natgillin/translations-raw huggingface dataset:
Næsten to tredjedele af disse indeholdt vigtige nye data vedrørende produkternes sikkerhed og effektive anvendelse.
Almost two-thirds of these contained important new data on the safety and effective use of the products.
Lovgivningsforslaget indeholder såvel forpligtelser som incitamenter, der skal motivere lægemiddelproducenterne til udvikling af nye præparater eller tilpasning af eksisterende medicin til pædiatriske formål.
To compensate for the extra research and costs involved in meeting the new requirements, companies would in effect be given a six-month extension to their patent. The patent extension would not apply retrospectively to studies already conducted before the regulation comes into force and where the studies have already been submitted to another regulatory authority.
Forlængelsen vil dog ikke blive givet tilbagevirkende for forsøg, der allerede er udført inden lovgivningens ikrafttrædelse og heller ikke i tilfælde, hvor forsøgsresultater allerede er forelagt en anden regeludstedende myndighed.
However, it is considering offering data protection for new studies on the paediatric safety and efficacy of the products and to link this to a fresh marketing authorisation which could be displayed on labels: the Paediatric Use Marketing Authorisation (PUMA).
Blandt de foreslåede krav er, at producenterne ved anmodning om godkendelse af nye præparater fremover skal fremlægge resultaterne af kliniske forsøg udført på børn, uanset om dataene er positive eller negative.
It would require companies to present the results of clinical trialsinvolvingchildren, irrespectiveofwhetherthe data are positive or negative, when requesting authorisation fornewmedicinalproducts.
Herved sikres det, at langt de fleste innovative lægemidler vil være afprøvet til anvendelse på børn, og at produkterne mærkes med de relevante informationer.
This will ensure that the vast majority of innovative medicines will have been tested for use by children and the appropriate information given on the label.
Forsøgsresultaterne tænkes lagret i en database, der gøres delvis offentligt tilgængelig
The information gleaned from the trials would be stored in a database and be partly available to the public.
Bæredygtig udvikling
Sustainable
Mere miljøvenlige dæk i fremtiden uropas dækindustri fremstiller omkring 300 mio. dæk om året
Tyres to tread more softly in future urope’s tyre industry produces around 300 million tyres per year and uses 250,000
For at tilgodese sundheds- og miljøhensyn og samtidig bevare konkurrenceevnen har Kommissionen foreslået et sæt regler, der vil kræve, at kræftfremkaldende additivolier i løbet af de næste fem år erstattes med nyudviklede, mere sikre stoffer.
In a move designed to address health and environmental concerns while safeguarding competitiveness, the Commission has proposed rules which will require the phasing out of carcinogenic extender oils in tyres over the next five years by developing new and safer substances.
tons additivolier for at lette forarbejdningen af gummiforbindelserne. Disse tilsætningsmidler er vigtige for dækkenes egenskaber, især holdbarhed og vejgreb.
The Commission, in consultation with the oil and tyre industries, Member States and experts, has proposed the introduction of restrictions on the marketing and use of extender oils and tyres if they contain levels of PAH above strict threshold limits.
Men additivolierne i dag indeholder polycykliske aromatiske kulbrinte (PAHer), hvoraf EU-lovgivningen klassificerer de otte som kræftfremkaldende.
The eight PAHs in question are substances of very high concern, classifiedascarcinogenic, mutagenic and toxic to reproduction.
Dette har motiveret industrien til på proaktiv vis at søge alternative olietyper medlavt PAH-indhold.
Furthermore, they are regarded as Persistent Organic Pollutants under the UNECE Protocol on POPs and are subject to an obligation to reduce total annual emissions.
De otte berørte PAHer er meget farlige stoffer, der er klassificeret som kræftfremkaldende, mutagene og forplantningstoksiske.
These are an essential component in technical performance, wear and endurance, in particular for road adherence and grip.
De samme kemikalier betegnes som »permanente organiske forurenere« i UNECE-protokollen herom, og er omfattet af pålæg om reduktion af den samlede årlige emissionsmængde.
However, the fact that they currently contain polycyclic aromatic hydrocarbons (PAH), eight of which are classified carcinogenic by European legislation, has motivated the industry to adopt a pro-active stance to search for alternative oils containing only slight quantities of PAHs.
- og dermed en længere bremselængde - i vådt føre.
According events will need to comply by to the European Association of 1 January 2012.
