.:
This may not apply to an injury scenario with a (young) child or other vulnerable user (see Table 1) who cannot read. When accidents have been reported that fit into the injury scenario, the probability for that scenario could increase.
Kad se rizik jasno može prepoznati, uključujući pomoću oznaka s upozorenjem, vjerojatnost će možda biti potrebno umanjiti jer će se korisnik proizvodom koristiti opreznije kako bi što je više moguće izbjegao ozljede.
When a fairly large number of conditions are needed for the injury to occur, the overall probability of the scenario would normally be lower. When the conditions needed for the injury to occur are easily met, this may increase the probability.
Kad se prijavljuju nezgode koje se uklapaju u scenarij ozljeđivanja, vjerojatnost za taj scenarij mogla bi se povećati.
International event 2.4.2. Local event
Lokalni događaj
Under Article 2(a) of the GPSD, consumer products for the purpose of RAPEX are: — ‘products intended for consumers’ products that are designed and manufactured for and made available to consumers, — ‘migrating products’ products that are designed and manufactured for professionals, which are likely, however, under reasonably foreseeable conditions, to be used by consumers. These are products manufactured for professionals that are made available to consumers, who can purchase and operate them without any special knowledge or training, e.g. a power drill, an angle grinder and a table saw designed and manufactured for professionals, but also supplied on the consumer market (i.e. consumers can readily purchase them in shops and operate them on their own without any special training).
Proizvodi koji nisu obuhvaćeni definicijom „proizvoda” utvrđenom člankom 2. točkom (a) GPSD-a:
Both products intended for consumers and migrating products can be given to consumers free of charge, can be purchased by consumers or can be provided to consumers in the context of a service. All three situations are covered by RAPEX. Products provided to consumers in the context of a service include: products supplied to consumers that are taken away and used outside the premises of a service provider, such as cars and lawn-mowing machines rented or leased in rental salons, and tattoo inks and implants (that are not classified as medical devices) implanted beneath the skin of a consumer by a service provider,
proizvodi koji su oblikovani i proizvedeni za, te su dostupni samo za profesionalnu uporabu, a za koje nije vjerojatno da će ih, pod razumno predvidljivim uvjetima, upotrebljavati potrošači (dalje u tekstu „profesionalni proizvodi”),
products used on the premises of a service provider, provided that consumers themselves actively operate a product (e.g. start the machine, have the option of stopping it, affect its operation by changing its position or intensity during use). Sun-beds used in tanning salons and fitness centres are examples of such products. Use of the products by consumers must be active, and involve a significant degree of control. Merely passive use, such as the use of shampoo by a person whose hair is washed by a hairdresser, or the use of a bus by its passengers, does not qualify as use by consumers. By contrast, equipment used or operated by a service provider to supply a service is beyond the scope of RAPEX and therefore such products cannot be notified through the system, e.g. equipment on which consumers ride or travel which are operated by a service provider.
rabljeni proizvodi ponuđeni kao antikviteti ili kao proizvodi koje treba popraviti ili vratiti u prvotno stanje prije ponovne uporabe, pod uvjetom da ponuđač o tome jasno obavijesti osobu kojoj nudi taj proizvod.
Products which are not covered by RAPEX: RAPEX does not cover: 1. Products that are not covered by the definition of a ‘product’ laid down in Article 2(a) of the GPSD: products that were designed and manufactured for and made available only to professionals and are not likely, under reasonably foreseeable conditions, to be used by consumers (‘professional products’), second-hand products supplied as antiques or as products to be repaired or reconditioned prior to being used, provided that a supplier clearly informs the person to whom he supplies the product to that effect.
Proizvodi koji su obuhvaćeni specifičnim i istovjetnim mehanizmima obavješćivanja utvrđenim drugim zakonodavstvom EGP-a:
food and feed covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council [4],medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council [5], and Directive 2001/82/EC of the European Parliament and of the Council [6],medical devices covered by Council Directive 93/42/EEC [7],in vitro diagnostic medical devices covered by Directive 98/79/EC of the European Parliament and of the Council [8],active implantable medical devices covered by Council Directive 90/385/EEC [9].2.2. Measures
Kategorije mjera Sve kategorije preventivnih i restriktivnih mjera poduzetih u pogledu trgovine i uporabe potrošačkih proizvoda koji predstavljaju ozbiljan rizik za zdravlje i sigurnost potrošača podložne su obvezi obavješćivanja putem RAPEX-a.
