natgillin/translations-raw huggingface dataset:
However, they must never be allowed to detract from the overriding aim of the Regulation on novel foods, namely food safety and consumer protection.
However, they must never be allowed to detract from the overriding aim of the Regulation on novel foods, namely food safety and consumer protection.
AVIZ al Comisiei pentru piaȚa internă și protecȚia consumatorilor
OPINION of the Committee on the Internal Market and Consumer Protection
The objective of the proposal for a regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXX (common procedure) is to ensure food safety, protect human health and secure the functioning of the internal market for food.
The objective of the proposal for a regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXX (common procedure) is to ensure food safety, protect human health and secure the functioning of the internal market for food.
Authorisation and use of novel foods and food ingredients is harmonised in the European Union since 1997 when Regulation EC No 258/97 was adopted.
Authorisation and use of novel foods and food ingredients is harmonised in the European Union since 1997 when Regulation EC No 258/97 was adopted.
This regulation lays down the general principles for authorisation of novel foods and food ingredients.
This regulation lays down the general principles for authorisation of novel foods and food ingredients.
The new proposal aims to streamline the existing rules for authorisation procedures, supervision, labelling and use of novel foods, and to clarify the definition of novel food.
The new proposal aims to streamline the existing rules for authorisation procedures, supervision, labelling and use of novel foods, and to clarify the definition of novel food.
The rapporteur supports the proposal, but suggests improvements along the following lines:
The rapporteur supports the proposal, but suggests improvements along the following lines:
· The rapporteur suggests that ethical aspects should be taken into account when considering authorisation of a novel food, and also suggests that the Committee on ethics and new technologies should be consulted where appropriate on ethical issues regarding science and new technologies.
· The rapporteur suggests that ethical aspects should be taken into account when considering authorisation of a novel food, and also suggests that the Committee on ethics and new technologies should be consulted where appropriate on ethical issues regarding science and new technologies.
· Furthermore the rapporteur wants to ensure that the implementing measures will be adopted before the Regulation enters into force.
· Furthermore the rapporteur wants to ensure that the implementing measures will be adopted before the Regulation enters into force.
This will reduce the uncertainties for businesses and confusion over what rules businesses should follow.
This will reduce the uncertainties for businesses and confusion over what rules businesses should follow.
If the implementing measures are not adopted there will still be difficulties with the interpretation and possible differences in the administration among the Member States, which will have a negative effect on the functioning of the internal market.
If the implementing measures are not adopted there will still be difficulties with the interpretation and possible differences in the administration among the Member States, which will have a negative effect on the functioning of the internal market.
The rapporteur furthermore suggests that the regulation should apply from 12 months after the date of publication instead of 6 months.
The rapporteur furthermore suggests that the regulation should apply from 12 months after the date of publication instead of 6 months.
This will make it possible to adopt the implementing measures before the application of the regulation.
This will make it possible to adopt the implementing measures before the application of the regulation.
· There is a borderline affecting medicinal products, which the rapporteur wants to clarify in the proposal.
· There is a borderline affecting medicinal products, which the rapporteur wants to clarify in the proposal.
A clarification of when it is a novel food and when it is a medicinal food will make it easier for the food industry to interpret the rules and reduce uncertainties over which rules are to be followed in which areas.
A clarification of when it is a novel food and when it is a medicinal food will make it easier for the food industry to interpret the rules and reduce uncertainties over which rules are to be followed in which areas.
· With traditional foods from third countries, the requirement of use for at least one generation is more clearly specified as 20 years, on the grounds that the wording ‘one generation’ is much too vague a legal term.
· With traditional foods from third countries, the requirement of use for at least one generation is more clearly specified as 20 years, on the grounds that the wording ‘one generation’ is much too vague a legal term.
· The use of foods in the Community is assessed irrespective of the entry of individual Member States to the EU, which will help clarify the situation particularly for the new Member States.
· The use of foods in the Community is assessed irrespective of the entry of individual Member States to the EU, which will help clarify the situation particularly for the new Member States.
· Targets are extended to include the support of innovation in the food industry and the smooth operation of the internal market, which are measures for the benefit of businesspeople in that sector.
· Targets are extended to include the support of innovation in the food industry and the smooth operation of the internal market, which are measures for the benefit of businesspeople in that sector.
· In some places consumer protection has been tightened up – for instance by expressly prohibiting the placing on the market of foods that are not included on the Community’s list.
· In some places consumer protection has been tightened up – for instance by expressly prohibiting the placing on the market of foods that are not included on the Community’s list.
· The report strengthens the transparency of information provided for the public, by making it compulsory for such information to be available on the Internet.
