natgillin/translations-raw huggingface dataset:
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 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.
Taotlejatel on õigus oma taotlust ameti ees kaitsta ja esitada toimiku ametipoolse hindamise käigus täiendavaid andmeid.
Applicants shall have the right to defend their applications before the Authority and shall have the right to provide additional data in the course of the Authority's evaluation of the dossier.
Amet püüab oma hinnangu koostamisel kinni pidada 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 peab oma hinnangu koostamisel kinni kolmekuulisest tähtajast alates kehtiva taotluse laekumisest.
In giving its opinion, the authority shall 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.
Taotlejal on otsene ligipääs ameti pädevatele organitele, õigus olla ära kuulatud ja õigus esitada täiendavaid andmeid.
The applicant shall have direct access to the competent panel of the Authority, the right to be heard and the right to provide additional particulars.
Oma arvamuse koostamiseks kontrollib amet, et tervisealase väite sõnastuse näide :
In order to prepare its opinion, the Authority shall verify that the illustrative example of wording of the health claim :
a) kas tervisealase väite väljapakutud sõnastus on teaduslike andmetega tõestatud;
(a) that the proposed wording of the health claim is substantiated by scientific data ;
a) on teaduslike teadmistega tõestatud;
(a) is substantiated by scientific knowledge ;
b) vastab käesoleva määruse kriteeriumidele,
(b) complies with the criteria laid down in this Regulation;
c) on tarbija jaoks mõistetav ja sisukas.
(c) is understandable and meaningful to the consumer.
Follows on from previous amendments.
Follows on from previous amendments.
Artikli 15 lõike 4 punkt b
Article 15, paragraph 4, point (b)
b) toiduaine või toiduainete kategooria, osa või osade nimetus, mille kohta tahetakse tervisealast väidet esitada, ning selle erilised omadused;
(b) the designation of the food or category of food or the constituent or constituents in respect of which the claim is to be used and its particular characteristics;
Follows from a definition of the health claim in Art. 2.
Follows from a definition of the health claim in Art. 2.
c) väljapakutud tervisealase väite s oovitav sõnastus kõigis ühenduse keeltes;
(c) the recommended wording , in all Community languages, of the proposed health claim;
c) kavandatava tervisealase väite tähendus ja sõnastuse näidis kõigis ühenduse keeltes;
(c) the meaning and an illustrative example of the wording , in all Community languages, of the proposed health claim;
Follows from amendment to Art. 14(2)(e) and 15(3).
Follows from amendment to Art. 14(2)(e) and 15(3).
Taotlejal on ühe kuu jooksul õigus vaidlustada ameti negatiivset või tingimuslikult positiivset hinnangut väite teadusliku väärtuse kohta.
The applicant shall have a right of appeal, which must be exercised within one month against any negative or conditional positive assessment of the Authority of the scientific merits of a claim.
The application should be provided with a right to appeal against negative or conditional positive decision on the authorisation of a certain claim.
The application should be provided with a right to appeal against negative or conditional positive decision on the authorisation of a certain claim.
Artikli 18 lõike 2 punkt c
Article 18, paragraph 2, point (c)
The publication of a list of claims rejected in the authorisation process will be disadvantageous because of the protection of fair competition and innovativeness in industry.
The publication of a list of claims rejected in the authorisation process will be disadvantageous because of the protection of fair competition and innovativeness in industry.
Artikli 19 lõike 1 sissejuhatav osa
Article 19, paragraph 1, introductory part
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:
Konfidentsiaalsetele andmetele põhjal lubatud tervisealaste väidete puhul ei tohi teaduslikke andmeid ja muud teavet, mis sisaldub artikli 14 lõikes 2 nõutud taotluse toimikus, seitsmeaastase perioodi jooksul loa andmise kuupäevast kasutada hilisema taotleja kasuks, välja arvatud juhul, kui hilisem taotleja on varasema taotlejaga niisuguste andmete ja teabe kasutamise osas kokku leppinud, kui:
With respect to health claims authorised on the basis of proprietary data, 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:
Artikli 19 lõige 2 a (uus)
Article 19, paragraph 2 a (new)
Lõiked 1 ja 2 ei välista loa andmist hilisematele taotlejatele juhul, kui sellise taotleja poolt taotletud tervisealasele väitele antakse luba taotluses esitatud konfidentsiaalsetele andmete põhjal või teiste teaduslike andmete ja konfidentsiaalsete andmete alla mitte kuuluva teabe põhjal, kui niisugustest andmetest või teabest piisab tervisealase väite lubamiseks.
