natgillin/translations-raw huggingface dataset:
Kui tervisealase väite teadusliku põhjendatuse suhtes on tekkinud tõsiseid kahtlusi ja ameti positiivset otsust tõenäoliselt ei langetata, võib komisjon tervisealase väite edaspidise kasutamise keelata.
Where there are such serious concerns with regard to the scientific substantiation of a health claim that a favourable opinion by the Authority cannot be expected, the Commission may prohibit the continued use of the health claim.
Muudatusettepanek 58
Amendment 58
Amet võib vajadusel nõuda taotlejalt taotlusele lisatud andmete täiendamist kindla tähtaja jooksul .
2 The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.
Tootjal või importijal on otsene ligipääs ameti pädevatele organitele, õigus olla ära kuulatud ja õigus esitada toimikule täiendavaid dokumente.
The manufacturer or importer shall have direct access to the competent panel of the Authority including the right to be heard and the right to provide additional particulars to the dossier.
Deleting an option of open catalogue of documents required during claim authorisation process will secure the notification process against discretion of the officials.
Deleting an option of open catalogue of documents required during claim authorisation process will secure the notification process against discretion of the officials.
On the other hand it is vital to provide the manufacturer or importer with an option of submitting additional explanations and, if needed, to supplement the dossier.
On the other hand it is vital to provide the manufacturer or importer with an option of submitting additional explanations and, if needed, to supplement the dossier.
Oma hinnangu ettevalmistamiseks kontrollib amet:
In order to prepare its opinion, the Authority shall verify:
a) kas tervisealase väite väljapakutud sõnastus on teaduslike andmetega kinnitatud;
(a) that the proposed wording of the health claim is substantiated by scientific data;
a) kas tervisealane väide on teaduslike tandmetega põhjendatud;
(a) that the health claim is substantiated by scientific data;
b) kas tervisealase väite sõnastus vastab käesoleva määruse kriteeriumidele;
(b) that the wording of the heath claim complies with the criteria laid down in this Regulation;
b) kas tervisealane väide vastab käesoleva määruse kriteeriumitele;
(b) that the health claim complies with the criteria laid down in this Regulation;
c) kas tervisealase väite väljapakutud sõnastus on tarbija jaoks mõistetav ja sisukas.
(c) that the proposed wording of the health claim is understandable and meaningful to the consumer.
c) kas tervisealane väide on tarbija jaoks mõistetav ja sisukas.
(c) that the health claim is understandable and meaningful to the consumer.
Muudatusettepanek 60
Amendment 60
Artikli 15 lõike 4 punkt a
Article 15, paragraph 4, point (a)
Muudatusettepanek 61
Amendment 61
Artikli 15 lõike 4 punkt c
Article 15, paragraph 4, point (c)
c) väljapakutud tervisealase väite soovitav sõnastus kõigis ühenduse keeltes ;
(c) the recommended wording , in all Community languages, of the proposed health claim;
c) tervisealase väite sõnastuse ettepanek ;
(c) a proposal for the wording of the health claim;
Muudatusettepanek 62
Amendment 62
Artikli 15 lõige 4 a (uus)
Article 15, paragraph 4 a (new)
Tervisealase väite kohta käiva tingimusliku arvamuse korral, saadetakse arvamus tootjale või importijale.
In the event of a conditional opinion on the health claim, the opinion shall be sent to the manufacturer or importer.
Tootjal või importijal on arvamuse saamisest alates aega üks kuu, et esitada ametile lisaandmeid, enne kui arvamus lõplikult vastu võetakse ja avaldatakse.
The manufacturer or importer shall have one month from the date of receipt of the opinion to provide further information to the Authority, before and opinion is finally adopted and published.
Muudatusettepanek 63
Amendment 63
Artikli 15 lõige 5
Article 15, paragraph 5
Amet edastab oma hinnangu koos tervisealase väite hindamisaruandega ja oma hinnangu põhjendusega komisjonile, liikmesriikidele ja taotlejale .
The Authority shall forward its opinion to the Commission, the Member States and the applicant , including a report describing its assessment of the health claim and stating the reasons for its opinion.
Amet edastab oma hinnangu koos tervisealase väite hindamisaruandega ja oma hinnangu põhjendusega komisjonile, liikmesriikidele, tootjale või importijale.