· The report strengthens the transparency of information provided for the public, by making it compulsory for such information to be available on the Internet.
· Legal certainty is improved for businesspeople who invest large sums in preparation for placing on the market new or traditional foods by requiring them to be informed without undue delay and in a demonstrable manner, in the event of objections during the authorisation process.
· Legal certainty is improved for businesspeople who invest large sums in preparation for placing on the market new or traditional foods by requiring them to be informed without undue delay and in a demonstrable manner, in the event of objections during the authorisation process.
· The Commission’s obligation to provide technical support for applicants is expanded and spelt out, especially for SMEs, including the option of submitting a uniform application by electronic means.
· The Commission’s obligation to provide technical support for applicants is expanded and spelt out, especially for SMEs, including the option of submitting a uniform application by electronic means.
· The requirement is more clearly specified for new foods on the market to be monitored after their approval, by requesting from the Commission the establishment of an adequate, precisely defined period for monitoring, which removes the potential of legal uncertainty for an unlimited period that would influence the attitudes of businesspeople in the competitive environment.
· The requirement is more clearly specified for new foods on the market to be monitored after their approval, by requesting from the Commission the establishment of an adequate, precisely defined period for monitoring, which removes the potential of legal uncertainty for an unlimited period that would influence the attitudes of businesspeople in the competitive environment.
· The report specifies how the protection of personal data is to coexist with the confidentiality (privacy) of such information in accordance with Article 12 of the Regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
· The report specifies how the protection of personal data is to coexist with the confidentiality (privacy) of such information in accordance with Article 12 of the Regulation of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings.
This combination of a period of protection of data and a period of protection of confidentiality would be guided by the principle of proportionality, which includes strengthening the sharing of scientific knowledge and the transparency of information for consumers (such as those with allergies, etc.).
This combination of a period of protection of data and a period of protection of confidentiality would be guided by the principle of proportionality, which includes strengthening the sharing of scientific knowledge and the transparency of information for consumers (such as those with allergies, etc.).
· The requirement is more clearly specified for the Member States to announce sanctions under their national legislation within 12 months from publication of the regulation in the EU Official Journal, together with the requirement on the Commission, which in order to preserve continuity will be required to present a report reviewing the situation by the end of 2013, the aim being to enable the European Parliament elected in the June 2009 elections to assess the regulation’s effectiveness.
· The requirement is more clearly specified for the Member States to announce sanctions under their national legislation within 12 months from publication of the regulation in the EU Official Journal, together with the requirement on the Commission, which in order to preserve continuity will be required to present a report reviewing the situation by the end of 2013, the aim being to enable the European Parliament elected in the June 2009 elections to assess the regulation’s effectiveness.
258/97 al Parlamentului European și al Consiliului 1 ar trebui înlocuită printr-o orientare revizuită, concentrată asupra alimentelor noi; Recomandarea 97/618/CE ar trebui însă să rămână aplicabilă, la cerere, până la înlocuirea sa prin orientarea revizuită.
However, applicants should continue to be able to avail themselves of Commission Recommendation 97/618/EC until it is replaced by revised guidance.
1 JO L 253, 16.9.1997, p.
1 OJ L 253, 16.9.1997, p.
Noua propunere de regulament prevede publicarea unui manual de îndrumare pentru sprijinirea solicitanților.
The proposed new regulation provides for publication of new guidance to assist applicants.
Manualul de îndrumare anterior ar trebui să rămână valabil până când este înlocuit de un manual de îndrumare prelucrat.
The present guidance should remain in force until it has been replaced by a revised guidance.
Utilizarea în cadrul Comunității se referă la utilizarea în statele membre, independent de data aderării acestora la Uniunea Europeană.
A use within the Community refers to a use in the Member States, independently of the date of their accession to the European Union.
This amendment clarifies the extent of the regulation’s impact on the internal market and so increases legal certainty for the those concerned, particularly in the Member States in Central and Eastern Europe.
This amendment clarifies the extent of the regulation’s impact on the internal market and so increases legal certainty for the those concerned, particularly in the Member States in Central and Eastern Europe.
(6a) Cu toate acestea, alimentele produse din animale clonate și din progeniturile acestora ar trebui excluse din domeniul de aplicare a prezentului regulament.
(6a) However, foods derived from cloned animals and their offspring should be excluded from the scope of this Regulation.
Aceste alimente ar trebui reglementate printr-un regulament specific, bazat pe procedura de codecizie și care să nu fie supus unei proceduri comune.
They should be dealt with in a specific regulation, adopted under the codecision procedure, and not be subject to the common procedure.
