natgillin/translations-raw huggingface dataset:
Tervisealaseid väited tohib esitada, kui need vastavad II peatüki üldistele nõuetele ja käesoleva peatüki erinõuetele ja nendest on vastavalt artikli 14 menetlusele teavitatud ja juhul, kui
Health claims shall be permitted if they comply with the general requirements in Chapter II and the specific requirements in this Chapter and have been notified in accordance with the procedure referred to in Article 14, and if
a) komisjon ei ole esitanud artikli 15 lõikes 1 sätestatud perioodi jooksul vastuväiteid, või
(a) the Commission has raised no objection within the period laid down in Article 15(1), or,
b) komisjon on küll esitanud vastuväite, kuid vastavalt artikli 16 menetlusele ei ole antud keeldu maksimaalselt 9 kuu jooksul pärast ametile teate esitamist.
(b) where the Commission has raised an objection, no adverse decision has been taken in accordance with the procedure laid down in Article 16(3) within 9 months of receipt of the notification.
The Regulation’s aim of providing a high level of consumer protection can just as well be achieved through a notification procedure, which is a milder alternative, since a notification requirement also ensures that the authorities responsible are informed of the use of health claims, so that they can investigate these if there is any doubt as to their truthfulness or foundation in scientific fact and, if necessary, prevent their being placed on the market.
The Regulation’s aim of providing a high level of consumer protection can just as well be achieved through a notification procedure, which is a milder alternative, since a notification requirement also ensures that the authorities responsible are informed of the use of health claims, so that they can investigate these if there is any doubt as to their truthfulness or foundation in scientific fact and, if necessary, prevent their being placed on the market.
The wording of paragraph 1(a) and (b) guarantees reliable time limits for the decision.
The wording of paragraph 1(a) and (b) guarantees reliable time limits for the decision.
Artikli 10 lõike 2 punkt a
Article 10, paragraph 2, point (a)
a) teatis, millega viidatakse tasakaalustatud toitumise ja tervisliku elustiili tähtsusele;
(a) a statement indicating the importance of a balanced diet and a healthy lifestyle;
a) märgistusel silmatorkavas kohas avaldus tasakaalustatud toitumise ja tervisliku eluviisi tähtsuse kohta;
(a) where appropriate, a statement indicating the importance of a balanced diet and a healthy lifestyle (in a prominent place on the label) ;
Some health claims may not have any relation to a balanced diet, for example.
Some health claims may not have any relation to a balanced diet, for example.
Muudatusettepanek 41
Amendment 41
Artili 11 pealkiri
Article 11, title
Kaudsed tervisealased väited
Implied health claims
Piirangud teatud tervisealaste väidete kasutamisel
Restrictions on the use of certain health claims
With respect to the content of the article, "Restrictions on the use" is the correct title.
With respect to the content of the article, "Restrictions on the use" is the correct title.
Muudatusettepanek 42
Amendment 42
Lubatud pole järgmised kaudsed tervisealased väited:
The following implied health claims shall not be allowed:
Lubatud pole järgmised tervisealased väited, välja arvatud, kui need on teaduslikult põhjendatud :
The following health claims shall not be allowed unless scientifically substantiated :
a) väited, mis viitavad toitaine või toiduaine üldistele, mittespetsiifilistele eelistele seoses üldise tervise ja heaoluga;
(a) claims which make reference to general, non-specific benefits of the nutrient or food for overall good health, well-being;
a) väited, mis jätavad mulje, et toiduainest loobumine võib tervist kahjustada ;
(a) claims which suggest that health could be affected by not consuming the food;
b) väited, mis puudutavad psüühilisi ja käitumisfunktsioone;
(b) claims which make reference to psychological and behavioural functions;
c) ilma et see piiraks direktiivi 96/8/EÜ kohaldamist, väited, mis viitavad salendavatele või kehakaalu kontrollivatele omadustele või tänu kasutamisele saavutatavale võimalikule kehakaalu alanemisele või näljatunde vähenemisele või täiskõhutunde suurenemisele või vähenenud energiaomastamisele tänu toote tarbimisele;
(c) without prejudice to Directive 96/8/EC claims which make reference to slimming or weight control, or to the rate or amount of weight loss which may result from their use or to a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet;
c) ilma et see piiraks direktiivi 96/8/EÜ kohaldamist, teave, mis viitab salendavatele või kehakaalu kontrollivatele omadustele või tasemele või tänu kasutamisele saavutatavale võimalikule kehakaalu alanemisele või näljatunde vähenemisele või küllastustunde suurenemisele või vähenenud energiaomastamisele tänu toote tarbimisele, välja arvatud, kui väiteid on võimalik teaduslikult põhjendada ja neist on teavitatud käesoleva määruse kohaselt;
(c) without prejudice to Directive 96/8/EC, claims which make reference to slimming or weight control, or to the rate or amount of weight loss which may result from their use or to a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet , unless scientifically substantiated and notified in accordance with this Regulation ;
d) väited, mis viitavad arstide või teiste tervishoiuspetsialistide, vastavate kutseliitude või heategevuslike organisatsioonide nõuandele, või jätavad mulje, et toiduainest loobumine võib tervist kahjustada.