The Authority shall forward its opinion to the Commission, the Member States and the manufacturer or importer , including a report describing its assessment of the health claim and stating the reasons for its opinion.
Muudatusettepanek 64
Amendment 64
Artikli 16 pealkiri ja lõige 1
Article 16, title and paragraph 1
Ühenduse luba
Community Authorisation
Otsus põhjendatud hinnangu kohta
Decision on the reasoned opinion
Komisjon esitab kolme kuu jooksul pärast ameti hinnangu saamist artikli 23 lõikes 1 osutatud komiteele otsuse eelnõu, võttes arvesse ameti hinnangut, ühenduse õiguse kõiki asjakohaseid sätteid ja teisi asjassepuutuvaid õiguslikke tegureid .
Within three months of receipt of the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 23(1) a draft of the decision to be taken in respect of the application , taking into account the opinion of the Authority , any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration .
Kui otsuse eelnõu ei lange kokku ameti hinnanguga, selgitab komisjon erinevuste põhjuseid.
Where the draft Decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
Komisjon esitab ühe kuu jooksul pärast ameti hinnangu saamist artikli 23 lõikes 1 osutatud komiteele otsuse eelnõu, võttes arvesse ameti hinnangut ja ühenduse õiguse kõiki asjakohaseid sätteid.
Within one month of receipt of the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 23(1) a draft of the decision to be taken, taking into account the opinion of the Authority and any relevant provisions of Community law.
It is not clear what other legitimate factors could be relevant in taking a decision as to the scientific substantiation of a claim.
It is not clear what other legitimate factors could be relevant in taking a decision as to the scientific substantiation of a claim.
The question to be decided is simply whether a health claim is truthful and scientifically substantiated or not.
The question to be decided is simply whether a health claim is truthful and scientifically substantiated or not.
There is no place for other general or health-policy considerations.
There is no place for other general or health-policy considerations.
Muudatusettepanek 65
Amendment 65
Artikli 16 lõige 4
Article 16, paragraph 4
Komisjon teavitab taotlejat kohe oma otsusest ja avaldab selle otsuse üksikasjad Euroopa Liidu Teatajas.
The Commission shall without delay inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union .
Komisjon teavitab tootjat või importijat kohe oma otsusest ja avaldab selle otsuse üksikasjad Euroopa Liidu Teatajas.
The Commission shall without delay inform the manufacturer or importer of the decision taken and publish details of the decision in the Official Journal of the European Union .
Artikli 17 pealkiri ja lõige 1
Article 17, title and paragraph 1
Lubade muutmine, peatamine ja tühistamine
Modification, suspension and revocation of authorisations
Otsuste muutmine, peatamine ja tühistamine
Modification, suspension and revocation of decisions
Loaomanik võib vastavalt artikli 14 menetlusele taotleda olemasoleva loa muudatusi.
The authorisation-holder may, in accordance with the procedure laid down in Article 14, apply for a modification of an existing authorisation .
Tootja või importija võib vastavalt artikli 14 menetlusele taotleda olemasoleva otsuse muudatusi.
The manufacturer or importer may, in accordance with the procedure laid down in Article 14, apply for a modification of an existing decision .
Komisjon kontrollib ameti hinnangut esimesel võimalusel .
The Commission shall examine the opinion of the Authority as soon as possible .
Vastavalt artikli 16 menetlusele toimub vajadusel loa muutmine, peatamine või tühistamine.
If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the procedure laid down in Article 16.
Komisjon kontrollib ameti hinnangut kolme kuu jooksul.
The Commission shall examine the opinion of the Authority within three months .
Vastavalt artikli 16 menetlusele toimub vajadusel otsuse muutmine, peatamine või tühistamine.
If appropriate, the decision shall be modified, suspended or revoked in accordance with the procedure laid down in Article 16.
Artikkel 17 a
Article 17 a (new)
Peale ametiga konsulteerimist esitab komisjon ettepaneku Euroopa Parlamendi ja nõukogu määruse kohta, mis kehtestab tasud teate hindamise eest.
After consulting the Authority, the Commission shall submit a proposal for a regulation of the European Parliament and of the Council establishing fees for the evaluation of notifications.
The industry should contribute to the administrative costs linked to a notification for health claims.