Der vil derfor kræves omfattende laboratorieforsøg og indtil to års afprøvning på vejene for at sikre tilstrækkelige hensyn til trafiksikkerheden. Ifølge den europæiske gummiindustris fællesorgan, BLIC, vil omkostningerne til omstilling af dækfremstillingsprocessen kunne beløbe sig til 50 mio. Euro.
The proposal the Rubber Industry (BLIC), the stressestheimportanceof costs to modify the tyre manu-controlling imports of tyres that facturing process could amount do not comply with the directive, to € 50 million.andnationalenforcement authorities will need to manage the specific identification of high The transition aromatic oils in tyres.
Overgangen til nye gummiblandinger og dækkonstruktioner kræver skovbrande og stegning på havegrill, hvilket gør det svært at opnå pålidelige oplysninger om, hvilken grad PAHerne fra dæk bidrager til den samlede miljøforurening.
PAHs are released from many different emission sources such as forest fires and home barbecues, making it difficult to obtain reliable data on the extent to which PAHs from tyres contribute to the overall contamination of the environment.
De færdige gummiprodukter og dækkomponenter er måske nok ufarlige for brugerne, men et personbildæk kan i sin levetid efterlade op til 1,5 kg - og et lastbildæk op til 12 kg - af sin vægt i naturen.
However, though finished rubber products and tyre compounds present no danger for the user, passenger car tyres can lose up to 1.5kg of their mass through abrasion, and truck tyres up to 12kg.
Dækresterne spredes mest på jorden langs vejene og skylles derfra sammen med afløbsvandet fra kørebanen og ned i undergrunden eller ud i vandmiljøet.
The tyre debris is mostly dispersed on the ground near roads and flushed away with the surface runoff, ending up as ground sediment or in the aquatic environment.
Den rette metode til at sikre et højt sundheds- og miljøbeskyttelsesniveau består i at mindske additivoliernes PAH-indhold.
The right way of ensuring a high level of protection for health and the environment is by reducing PAH levels in the extender oils.
men det vil give de
Finding alternatives
PAHerne blandes ikke forsætligt i additivolierne men dannes under olieraffineringen eller findes i råolien.
While PAHs are not intentionally but European producers added to the extender oils, they are generated in the oil will gain a refining process or exist within the natural oil source.
De europæiske olieselskaber lægger i dag stor vægt på at udvikle ny teknologi til fremstilling af alternative additivolier som f.eks. MESer (Mild Extract Solvates) og TDAEer (Treated Distillate Aromatic Extracts). Disse olietyper ville kunne overholde de tærskelværdier, som Kommissionen har foreslået, og samtidig dækfabrikanternes sikkerhedskrav.
European competitive edge oil companies are now attaching great importance to the develop-over rivals in both ment of new technologies to produce alternative extender EU and global marketsoils such as, for example, Mild Extract Solvates (MES) and Treated Distillate Aromatic The costs for the whole EU tyre Extracts (TDAE).
For at minimere generne for den europæiske dækindustri ville det blive påkrævet at forbedre den aktuelle tilgængelighed af MESer og TDAEer under udfasningen af de højaromatiske olier.
The rivals in both EU markets and, current availability of MES and as the use of new extender oils TDAE will need to be increased might well become a worldwide during the phasing out of standard in the longer term, in high aromatic oils in order to global markets.minimise impact on the European tyre industry.
Samarbejde med industrien
Working with the industry europa.eu.int/comm/ enterprise/chemicals/legislation/ markrestr/preparation.htm
Sidste år indgik de europæiske dækproducenter en frivillig aftale om at nedtrappe brugen af de stærkt PAH-holdige additivolier.
Last year, European tyre producers made a voluntary commitment to phase out PAH-rich extender oils.
Men overgangen til nye gummiblandinger og dækkonstruktioner vil kræve en betydelig mængde kemiingeniørarbejde med omstilling af fremstillingsprocessen og godkendelse af de nye produkter.
But the transition to new rubber and tyre formulations will entail significant effort in chemical
Kina skifter ansigt amarbejdet mellem EU og Kina lovregulering er af fremad.
China’s changing face egulatory cooperation between the Union and China is relatively new.
Den forholdsvis ny dato, men det går hurtigt
But it is growing at a fast pace. Formal endorsement of the consultation
S formelle anerkendelse af en høringsrunde om industri- produkter var først på plads i oktober 2002, mens der inden for rammerne af den bredere dialog om industripolitikken holdes det første plenarmøde til september i år, præcis et år efter, at drøftelserne blev indledt.