Categories of measures All categories of preventive and restrictive measures taken in relation to the marketing and use of consumer products posing a serious risk to the health and safety of consumers are subject to the notification obligation under RAPEX.
U članku 8. stavku 1. točkama (b) do (f) GPSD-a naveden je popis različitih kategorija mjera o kojima je potrebno obavješćivati u skladu sa sustavom RAPEX, uključujući sljedeće mjere:
making the marketing of a product subject to prior conditions, warning consumers of the risks that could be posed by a product for certain persons,
upozoravanje potrošača na rizike koje bi taj proizvod mogao predstavljati za određene osobe,
Obligatory measures initiated by authorities in charge of external border controls Measures adopted by the authorities in charge of external border controls that prevent the marketing in the EEA of a consumer product posing a serious risk to the health and safety of consumers (e.g. decisions to stop the import at the national border) should be notified to the EFTA Surveillance Authority through RAPEX in the same manner as measures adopted by market surveillance authorities that restrict the marketing or use of a product.
Isključivanje općenito primjenjivih obveznih mjera
Exclusion of generally applicable obligatory measures Generally applicable acts adopted at national level and aimed at preventing or restricting the marketing and use of (a) generally described category(ies) of consumer products due to the serious risk they pose to the health and safety of consumers should not be notified to the EFTA Surveillance Authority through the RAPEX system.
Nadzorno tijelo EFTA-e nije potrebno obavješćivati putem RAPEX-a o općenito primjenljivim aktima koji se donose na nacionalnoj razini i čiji je cilj sprječavanje ili ograničavanje trgovine i uporabe (a) općenito opisanih kategorija potrošačkih proizvoda koji predstavljaju ozbiljan rizik za zdravlje i sigurnost potrošača.
Chapter 4.2 on the content of reactions (data provided, completeness, updating, responsibility for reactions), Chapter 4.3 on confidentiality,
Poglavlje 3.7. o pratećim aktivnostima (ciljevi, prateća aktivnost),
‘Article 11 notifications’ and reactions to them by EFTA States are prepared and sent to the EFTA Surveillance Authority by the RAPEX contact points. Chapters 5.1 to 5.3 in Part II of the Guidelines concerning the operation of RAPEX networks (established at EEA and national levels) and on practical and technical arrangements (languages, online application, and operation outside normal working hours) are relevant to the Article 11 notification procedure.
„Obavijesti prema članku 11.” i reakcije na njih od strane država EFTA-e pripremaju kontaktne točke RAPEX te ih šalju Nadzornom tijelu EFTA-e Poglavlja 5.1. do 5.3. dijela II. smjernica koja se odnose na rad mreža RAPEX (uspostavljenih na razini EGP-a i na nacionalnoj razini) te o praktičnim i tehničkim rješenjima (jezici, internetska aplikacija i rad izvan redovnog radnog vremena) relevantni su za postupak obavješćivanja iz članka 11.
Risk — combination of hazard and probability 2.2. A risk assessment in three steps 2.3. Some useful tips
Nekoliko korisnih savjeta
Risk — combination of hazard and probability Risk is generally understood as something that threatens the health or even the lives of people, or that may cause considerable material damage.
Utvrdite vjerojatnost ozljeđivanja potrošača u praksi intrinzičnom opasnošću proizvoda.
For example: Climbing a ladder always includes the possibility of falling off and injuring oneself.
Ta se vjerojatnost može izraziti kao postotak, kao primjerice „> 50 %” ili „> 1/1000” (vidjeti lijevi dio tablice 4.).
Nevertheless, when the cleaner is handled properly, the hazard does not materialise. Proper handling may include wearing plastic gloves and protective glasses.
U tom je slučaju također važno poduzeti mjere protiv tog rizika kako bi se svi rizici učinkovito umanjili.
A risk assessment in three steps It takes three steps to determine the risk: 1. Anticipate an injury scenario in which the intrinsic product hazard harms the consumer (see Table 1). Determine how severe the consumer's injury is.
Nekoliko korisnih savjeta
A yardstick for quantifying the intrinsic product hazard is the extent of the adverse effect that it can cause to the health of a consumer. The risk assessor therefore anticipates an ‘injury scenario’ that describes step by step how the hazard leads to the injury of a consumer (see Table 2).
Tražite informacije