(d) claims which make reference to the advice of doctors or other health professionals, or their professional associations, or charities, or suggest that health could be affected by not consuming the food.
d) väited, mis viitavad arstide või teiste tervishoiuspetsialistide, vastavate kutseliitude või heategevuslike organisatsioonide nõuandele , välja arvatud, kui väiteid on võimalik teaduslikult põhjendada ja neist on teavitatud käesoleva määruse kohaselt;
(d) claims which make reference to the advice of doctors or other health professionals, or their professional associations, or charities , unless scientifically substantiated and notified in accordance with this Regulation.
d a) väited, mis on suunatud üksnes lastele.
(da) claims which are exclusively directed at children.
Muudatusettepanek 43
Amendment 43
Samuti avaldab komisjon pärast ametiga konsulteerimist üksikasjaliku juhise käesoleva artikli rakendamiseks, kui see on vajalik.
Where appropriate, the Commission having first consulted the Authority shall publish detailed guidelines for the implementation of this article.
Vajaduse korral avaldab komisjon pärast ameti ning toiduainetööstust ja tarbijat esindavate organisatsioonidega konsulteerimist üksikasjalikud suunised käesoleva lõike rakendamiseks, mille koostamisel on järgitud artikli 23 lõikes 2 ettenähtud menetlust.
Where appropriate, the Commission, having first consulted the Authority and organisations representing the food industry and consumers, shall publish detailed guidelines for the implementation of this article , drawn up in accordance with the procedure referred to in Article 23(2) .
It is desirable that the Commission should also consult interested parties and draw on their knowledge.
It is desirable that the Commission should also consult interested parties and draw on their knowledge.
Muudatusettepanek 44
Amendment 44
Erandina artikli 10 lõikest 1 tohib esitada tervisealaseid väiteid, mis kirjeldavad toitaine või mõne muu aine tähtsust kasvamisele, arengule ja organismi normaalsetele füsioloogilistele funktsioonidele, kui need põhinevad üldiselt aktsepteeritud teaduslikel andmetel , on keskmisele tarbijale hästi mõistetavad ning kuuluvad lõikes 2 ettenähtud nimekirja .
By way of derogation from Article 10 (1), health claims describing the role of a nutrient or of another substance in growth, development and the normal functions of the body, which are based on generally accepted scientific data and well understood by the average consumer , may be made if they are included in the list provided for in paragraph 2.
Erandina artikli 10 lõikest 1 tohib esitada tervisealaseid väiteid, mis kirjeldavad toitaine või muu aine tähtsust kasvamisele, arengule ja organismi funktsioonidele, kui need põhinevad aktsepteeritud ning korralikult põhjendatud teaduslikel teadmistel , ning lähtuvad lõikes 2 ettenähtud nimekirjast.
By way of derogation from Article 10 (1), health claims describing the role of a nutrient or other substance in growth, development and the functions of the body, which are based on accepted and properly substantiated scientific knowledge , may be made if they are based on the list provided for in paragraph 2.
Artikli 12 lõike 2 esimene lõik
Article 12, paragraph 2, subparagraph 1
Liikmesriigid edastavad komisjonile hiljemalt ... [üks aasta pärast antud määruse vastuvõtmise kuu viimast päeva] väidete nimekirjad vastavalt lõikele 1.
Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by … at the latest [last day of the month of adoption of this Regulation + 1 year].
