natgillin/translations-raw huggingface dataset:
Dacă este cazul, în ceea ce privește problemele de etică de importanță majoră din domeniul științific și al noilor tehnologii, din proprie inițiativă sau la solicitarea unui stat membru, Comisia poate consulta Grupul european pentru etică și noi tehnologii, pentru a obține avizul său privind aspectele de ordin etic.
Where appropriate, on ethical questions relating to science and new technologies of major ethical importance, the Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics and new Technologies, with a view to obtaining its opinion on ethical issues.
Comisia pune la dispoziția publicului avizul menționat.
The Commission shall make this opinion available to the public.
La cererea solicitantului, justificată prin informații adecvate și verificabile incluse în dosarul de cerere, dovezile științifice recente și datele științifice care fac obiectul unui drept de proprietate furnizate pentru a justifica cererile, nu pot fi folosite în beneficiul unei alte cereri pentru o perioadă de cinci ani de la data includerii alimentului nou pe lista comunitară fără acordul solicitantului.
On request by the applicant, supported by appropriate and verifiable information included in the application dossier, newly developed scientific evidence and proprietary scientific data provided to support the applications, may not be used for the benefit of another application during a period of five years from the date of the inclusion of the novel food in the Community list without the agreement of the applicant.
(a) datele științifice și alte informații au fost desemnate ca date care fac obiectul unui drept de proprietate de către solicitantul inițial atunci când s-a depus cererea inițială; și
(a) the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
(b) solicitantul inițial beneficia, la momentul când a fost depusă cererea inițială, de dreptul exclusiv de a face trimiteri la datele care fac obiectul dreptului de proprietate; și
(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
(c) alimentul nou nu ar fi putut fi autorizat fără transmiterea de către solicitantul inițial a datelor care fac obiectul drepturilor de proprietate.
(c) the novel food could not have been authori s ed without the submission of the proprietary data by the prior applicant.
Articolul 21 din Regulamentul 1924/2006/CE privind mențiunile nutriționale și de sănătate conține o definiție mai clară a protecției datelor.
Article 21 of Regulation 1924/2006/EC on nutrition and health claims includes a clearer definition of data protection.
Ar trebui revizuit articolul 12 pentru a asigura coerența cu Regulamentul 1924/2006/CE în ceea ce privește dispozițiile referitoare la protecția datelor.
Article 12 should be revised for consistency of data protection provisions with Regulation 1924/2006/EC.
Dacă banii publici sunt folosiți pentru a genera cunoștințe, aceste cunoștințe ar trebui să fie accesibile și publicului.
If public money is involved to generate knowledge, this knowledge should also be accessible to the public.
Articolul 12 – alineatul 1b (nou)
Article 12 – paragraph 1 b (new)
În acest context, studiile care implică teste efectuate pe animale vertebrate și studiile care pot preveni testarea pe animale nu vor intra sub incidența prevederilor privind protecția datelor.
In this context, studies involving tests on vertebrate animals and studies that may prevent animal testing will not be covered by data protection.
Astfel, trebuie permis accesul la studii efectuate pe animale vertebrate și la alte studii care pot preveni testarea pe animale.
Thus access to studies on vertebrates and other studies that may prevent animal testing must be allowed.
Ar trebui inclusă aici mențiunea că proprietarul unui test sau studiu nu poate împiedica folosirea acestuia de către o altă persoană în cazurile în care acest lucru ar duce la evitarea testării pe animale.
It should be included here that the owner of a test or study cannot prevent it being used by another person where this would avoid animal testing.
Protecția armonizată a datelor
Harmonised data protection
Fără a aduce atingere autorizării unui aliment nou în temeiul articolelor 7 și 14 din Regulamentul (CE) nr. …/... [procedura comună], precum și autorizării privind o mențiune de sănătate în temeiul articolelor 17, 18 și 25 din Regulamentul (CE) 1924/2006, datele referitoare la autorizare și publicarea autorizației în Jurnalul Oficial sunt identice, iar perioadele de protecție a datelor se desfășoară simultan, în cazul în care se dorește obținerea unei autorizări pentru un aliment nou și pentru mențiunea de sănătate aplicabilă acestuia și totodată se garantează protecția datelor în conformitate cu prevederile ambelor regulamente, la cererea solicitantului.
Notwithstanding authorisation of a novel food pursuant to Articles 7 and 14 of Regulation (EC) No .../... [common procedure] or authorisation of a health claim pursuant to Articles 17, 18 and 25 of Regulation (EC) No 1924/2006, the data concerning the authorisation and the publication of the authorisation in the Official Journal shall be identical and the data protection periods shall run concurrently where authorisation is sought for a novel food and for a health claim relating to that food, and where data protection pursuant to the provisions of both Regulations is warranted and requested by the applicant.