Paragraphs 1 and 2 shall not preclude subsequent applicants from being granted an authorisation in the event that a health claim applied for by such applicant would be authorised on the basis of proprietary data or any other scientific data and information not designated as proprietary provided in the application if such data or information are sufficient for authorisation of the health claim.
The provision allowing seven years of data protection and market exclusivity for health claims based on proprietary data is welcomed.
The provision allowing seven years of data protection and market exclusivity for health claims based on proprietary data is welcomed.
However, the Commission's intention is not fully clear.
However, the Commission's intention is not fully clear.
The proposal does not, for instance, specify whether two manufacturers who submitted a dossier of the same evidence would both have such exclusivity or whether other applicants would be precluded from receiving authorisation.
The proposal does not, for instance, specify whether two manufacturers who submitted a dossier of the same evidence would both have such exclusivity or whether other applicants would be precluded from receiving authorisation.
Therefore, paragraph 2a aims at clarifying this issue.
Therefore, paragraph 2a aims at clarifying this issue.
Artikli 19 lõige 2 b (uus)
Article 19, paragraph 2 b (new)
Lõikeid 1 ja 2 kohaldatakse kõikidele konfidentsiaalsetele andmetele põhinevate taotluste suhtes, vaatamata sellele, millises järjekorras taotlus esitati.
Paragraphs 1 and 2 shall apply to any application based on proprietary data irrespective of the priority order in which the application was submitted.
Therefore, paragraph 2b aims at clarifying this issue.
Therefore, paragraph 2b aims at clarifying this issue.
Taotleja võib näidata, milliseid käesoleva määruse kohaselt esitatut andmeid ja teavet soovib ta käsitleda konfidentsiaalsena, sest selle avaldamine võiks oluliselt kahjustada tema konkurentsivõimet.
An applicant may indicate which data and information submitted under this Regulation he wishes to be treated as confidential on the grounds that its disclosure might significantly harm his competitive position.
Esitada tuleb kontrollitavad põhjused.
Verifiable reasons must be given.
Pärast taotlejaga konsulteerimist otsustab komisjon, milliseid andmeid ja teavet peale lõikes 3 sätestatu tuleks hoida konfidentsiaalsena, ja teavitab taotlejat oma otsusest.
The Commission shall determine, after consultation with the applicant, which data and information other than that specified in paragraph 3 should be kept confidential and shall inform the applicant of its decision.
Konfidentsiaalseks ei loeta järgmiseid andmeid ja teavet:
The following data and information shall not be considered confidential:
a) tervisega seotud eriliste omadustega toiduaine nimetus ja olulised tunnused;
(a) the name and essential characteristics of the food that confer its health related properties;
b) katseklaasis, loomadel ja inimestel tehtud katsete tulemused, mis on olulised toiduainete ja nende koostisosade mõju hindamisel inimeste toitumisele ja tervisele;
(b) the conclusions of any tests performed on in vitro models, on animals or on humans, relevant to an evaluation of the effects of the food and its constituents on human nutrition and health;
c) toiduainete või nende koostisosade avastamise või nende koguse määramise meetodid, mida võidakse vajada ametlikuks kontrolliks;
(c) methods for the detection or quantification of key characteristics of the food or its constituents, as may be needed for official control.
Vaatamata lõikele 2 peab amet nõudmise korral esitama komisjonile ja liikmesriikidele kõik enda valduses olevad andmed ja teabe, sealhulgas lõike 2 alusel konfidentsiaalseks tunnistatud andmed ja teabe.
Notwithstanding paragraph 2, the Authority shall, on request, supply the Commission and the Member States with all information in its possession, including any data and information identified as confidential pursuant to paragraph 2.
Amet peab oma valduses olevatele dokumentidele juurdepääsu taotlusi käsitledes järgima Euroopa Parlamendi ja nõukogu 30. mai 2001. aasta määruse (EÜ) nr 1049/2001 põhimõtteid üldsuse juurdepääsu kohta Euroopa Parlamendi, nõukogu ja Euroopa Komisjoni dokumentidele 1 .
The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents¹ when processing applications for access to documents held by the Authority.
Liikmesriigid, komisjon ja amet hoiavad konfidentsiaalsena kõik andmed ja kogu teabe, mis on tunnistatud konfidentsiaalseks vastavalt lõikele 2, välja arvatud juhul, kui sellised andmed ja teave tuleb muuta avalikuks, kaitsmaks inimeste tervist.
The Member States, the Commission and the Authority shall keep confidential all data and information identified as confidential under paragraph 2 except where it is appropriate for such data and information to be made public in order to protect human health.