Liikmesriigid ja toiduainetööstust ning tarbijaid esindavad organisatsioonid edastavad komisjonile hiljemalt ... [üks aasta pärast antud määruse vastuvõtmise kuu viimast päeva] väidete nimekirjad vastavalt lõikele 1.
Member States and organisations representing the food industry and consumers shall provide the Commission with lists of claims as referred to in paragraph 1 by ... at the latest [last day of the month of adoption of this Regulation + 1 year] .
Erandina direktiivi 2000/13/EÜ artikli 2 lõikest 1 tohib esitada haiguse ohu vähenemise väiteid, kui selleks on vastavalt käesolevale määrusele luba antud.
By way of derogation from Article 2 (1) of Directive 2000/13/EC, reduction of disease risk claims may be made where they have been authorised in accordance with this Regulation.
Erandina direktiivi 2000/13/EÜ artikli 2 lõikest 1 tohib esitada haiguse ohu vähenemise väiteid, kui nendest on vastavalt käesolevale määrusele teavitatud.
By way of derogation from Article 2 (1) of Directive 2000/13/EC, reduction of disease risk claims may be made where they have been notified in accordance with this Regulation.
This amendment follows necessarily from the amendment to Article 10 (1) and the change to a notification procedure provided for in it.
This amendment follows necessarily from the amendment to Article 10 (1) and the change to a notification procedure provided for in it.
Muudatusettepanek 47
Amendment 47
Artikli 14 pealkiri ja lõige 1
Article 14, title and paragraph 1
Loa taotlemine
Application for authorisation
Artikli 10 lõikes 1 nimetatud loa saamiseks tuleb ametile esitada taotlus .
To obtain the authorisation referred to in Article 10 (1) , an application shall be submitted to the Authority.
Ametit teavitab kooskõlas artikli 10 lõikes 1 sätestatuga tavaposti või eelistavalt tänapäevast kommunikatsioonitehnoloogiat kasutades (kaasa arvatud e-posti) t ootja, kui toode turule tuuakse, või juhul, kui toode on valmistatud kolmandas riigis, siis importija.
Notification in accordance with Article 10(1) shall be made to the Authority by normal post or, preferably, using modern communication techniques (including e-mail), by the manufacturer when the product is first placed on the market or, in the case of a product manufactured in a third country, by the importer .
a) kinnitab taotluse saamist kirjalikult 14 päeva jooksul pärast selle laekumist.
(a) shall acknowledge receipt of an application in writing within 14 days of its receipt.
Kinnituses on märgitud taotluse laekumise kuupäev;
The acknowledgement shall state the date of receipt of the application ;
a) kinnitab teate saamist kirjalikult 14 päeva jooksul pärast selle laekumist.
(a) shall acknowledge receipt of the notification in writing within 14 days of its receipt.
Kinnituses on märgitud teate laekumise kuupäev;
The acknowledgement shall state the date of receipt of the notification ;
b) teavitab liikmesriike ja komisjoni viivitamatult taotlusest ning annab nende käsutusse nii taotluse enda kui ka kogu taotleja esitatud lisainfo;
(b) shall inform without delay the Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
b) teavitab liikmesriike ja komisjoni viivitamata teatest ja annab nende käsutusse nii teate enda kui ka kogu tootja või importija esitatud lisainfo;
(b) shall inform without delay the Member States and the Commission of the notification and shall make the notification and any supplementary information supplied by the manufacturer or importer available to them;
c) teeb avalikkusele kättesaadavaks lõike 3 punktis f nimetatud toimiku kokkuvõtte.
(c) shall make the summary of the dossier referred to in paragraph 3(f) available to the public.
The authorisation procedure proposed by the Commission is replaced by a less onerous notification procedure.
The authorisation procedure proposed by the Commission is replaced by a less onerous notification procedure.
Retaining the requirement to produce relevant supporting documents ensures that the competent authorities have all the necessary information.
Retaining the requirement to produce relevant supporting documents ensures that the competent authorities have all the necessary information.
The most important difference between this and the system proposed by the Commission is that the lengthy authorisation procedure does not have to be gone through in every case.
The most important difference between this and the system proposed by the Commission is that the lengthy authorisation procedure does not have to be gone through in every case.