R mechanism on industrial products only came in October 2002, while the wider dialogue on industrial policy will hold its first plenary meeting this September, exactly a year after it was launched.
Ijuni 2003, kort før afslutningen af sit mandat, aflagde Europa-Kommissæren for Erhvervspolitik og Informationssamfund, Erkki Likkanen, besøg i Kina, hvor han tog initiativ til at fremme dialogen om principperne for en reguleringsreform.
Shortly before stepping down as the Commissioner for Enterprise and the Information Society, Erkki Liikanen continued this trend by pushing forward dialogue on regulatory reform principles when visiting China at the end of June.
Principperne, der bygger på et forstudie udført af OECD, fremmer en forenkling af reglerne, foreskriver konsekvensanalyser under regeludarbejdelsen og generel fremme af kontakt og gennemsigtighed i samarbejdet mellem myndigheder og berørte parter.
Based on work by the OECD, these promote the simplification of regulations, provide for impact assessments to be conducted when regulations are being drawn up and encourage greater contacts and transparency between administrations and stakeholders.
Reguleringssamarbejdet med EU hilses stadig mere velkommen af Kina i takt med, at landets økonomi modnes og samhandelen vokser.
As its economy matures and trade expands, China is learning to welcome regulatory cooperation with the European Union.
GD Erhvervspolitik plejer en tæt dialog med de kinesiske myndigheder om konkrete vanskeligheder i relation til bestemte industriprodukter såvel som i en bredere sammenhæng, når det gælder industripolitiske tendenser med indflydelse på virksomheders generelle konkurrenceevne.
The Enterprise Directorate-General maintains a close dialogue with its Chinese counterparts, focusing both on the specific difficulties individual industrial products might encounter, but also taking a broader look at industrial policy trends that impact on business competitiveness as a whole.
Forøget opmærksomhed omkring reguleringssamarbejde er en logisk udvikling af den generelle tendens til liberalisering af verdenshandelen.
The increased attention being given to regulatory cooperation is a logical development of the overall trend towards liberalisation in world trade.
Efterhånden, som toldsatserne mindskes, bliver det stadig vigtigere at sikre, at der ikke opstår nye handelsbarrierer på andre felter, hverken forsætlige eller tilfældige.
As tariffs are gradually reduced, it becomes even more important to ensure that non-tariff barriers are not erected, either deliberately or accidentally, to stifle trade.
I denne henseende arbejder GD Erhvervspolitik tæt sammen med de kinesiske myndigheder, navnlig AQSIQ (the General Administration of Quality Supervision, Inspection and Quarantine) og NDRC (National Development and Reform Commission) om at indkredse og afhjælpe problemer af betydning for europæiske og kinesiske erhvervsdrivende.
In this regard, the Enterprise Directorate-Generalworks closely with the Chinese authorities, notably with AQSIQ (the General Administration of Quality,Supervisionand Quarantine) and the NDRC (National Development and Reform Commission) to identify and resolve issues of concern to European and Chinese entrepreneurs.
Da Europas kosmetikeksport pludselig blev afbrudt på grund af nye kinesiske standarder, lykkedes det Kommissionen at gribe ind og påvise, at produkterne ikke var sundhedsfarlige for mennesker, således som kineserne havde frygtet, og der blev genåbnet for salget.
This has provided a channel for the Union to voice its concerns at initiatives that could lead to new obstacles for European companies working in China and to stress that any new policies must comply with World Trade Organisation obligations.
Kommissionen tager sig også af andre sager, hvor europæisk industri møder vanskeligheder med at overholde Kinas obligatoriske certificeringssystem.
Given the large amount of European foreign direct investment in the country, it is obviously in both partners’ best interests that potential disputes are avoided.
I lyset af den store mængde direkte europæiske investeringer i Kina er det klart i begge parters interesse at undgå potentielle konflikter.
It also takes up other cases when European industry meets difficulties in complying with the Chinese Compulsory Certification system.
Kina henter belønninger for sin villighed til at indføre europæiske sikkerhedsnormer
implement European safety standards is bringing its own rewards
Disse parallelle dialoger er til direkte fordel for europæisk industri, idet de giver adgang til den vigtigste aktør i den kinesiske økonomi, nemlig regeringen.
These parallel dialogues are of direct benefit to European industry. They offer access to the most important player in the Chinese economy: the government.
De medvirker til at løse eller forebygge problemer.
They help to solve problems, or to prevent them from arising.
De danner et forum til debat af bredere politiske tiltag, som af erhvervsdrivende i EU måtte frygtes at kunne skade deres konkurrenceevne.