A se vedea justificarea de la Considerentul 22.
See justification concerning recital 22.
Articolul 12b (nou)
Article 12 b (new)
Articolul 12b
Article 12 b
Măsuri de inspecție și control
Inspection and control measures
În propunerea Comisiei nu se menționează măsurile de inspecție și control în niciun articol.
In the Commission proposal, inspection and control measures are not referred to in an Article.
Statele membre stabilesc norme privind sancțiunile aplicabile în cazul încălcării dispozițiilor prezentului regulament și iau toate măsurile necesare pentru a asigura punerea acestora în aplicare.
The Member States shall lay down the rules on penalties applicable to infringements of the provision of this Regulation and shall take all measures necessary to ensure that they are implemented.
Sancțiunile stabilite trebuie să fie eficiente, proporționale și cu efect de descurajare.
The penalties provided for must be effective, proportionate and dissuasive.
Statele membre notifică aceste dispoziții Comisiei până la […] cel târziu, și o informează pe aceasta fără întârziere cu privire la orice modificare ulterioară a acestor dispoziții.
The Member States shall notify those provisions to the Commission by [ ..] at the latest and shall notify it without delay of any subsequent amendment affecting them.
Statele membre notifică aceste dispoziții Comisiei în termen de cel mult 12 luni și o informează pe aceasta fără întârziere cu privire la orice modificare ulterioară a acestor dispoziții.
The Member States shall notify those provisions to the Commission within 12 months at the latest and shall notify it without delay of any subsequent amendment affecting them.
Stabilindu-se un termen precis pentru notificare (12 luni), termen în care statele membre trebuie să anunțe normele privind impunerea sancțiunilor pentru încălcarea prezentului regulament, se sporește certitudinea juridică.
By setting a clear deadline for notification (12 months) by which the Member States must announce rules for imposing sanctions for infringement of this regulation we can increase legal certainty.
În plus, amendamentul asigură coerența cu perioada mai lungă stabilită în alte articole pentru adoptarea normelor de punere în aplicare de către Comisia Europeană.
In addition, the amendment is consistent with the longer period set out in other articles for the adoption of implementing arrangements by the European Commission.
Privilegii ale statelor membre
Privileges of Member States
(2) Comisia examinează, în strânsă cooperare cu EFSA și în cel mai scurt timp posibil, motivele menționate la alineatul (1) și ia măsurile necesare.
The Commission, in close cooperation with EFSA, shall examine the grounds referred to in paragraph 1 as soon as possible and shall take the appropriate measures.
Statul membru care a luat decizia menționată la alineatul (1) o poate menține până la intrarea în vigoare a măsurilor.
The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.
Cel târziu până la [1 ianuarie 2015] și având în vedere experiența acumulată, Comisia înaintează Parlamentului European și Consiliului un raport privind punerea în aplicare a prezentului regulament, în special a articolului 8 , însoțit, după caz, de propuneri.
No later than [1 January 2015] and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation and in particular of Article 8, accompanied, where appropriate, by any proposals.
Raportul și eventualele propuneri sunt accesibile publicului.
The report and any proposal shall be made accessible to the public.
Cel târziu până la 31 decembrie 2013 și având în vedere experiența acumulată, Comisia înaintează Parlamentului European și Consiliului un raport privind punerea în aplicare a prezentului regulament, în special a articolelor 8 și 12 , ținând cont de diferitele definiții ale nano-materialelor publicate de diferite organisme, precum și de continuul progres tehnico-științific în domeniul nanotehnologiilor, însoțit, după caz, de propuneri.
Not later than 31 December 2013 and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation , particularly of Articles 8 and 12 , in view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, accompanied, where appropriate, by any proposals.
În vederea continuității, este mai potrivit ca Parlamentul European să se ocupe de reexaminarea regulamentului pe durata următoarei legislaturi.
For the sake of continuity it is more appropriate for the review of the regulation to be dealt with by the European Parliament in the next parliamentary term.
În plus, în ceea ce privește noul instrument juridic pentru protecția datelor în temeiul articolului 12, ar fi adecvat ca în cadrul reexaminării, Comisia să se concentreze și asupra aspectelor legate de punerea în aplicare în statele membre.
Moreover as regards the new legal instrument for data protection under Article 12, it would seem appropriate for the Commission also to focus on implementation in the Member States in its review.