If doubts should arise with regard to scientific substantiation, the information submitted under the notification procedure still means that the necessary investigations can be carried out.
If doubts should arise with regard to scientific substantiation, the information submitted under the notification procedure still means that the necessary investigations can be carried out.
In accordance with normal modern administrative practice, electronic means of communication should be used in order to simplify administrative procedures.
In accordance with normal modern administrative practice, electronic means of communication should be used in order to simplify administrative procedures.
This is also important in ensuring easier access for SMEs to administrative procedures.
This is also important in ensuring easier access for SMEs to administrative procedures.
Artikli 14 lõike 2 sissejuhatav osa
Article 14, paragraph 2, introductory part
Taotlusele tuleb lisada järgmine info ja dokumendid:
The application shall be accompanied by the following particulars and documents:
Teatele tuleb lisada järgmine info ja dokumendid:
The notification shall be accompanied by the following particulars and documents:
Artikli 14 lõike 2 punkt a
Article 14, paragraph 2, point (a)
a) taotleja nimi ja aadress;
(a) the name and address of the applicant ;
a) tootja või importija nimi ja aadress,
(a) the name and address of the manufacturer or importer ;
Artikli 14 lõike 2 punkt b
Article 14, paragraph 2, point (b)
b) toiduaine või toiduainete kategooria, mille kohta esitatakse tervisealane väide, ning selle erilised omadused;
(b) the food or the category of food in respect of which the health claim is to be made and its particular characteristics;
b) toitaine või muu aine, toiduaine või toiduainete kategooria, mille kohta esitatakse tervisealane väide, ning selle erilised omadused;
(b) the nutrient or other substance or the food or the category of food in respect of which the health claim is to be made and its particular characteristics;
Muudatusettepanek 51
Amendment 51
Artikli 14 lõike 2 punkt e
Article 14, paragraph 2, point (e)
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 ;
e) tervisealase väite sõnastuse ettepanek; (konkreetsed kirjeldavad meetmed väikeste ja keskmise suurusega ettevõtete jaoks võib vastu võtta vastavalt artikli 23 lõikes 2 viidatud menetlusele);
(e) a proposal for the wording of the health claim ; (special illustrative measures for SMEs may be adopted under the procedure referred to in Article 23(2)) ;
Muudatusettepanek 52
Amendment 52
Artikli 14 lõike 2 punkt e a (uus)
Article 14, paragraph 2, point (e a) (new)
e a) kavandatava toidu, mille kohta esitatakse väide pakendi näidis, näidates selgelt ära tervisealase väite sõnastuse ning kasutatava märgistuse;
(ea) where appropriate, a sample of the proposed food packaging on which the claim is to be made, clearly showing the proposal for the wording of the health claim and the label used;
By virtue of Article 24, Member States have the right to ask for a sample of the labelling used for a food for which the manufacturer is making a claim.
By virtue of Article 24, Member States have the right to ask for a sample of the labelling used for a food for which the manufacturer is making a claim.
As part of the health claims approval procedure to which this Article 14 refers, over and above the proposed wording of the claim for which authorisation is being sought, a sample of the proposed packaging should also be supplied, clearly showing the wording of the claim and the label used.
As part of the health claims approval procedure to which this Article 14 refers, over and above the proposed wording of the claim for which authorisation is being sought, a sample of the proposed packaging should also be supplied, clearly showing the wording of the claim and the label used.
With regard to information, both the content and the form are equally important, and can have a greater or lesser impact on the attitudes of potential buyers.
With regard to information, both the content and the form are equally important, and can have a greater or lesser impact on the attitudes of potential buyers.
Muudatusettepanek 53
Amendment 53
Käesoleva artikli rakenduseeskirjad, kaasa arvatud taotluse koostamise ja esitamise sätted, kehtestatakse pärast ameti ärakuulamist vastavalt artikli 23 lõikes 2 nimetatud menetlusele.
Implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application shall be established in accordance with the procedure referred to in Article 23 (2), after consultation of the Authority.
Käesoleva artikli rakenduseeskirjad, kaasa arvatud teate koostamise ja esitamise sätted, kehtestatakse pärast ameti ärakuulamist vastavalt artikli 23 lõikes 2 nimetatud menetlusele.
Implementing rules for the application of this Article, including rules concerning the preparation and presentation of the notification shall be established in accordance with the procedure referred to in Article 23 (2), after consultation of the Authority.
