natgillin/translations-raw huggingface dataset:
c) tervisealase väite suhtes korraldatud uuringute koopiad, kaasa arvatud – kui on olemas – sõltumatute ja vastastikusele eksperdihinnangule allutatud uurimistööde koopiad ning igasugune muu materjal, mis tõestab, et teave vastab käesoleva määruse kriteeriumitele;
(c) a copy of the studies which have been carried out with regard to the health claim including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that it complies with the criteria provided for in this Regulation;
d) teiste teadusuuringute koopiad, mis on antud tervisealaste väidete seisukohalt olulised;
(d) a copy of other scientific studies which are relevant to that health claim;
e) tervisealase väite sõnastuse ettepanek – kõigis ühenduse keeltes –, mille lubamist taotletakse, vajadusel koos kasutamise eritingimustega;
(e) a proposal for the wording, in all Community languages, of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
f) toimiku kokkuvõte.
(f) a summary of the dossier.
Enne kuupäeva, millest alates käesolev määrus jõustub, avaldab amet üksikasjaliku juhise, et lihtsustada taotlejatel taotluste koostamist ja esitamist.
Before the date of application of this Regulation, the Authority shall publish detailed guidance to assist applicants in the preparation and the presentation of applications.
The prior assessment procedure should therefore be abandoned.
The prior assessment procedure should therefore be abandoned.
Ameti hinnang
Opinion of the Authority
Amet püüab oma hinnangu koostamisel pidada kinni kolmekuulisest tähtajast alates kehtiva taotluse laekumisest.
In giving its opinion, the Authority shall endeavour to respect a time limit of three months from the date of receipt of a valid application.
Amet võib vajadusel nõuda taotlejalt taotlusele lisatud andmete täiendamist kindla tähtaja jooksul.
The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.
Kui hinnangus toetatakse tervisealase väite kasutamist, sisaldab hinnang lisaks järgmisi andmeid:
In the event of an opinion in favour of approving the health claim, the opinion shall include the following particulars:
b) toiduaine või toiduainete kategooria nimetus, mille kohta tahetakse tervisealast väidet esitada, ning selle erilised omadused;
(b) the designation of the food or category of food in respect of which a claim is to be used and its particular characteristics;
c) väljapakutud tervisealase väite soovitav sõnastus kõigis ühenduse keeltes;
(c) the recommended wording, in all Community languages, of the proposed health claim;
d) vajadusel toiduaine kasutustingimused ja/või täiendavad selgitused või hoiatused, mis peaksid kaasnema tervisealase väitega etiketil või reklaamis.
(d) where necessary, conditions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and advertising.
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 teeb oma hinnangu vastavalt määruse (EÜ) nr 178/2002 artikli 38 lõikele 1 avalikuks.
The Authority in accordance with Article 38(1) of Regulation (EC) No 178/2002 shall make its opinion public.
Avalikkus võib 30 päeva jooksul pärast avaldamist edastada komisjonile selle kohta märkused.
The public may submit comments to the Commission within 30 days from such publication.
Artikli 15 lõike 3 punkt a
Article 15, paragraph 3, point (a)
a) tervisealase väite väljapakutud sõnastus on teaduslike andmetega tõestatud;
(a) that the proposed wording of the health claim is substantiated by scientific data ;
a) tervisealase väite väljapakutud sõnastus on teaduslikult tõestatud;
(a) that the proposed wording of the health claim is substantiated scientifically ;
Scientific knowledge rather than data may be sufficient to substantiate the proposed wording of the health claim.
Scientific knowledge rather than data may be sufficient to substantiate the proposed wording of the health claim.
c) soovitud tervisealase väite soovitav sõnastus kõigis ühenduse keeltes ;
(c) the recommended wording, in all Community languages , of the proposed health claim;
c) soovitud tervisealase väite soovitava sõnastuse ettepanek keeltes , milles teave antakse;
(c) a proposal for the recommended wording, in the languages in which the proposed health claim will be made ;
The scientific basis and the meaning of a claim can and must be covered by prior authorisation, but it is very important to allow manufacturers a measure of flexibility when they impart messages about diet and health aimed at consumers.
The scientific basis and the meaning of a claim can and must be covered by prior authorisation, but it is very important to allow manufacturers a measure of flexibility when they impart messages about diet and health aimed at consumers.
The Authority should, however, produce a proposal for guidance.
The Authority should, however, produce a proposal for guidance.
The obligation to word the proposal in all Community languages is cumbersome and unnecessary when the claim will not be used in all languages.
The obligation to word the proposal in all Community languages is cumbersome and unnecessary when the claim will not be used in all languages.