They provide a forum for addressing wider policy measures which EU entrepreneurs fear could have a negative impact on their competitiveness.
Industripolitisk dialog fremmes
Promoting industrial policy dialogue
Kineserne nyder også selv godt af deres villighed til at indføre euro-pæiskesikkerhedsnormer.
Equally, China’s readiness to implement European safety standards is bringing its own rewards.
Adskillige års fælles bestræbelser på at forbedre sikkerheden af kinesisk legetøj og el-udstyr har medført et relativt fald i antallet af sporede defekte produkter på det europæiske marked, selv om andelen stadig er for høj.
Concerted efforts over several years to improve the safety of Chinese toys and electrical equipment exports led to a relative fall in the number of defective products found on the European market even though this number is still too high.
De nære forbindelser er endvidere blevet udnyttet til rådslagninger mellem Kina og Europa-Kommissionen om EUs planer vedrørende REACH-programmet for kemikalieindustrien.
The close contacts were also used for consultations between the Chinese and the Commission on the Union’s plans for its REACH programme for the chemical industry.
Endnu et emne på den bilaterale dagsorden er den hurtigtvoksende kinesiske økonomis indflydelse på Europas metalindustri.
Another issue now on the bilateral agenda is the impact which the strong growth in the Chinese economy is having on Europe’s metal industry.
Efterspørgslen fra Kinas bygge- og anlægssektor, som er i hastig udvikling, har øget konkurrencen på markedet for råmaterialer, f.eks. stål, ædelmetaller, ikke-jernholdige metaller, koksbrændingskul og metalskrot til genbrug.
The demands of China’s booming construction sector have led to increased competition for raw materials such as steel, precious and non-ferrous metals and coking coal, and for recycled metal waste.
Den kinesiske økonomi er inde i en rivende udvikling og samhandelen med EU overstiger nu 150 mia. Euro om året.
The Chinese economy is expanding at a dizzy pace and trade with the European Union is now more than € 150 billion annually.
Det er derfor vigtigt at sikre, at der hersker fuld bevidsthed om de bredere konsekvenser, navnlig for europæiske virksomheder, af Kinas indenrigspolitik, og at internationale handels- og konkurrenceregler respekteres.
It is important, therefore, to ensure that the wider consequences, particularly on European companies, of the country’s domestic policies are taken fully on board and that international commercial and competition rules are respected.
Samarbejdet bevæger sig nu ind på emner i tilknytning til virksomheders sociale ansvar, efterhånden som de kinesiske tekstil- og legetøjsproducenter erkender behovet for at overholde visse minimumsstandarder for arbejdskraften og dens vilkår for at kunne møde de europæiske forbrugeres stigende efterspørgsel.
Cooperation is now moving into the sphere of corporate social governance as Chinese textile and toy manufacturers become sensitive to the need to comply with minimum labour standards to meet the growing demands of European consumers.
Dette har presset priserne op og skabt en strøm af råmaterialer fra Europa til Kina.
This has pushed up prices and diverted raw materials from Europe to China.
Denne tendens udgør en potentiel risiko for europæiske virksomheders konkurrenceevne, idet 30-35 % af EUs metalproduktion afhænger af genbrugeligt metalaffald. Set fra et kinesisk synspunkt er der risiko for en økonomisk overophedning.
The trend poses a threat to the competitiveness of European enterprises since 30 to 40% of metal production in the EU depends on recyclable metal waste, while, from China’s point of view, there are dangers from an overheating economy.
Der er i de seneste to år blevet nedsat et dusin arbejdsgrupper om konkrete emner, lige fra standardisering og teknisk regulering til legetøj, trykudstyr og kosmetik.
The industrial policy dialogue initiated in Beijing in September 2003 enables the Commission to explore these wider issues with the NDRC whose remit is to focus on the country’s longterm industrial and economic development.
Formålet er at afhjælpe eventuelle problemer forude, til fordel for såvel europæiske som kinesiske eksportører.
Given China’s aim of becoming the world’s fifthbiggestvehiclemanu-facturerby2010,thefirst workinggrouptobeestab-lished under the dialogue is devoted to automobile issues.
På baggrund af Kinas mål om at blive verdens femtestørste bilproducerende nation inden 2010 skal den første arbejdsgruppe, som nedsættes under dialogen, udelukkende beskæftige sig med denne sektor.