Comisia ar trebui să prezinte o propunere legislativă în acest sens înainte de intrarea în vigoare a prezentului regulament.
Pending the entry into force of this Regulation, the Commission should put forward a corresponding legislative proposal.
Introducerea pe piață a alimentelor produse din animale clonate și din progeniturile acestora ar trebui să fie supusă unui moratoriu înainte de intrarea în vigoare a unui regulament privind animalele clonate.
Pending the entry into force of a regulation on cloned animals, a moratorium should be imposed on the placing on the market of foods manufactured from cloned animals and their offspring .
(8a) Dispozițiile Directivei 2001/83/CE a Parlamentului European și a Consiliului din 6 noiembrie 2001 de instituire a unui cod comunitar cu privire la medicamentele de uz uman 1 ar trebui să se aplice în cazul în care, ținând seama de toate caracteristicile sale, un produs poate fi definit drept „medicament” și respectă definiția de produs în sensul altor acte legislative comunitare.
(8a) The provisions of 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 1 should apply where, taking into account all its characteristics, a product may fall within the definition of “medicinal product” and within the definition of a product covered by other Community legislation.
În acest sens, dacă un stat membru stabilește, în conformitate cu Directiva 2001/83/CE că o substanță este un medicament, acesta poate restricționa introducerea pe piață a unui astfel de produs conform dreptului comunitar.
In this respect, a Member State may, if it establishes in accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the placing on the market of such a product in accordance with Community law.
1 JO L 311, 28.11.2001, p.
1 OJ L 311, 28.11.2001, p.
The definition of food according to Regulation 178/2002 implies that a product which is a medicine cannot be a food.
The definition of food according to Regulation 178/2002 implies that a product which is a medicine cannot be a food.
As the categorisation of a product as a medicine according to Directive 2001/83 is not totally harmonised among Member States, some differences in categorisation of a product as a medicine exist.
As the categorisation of a product as a medicine according to Directive 2001/83 is not totally harmonised among Member States, some differences in categorisation of a product as a medicine exist.
This has an implication for harmonisation also in the area of food.
This has an implication for harmonisation also in the area of food.
Many borderline issues arise when dealing with novel foods.
Many borderline issues arise when dealing with novel foods.
This recital provides more clarity for industry and consumers about the functioning of the market in relation to borderline products.
This recital provides more clarity for industry and consumers about the functioning of the market in relation to borderline products.
În cazul în care Comisia nu deține informații referitoare la consumul uman înainte de 15 mai 1997, trebuie stabilită o procedură simplă și transparentă de colectare a acestor informații, prin implicarea statelor membre și a oricăror părți interesate.
Where the Commission does not have information on human consumption before 15 May 1997, a simple and transparent procedure for collecting that information should be established involving the Member States and any interested parties.
În cazul în care Comisia nu deține informații referitoare la consumul uman înainte de 15 mai 1997, trebuie stabilită o procedură de colectare a acestor informații, prin implicarea statelor membre și a oricăror părți interesate.
Where the Commission does not have information on human consumption before 15 May 1997, a procedure for collecting that information should be established involving the Member States and any interested parties.
Această procedură ar trebui să fie simplă și transparentă, evitând orice perturbare nejustificată a pieței și ar trebui adoptată în termen de șase luni de la intrarea în vigoare a prezentului regulament.
This procedure should be simple and transparent, whilst avoiding any unjustified disruption to the market, and should be adopted no later than six months after the entry into force of this Regulation .
The information collection procedure may involve raising questions about products that are ultimately found not to be novel foods.
The information collection procedure may involve raising questions about products that are ultimately found not to be novel foods.
In the process of a transparent collection of data, these products’ competitive position should not be negatively affected by incorrect inferences of novel status.
In the process of a transparent collection of data, these products’ competitive position should not be negatively affected by incorrect inferences of novel status.
The Commission procedure should therefore be sensitive to such problems and avoid any unjustified disruption of the market.
The Commission procedure should therefore be sensitive to such problems and avoid any unjustified disruption of the market.
It is essential that in the process of approving new foods (since this also covers new foods gained from nanotechnologies or cloning processes) all the relevant factors essential for the final decision are taken into account, including the ethical issues.
It is essential that in the process of approving new foods (since this also covers new foods gained from nanotechnologies or cloning processes) all the relevant factors essential for the final decision are taken into account, including the ethical issues.
The wording of recital 20 should be aligned with the wording of recital 31 of Regulation 1924/2006 on nutrition and health claims.
The wording of recital 20 should be aligned with the wording of recital 31 of Regulation 1924/2006 on nutrition and health claims.