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.
Iga otsuse eelnõu, mis näeb ette loa andmist, sisaldab artikli 15 lõikes 4 loetletud andmeid ja loa omaniku nime.
Any draft decision which envisages the granting of authorisation shall include the particulars referred to in Article 15(4) and the name of the authorisation-holder.
Lõplik otsus taotluse suhtes tehakse vastavalt artikli 23 lõikes 2 nimetatud menetlusele.
A final decision on the application shall be adopted in accordance with the procedure referred to in Article 23(2).
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.
Loa andmine ei piira toiduainetootja üldist tsiviil- ja kriminaalvastutust seoses asjassepuutuva toiduainega.
The granting of authorisation shall not lessen the general civil and criminal liability of any food operator in respect of the food concerned.
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.
Omal algatusel või mõne liikmesriigi või komisjoni taotlusel esitab amet selle kohta hinnangu, kas tervisealase väite kasutamist lubav otsus vastab jätkuvalt käesoleva määruse tingimustele.
On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether a decision for the use of a health claim continues to meet the conditions laid down in this Regulation.
Amet edastab oma hinnangu viivitamatult komisjonile, loaomanikule ja liikmesriikidele.
It shall forthwith transmit its opinion to the Commission, the authorisation–holder and the Member States.
Amet teeb oma hinnangu vastavalt määruse (EÜ) nr 178/2002 artikli 38 lõikele 1 avalikuks.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
Avalikkus võib 30 päeva jooksul pärast avaldamist edastada komisjonile selle kohta märkused.
The public may submit comments to the Commission within 30 days of such publication.
Komisjon kontrollib ameti hinnangut esimesel võimalusel.
The Commission shall examine the opinion of the Authority as soon as possible.
Ühenduse register
Community Register
Komisjon loob toiduainete toitumis- ja tervisealaste väidete kohta ühenduse registri ja haldab seda, edaspidi “register”.
The Commission shall establish and maintain a Community Register of nutrition and health claims made on food, hereinafter referred to as 'the Register'.
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 a p plicant that was granted authorisation;
(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 a p plicant.
Register avalikustatakse.
The Register shall be made available to the public.
Teaduslikke andmeid ja muud teavet, mis sisaldub vastavalt artikli 14 lõikes 2 nõutud taotluse toimikus, ei tohi seitsmeaastase perioodi jooksul alates loa andmise kuupäevast kasutada hilisema taotleja kasuks, välja arvatud juhul, kui hilisem taotleja on varasema taotlejaga kokku leppinud, et neid andmeid ja seda teavet võib kasutada, ning:
The scientific data and other information in the application dossier required under Article 14 (2) may not be used for the benefit of a subsequent applicant for a period of seven years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:
a) algne taotleja deklareeris teaduslikud andmed ja muu teabe algse taotluse ajahetkel konfidentsiaalsena ja
(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) algsel taotlejal oli algse taotluse esitamise ajal eranditu õigus konfidentsiaalsete andmete kasutamisele ja
(b) the prior applicant had exclusive right of reference to the proprietary data at the time the prior applic a tion was made; and,
c) tervisealast väidet poleks saanud lubada ilma konfidentsiaalsete andmete esitamiseta algse taotleja poolt.
(c) the health claim could not have been approved without the submission of the proprietary data by the prior applicant.
Kuni seitsmeaastase perioodi möödumiseni vastavalt lõikele 1 pole ühelgi järgneval taotlejal õigust tugineda eelnimetatud taotleja poolt konfidentsiaalsena deklareeritud andmetele, kui komisjon ei võta vastu otsust, mille kohaselt eelnenud taotlejale antud loa saaks või oleks saanud anda ka ilma konfidentsiaalseks nimetatud andmeteta.
Until the end of the seven years period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as pr o prietary by a prior applicant unless and until the Commission takes a decision on whether an authorisation could be or could have been granted without the submission of data designated as proprietary by the prior applicant.
Artikkel 19 a (uus)
Article 19 a (new)
Artikkel 19 a
Article 19 a
Taotluse esitamine väite heakskiitmiseks või sellise väite registreerimiseks või avaldamiseks ei piira mis tahes intellektuaalomandi õigusi, mis taotlejal võivad olla seoses väite endaga või seoses mis tahes teaduslike andmete või taotluse toimikus sisalduva mis tahes teabega.
The submission of an application for approval of a claim, or the registration or publication of such a claim, shall be without prejudice to any intellectual property rights which the applicant may enjoy in relation to the claim itself, or to any scientific data or any information contained in the application dossier.
Selliseid õigusi käsitletakse vastavalt ühenduse õigusele või siseriiklikele sätetele, mis ei ole vastuolus ühenduse õigusega.