Muudatusettepanek 54
Amendment 54
Väikestele ja keskmistele ettevõtetele tuleks toimikute ettevalmistamisel olulist abi osutada.
SMEs should be given substantial aid in preparing the dossiers.
SMEs must not be penalised by the implementation of the new system.
SMEs must not be penalised by the implementation of the new system.
Muudatusettepanek 55
Amendment 55
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 .
Enne käesoleva määruse jõustumise kuupäeva, määrab ja avaldab amet üksikasjaliku juhise, et lihtsustada tootjatel ja importijatel teadete koostamist ja esitamist.
Before the date of application of this Regulation, the Authority shall identify and publish detailed guidance to assist manufacturers and importers in the preparation and the presentation of notifications .
Teadete koostamisele ja esitamisele kehtestatavad reeglid sisaldavad sätet, mis annab tootjatel või importijatel õiguse oma väidet ameti ees kaitsta.
The rules concerning the preparation and presentation of notifications shall include a provision granting the right to the manufacturer or importer to defend its notification in front of the Authority.
Käesolev säte hõlmab selgesõnaliselt õigust esitada toimiku ameti-poolse hindamise käigus täiendavaid andmeid.
This provision will explicitly include the right to provide additional data in the course of the evaluation of the dossier by the Authority.
Muudatusettepanek 56
Amendment 56
Komisjon võib kooskõlas artikli 10 lõikes 1 sätestatuga teate esitamise nelja kuu jooksul esitada ametile oma põhjendatud arvamuse, kui ta on jõudnud järeldusele, et tervisealane väide ei vasta II peatükis esitatud üldnõuetele või käesolevas peatükis esitatud erinõuetele.
The Commission may, within four months of submission of a notification in accordance with Article 10(1), deliver to the Authority a reasoned opinion if it has reached the conclusion that a health claim does not comply with the general requirements set out in Chapter II or the specific requirements set out in this Chapter.
Põhjendatud arvamuse esitamine tähendab, et amet peab koostama vastuse, milles hindab tervisealase väite vastavust II peatükis esitatud üldnõuetele ja käesolevas peatükis esitatud erinõuetele.
Delivery of the reasoned opinion shall imply that the Authority is called upon to draw up an opinion on the consistency of the health claim with the general requirements set out in Chapter II and the specific requirements set out in this Chapter.
Amet teavitab tootjat või importijat viivitamata asjaolust, et tervisealase väite kasutamine tuleb peatada kuni selle ajani, kui kas
The Authority shall notify the manufacturer or importer without delay that use of the health claim must cease until such time as either
– vastavalt artikli 16 menetlusele langetatakse positiivne otsus või
- a favourable decision has been reached in accordance with the procedure set out in Article 16 or
– möödunud on kuus kuud teate saamisest vastavalt artikli 10 lõikele 1 ilma, et otsust oleks langetatud.
- a period of six months has elapsed since receipt of the notification in accordance with Article 10(1) without any decision being reached.
The amendment sets out the detailed arrangements for a ‘Reasoned opinion of the Commission’.
The amendment sets out the detailed arrangements for a ‘Reasoned opinion of the Commission’.
Amet püüab oma hinnangu koostamisel pidada kinni kolme kuulisest 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 .
Seda tähtaega pikendatakse, kui amet nõuab taotlejalt vastavalt lõikele 2 lisateavet.
That time limit shall be extended where the Authority seeks supplementary information from the applicant pursuant to paragraph 2.
Kui tervisealase väite teadusliku põhjendatuse suhtes on tekkinud kahtlusi võib komisjoni nõudmisel ametilt taotleda hinnangu esitamist.
Where there are doubts regarding the scientific substantiation of a health claim the Authority may, at the request of the Commission, draw up an opinion.
Amet püüab oma hinnangu koostamisel pidada kinni kuue kuulisest tähtajast alates teate laekumisest.
In giving its opinion, the Authority shall endeavour to respect a time limit of six months from the date of receipt of the notification .
Seda tähtaega pikendatakse, kui amet nõuab tootjalt või importijalt vastavalt lõikele 2 lisateavet.
That time limit shall be extended where the Authority seeks supplementary information from the manufacturer or importer pursuant to paragraph 2.