A se vedea amendamentul la articolul 16.
See amendment to Article 16.
The purpose of the Commission proposal is to amend Regulation (EC) No 258/97 on novel foods, with the aim of simplifying and centralising the procedures for authorising novel foods and placing them on the market.
The purpose of the Commission proposal is to amend Regulation (EC) No 258/97 on novel foods, with the aim of simplifying and centralising the procedures for authorising novel foods and placing them on the market.
Thus it has been decided that new regulation is necessary.
Thus it has been decided that new regulation is necessary.
The rapporteur considers that if it is decided to adopt regulations, it must be very clear what their purpose is.
The rapporteur considers that if it is decided to adopt regulations, it must be very clear what their purpose is.
In the rapporteur's view, the objectives of the new regulation on novel foods are to attain a high level of food safety, consumer protection, environmental protection and protection of animal health while at all times the precautionary principle as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
In the rapporteur's view, the objectives of the new regulation on novel foods are to attain a high level of food safety, consumer protection, environmental protection and protection of animal health while at all times the precautionary principle as laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
All other objectives are of secondary importance.
All other objectives are of secondary importance.
Novel foods must not endanger or mislead consumers, either.
Novel foods must not endanger or mislead consumers, either.
Where novel foods serve to replace another food, the novel foods must not be nutritionally inferior from the consumer's point of view.
Where novel foods serve to replace another food, the novel foods must not be nutritionally inferior from the consumer's point of view.
The Commission proposal seeks to clarify the definition of novel foods and the associated definitions.
The Commission proposal seeks to clarify the definition of novel foods and the associated definitions.
The rapporteur endorses this aim, but considers that the Commission has negligently fallen short in achieving it.
The rapporteur endorses this aim, but considers that the Commission has negligently fallen short in achieving it.
Its proposal did not include clear definitions, and the rapporteur has therefore clarified the existing definitions and where necessary supplemented them with new ones.
Its proposal did not include clear definitions, and the rapporteur has therefore clarified the existing definitions and where necessary supplemented them with new ones.
These include, for example, a definition of foods derived from cloned animals and foods produced using nanotechnology.
These include, for example, a definition of foods derived from cloned animals and foods produced using nanotechnology.
The rapporteur considers it very important that foods derived from cloned animals should be excluded from the scope of the Regulation on novel foods.
The rapporteur considers it very important that foods derived from cloned animals should be excluded from the scope of the Regulation on novel foods.
As no democratic agreement has yet been reached on the desirability of these foods, particularly from the point of view of animal health and welfare, the decision as to whether or not to place on the market foods derived from cloned animals and their descendants cannot be left to the commitology procedure.
As no democratic agreement has yet been reached on the desirability of these foods, particularly from the point of view of animal health and welfare, the decision as to whether or not to place on the market foods derived from cloned animals and their descendants cannot be left to the commitology procedure.
It must be resolved by means of a specific regulation of the European Parliament and of the Council under the codecision procedure.
It must be resolved by means of a specific regulation of the European Parliament and of the Council under the codecision procedure.
Lastly, account must also be taken of whether a society regards a novel food as inedible on ethical grounds.
Lastly, account must also be taken of whether a society regards a novel food as inedible on ethical grounds.
All applications for authorisation of novel foods will be submitted to the Commission and must comply with the criteria laid down in this Regulation; they will then be forwarded for consideration to the European Food Safety Authority (EFSA), which will assess the foods' safety.
All applications for authorisation of novel foods will be submitted to the Commission and must comply with the criteria laid down in this Regulation; they will then be forwarded for consideration to the European Food Safety Authority (EFSA), which will assess the foods' safety.
This assessment must also take account of ethical and environmental aspects.
This assessment must also take account of ethical and environmental aspects.
Consequently the opinions of the European Group on Ethics in Science and New Technologies and the European Environment Agency must be involved in the safety assessment.
Consequently the opinions of the European Group on Ethics in Science and New Technologies and the European Environment Agency must be involved in the safety assessment.
At present, the Commission is promising consumers and citizens that it will take responsibility for environmental and animal welfare aspects, inter alia in view of the problems of climate change and animal welfare, and European policy must therefore be comprehensive and sound with reference to all relevant fields of legislation and therefore also to the Regulation on novel foods.
At present, the Commission is promising consumers and citizens that it will take responsibility for environmental and animal welfare aspects, inter alia in view of the problems of climate change and animal welfare, and European policy must therefore be comprehensive and sound with reference to all relevant fields of legislation and therefore also to the Regulation on novel foods.