Liikmesriigid käsitlevad käesoleva määruse alusel saadud dokumentidele juurdepääsu taotlusi vastavalt määruse (EÜ) nr 1049/2001 artiklile 5.
Member States shall process applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.
Kui taotleja võtab avalduse tagasi, siis liikmesriigid, komisjon ja amet hoiavad konfidentsiaalsena äri- ja tööstusteabe, sealhulgas teadus- ja arendustegevust puudutava teabe ning teabe, mille konfidentsiaalsuses komisjon ja taotleja on lahkarvamusel.
Where an applicant withdraws an application, the Member States, the Commission and the Authority shall respect the confidentiality of commercial and industrial data and information, including research and development information, as well as information on which the Commission and the applicant disagree as to its confidentiality.
Artikkel 19 b
Article 19 b (new)
Teaduslikke andmeid ja muud teavet, mis sisaldub artiklis 10 nõutud taotluse toimikus ja mis on kaitstud artikliga 19, ei tohi seitsmeaastase perioodi jooksul alates loa andmise kuupäevast kasutada teise taotleja kasuks, välja arvatud juhul, kui teine taotleja on varasema taotlejaga kokku leppinud, et neid andmeid ja seda teavet võib kasutada.
Scientific data and other information in the application dossier required under Article 10 which is protected under Article 19, may not be used for the benefit of another applicant for a period of 7 years from the date of authorisation, unless the second applicant has agreed with the first that such data and information may be used.
Seitsmeaastase perioodi lõppedes võib amet kasutada taotluse toimikus sisalduvate teaduslike andmete ja teabe alusel korraldatud kogu hindamise või selle osade tulemusi teise taotleja kasuks.
On the expiry of the 7-year period, the findings of all or part of the evaluation conducted on the basis of the scientific data and information contained in the application dossier may be used by the Authority for the benefit of other applicants.
Artikkel 19 c (uus)
Article 19 c (new)
Artikkel 19 cOmandatud õiguste austamine
Article 19c Respect of acquired rights
Taotluse esitamine, vastuvõtutõend või väitele loa andmine ei piira mis tahes intellektuaalomandi õigust, mis taotlejal võib olla sellele väitele või mis tahes teaduslikele andmetele või taotluse toimikus sisalduvale teabele.
The submission of an application, the acknowledgement of receipt or the granting of an authorisation for a claim are made without prejudice to any intellectual property rights that the applicant may have on that claim or on any scientific data or information included in the application dossier.
Nimetatud õigusi käsitletakse vastavalt ühenduse õigusaktidele või mis tahes siseriiklike õigusaktide sätetele, mis ei ole vastuolus ühenduse õigusaktidega.
The abovementioned rights will be considered in accordance with Community law or with any provision of any national law that is not in contradiction with Community law.
Artikli 21 lõige 1
Article 21, paragraph 1
Juhul kui viidatakse käesolevale artiklile, kehtib lõikudes 2, 3 ja 4 sätestatud menetlus.
Where reference is made to this Article, the procedure laid down in paragraphs 2, 3 and 4 shall apply.
Artikli 21 lõige 3
Article 21, paragraph 3
Komisjon konsulteerib määruse (EÜ) nr 178/2002 artikli 58 lõike 1 alusel moodustatud toiduahela ja loomatervishoiu alalise komisjoniga (edaspidi "komisjon") , kui peab seda mõistlikuks või kui liikmesriik seda nõuab, ja võtab kavandatavate meetmete suhtes seisukoha.
The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002 (hereinafter referred to as the "Committee") if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
Komisjon konsulteerib määruse (EÜ) nr 178/2002 artikli 58 lõike 1 alusel moodustatud toiduahela ja loomatervishoiu alalise komisjoniga, kui peab seda mõistlikuks või kui liikmesriik seda nõuab, ja võtab kavandatavate meetmete suhtes seisukoha.
The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002 if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
Definition not required, not useful.
Definition not required, not useful.
The proposal allows individual Member States to set potentially lengthy procedures for approval of claims and grants them the possibility to temporarily suspend the use of claims.
The proposal allows individual Member States to set potentially lengthy procedures for approval of claims and grants them the possibility to temporarily suspend the use of claims.
This appears to be disproportionate to the aims of the regulation and could massively increase costs to business whilst discouraging the cross-border provision of goods.
This appears to be disproportionate to the aims of the regulation and could massively increase costs to business whilst discouraging the cross-border provision of goods.
Artikli 23 lõige 1
Article 23, paragraph 1
Euroopa Komisjon konsulteerib määruse (EÜ) nr 178/2002 artikli 58 lõike 1 alusel moodustatud toiduahela ja loomatervishoiu alalise komisjoniga, edaspidi “komisjon”.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002, hereafter referred to as the "Committee".