The industry should contribute to the administrative costs linked to a notification for health claims.
Register sisaldab järgmisi elemente:
The Register shall include the following:
a) toitumisalased väited ja nende kasutamise tingimused vastavalt lisale;
(a) the nutrition claims and the conditions applying to them as set out in the Annex;
b) tervislikkust puudutav lubatud teave ja selle kasutamise tingimused vastavalt artikli 13 lõikele 2, artikli 17 lõikele 2, artikli 19 lõigetele 1 ja 2, artikli 21 lõikele 2 ning artikli 22 lõikele 2;
(b) the authorised health claims and the conditions applying to them provided for in Articles 13(2), 17(2), 19 (1) and (2), 21(2) and 22(2);
b) tervisealased väited vastavalt artiklile 12 ja tervisealased väited, mille kohta on tehtud positiivne otsus vastavalt artikli 13 lõikele 2, artikli 17 lõikele 2, artikli 19 lõikele 1 ja 2, artikli 21 lõikele 2 ja artikli 22 lõikele 2 ja nendele kohalduvad tingimused ;
(b) the health claims within the meaning of Article 12 and the health claims on which a favourable decision has been reached in accordance with Articles 13(2), 17(2), 19 (1) and (2), 21(2) and 22(2) , and any conditions applying to them ;
c) tagasi lükatud tervisealaste väidete nimekiri.
(c) a list of rejected health claims.
Tervisealased väited, mida lubatakse konfidentsiaalsete andmete põhjal, koondatakse registri eraldi lisasse koos järgmise infoga:
Health claims authorised on the basis of proprietary data shall be placed on a separate Annex to the Register with the following information:
Tervisealased väited, mille kohta on langetatud positiivne otsus konfidentsiaalsete andmete põhjal, koondatakse registri eraldi lisasse järgmise infoga:
Health claims on which a favourable decision has been taken on the basis of proprietary data shall be placed on a separate Annex to the Register with the following information:
1) kuupäev, millal komisjon andis tervisealase väite jaoks loa , ja algse taotleja nimi, kellele luba väljastati;
(1) the date the Commission authorised the health claim and the name of the original applicant that was granted authorisation ;
1) komisjoni tervisealase väite kohta tehtud otsuse kuupäev ja algse teataja nimi;
(1) the date of the decision by the Commission on the health claim and the name of the original notifier ;
2) viide sellele, et komisjon andis tervisealase väite jaoks loa konfidentsiaalsete andmete põhjal;
(2) that the Commission authorised the health claim on the basis of proprietary data;
2) viide sellele, et otsus langetati konfidentsiaalsete andmete põhjal;
(2) that the decision was reached on the basis of proprietary data;
(3) viide sellele, et tervisealase väite kasutamine on piiratud, välja arvatud juhul, kui hilisem taotleja saab loa ilma algse taotleja konfidentsiaalsetele andmetele toetumata.
(3) that the health claim is restricted for use unless a subsequent applicant obtains authorisation for the claim without reference to the proprietary data of the original applicant .
3) viide sellele, et tervisealase väite kasutamine on piiratud, välja arvatud juhul, kui hilisem tootja või importija saab positiivse otsuse ilma algse tootja või importija konfidentsiaalsetele andmetele toetumata.
(3) that the health claim is restricted for use unless a subsequent manufacturer or importer obtains a favourable decision without reference to the proprietary data of the original manufacturer or importer .
Intellektuaalomandi õigused
Intellectual property rights
Artikkel 25
Article 25
Hiljemalt … [jõustumise kuupäevale järgneva viienda kuu viimane päev+ 6 aastat ], esitab komisjon Euroopa Parlamendile ja nõukogule raporti käesoleva määruse rakendamisest, eriti nende toiduainete turu arengust, mille kohta esitatakse toitumis- ja tervisealaseid väiteid, lisades vajadusel oma muudatusettepanekud.
By … at the latest [last day of the fifth month following date of adoption + 6 years ], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market of foods in respect of which nutrition or health claims are made, together with a proposal for amendments if necessary.