It is essential that when labelling new foods (since they include new foods gained from nanotechnologies or cloning processes) the ethical issues are taken into account in appropriate cases, as consumers need transparent information to be able to make informed choices and purchases.
It is essential that when labelling new foods (since they include new foods gained from nanotechnologies or cloning processes) the ethical issues are taken into account in appropriate cases, as consumers need transparent information to be able to make informed choices and purchases.
În cazul în care un solicitant intenționează să aplice unui aliment nou o mențiune de sănătate, care trebuie aprobată conform articolului 17 sau 18 din respectivul regulament, și atât cererea de aprobarea a noului aliment, cât și cererea de aprobare a mențiunii de sănătate sunt prezentate simultan și conțin o solicitare de protecție a datelor, ar trebui ca, la cererea solicitantului, perioadele de protecție a datelor să înceapă și să se desfășoare simultan.
Where an applicant intends a novel food to carry a health claim authorised in accordance with Articles 17 or 18 of that Regulation, and where the novel food and health claim applications are introduced at the same time and both include a request for the protection of proprietary data, at the request of the applicant the periods of data protection should start together and run concurrently.
Solicitările aferente de autorizare a unui aliment nou și a unei mențiuni privind beneficiile pentru sănătate ale produsului respectiv, ambele bazate pe date care fac obiectul dreptului de proprietate comercială, se pot derula conform unor calendare diferite.
Related applications for authorisation of a novel food and of a health claim relevant for the same product and both based on proprietary data could proceed according to different schedules.
Prin urmare, este posibil ca perioada de protecție a datelor aferentă unei autorizații să se fi scurs în mare parte înainte de începerea perioadei de protecție a datelor aferente autorizației corelate.
Consequently, the period of data protection under one authorisation could have elapsed to a significant degree before the data protection period of the related authorisation starts.
Trebuie să se introducă o dispoziție privind alinierea perioadelor de protecție a datelor aferente unor autorizații corelate, în cazul în care solicitantul cere acest lucru.
Provision must be made to align the data protection periods of related authorisations if requested by the applicant.
(24) Grupul european pentru etică în domeniul științei și al noilor tehnologii instituit prin decizia Comisiei din 16 decembrie 1997 ar trebui consultat, în cazurile justificate , în vederea obținerii de consiliere cu privire la aspectele etice referitoare la introducerea pe piață a alimentelor noi.
(24) The European Group on Ethics in Science and New Technologies established by Commission Decision of 16 December 1997 should be consulted in substantiated cases with a view to obtaining advice on ethical issues regarding the placing on the market of novel foods.
(25) Alimentele noi introduse pe piața comunitară în conformitate cu Regulamentul (CE) nr.
(25) Novel foods placed on the Community market under Regulation (EC) No 258/97 should continue to be placed on the market.
În cazul exprimării avizului, autoritatea și statul membru ar trebui să aibă în vedere rezultatele evaluării inițiale.
When required to give an opinion, the Authority and the Member States should take the outcome of the initial assessment into account.
Textul propus de Comisie ar putea să dezavantajeze acele solicitări pentru care a fost deja înaintată o evaluare către Comisie, deoarece poate exista posibilitatea de a autoriza o astfel de solicitare fără a o redirecționa către EFSA pentru evaluare, dacă nu există nicio obiecție.
The Commission’s proposed text potentially disadvantages applications for which an initial assessment has already been forwarded to the Commission, since it may be possible to authorize such an application without redirection of the application to EFSA for evaluation if no objections are raised.
Toate solicitările pentru care a fost deja înaintat un raport de evaluare inițială către Comisie ar trebui să urmeze în continuare procedura definită în 258/97/CE.
All applications for which an initial assessment report has already been forwarded to the Commission should continue according to the procedure defined in 258/97/EC.
Prezentul regulament stabilește normele armonizate pentru introducerea pe piață a alimentelor noi în Comunitate în vederea garantării unui nivel ridicat de protecție a sănătății umane și a consumatorilor, asigurând în același timp funcționarea eficientă a pieței interne.
This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of human health and consumers’ protection, whilst ensuring the effective functioning of the internal market.
Prezentul regulament stabilește normele armonizate pentru introducerea pe piață a alimentelor noi în Comunitate în vederea garantării unui nivel ridicat de protecție a sănătății umane și a consumatorilor, asigurând în același timp funcționarea eficientă a pieței interne și stimulând inovarea în cadrul industriilor relevante .
This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of human health and consumers’ protection, whilst ensuring the effective functioning of the internal market and stimulating innovation within the relevant industries .