Overthepasttwoyears,a dozen working groups covering specificissuesrangingfrom standardisation and technical regulationtotoys,pressure equipment and cosmetics have
Næste udvidelse forberedes
Preparing for the next enlargement
Bulgarien og Rumænien stiler mod at blive de næste lande, der kommer ind i EU, og målet er 2007.
Bulgaria and Romania are aiming to be the next countries to join the European Union and have set 2007 as the target date.
Sideløbende med tiltrædelsesforhandlingerne samarbejder GD Erhvervspolitik allerede med begge lande på en række fronter for at sikre, at landene og deres erhvervsdrivende vil kunne opfylde kravene ved EU-medlemsskab.
In parallel with the accession negotiations, the Enterprise Directorate-General is already cooperating with both on a number of fronts to ensure that they, and their business communities, will be ready for the demands of EU membership.
or at nå målet vil begge lande inden årets udgang skulle
o achieve their goal, both countries will have to complete the lengthy
F afslutte de langvarige udvidelses- forhandlinger.
G he ment enlargement negotiations before the end of the year.
Ved udgangen af juni havde Bulgarien foreløbigt gennemført dette, mens Rumænien stadig manglede at nå til enighed med EU om en håndfuld meget følsomme emner, herunder landbrug, konkurrenceregler samt finansielle og budgetmæssige ordninger.
By June, Bulgaria had provisionally done so, while Romania still had to reach agreement with the Union on a handful of highly sensitive issues, such as agriculture, competition rules, and financial and budgetary arrangements.
Rumæniens Handelsbank (BCR), hvis hovedsæde ligger ved Dambovitas bredder, regnes for at være den næstmest magtfulde bank i Sydøsteuropa.
The Romanian Commercial Bank (BCR) headquarters building, located along the waterfront of the Dambovita, is rated the second most powerful bank in Central and South-Eastern Europe.
Blandt forhandlingernes 31 særskilte politikområder er de tre kapitler af størst direkte interesse for erhvervslivet: fri varebevægelighed, industripolitik samt små og mellemstore virksomheder.
Among the 31 separate policy areas in the negotiations, the three chapters of most direct interest to business are the free movement of goods, industrial policy and small and mediumsized enterprises.
Enighed om indholdet bekræfter at begge lande er godt på vej til at overholde EU-lovgivningen på disse områder.
Agreement on their contents confirms that both countries are well on their way towards complying with EU legislation in these areas.
Fremskridtene er dog ikke tilstrækkelige.
However, this progress is not sufficient.
I sin seneste rapport bemærkede Kommissionen, at begge lande måtte bestræbe sig yderligere på at forbedre deres generelle administrationskapacitet, tage skridt til at sikre fuld overholdelse af reglerne og gøre en større indsats for at overholde EU-reglerne om offentlige udbud og visse sektorspecifikke krav.
In its most recent report, the Commission noted that both had to make further efforts to improve their overall administrative capacity, take measures to ensure rules are fully respected and be more energetic in meeting EU public procurement and certain sectorspecific requirements.
politikken dog nok det, der savner mest opmærksomhed.
But perhaps out of the three areas of Enterprise Directorate-General responsibility, SMEs need the most attention.
I begge lande må der gøres mere for at udvikle en iværksætterkultur og styrke konkurrenceevnen.
More must be done in both countries to support the development of an enterprise culture and increase competitiveness.
De mindre virksomheder støder på generelle hindringer i forsøget på at drive forretning, når de konfronteres med ineffektivitet i de administrative og retlige instanser, yderligere forværret af problemer med »gråzoneøkonomi.«
Small companies face general obstacles of trying to do business when confronted with inefficiencies in administrative and judicial systems and difficulties associated with a grey economy.
Således havde Bulgarien ved udgangen af 2002 indført næsten 6000 europæiske standarder, svarende til godt halvdelen af den samlede mængde.
For instance, Bulgaria had put in place almost 6,000 European standards – equivalent to just over 50% of all those on the table – by the end of 2002.
Hvis landet kan opretholde dette fremskridtstempo, skulle det pr. december i år have nået 80 % af den »overholdelsesgrad,« der kræves for at blive medlem af europæiske standardiseringsorganer som CEN og CENELEC.
If the country can maintain that rate of progress, it should satisfy by December the 80% compliance rate required to become a member of European standards bodies such as CEN and CENELEC.
På det industripolitiske område står der lignende udfordringer tilbage.
In Romania, standardisation and accreditation bodies have been
Blandt de tre områder under GD Erhvervspolitiks ansvar er SMV-
Similar challenges remain for industrial policy.