Hiljemalt … [jõustumise kuupäevale järgneva viienda kuu viimane päev+ 3 aastat ], esitab komisjon Euroopa Parlamendile ja nõukogule aruande käesoleva määruse rakendamisest, eriti nende toiduainete turu arengust, mille kohta esitatakse toitumis- ja tervisealaseid väiteid, ja kaubamärke käsitleva artikli 1 lõike 4 a kohaldamisel esinenud raskuste kohta, lisades vajadusel oma muudatusettepanekud.
By ... at the latest [last day of the month following date of adoption + 3 years ], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market in foods in respect of which nutrition or health claims are made and on any problems encountered in the application of Article 1(4 a) on trade marks , together with a proposal for amendments if necessary.
Aruanne peaks sisaldama ka hinnangut käesoleva määruse mõjust rahva tervisele.
The report should also include an evaluation of the impact of this Regulation on public health.
An earlier review date would provide the opportunity to explore any conflicts between the Regulation and the relevant Trade Mark legislation.
An earlier review date would provide the opportunity to explore any conflicts between the Regulation and the relevant Trade Mark legislation.
Artikkel 26
Article 26
See kehtib alates [avaldamisele järgneva kuuenda kuu esimesest päevast].
It shall apply from [first day of the sixth month following publication].
See kehtib alates [avaldamisele järgneva kaheksateistkümnenda kuu esimesest päevast].
It shall apply from [first day of the eighteenth month following publication].
Enne nimetatud kuupäeva turule viidud või märgistatud toiduaineid, mis ei vasta käesolevale määrusele, võib turustada kuni [ avaldamisele järgneva üheteistkümnenda kuu viimase päevani ].
Foods placed on the market or labelled prior to that date which do not comply with this Regulation may be marketed until [last day of the eleventh month following publication ].
Enne käesoleva määruse jõustumise kuupäeva turule viidud või märgistatud toiduaineid, mis ei vasta käesolevale määrusele, võib turustada kuni [ jõustumisele järgneva üheteistkümnenda kuu viimase päevani ] või kuni nende säilimisaja lõpuni, olenevalt, kumb periood on pikem .
Foods placed on the market or labelled prior to the date of entry into force of this Regulation and which do not comply with this Regulation may be marketed until [ last day of the eleventh month following application ] or the end of their shelf life, which ever is longer.
Olemasolevate seadusesätetega kooskõlas kasutatavaid tervisealaseid väiteid, välja arvatud artikli 12 lõikes 1 toodud väiteid, mis on antud toiduainete, toiduainete kategooriate või toiduainete koostisosade kohta käesoleva määruse jõustumise ajal, võib jätkuvalt kasutada tingimusel, et teavitamine toimub vastavalt artiklile 14 kaheteistkümne kuu jooksul alates käesoleva määruse jõustumisest ja enne kuue kuu möödumist pärast lõpliku otsuse vastuvõtmist vastavalt artiklile 16.
Health claims other than those referred to in Article 12(1) that are used in compliance with existing provisions, for foods, categories of foods or food constituents at the time this Regulation enters into force, may continue to be used provided a notification is made pursuant to Article 14 within twelve months of the date of entry into force of this Regulation and until six months after a final decision is taken pursuant to Article 16.
Provision should be made for an 18-month transitional period.
Provision should be made for an 18-month transitional period.
The unrestricted sale of foods placed on the market prior to the regulation's entry into force should be permitted up until the end of their shelf lives, as has been the case with previous pieces of Community legislation.
The unrestricted sale of foods placed on the market prior to the regulation's entry into force should be permitted up until the end of their shelf lives, as has been the case with previous pieces of Community legislation.
The time limits for implementation should take account of both products with a limited shelf life, for which packaging and other changes may take several months to make, and those with a long shelf life that have already been manufactured by the time the regulation is published.
The time limits for implementation should take account of both products with a limited shelf life, for which packaging and other changes may take several months to make, and those with a long shelf life that have already been manufactured by the time the regulation is published.
The proposal for a regulation lays down the conditions under which the labelling and advertising of foods with nutrition and health claims will be permitted in future.
The proposal for a regulation lays down the conditions under which the labelling and advertising of foods with nutrition and health claims will be permitted in future.
While nutritional claims such as 'low-fat' or 'sugar-free' must comply with the rules laid down in the proposal for a regulation and while the Commission reserves the right, where certain foods are concerned, to establish so-called nutritional profiles which must be complied with if those foods are to be advertised with nutrition or health claims, under the Commission proposal health claims will be permitted only on the basis of scientific proof and following official authorisation.