Such rights shall be treated in accordance with Community law, or with any national provisions which do not conflict with Community law.
Kui liikmesriigil on tõsised põhjused arvata, et teave ei ole käesoleva määrusega kooskõlas või et artiklis 7 sätestatud teaduslik tõestus on ebapiisav, võib see liikmesriik ajutiselt peatada sellise teabe kasutamise oma territooriumil.
Where a Member State has serious grounds for considering that a claim does not comply with this Regulation, or that the scientific substantiation provided for in Article 7 is insufficient, that Member State may temporarily suspend the use of that claim within its territory.
Ta teavitab teisi liikmesriike ja komisjoni ning esitab peatamise põhjused.
It shall inform the other Member States and the Commission and give reasons for the suspension.
Vastavalt artikli 23 lõikes 2 viidatud menetlusele võtetakse otsus vastu pärast ametilt arvamuse saamist.
In accordance with the procedure referred to in Article 23(2), a decision shall be taken, where appropriate after obtaining an opinion from the Authority.
Komisjon võib algatada selle protseduuri enda algatusel.
The Commission may initiate this procedure on its own initiative.
Lõikes 1 viidatud liikmesriik võib kohaldada peatamist, kuni talle tehakse teatavaks lõikes 2 viidatud otsus.
The Member State referred to in paragraph 1 may maintain the suspension until the decision referred to in paragraph 2 has been notified to it.
A provision permitting the 'temporary suspension' of claims which do not comply with the regulation or of those where the scientific substantiation appears uncertain infringes Article 28 of the EC Treaty (principle of the free movement of goods).
A provision permitting the 'temporary suspension' of claims which do not comply with the regulation or of those where the scientific substantiation appears uncertain infringes Article 28 of the EC Treaty (principle of the free movement of goods).
Against the backdrop of the untrammelled free movement of goods in the European internal market Article 22 should be deleted.
Against the backdrop of the untrammelled free movement of goods in the European internal market Article 22 should be deleted.
Should it be impossible to delete it, the Member States' right referred to above only makes sense in the case of claims pursuant to Article 12(3), since the other claims are permitted by the EFSA and thus comply with the regulation.
Should it be impossible to delete it, the Member States' right referred to above only makes sense in the case of claims pursuant to Article 12(3), since the other claims are permitted by the EFSA and thus comply with the regulation.
In addition, a measure adopted by a Member State would be justified only in a case where a misleading claim might be the basis for an actual health risk .
In addition, a measure adopted by a Member State would be justified only in a case where a misleading claim might be the basis for an actual health risk .
Article 22 would therefore have to be amended as indicated in Amendment 112.
Article 22 would therefore have to be amended as indicated in Amendment 112.
Artikkel 24
Article 24
Hõlbustamaks efektiivset järelevalvet toitumis- või tervisealaseid väiteid kandvate toiduainete üle, võivad liikmesriigid nõuda oma territooriumil tootjalt või selliseid toiduaineid turule viivatelt isikult pädeva asutuse teavitamist toiduaine turuleviimisest, edastades talle tootel kasutatava märgise näidise.
To facilitate efficient monitoring of foods bearing nutrition or health claims, Member States may require the manufacturer or the person placing such foods on the market in their territory to notify the competent authority of that placing on the market by forwarding it a model of the label used for the product.
Amet valvab toitumis- ja tervisealaseid väiteid kandvate toiduainete reklaamikampaaniate järele tagamaks, et kooskõlas direktiiviga 2000/12/EÜ ei eksitataks tarbijat esitatud teabega.
The Authority will monitor advertising campaigns for foods including nutrition and health claims to ensure that, in line with Directive 2000/13/EC, the consumer is not misled by the information provided.
The advertising campaigns/logos/product endorsements by sportspersons play an important role in the way nutrition and health claims are perceived by the consumer.
The advertising campaigns/logos/product endorsements by sportspersons play an important role in the way nutrition and health claims are perceived by the consumer.
In the United States the validity of food advertising campaigns is monitored by the Federal Trade Commission and a similar situation should prevail at EU level, with the EFSA being permitted to monitor and comment upon particular cases where advertising misleads rather than informs the consumer.
In the United States the validity of food advertising campaigns is monitored by the Federal Trade Commission and a similar situation should prevail at EU level, with the EFSA being permitted to monitor and comment upon particular cases where advertising misleads rather than informs the consumer.