Euroopa Komisjon konsulteerib määruse (EÜ) nr 178/2002 artikli 58 lõike 1 alusel moodustatud toiduahela ja loomatervishoiu alalise komisjoniga.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health instituted by Article 58 (1) of Regulation (EC) No 178/2002.
Artikli 23 lõike 2 teine lõik
Article 23, paragraph 2, subparagraph 2
Otsuse 1999/468/EÜ artikli 5 lõikes 6 nimetatud ajavahemikuks määratakse kolm kuud.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be three months.
Otsuse 1999/468/EÜ artikli 5 lõikes 6 nimetatud ajavahemik ei ületa kahte kuud.
The period laid down in Article 5(6) of Decision 1999/468/EC shall not exceed two months.
In order to reduce lengthy procedures, the time period shall be limited to 2 months.
In order to reduce lengthy procedures, the time period shall be limited to 2 months.
This amendment would also reflect the letter and the spirit of Art. 5(6) of Decision 1999/468/EC which does not state that the period “shall be three months” as currently phrased in the proposed Regulation but provides that relevant period should be "laid down in each basic instrument" and "in no case exceed three months from the date of referral to the Council".
This amendment would also reflect the letter and the spirit of Art. 5(6) of Decision 1999/468/EC which does not state that the period “shall be three months” as currently phrased in the proposed Regulation but provides that relevant period should be "laid down in each basic instrument" and "in no case exceed three months from the date of referral to the Council".
Hiljemalt … [jõustumise kuupäevale järgneva viienda kuu viimane päev + 3 aastat ] esitab komisjon Euroopa Parlamendile ja nõukogule aruande käesoleva määruse rakendamise kohta, eelkõige toitumis- ja tervisealasete väidetega varustatud toiduainete turu arengu ja artikli 1 lõike 4 a kohaldamisel esinenud raskuste kohta , lisades vajaduse korral oma muudatusettepanekud..
By … at the latest [last day of the fifth 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 of foods in respect of which nutrition or health claims are made and on any difficulties encountered in the application of the Article 1(4a) , together with a proposal for amendments if necessary.
Artikkel 25 aÜleminekumeetmed
Article 25 a (new)
Selliste taotluste puhul ei kohaldata artikli 15 lõigetes 1 ja 2 ning artikli 16 lõikes 1 sätestatud ajapiiranguid.
In the case of such applications, the time limits provided for in Articles 15(1)and (2) and 16(1) shall not apply.
It is essential to provide for a transition period that allows existing, science-based, legally made claims to remain in use until they are appropriately brought under the proposed regulation.
It is essential to provide for a transition period that allows existing, science-based, legally made claims to remain in use until they are appropriately brought under the proposed regulation.
Artikkel 25 b
Article 25 b (new)
Väiteid intensiivse lihaspinge korvamiseks mõeldud toiduainetel, mida on kasutatud kooskõlas siseriiklike õigusaktidega enne artiklis 26 sätestatud jõustumise tähtaega, võib kasutada, kuni jõustub komisjoni direktiiv toiduainetest, mis on mõeldud intensiivsest lihaspingest tingitud energiakao korvamiseks, eriti sportlaste puhul, mis põhineb direktiivil 89/398/EMÜ eritoiduks ettenähtud toiduainete kohta 1 .
Claims on food for intense muscular effort which have been used in compliance with national provisions before the entry into force of this Regulation, may continue to be made until the adoption of the Commission Directive on foods intended to meet the expenditure of intense muscular effort, especially for sports people, based on Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses¹.
The European 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).
The European 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).
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.
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 application of this Regulation and which do not comply with this Regulation may be marketed until [last day of the eleventh month following its application] or the end of their shelf life, which ever is longer.
Alates artiklis 26 kindlaks määratud käesoleva määruse jõustumise kuupäevast kuni artikli 12 lõikes 2 toodud nimekirja vastuvõtmiseni võivad ettevõtjad lubada enda vastutusel artikli 12 lõikes 1 toodud tervisealaseid väiteid, kui need on kooskõlas käesoleva määrusega ja asjassepuutuvate siseriiklike seadusesätetega ning ei piira artiklis 22 toodud kaitsemeetmete kehtestamist.
Health claims as referred to in Article 12(1) may be made from the date of entry into force of this Regulation specified in Article 26 until the adoption of the list referred to in Article 12(2), under the responsibility of business operators provided that they are in accordance with this Regulation and with existing national provisions applicable to them, and without prejudice to the adoption of transition measures as referred to in Article 22.