While nutritional claims such as 'low-fat' or 'sugar-free' must comply with the rules laid down in the proposal for a regulation and while the Commission reserves the right, where certain foods are concerned, to establish so-called nutritional profiles which must be complied with if those foods are to be advertised with nutrition or health claims, under the Commission proposal health claims will be permitted only on the basis of scientific proof and following official authorisation.
Mood- or fitness-related claims about foods, such as that a food keeps people fit or young, or makes them happy, are totally prohibited.
Mood- or fitness-related claims about foods, such as that a food keeps people fit or young, or makes them happy, are totally prohibited.
Your draftswoman takes a very critical view of the Commission proposal, and considers that many aspects require changes.
Your draftswoman takes a very critical view of the Commission proposal, and considers that many aspects require changes.
Even the Commission's basic approach underlying the draft regulation, namely prohibition with the possibility of authorisation, has to be scrutinised.
Even the Commission's basic approach underlying the draft regulation, namely prohibition with the possibility of authorisation, has to be scrutinised.
It is essential for consumers to have precise and meaningful information about the foods that they use on a daily basis.
It is essential for consumers to have precise and meaningful information about the foods that they use on a daily basis.
A substantial proportion of such information is supplied by the manufacturers themselves.
A substantial proportion of such information is supplied by the manufacturers themselves.
In addition to factors such as price, it may influence purchase decisions.
In addition to factors such as price, it may influence purchase decisions.
However, European food manufacturers do not operate in a legal vacuum.
However, European food manufacturers do not operate in a legal vacuum.
There is already a multiplicity of national and European rules on labelling and nutritional information.
There is already a multiplicity of national and European rules on labelling and nutritional information.
In addition, there is a general ban on misleading advertising.
In addition, there is a general ban on misleading advertising.
There are reservations, above all, about the introduction of nutritional profiles for foods which is envisaged in Article 4 of the proposal for a regulation.
There are reservations, above all, about the introduction of nutritional profiles for foods which is envisaged in Article 4 of the proposal for a regulation.
The Commission's intention is that the sugar, salt or fat content, in particular, of foods will have to be measured before they may be advertised with nutrition or health claims.
The Commission's intention is that the sugar, salt or fat content, in particular, of foods will have to be measured before they may be advertised with nutrition or health claims.
However, the classification of foods into those with a beneficial nutritional profile and those with a less beneficial profile contradicts the idea of a balanced diet.
However, the classification of foods into those with a beneficial nutritional profile and those with a less beneficial profile contradicts the idea of a balanced diet.
There are, in principle, no good or bad foods.
There are, in principle, no good or bad foods.
The decisive factor, instead, is the proportions in which foods are consumed.
The decisive factor, instead, is the proportions in which foods are consumed.
Moreover, the draft regulation largely leaves open the precise definition, and establishment, of the concept of a nutritional profile.
Moreover, the draft regulation largely leaves open the precise definition, and establishment, of the concept of a nutritional profile.
Until this is resolved scientifically, nutritional profiles should not be introduced.
Until this is resolved scientifically, nutritional profiles should not be introduced.
Article 10 of the draft regulation provides for a single authorisation procedure, lasting several months and conducted by a European food agency, for the use of health claims in food advertising.
Article 10 of the draft regulation provides for a single authorisation procedure, lasting several months and conducted by a European food agency, for the use of health claims in food advertising.
This proposal is bureaucratic, impractical and, especially in the light of the Lisbon strategy, unacceptable.
This proposal is bureaucratic, impractical and, especially in the light of the Lisbon strategy, unacceptable.
Your draftswoman supports the Commission's aim of embodying the requirements regarding food labelling and advertising in practical measures, but roundly rejects the proposed grandiose prior assessment procedure.
Your draftswoman supports the Commission's aim of embodying the requirements regarding food labelling and advertising in practical measures, but roundly rejects the proposed grandiose prior assessment procedure.
Furthermore, the prohibition of so-called implied health claims in Article 11 of the proposal for a regulation should be the subject of debate.
Furthermore, the prohibition of so-called implied health claims in Article 11 of the proposal for a regulation should be the subject of debate.