Väiteid intensiivseks lihasepingutuseks mõeldud toiduainete kohta, mis on esitatud kooskõlas siseriiklike sätetega enne artiklis 26 sätestatud jõustumiskuupäeva, võib jätkuvalt esitada kuni komisjoni direktiivi vastuvõtmiseni intensiivsest lihasepingutusest tingitud energiakao korvamiseks, eriti sportlastele mõeldud toiduainete puhul, vastavalt direktiivile 89/398/EMÜ erilise toitumisotstarbega toiduainete kohta.
Claims for foods for intense muscular effort which have been made in compliance with national provisions before the date of entry into force laid down in Article 26 may continue to be made until the adoption of a Commission directive on foods intended to meet the expenditure of intense muscular effort, especially for sports people, based on Directive 89/398/EEC on foods intended for particular nutritional uses.
The Commission is currently working on a Commission directive on foods for intense muscular effort, under the framework directive on foods for particular nutritional uses (Directive 89/398/EEC).
The Commission is currently working on a Commission directive on foods for intense muscular effort, under the framework directive on foods for particular nutritional uses (Directive 89/398/EEC).
This upcoming directive will clarify the requirements for claims in sports foods.
This upcoming directive will clarify the requirements for claims in sports foods.
These claims are very specific to products used by athletes and therefore the specific directive enables the appropriate claims criteria to be defined.
These claims are very specific to products used by athletes and therefore the specific directive enables the appropriate claims criteria to be defined.
For this reason, it is appropriate to foresee transitional measures in this regulation until the appropriate directive has been adopted.
For this reason, it is appropriate to foresee transitional measures in this regulation until the appropriate directive has been adopted.
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 ]
To allow reasonable time to adapt to the new rules laid down in the regulation, the transitional period, from the time of publication of the regulation to the date on which it becomes applicable, should be 18 months.
To allow reasonable time to adapt to the new rules laid down in the regulation, the transitional period, from the time of publication of the regulation to the date on which it becomes applicable, should be 18 months.
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 rakendamise esimest päeva turule viidud või märgistatud toiduaineid, mis ei vasta määrusele, võib turustada kuni [ määruse rakendamise esimesele päevale järgneva kaheksateistkümnenda kuu viimase päevani ] või kuni nende säilivustähtaja lõpuni, olenevalt sellest, kumb periood on pikem.
Foods placed on the market or labelled prior to the first day of application of this Regulation which do not comply herewith may be marketed until [ last day of the eighteenth month following the first day of its application ] or until the end of their useful life, whichever period is the longer .
The transitional period may not be sufficient, since publication of the EFSA guidelines, the authorisation procedure (6 months at least), and the alterations to labelling and presentation might not be possible to complete within the 11 months specified in the Commission proposal as it now stands.
The transitional period may not be sufficient, since publication of the EFSA guidelines, the authorisation procedure (6 months at least), and the alterations to labelling and presentation might not be possible to complete within the 11 months specified in the Commission proposal as it now stands.
Artikli 26 lõige 3 a (uus)
Article 26, paragraph 3 a (new)
Tervisealaseid väiteid, v.a artikli 12 lõikes 1 viidatud teavet, mis on esitatud toiduainete, toiduainete kategooriate või toiduainete koostisosade kohta enne käesoleva määruse jõustumist kooskõlas olemasolevate seadussätetega, võib jätkuvalt esitada tingimusel, et taotlus esitatakse 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 made for foods, categories of foods or food constituents before this Regulation enters into force in compliance with existing provisions may continue to be made provided that an application is made pursuant to Article 14 within 12 months of the entry into force of this Regulation and before the expiry of a period of six months after a final decision is taken pursuant to Article 16.
Selliste taotluste suhtes ei kohaldata ajapiiranguid, mis on sätestatud artikli 15 lõigetes 1 ja 2 ning artikli 16 lõikes 1.
In respect of such applications, the time limits provided for in Articles 15(1), 15(2) and 16(1) shall not apply.
Adequate transition arrangements are necessary.
Adequate transition arrangements are necessary.
From the time the regulation applies, six months after publication, products need to be labelled in compliance with the new regulation.
From the time the regulation applies, six months after publication, products need to be labelled in compliance with the new regulation.
However, the procedures outlined in Articles 14–17 of the Commission proposal will take significantly longer than six months.
However, the procedures outlined in Articles 14–17 of the Commission proposal will take significantly longer than six months.
Companies should therefore be permitted to continue to market their products which are currently on the market until a final decision by the EFSA and the Standing Committee, provided that the company in question has made an application for the claim to be approved according to the authorisation procedure.
Companies should therefore be permitted to continue to market their products which are currently on the market until a final decision by the EFSA and the Standing Committee, provided that the company in question has made an application for the claim to be approved according to the authorisation procedure.