The Commission proposal seeks to make the authorisation procedure more effective and transparent and to implement it better.
The Commission proposal seeks to make the authorisation procedure more effective and transparent and to implement it better.
This will contribute to better implementation of the Regulation and give consumers greater power and more options because they will have more information at their disposal.
This will contribute to better implementation of the Regulation and give consumers greater power and more options because they will have more information at their disposal.
Here too, the Commission has got ahead of itself by taking the view that the Regulation on novel foods should be governed, inter alia, by the Regulation establishing a common authorisation procedure for food additives, food enzymes and flavourings.
Here too, the Commission has got ahead of itself by taking the view that the Regulation on novel foods should be governed, inter alia, by the Regulation establishing a common authorisation procedure for food additives, food enzymes and flavourings.
The European Parliament and the Council have not yet taken a democratic decision on the uniform authorisation procedure.
The European Parliament and the Council have not yet taken a democratic decision on the uniform authorisation procedure.
The rapporteur has therefore opted to propose an authorisation procedure based on the procedure laid down in Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
The rapporteur has therefore opted to propose an authorisation procedure based on the procedure laid down in Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed
For traditional foods from third countries, the Commission proposes a simpler authorisation procedure, under which safety would be assessed in the light of the history of safe use in the country of origin.
For traditional foods from third countries, the Commission proposes a simpler authorisation procedure, under which safety would be assessed in the light of the history of safe use in the country of origin.
It is important that it should be precisely established what period of safe use of such traditional foods from third countries is long enough to guarantee the safety of the product, and the rapporteur proposes a period of 50 years for this, rather than the 'one generation' proposed by the Commission, which is difficult to define.
It is important that it should be precisely established what period of safe use of such traditional foods from third countries is long enough to guarantee the safety of the product, and the rapporteur proposes a period of 50 years for this, rather than the 'one generation' proposed by the Commission, which is difficult to define.
The Commission proposal aims to achieve a certain level of data protection for a five-year period for applications under this Regulation.
The Commission proposal aims to achieve a certain level of data protection for a five-year period for applications under this Regulation.
This surprises the rapporteur, as the Commission adduced a completely different line of argument during the consideration of the uniform authorisation procedure in the European Parliament.
This surprises the rapporteur, as the Commission adduced a completely different line of argument during the consideration of the uniform authorisation procedure in the European Parliament.
The Commission claimed there that a data protection system would result in an increase in regulation and would render monitoring systems and administrative procedures more complex.
The Commission claimed there that a data protection system would result in an increase in regulation and would render monitoring systems and administrative procedures more complex.
In addition, a data protection system would constitute an obstacle to free movement of goods which are safe and meet the criteria of the relevant legislation, which is contrary to the purposes of a measure adopted under Article 95 of the EC Treaty.
In addition, a data protection system would constitute an obstacle to free movement of goods which are safe and meet the criteria of the relevant legislation, which is contrary to the purposes of a measure adopted under Article 95 of the EC Treaty.
This inconsistency in the Commission's legislative proposals is highly unsatisfactory.
This inconsistency in the Commission's legislative proposals is highly unsatisfactory.
The rapporteur therefore proposes retaining the system of confidentiality of manufacturing data laid down in Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97
The rapporteur therefore proposes retaining the system of confidentiality of manufacturing data laid down in Commission Regulation (EC) No 1852/2001 of 20 September 2001 laying down detailed rules for making certain information available to the public and for the protection of information submitted pursuant to European Parliament and Council Regulation (EC) No 258/97
The Commission proposal envisages Member States being required to impose penalties on those who violate the provisions of the regulation on novel foods.
The Commission proposal envisages Member States being required to impose penalties on those who violate the provisions of the regulation on novel foods.
The rapporteur strongly emphasises that the criminal law is always a matter for Member States.
The rapporteur strongly emphasises that the criminal law is always a matter for Member States.
It is highly desirable that Member States should be able to decide freely whether a penalty is to be imposed under the criminal law or whether it should be administrative or of some other nature.
It is highly desirable that Member States should be able to decide freely whether a penalty is to be imposed under the criminal law or whether it should be administrative or of some other nature.
So long as a Member State takes adequate action against violations of the Regulation on novel foods, it will be fulfilling its obligations under Community law.
So long as a Member State takes adequate action against violations of the Regulation on novel foods, it will be fulfilling its obligations under Community law.
The rapporteur supports all measures to lessen administrative burdens and improve transparency and efficiency.
The rapporteur supports all measures to lessen administrative burdens and improve transparency and efficiency.